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A Study of RO7123520 to Evaluate the Safety and Efficacy in Participants With Moderately To Severely Active Rheumatoid Arthritis (RA) Who Are Inadequately Responding to Anti-Tumor Necrosis Factor (TNF)-Alpha Therapy

Primary Purpose

Rheumatoid Arthritis

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Anti-TNF-alpha
Methotrexate
Placebo
RO7123520
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

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

Inclusion Criteria:

  • Diagnosis of adult-onset RA as defined by the ACR 2010 criteria, for at least 6 months before screening
  • Moderately to severely active RA as defined by at least 4/28 tender joints and at least 4/28 swollen joints, and a DAS28 greater than or equal to (≥) 3.2
  • For Part 2 only: Active synovitis and/or osteitis as determined by contrast-enhanced magnetic resonance imaging
  • Participants must be taking stable dose of anti-TNF-alpha therapies
  • Participants on stable oral glucocorticoids within 6 weeks of planned randomization
  • Participants taking non-steroidal anti-inflammatory drugs (NSAIDs) intermittently (up to 2-3 times weekly) for short-term relief of pain and participants on regular NSAID use (on stable dose for ≥ 4 weeks)

Exclusion Criteria:

  • Parenteral glucocorticoids administration (intramuscular, IV) of ≥50 mg within 6 weeks or less than or equal to (≤) 50 milligrams (mg) within 4 weeks prior to planned randomization, or scheduled parenteral administrations during the study
  • Joint(s) injected with intra-articular glucocorticoids or hyaluronic acid within 6 weeks prior to planned randomization
  • Active inflammatory diseases of the joints not related to RA
  • Systemic autoimmune disease other than RA
  • Juvenile idiopathic arthritis or juvenile RA and/or RA developed before the age of 16
  • Active fibromyalgia that makes appropriate assessment of RA disease activity challenging in the opinion of the Investigator
  • RA participants functional status class IV according to the ACR 1991 criteria
  • Participants with severe chronic or recurrent viral, bacterial, parasitic, or fungal infections
  • History of active hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) infection
  • Any identified confirmed congenital or acquired immunodeficiency
  • Abnormal laboratory values and liver function test
  • Myocardial infarction within less than 6 months prior to participation in the study
  • Severe central or peripheral nervous system diseases

