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A Study of the Impact of Methotrexate (MTX) Discontinuation on the Efficacy of Subcutaneous (SC) Tocilizumab (TCZ) With MTX

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Tocilizumab (TCZ)
Methotrexate (MTX)
Placebo (PBO)
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:

  • Body weight </=150 kg
  • Active moderate to severe rheumatoid arthritis (DAS28 >/=4.4) according to the revised 1987 ACR criteria at screening and baseline (prior to treatment on Day 1)
  • Currently receiving oral MTX for at least 24 weeks and on a stable oral dose of at least 15 mg/week for at least 6 weeks prior to treatment (Day 1), with the following exception: a stable dose of at least 10 mg/week is allowed for participants with a body weight <50 kg or calculated glomerular filtration rate (or creatinine clearance) <60 milliliters per minute (mL/min)
  • History of parenteral (SC or intramuscular [IM]) MTX is allowed, but not within 6 weeks prior to treatment (Day 1). Participants must not have a documented, clinically significant intolerance to oral MTX and must be receiving oral MTX at a dose of 15 mg/week for at least 6 weeks prior to treatment (Day 1)
  • Participants who have received one prior anti-tumor necrosis factor (TNF) must have discontinued etanercept, infliximab, certolizumab, adalimumab, or golimumab for at least 6 months prior to screening
  • Oral corticosteroids must have been </=10 mg/day prednisone (or equivalent) and stable for at least 25 out of 28 days prior to treatment (Day 1)
  • Participants receiving treatment on an outpatient basis

Exclusion Criteria:

  • Documented medical history of significant intolerance to oral MTX >/=15 mg/week
  • Participants receiving other (non-MTX) disease modifying anti-rheumatic drugs (DMARDs) within 8 weeks of screening
  • Previous treatment with abatacept, rituximab, tofacitinib, or anakinra
  • Treatment with parenteral corticosteroids within 4 weeks prior to treatment
  • Previous treatment with cell-depleting therapies or alkylating agents
  • Previous treatment with TCZ
  • Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery during the study
  • Rheumatic autoimmune disease other than rheumatoid arthritis
  • Non-rheumatic active autoimmune diseases (for example, inflammatory bowel diseases, psoriasis, multiple sclerosis)
  • Prior history of or current inflammatory joint disease other than rheumatoid arthritis
  • Functional Class IV according to the revised (1987) ACR criteria for rheumatoid arthritis
  • History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies
  • Evidence of significant uncontrolled concomitant diseases; uncontrolled disease states where flares are commonly treated with oral or parenteral corticosteroids
  • Active current or history of recurrent infection, or any major episode of infection requiring hospitalization or treatment with intravenous antibiotics within 4 weeks prior to screening or oral antibiotics within 2 weeks prior to screening
  • Active tuberculosis requiring treatment within the previous 3 years
  • History of or currently active primary or secondary immunodeficiency
  • Pregnant or breast-feeding women
  • Positive for hepatitis B or hepatitis C infection
  • For potential MRI substudy participants: the presence of any metal-containing device or object in the body

