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Efficacy and Safety of Olokizumab in Subjects With Moderately to Severely Active Rheumatoid Arthritis (CREDO 4)

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Olokizumab 64 mg SC q4w
Olokizumab 64 mg SC q2w
Concomitant treatment
Sponsored by
R-Pharm International, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Rheumatoid Arthritis, moderate, severe, subcutaneous, Olokizumab, open-label

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subjects may be enrolled in the study only if they meet all of the following criteria:

  1. Subject must be willing and able to sign informed consent
  2. Subject must have completed the 24-week double-blind Treatment Period in 1 of the 3 core studies (CL04041022, CL04041023, or CL04041025).
  3. Subject must have maintained their stable dose (and route) of MTX 15 to 25 mg/week (or ≥ 10 mg/week if there is documented intolerance to higher doses) during the core study and plan to maintain the same dose and route of administration for ≥ 12 additional weeks
  4. Subjects must be willing to take folic acid or equivalent throughout the study.

Exclusion Criteria:

  1. Subject with any medically important condition in the core study (e.g., clinically significant laboratory values, frequent Adverse events (AEs) or serious adverse events (SAEs), infection SAEs, and/or other concurrent severe and/or uncontrolled medical condition) which would make this subject unsuitable for inclusion in the open-label extension (OLE) study in the Investigator's judgement.
  2. Subject has evidence of active tuberculosis (TB)

  3. Subject with a positive or repeated indeterminate interferon-gamma release assay (IGRA) result at Week 22 of the core study

    - Subjects may be enrolled in the OLE study if they fulfill all 3 of the following criteria prior to the first dose of study treatment:

    1. Active TB is ruled out by a certified TB specialist or pulmonologist who is familiar with diagnosing and treating TB (as acceptable per local practice);
    2. The subject starts prophylaxis for latent TB infection (LTBI) according to country-specific/Centers for Disease Control and Prevention (CDC) guidelines (treatment with isoniazid for 6 months is not an appropriate prophylactic regime for this study and it should not be used); and
    3. The subject is willing to complete the entire course of recommended LTBI therapy.
  4. Subject has planned surgery during the first 12 weeks of the OLE study
  5. Female subjects who are pregnant or who are planning to become pregnant during the study or within 6 months of the last dose of study drug

  6. Female subjects of childbearing potential (unless permanent cessation of menstrual periods, determined retrospectively after a woman has experienced 12 months of natural amenorrhea as defined by the amenorrhea with underlying status [e.g., correlative age] or 6 months of natural amenorrhea with documented serum follicle-stimulating hormone levels >40 mIU/mL and estradiol <20 pg/mL) who are not willing to use a highly effective method of contraception during the study and for at least 6 months after the last administration of study treatment OR Male subjects with partners of childbearing potential not willing to use a highly effective method of contraception during the study and for at least 3 months after the last administration of study treatment.

    Highly effective contraception is defined as:

    • Female sterilization surgery: hysterectomy, surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least 6 weeks prior to the first dose of study treatment in the core study

      • In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by documented follow-up hormone level assessment
    • Total abstinence if it is the preferred and constant lifestyle of the subject. Thus, periodic abstinence such as ovulation, symptothermal, postovulation, calendar methods, and withdrawal are not acceptable methods of contraception.
    • Male sterilization surgery: at least 6 months prior to the first dose of study treatment in the core study (with the appropriate postvasectomy documentation of the absence of sperm in the ejaculate). For female subjects, the vasectomized male should be the only partner.
    • Placement of established intrauterine device (IUD): IUD copper or IUD with progesterone
    • Barrier method (condom and intravaginal spermicide, cervical caps with spermicide, or diaphragm with spermicide) in combination with the following: established oral, injected, or implanted hormone methods of contraception or contraceptive patch.
  7. Subject is unwilling or unable to follow the procedures outlined in the protocol.
  8. Other medical or psychiatric conditions, or laboratory abnormalities that may increase the potential risk associated with study participation and administration of the study treatment, or that may affect study results interpretation and, as per Investigator's judgement, make the subject ineligible.