Sites / Locations

  • Pinnacle Research Group; Llc, Central
  • Arizona Arthritis & Rheumatology Associates, P.C.
  • Arizona Arthritis and Rheuma
  • Arizona Arthritis & Rheumatology Research, PLLC
  • Medvin Clinical Research
  • University of California San Diego
  • Advanced Medical Research, LLC
  • Stanford hospital & Clinics; Investigational Drug Services
  • Omega Research Consultants LLC
  • San Marcus Research Clinic, Inc.
  • Millenium Research
  • Clinical Pharmacology Study Group
  • Shores Rheumatology PC
  • Arthritis & Osteoporosis Associates
  • Atlantic Coast Rheumatology
  • Ocean Rheumatology
  • Albuquerque Center For Rheumatology
  • Albuquerque Clinical Trials
  • Saint Lawrence Health System; Rheumatology
  • Paramount Medical Research
  • Altoona Center For Clinical Research
  • Advanced Rheumatology & Arthritis Research Center
  • Low Country Rheumatology, PA
  • Columbia Arthritis Center (Partnership Practice)
  • West Tennessee Research Institute
  • Adriana Pop-Moody MD Clinic PA
  • Metroplex Clinical Research
  • Pioneer Research Solutions
  • Accurate Clinical Research
  • Accurate Clinical Research
  • Southwest Rheumatology
  • Accurate Clinical Research, Inc
  • Organización medica de Investi
  • Centro de Investigaciones Reumatologicas y Osteologicas
  • Cer San Juan
  • Centro Medico Privado de Reumatologia; Reumathology
  • Medizinische Universität Wien, Allgemeines Krankenhaus der Stadt Wien
  • Centro Integral de Reumatologia del Caribe SAS CIRCARIBE SAS
  • Centro de Investigacion en Reumatologia y Especialdades Medicas SAS. CIREEM
  • Riesgo de Fractura S.A.
  • Fundación Instituto de Reumatología Fernando Chalem
  • Servimed S.A.S.
  • Healthy Medical Center SAS
  • Charité Research Organisation GmbH
  • Centro de Estudio y Tratamiento de Enfermedades Reumaticas
  • Clinica Privada de Reumatologia Dr. Henry Briones Alvarado
  • Azienda Ospedaliera Città della Salute e della Scienza di Torino; Radiology
  • Azienda Ospedaliero-Universitaria Policlinico S. Orsola Malpighi; U.O. Malattie Infettive
  • Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele
  • Azienda Ospedaliero Universitaria Careggi - SOD Reumatologia
  • Centro de Investigacion del Noroeste SC
  • Investigacion y Biomedicina de Chihuahua, Sociedad Civil
  • Centro Integral en Reumatología S.A. de C.V. (CIRSA)
  • Centro Médico de las Américas
  • Unidad de Atencion Medica e Investigacion en Salud (UNAMIS)
  • Javier Orozco Private Practice
  • Centro de Investigación; Artritis y Osteoporosis S.C.
  • Hospital Angeles Lindavista
  • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
  • Policlinica Medica de Queretaro S.C.
  • Hogar Clínica San Juan de Dios
  • Clinica Internacional Sede Lima
  • Clinica Internacional, Sede San Borja; Unidad de Investigacion de Clínica Internacional
  • Instituto de Ginecología y Reproducción
  • Hospital Universitario Marques de Valdecilla; Servicio de Reumatologia
  • Complexo Hospitalario Universitario A Coruña; Servicio de Reumatología
  • Hospital de Basurto; Servicio de Reumatologia
  • Hospital Universitario de la Princesa; Servicio de Reumatologia
  • Hospital General Universitario Gregorio Marañon; Servicio de Reumatología
  • Hospital Universitario 12 de Octubre
  • Hospital Regional Universitario Carlos Haya; Servicio de Psiquiatria
  • Hospital Universitario Reina Sofía; Servicio de Aparato Digestivo
  • New Queen Elizabeth Hospital Birmingham
  • Cambridge University Hospitals NHS Foundation Trust
  • Glasgow Royal Infirmary
  • Barts Hospital; Department of Rheumatology
  • Guys and St Thomas NHS Foundation Trust, Guys Hospital
  • Newcastle U. Medical School; Institute of Cellular Medicine
  • University of Oxford, Botnar Research Centre
  • Derriford Hospital
  • Lister Hospital; Rheumatology Dept

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Arm Label

Part 1: Placebo

Part 1: RO7123520

Part 2: Placebo

Part 2: RO7123520

Part 3: Placebo

Part 3: RO7123520

Arm Description

Participants will receive placebo (matched to RO7123520) on Days 1, 14, 28, and 56 with pre-trial anti-TNF-alpha and methotrexate.

Participants will receive RO7123520 on Days 1, 14, 28, and 56 with pre-trial anti-TNF-alpha and methotrexate.

Participants will receive placebo (matched to RO7123520) on Days 1, 14, 28, and 56 with pre-trial anti-TNF-alpha and methotrexate.

Participants will receive RO7123520 on Days 1, 14, 28, and 56 with pre-trial anti-TNF-alpha and methotrexate.

Participants will receive placebo (matched to RO7123520) on Days 1, 14, 28, and 56 with pre-trial anti-TNF-alpha and methotrexate. NOTE: Part 3 was not conducted.

Participants will receive RO7123520 on Days 1, 14, 28, and 56 with pre-trial anti-TNF-alpha and methotrexate. NOTE: Part 3 was not conducted.

