Back to results

A Study Of PF-06410293 (Adalimumab-Pfizer) And Adalimumab (Humira®) In Combination With Methotrexate In Subjects With Active Rheumatoid Arthritis (REFLECTIONS B538-02).

Primary Purpose

Rheumatoid Arthritis

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

PF-06410293

Adalimumab

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Phase 3, adalimumab, rheumatoid arthritis

Eligibility Criteria

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

Inclusion Criteria:

Diagnosis of rheumatoid arthritis based on 2010 ACR/EULAR criteria for at least 4 months.
At least 6 tender (of 68 assessed) and 6 swollen (of 66 assessed) joints at screening and baseline.
Hs-CRP equal or greater than 8 mg/L.
Must have received methotrexate for at least 12 weeks and been on a stable dose for at least 4 weeks prior to the first study dose.

Exclusion Criteria:

Evidence of untreated or inadequately treated latent or active TB.
Evidence of uncontrolled, clinically significant diseases, including moderate or severe heart failure (NYHA Class III/IV) or malignancy in the previous 5 years.
History of infection requiring hospitalization or parenteral antimicrobial therapy within 6 months prior to first dose of study drug.
May have received no more than 2 doses of one biologic therapy (other than adalimumab or lymphocyte depleting therapy).
Any second DMARD must be washed out prior to the first study dose.

Sites / Locations

ArthroCare, Arthritis Care & Research P.C.
Arizona Arthritis & Rheumatology Associates, PC
Arizona Arthritis & Rheumatology Associates, PC
St. Jude Hospital Yorba Linda DBA St. Joseph Heritage Healthcare
East Bay Rheumatology Medical Group, Inc.
Westlake Medical Research
Inland Rheumatology Clinical Trials, Inc.
Desert Valley Medical Group
Javed Rheumatology Associates, Inc
Arthritis and Rheumatic Disease Specialties
Robert W. Levin, MD, PA
International Medical Research
SIMED Arthritis Center
Southeastern Integrated Medical, PL, d/b/a Florida Medical Research
Rheumatology Associates of Central Florida, P.A.
Sarasota Arthritis Research Center
Alastair C. Kennedy, MD
Indian River Primary Care
St Luke's Intermountain Research Center
St Luke' s Clinic
Physician's Clinic of Iowa, P.C.
Graves-Gilbert Clinic Bowling Green
The Center for Rheumatology and Bone Research
Bronson Internal Medicine and Rheumatology
North Mississippi Medical Clinics, Inc. - Clinical Research
Physician Research Collaboration, LLC
Westroads Clinical Research, Inc.
Arthritis, Rheumatic & Back Disease Associates, P.A.
Manhattan Medical Research
Buffalo Rheumatology and Medicine PLLC
Physicians East PA
Cincinnati Rheumatic Disease Study Group, Inc.
Altoona Center for Clinical Research
Clinical Research of Reading, LLC
Low Country Rheumatology, PA
Regional Health Clinical Research
Regional Medical Clinic - Rheumatology
West Tennessee Research Institute
Ramesh C Gupta, M.D.
Amarillo Center for Clinical Research, Ltd.
Austin Regional Clinic
Metroplex Clinical Research Center
The Clinical Research Institute of Houston, LLC
Accurate Clinical Research
Southwest Rheumatology Research, LLC
Northwest Diagnostic Clinic, PA
Center for Arthritis and Rheumatic Diseases, P.C.
Wenatchee Valley Hospitals & Clinics
Rheumatology and Pulmonary Clinic
Paradise Arthritis & Rheumatology Pty Ltd
The Queen Elizabeth Hospital
RK Will Pty Ltd
EDUMED Educação em Saúde S/S Ltda
MHAT Plovdiv AD
University Multiprofile Hospital for Active Treatment (UMHAT) Kaspela EOOD
UMHAT "Sv. Ivan Rilski" EAD
University Multiprofile Hospital for Active Treatment "Sv. Ivan Rilski" EAD
Fundacion Instituto de Reumatologia Fernando Chalem
Lekarna Na vrsku
Revmatologie Bruntal, s.r.o.
L.K.N. Arthrocentrum, s.r.o.
Lekarna Vesalion
Benu Lekarna
CCBR-SYNARC, a.s.
Revmatologicky ustav
Lekarna Hradebni s.r.o.
MEDICAL PLUS, s.r.o.
Innomedica OÜ
East Tallinn Central Hospital
LTD "Unimed Adjara"
Unimedi Kakheti Ltd, Telavi Referral Hospital
V.Tsitlanadze Scientifically-Practical Rheumatology Center LTD
V.Tsitlanadze Scientifically-Practical Rheumatology Center
LTD Israeli-Georgian Medical Research Clinic Helsicore"
LTD Cardio-Reanimation Center
Tbilisi Heart and Vascular Clinic LTD
LTD Altravita
LTD.MediClubGeorgia
JSC Medical Corporation Evex
Schlosspark-Klinik
Gemeinschaftspraxis Dr. von Hinüber/Dr. Demary
Klinikum der Universität München
Praxiszentrum St. Bonifatius
Rheumapraxis Dr. Martin Welcker und Kollegen
Knappschaftsklinikum Saar GmbH
Rheumazentrum Ratingen
Debreceni Egyetem Klinikai Központ
Qualiclinic Kft.
Vital Medical Center Orvosi es Fogorvosi Kozpont
Anjo Kosei Hospital
Inoue Hospital
National Hospital Organization Asahikawa Medical Center
Katayama Orthopaedic Rheumatology Clinic
Sapporo City General Hospital
Hokkaido University Hospital
Matsubara Mayflower Hospital
National Hospital Organization Nagasaki Medical Center
Saitama Medical Center
Hirose Clinic
Kondo clinic for rheumatism and orthopaedics
National Hospital Organization Kyushu Medical Center
Chonnam National University Hospital
Seoul National University Hospital
Severance Hospital, Yonsei University Health System
Konkuk University Medical Center
Hanyang University Seoul Hospital
LSMUL Kauno klinikos
Klaipedos universitetine ligonine
Vilniaus universiteto ligonines Santariskiu klinikos
Consultorio Medico Privado de Reumatologia
Consultorio de Reumatologia
MedLab
Timaru Hospital
Timaru Rheumatology Studies
Waikato Hospital
Wellington Hospital, Capital Coast District Health Board
Oficina administrativa
Unidad de Investigacion en Medicina Interna y Enfermedades Criticas
Oficina Administrativa
ABK REUMA SRL-Medicentro Biociencias Peru SRL
Clinica Medica Cayetano Heredia
Centro de Investigación para el Estudio de Enfermedades Reumáticas
Instituto de Ginecología y Reproducción & Cirugía Mínimamente Invasiva
Gabinet Internistyczno-Reumatologiczny Piotr Adrian Klimiuk
NZOZ Zdrowie Osteo-Medic s.c.
Centrum Kliniczno-Badawcze J.Brzezicki, B. Gornikiewicz-Brzezicka Lekarze Spolka Partnerska
NZOZ Centrum Reumatologiczne Indywidualna Specjalistyczna Praktyka Lekarska Lek. med. Barbara Bazela
Synexus Polska Sp. z o.o. Oddzial w Gdyni
Synexus Polska Sp. z o.o. Oddzial w Katowicach
Centrum Medyczne Pratia Katowice
Zespol Poradni Specjalistycznych "REUMED" Filia nr 2
NZOZ Lecznica MAK-MED. S.C.
Prywatna Praktyka Lekarska Prof. UM Dr Hab. Med. Pawel Hrycaj
Niepubliczny Zaklad Opieki Zdrowotnej ''Nasz Lekarz''
Synexus Polska Sp. z o.o. Oddzial w Warszawie
Centrum Medyczne AMED
MTZ Clinical Research Sp. z o.o.
''Rheuma Medicus'' Zakład Opieki Zdrowotnej
Synexus Polska Sp. z o.o. Oddział we Wroclawiu
GBUZ Republican hospital n.a. V.A. Baranov
LLC Alliance Biomedical Ural group
GAUZ of Kemerovo Region "Regional clinical hospital for war veterans"
GMU Kursk Regional Clinical Hospital of the Healthcare Committee of the Kursk Region
Municipal Clinical Hospital No. 1 Named after N.I. Pirogov
GBUZ of city of Moscow City clinical hospital n.a. A.K.Eramishantsev of Ministry of Healthcare of
Orenburg State Medical Academy
Regional Clinical Hospital
GBOU VPO Ryazan State Medical University Named after Academician I.P. Pavlov
GBU of Ryazan region Regional clinical cardiology dispanser
Spb GBUZ "Clinical rheumatology hospital # 25" City CDC prevention of osteoporosis
GUZ " Regional clinical hospital"
GBUZ VO Regional clinical hospital
GBKUZ of Yaroslavl region "City hospital n. a. N.A. Semashko"
Institute of Rheumatology
Military Medical Academy,
Institute for Treatment and Rehabilitation Niska Banja
Special Hospital for Rheumatic Diseases Novi Sad
Charlotte Maxeke Johannesburg Academic Hospital
Clinresco Centres (Pty) Ltd
St. Augustine's Hospital
Arthritis Clinical Research Trials, Dr. C.E Spargo and Dr. R.B Bhorat Practice
Panorama Medical Centre
Hospital Universitario de Fuenlabrada
Hospital Universitario Cruces
Hospital Universitario A Coruña
Hospital Universitario Ramón y Cajal
Hospital Infanta Luisa
Chung Shan Medical University Hospital
China Medical University Hospital
Taipei Medical University Hospital
Kyivska miska klinichna likarnia #6
Lvivskyi oblasnyi klinichnyi diahnostychnyi tsentr,
Komunalna 4-a miska klinichna likarnia m. Lvova,
Komunalnyi zaklad okhorony zdorovia "Kharkivska miska klinichna likarnia #8"
Komunalnyi zaklad Kyivskoi oblasnoi rady "Kyivska oblasna klinichna likarnia",
Bahatoprofilnyi medychnyi tsentr (Universytetska klinika #1)
Komunalnyi zaklad Sumskoi oblasnoi rady "Sumska oblasna klinichna
Vinnytska oblasna klinichna likarnia im. M.I.Pyrohova revmatolohichne viddilennia
Komunalna ustanova "Zaporizka oblasna klinichna likarnia" Zaporizkoi oblasnoi rady
Basingstoke and North Hampshire Hospital, Hampshire Hospitals NHS Foundation Trust
Arrowe Park Hospital, Wirral University Teaching Hospitals NHS Foundation Trust
Royal United Hospital Bath NHS Foundation Trust ,Royal National Hospital for Rheumatic Diseases
The Leeds Institute of Rheumatic and Musculoskeletal Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PF-06410293