Sites / Locations

  • AZ Arthritis & Rheum' Research
  • Arizona Arthritis & Rheumatology Associates, P.C.
  • Arizona Arthritis & Rheumatology Research, PLLC
  • CHI St. Vincent Hot Springs
  • Medvin Clinical Research
  • C.V Mehta MD Med Corp..
  • Advanced Medical Research, LLC
  • Valerius Medical Group
  • Stanford University School of Medicine
  • Rheumatology Center of San Diego
  • East Bay Rheumatology Medical Group, Inc.
  • Inland Rheumatology Clinical Trials, Inc.
  • Center for Rheumatology Research, Comprehensive Rheumatology Center
  • Medvin Clinical Research
  • Denver Arthritis Clinic
  • New England Research Associates LLC
  • Javed Rheumatology Associates
  • RASF - Clinical Research Center
  • Reliable Clinical Research, LLC
  • Pharmax Research Clinic
  • Medical Research Center of Miami
  • Suncoast Research Group, LLC
  • Omega Research Consultants
  • Arthritis Research of Florida, INC
  • Family Clinical Trials, LLC.
  • AdventHealth Medical Group, PA
  • Lovelace Scientific Resources, Inc.
  • Arthritis Center of North Georgia
  • Marietta Rheumatology Associates, PC
  • Institute of Arthritis Research
  • University of Kansas Hospital
  • Graves Gilbert Clinic
  • The Arthritis & Diabetes Clinic, Inc.
  • Klein and Associates, M.D., P.A.
  • The Center for Rheumatology and Bone Research
  • Clinical Pharmacology Study Group
  • AA MRC LLC Ahmed Arif Medical Research Center
  • North MS Medical Clinics, Inc.
  • Glacier View Research Institute-Rheumatology
  • Physician Research Collaboration
  • Arthritis & Osteoporosis Associates, PA
  • Lovelace Scientific Resources, Inc.
  • NYU Langone ambulatory care
  • Medication Management, LLC
  • Cape Fear Arthritis Care
  • Carolina Arthritis Associates
  • Trinity Medical Group
  • Cincinnati Rheumatic Disease Study Group
  • STAT Research, Inc.
  • Clinical Research Source, Inc.
  • Health Research of Oklahoma, PLLC
  • Lynn Health Science Institute
  • Altoona Center for Clinical Research, P.C.
  • Arthritis Group
  • Low Country Rheumatology, PA
  • Amarillo Center for Clinical Research
  • Austin Regional Clinic, P.A.
  • Accurate Clinical Management., LLC
  • Precision Comprehensive Clinical Research Solutions
  • Pioneer Research Solutions, Inc.
  • Therapeutic Concepts Rheumatology,LLC
  • Rheumatology Clinic of Houston, P.A.
  • Houston Institute For Clinical Research
  • Accurate Clinical Mangemnt - Partner
  • Accurate Clinical Research, Inc.
  • Accurate Clinical Research, Inc.
  • West Texas Clinical Research
  • Dr Alex De Jesus Rheumatology, P.A.
  • Advanced Rheumatology of Houston
  • DM Clinical Research
  • Arthritis Northwest, PLLC
  • Centro de Investigaciones Medicas Mar del Plata
  • Instituto Medico CER
  • Instituto de Investigaciones Clinicas Quilmes
  • Sanatorio San Martin
  • Centro Medico Privado de Reumatologia
  • Instituto de Investigaciones Clinicas-Mar del Plata
  • Organizacion Medica de Investigacion (OMI)
  • APRILLUS Asistencia e Investigacion
  • Instituto Centenario
  • Hospital Privado Centro Medico de Cordoba
  • Instituto DAMIC Fundacion Rusculleda
  • CER San Juan Centro Polivalente de Asistencia e Inv. Clinica
  • Clinica de Higado y Aparato Digestivo
  • Centro de Investigaciones Reumatológicas
  • Minsk City Clinical Hospital #1
  • Vitebsk Clinical Hospital
  • HUWC - UFC - Hospital Universitário Walter Cantídio - Universidade Federal do Ceará
  • CEDOES - Diagnóstico e Pesquisa
  • CIP - Centro Internacional de Pesquisa
  • CMiP - Centro Mineiro de Pesquisa
  • CETI - Centro de Estudos em Terapias Inovadoras Ltda.
  • Clinilive - Clínica do Idoso e Pesquisa Clínica
  • Hospital Bruno Born
  • LMK Serviços Médicos S/S Ltda
  • Clínica de Neoplasias Litoral Ltda.
  • Faculdade de Medicina do ABC
  • Centro Multidisciplinar de Estudos Clínicos - CEMEC
  • CCBR Brasil Centro de Pesquisas e Análises Clínicas Ltda.
  • CPCLIN - Centro de Pesquisas Clínicas Ltda.
  • Associação de Assistência à Criança Deficiente - AACD
  • DCC 'Sv. Pantaleymon' OOD
  • UMHAT Pulmed OOD
  • UMHAT "Kaspela", EOOD
  • MHAT - Ruse, AD
  • Medizinski Zentar-1-Sevlievo EOOD
  • MHAT - Shumen, AD
  • NMTH "Tsar Boris III"
  • MHAT "Lyulin", EAD
  • Medical Center "Excelsior", OOD
  • UMHAT "Sv. Ivan Rilski", EAD
  • MC "Synexus - Sofia", EOOD
  • MDHAT 'Dr. Stefan Cherkezov', AD
  • Centro de Reumatologia y Ortopedia SAS
  • Centro de Investigacion en Reumatologia y Especialidades Medicas SAS. CIREEM
  • Fundacion Instituto de Reumatologia Fernando Chalem
  • Medicity S.A.S.
  • Clinica de Artritis Temprana S.A.S
  • CCR Brno s.r.o
  • IMEDICA s.r.o.
  • Revmatologie s.r.o.
  • Nemocnice Jihlava p.o.
  • MUDr Gabriela Simkova Ordinace Lekare Specialisty Interna Revmatologie
  • CTCenter MaVe s.r.o.
  • ARTROSCAN s.r.o.
  • Vesalion s.r.o.
  • ARTHROHELP s.r.o.
  • CCR Czech, a.s.
  • Revmatologicky ustav
  • CCR Prague s.r.o.
  • MUDR Zuzana URBANOVA Revmatologie
  • MUDR Zuzana URBANOVA Revmatologie
  • Fakultni nemocnice v Motole
  • CLINTRIAL s.r.o.
  • Affidea Praha s.r.o.
  • Medical Plus s.r.o.
  • PV - MEDICAL, s.r.o.
  • East Tallinn Central Hospital
  • Meditrials OU
  • Kerckhoff-Klinik gGmbH
  • Rheumapraxis Dr. med. Reiner Kurthen
  • Studienambulanz Dr. Wassenberg
  • SMO.MD GmbH
  • Klinische Forschung Berlin-Mitte GmbH
  • HRF Hamburger Rheuma Forschungszentrum
  • Principal SMO Kft.
  • DRC Gyogyszervizsgalo Kozpont Kft.
  • Clinexpert Kft.
  • Obudai Egeszsegugyi Centrum Kft.
  • Kiskunhalasi Semmelweis Korhaz
  • MAV Korhaz es Rendelointezet
  • DRC Szekesfehervar
  • Vital-Medicina Kft.
  • Hallym University Sacred Heart Hospital
  • Ajou University Hospital
  • Eulji University Hospital
  • Chonnam National University Hospital
  • Jeju National University Hospital
  • Severance Hospital, Yonsei University No. 31 Office, Pediatric Oncology Clinic
  • The Catholic University of Korea, Seoul St. Mary's Hospital
  • Dr.Saulite-Kandevica Private Practice
  • Alytus Regional S. Kudirkos Hospital, Public Institution
  • Republican Kaunas Hospital, Public Institution
  • Klaipeda University Hospital, Public Institution
  • Siauliai Republican Hospital, Public Institution
  • Center Outpatient Clinic, Public Institution
  • Vilnius University Hospital Santariskiu Clinics, Public Institution
  • Clinicos Asociados BOCM S.C.
  • Centro de Investigacion Clínica GRAMEL S.C
  • Comite Mexicano Para la Prevencion de Osteoporosis AC
  • Clinstile, S.A. de C.V.
  • Clinica de Investigacion en Reumatologia y Obesidad S.C.
  • Centro de Estudios de Investigacion Basica y Clinica SC
  • Accelerium S. de R.L. de C.V.
  • Universidad Autonoma de Nuevo Leon, Hospital Universitario Dr. Jose Eleuterio Gonzalez
  • Investigacion y Biomedicina de Chihuahua, S.C.
  • Clinical Research Institute S.C.
  • Centro de Alta Especialidad en Reumatología e Investigación del Potosí, S.C.
  • CERMED
  • ZDROWIE Osteo-Medic
  • Szpital Uniwersytecki nr 2 im.dr J. Biziela
  • MCBK Iwona Czajkowska Anna Podrażka- Szczepaniak S.C.
  • Polimedica Centrum Badań, Profilaktyki I Leczenia
  • CCBR - Lodz - PL
  • Centrum Medyczne AMED
  • ETYKA Osrodek Badan Klinicznych
  • Szpital Wojewodzki im. Prymasa Kardynala Stefana Wyszynskiego
  • Clinmed Research
  • RCMed
  • KO-MED Centra Kliniczne Staszow
  • Samodzielny Publiczny ZOZ Tomaszow Lubelski
  • Nasz lekarz Przychodnie Medyczne
  • Medycyna Kliniczna
  • Rheuma Medicus Zaklad Opieki Zdrowotnej
  • McM Polimedica
  • KO-MED Centra Kliniczne Zamosc
  • Santa Familia Centrum Badan, Profilaktyki i Leczenia
  • FSBEI HE "Altai State Medical University of the Ministry of Healthcare of Russian Federation"
  • Medical Center LLC "Maksimum Zdoroviya"
  • SAHI of Kemerovo region "Regional Clinical Hospital for War Veterans"
  • Budgetary Healthcare Institution "Kursk Regional Clinical Hospital" of Healthcare Committee of Kursk region
  • SPb SBHI "Clinical Rheumatological Hospital #25", Fourth Rheumatology Unit
  • SBHI of Moscow "City Clinical Hospital No.1 n.a. Pirogov" Healthcare Department of Moscow
  • FSAEI HE "First MSMU n.a. I.M. Sechenov of the Ministry of Health of the Russian Federation" University Clinical Hospital No.1
  • FSAEI HE "First MSMU n.a. I.M. Sechenov of the Ministry of Health of the Russian Federation"
  • State Budgetary Healthcare Institution "City Clinical Hospital # 15 n.a O.M. Filatov" of Moscow Healtheare Department
  • SBHI of Moscow "City Clinical Hospital #4 of Moscow Healthcare Departament"
  • SBHI of Nizhny Novgorod Region "Nizhny Novgorod Regional Clinical Hospital n.a.Semashko"
  • SBHI of Nizhegorodsky Region "State Clinical Hospital #5 of Nizhegorodsky District of Nizhny Novgorod"
  • State Autonomous Healthcare Institution of Novosibirsk region "City Polyclinic #1"
  • LLC "Clinical Diagnostic Center "Ultramed"
  • Budgetary Healthcare Institution of Omsk Region "Regional Clinical Hospital"
  • SBHI of the Republic of Karelia "Republican Hospital named after V.A. Baranov"
  • State Budgetary Healthcare Institution "Republican Clinical Hospital n.a. G.G. Kuvatov"
  • FSBEI HE "Rostov State Medical Unversity" of Ministry of Health of the Russian Federation
  • FSBEI HE 'Ryazan State Medical University n.a. I.P.Pavlov" of the Ministry of Health of Russian Federation
  • FSBEI HE "Saratov SMU n.a. V.I.Razumovsky of Ministry of Health of Russian Federation"
  • State Healthcare Institution "Regional Clinical Hospital"
  • Private Healthcare Institution "Clinical Hospital Russian Railways-Medicine of City Smolensk"
  • FSBEI HE StSMU MOH Russia based on SBHI of Stavropol Region "Stavropol Regional Clinical Hospital"
  • State Autonomous Healthcare Institution of Sverdlovsk Region "Sverdlovsk Regional Clinical Hospital No.1"
  • FSBEI HE "Ural State Medical University" of Ministry of Health of Russian Federation based on MBI "Central City Clinical Hospital No.6"
  • FSBEI HE "Kazan State Medical University of the Ministry of Health of the Russian Federation" on the base of SAHI "Republican Clinical Hospital of the Ministry of Health of Tatarstan Republic"
  • State Healthcare Institution of Tula region "Tula Regional Clinical Hospital"
  • State Healthcare Institution "Ulyanovsk Regional Clinical Hospital"
  • SBHI of Vladimir Region "Regional Clinical Hospital", Rheumatology Departament
  • State Autonomous Helthcare Institution of Yaroslavl region "Clinical Hospital of Emergency Care n.a. Solovyev"
  • SBHI "Yaroslavl Regional Clinical Hospital", Rheumatology department
  • FSBSI "Scientific Research Institute of Rheumatology n.a. V.A. Nasonova"
  • FSAEI HE "First MSMU n.a. I.M. Sechenov of the Ministry of Health of the Russian Federation"
  • FSBI "National Medical Research Center n.a. V.A.Almazov" of the Ministry of Healthcare of the Russian Federation
  • Chi Mei Medical Center, Yung Kang Branch
  • Chang Gung Memorial Hospital, Linkou
  • Torbay Hospital
  • Whipps Cross University Hospital
  • Royal Free Hospital
  • Basingstoke and North Hampshire Hospital
  • Maidstone Hospital
  • Arrowe Park Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Treatment Arm 1: OKZ 64 mg q4w + MTX

Treatment Arm 2: OKZ 64 mg q2w + MTX

Arm Description

Olokizumab 64 mg SC q4w + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular).

Olokizumab 64 mg SC q2w + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular).

Outcomes

Primary Outcome Measures

Incidence of Treatment-Emergent Adverse Events (AEs), by System Organ Class and Preferred Term (Safety Population)
Incidence of Treatment-Emergent Adverse Events Reported for ≥5% of Subjects in Any Treatment Group by System Organ Class or Preferred Term
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Incidence of Serious Treatment-Emergent Adverse Events by System Organ Class or Preferred Term. Deaths are included.
Incidence of Treatment-Emergent Adverse Events of Special Interest (AESI)
Incidence of Treatment-Emergent AEs Leading to Withdrawal of the Study Treatment
Incidence Rate of Treatment Emergent AEs Per Patient-years of Exposure
Incidence Rate of all Subjects with at Least One Treatment Emergent AE. Subject Incidence Rate (IR) is summarized per 100 subject years (SY) of follow-up (/100 SY) based on the OLE safety population and presented by study treatments.
Incidence Rate of Treatment Emergent SAEs Per Patient-years of Exposure
Incidence Rate of all Subjects with at Least One Treatment Emergent SAE. Subject Incidence Rate (IR) is summarized per 100 subject years (SY) of follow-up (/100 SY) based on the OLE safety population and presented by study treatments.
Incidence Rate of Treatment Emergent AESIs (Safety Population)
Incidence Rate of all Subjects with at Least One Treatment Emergent AESI. Subject Incidence Rate (IR) is summarized per 100 subject years (SY) of follow-up (/100 SY) based on the OLE safety population and presented by study treatments.