Sites / Locations

  • Pinnacle Research Group; Llc, Central
  • Uni Of Alabama,Birmingham; Medicine - Rheumatology
  • Rheumatology Associates of North Alabama
  • Clnical & Translational Reseach Center for Alabama, PC
  • Arizona Arthritis & Rheumatology Associates, P.C.
  • Arizona Arthritis & Rheumatology Research, Pllc
  • Arizona Arthritis and Rheuma
  • Valley Arthritis Care
  • Advanced Arthritis Care & Research
  • Fort Smith Rheumatology, PC
  • CHI St. Vincent Medical Group Hot Springs
  • NEA Baptist Clinic
  • Little Rock Diagnostic Clinic
  • Medvin Clinical Research
  • TriWest Research Associates, LLC
  • St. Jude Hospital Yorba Linda DBA St. Joseph
  • CV Mehta MD Medical Corp
  • Valerius Medical Group
  • NRC Research Institute
  • San Diego Arthritis Med Clnc
  • C Michael Neuwelt MD Inc
  • Inland Rheumatology; Clinical Trials, Inc.
  • Medvin Clinical Research
  • University of Colorado Hospital
  • Arthritis Assoc & Osteoporosis; Ctr of Colorado Springs
  • Denver Arthritis Clinic
  • Joao Nascimento
  • Clinical Research Center of Ct/Ny
  • Arthritis & Osteoporosis Center Pc
  • New England Research Associates
  • Rheumatolgy Consultants of Deleware
  • Javed Rheumatology Associates, Inc.
  • Arthritis & Rheumatism; Disease Specialities
  • Robert Levin, Md; Research Dept
  • Precision Research Organization
  • Suncoast Research Group LLC
  • South Coast Research Center, Inc.
  • Jeffrey Alper M.D Research
  • Rheumatology Associates of Central Florida
  • Arthritis and Rheumatology Clinic
  • Arthritis Center Palm Harbor
  • Arthritis Rsrch of Florida, Inc.
  • Pinellas Medical Research - Allegry & Rheumatology Associates, LLC
  • Sarasota Arthritis Res Center
  • West Broward Rheumatology Associates, Inc.
  • McIlwain Medical Group
  • Burnette & Silverfield, MDS
  • Advanced Clinical Research of Orlando, Inc.
  • North Georgia Rheumatology
  • Arthritis Center of North Georgia
  • North Georgia Rheumatology Group, PC
  • Institute of Arthritis Research
  • Springfield Clinic
  • Indiana Uni Medical Center
  • Diagnostic Rheumatology & Research
  • Kansas City Internal Medicine
  • Bluegrass Comm Research, Inc.
  • Arthritis & Diabetes Clinic, Inc
  • Klein & Associates, M.D., P.A.
  • New England Medical Center; Dept. of Medicine, Div. of Rheumatology
  • Phase Iii Clinical Research
  • Mansfield Medical Center
  • Reliant Medical Group, Inc; Rheumatology
  • UMass Memorial Medical Center
  • Clinical Pharmacology Study Group
  • Advanced Rheumatology, PC
  • Fiechtner Research Inc
  • Nisus Research/Northern Michigan Hospital
  • Shores Rheumatology
  • St. Luke's Hospital Association of Duluth
  • St. Paul Rheumatology
  • Arthritis and Osteoporosis; Treatment and Research Center
  • Jackson Arthritis Clinic
  • David S Rosenberg
  • Clinical Research Consultants,LLC
  • Clayton Medical Research
  • Arthritis Consultants
  • G. T. Kelly, MD
  • Rheumatology Research Group
  • Nashua Rheumatology - Foundation Medical Partners
  • Arthritis and Osteoporosis Associates
  • Atlantic Coast Rheumatology
  • Ocean Rheumatology
  • Arthritis Rheumatic & Back Disease Associates
  • Cooper Cancer Institute
  • Albuquerque Clinical Trials
  • Arthritis and Osteoporosis Associates of New Mexico
  • The Center for Rheumatology
  • Arthritis & Osteoporosis Center
  • Manhasset Rheumatology
  • Manhattan Medical Reserach
  • Buffalo Rheumatology Associates
  • Office of Premier Chatpar Md
  • Rheumatology Associates of Long Island
  • Arthritis Health Associates
  • Asheville Arthritis & Osteoporosis Center, PA
  • Carolina Bone & Joint P.A.
  • Triangle Orthopaedics Associates, P.A.
  • Medication Management
  • PMG Research of Hickory LLC
  • Cape Fear Arthritis Care
  • Shanahan Rheumatology & Immunology, PLLC
  • St. Alexius Medical Center; Arthritis Clinic
  • Odyssey Research Services; Main Medical Building
  • Crystal Arthritis Center, Inc.
  • Cincinnati Rheumatic Disease Study Group
  • University Hospitals Case Medical Center
  • Ohio State University; Rheumatology; Immun/Rheum
  • Columbus Arthritis Center
  • STAT Research Inc
  • Paramount Medical Research
  • Clinical Research Source, Inc.
  • Arthritis Care Center Oklahoma
  • Arthritis and Rheumatology; Center of Oklahoma PLLC
  • Health Research of Oklahoma, Llc
  • Lynn Health Science Inst.
  • Oklahoma Center For Arthritis Therapy & Research
  • Healthcare Research Consultants
  • Altoona Center For Clinical Research
  • Arthritis Associates
  • Arthritis Group
  • Advanced Rheumatology & Arthritis Research Center
  • Clinical Research Center of Reading
  • Emkey Arthritis & Osteoporosis
  • Low Country Rheumatology, PA
  • Columbia Arthritis Center (Partnership Practice)
  • Piedmont Arthritis Clinic
  • West Tennessee Research Institute
  • Ramesh Gupta - PP
  • Amarillo Center For Clinical Research
  • Austin Regional Clinic
  • Lovelace Scientific Resources Inc.
  • Diagnostic Group
  • AOCBV
  • Adriana Pop-Moody MD Clinic PA
  • Arthritis Care & Diagnostic Center
  • Metroplex Clinical Research
  • Rheumatic Disease Clin Res Ctr
  • IntraFusion Researh Network
  • Houston Inst. For Clinical Research
  • Accurate Clinical Research
  • Southwest Rheumatology
  • Accurate Clinical Management
  • NextGen Clinical Research Inc
  • Arthiritis & Osteoporosis Centre of South Texas
  • Arthritis Clinic Of Central Texas
  • Crossroads Clinical Research, LLC
  • Arthritis & Osteoporosis Clinic
  • South Puget Sound Clinical Research
  • Arthritis Northwest, Spokane
  • Wenatchee Valley Hospital & Clinics
  • Mountain State Clinical Research
  • Rheumatic Disease Center
  • Lakeshore Orthopedics
  • Gundersen Clinic Ltd;Sec. Rheumatology/Dept. of Internal Med