Adalimumab

Arm Description

Outcomes

Primary Outcome Measures

Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12: Period 1

ACR20 is a categorical variable indicating a 20% or greater improvement in tender and swollen joint counts and 20% or greater improvement in 3 of the 5 other ACR-core set measures: patient's assessment of arthritis pain (PAAP); patient's global assessment of arthritis (PGA); physician's global assessment of arthritis (PGAA); high sensitivity C-reactive protein (hs-CRP); and Health Assessment Questionnaire - Disability Index (HAQ-DI).

Secondary Outcome Measures

Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Other Time Points Other Than Week 12: Period 1

Number of Participants With an American College of Rheumatology 20% (ACR20) Response: Period 2

Number of Participants With an American College of Rheumatology 20% (ACR20) Response: Period 3

Number of Participants With an American College of Rheumatology 50% (ACR50) Response: Period 1

ACR50 is a categorical variable indicating a 50% or greater improvement in tender and swollen joint counts and 50% or greater improvement in 3 of the 5 other ACR-core set measures: patient's assessment of arthritis pain (PAAP); patient's global assessment of arthritis (PGA); physician's global assessment of arthritis (PGAA); high sensitivity C-reactive protein (hs-CRP); and Health Assessment Questionnaire - Disability Index (HAQ-DI).

Number of Participants With an American College of Rheumatology 50% (ACR50) Response: Period 2

Number of Participants With an American College of Rheumatology 50% (ACR50) Response: Period 3

Number of Participants With an American College of Rheumatology 70% (ACR70) Response: Period 1

ACR70 is a categorical variable indicating a 70% or greater improvement in tender and swollen joint counts and 70% or greater improvement in 3 of the 5 other ACR-core set measures: patient's assessment of arthritis pain (PAAP); patient's global assessment of arthritis (PGA); physician's global assessment of arthritis (PGAA); high sensitivity C-reactive protein (hs-CRP); and Health Assessment Questionnaire - Disability Index (HAQ-DI).

Number of Participants With an American College of Rheumatology 70% (ACR70) Response: Period 2

Number of Participants With an American College of Rheumatology 70% (ACR70) Response: Period 3

Change From Baseline in Tender Joint Count: Period 1

Sixty-eight (68) joints were assessed by an independent blinded joint assessor to determine the number of joints that were considered tender. The 68 joints assessed were: upper body including temporomandibular, sternoclavicular, acromioclavicular; upper extremity including shoulder, elbow, wrist (radiocarpal, carpal and carpometacarpal considered as 1 unit), metacarpophalangeals (MCP I, II, III, IV, V), thumb interphalangeal, proximal interphalangeals (PIP II, III, IV, V), and distal interphalangeals (DIP II, III, IV, V); lower extremity including hip, knee, ankle, tarsus (subtalar, transverse tarsal and tarsometatarsal considered as 1 unit), metatarsophalangeals (MTP I, II, III, IV, V), great toe interphalangeal, proximal and distal interphalangeals combined (PIP and DIP II, III, IV, V).

Change From Baseline in Tender Joint Count: Period 2

Change From Baseline in Tender Joint Count: Period 3

Change From Baseline in Swollen Joint Count: Period 1

Sixty-six (66) joints were assessed for swelling, the same as those listed for tender joint count, excluding the right and left hip joints.

Change From Baseline in Swollen Joint Count: Period 2

Sixty-six (66) joints were assessed for swelling, the same as those listed for tender joint count, excluding the right and left hip joints.

Change From Baseline in Swollen Joint Count: Period 3

Sixty-six (66) joints were assessed for swelling, the same as those listed for tender joint count, excluding the right and left hip joints.

Change From Baseline in Physician's Global Assessment of Arthritis (PGAA): Period 1

The investigator assessed how the participant's overall arthritis appeared at the time of the visit. This was an evaluation based on the participant's disease symptoms, functional capacity and physical examination, and independent of the participant's reported assessments of PGA (patient's global assessment of arthritis) and PAAP (patient's assessment of arthritis pain). The investigator's response was recorded using a 100 mm visual analog scale (VAS), with the 0 mm end labeled "None" and the 100 mm end labeled "Extreme".

Change From Baseline in Physician's Global Assessment of Arthritis (PGAA): Period 2

Change From Baseline in Physician's Global Assessment of Arthritis (PGAA): Period 3

Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP): Period 1

Participants assessed the severity of their arthritis pain using a 100 mm Visual Analog Scale (VAS) by placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain.

Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP): Period 2

Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP): Period 3

Change From Baseline in Patient's Global Assessment of Arthritis (PGA): Period 1

Participants answered the following question, "Considering all the ways your arthritis affects you, how are you feeling today?" The participant's response was recorded using a 100 mm visual analog scale (VAS), with the 0 mm end labeled "Very Well" and the 100 mm end labeled "Very Poorly".

Change From Baseline in Patient's Global Assessment of Arthritis (PGA): Period 2

Change From Baseline in Patient's Global Assessment of Arthritis (PGA): Period 3

Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI): Period 1

HAQ-DI assesses the degree of difficulty a participant had experienced during the past week in 8 domains of daily activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consisted of 2-3 items. For each question in the questionnaire, the level of difficulty was scored from 0 to 3 with 0 representing "no difficulty", 1 as "some difficulty", 2 as "much difficulty", and 3 as "unable to do". Any activity that required assistance from another individual or required the use of an assistive device would adjust to a minimum score of 2 to represent a more limited functional status. Overall score was computed as the sum of scores divided by the number of domains answered. Total possible score range was 0-3 with 0 representing "no difficulty", 1 as "some difficulty", 2 as "much difficulty", and 3 as "unable to do". Higher score indicate more difficulty in performing daily living activities.

Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI): Period 2

Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI): Period 3

Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP): Period 1

Serum samples were analyzed to determine the level of hs-CRP, which was an acute-phase reactant.

Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP): Period 2

Serum samples were analyzed to determine the level of hs-CRP, which was an acute-phase reactant.

Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP): Period 3

Serum samples were analyzed to determine the level of hs-CRP, which was an acute-phase reactant.

Change From Baseline in Disease Activity Score-28 (4 Components Based on High-Sensitivity C-Reactive Protein) (DAS28-4 [CRP]): Period 1

The DAS assessment is a continuous composite measure derived using differential weighting given to each component. The components of the DAS28-4 (CRP) assessment included: tender joint count with 28 joints assessed, swollen joint count with 28 joints assessed, high-sensitivity C-reactive protein (hs-CRP) and patient's global assessment of arthritis (PGA). DAS28-4 (CRP) was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 ln(CRP [mg/L] +1) + 0.014 (PGA [mm]) + 0.96. Higher score indicate more disease activity. The possible lowest score is 0.96. The possible highest score is difficult to be determined, due to indeterminable nature of hs-CRP level; assuming hs-CRP level is 0 to 500 mg/L, the possible highest score would be 6.8 (when hs-CRP is 0) to 9.04 (when hs-CRP is 500 mg/L).