Secondary Outcome Measures

American College of Rheumatology 20% (ACR20) Response Rates Compare Against Core Baseline Through Week 82
Number and Proportion of subjects achieving an ACR20 response who remain on randomized open-label treatment and in the study, assessed at several timepoints up to Week 82. American College of Rheumatology 20 % response is a composite defined as a ≥ 20% improvement from baseline in the swollen joint counts assessed in 66 joints and in the tender joint count assessed in 68 joints; and a ≥20% improvement from baseline in at least 3 of the 5 remaining core set measures: Patient Global Assessment of Disease Activity (VAS) Patient Assessment of Pain (VAS) HAQ-DI Physician Global Assessment (VAS) Level of acute phase reactant (CRP)
American College of Rheumatology 50% (ACR50) Response Rates Compare Against Core Baseline Through Week 82
Number and Proportion of subjects achieving an ACR50 response who remain on randomized open-label treatment and in the study, assessed at several timepoints up to Week 82 American College of Rheumatology 50 % response is a composite defined as a ≥ 50% improvement from baseline in the swollen joint counts assessed in 66 joints and in the tender joint count assessed in 68 joints; and a ≥ 50% improvement from baseline in at least 3 of the 5 remaining core set measures: Patient Global Assessment of Disease Activity (VAS) Patient Assessment of Pain (VAS) HAQ-DI Physician Global Assessment (VAS) Level of acute phase reactant (CRP)
American College of Rheumatology 70% (ACR70) Response Rates Compare Against Core Baseline Through Week 82
Number and Proportion of subjects achieving an ACR70 response who remain on randomized open-label treatment and in the study, assessed at several timepoints up to Week 82 American College of Rheumatology 70 % response is a composite defined as a ≥ 70% improvement from baseline in the swollen joint counts assessed in 66 joints and in the tender joint count assessed in 68 joints; and a ≥ 70% improvement from baseline in at least 3 of the 5 remaining core set measures: Patient Global Assessment of Disease Activity (VAS) Patient Assessment of Pain (VAS) HAQ-DI Physician Global Assessment (VAS) Level of acute phase reactant (CRP)
Proportion of Subjects With Simplified Disease Activity Index (SDAI) Remission Through Week 82
The number and proportion of subjects with SDAI score ≤ 3.3 (considered to be in remission). The SDAI was calculated in the statistical database for analysis purposes using the SJC (28 joints), TJC (28 joints), CRP (mg/dL), the Patient Global Assessment of Disease Activity (VAS) (in cm), and the Physician Global Assessment (VAS) (in cm) according to the following formula: SJC + TJC + Patient Global Assessment of Disease Activity (VAS) + Physician Global Assessment (VAS) + CRP (mg/dL)
Disease Activity Score 28-joint Count (DAS28) Response Rates Through Week 82
Number and Proportion of subjects with DAS28 low disease activity (based on DAS28 C-reactive protein (CRP) < 3.2), who remain on randomized open-label treatment and in the study, assessed at several timepoints up to Week 82. The DAS28 (CRP) was calculated in the statistical database for analysis purposes using the Swollen joint count (SJC) (28 joints), Tender joint count (TJC) (28 joints), CRP level, and the Patient Global Assessment of Disease Activity Visual Analog Scale (VAS) (100 mm VAS, where 0 is "no disease activity" and 100 was "maximal disease activity") according to the following formula: [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.36 × natural log (CRP+1)] + [0.014 × VAS] + 0.96.
Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Core Baseline at Week 12
HAQ-DI Range: 0 (the best outcome) - 3 (the worst outcome), with a decrease from baseline indicating improvement. The HAQ-DI assesses the degree of difficulty experienced in 8 domains of daily living activities using 20 questions. The domains are dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities, and each domain (activity) consists of 2 or 3 items. For each question, the level of difficulty is scored from 0 to 3, where 0 = without any difficulty (the best outcome), 1 = with some difficulty, 2 = much difficulty, and 3 = unable to do (the worst outcome). Each category is given a score by taking the maximum score of each question (i.e., question in each category with the highest score for that category). The HAQ-DI was calculated by dividing the sum of the category scores by the number of categories with at least 1 question answered.
Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Core Baseline at Week 20
HAQ-DI Range: 0 (the best outcome) - 3 (the worst outcome), with a decrease from baseline indicating improvement. The HAQ-DI assesses the degree of difficulty experienced in 8 domains of daily living activities using 20 questions. The domains are dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities, and each domain (activity) consists of 2 or 3 items. For each question, the level of difficulty is scored from 0 to 3, where 0 = without any difficulty (the best outcome), 1 = with some difficulty, 2 = much difficulty, and 3 = unable to do (the worst outcome). Each category is given a score by taking the maximum score of each question (i.e., question in each category with the highest score for that category). The HAQ-DI was calculated by dividing the sum of the category scores by the number of categories with at least 1 question answered.
Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Core Baseline at Week 28
HAQ-DI Range: 0 (the best outcome) - 3 (the worst outcome), with a decrease from baseline indicating improvement. The HAQ-DI assesses the degree of difficulty experienced in 8 domains of daily living activities using 20 questions. The domains are dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities, and each domain (activity) consists of 2 or 3 items. For each question, the level of difficulty is scored from 0 to 3, where 0 = without any difficulty (the best outcome), 1 = with some difficulty, 2 = much difficulty, and 3 = unable to do (the worst outcome). Each category is given a score by taking the maximum score of each question (i.e., question in each category with the highest score for that category). The HAQ-DI was calculated by dividing the sum of the category scores by the number of categories with at least 1 question answered.
Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Core Baseline at Week 40
HAQ-DI Range: 0 (the best outcome) - 3 (the worst outcome), with a decrease from baseline indicating improvement. The HAQ-DI assesses the degree of difficulty experienced in 8 domains of daily living activities using 20 questions. The domains are dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities, and each domain (activity) consists of 2 or 3 items. For each question, the level of difficulty is scored from 0 to 3, where 0 = without any difficulty (the best outcome), 1 = with some difficulty, 2 = much difficulty, and 3 = unable to do (the worst outcome). Each category is given a score by taking the maximum score of each question (i.e., question in each category with the highest score for that category). The HAQ-DI was calculated by dividing the sum of the category scores by the number of categories with at least 1 question answered.
Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Core Baseline at Week 52
HAQ-DI Range: 0 (the best outcome) - 3 (the worst outcome), with a decrease from baseline indicating improvement. The HAQ-DI assesses the degree of difficulty experienced in 8 domains of daily living activities using 20 questions. The domains are dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities, and each domain (activity) consists of 2 or 3 items. For each question, the level of difficulty is scored from 0 to 3, where 0 = without any difficulty (the best outcome), 1 = with some difficulty, 2 = much difficulty, and 3 = unable to do (the worst outcome). Each category is given a score by taking the maximum score of each question (i.e., question in each category with the highest score for that category). The HAQ-DI was calculated by dividing the sum of the category scores by the number of categories with at least 1 question answered.
Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Core Baseline at Week 64
HAQ-DI Range: 0 (the best outcome) - 3 (the worst outcome), with a decrease from baseline indicating improvement. The HAQ-DI assesses the degree of difficulty experienced in 8 domains of daily living activities using 20 questions. The domains are dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities, and each domain (activity) consists of 2 or 3 items. For each question, the level of difficulty is scored from 0 to 3, where 0 = without any difficulty (the best outcome), 1 = with some difficulty, 2 = much difficulty, and 3 = unable to do (the worst outcome). Each category is given a score by taking the maximum score of each question (i.e., question in each category with the highest score for that category). The HAQ-DI was calculated by dividing the sum of the category scores by the number of categories with at least 1 question answered.
Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Core Baseline at Week 82
HAQ-DI Range: 0 (the best outcome) - 3 (the worst outcome), with a decrease from baseline indicating improvement. The HAQ-DI assesses the degree of difficulty experienced in 8 domains of daily living activities using 20 questions. The domains are dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities, and each domain (activity) consists of 2 or 3 items. For each question, the level of difficulty is scored from 0 to 3, where 0 = without any difficulty (the best outcome), 1 = with some difficulty, 2 = much difficulty, and 3 = unable to do (the worst outcome). Each category is given a score by taking the maximum score of each question (i.e., question in each category with the highest score for that category). The HAQ-DI was calculated by dividing the sum of the category scores by the number of categories with at least 1 question answered.
Proportion of Subjects With Health Assessment Questionnaire - Disability Index (HAQ-DI) Improvement Through Week 82
The number and proportion of subjects with HAQ-DI improvement ≥ 0.22 Against OLE Baseline. HAQ-DI Range: 0 (the best outcome) - 3 (the worst outcome), with a decrease from baseline indicating improvement. The HAQ-DI assesses the degree of difficulty experienced in 8 domains of daily living activities using 20 questions. The domains are dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities, and each domain (activity) consists of 2 or 3 items. For each question, the level of difficulty is scored from 0 to 3, where 0 = without any difficulty (the best outcome), 1 = with some difficulty, 2 = much difficulty, and 3 = unable to do (the worst outcome). Each category is given a score by taking the maximum score of each question (i.e., question in each category with the highest score for that category). The HAQ-DI was calculated by dividing the sum of the category scores by the number of categories with at least 1 question answered.
Changes From Core Baseline Over Time in Clinical Disease Activity Index (CDAI)
CDAI Range: 0 (the best outcome) - 76 (the worst outcome), with a decrease from baseline indicating improvement. The CDAI was calculated in the statistical database for analysis purposes using the SJC (28 joints), TJC (28 joints), the Patient Global Assessment of Disease Activity (VAS) (in cm), and the Physician Global Assessment (VAS) (in cm) according to the following formula: CDAI = SJC + TJC + Patient Global Assessment of Disease Activity (VAS) + Physician Global Assessment (VAS)

Full Information

First Posted
February 7, 2017
Last Updated
September 28, 2023
Sponsor
R-Pharm International, LLC
Collaborators
IQVIA Pvt. Ltd, OCT Clinical Trials
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1. Study Identification

Unique Protocol Identification Number
NCT03120949
Brief Title
Efficacy and Safety of Olokizumab in Subjects With Moderately to Severely Active Rheumatoid Arthritis
Acronym
CREDO 4
Official Title
A Multicenter, Open-Label, Phase III Study of the Efficacy and Safety of Olokizumab in Subjects With Moderately to Severely Active Rheumatoid Arthritis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
July 4, 2017 (Actual)
Primary Completion Date
September 1, 2021 (Actual)
Study Completion Date
September 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
R-Pharm International, LLC
Collaborators
IQVIA Pvt. Ltd, OCT Clinical Trials