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Non-Randomized Participants (TCZ + MTX)

Randomized Participants (TCZ + MTX)

Randomized Participants (TCZ + PBO)

Arm Description

All participants will receive initial treatment with open-label TCZ + MTX. Participants who complete 24-week treatment with open-label TCZ + MTX and did not achieve a DAS28 score </=3.2 at Week 24, will continue receiving TCZ + MTX in open label manner up to Week 52.

Participants who complete the initial 24-week treatment with open-label TCZ + MTX and achieve a DAS28 score </=3.2 at Week 24, will be randomized to receive TCZ along with MTX up to Week 52.

Participants who complete the initial 24-week treatment with open-label TCZ + MTX and achieve a DAS28 score </=3.2 at Week 24, will be randomized to receive TCZ along with MTX matched placebo (PBO) up to Week 52.

Outcomes

Primary Outcome Measures

Change From Week 24 in Disease Activity Score Based on 28 Joints (DAS28) Score at Week 40
The DAS28 was derived from assessments of erythrocyte sedimentation rate (ESR) measured in millimeters per hour (mm/h), tender joint count on 28 joints (TJC28), swollen joint count on 28 joints (SJC28), and Patient's Global Assessment of disease activity according to 100--millimeter (mm) Visual Analog Scale (VAS). DAS28 score was calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. DAS28 score could range from 0 to 10, where higher score represented higher disease activity. The change from Week 24 to Week 40 was averaged among all participants, where negative changes indicated an improvement in disease activity.