Change From Baseline in Disease Activity Score-28 (4 Components Based on High-Sensitivity C-Reactive Protein) (DAS28-4 [CRP]): Period 2

Change From Baseline in Disease Activity Score-28 (4 Components Based on High-Sensitivity C-Reactive Protein) (DAS28-4 [CRP]): Period 3

Number of Participants Achieving European League Against Rheumatism (EULAR) Response: Period 1

EULAR response was based on DAS28 EULAR response criteria. Good response was achieved if DAS28 improvement from baseline >1.2 and DAS28 =<3.2. Moderate response was achieved if DAS28 improvement from baseline >0.6 to =<1.2 and DAS28 =<5.1; or DAS improvement from baseline >1.2 and DAS28 >3.2. No response was achieved if DAS improvement from baseline =<0.6 (no matter present DAS28 score); or DAS improvement from baseline >0.6 to =<1.2 and DAS28 >5.1.

Number of Participants Achieving European League Against Rheumatism (EULAR) Response: Period 2

Number of Participants Achieving European League Against Rheumatism (EULAR) Response: Period 3

Number of Participants Achieving Disease Activity Score Remission (DAS <2.6): Period 1

The DAS assessment is a continuous composite measure derived using differential weighting given to each component. The components of the DAS28-4 (CRP) assessment included: tender joint count with 28 joints assessed, swollen joint count with 28 joints assessed, high-sensitivity C-reactive protein (hs-CRP) and patient's global assessment of arthritis (PGA). DAS28-4 (CRP) was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 ln(CRP [mg/L] +1) + 0.014 (PGA [mm]) + 0.96. The possible lowest score is 0.96. The possible highest score is difficult to be determined, due to indeterminable nature of hs-CRP level; assuming hs-CRP level is 0 to 500 mg/L, the possible highest score would be 6.8 (when hs-CRP is 0) to 9.04 (when hs-CRP is 500 mg/L). Higher score indicate more disease activity; DAS28-4 (CRP) <2.6 indicates remission.

Number of Participants Achieving Disease Activity Score Remission (DAS <2.6): Period 2

The DAS assessment is a continuous composite measure derived using differential weighting given to each component. The components of the DAS28-4 (CRP) assessment included: tender joint count with 28 joints assessed, swollen joint count with 28 joints assessed, high-sensitivity C-reactive protein (hs-CRP) and patient's global assessment of arthritis (PGA). DAS28-4 (CRP) was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 ln(CRP [mg/L] +1) + 0.014 (PGA [mm]) + 0.96. The possible lowest score is 0.96. The possible highest score is difficult to be determined, due to indeterminable nature of hs-CRP level; assuming hs-CRP level is 0 to 500 mg/L, the possible highest score would be 6.8 (when hs-CRP is 0) to 9.04 (when hs-CRP is 500 mg/L). Higher score indicate more disease activity; DAS28-4 (CRP) <2.6 indicates remission.

Number of Participants Achieving Disease Activity Score Remission (DAS <2.6): Period 3

The DAS assessment is a continuous composite measure derived using differential weighting given to each component. The components of the DAS28-4 (CRP) assessment included: tender joint count with 28 joints assessed, swollen joint count with 28 joints assessed, high-sensitivity C-reactive protein (hs-CRP) and patient's global assessment of arthritis (PGA). DAS28-4 (CRP) was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 ln(CRP [mg/L] +1) + 0.014 (PGA [mm]) + 0.96. The possible lowest score is 0.96. The possible highest score is difficult to be determined, due to indeterminable nature of hs-CRP level; assuming hs-CRP level is 0 to 500 mg/L, the possible highest score would be 6.8 (when hs-CRP is 0) to 9.04 (when hs-CRP is 500 mg/L). Higher score indicate more disease activity; DAS28-4 (CRP) <2.6 indicates remission.

Number of Participants Achieving American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Response：Period 1

Participants were considered to be in ACR/EULAR remission when either of the following criteria was met: scores on the tender joint count, swollen joint count, hs-CRP (mg/dL) and PGA (0-10 cm scale) were all =<1; or the score on the simplified disease activity index (SDAI) was =<3.3. SDAI score was the sum of tender joint count (28), swollen joint count (28), PGA (0-10 cm scale), physician's global assessment of arthritis (PGAA, 0-10 cm scale) and hs-CRP (mg/dL).

Number of Participants Achieving American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Response: Period 2

Number of Participants Achieving American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Response: Period 3

Serum Concentration Versus Time Summary: Period 1

Serum Concentration Versus Time Summary: Period 2

Serum Concentration Versus Time Summary: Period 3

Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (NAb): Period 1

Serum samples were analyzed for the presence or absence of ADA using a semi-quantitative electrochemiluminescent (ECL) assay, and ADA positive was defined as ADA titer >=1.88. Serum samples tested positive for ADA were further analyzed for the presence or absence of NAb using a semi-quantitative cell-based assay, and NAb positive was defined as NAb titer >=0.70.

Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (NAb): Period 2

Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (NAb): Period 3

Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 1

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs for Period 1 were events between first dose of study drug in Period 1 and up to Week 26 pre-dose assessments that were absent before treatment or that worsened relative to pre-treatment state. Treatment-related TEAE was any untoward medical occurrence attributed to study drug. AEs included both serious and non-serious AEs.

Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 2

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs for Period 2 were events between first dose of study drug in Period 2 and up to Week 52 pre-dose assessments that were absent before treatment or that worsened relative to prior state. Treatment-related TEAE was any untoward medical occurrence attributed to study drug. AEs included both serious and non-serious AEs.

Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 3

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs for Period 3 were events between first dose of study drug in Period 3 and up to Week 92 visit that were absent before treatment or that worsened relative to prior state. Treatment-related TEAE was any untoward medical occurrence attributed to study drug. AEs included both serious and non-serious AEs.

Number of Participants With Laboratory Abnormalities: Period 1

Laboratory evaluation included hematology, clinical chemistry, and urinalysis. Each parameter was evaluated against commonly used and widely accepted criteria. Number of participants with any laboratory abnormality during Period 1 (without regard to baseline abnormality) is presented.

Number of Participants With Laboratory Abnormalities: Period 2

Laboratory evaluation included hematology, clinical chemistry, and urinalysis. Each parameter was evaluated against commonly used and widely accepted criteria. Number of participants with any laboratory abnormality during Period 2 (without regard to baseline abnormality) is presented.

Number of Participants With Laboratory Abnormalities: Period 3

Laboratory evaluation included hematology, clinical chemistry, and urinalysis. Each parameter was evaluated against commonly used and widely accepted criteria. Number of participants with any laboratory abnormality during Period 3 (without regard to baseline abnormality) is presented.

Full Information

NCT ID

NCT02480153

First Posted

June 19, 2015

Last Updated

January 18, 2019

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT02480153

Brief Title

A Study Of PF-06410293 (Adalimumab-Pfizer) And Adalimumab (Humira®) In Combination With Methotrexate In Subjects With Active Rheumatoid Arthritis (REFLECTIONS B538-02).

Official Title

A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06410293 AND ADALIMUMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Completed

Study Start Date

June 25, 2015 (Actual)

Primary Completion Date

August 31, 2016 (Actual)

Study Completion Date

December 6, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The study will assess the efficacy, safety, and immunogenicity of PF-06410293 and adalimumab in combination with methotrexate in subjects with moderately to severly active rheumatoid arthritis who have had an inadequate response to methotrexate. In an additional optional portion of the study, during open label Treatment Period 3 (TP3), a subset of subjects used a Prefilled Pen (PFP) to administer up to 3 injections of their study treatment (PF-06410293) at home.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rheumatoid Arthritis

Keywords

Phase 3, adalimumab, rheumatoid arthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

597 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PF-06410293

Arm Type

Experimental

Arm Title

Adalimumab

Arm Type

Active Comparator

Intervention Type

Biological

Intervention Name(s)

PF-06410293

Other Intervention Name(s)

Adalimumab-Pfizer

Intervention Description

PF-06410293 will be administered with a uniform dose regimen, which is SC injection at a dose of 40 mg every other week, throughout the study treatment.

Intervention Type

Biological

Intervention Name(s)

Adalimumab

Other Intervention Name(s)

Adalimumab-European Union, Humira®

Intervention Description

Adalimumab will be administered with a uniform dose regimen, which is SC injection at a dose of 40 mg every other week, throughout the study treatment.