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary objective of this study was to evaluate the long-term safety and tolerability of olokizumab (OKZ) 64 mg administered subcutaneously (SC) once every 2 weeks (q2w) or once every 4 weeks (q4w) in subjects with moderately to severely active rheumatoid arthritis (RA) who previously had completed 24 weeks of double-blind treatment in Study CREDO 1, 2 or 3 (core studies). The long-term efficacy, immunogenicity, the physical function and quality of life of subjects received long-term treatment with OKZ were assessed as well.
Detailed Description
This OLE study (CL04041024) included an 82-week open-label Treatment Period that followed completion of one of the core studies (Study CREDO 1, 2 or 3). The OLE open-label Treatment Period lasted from Visit 1 (OLE Baseline/Week 24) to Visit 10 (End of Treatment (EoT)/Week 106), followed by a 20-week Safety Follow-Up Period from Week 106 to Week 126. The first visit of the OLE study was the same visit as the Week 24 visit in the core studies. Subjects were randomized to 1 of the 2 OKZ treatment groups in the OLE study based on the treatment received in the core studies. Subjects who had received OKZ (q2w or q4w) in the core study in which they had participated (including subjects who received placebo in Study CREDO 3 and were re-randomized to OKZ at Week 16) received the same OKZ treatment regimen in the OLE study. Subjects who had received placebo (Study CREDO 1 and CREDO 2) or adalimumab (Study CREDO 2) in the core study in which they had participated were randomized in a 1:1 ratio to OKZ 64 mg q2w or OKZ 64 mg q4w regimens in the OLE study. For the first 12 weeks of the OLE, all subjects were required to remain on a stable dose of background methotrexate (MTX) at 15 to 25 mg/week (or≥10 mg/week if there was documented intolerance to higher doses) with a stable route of administration (oral, SC, or intramuscular (IM)). After 12 weeks (Visit 4 [Week 36] of the OLE study), the Investigator might adjust the MTX dosage and route, per local guidelines. Methotrexate might be adjusted only for safety reasons according to Investigator discretion before Visit 4 (Week 36) of the OLE study. Subjects who had been on rescue disease-modifying anti-rheumatic drugs (DMARDs) during the core studies were asked to continue these medications for the first 12 weeks of the OLE study. The Investigator could adjust these background medications if deemed appropriate after Visit 4 (Week 36) of the OLE study. Background rescue therapy might be adjusted only for safety reasons according to Investigator discretion before Visit 4 (Week 36) of the OLE study. Throughout the study, concomitant treatment with folic acid ≥ 5 mg per week or equivalent was required for all subjects. Subjects returned to the study site periodically for safety and response assessments as per the Schedule of Events. The last dose of open-label study treatment in the OLE study was administered at Week 104 for all subjects. After completion of the 82-week open-label Treatment Period, subjects entered the 20-week Safety Follow-Up Period. During the Safety Follow-Up Period, subjects returned for 3 visits at +4, +8, and +22 weeks after the last dose of study treatment. Subjects who discontinued the open-label treatment prematurely required to come for the EoT Visit 2 weeks after the last study treatment administration and then return for the 3 Safety Follow-Up Visits +4, +8, and +22 weeks after the last study treatment administration. Adverse events were assessed throughout the study period and evaluated using the Common Technology Criteria version 4.0 (CTCAE v 4.0). There were ongoing monitoring of safety events, including laboratory findings by the Sponsor or its designee. In addition, safety parameters were assessed throughout the study by an independent Data Safety Monitoring Board (DSMB).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Rheumatoid Arthritis, moderate, severe, subcutaneous, Olokizumab, open-label

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2106 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Arm 1: OKZ 64 mg q4w + MTX
Arm Type
Experimental
Arm Description
Olokizumab 64 mg SC q4w + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular).
Arm Title
Treatment Arm 2: OKZ 64 mg q2w + MTX
Arm Type
Experimental
Arm Description
Olokizumab 64 mg SC q2w + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular).
Intervention Type
Drug
Intervention Name(s)
Olokizumab 64 mg SC q4w
Intervention Description
160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial with target volume of 0.4 mL or in the pre-filled syringe (PFS).PFS is composed of a 1 mL clear Type I glass barrel vial with target volume of 0.4 mL.
Intervention Type
Drug
Intervention Name(s)
Olokizumab 64 mg SC q2w
Intervention Description
160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial with target volume of 0.4 mL or in the pre-filled syringe (PFS). PFS is composed of a 1 mL clear Type I glass barrel vial with target volume of 0.4 mL.
Intervention Type
Drug
Intervention Name(s)
Concomitant treatment
Intervention Description
Methotrexate 15 to 25 mg/week (or ≥ 10 mg/week if there was documented intolerance to higher doses). (Subject maintained their stable dose and route (oral, SC, or IM) during the core study and for ≥ 12 additional weeks of OLE.) Folic acid ≥ 5 mg per week or equivalent
Primary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events (AEs), by System Organ Class and Preferred Term (Safety Population)
Description
Incidence of Treatment-Emergent Adverse Events Reported for ≥5% of Subjects in Any Treatment Group by System Organ Class or Preferred Term
Time Frame
up to Week 126
Title
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Description
Incidence of Serious Treatment-Emergent Adverse Events by System Organ Class or Preferred Term. Deaths are included.
Time Frame
up to Week 126
Title
Incidence of Treatment-Emergent Adverse Events of Special Interest (AESI)
Time Frame
up to Week 126
Title
Incidence of Treatment-Emergent AEs Leading to Withdrawal of the Study Treatment
Time Frame
up to Week 126
Title
Incidence Rate of Treatment Emergent AEs Per Patient-years of Exposure
Description
Incidence Rate of all Subjects with at Least One Treatment Emergent AE. Subject Incidence Rate (IR) is summarized per 100 subject years (SY) of follow-up (/100 SY) based on the OLE safety population and presented by study treatments.
Time Frame
up to Week 126
Title
Incidence Rate of Treatment Emergent SAEs Per Patient-years of Exposure
Description
Incidence Rate of all Subjects with at Least One Treatment Emergent SAE. Subject Incidence Rate (IR) is summarized per 100 subject years (SY) of follow-up (/100 SY) based on the OLE safety population and presented by study treatments.
Time Frame
up to Week 126
Title
Incidence Rate of Treatment Emergent AESIs (Safety Population)
Description
Incidence Rate of all Subjects with at Least One Treatment Emergent AESI. Subject Incidence Rate (IR) is summarized per 100 subject years (SY) of follow-up (/100 SY) based on the OLE safety population and presented by study treatments.
Time Frame
up to Week 126
Secondary Outcome Measure Information:
Title
American College of Rheumatology 20% (ACR20) Response Rates Compare Against Core Baseline Through Week 82
Description
Number and Proportion of subjects achieving an ACR20 response who remain on randomized open-label treatment and in the study, assessed at several timepoints up to Week 82. American College of Rheumatology 20 % response is a composite defined as a ≥ 20% improvement from baseline in the swollen joint counts assessed in 66 joints and in the tender joint count assessed in 68 joints; and a ≥20% improvement from baseline in at least 3 of the 5 remaining core set measures: Patient Global Assessment of Disease Activity (VAS) Patient Assessment of Pain (VAS) HAQ-DI Physician Global Assessment (VAS) Level of acute phase reactant (CRP)
Time Frame
up to Week 82
Title
American College of Rheumatology 50% (ACR50) Response Rates Compare Against Core Baseline Through Week 82
Description
Number and Proportion of subjects achieving an ACR50 response who remain on randomized open-label treatment and in the study, assessed at several timepoints up to Week 82 American College of Rheumatology 50 % response is a composite defined as a ≥ 50% improvement from baseline in the swollen joint counts assessed in 66 joints and in the tender joint count assessed in 68 joints; and a ≥ 50% improvement from baseline in at least 3 of the 5 remaining core set measures: Patient Global Assessment of Disease Activity (VAS) Patient Assessment of Pain (VAS) HAQ-DI Physician Global Assessment (VAS) Level of acute phase reactant (CRP)
Time Frame
up to Week 82
Title
American College of Rheumatology 70% (ACR70) Response Rates Compare Against Core Baseline Through Week 82
Description
Number and Proportion of subjects achieving an ACR70 response who remain on randomized open-label treatment and in the study, assessed at several timepoints up to Week 82 American College of Rheumatology 70 % response is a composite defined as a ≥ 70% improvement from baseline in the swollen joint counts assessed in 66 joints and in the tender joint count assessed in 68 joints; and a ≥ 70% improvement from baseline in at least 3 of the 5 remaining core set measures: Patient Global Assessment of Disease Activity (VAS) Patient Assessment of Pain (VAS) HAQ-DI Physician Global Assessment (VAS) Level of acute phase reactant (CRP)
Time Frame
up to Week 82
Title
Proportion of Subjects With Simplified Disease Activity Index (SDAI) Remission Through Week 82
Description