Outcomes

Primary Outcome Measures

Percentage of Participants With Adverse Events
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Proportion of Participants Achieving an American College of Rheumatology (ACR) 50 Response at Week 12
The ACR50 is a composite measure defined as both improvement of 50% in the number of tender and number of swollen joints, and a 50% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure [most often Health Assessment Questionnaire (HAQ)], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP). The ACR is reported as percent improvement at discrete time points.
Percentage of Participants With Anti-Drug Antibodies
Change From Baseline in Bone Mineral Density Lumbar Spine L1-L4 as Assessed by Dual Energy X-ray Absorptiometry (DEXA) Scans

Secondary Outcome Measures

Change From Baseline in Clinical Disease Activity Index (CDAI) Score at Week 12
The CDAI for Rheumatoid Arthritis (RA) assesses the severity of the disease using clinical data. It consists of the Patient Global disease Activity (PGA) estimate and the Evaluator Global disease Activity (EGA) estimate, each of which represent assessments of disease activity on a scale of 1-10, with 10 being maximum activity.
Change From Baseline in Disease Activity Score 28 (DAS28) at Week 12
The DAS28 is a combined index for measuring disease activity in RA; the "28" refers to the number of joints included in the assessment. The index includes swollen and tender joint counts, acute phase response, and general arthritis disease activity status. An overall disease activity score of 5.1 or greater implies active disease, less than 3.2 implies low disease activity, and less that 2.6 implies disease remission.
Percentage of Participants Achieving DAS28 Remission at Week 12
The DAS28 is a combined index for measuring disease activity in RA; the "28" refers to the number of joints included in the assessment. The index includes swollen and tender joint counts, acute phase response, and general arthritis disease activity status. An overall disease activity score of 5.1 or greater implies active disease, less than 3.2 implies low disease activity, and less that 2.6 implies disease remission.
Percentage of Participants Achieving CDAI Remission at Week 12
The CDAI for Rheumatoid Arthritis (RA) assesses the severity of the disease using clinical data. It consists of the Patient Global disease Activity (PGA) estimate and the Evaluator Global disease Activity (EGA) estimate, each of which represent assessments of disease activity on a scale of 1-10, with 10 being maximum activity. CDAI remission is defined as a score of less than or equal to 2.8.
Percentage of Participants Achieving ACR20 Response at Week 12
The ACR20 is a composite measure defined as both improvement of 20% in the number of tender and number of swollen joints, and a 20% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure [most often Health Assessment Questionnaire (HAQ)], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP). The ACR is reported as percent improvement at discrete time points.
Percentage of Participants Achieving ACR70 Response at Week 12
The ACR70 is a composite measure defined as both improvement of 70% in the number of tender and number of swollen joints, and a 70% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure [most often Health Assessment Questionnaire (HAQ)], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP). The ACR is reported as percent improvement at discrete time points.
Change From Baseline in Simple Disease Activity Index (SDAI) Score at Week 12
The SDAI consists of 5 parameters used to assess RA disease activity: 28-joint count assessments of tenderness and swelling, participant and investigator global assessments, and CRP levels. A composite score is produced, with remission defined as an SDAI of <3.3, low disease activity as ≤11, moderate disease activity as ≤26 and high disease activity as >26.
Change From Baseline in the Stanford Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12
The HAQ-DI is a 20-item, validated questionnaire used to assess difficulty in performing activities of daily living. The questionnaire assesses eight domains of physical functioning: Dressing and Grooming (2 items), Hygiene (3 items), Arising (2 items), Reach (2 items), Eating (3 items), Grip (3 items), Walking (2 items), Common Daily Activities (3 items). The questions assess usual abilities ranging from 0 "without any difficulty" to 3 "unable to do." A lower HAQ-DI score indicates better quality of life. Subscale scores are combined and the mean value is reported for each arm per timepoint.
Serum RO7123520 Concentration
Synovial Fluid RO7123520 Concentration