Primary Outcome Measure Information:

Title

Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12: Period 1

Description

Time Frame

Week 12

Secondary Outcome Measure Information:

Title

Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Other Time Points Other Than Week 12: Period 1

Description

Time Frame

Weeks 2, 4, 6, 8, 18 and 26 (pre-dose)

Title

Number of Participants With an American College of Rheumatology 20% (ACR20) Response: Period 2

Description

Time Frame

Weeks 26, 30, 36, 44 and 52 (pre-dose)

Title

Number of Participants With an American College of Rheumatology 20% (ACR20) Response: Period 3

Description

Time Frame

Weeks 52, 56, 66, 76 and 78

Title

Number of Participants With an American College of Rheumatology 50% (ACR50) Response: Period 1

Description

Time Frame

Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)

Title

Number of Participants With an American College of Rheumatology 50% (ACR50) Response: Period 2

Description

Time Frame

Weeks 26, 30, 36, 44 and 52 (pre-dose)

Title

Number of Participants With an American College of Rheumatology 50% (ACR50) Response: Period 3

Description

Time Frame

Weeks 52, 56, 66, 76 and 78

Title

Number of Participants With an American College of Rheumatology 70% (ACR70) Response: Period 1

Description

Time Frame

Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)

Title

Number of Participants With an American College of Rheumatology 70% (ACR70) Response: Period 2

Description

Time Frame

Weeks 26, 30, 36, 44 and 52 (pre-dose)

Title

Number of Participants With an American College of Rheumatology 70% (ACR70) Response: Period 3

Description

Time Frame

Weeks 52, 56, 66, 76 and 78

Title

Change From Baseline in Tender Joint Count: Period 1

Description

Time Frame

Baseline, Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)

Title

Change From Baseline in Tender Joint Count: Period 2

Description

Time Frame

Baseline, Weeks 26, 30, 36, 44 and 52 (pre-dose)

Title

Change From Baseline in Tender Joint Count: Period 3

Description

Time Frame

Baseline, Weeks 52, 56, 66, 76 and 78

Title

Change From Baseline in Swollen Joint Count: Period 1

Description

Sixty-six (66) joints were assessed for swelling, the same as those listed for tender joint count, excluding the right and left hip joints.

Time Frame

Baseline, Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)

Title

Change From Baseline in Swollen Joint Count: Period 2

Description

Sixty-six (66) joints were assessed for swelling, the same as those listed for tender joint count, excluding the right and left hip joints.

Time Frame

Baseline, Weeks 26, 30, 36, 44 and 52 (pre-dose)

Title

Change From Baseline in Swollen Joint Count: Period 3

Description

Sixty-six (66) joints were assessed for swelling, the same as those listed for tender joint count, excluding the right and left hip joints.

Time Frame

Baseline, Weeks 52, 56, 66, 76 and 78

Title

Change From Baseline in Physician's Global Assessment of Arthritis (PGAA): Period 1

Description

Time Frame

Baseline, Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)

Title

Change From Baseline in Physician's Global Assessment of Arthritis (PGAA): Period 2

Description

Time Frame

Baseline, Weeks 26, 30, 36, 44 and 52 (pre-dose)

Title

Change From Baseline in Physician's Global Assessment of Arthritis (PGAA): Period 3

Description

Time Frame

Baseline, Weeks 52, 56, 66, 76 and 78

Title

Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP): Period 1

Description

Time Frame

Baseline, Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)

Title

Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP): Period 2

Description

Time Frame

Baseline, Weeks 26, 30, 36, 44 and 52 (pre-dose)

Title

Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP): Period 3

Description

Time Frame

Baseline, Weeks 52, 56, 66, 76 and 78

Title

Change From Baseline in Patient's Global Assessment of Arthritis (PGA): Period 1

Description

Time Frame

Baseline, Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)

Title

Change From Baseline in Patient's Global Assessment of Arthritis (PGA): Period 2

Description

Time Frame

Baseline, Weeks 26, 30, 36, 44 and 52 (pre-dose)

Title

Change From Baseline in Patient's Global Assessment of Arthritis (PGA): Period 3

Description

Time Frame

Baseline, Weeks 52, 56, 66, 76 and 78

Title

Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI): Period 1

Description

Time Frame

Baseline, Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)

Title

Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI): Period 2

Description

Time Frame

Baseline, Weeks 26, 30, 36, 44 and 52 (pre-dose)

Title

Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI): Period 3

Description

Time Frame

Baseline, Weeks 52, 56, 66, 76 and 78

Title

Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP): Period 1

Description

Serum samples were analyzed to determine the level of hs-CRP, which was an acute-phase reactant.

Time Frame

Baseline, Weeks1, 2, 4, 6, 8, 12, 18 and 26 (pre-dose)

Title

Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP): Period 2

Description

Serum samples were analyzed to determine the level of hs-CRP, which was an acute-phase reactant.

Time Frame

Baseline, Weeks 26, 30, 36, 44 and 52 (pre-dose)

Title

Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP): Period 3

Description

Serum samples were analyzed to determine the level of hs-CRP, which was an acute-phase reactant.

Time Frame

Baseline, Weeks 52, 56, 66, 76 and 78

Title

Change From Baseline in Disease Activity Score-28 (4 Components Based on High-Sensitivity C-Reactive Protein) (DAS28-4 [CRP]): Period 1

Description

Time Frame

Baseline, Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)

Title

Change From Baseline in Disease Activity Score-28 (4 Components Based on High-Sensitivity C-Reactive Protein) (DAS28-4 [CRP]): Period 2

Description

Time Frame

Baseline, Weeks 26, 30, 36, 44 and 52 (pre-dose)

Title

Change From Baseline in Disease Activity Score-28 (4 Components Based on High-Sensitivity C-Reactive Protein) (DAS28-4 [CRP]): Period 3

Description

Time Frame

Baseline, Weeks 52, 56, 66, 76 and 78

Title

Number of Participants Achieving European League Against Rheumatism (EULAR) Response: Period 1

Description

Time Frame

Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)

Title

Number of Participants Achieving European League Against Rheumatism (EULAR) Response: Period 2

Description

Time Frame

Weeks 26, 30, 36, 44 and 52 (pre-dose)

Title

Number of Participants Achieving European League Against Rheumatism (EULAR) Response: Period 3

Description

Time Frame

Weeks 52, 56, 66, 76 and 78

Title

Number of Participants Achieving Disease Activity Score Remission (DAS <2.6): Period 1

Description

The DAS assessment is a continuous composite measure derived using differential weighting given to each component. The components of the DAS28-4 (CRP) assessment included: tender joint count with 28 joints assessed, swollen joint count with 28 joints assessed, high-sensitivity C-reactive protein (hs-CRP) and patient's global assessment of arthritis (PGA). DAS28-4 (CRP) was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 ln(CRP [mg/L] +1) + 0.014 (PGA [mm]) + 0.96. The possible lowest score is 0.96. The possible highest score is difficult to be determined, due to indeterminable nature of hs-CRP level; assuming hs-CRP level is 0 to 500 mg/L, the possible highest score would be 6.8 (when hs-CRP is 0) to 9.04 (when hs-CRP is 500 mg/L). Higher score indicate more disease activity; DAS28-4 (CRP) <2.6 indicates remission.

Time Frame

Baseline, Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)

Title

Number of Participants Achieving Disease Activity Score Remission (DAS <2.6): Period 2

Description

The DAS assessment is a continuous composite measure derived using differential weighting given to each component. The components of the DAS28-4 (CRP) assessment included: tender joint count with 28 joints assessed, swollen joint count with 28 joints assessed, high-sensitivity C-reactive protein (hs-CRP) and patient's global assessment of arthritis (PGA). DAS28-4 (CRP) was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 ln(CRP [mg/L] +1) + 0.014 (PGA [mm]) + 0.96. The possible lowest score is 0.96. The possible highest score is difficult to be determined, due to indeterminable nature of hs-CRP level; assuming hs-CRP level is 0 to 500 mg/L, the possible highest score would be 6.8 (when hs-CRP is 0) to 9.04 (when hs-CRP is 500 mg/L). Higher score indicate more disease activity; DAS28-4 (CRP) <2.6 indicates remission.

Time Frame

Weeks 26, 30, 36, 44 and 52 (pre-dose)

Title

Number of Participants Achieving Disease Activity Score Remission (DAS <2.6): Period 3

Description

The DAS assessment is a continuous composite measure derived using differential weighting given to each component. The components of the DAS28-4 (CRP) assessment included: tender joint count with 28 joints assessed, swollen joint count with 28 joints assessed, high-sensitivity C-reactive protein (hs-CRP) and patient's global assessment of arthritis (PGA). DAS28-4 (CRP) was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 ln(CRP [mg/L] +1) + 0.014 (PGA [mm]) + 0.96. The possible lowest score is 0.96. The possible highest score is difficult to be determined, due to indeterminable nature of hs-CRP level; assuming hs-CRP level is 0 to 500 mg/L, the possible highest score would be 6.8 (when hs-CRP is 0) to 9.04 (when hs-CRP is 500 mg/L). Higher score indicate more disease activity; DAS28-4 (CRP) <2.6 indicates remission.