The number and proportion of subjects with SDAI score ≤ 3.3 (considered to be in remission). The SDAI was calculated in the statistical database for analysis purposes using the SJC (28 joints), TJC (28 joints), CRP (mg/dL), the Patient Global Assessment of Disease Activity (VAS) (in cm), and the Physician Global Assessment (VAS) (in cm) according to the following formula: SJC + TJC + Patient Global Assessment of Disease Activity (VAS) + Physician Global Assessment (VAS) + CRP (mg/dL)
Time Frame
up to week 82
Title
Disease Activity Score 28-joint Count (DAS28) Response Rates Through Week 82
Description
Number and Proportion of subjects with DAS28 low disease activity (based on DAS28 C-reactive protein (CRP) < 3.2), who remain on randomized open-label treatment and in the study, assessed at several timepoints up to Week 82. The DAS28 (CRP) was calculated in the statistical database for analysis purposes using the Swollen joint count (SJC) (28 joints), Tender joint count (TJC) (28 joints), CRP level, and the Patient Global Assessment of Disease Activity Visual Analog Scale (VAS) (100 mm VAS, where 0 is "no disease activity" and 100 was "maximal disease activity") according to the following formula: [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.36 × natural log (CRP+1)] + [0.014 × VAS] + 0.96.
Time Frame
up to Week 82
Title
Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Core Baseline at Week 12
Description
HAQ-DI Range: 0 (the best outcome) - 3 (the worst outcome), with a decrease from baseline indicating improvement. The HAQ-DI assesses the degree of difficulty experienced in 8 domains of daily living activities using 20 questions. The domains are dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities, and each domain (activity) consists of 2 or 3 items. For each question, the level of difficulty is scored from 0 to 3, where 0 = without any difficulty (the best outcome), 1 = with some difficulty, 2 = much difficulty, and 3 = unable to do (the worst outcome). Each category is given a score by taking the maximum score of each question (i.e., question in each category with the highest score for that category). The HAQ-DI was calculated by dividing the sum of the category scores by the number of categories with at least 1 question answered.
Time Frame
Core baseline, Week 12
Title
Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Core Baseline at Week 20
Description
HAQ-DI Range: 0 (the best outcome) - 3 (the worst outcome), with a decrease from baseline indicating improvement. The HAQ-DI assesses the degree of difficulty experienced in 8 domains of daily living activities using 20 questions. The domains are dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities, and each domain (activity) consists of 2 or 3 items. For each question, the level of difficulty is scored from 0 to 3, where 0 = without any difficulty (the best outcome), 1 = with some difficulty, 2 = much difficulty, and 3 = unable to do (the worst outcome). Each category is given a score by taking the maximum score of each question (i.e., question in each category with the highest score for that category). The HAQ-DI was calculated by dividing the sum of the category scores by the number of categories with at least 1 question answered.
Time Frame
Core baseline, Week 20
Title
Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Core Baseline at Week 28
Description
HAQ-DI Range: 0 (the best outcome) - 3 (the worst outcome), with a decrease from baseline indicating improvement. The HAQ-DI assesses the degree of difficulty experienced in 8 domains of daily living activities using 20 questions. The domains are dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities, and each domain (activity) consists of 2 or 3 items. For each question, the level of difficulty is scored from 0 to 3, where 0 = without any difficulty (the best outcome), 1 = with some difficulty, 2 = much difficulty, and 3 = unable to do (the worst outcome). Each category is given a score by taking the maximum score of each question (i.e., question in each category with the highest score for that category). The HAQ-DI was calculated by dividing the sum of the category scores by the number of categories with at least 1 question answered.
Time Frame
Core baseline, Week 28
Title
Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Core Baseline at Week 40
Description
HAQ-DI Range: 0 (the best outcome) - 3 (the worst outcome), with a decrease from baseline indicating improvement. The HAQ-DI assesses the degree of difficulty experienced in 8 domains of daily living activities using 20 questions. The domains are dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities, and each domain (activity) consists of 2 or 3 items. For each question, the level of difficulty is scored from 0 to 3, where 0 = without any difficulty (the best outcome), 1 = with some difficulty, 2 = much difficulty, and 3 = unable to do (the worst outcome). Each category is given a score by taking the maximum score of each question (i.e., question in each category with the highest score for that category). The HAQ-DI was calculated by dividing the sum of the category scores by the number of categories with at least 1 question answered.
Time Frame
Core baseline, Week 40
Title
Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Core Baseline at Week 52
Description
HAQ-DI Range: 0 (the best outcome) - 3 (the worst outcome), with a decrease from baseline indicating improvement. The HAQ-DI assesses the degree of difficulty experienced in 8 domains of daily living activities using 20 questions. The domains are dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities, and each domain (activity) consists of 2 or 3 items. For each question, the level of difficulty is scored from 0 to 3, where 0 = without any difficulty (the best outcome), 1 = with some difficulty, 2 = much difficulty, and 3 = unable to do (the worst outcome). Each category is given a score by taking the maximum score of each question (i.e., question in each category with the highest score for that category). The HAQ-DI was calculated by dividing the sum of the category scores by the number of categories with at least 1 question answered.
Time Frame
Core baseline, Week 52
Title
Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Core Baseline at Week 64
Description
HAQ-DI Range: 0 (the best outcome) - 3 (the worst outcome), with a decrease from baseline indicating improvement. The HAQ-DI assesses the degree of difficulty experienced in 8 domains of daily living activities using 20 questions. The domains are dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities, and each domain (activity) consists of 2 or 3 items. For each question, the level of difficulty is scored from 0 to 3, where 0 = without any difficulty (the best outcome), 1 = with some difficulty, 2 = much difficulty, and 3 = unable to do (the worst outcome). Each category is given a score by taking the maximum score of each question (i.e., question in each category with the highest score for that category). The HAQ-DI was calculated by dividing the sum of the category scores by the number of categories with at least 1 question answered.
Time Frame
Core baseline, Week 64
Title
Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Core Baseline at Week 82
Description
HAQ-DI Range: 0 (the best outcome) - 3 (the worst outcome), with a decrease from baseline indicating improvement. The HAQ-DI assesses the degree of difficulty experienced in 8 domains of daily living activities using 20 questions. The domains are dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities, and each domain (activity) consists of 2 or 3 items. For each question, the level of difficulty is scored from 0 to 3, where 0 = without any difficulty (the best outcome), 1 = with some difficulty, 2 = much difficulty, and 3 = unable to do (the worst outcome). Each category is given a score by taking the maximum score of each question (i.e., question in each category with the highest score for that category). The HAQ-DI was calculated by dividing the sum of the category scores by the number of categories with at least 1 question answered.
Time Frame
Core baseline, Week 82
Title
Proportion of Subjects With Health Assessment Questionnaire - Disability Index (HAQ-DI) Improvement Through Week 82
Description
The number and proportion of subjects with HAQ-DI improvement ≥ 0.22 Against OLE Baseline. HAQ-DI Range: 0 (the best outcome) - 3 (the worst outcome), with a decrease from baseline indicating improvement. The HAQ-DI assesses the degree of difficulty experienced in 8 domains of daily living activities using 20 questions. The domains are dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities, and each domain (activity) consists of 2 or 3 items. For each question, the level of difficulty is scored from 0 to 3, where 0 = without any difficulty (the best outcome), 1 = with some difficulty, 2 = much difficulty, and 3 = unable to do (the worst outcome). Each category is given a score by taking the maximum score of each question (i.e., question in each category with the highest score for that category). The HAQ-DI was calculated by dividing the sum of the category scores by the number of categories with at least 1 question answered.
Time Frame
up to week 82
Title
Changes From Core Baseline Over Time in Clinical Disease Activity Index (CDAI)
Description
CDAI Range: 0 (the best outcome) - 76 (the worst outcome), with a decrease from baseline indicating improvement. The CDAI was calculated in the statistical database for analysis purposes using the SJC (28 joints), TJC (28 joints), the Patient Global Assessment of Disease Activity (VAS) (in cm), and the Physician Global Assessment (VAS) (in cm) according to the following formula: CDAI = SJC + TJC + Patient Global Assessment of Disease Activity (VAS) + Physician Global Assessment (VAS)
Time Frame
up to week 82