Full Information

First Posted
December 20, 2016
Last Updated
January 17, 2020
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT03001219
Brief Title
A Study of RO7123520 to Evaluate the Safety and Efficacy in Participants With Moderately To Severely Active Rheumatoid Arthritis (RA) Who Are Inadequately Responding to Anti-Tumor Necrosis Factor (TNF)-Alpha Therapy
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase II Study to Evaluate The Safety and Efficacy of RO7123520 as Adjunct Treatment in Patients With Moderately to Severely Active Rheumatoid Arthritis and an Inadequate Response to TNF-alpha Inhibitors
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Terminated
Why Stopped
The trial was prematurely terminated due to a lack of efficacy of the investigational drug.
Study Start Date
December 22, 2016 (Actual)
Primary Completion Date
November 6, 2018 (Actual)
Study Completion Date
November 6, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

5. Study Description

Brief Summary
This is a Phase IIa/b double-blind, placebo-controlled, randomized, parallel group, multicenter study to evaluate the safety and efficacy of RO7123520 as adjunctive therapy in participants with RA who are inadequately responding to standard-of-care (methotrexate and anti-TNF-alpha therapy). Part 1 of the study will evaluate safety. Part 2 will evaluate efficacy and safety. Part 3 will evaluate dose-ranging efficacy. Participants will have the option of continuing to the extension period of the study.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
109 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Part 1: Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo (matched to RO7123520) on Days 1, 14, 28, and 56 with pre-trial anti-TNF-alpha and methotrexate.
Arm Title
Part 1: RO7123520
Arm Type
Experimental
Arm Description
Participants will receive RO7123520 on Days 1, 14, 28, and 56 with pre-trial anti-TNF-alpha and methotrexate.
Arm Title
Part 2: Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo (matched to RO7123520) on Days 1, 14, 28, and 56 with pre-trial anti-TNF-alpha and methotrexate.
Arm Title
Part 2: RO7123520
Arm Type
Experimental
Arm Description
Participants will receive RO7123520 on Days 1, 14, 28, and 56 with pre-trial anti-TNF-alpha and methotrexate.
Arm Title
Part 3: Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo (matched to RO7123520) on Days 1, 14, 28, and 56 with pre-trial anti-TNF-alpha and methotrexate. NOTE: Part 3 was not conducted.
Arm Title
Part 3: RO7123520
Arm Type
Experimental
Arm Description
Participants will receive RO7123520 on Days 1, 14, 28, and 56 with pre-trial anti-TNF-alpha and methotrexate. NOTE: Part 3 was not conducted.
Intervention Type
Drug
Intervention Name(s)
Anti-TNF-alpha
Intervention Description
Participants will continue their pre-trial anti-TNF-alpha therapy at a stable dose.
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Intervention Description
Participants will continue their pre-trial methotrexate therapy at a stable dose.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Participants will receive intravenous infusion of placebo.
Intervention Type
Drug
Intervention Name(s)
RO7123520
Intervention Description
Participants will receive intravenous infusion of RO7123520.
Primary Outcome Measure Information:
Title
Percentage of Participants With Adverse Events
Description
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Time Frame
Baseline to last participant last visit (approximately 2 years)
Title
Proportion of Participants Achieving an American College of Rheumatology (ACR) 50 Response at Week 12
Description
The ACR50 is a composite measure defined as both improvement of 50% in the number of tender and number of swollen joints, and a 50% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure [most often Health Assessment Questionnaire (HAQ)], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP). The ACR is reported as percent improvement at discrete time points.
Time Frame
Week 12 of PoC and Week 12 of Extension Period Analysis (overall study week 24)
Title
Percentage of Participants With Anti-Drug Antibodies
Time Frame
Baseline
Title
Change From Baseline in Bone Mineral Density Lumbar Spine L1-L4 as Assessed by Dual Energy X-ray Absorptiometry (DEXA) Scans
Time Frame
Baseline, Week 12 of PoC and Week 12 of Extension Period Analysis (overall study week 24)
Secondary Outcome Measure Information:
Title
Change From Baseline in Clinical Disease Activity Index (CDAI) Score at Week 12
Description
The CDAI for Rheumatoid Arthritis (RA) assesses the severity of the disease using clinical data. It consists of the Patient Global disease Activity (PGA) estimate and the Evaluator Global disease Activity (EGA) estimate, each of which represent assessments of disease activity on a scale of 1-10, with 10 being maximum activity.