Time Frame

Weeks 52, 56, 66, 76 and 78

Title

Number of Participants Achieving American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Response：Period 1

Description

Time Frame

Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)

Title

Number of Participants Achieving American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Response: Period 2

Description

Time Frame

Weeks 26, 30, 36, 44 and 52 (pre-dose)

Title

Number of Participants Achieving American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Response: Period 3

Description

Time Frame

Weeks 52, 56, 66, 76 and 78

Title

Serum Concentration Versus Time Summary: Period 1

Time Frame

Pre-dose on Days 1, 15, 43, 85 and 183, and at any time during Day 8 visit

Title

Serum Concentration Versus Time Summary: Period 2

Time Frame

Pre-dose on Days 183, 211, 253 and 365

Title

Serum Concentration Versus Time Summary: Period 3

Time Frame

Pre-dose on Days 365, 393, 463, 547 and 575

Title

Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (NAb): Period 1

Description

Time Frame

Baseline up to Week 26 (pre-dose)

Title

Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (NAb): Period 2

Description

Time Frame

Week 26 dosing up to Week 52 (pre-dose)

Title

Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (NAb): Period 3

Description

Time Frame

Week 52 dosing up to follow-up visit (Week 92)

Title

Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 1

Description

Time Frame

Baseline (Day 1) up to Week 26 (pre-dose)

Title

Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 2

Description

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs for Period 2 were events between first dose of study drug in Period 2 and up to Week 52 pre-dose assessments that were absent before treatment or that worsened relative to prior state. Treatment-related TEAE was any untoward medical occurrence attributed to study drug. AEs included both serious and non-serious AEs.

Time Frame

Week 26 dosing up to Week 52 (pre-dose)

Title

Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 3

Description

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs for Period 3 were events between first dose of study drug in Period 3 and up to Week 92 visit that were absent before treatment or that worsened relative to prior state. Treatment-related TEAE was any untoward medical occurrence attributed to study drug. AEs included both serious and non-serious AEs.

Time Frame

Week 52 dosing up to follow-up visit (Week 92)

Title

Number of Participants With Laboratory Abnormalities: Period 1

Description

Time Frame

Baseline (Day 1) up to Week 26 (pre-dose)

Title

Number of Participants With Laboratory Abnormalities: Period 2

Description

Laboratory evaluation included hematology, clinical chemistry, and urinalysis. Each parameter was evaluated against commonly used and widely accepted criteria. Number of participants with any laboratory abnormality during Period 2 (without regard to baseline abnormality) is presented.

Time Frame

Week 26 dosing up to Week 52 (pre-dose)

Title

Number of Participants With Laboratory Abnormalities: Period 3

Description

Laboratory evaluation included hematology, clinical chemistry, and urinalysis. Each parameter was evaluated against commonly used and widely accepted criteria. Number of participants with any laboratory abnormality during Period 3 (without regard to baseline abnormality) is presented.

Time Frame

Week 52 dosing up to follow-up visit (Week 92)

Other Pre-specified Outcome Measures:

Title

Percentage of Participants Who Achieved Delivery Success in Sub-study

Description

A sub-study was conducted to determine whether participants or their non-healthcare professional caregivers could safely and effectively administer PF-06410293 with the sponsor's prefilled pen (PFP) device.

Time Frame

Weeks 56, 58, 60, 62, 64, 66

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Diagnosis of rheumatoid arthritis based on 2010 ACR/EULAR criteria for at least 4 months. At least 6 tender (of 68 assessed) and 6 swollen (of 66 assessed) joints at screening and baseline. Hs-CRP equal or greater than 8 mg/L. Must have received methotrexate for at least 12 weeks and been on a stable dose for at least 4 weeks prior to the first study dose. Exclusion Criteria: Evidence of untreated or inadequately treated latent or active TB. Evidence of uncontrolled, clinically significant diseases, including moderate or severe heart failure (NYHA Class III/IV) or malignancy in the previous 5 years. History of infection requiring hospitalization or parenteral antimicrobial therapy within 6 months prior to first dose of study drug. May have received no more than 2 doses of one biologic therapy (other than adalimumab or lymphocyte depleting therapy). Any second DMARD must be washed out prior to the first study dose.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

ArthroCare, Arthritis Care & Research P.C.

City

Gilbert

State/Province

Arizona

ZIP/Postal Code

85234

Country

United States

Facility Name

Arizona Arthritis & Rheumatology Associates, PC

City

Glendale

State/Province

Arizona

ZIP/Postal Code

85306

Country

United States

Facility Name

Arizona Arthritis & Rheumatology Associates, PC

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85032

Country

United States

Facility Name

St. Jude Hospital Yorba Linda DBA St. Joseph Heritage Healthcare

City

Fullerton

State/Province

California

ZIP/Postal Code

92835

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

Westlake Medical Research

City

Thousand Oaks

State/Province

California

ZIP/Postal Code

91360

Country

United States

Facility Name

Inland Rheumatology Clinical Trials, Inc.

City

Upland

State/Province

California

ZIP/Postal Code

91786

Country

United States

Facility Name

Desert Valley Medical Group

City

Victorville

State/Province

California

ZIP/Postal Code

92395

Country

United States

Facility Name

Javed Rheumatology Associates, Inc

City

Newark

State/Province

Delaware

ZIP/Postal Code

19713

Country

United States

Facility Name

Arthritis and Rheumatic Disease Specialties

City

Aventura

State/Province

Florida

ZIP/Postal Code

33180

Country

United States

Facility Name

Robert W. Levin, MD, PA

City

Clearwater

State/Province

Florida

ZIP/Postal Code

33765

Country

United States

Facility Name

International Medical Research

City

Daytona Beach

State/Province

Florida

ZIP/Postal Code

32117

Country

United States

Facility Name

SIMED Arthritis Center

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32607

Country

United States

Facility Name

Southeastern Integrated Medical, PL, d/b/a Florida Medical Research

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32607

Country

United States

Facility Name

Rheumatology Associates of Central Florida, P.A.

City

Orlando

State/Province

Florida

ZIP/Postal Code

32806

Country

United States

Facility Name

Sarasota Arthritis Research Center

City

Sarasota

State/Province

Florida

ZIP/Postal Code

34239

Country

United States

Facility Name

Alastair C. Kennedy, MD

City

Vero Beach

State/Province

Florida

ZIP/Postal Code

32960

Country

United States

Facility Name

Indian River Primary Care

City

Vero Beach

State/Province

Florida

ZIP/Postal Code

32960

Country

United States

Facility Name

St Luke's Intermountain Research Center

City

Boise

State/Province

Idaho

ZIP/Postal Code

83702

Country

United States

Facility Name

St Luke' s Clinic

City

Meridian

State/Province

Idaho

ZIP/Postal Code

83642

Country

United States

Facility Name

Physician's Clinic of Iowa, P.C.

City

Cedar Rapids

State/Province

Iowa

ZIP/Postal Code

52403

Country

United States

Facility Name

Graves-Gilbert Clinic Bowling Green

City

Bowling Green

State/Province

Kentucky

ZIP/Postal Code

42101

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

Bronson Internal Medicine and Rheumatology

City

Battle Creek

State/Province

Michigan

ZIP/Postal Code

49015

Country

United States

Facility Name

North Mississippi Medical Clinics, Inc. - Clinical Research

City

Tupelo

State/Province

Mississippi

ZIP/Postal Code

38801

Country

United States

Facility Name

Physician Research Collaboration, LLC

City

Lincoln

State/Province

Nebraska

ZIP/Postal Code

68516

Country

United States

Facility Name

Westroads Clinical Research, Inc.

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68114

Country

United States

Facility Name

Arthritis, Rheumatic & Back Disease Associates, P.A.

City

Voorhees

State/Province

New Jersey

ZIP/Postal Code

08043

Country

United States

Facility Name

Manhattan Medical Research

City

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

Facility Name

Buffalo Rheumatology and Medicine PLLC

City

Orchard Park

State/Province

New York

ZIP/Postal Code

14127

Country

United States

Facility Name

Physicians East PA

City

Greenville

State/Province

North Carolina

ZIP/Postal Code

27834

Country

United States

Facility Name

Cincinnati Rheumatic Disease Study Group, Inc.