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects may be enrolled in the study only if they meet all of the following criteria: Subject must be willing and able to sign informed consent Subject must have completed the 24-week double-blind Treatment Period in 1 of the 3 core studies (CL04041022, CL04041023, or CL04041025). Subject must have maintained their stable dose (and route) of MTX 15 to 25 mg/week (or ≥ 10 mg/week if there is documented intolerance to higher doses) during the core study and plan to maintain the same dose and route of administration for ≥ 12 additional weeks Subjects must be willing to take folic acid or equivalent throughout the study. Exclusion Criteria: Subject with any medically important condition in the core study (e.g., clinically significant laboratory values, frequent Adverse events (AEs) or serious adverse events (SAEs), infection SAEs, and/or other concurrent severe and/or uncontrolled medical condition) which would make this subject unsuitable for inclusion in the open-label extension (OLE) study in the Investigator's judgement. Subject has evidence of active tuberculosis (TB) Subject with a positive or repeated indeterminate interferon-gamma release assay (IGRA) result at Week 22 of the core study - Subjects may be enrolled in the OLE study if they fulfill all 3 of the following criteria prior to the first dose of study treatment: Active TB is ruled out by a certified TB specialist or pulmonologist who is familiar with diagnosing and treating TB (as acceptable per local practice); The subject starts prophylaxis for latent TB infection (LTBI) according to country-specific/Centers for Disease Control and Prevention (CDC) guidelines (treatment with isoniazid for 6 months is not an appropriate prophylactic regime for this study and it should not be used); and The subject is willing to complete the entire course of recommended LTBI therapy. Subject has planned surgery during the first 12 weeks of the OLE study Female subjects who are pregnant or who are planning to become pregnant during the study or within 6 months of the last dose of study drug Female subjects of childbearing potential (unless permanent cessation of menstrual periods, determined retrospectively after a woman has experienced 12 months of natural amenorrhea as defined by the amenorrhea with underlying status [e.g., correlative age] or 6 months of natural amenorrhea with documented serum follicle-stimulating hormone levels >40 mIU/mL and estradiol <20 pg/mL) who are not willing to use a highly effective method of contraception during the study and for at least 6 months after the last administration of study treatment OR Male subjects with partners of childbearing potential not willing to use a highly effective method of contraception during the study and for at least 3 months after the last administration of study treatment. Highly effective contraception is defined as: Female sterilization surgery: hysterectomy, surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least 6 weeks prior to the first dose of study treatment in the core study In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by documented follow-up hormone level assessment Total abstinence if it is the preferred and constant lifestyle of the subject. Thus, periodic abstinence such as ovulation, symptothermal, postovulation, calendar methods, and withdrawal are not acceptable methods of contraception. Male sterilization surgery: at least 6 months prior to the first dose of study treatment in the core study (with the appropriate postvasectomy documentation of the absence of sperm in the ejaculate). For female subjects, the vasectomized male should be the only partner. Placement of established intrauterine device (IUD): IUD copper or IUD with progesterone Barrier method (condom and intravaginal spermicide, cervical caps with spermicide, or diaphragm with spermicide) in combination with the following: established oral, injected, or implanted hormone methods of contraception or contraceptive patch. Subject is unwilling or unable to follow the procedures outlined in the protocol. Other medical or psychiatric conditions, or laboratory abnormalities that may increase the potential risk associated with study participation and administration of the study treatment, or that may affect study results interpretation and, as per Investigator's judgement, make the subject ineligible.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mikhail Samsonov
Organizational Affiliation
Chief Medical Officer, R-Pharm
Official's Role
Study Director
Facility Information:
Facility Name
AZ Arthritis & Rheum' Research
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85210
Country
United States
Facility Name
Arizona Arthritis & Rheumatology Associates, P.C.
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Arizona Arthritis & Rheumatology Research, PLLC
City
Sun City
State/Province
Arizona
ZIP/Postal Code
85351
Country
United States
Facility Name
CHI St. Vincent Hot Springs
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Facility Name
Medvin Clinical Research
City
Covina
State/Province
California
ZIP/Postal Code
91722
Country
United States
Facility Name
C.V Mehta MD Med Corp..
City
Hemet
State/Province
California
ZIP/Postal Code
92543
Country
United States
Facility Name
Advanced Medical Research, LLC
City
La Palma
State/Province
California
ZIP/Postal Code
90623
Country
United States
Facility Name
Valerius Medical Group
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720-5403
Country
United States
Facility Name
Stanford University School of Medicine
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Rheumatology Center of San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92128
Country
United States
Facility Name
East Bay Rheumatology Medical Group, Inc.
City
San Leandro
State/Province
California
ZIP/Postal Code
94578
Country
United States
Facility Name
Inland Rheumatology Clinical Trials, Inc.
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
Center for Rheumatology Research, Comprehensive Rheumatology Center
City
West Hills
State/Province
California
ZIP/Postal Code
91307
Country
United States
Facility Name
Medvin Clinical Research
City
Whittier
State/Province
California
ZIP/Postal Code
90602
Country
United States
Facility Name
Denver Arthritis Clinic
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230
Country
United States
Facility Name
New England Research Associates LLC
City
Bridgeport
State/Province
Connecticut
ZIP/Postal Code
06606
Country
United States
Facility Name
Javed Rheumatology Associates
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
RASF - Clinical Research Center
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Reliable Clinical Research, LLC
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Pharmax Research Clinic
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
Medical Research Center of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Suncoast Research Group, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33135
Country
United States
Facility Name
Omega Research Consultants
City
Orlando
State/Province
Florida
ZIP/Postal Code
32810
Country
United States
Facility Name
Arthritis Research of Florida, INC
City
Palm Harbor
State/Province
Florida
ZIP/Postal Code
34684
Country
United States
Facility Name
Family Clinical Trials, LLC.
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33026
Country
United States
Facility Name
AdventHealth Medical Group, PA
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
Lovelace Scientific Resources, Inc.
City
Venice
State/Province
Florida
ZIP/Postal Code
34292
Country
United States
Facility Name
Arthritis Center of North Georgia
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States
Facility Name
Marietta Rheumatology Associates, PC
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Institute of Arthritis Research
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
University of Kansas Hospital
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Graves Gilbert Clinic
City
Bowling Green
State/Province
Kentucky
ZIP/Postal Code
42101
Country
United States
Facility Name
The Arthritis & Diabetes Clinic, Inc.
City
Monroe
State/Province
Louisiana
ZIP/Postal Code
71203
Country
United States
Facility Name
Klein and Associates, M.D., P.A.
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21740
Country
United States
Facility Name
The Center for Rheumatology and Bone Research
City
Wheaton
State/Province
Maryland
ZIP/Postal Code
20902
Country
United States
Facility Name
Clinical Pharmacology Study Group
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
Facility Name
AA MRC LLC Ahmed Arif Medical Research Center
City
Grand Blanc
State/Province
Michigan
ZIP/Postal Code
48439
Country
United States
Facility Name
North MS Medical Clinics, Inc.
City
Tupelo
State/Province
Mississippi
ZIP/Postal Code
38801
Country
United States
Facility Name
Glacier View Research Institute-Rheumatology
City
Kalispell
State/Province
Montana
ZIP/Postal Code
59901
Country
United States
Facility Name
Physician Research Collaboration
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68516
Country
United States
Facility Name
Arthritis & Osteoporosis Associates, PA
City
Freehold
State/Province
New Jersey
ZIP/Postal Code
07728
Country
United States
Facility Name
Lovelace Scientific Resources, Inc.
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87114
Country
United States
Facility Name
NYU Langone ambulatory care
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11201
Country
United States
Facility Name
Medication Management, LLC
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27408
Country
United States
Facility Name
Cape Fear Arthritis Care
City
Leland
State/Province
North Carolina
ZIP/Postal Code
28451
Country
United States
Facility Name
Carolina Arthritis Associates
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Trinity Medical Group
City
Minot
State/Province
North Dakota
ZIP/Postal Code
58701
Country
United States
Facility Name
Cincinnati Rheumatic Disease Study Group
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
STAT Research, Inc.
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45417
Country
United States
Facility Name
Clinical Research Source, Inc.
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States
Facility Name
Health Research of Oklahoma, PLLC
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Lynn Health Science Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Altoona Center for Clinical Research, P.C.
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Arthritis Group
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19152
Country
United States
Facility Name
Low Country Rheumatology, PA
City
Summerville
State/Province
South Carolina
ZIP/Postal Code
29486
Country
United States
Facility Name
Amarillo Center for Clinical Research
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79124
Country
United States
Facility Name
Austin Regional Clinic, P.A.
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Accurate Clinical Management., LLC
City
Baytown
State/Province
Texas
ZIP/Postal Code
77521
Country
United States
Facility Name
Precision Comprehensive Clinical Research Solutions
City
Colleyville
State/Province
Texas
ZIP/Postal Code
76034
Country
United States
Facility Name
Pioneer Research Solutions, Inc.
City
Cypress
State/Province
Texas
ZIP/Postal Code
77429
Country
United States