Secondary Outcome Measures

Percentage of Participants Achieving 20% Improvement in American College of Rheumatology (ACR20) Response
The ACR20 response at any time was defined as >/=20% improvement compared to baseline in TJC (assessed on 68 joints) and SJC (assessed on 66 joints); and 20% improvement compared to baseline in 3 of the following 5 criteria, respectively: 1) Patient's global assessment of disease activity according to 100-mm VAS, 2) Physician's global assessment of disease activity according to 100-mm VAS, 3) participant's global assessment of pain according to 100-mm VAS, 4) Participant's assessment of functional ability via a Health Assessment Questionnaire-Disability Index (HAQ-DI), and 5) Acute phase reactant (ESR in mm/h or C-Reactive Protein [CRP] in milligrams per deciliter [mg/dL]).
Percentage of Participants Achieving 50% Improvement in American College of Rheumatology (ACR50) Response
The ACR50 response at any time was defined as >/=50% improvement compared to baseline in TJC (assessed on 68 joints) and SJC (assessed on 66 joints); and 50% improvement compared to baseline in 3 of the following 5 criteria, respectively: 1) Patient's global assessment of disease activity according to 100-mm VAS, 2) Physician's global assessment of disease activity according to 100-mm VAS, 3) participant's global assessment of pain according to 100-mm VAS, 4) Participant's assessment of functional ability via HAQ-DI, and 5) Acute phase reactant (ESR in mm/h or CRP in mg/dL).
Percentage of Participants Achieving 70% Improvement in American College of Rheumatology (ACR70) Response
The ACR70 response at any time was defined as >/=70% improvement compared to baseline in TJC (assessed on 68 joints) and SJC (assessed on 66 joints); and 70% improvement compared to baseline in 3 of the following 5 criteria, respectively: 1) Patient's global assessment of disease activity according to 100-mm VAS, 2) Physician's global assessment of disease activity according to 100-mm VAS, 3) participant's global assessment of pain according to 100-mm VAS, 4) Participant's assessment of functional ability via HAQ-DI, and 5) Acute phase reactant (ESR in mm/h or CRP in mg/dL).
Percentage of Participants With >/=1.2 Points Increase (Worsening) From Week 24 in DAS28 Score at Week 40 and 52
The DAS28 was derived from assessments of ESR measured in mm/h, TJC28, SJC28, and Patient's global assessment of disease activity according to 100-mm VAS. DAS28 score was calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. DAS28- score could range from 0 to 10, where higher score represented higher disease activity.
Percentage of Participants With DAS28 Score <2.6 (DAS28 Remission)
The DAS28 was derived from assessments of ESR measured in mm/h, TJC28, SJC28, and Patient's global assessment of disease activity according to 100-mm VAS. DAS28 score was calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. DAS28 score could range from 0 to 10, where higher score represented higher disease activity.
Percentage of Participants With DAS28 Score </=3.2 (Low DAS28)
The DAS28 was derived from assessments of ESR measured in mm/h, TJC28, SJC28, and Patient's global assessment of disease activity according to 100-mm VAS. DAS28 score was calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. DAS28-ESR score could range from 0 to 10, where higher score represented higher disease activity.
Change From Week 24 in Bone Erosion Score at Week 40 for Participants in the Magnetic Resonance Imaging (MRI) Substudy
Bones from the wrist regions (carpal bones, distal radius, distal ulna, and metacarpal bases) and the metacarpophalangeal (MCP) joints (metacarpal heads and phalangeal bases) were assessed for erosion via MRI and scored separately based on the proportion of eroded bone compared to the 'assessed bone volume' judged from all available images. Scoring ranged from 0 (no erosion) to 10 (91-100%). Results were summed, resulting in scores from 0 to 80 for the wrist region, 0 to 150 for the MCP joints, and 0 to 230 on aggregate. A negative value for change from Week 24 in bone erosion score indicated an improvement.
Percentage of Participants With Anti-Therapeutic Antibodies (ATA) to TCZ
Percentage of participants with positive results for ATA against TCZ at Baseline and at any of the post-baseline assessment time-points was reported. Participants positive at any post-baseline time points were participants who had no positivity at baseline for the same assay.
Mean TCZ Serum Concentration
Mean Soluble Interleukin-6 (IL-6) Receptor Concentration