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45242

Country

United States

Facility Name

Altoona Center for Clinical Research

City

Duncansville

State/Province

Pennsylvania

ZIP/Postal Code

16635

Country

United States

Facility Name

Clinical Research of Reading, LLC

City

Wyomissing

State/Province

Pennsylvania

ZIP/Postal Code

19610

Country

United States

Facility Name

Low Country Rheumatology, PA

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29406

Country

United States

Facility Name

Regional Health Clinical Research

City

Rapid City

State/Province

South Dakota

ZIP/Postal Code

57701

Country

United States

Facility Name

Regional Medical Clinic - Rheumatology

City

Rapid City

State/Province

South Dakota

ZIP/Postal Code

57701

Country

United States

Facility Name

West Tennessee Research Institute

City

Jackson

State/Province

Tennessee

ZIP/Postal Code

38305

Country

United States

Facility Name

Ramesh C Gupta, M.D.

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38119

Country

United States

Facility Name

Amarillo Center for Clinical Research, Ltd.

City

Amarillo

State/Province

Texas

ZIP/Postal Code

79124

Country

United States

Facility Name

Austin Regional Clinic

City

Austin

State/Province

Texas

ZIP/Postal Code

78731

Country

United States

Facility Name

Metroplex Clinical Research Center

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

Facility Name

The Clinical Research Institute of Houston, LLC

City

Houston

State/Province

Texas

ZIP/Postal Code

77090

Country

United States

Facility Name

Accurate Clinical Research

City

League City

State/Province

Texas

ZIP/Postal Code

77573

Country

United States

Facility Name

Southwest Rheumatology Research, LLC

City

Mesquite

State/Province

Texas

ZIP/Postal Code

75150

Country

United States

Facility Name

Northwest Diagnostic Clinic, PA

City

Shenandoah

State/Province

Texas

ZIP/Postal Code

77380

Country

United States

Facility Name

Center for Arthritis and Rheumatic Diseases, P.C.

City

Chesapeake

State/Province

Virginia

ZIP/Postal Code

23320

Country

United States

Facility Name

Wenatchee Valley Hospitals & Clinics

City

Wenatchee

State/Province

Washington

ZIP/Postal Code

98801

Country

United States

Facility Name

Rheumatology and Pulmonary Clinic

City

Beckley

State/Province

West Virginia

ZIP/Postal Code

25801

Country

United States

Facility Name

Paradise Arthritis & Rheumatology Pty Ltd

City

Southport

State/Province

Queensland

ZIP/Postal Code

4215

Country

Australia

Facility Name

The Queen Elizabeth Hospital

City

Woodville South

State/Province

South Australia

ZIP/Postal Code

5011

Country

Australia

Facility Name

RK Will Pty Ltd

City

Victoria Park

State/Province

Western Australia

ZIP/Postal Code

6100

Country

Australia

Facility Name

EDUMED Educação em Saúde S/S Ltda

City

Curitiba

State/Province

Paraná

ZIP/Postal Code

80440-080

Country

Brazil

Facility Name

MHAT Plovdiv AD

City

Plovdiv

ZIP/Postal Code

4000

Country

Bulgaria

Facility Name

University Multiprofile Hospital for Active Treatment (UMHAT) Kaspela EOOD

City

Plovdiv

ZIP/Postal Code

4002

Country

Bulgaria

Facility Name

UMHAT "Sv. Ivan Rilski" EAD

City

Sofia

ZIP/Postal Code

1612

Country

Bulgaria

Facility Name

University Multiprofile Hospital for Active Treatment "Sv. Ivan Rilski" EAD

City

Sofia

ZIP/Postal Code

1612

Country

Bulgaria

Facility Name

Fundacion Instituto de Reumatologia Fernando Chalem

City

Bogota

Country

Colombia

Facility Name

Lekarna Na vrsku

City

Bruntal

ZIP/Postal Code

792 01

Country

Czechia

Facility Name

Revmatologie Bruntal, s.r.o.

City

Bruntal

ZIP/Postal Code

792 01

Country

Czechia

Facility Name

L.K.N. Arthrocentrum, s.r.o.

City

Hlucin

ZIP/Postal Code

748 01

Country

Czechia

Facility Name

Lekarna Vesalion

City

Ostrava

ZIP/Postal Code

702 00

Country

Czechia

Facility Name

Benu Lekarna

City

Pardubice

ZIP/Postal Code

530 02

Country

Czechia

Facility Name

CCBR-SYNARC, a.s.

City

Pardubice

ZIP/Postal Code

530 02

Country

Czechia

Facility Name

Revmatologicky ustav

City

Praha 2

ZIP/Postal Code

128 50

Country

Czechia

Facility Name

Lekarna Hradebni s.r.o.

City

Uherske Hradiste

ZIP/Postal Code

686 01

Country

Czechia

Facility Name

MEDICAL PLUS, s.r.o.

City

Uherske Hradiste

ZIP/Postal Code

686 01

Country

Czechia

Facility Name

Innomedica OÜ

City

Tallinn

ZIP/Postal Code

10117

Country

Estonia

Facility Name

East Tallinn Central Hospital

City

Tallinn

ZIP/Postal Code

11312

Country

Estonia

Facility Name

LTD "Unimed Adjara"

City

Batumi

State/Province

Ajaria

ZIP/Postal Code

6010

Country

Georgia

Facility Name

Unimedi Kakheti Ltd, Telavi Referral Hospital

City

Telavi

State/Province

Kakheti

ZIP/Postal Code

2200

Country

Georgia

Facility Name

V.Tsitlanadze Scientifically-Practical Rheumatology Center LTD

City

Tbilisi

ZIP/Postal Code

0102

Country

Georgia

Facility Name

V.Tsitlanadze Scientifically-Practical Rheumatology Center

City

Tbilisi

ZIP/Postal Code

0105

Country

Georgia

Facility Name

LTD Israeli-Georgian Medical Research Clinic Helsicore"

City

Tbilisi

ZIP/Postal Code

0112

Country

Georgia

Facility Name

LTD Cardio-Reanimation Center

City

Tbilisi

ZIP/Postal Code

0159

Country

Georgia

Facility Name

Tbilisi Heart and Vascular Clinic LTD

City

Tbilisi

ZIP/Postal Code

0159

Country

Georgia

Facility Name

LTD Altravita

City

Tbilisi

ZIP/Postal Code

0160

Country

Georgia

Facility Name

LTD.MediClubGeorgia

City

Tbilisi

ZIP/Postal Code

0160

Country

Georgia

Facility Name

JSC Medical Corporation Evex

City

Tbilisi

ZIP/Postal Code

0177

Country

Georgia

Facility Name

Schlosspark-Klinik

City

Berlin

ZIP/Postal Code

14059

Country

Germany

Facility Name

Gemeinschaftspraxis Dr. von Hinüber/Dr. Demary

City

Hildesheim

ZIP/Postal Code

31134

Country

Germany

Facility Name

Klinikum der Universität München

City

München

ZIP/Postal Code

80336

Country

Germany

Facility Name

Praxiszentrum St. Bonifatius

City

München

ZIP/Postal Code

81541

Country

Germany

Facility Name

Rheumapraxis Dr. Martin Welcker und Kollegen

City

Planegg

ZIP/Postal Code

82152

Country

Germany

Facility Name

Knappschaftsklinikum Saar GmbH

City

Püttlingen

ZIP/Postal Code

66346

Country

Germany

Facility Name

Rheumazentrum Ratingen

City

Ratingen

ZIP/Postal Code

40878

Country

Germany

Facility Name

Debreceni Egyetem Klinikai Központ

City

Debrecen

State/Province

Hajdú-bihar

ZIP/Postal Code

H-4032

Country

Hungary

Facility Name

Qualiclinic Kft.