Facility Name
Therapeutic Concepts Rheumatology,LLC
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Rheumatology Clinic of Houston, P.A.
City
Houston
State/Province
Texas
ZIP/Postal Code
77065
Country
United States
Facility Name
Houston Institute For Clinical Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Facility Name
Accurate Clinical Mangemnt - Partner
City
Houston
State/Province
Texas
ZIP/Postal Code
77089
Country
United States
Facility Name
Accurate Clinical Research, Inc.
City
Houston
State/Province
Texas
ZIP/Postal Code
77089
Country
United States
Facility Name
Accurate Clinical Research, Inc.
City
League City
State/Province
Texas
ZIP/Postal Code
77573
Country
United States
Facility Name
West Texas Clinical Research
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79410
Country
United States
Facility Name
Dr Alex De Jesus Rheumatology, P.A.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Advanced Rheumatology of Houston
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77382
Country
United States
Facility Name
DM Clinical Research
City
Tomball
State/Province
Texas
ZIP/Postal Code
77375
Country
United States
Facility Name
Arthritis Northwest, PLLC
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Centro de Investigaciones Medicas Mar del Plata
City
Mar del Plata
State/Province
Buenos Aires
ZIP/Postal Code
B7600FYK
Country
Argentina
Facility Name
Instituto Medico CER
City
Quilmes
State/Province
Buenos Aires
ZIP/Postal Code
B1878DVB
Country
Argentina
Facility Name
Instituto de Investigaciones Clinicas Quilmes
City
Quilmes
State/Province
Buenos Aires
ZIP/Postal Code
B1878GEG
Country
Argentina
Facility Name
Sanatorio San Martin
City
Venado Tuerto
State/Province
Santa Fe
ZIP/Postal Code
S2600KUE
Country
Argentina
Facility Name
Centro Medico Privado de Reumatologia
City
San Miguel de Tucuman
State/Province
Tucuman
ZIP/Postal Code
T4000AXL
Country
Argentina
Facility Name
Instituto de Investigaciones Clinicas-Mar del Plata
City
Buenos Aires
ZIP/Postal Code
B7600FZN
Country
Argentina
Facility Name
Organizacion Medica de Investigacion (OMI)
City
Ciudad Autonoma Buenos Aires
ZIP/Postal Code
C1015ABO
Country
Argentina
Facility Name
APRILLUS Asistencia e Investigacion
City
Ciudad Autonoma Buenos aires
ZIP/Postal Code
C1046AAQ
Country
Argentina
Facility Name
Instituto Centenario
City
Ciudad Autonoma Buenos Aires
ZIP/Postal Code
C1204AAD
Country
Argentina
Facility Name
Hospital Privado Centro Medico de Cordoba
City
Cordoba
ZIP/Postal Code
5016
Country
Argentina
Facility Name
Instituto DAMIC Fundacion Rusculleda
City
Córdoba
ZIP/Postal Code
X5003DCE
Country
Argentina
Facility Name
CER San Juan Centro Polivalente de Asistencia e Inv. Clinica
City
San Juan
ZIP/Postal Code
5400
Country
Argentina
Facility Name
Clinica de Higado y Aparato Digestivo
City
Santa Fe
ZIP/Postal Code
S2000CFJ
Country
Argentina
Facility Name
Centro de Investigaciones Reumatológicas
City
Tucuman
ZIP/Postal Code
T4000BRD
Country
Argentina
Facility Name
Minsk City Clinical Hospital #1
City
Minsk
State/Province
Minsk Oblast
ZIP/Postal Code
220013
Country
Belarus
Facility Name
Vitebsk Clinical Hospital
City
Vitebsk
State/Province
Vitebsk Oblast
ZIP/Postal Code
210037
Country
Belarus
Facility Name
HUWC - UFC - Hospital Universitário Walter Cantídio - Universidade Federal do Ceará
City
Fortaleza
State/Province
Ceará
ZIP/Postal Code
60430-370
Country
Brazil
Facility Name
CEDOES - Diagnóstico e Pesquisa
City
Vitória
State/Province
Espírito Santo
ZIP/Postal Code
29055-450
Country
Brazil
Facility Name
CIP - Centro Internacional de Pesquisa
City
Goiânia
State/Province
Goiás
ZIP/Postal Code
74110-120
Country
Brazil
Facility Name
CMiP - Centro Mineiro de Pesquisa
City
Juiz de Fora
State/Province
Minas Gerais
ZIP/Postal Code
36010-570
Country
Brazil
Facility Name
CETI - Centro de Estudos em Terapias Inovadoras Ltda.
City
Curitiba
State/Province
Paraná
ZIP/Postal Code
80030-110
Country
Brazil
Facility Name
Clinilive - Clínica do Idoso e Pesquisa Clínica
City
Maringá
State/Province
Paraná
ZIP/Postal Code
87013-250
Country
Brazil
Facility Name
Hospital Bruno Born
City
Lajeado
State/Province
Rio Grande Do Sul
ZIP/Postal Code
95900-010
Country
Brazil
Facility Name
LMK Serviços Médicos S/S Ltda
City
Pôrto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90480-000
Country
Brazil
Facility Name
Clínica de Neoplasias Litoral Ltda.
City
Itajaí
State/Province
Santa Catarina
ZIP/Postal Code
88301-215
Country
Brazil
Facility Name
Faculdade de Medicina do ABC
City
Santo André
State/Province
Sao Paulo
ZIP/Postal Code
09060-650
Country
Brazil
Facility Name
Centro Multidisciplinar de Estudos Clínicos - CEMEC
City
Sao Bernardo Do Campo
State/Province
Sao Paulo
ZIP/Postal Code
09715-090
Country
Brazil
Facility Name
CCBR Brasil Centro de Pesquisas e Análises Clínicas Ltda.
City
Rio de Janeiro
ZIP/Postal Code
20241-180
Country
Brazil
Facility Name
CPCLIN - Centro de Pesquisas Clínicas Ltda.
City
São Paulo
ZIP/Postal Code
01228-200
Country
Brazil
Facility Name
Associação de Assistência à Criança Deficiente - AACD
City
São Paulo
ZIP/Postal Code
04032-060
Country
Brazil
Facility Name
DCC 'Sv. Pantaleymon' OOD
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
UMHAT Pulmed OOD
City
Plovdiv
ZIP/Postal Code
4000
Country
Bulgaria
Facility Name
UMHAT "Kaspela", EOOD
City
Plovdiv
ZIP/Postal Code
4001
Country
Bulgaria
Facility Name
MHAT - Ruse, AD
City
Ruse
ZIP/Postal Code
7002
Country
Bulgaria
Facility Name
Medizinski Zentar-1-Sevlievo EOOD
City
Sevlievo
ZIP/Postal Code
5400
Country
Bulgaria
Facility Name
MHAT - Shumen, AD
City
Shumen
ZIP/Postal Code
9700
Country
Bulgaria
Facility Name
NMTH "Tsar Boris III"
City
Sofia
ZIP/Postal Code
1233
Country
Bulgaria
Facility Name
MHAT "Lyulin", EAD
City
Sofia
ZIP/Postal Code
1336
Country
Bulgaria
Facility Name
Medical Center "Excelsior", OOD
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Facility Name
UMHAT "Sv. Ivan Rilski", EAD
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
MC "Synexus - Sofia", EOOD
City
Sofia
ZIP/Postal Code
1784
Country
Bulgaria
Facility Name
MDHAT 'Dr. Stefan Cherkezov', AD
City
Veliko Tarnovo
ZIP/Postal Code
5000
Country
Bulgaria
Facility Name
Centro de Reumatologia y Ortopedia SAS
City
Barranquilla
ZIP/Postal Code
80020
Country
Colombia
Facility Name
Centro de Investigacion en Reumatologia y Especialidades Medicas SAS. CIREEM
City
Bogotá
ZIP/Postal Code
110221
Country
Colombia
Facility Name
Fundacion Instituto de Reumatologia Fernando Chalem
City
Bogotá
ZIP/Postal Code
111211
Country
Colombia
Facility Name
Medicity S.A.S.
City
Bucaramanga
ZIP/Postal Code
680003
Country
Colombia
Facility Name
Clinica de Artritis Temprana S.A.S
City
Cali
ZIP/Postal Code
76001
Country
Colombia
Facility Name
CCR Brno s.r.o
City
Brno
ZIP/Postal Code
602 00
Country
Czechia
Facility Name
IMEDICA s.r.o.
City
Brno
ZIP/Postal Code
602 00
Country
Czechia
Facility Name
Revmatologie s.r.o.
City
Brno
ZIP/Postal Code
638 00
Country
Czechia
Facility Name
Nemocnice Jihlava p.o.
City
Jihlava
ZIP/Postal Code
586 01
Country
Czechia
Facility Name
MUDr Gabriela Simkova Ordinace Lekare Specialisty Interna Revmatologie
City
Kladno
ZIP/Postal Code
272 01
Country
Czechia
Facility Name
CTCenter MaVe s.r.o.
City
Olomouc
ZIP/Postal Code
77900
Country
Czechia
Facility Name
ARTROSCAN s.r.o.
City
Ostrava - Trebovice
ZIP/Postal Code
722 00
Country
Czechia
Facility Name
Vesalion s.r.o.
City
Ostrava
ZIP/Postal Code
70200
Country
Czechia
Facility Name
ARTHROHELP s.r.o.
City
Pardubice
ZIP/Postal Code
530 02
Country
Czechia
Facility Name
CCR Czech, a.s.
City
Pardubice
ZIP/Postal Code
530 02
Country
Czechia
Facility Name
Revmatologicky ustav
City
Praha 2
ZIP/Postal Code
128 00
Country
Czechia
Facility Name
CCR Prague s.r.o.
City
Praha 3
ZIP/Postal Code
130 00
Country
Czechia
Facility Name
MUDR Zuzana URBANOVA Revmatologie
City
Praha 4 Nusle
ZIP/Postal Code
140 00
Country
Czechia
Facility Name
MUDR Zuzana URBANOVA Revmatologie
City
Praha 4
ZIP/Postal Code
140 00
Country
Czechia
Facility Name
Fakultni nemocnice v Motole
City
Praha 5
ZIP/Postal Code
150 06
Country
Czechia
Facility Name
CLINTRIAL s.r.o.
City
Praha
ZIP/Postal Code
110 00
Country
Czechia
Facility Name
Affidea Praha s.r.o.
City
Praha
ZIP/Postal Code
148 00
Country
Czechia
Facility Name
Medical Plus s.r.o.
City
Uherske Hradiste
ZIP/Postal Code
686 01
Country
Czechia
Facility Name
PV - MEDICAL, s.r.o.
City
Zlin
ZIP/Postal Code
760 01
Country
Czechia
Facility Name
East Tallinn Central Hospital
City
Tallinn
ZIP/Postal Code
11312
Country
Estonia
Facility Name
Meditrials OU
City
Tartu
ZIP/Postal Code
50708
Country
Estonia
Facility Name
Kerckhoff-Klinik gGmbH
City
Bad Nauheim
State/Province
Hessen
ZIP/Postal Code
61231
Country
Germany
Facility Name
Rheumapraxis Dr. med. Reiner Kurthen
City
Aachen
State/Province
Nordrhein Westfalen
ZIP/Postal Code
52064
Country
Germany
Facility Name
Studienambulanz Dr. Wassenberg
City
Ratingen
State/Province
Nordrhein Westfalen
ZIP/Postal Code
40878
Country
Germany
Facility Name
SMO.MD GmbH
City
Magdeburg
State/Province
Sachsen Anhalt
ZIP/Postal Code
39120
Country
Germany
Facility Name
Klinische Forschung Berlin-Mitte GmbH
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
HRF Hamburger Rheuma Forschungszentrum
City
Hamburg
ZIP/Postal Code
20095
Country
Germany
Facility Name
Principal SMO Kft.
City
Baja
ZIP/Postal Code
6500
Country
Hungary
Facility Name
DRC Gyogyszervizsgalo Kozpont Kft.
City
Balatonfüred
ZIP/Postal Code
8230
Country
Hungary
Facility Name
Clinexpert Kft.
City
Budapest
ZIP/Postal Code
1033
Country
Hungary
Facility Name
Obudai Egeszsegugyi Centrum Kft.
City
Budapest
ZIP/Postal Code
1036
Country
Hungary
Facility Name
Kiskunhalasi Semmelweis Korhaz
City
Kiskunhalas
ZIP/Postal Code
6400
Country
Hungary
Facility Name
MAV Korhaz es Rendelointezet
City
Szolnok
ZIP/Postal Code
5000
Country
Hungary
Facility Name
DRC Szekesfehervar
City
Székesfehérvár
ZIP/Postal Code
8000
Country
Hungary
Facility Name
Vital-Medicina Kft.
City
Veszprem
ZIP/Postal Code
8200
Country
Hungary
Facility Name
Hallym University Sacred Heart Hospital
City
Anyang-si
State/Province
Gyeonggi-do
ZIP/Postal Code
431-796
Country
Korea, Republic of
Facility Name
Ajou University Hospital
City
Suwon-si
State/Province
Gyeonggi-do
ZIP/Postal Code
443-380
Country
Korea, Republic of
Facility Name
Eulji University Hospital
City
Daejeon
ZIP/Postal Code
35233
Country
Korea, Republic of
Facility Name
Chonnam National University Hospital
City
Gwangju
ZIP/Postal Code
501-757
Country
Korea, Republic of
Facility Name
Jeju National University Hospital
City
Jeju
ZIP/Postal Code
63241
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University No. 31 Office, Pediatric Oncology Clinic
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, Seoul St. Mary's Hospital
City
Seoul
ZIP/Postal Code
6591
Country
Korea, Republic of
Facility Name
Dr.Saulite-Kandevica Private Practice
City
Liepaja
ZIP/Postal Code
LV-3401
Country
Latvia
Facility Name
Alytus Regional S. Kudirkos Hospital, Public Institution
City
Alytus
ZIP/Postal Code
62114
Country
Lithuania
Facility Name
Republican Kaunas Hospital, Public Institution
City
Kaunas
ZIP/Postal Code
45130
Country
Lithuania
Facility Name
Klaipeda University Hospital, Public Institution
City
Klaipeda
ZIP/Postal Code
92288
Country
Lithuania
Facility Name
Siauliai Republican Hospital, Public Institution
City
Siauliai
ZIP/Postal Code
76231
Country
Lithuania
Facility Name
Center Outpatient Clinic, Public Institution