Full Information

First Posted
May 14, 2013
Last Updated
November 30, 2017
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT01855789
Brief Title
A Study of the Impact of Methotrexate (MTX) Discontinuation on the Efficacy of Subcutaneous (SC) Tocilizumab (TCZ) With MTX
Official Title
A Randomized, Double-Blind Trial Assessing the Impact of Methotrexate Discontinuation on the Efficacy of Subcutaneous Tocilizumab With Methotrexate Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
November 7, 2013 (Actual)
Primary Completion Date
October 14, 2016 (Actual)
Study Completion Date
October 14, 2016 (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 randomized, multicenter, double-blind, parallel group study will evaluate the impact of MTX discontinuation on the efficacy of SC TCZ in participants with moderate to severe active rheumatoid arthritis who have an inadequate response to current MTX therapy. Participants will initiate treatment with TCZ weekly or every 2 weeks along with MTX at a stable dose orally in an open-label manner for 24 weeks. Participants with a disease activity score based on 28 joints (DAS28) less than or equal to (</=) 3.2 at Week 24, will be randomized to either continue receiving a stable dose of MTX or to switch to matching placebo up to Week 52. Participants without a DAS28 score </=3.2 at Week 24, will continue the same treatment in a non-randomized open-label manner up to Week 52.

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 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
718 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Non-Randomized Participants (TCZ + MTX)
Arm Type
Experimental
Arm Description
All participants will receive initial treatment with open-label TCZ + MTX. Participants who complete 24-week treatment with open-label TCZ + MTX and did not achieve a DAS28 score </=3.2 at Week 24, will continue receiving TCZ + MTX in open label manner up to Week 52.
Arm Title
Randomized Participants (TCZ + MTX)
Arm Type
Experimental
Arm Description
Participants who complete the initial 24-week treatment with open-label TCZ + MTX and achieve a DAS28 score </=3.2 at Week 24, will be randomized to receive TCZ along with MTX up to Week 52.
Arm Title
Randomized Participants (TCZ + PBO)
Arm Type
Active Comparator
Arm Description
Participants who complete the initial 24-week treatment with open-label TCZ + MTX and achieve a DAS28 score </=3.2 at Week 24, will be randomized to receive TCZ along with MTX matched placebo (PBO) up to Week 52.
Intervention Type
Drug
Intervention Name(s)
Tocilizumab (TCZ)
Other Intervention Name(s)
Actemra
Intervention Description
TCZ will be administered at a dose of 162 milligrams (mg) via SC injection weekly (if body weight is greater than or equal to [>/=] 100 kilograms [kg]) or every 2 weeks (if body weight was less than [<] 100 kg).
Intervention Type
Drug
Intervention Name(s)
Methotrexate (MTX)
Intervention Description
MTX will be administered at a stable dose (15 mg to 25 mg per week) orally.
Intervention Type
Drug
Intervention Name(s)
Placebo (PBO)
Intervention Description
PBO matching to MTX will be administered orally.
Primary Outcome Measure Information:
Title
Change From Week 24 in Disease Activity Score Based on 28 Joints (DAS28) Score at Week 40
Description
The DAS28 was derived from assessments of erythrocyte sedimentation rate (ESR) measured in millimeters per hour (mm/h), tender joint count on 28 joints (TJC28), swollen joint count on 28 joints (SJC28), and Patient's Global Assessment of disease activity according to 100--millimeter (mm) Visual Analog Scale (VAS). DAS28 score was calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. DAS28 score could range from 0 to 10, where higher score represented higher disease activity. The change from Week 24 to Week 40 was averaged among all participants, where negative changes indicated an improvement in disease activity.
Time Frame
Week 24, Week 40
Secondary Outcome Measure Information:
Title
Percentage of Participants Achieving 20% Improvement in American College of Rheumatology (ACR20) Response
Description