City

Budapest

ZIP/Postal Code

1036

Country

Hungary

Facility Name

Vital Medical Center Orvosi es Fogorvosi Kozpont

City

Veszprem

ZIP/Postal Code

8200

Country

Hungary

Facility Name

Anjo Kosei Hospital

City

Anjo-shi

State/Province

Aichi

ZIP/Postal Code

446-8602

Country

Japan

Facility Name

Inoue Hospital

City

Takasaki

State/Province

Gunma

ZIP/Postal Code

370-0053

Country

Japan

Facility Name

National Hospital Organization Asahikawa Medical Center

City

Asahikawa

State/Province

Hokkaido

ZIP/Postal Code

070-8644

Country

Japan

Facility Name

Katayama Orthopaedic Rheumatology Clinic

City

Asahikawa

State/Province

Hokkaido

ZIP/Postal Code

078-8243

Country

Japan

Facility Name

Sapporo City General Hospital

City

Sapporo

State/Province

Hokkaido

ZIP/Postal Code

060-8604

Country

Japan

Facility Name

Hokkaido University Hospital

City

Sapporo

State/Province

Hokkaido

ZIP/Postal Code

060-8648

Country

Japan

Facility Name

Matsubara Mayflower Hospital

City

Kato

State/Province

Hyogo

ZIP/Postal Code

673-1462

Country

Japan

Facility Name

National Hospital Organization Nagasaki Medical Center

City

Omura

State/Province

Nagasaki

ZIP/Postal Code

856-8562

Country

Japan

Facility Name

Saitama Medical Center

City

Kawagoe

State/Province

Saitama

ZIP/Postal Code

350-8550

Country

Japan

Facility Name

Hirose Clinic

City

Tokorozawa

State/Province

Saitama

ZIP/Postal Code

359-1111

Country

Japan

Facility Name

Kondo clinic for rheumatism and orthopaedics

City

Fukuoka

ZIP/Postal Code

810-0001

Country

Japan

Facility Name

National Hospital Organization Kyushu Medical Center

City

Fukuoka

ZIP/Postal Code

810-8563

Country

Japan

Facility Name

Chonnam National University Hospital

City

Gwangju

ZIP/Postal Code

61469

Country

Korea, Republic of

Facility Name

Seoul National University Hospital

City

Seoul

ZIP/Postal Code

03080

Country

Korea, Republic of

Facility Name

Severance Hospital, Yonsei University Health System

City

Seoul

ZIP/Postal Code

03722

Country

Korea, Republic of

Facility Name

Konkuk University Medical Center

City

Seoul

ZIP/Postal Code

05030

Country

Korea, Republic of

Facility Name

Hanyang University Seoul Hospital

City

Seoul

ZIP/Postal Code

133-817

Country

Korea, Republic of

Facility Name

LSMUL Kauno klinikos

City

Kaunas

ZIP/Postal Code

LT-50161

Country

Lithuania

Facility Name

Klaipedos universitetine ligonine

City

Klaipeda

ZIP/Postal Code

LT-92288

Country

Lithuania

Facility Name

Vilniaus universiteto ligonines Santariskiu klinikos

City

Vilnius

ZIP/Postal Code

LT-08661

Country

Lithuania

Facility Name

Consultorio Medico Privado de Reumatologia

City

Mexicali

State/Province

BAJA California

ZIP/Postal Code

21100

Country

Mexico

Facility Name

Consultorio de Reumatologia

City

Ciudad de Mexico

ZIP/Postal Code

CP 07760

Country

Mexico

Facility Name

MedLab

City

Timaru

State/Province

South Canterbury

ZIP/Postal Code

7940

Country

New Zealand

Facility Name

Timaru Hospital

City

Timaru

State/Province

South Canterbury

ZIP/Postal Code

7940

Country

New Zealand

Facility Name

Timaru Rheumatology Studies

City

Timaru

State/Province

South Canterbury

ZIP/Postal Code

7940

Country

New Zealand

Facility Name

Waikato Hospital

City

Hamilton

ZIP/Postal Code

3204

Country

New Zealand

Facility Name

Wellington Hospital, Capital Coast District Health Board

City

Wellington

ZIP/Postal Code

6021

Country

New Zealand

Facility Name

Oficina administrativa

City

Arequipa, Arequipa

ZIP/Postal Code

04020

Country

Peru

Facility Name

Unidad de Investigacion en Medicina Interna y Enfermedades Criticas

City

Arequipa

ZIP/Postal Code

CP656

Country

Peru

Facility Name

Oficina Administrativa

City

Lima, Lima

ZIP/Postal Code

Lima 33

Country

Peru

Facility Name

ABK REUMA SRL-Medicentro Biociencias Peru SRL

City

Lima

ZIP/Postal Code

Lima 21

Country

Peru

Facility Name

Clinica Medica Cayetano Heredia

City

Lima

ZIP/Postal Code

Lima 31

Country

Peru

Facility Name

Centro de Investigación para el Estudio de Enfermedades Reumáticas

City

Lima

ZIP/Postal Code

Lima 33

Country

Peru

Facility Name

Instituto de Ginecología y Reproducción & Cirugía Mínimamente Invasiva

City

Lima

ZIP/Postal Code

Lima 33

Country

Peru

Facility Name

Gabinet Internistyczno-Reumatologiczny Piotr Adrian Klimiuk

City

Bialystok

ZIP/Postal Code

15-099

Country

Poland

Facility Name

NZOZ Zdrowie Osteo-Medic s.c.

City

Bialystok

ZIP/Postal Code

15-351

Country

Poland

Facility Name

Centrum Kliniczno-Badawcze J.Brzezicki, B. Gornikiewicz-Brzezicka Lekarze Spolka Partnerska

City

Elblag

ZIP/Postal Code

82-300

Country

Poland

Facility Name

NZOZ Centrum Reumatologiczne Indywidualna Specjalistyczna Praktyka Lekarska Lek. med. Barbara Bazela

City

Elblag

ZIP/Postal Code

82-300

Country

Poland

Facility Name

Synexus Polska Sp. z o.o. Oddzial w Gdyni

City

Gdynia

ZIP/Postal Code

81-537

Country

Poland

Facility Name

Synexus Polska Sp. z o.o. Oddzial w Katowicach

City

Katowice

ZIP/Postal Code

40-040

Country

Poland

Facility Name

Centrum Medyczne Pratia Katowice

City

Katowice

ZIP/Postal Code

40-081

Country

Poland

Facility Name

Zespol Poradni Specjalistycznych "REUMED" Filia nr 2

City

Lublin

ZIP/Postal Code

20-582

Country

Poland

Facility Name

NZOZ Lecznica MAK-MED. S.C.

City

Nadarzyn

ZIP/Postal Code

05-830

Country

Poland

Facility Name

Prywatna Praktyka Lekarska Prof. UM Dr Hab. Med. Pawel Hrycaj

City

Poznan

ZIP/Postal Code

61-397

Country

Poland

Facility Name

Niepubliczny Zaklad Opieki Zdrowotnej ''Nasz Lekarz''

City

Torun

ZIP/Postal Code

87-100

Country

Poland

Facility Name

Synexus Polska Sp. z o.o. Oddzial w Warszawie

City

Warszawa

ZIP/Postal Code

01-192

Country

Poland

Facility Name

Centrum Medyczne AMED

City

Warszawa

ZIP/Postal Code

01-518

Country

Poland

Facility Name

MTZ Clinical Research Sp. z o.o.

City

Warszawa

ZIP/Postal Code

02-106

Country

Poland

Facility Name

''Rheuma Medicus'' Zakład Opieki Zdrowotnej

City

Warszawa

ZIP/Postal Code

02-118

Country

Poland

Facility Name

Synexus Polska Sp. z o.o. Oddział we Wroclawiu

City

Wroclaw

ZIP/Postal Code

50-381

Country

Poland

Facility Name

GBUZ Republican hospital n.a. V.A. Baranov

City

Petrozavodsk

State/Province

Republic OF Karelia

ZIP/Postal Code

185019

Country

Russian Federation

Facility Name

LLC Alliance Biomedical Ural group

City

Izhevsk

ZIP/Postal Code

426035

Country

Russian Federation

Facility Name

GAUZ of Kemerovo Region "Regional clinical hospital for war veterans"

City

Kemerovo

ZIP/Postal Code

650000

Country

Russian Federation

Facility Name

GMU Kursk Regional Clinical Hospital of the Healthcare Committee of the Kursk Region

City

Kursk

ZIP/Postal Code

305007

Country

Russian Federation

Facility Name

Municipal Clinical Hospital No. 1 Named after N.I. Pirogov

City

Moscow

ZIP/Postal Code

119049

Country

Russian Federation

Facility Name

GBUZ of city of Moscow City clinical hospital n.a. A.K.Eramishantsev of Ministry of Healthcare of

City

Moscow

ZIP/Postal Code

129327

Country

Russian Federation

Facility Name

Orenburg State Medical Academy

City

Orenburg

ZIP/Postal Code

460000

Country

Russian Federation

Facility Name

Regional Clinical Hospital

City

Orenburg

ZIP/Postal Code

460018

Country

Russian Federation

Facility Name

GBOU VPO Ryazan State Medical University Named after Academician I.P. Pavlov

City

Ryazan

ZIP/Postal Code

390026

Country

Russian Federation

Facility Name

GBU of Ryazan region Regional clinical cardiology dispanser

City

Ryazan

ZIP/Postal Code

390026

Country

Russian Federation

Facility Name

Spb GBUZ "Clinical rheumatology hospital # 25" City CDC prevention of osteoporosis

City

Saint-Petersburg

ZIP/Postal Code

190068

Country

Russian Federation

Facility Name

GUZ " Regional clinical hospital"

City

Saratov

ZIP/Postal Code

410053

Country

Russian Federation

Facility Name

GBUZ VO Regional clinical hospital

City

Vladimir

ZIP/Postal Code

600023

Country

Russian Federation

Facility Name

GBKUZ of Yaroslavl region "City hospital n. a. N.A. Semashko"