Time Frame
Baseline, Week 12 of PoC and Week 12 of Extension Period Analysis (overall study week 24)
Title
Change From Baseline in Disease Activity Score 28 (DAS28) at Week 12
Description
The DAS28 is a combined index for measuring disease activity in RA; the "28" refers to the number of joints included in the assessment. The index includes swollen and tender joint counts, acute phase response, and general arthritis disease activity status. An overall disease activity score of 5.1 or greater implies active disease, less than 3.2 implies low disease activity, and less that 2.6 implies disease remission.
Time Frame
Baseline, Week 12 of PoC and Week 12 of Extension Period Analysis (overall study week 24)
Title
Percentage of Participants Achieving DAS28 Remission at Week 12
Description
The DAS28 is a combined index for measuring disease activity in RA; the "28" refers to the number of joints included in the assessment. The index includes swollen and tender joint counts, acute phase response, and general arthritis disease activity status. An overall disease activity score of 5.1 or greater implies active disease, less than 3.2 implies low disease activity, and less that 2.6 implies disease remission.
Time Frame
Week 12 of PoC and Week 12 of Extension Period Analysis (overall study week 24)
Title
Percentage of Participants Achieving CDAI Remission at Week 12
Description
The CDAI for Rheumatoid Arthritis (RA) assesses the severity of the disease using clinical data. It consists of the Patient Global disease Activity (PGA) estimate and the Evaluator Global disease Activity (EGA) estimate, each of which represent assessments of disease activity on a scale of 1-10, with 10 being maximum activity. CDAI remission is defined as a score of less than or equal to 2.8.
Time Frame
Week 12 of PoC and Week 12 of Extension Period Analysis (overall study week 24)
Title
Percentage of Participants Achieving ACR20 Response at Week 12
Description
The ACR20 is a composite measure defined as both improvement of 20% in the number of tender and number of swollen joints, and a 20% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure [most often Health Assessment Questionnaire (HAQ)], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP). The ACR is reported as percent improvement at discrete time points.
Time Frame
Week 12 of PoC and Week 12 of Extension Period Analysis (overall study week 24)
Title
Percentage of Participants Achieving ACR70 Response at Week 12
Description
The ACR70 is a composite measure defined as both improvement of 70% in the number of tender and number of swollen joints, and a 70% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure [most often Health Assessment Questionnaire (HAQ)], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP). The ACR is reported as percent improvement at discrete time points.
Time Frame
Week 12 of PoC and Week 12 of Extension Period Analysis (overall study week 24)
Title
Change From Baseline in Simple Disease Activity Index (SDAI) Score at Week 12
Description
The SDAI consists of 5 parameters used to assess RA disease activity: 28-joint count assessments of tenderness and swelling, participant and investigator global assessments, and CRP levels. A composite score is produced, with remission defined as an SDAI of <3.3, low disease activity as ≤11, moderate disease activity as ≤26 and high disease activity as >26.
Time Frame
Baseline, Week 12 of PoC and Week 12 of Extension Period Analysis (overall study week 24)
Title
Change From Baseline in the Stanford Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12
Description
The HAQ-DI is a 20-item, validated questionnaire used to assess difficulty in performing activities of daily living. The questionnaire assesses eight domains of physical functioning: Dressing and Grooming (2 items), Hygiene (3 items), Arising (2 items), Reach (2 items), Eating (3 items), Grip (3 items), Walking (2 items), Common Daily Activities (3 items). The questions assess usual abilities ranging from 0 "without any difficulty" to 3 "unable to do." A lower HAQ-DI score indicates better quality of life. Subscale scores are combined and the mean value is reported for each arm per timepoint.
Time Frame
Baseline, Week 12 of PoC and Week 12 of Extension Period Analysis (overall study week 24)
Title
Serum RO7123520 Concentration
Time Frame
Pre-dose (0 hour), 1 hour post infusion (duration of infusion: approximately 1 hour) on Days 1, 14, 28, 56; Pre-dose (0 hour) on Days 84, 112
Title
Synovial Fluid RO7123520 Concentration
Time Frame
Pre-dose (0 hour) on Days 1, 84