City
Vilnius
ZIP/Postal Code
LT-01117
Country
Lithuania
Facility Name
Vilnius University Hospital Santariskiu Clinics, Public Institution
City
Vilnius
ZIP/Postal Code
LT-08661
Country
Lithuania
Facility Name
Clinicos Asociados BOCM S.C.
City
Mexico
State/Province
Distrito Federal
ZIP/Postal Code
3300
Country
Mexico
Facility Name
Centro de Investigacion Clínica GRAMEL S.C
City
Mexico
State/Province
Distrito Federal
ZIP/Postal Code
3720
Country
Mexico
Facility Name
Comite Mexicano Para la Prevencion de Osteoporosis AC
City
Mexico
State/Province
Distrito Federal
ZIP/Postal Code
6100
Country
Mexico
Facility Name
Clinstile, S.A. de C.V.
City
Mexico
State/Province
Distrito Federal
ZIP/Postal Code
6700
Country
Mexico
Facility Name
Clinica de Investigacion en Reumatologia y Obesidad S.C.
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44650
Country
Mexico
Facility Name
Centro de Estudios de Investigacion Basica y Clinica SC
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44690
Country
Mexico
Facility Name
Accelerium S. de R.L. de C.V.
City
Monterrey
State/Province
Nuevo León
ZIP/Postal Code
64000
Country
Mexico
Facility Name
Universidad Autonoma de Nuevo Leon, Hospital Universitario Dr. Jose Eleuterio Gonzalez
City
Monterrey
State/Province
Nuevo León
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Investigacion y Biomedicina de Chihuahua, S.C.
City
Chihuahua
ZIP/Postal Code
31000
Country
Mexico
Facility Name
Clinical Research Institute S.C.
City
Mexico City
ZIP/Postal Code
54055
Country
Mexico
Facility Name
Centro de Alta Especialidad en Reumatología e Investigación del Potosí, S.C.
City
San Luis Potosí
ZIP/Postal Code
78213
Country
Mexico
Facility Name
CERMED
City
Bialystok
ZIP/Postal Code
15-270
Country
Poland
Facility Name
ZDROWIE Osteo-Medic
City
Bialystok
ZIP/Postal Code
15-351
Country
Poland
Facility Name
Szpital Uniwersytecki nr 2 im.dr J. Biziela
City
Bydgoszcz
ZIP/Postal Code
85-168
Country
Poland
Facility Name
MCBK Iwona Czajkowska Anna Podrażka- Szczepaniak S.C.
City
Grodzisk Mazowiecki
ZIP/Postal Code
05-825
Country
Poland
Facility Name
Polimedica Centrum Badań, Profilaktyki I Leczenia
City
Kielce
ZIP/Postal Code
25-355
Country
Poland
Facility Name
CCBR - Lodz - PL
City
Lodz
ZIP/Postal Code
90-368
Country
Poland
Facility Name
Centrum Medyczne AMED
City
Lodz
ZIP/Postal Code
91-363
Country
Poland
Facility Name
ETYKA Osrodek Badan Klinicznych
City
Olsztyn
ZIP/Postal Code
10-117
Country
Poland
Facility Name
Szpital Wojewodzki im. Prymasa Kardynala Stefana Wyszynskiego
City
Sieradz
ZIP/Postal Code
98-200
Country
Poland
Facility Name
Clinmed Research
City
Skierniewice
ZIP/Postal Code
96-100
Country
Poland
Facility Name
RCMed
City
Sochaczew
ZIP/Postal Code
96-500
Country
Poland
Facility Name
KO-MED Centra Kliniczne Staszow
City
Staszow
ZIP/Postal Code
28-200
Country
Poland
Facility Name
Samodzielny Publiczny ZOZ Tomaszow Lubelski
City
Tomaszow Lubelski
ZIP/Postal Code
22-600
Country
Poland
Facility Name
Nasz lekarz Przychodnie Medyczne
City
Torun
ZIP/Postal Code
87-100
Country
Poland
Facility Name
Medycyna Kliniczna
City
Warszawa
ZIP/Postal Code
00-874
Country
Poland
Facility Name
Rheuma Medicus Zaklad Opieki Zdrowotnej
City
Warszawa
ZIP/Postal Code
02-118
Country
Poland
Facility Name
McM Polimedica
City
Warszawa
ZIP/Postal Code
02-777
Country
Poland
Facility Name
KO-MED Centra Kliniczne Zamosc
City
Zamosc
ZIP/Postal Code
22-400
Country
Poland
Facility Name
Santa Familia Centrum Badan, Profilaktyki i Leczenia
City
Zgierz
ZIP/Postal Code
95-100
Country
Poland
Facility Name
FSBEI HE "Altai State Medical University of the Ministry of Healthcare of Russian Federation"
City
Barnaul
State/Province
Altai Region
ZIP/Postal Code
656038
Country
Russian Federation
Facility Name
Medical Center LLC "Maksimum Zdoroviya"
City
Kemerovo
State/Province
Kemerovo Oblast
ZIP/Postal Code
650066
Country
Russian Federation
Facility Name
SAHI of Kemerovo region "Regional Clinical Hospital for War Veterans"
City
Kemerovo
State/Province
Kemerovskaya Oblast
ZIP/Postal Code
650000
Country
Russian Federation
Facility Name
Budgetary Healthcare Institution "Kursk Regional Clinical Hospital" of Healthcare Committee of Kursk region
City
Kursk
State/Province
Kurskaya Oblast
ZIP/Postal Code
305007
Country
Russian Federation
Facility Name
SPb SBHI "Clinical Rheumatological Hospital #25", Fourth Rheumatology Unit
City
Saint Petersburg
State/Province
Leningradskaya Oblast
ZIP/Postal Code
190068
Country
Russian Federation
Facility Name
SBHI of Moscow "City Clinical Hospital No.1 n.a. Pirogov" Healthcare Department of Moscow
City
Moscow
State/Province
Moscovskaya Oblast
ZIP/Postal Code
119049
Country
Russian Federation
Facility Name
FSAEI HE "First MSMU n.a. I.M. Sechenov of the Ministry of Health of the Russian Federation" University Clinical Hospital No.1
City
Moscow
State/Province
Moscovskaya Oblast
ZIP/Postal Code
119435
Country
Russian Federation
Facility Name
FSAEI HE "First MSMU n.a. I.M. Sechenov of the Ministry of Health of the Russian Federation"
City
Moscow
State/Province
Moscovskaya Oblast
ZIP/Postal Code
119991
Country
Russian Federation
Facility Name
State Budgetary Healthcare Institution "City Clinical Hospital # 15 n.a O.M. Filatov" of Moscow Healtheare Department
City
Moscow
State/Province
Moscow Region
ZIP/Postal Code
111539
Country
Russian Federation
Facility Name
SBHI of Moscow "City Clinical Hospital #4 of Moscow Healthcare Departament"
City
Moscow
State/Province
Moskovskaya Oblast
ZIP/Postal Code
115093
Country
Russian Federation
Facility Name
SBHI of Nizhny Novgorod Region "Nizhny Novgorod Regional Clinical Hospital n.a.Semashko"
City
Nizhniy Novgorod
State/Province
Nizhegorodskaya Oblast
ZIP/Postal Code
603126
Country
Russian Federation
Facility Name
SBHI of Nizhegorodsky Region "State Clinical Hospital #5 of Nizhegorodsky District of Nizhny Novgorod"
City
Nizhny Novgorod
State/Province
Nizhny Novgorod Oblast
ZIP/Postal Code
603005
Country
Russian Federation
Facility Name
State Autonomous Healthcare Institution of Novosibirsk region "City Polyclinic #1"
City
Novosibirsk
State/Province
Novosibirsk Oblast
ZIP/Postal Code
630005
Country
Russian Federation
Facility Name
LLC "Clinical Diagnostic Center "Ultramed"
City
Omsk
State/Province
Omskaya Oblast
ZIP/Postal Code
644024
Country
Russian Federation
Facility Name
Budgetary Healthcare Institution of Omsk Region "Regional Clinical Hospital"
City
Omsk
State/Province
Omskaya Oblast
ZIP/Postal Code
644111
Country
Russian Federation
Facility Name
SBHI of the Republic of Karelia "Republican Hospital named after V.A. Baranov"
City
Petrozavodsk
State/Province
Republic Of Karelia
ZIP/Postal Code
185019
Country
Russian Federation
Facility Name
State Budgetary Healthcare Institution "Republican Clinical Hospital n.a. G.G. Kuvatov"
City
Ufa
State/Province
Respublic Of Bashkortostan
ZIP/Postal Code
450005
Country
Russian Federation
Facility Name
FSBEI HE "Rostov State Medical Unversity" of Ministry of Health of the Russian Federation
City
Rostov
State/Province
Rostovskaya Oblast
ZIP/Postal Code
344022
Country
Russian Federation
Facility Name
FSBEI HE 'Ryazan State Medical University n.a. I.P.Pavlov" of the Ministry of Health of Russian Federation
City
Ryazan
State/Province
Ryazan Oblast
ZIP/Postal Code
390026
Country
Russian Federation
Facility Name
FSBEI HE "Saratov SMU n.a. V.I.Razumovsky of Ministry of Health of Russian Federation"
City
Saratov
State/Province
Saratovskaya Oblast
ZIP/Postal Code
410012
Country
Russian Federation
Facility Name
State Healthcare Institution "Regional Clinical Hospital"
City
Saratov
State/Province
Saratovskaya Oblast
ZIP/Postal Code
410053
Country
Russian Federation
Facility Name
Private Healthcare Institution "Clinical Hospital Russian Railways-Medicine of City Smolensk"
City
Smolensk
State/Province
Smolenskaya Oblast
ZIP/Postal Code
214025
Country
Russian Federation
Facility Name
FSBEI HE StSMU MOH Russia based on SBHI of Stavropol Region "Stavropol Regional Clinical Hospital"
City
Stavropol'
State/Province
Stavropol Region
ZIP/Postal Code
355030
Country
Russian Federation
Facility Name
State Autonomous Healthcare Institution of Sverdlovsk Region "Sverdlovsk Regional Clinical Hospital No.1"
City
Ekaterinburg
State/Province
Sverdlovskaya Oblast
ZIP/Postal Code
620102
Country
Russian Federation
Facility Name
FSBEI HE "Ural State Medical University" of Ministry of Health of Russian Federation based on MBI "Central City Clinical Hospital No.6"
City
Ekaterinburg
State/Province
Sverdlovskaya Oblast
ZIP/Postal Code
620149
Country
Russian Federation
Facility Name
FSBEI HE "Kazan State Medical University of the Ministry of Health of the Russian Federation" on the base of SAHI "Republican Clinical Hospital of the Ministry of Health of Tatarstan Republic"
City
Kazan'
State/Province
The Republic Of Tatarstan
ZIP/Postal Code
420012
Country
Russian Federation
Facility Name
State Healthcare Institution of Tula region "Tula Regional Clinical Hospital"
City
Tula
State/Province
Tulskaya Oblast
ZIP/Postal Code
300053
Country
Russian Federation
Facility Name
State Healthcare Institution "Ulyanovsk Regional Clinical Hospital"
City
Ulyanovsk
State/Province
Ulyanovskaya Oblast
ZIP/Postal Code
432063
Country
Russian Federation
Facility Name
SBHI of Vladimir Region "Regional Clinical Hospital", Rheumatology Departament
City
Vladimir
State/Province
Vladimirskaya Oblast
ZIP/Postal Code
600023
Country
Russian Federation
Facility Name
State Autonomous Helthcare Institution of Yaroslavl region "Clinical Hospital of Emergency Care n.a. Solovyev"
City
Yaroslavl
State/Province
Yaroslavsakaya Oblast
ZIP/Postal Code
150003
Country
Russian Federation
Facility Name
SBHI "Yaroslavl Regional Clinical Hospital", Rheumatology department
City
Yaroslavl'
State/Province
Yaroslavskaya Oblast
ZIP/Postal Code
150062
Country
Russian Federation
Facility Name
FSBSI "Scientific Research Institute of Rheumatology n.a. V.A. Nasonova"
City
Moscow
ZIP/Postal Code
115522
Country
Russian Federation
Facility Name
FSAEI HE "First MSMU n.a. I.M. Sechenov of the Ministry of Health of the Russian Federation"
City
Moscow
ZIP/Postal Code
119991
Country
Russian Federation
Facility Name
FSBI "National Medical Research Center n.a. V.A.Almazov" of the Ministry of Healthcare of the Russian Federation
City
Saint Petersburg
ZIP/Postal Code
197341
Country
Russian Federation
Facility Name
Chi Mei Medical Center, Yung Kang Branch
City
Tainan
ZIP/Postal Code
710
Country
Taiwan
Facility Name
Chang Gung Memorial Hospital, Linkou
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Torbay Hospital
City
Torquay
State/Province
Devon
ZIP/Postal Code
TQ2 7AA
Country
United Kingdom
Facility Name
Whipps Cross University Hospital
City
London
State/Province
Greater London
ZIP/Postal Code
E11 1NR
Country
United Kingdom
Facility Name
Royal Free Hospital
City
London
State/Province
Greater London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
Basingstoke and North Hampshire Hospital
City
Basingstoke
State/Province
Hampshire
ZIP/Postal Code
RG24 9NA
Country
United Kingdom
Facility Name
Maidstone Hospital
City
Maidstone
State/Province
Kent
ZIP/Postal Code
ME16 9QQ
Country
United Kingdom
Facility Name
Arrowe Park Hospital
City
Wirral
State/Province
Merseyside
ZIP/Postal Code
L49 5PE
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Efficacy and Safety of Olokizumab in Subjects With Moderately to Severely Active Rheumatoid Arthritis

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