City

Yaroslavl

ZIP/Postal Code

150002

Country

Russian Federation

Facility Name

Institute of Rheumatology

City

Belgrade

ZIP/Postal Code

11000

Country

Serbia

Facility Name

Military Medical Academy,

City

Belgrade

ZIP/Postal Code

11000

Country

Serbia

Facility Name

Institute for Treatment and Rehabilitation Niska Banja

City

Niska Banja

ZIP/Postal Code

18205

Country

Serbia

Facility Name

Special Hospital for Rheumatic Diseases Novi Sad

City

Novi Sad

ZIP/Postal Code

21112

Country

Serbia

Facility Name

Charlotte Maxeke Johannesburg Academic Hospital

City

Johannesburg

State/Province

Gauteng

ZIP/Postal Code

2193

Country

South Africa

Facility Name

Clinresco Centres (Pty) Ltd

City

Kempton Park

State/Province

Gauteng

ZIP/Postal Code

1619

Country

South Africa

Facility Name

St. Augustine's Hospital

City

Durban

State/Province

Kwa-zulu Natal

ZIP/Postal Code

4001

Country

South Africa

Facility Name

Arthritis Clinical Research Trials, Dr. C.E Spargo and Dr. R.B Bhorat Practice

City

Cape Town

State/Province

Western CAPE

ZIP/Postal Code

7405

Country

South Africa

Facility Name

Panorama Medical Centre

City

Cape Town

State/Province

Western CAPE

ZIP/Postal Code

7500

Country

South Africa

Facility Name

Hospital Universitario de Fuenlabrada

City

Fuenlabrada

State/Province

Madrid

ZIP/Postal Code

28942

Country

Spain

Facility Name

Hospital Universitario Cruces

City

Barakaldo

State/Province

Vizcaya

ZIP/Postal Code

48903

Country

Spain

Facility Name

Hospital Universitario A Coruña

City

A Coruña

ZIP/Postal Code

15006

Country

Spain

Facility Name

Hospital Universitario Ramón y Cajal

City

Madrid

ZIP/Postal Code

28034

Country

Spain

Facility Name

Hospital Infanta Luisa

City

Sevilla

ZIP/Postal Code

41010

Country

Spain

Facility Name

Chung Shan Medical University Hospital

City

Taichung

ZIP/Postal Code

40201

Country

Taiwan

Facility Name

China Medical University Hospital

City

Taichung

ZIP/Postal Code

40447

Country

Taiwan

Facility Name

Taipei Medical University Hospital

City

Taipei

ZIP/Postal Code

11031

Country

Taiwan

Facility Name

Kyivska miska klinichna likarnia #6

City

Kyiv

ZIP/Postal Code

03680

Country

Ukraine

Facility Name

Lvivskyi oblasnyi klinichnyi diahnostychnyi tsentr,

City

Lviv

ZIP/Postal Code

79010

Country

Ukraine

Facility Name

Komunalna 4-a miska klinichna likarnia m. Lvova,

City

Lviv

ZIP/Postal Code

79011

Country

Ukraine

Facility Name

Komunalnyi zaklad okhorony zdorovia "Kharkivska miska klinichna likarnia #8"

City

M. Kharkiv

ZIP/Postal Code

61176

Country

Ukraine

Facility Name

Komunalnyi zaklad Kyivskoi oblasnoi rady "Kyivska oblasna klinichna likarnia",

City

M. Kyiv,

ZIP/Postal Code

04107

Country

Ukraine

Facility Name

Bahatoprofilnyi medychnyi tsentr (Universytetska klinika #1)

City

Odesa

ZIP/Postal Code

65026

Country

Ukraine

Facility Name

Komunalnyi zaklad Sumskoi oblasnoi rady "Sumska oblasna klinichna

City

Sumy

ZIP/Postal Code

40022

Country

Ukraine

Facility Name

Vinnytska oblasna klinichna likarnia im. M.I.Pyrohova revmatolohichne viddilennia

City

Vinnytsia

ZIP/Postal Code

21018

Country

Ukraine

Facility Name

Komunalna ustanova "Zaporizka oblasna klinichna likarnia" Zaporizkoi oblasnoi rady

City

Zaporizhzhia

ZIP/Postal Code

69600

Country

Ukraine

Facility Name

Basingstoke and North Hampshire Hospital, Hampshire Hospitals NHS Foundation Trust

City

Basingstoke

State/Province

Hampshire

ZIP/Postal Code

RG24 9NA

Country

United Kingdom

Facility Name

Arrowe Park Hospital, Wirral University Teaching Hospitals NHS Foundation Trust

City

Wirral

State/Province

Merseyside

ZIP/Postal Code

CH49 5PE

Country

United Kingdom

Facility Name

Royal United Hospital Bath NHS Foundation Trust ,Royal National Hospital for Rheumatic Diseases

City

Bath

State/Province

Somerset

ZIP/Postal Code

BA1 1RL

Country

United Kingdom

Facility Name

The Leeds Institute of Rheumatic and Musculoskeletal Medicine

City

Leeds

State/Province

WEST Yorkshire

ZIP/Postal Code

LS7 4SA

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

IPD Sharing URL

https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

Citations:

PubMed Identifier

36180101

Citation

Kay J, Bock AE, Rehman M, Zhang W, Zhang M, Iikuni N, Alvarez DF. Use of multibiomarker disease activity scores in biosimilarity studies for the treatment of patients with rheumatoid arthritis. RMD Open. 2022 Sep;8(2):e002423. doi: 10.1136/rmdopen-2022-002423.

Results Reference

derived

PubMed Identifier

35304684

Citation

Fleischmann RM, Bock AE, Zhang W, Godfrey CM, Vranic I, Cronenberger C, Dokoupilova E. Usability Study of PF-06410293, an Adalimumab Biosimilar, by Prefilled Pen: Open-Label, Single-Arm, Sub-Study of a Phase 3 Trial in Patients with Rheumatoid Arthritis. Rheumatol Ther. 2022 Jun;9(3):839-850. doi: 10.1007/s40744-022-00439-8. Epub 2022 Mar 18.

Results Reference

derived

PubMed Identifier

34563243

Citation

Fleischmann RM, Alvarez DF, Bock AE, Cronenberger C, Vranic I, Zhang W, Alten R. Long-term efficacy, safety, and immunogenicity of the adalimumab biosimilar, PF-06410293, in patients with rheumatoid arthritis after switching from reference adalimumab (Humira(R)) or continuing biosimilar therapy: week 52-92 data from a randomized, double-blind, phase 3 trial. Arthritis Res Ther. 2021 Sep 25;23(1):248. doi: 10.1186/s13075-021-02626-4.

Results Reference

derived

PubMed Identifier

33883254

Citation

Fleischmann RM, Alvarez DF, Bock AE, Cronenberger C, Vranic I, Zhang W, Alten R. Randomised study of PF-06410293, an adalimumab (ADL) biosimilar, compared with reference ADL for the treatment of active rheumatoid arthritis: results from weeks 26-52, including a treatment switch from reference ADL to PF-06410293. RMD Open. 2021 Apr;7(2):e001578. doi: 10.1136/rmdopen-2021-001578.

Results Reference

derived

PubMed Identifier

33263165

Citation

Huizinga TWJ, Torii Y, Muniz R. Adalimumab Biosimilars in the Treatment of Rheumatoid Arthritis: A Systematic Review of the Evidence for Biosimilarity. Rheumatol Ther. 2021 Mar;8(1):41-61. doi: 10.1007/s40744-020-00259-8. Epub 2020 Dec 1.

Results Reference

derived

PubMed Identifier

30111357

Citation

Fleischmann RM, Alten R, Pileckyte M, Lobello K, Hua SY, Cronenberger C, Alvarez D, Bock AE, Sewell KL. A comparative clinical study of PF-06410293, a candidate adalimumab biosimilar, and adalimumab reference product (Humira(R)) in the treatment of active rheumatoid arthritis. Arthritis Res Ther. 2018 Aug 15;20(1):178. doi: 10.1186/s13075-018-1676-y.

Results Reference

derived

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B5381002&StudyName=A%20Study%20Of%20PF-06410293%20%28Adalimumab-Pfizer%29%20And%20Adalimumab%20%28Humira%29%20In%20Combination%20With%20Methotrexate%20In%20Subjects%20With%20Active%20Rheumatoid

Description

To obtain contact information for a study center near you, click here.

Learn more about this trial

A Study Of PF-06410293 (Adalimumab-Pfizer) And Adalimumab (Humira®) In Combination With Methotrexate In Subjects With Active Rheumatoid Arthritis (REFLECTIONS B538-02).

We'll reach out to this number within 24 hrs