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of adult-onset RA as defined by the ACR 2010 criteria, for at least 6 months before screening Moderately to severely active RA as defined by at least 4/28 tender joints and at least 4/28 swollen joints, and a DAS28 greater than or equal to (≥) 3.2 For Part 2 only: Active synovitis and/or osteitis as determined by contrast-enhanced magnetic resonance imaging Participants must be taking stable dose of anti-TNF-alpha therapies Participants on stable oral glucocorticoids within 6 weeks of planned randomization Participants taking non-steroidal anti-inflammatory drugs (NSAIDs) intermittently (up to 2-3 times weekly) for short-term relief of pain and participants on regular NSAID use (on stable dose for ≥ 4 weeks) Exclusion Criteria: Parenteral glucocorticoids administration (intramuscular, IV) of ≥50 mg within 6 weeks or less than or equal to (≤) 50 milligrams (mg) within 4 weeks prior to planned randomization, or scheduled parenteral administrations during the study Joint(s) injected with intra-articular glucocorticoids or hyaluronic acid within 6 weeks prior to planned randomization Active inflammatory diseases of the joints not related to RA Systemic autoimmune disease other than RA Juvenile idiopathic arthritis or juvenile RA and/or RA developed before the age of 16 Active fibromyalgia that makes appropriate assessment of RA disease activity challenging in the opinion of the Investigator RA participants functional status class IV according to the ACR 1991 criteria Participants with severe chronic or recurrent viral, bacterial, parasitic, or fungal infections History of active hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) infection Any identified confirmed congenital or acquired immunodeficiency Abnormal laboratory values and liver function test Myocardial infarction within less than 6 months prior to participation in the study Severe central or peripheral nervous system diseases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Pinnacle Research Group; Llc, Central
City
Anniston
State/Province
Alabama
ZIP/Postal Code
36207
Country
United States
Facility Name
Arizona Arthritis & Rheumatology Associates, P.C.
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85306
Country
United States
Facility Name
Arizona Arthritis and Rheuma
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85202
Country
United States
Facility Name
Arizona Arthritis & Rheumatology Research, PLLC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85037
Country
United States
Facility Name
Medvin Clinical Research
City
Covina
State/Province
California
ZIP/Postal Code
91723
Country
United States
Facility Name
University of California San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Advanced Medical Research, LLC
City
Lakewood
State/Province
California
ZIP/Postal Code
90712
Country
United States
Facility Name
Stanford hospital & Clinics; Investigational Drug Services
City
Stanford
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Omega Research Consultants LLC
City
DeBary
State/Province
Florida
ZIP/Postal Code
32713-1817
Country
United States
Facility Name
San Marcus Research Clinic, Inc.
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33015-5110
Country
United States
Facility Name
Millenium Research
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Clinical Pharmacology Study Group
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01610
Country
United States
Facility Name
Shores Rheumatology PC
City
Saint Clair Shores
State/Province
Michigan
ZIP/Postal Code
48080
Country
United States
Facility Name
Arthritis & Osteoporosis Associates
City
Freehold
State/Province
New Jersey
Country
United States
Facility Name
Atlantic Coast Rheumatology
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Facility Name
Ocean Rheumatology
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08775
Country
United States
Facility Name
Albuquerque Center For Rheumatology
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Albuquerque Clinical Trials
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Saint Lawrence Health System; Rheumatology
City
Canton
State/Province
New York
ZIP/Postal Code
13617
Country
United States
Facility Name
Paramount Medical Research
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Facility Name
Altoona Center For Clinical Research
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Advanced Rheumatology & Arthritis Research Center
City
Wexford
State/Province
Pennsylvania
ZIP/Postal Code
15090
Country
United States
Facility Name
Low Country Rheumatology, PA
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
Columbia Arthritis Center (Partnership Practice)
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29204
Country
United States
Facility Name
West Tennessee Research Institute
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
Adriana Pop-Moody MD Clinic PA
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78404
Country
United States
Facility Name
Metroplex Clinical Research
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Pioneer Research Solutions
City
Houston
State/Province
Texas
ZIP/Postal Code
077099
Country
United States
Facility Name
Accurate Clinical Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77058-3675
Country
United States
Facility Name
Accurate Clinical Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77089
Country
United States
Facility Name
Southwest Rheumatology
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75150
Country
United States
Facility Name
Accurate Clinical Research, Inc
City
Stafford
State/Province
Texas
ZIP/Postal Code
77477
Country
United States
Facility Name
Organización medica de Investi
City
Cap fed
ZIP/Postal Code
1015
Country
Argentina
Facility Name
Centro de Investigaciones Reumatologicas y Osteologicas
City
Ciudad Autonoma de Buenos Aires
ZIP/Postal Code
1111
Country
Argentina
Facility Name
Cer San Juan
City
San Juan
ZIP/Postal Code
5400
Country
Argentina
Facility Name
Centro Medico Privado de Reumatologia; Reumathology
City
San Miguel
ZIP/Postal Code
T4000AXL
Country
Argentina
Facility Name
Medizinische Universität Wien, Allgemeines Krankenhaus der Stadt Wien
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Centro Integral de Reumatologia del Caribe SAS CIRCARIBE SAS
City
Barranquilla
ZIP/Postal Code
00000
Country
Colombia
Facility Name
Centro de Investigacion en Reumatologia y Especialdades Medicas SAS. CIREEM
City
Bogota
ZIP/Postal Code
110221
Country
Colombia
Facility Name
Riesgo de Fractura S.A.
City
Bogota
ZIP/Postal Code
110221
Country
Colombia
Facility Name
Fundación Instituto de Reumatología Fernando Chalem
City
Bogota
ZIP/Postal Code
111211
Country
Colombia
Facility Name
Servimed S.A.S.
City
Bucaramanga
ZIP/Postal Code
680003
Country
Colombia
Facility Name
Healthy Medical Center SAS
City
Zipaquirá
Country
Colombia
Facility Name
Charité Research Organisation GmbH
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Centro de Estudio y Tratamiento de Enfermedades Reumaticas
City
Guatemala
Country
Guatemala
Facility Name
Clinica Privada de Reumatologia Dr. Henry Briones Alvarado
City
Guatemala
Country
Guatemala
Facility Name
Azienda Ospedaliera Città della Salute e della Scienza di Torino; Radiology
City
Torino
State/Province
Abruzzo
ZIP/Postal Code
10126
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria Policlinico S. Orsola Malpighi; U.O. Malattie Infettive
City
Bologna
State/Province
Emilia-Romagna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele
City
Catania
State/Province
Sicilia
ZIP/Postal Code
95123
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Careggi - SOD Reumatologia
City
Firenze
State/Province
Toscana
ZIP/Postal Code
50134
Country
Italy
Facility Name
Centro de Investigacion del Noroeste SC
City
Tijuana
State/Province
BAJA California
ZIP/Postal Code
22010
Country
Mexico
Facility Name
Investigacion y Biomedicina de Chihuahua, Sociedad Civil
City
Chichuahua
State/Province
Chihuahua
ZIP/Postal Code
31000
Country
Mexico
Facility Name
Centro Integral en Reumatología S.A. de C.V. (CIRSA)
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44160
Country
Mexico
Facility Name
Centro Médico de las Américas
City
Merida
State/Province
Yucatan
Country
Mexico
Facility Name
Unidad de Atencion Medica e Investigacion en Salud (UNAMIS)
City
Mérida
State/Province
Yucatan
ZIP/Postal Code
97070
Country
Mexico
Facility Name
Javier Orozco Private Practice
City
Guadalajara
ZIP/Postal Code
44650
Country
Mexico
Facility Name
Centro de Investigación; Artritis y Osteoporosis S.C.
City
Mexicali
ZIP/Postal Code
21200
Country
Mexico
Facility Name
Hospital Angeles Lindavista
City
Mexico
ZIP/Postal Code
07760
Country
Mexico
Facility Name
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
City
Monterrey
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Policlinica Medica de Queretaro S.C.
City
Queretaro
ZIP/Postal Code
76000
Country
Mexico
Facility Name
Hogar Clínica San Juan de Dios
City
Arequipa
Country
Peru
Facility Name
Clinica Internacional Sede Lima
City
LIma
ZIP/Postal Code
Lima 01
Country
Peru
Facility Name
Clinica Internacional, Sede San Borja; Unidad de Investigacion de Clínica Internacional
City
Lima
ZIP/Postal Code
Lima 41
Country
Peru
Facility Name
Instituto de Ginecología y Reproducción
City
Lima
Country
Peru
Facility Name
Hospital Universitario Marques de Valdecilla; Servicio de Reumatologia
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
Facility Name
Complexo Hospitalario Universitario A Coruña; Servicio de Reumatología
City
A Coruña
State/Province
LA Coruña
ZIP/Postal Code
15006
Country
Spain
Facility Name
Hospital de Basurto; Servicio de Reumatologia
City
Bilbao
State/Province
Vizcaya
ZIP/Postal Code
48013
Country
Spain
Facility Name
Hospital Universitario de la Princesa; Servicio de Reumatologia
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Hospital General Universitario Gregorio Marañon; Servicio de Reumatología
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Regional Universitario Carlos Haya; Servicio de Psiquiatria
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital Universitario Reina Sofía; Servicio de Aparato Digestivo
City
Murcia
ZIP/Postal Code
30003
Country
Spain
Facility Name
New Queen Elizabeth Hospital Birmingham
City
Birmingham
ZIP/Postal Code
B15 2WB
Country
United Kingdom
Facility Name
Cambridge University Hospitals NHS Foundation Trust
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
Glasgow Royal Infirmary
City
Glasgow
ZIP/Postal Code
G4 0SF
Country
United Kingdom
Facility Name
Barts Hospital; Department of Rheumatology
City
London
ZIP/Postal Code
E1 4DG
Country
United Kingdom
Facility Name
Guys and St Thomas NHS Foundation Trust, Guys Hospital
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
Newcastle U. Medical School; Institute of Cellular Medicine
City
Newcastle
Country
United Kingdom
Facility Name
University of Oxford, Botnar Research Centre
City
Oxford
Country
United Kingdom
Facility Name
Derriford Hospital
City
Plymouth
ZIP/Postal Code
PL6 8DH
Country
United Kingdom
Facility Name
Lister Hospital; Rheumatology Dept
City
Stevenage
ZIP/Postal Code
SG1 4AB
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

A Study of RO7123520 to Evaluate the Safety and Efficacy in Participants With Moderately To Severely Active Rheumatoid Arthritis (RA) Who Are Inadequately Responding to Anti-Tumor Necrosis Factor (TNF)-Alpha Therapy

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