The ACR20 response at any time was defined as >/=20% improvement compared to baseline in TJC (assessed on 68 joints) and SJC (assessed on 66 joints); and 20% improvement compared to baseline in 3 of the following 5 criteria, respectively: 1) Patient's global assessment of disease activity according to 100-mm VAS, 2) Physician's global assessment of disease activity according to 100-mm VAS, 3) participant's global assessment of pain according to 100-mm VAS, 4) Participant's assessment of functional ability via a Health Assessment Questionnaire-Disability Index (HAQ-DI), and 5) Acute phase reactant (ESR in mm/h or C-Reactive Protein [CRP] in milligrams per deciliter [mg/dL]).
Time Frame
Weeks 24, 40, and 52
Title
Percentage of Participants Achieving 50% Improvement in American College of Rheumatology (ACR50) Response
Description
The ACR50 response at any time was defined as >/=50% improvement compared to baseline in TJC (assessed on 68 joints) and SJC (assessed on 66 joints); and 50% improvement compared to baseline in 3 of the following 5 criteria, respectively: 1) Patient's global assessment of disease activity according to 100-mm VAS, 2) Physician's global assessment of disease activity according to 100-mm VAS, 3) participant's global assessment of pain according to 100-mm VAS, 4) Participant's assessment of functional ability via HAQ-DI, and 5) Acute phase reactant (ESR in mm/h or CRP in mg/dL).
Time Frame
Weeks 24, 40, and 52
Title
Percentage of Participants Achieving 70% Improvement in American College of Rheumatology (ACR70) Response
Description
The ACR70 response at any time was defined as >/=70% improvement compared to baseline in TJC (assessed on 68 joints) and SJC (assessed on 66 joints); and 70% improvement compared to baseline in 3 of the following 5 criteria, respectively: 1) Patient's global assessment of disease activity according to 100-mm VAS, 2) Physician's global assessment of disease activity according to 100-mm VAS, 3) participant's global assessment of pain according to 100-mm VAS, 4) Participant's assessment of functional ability via HAQ-DI, and 5) Acute phase reactant (ESR in mm/h or CRP in mg/dL).
Time Frame
Weeks 24, 40, and 52
Title
Percentage of Participants With >/=1.2 Points Increase (Worsening) From Week 24 in DAS28 Score at Week 40 and 52
Description
The DAS28 was derived from assessments of ESR measured in mm/h, TJC28, SJC28, and Patient's global assessment of disease activity according to 100-mm VAS. DAS28 score was calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. DAS28- score could range from 0 to 10, where higher score represented higher disease activity.
Time Frame
Week 24, 40, and 52
Title
Percentage of Participants With DAS28 Score <2.6 (DAS28 Remission)
Description
The DAS28 was derived from assessments of ESR measured in mm/h, TJC28, SJC28, and Patient's global assessment of disease activity according to 100-mm VAS. DAS28 score was calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. DAS28 score could range from 0 to 10, where higher score represented higher disease activity.
Time Frame
Week 40, Week 52
Title
Percentage of Participants With DAS28 Score </=3.2 (Low DAS28)
Description
The DAS28 was derived from assessments of ESR measured in mm/h, TJC28, SJC28, and Patient's global assessment of disease activity according to 100-mm VAS. DAS28 score was calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. DAS28-ESR score could range from 0 to 10, where higher score represented higher disease activity.
Time Frame
Week 40, Week 52
Title
Change From Week 24 in Bone Erosion Score at Week 40 for Participants in the Magnetic Resonance Imaging (MRI) Substudy
Description
Bones from the wrist regions (carpal bones, distal radius, distal ulna, and metacarpal bases) and the metacarpophalangeal (MCP) joints (metacarpal heads and phalangeal bases) were assessed for erosion via MRI and scored separately based on the proportion of eroded bone compared to the 'assessed bone volume' judged from all available images. Scoring ranged from 0 (no erosion) to 10 (91-100%). Results were summed, resulting in scores from 0 to 80 for the wrist region, 0 to 150 for the MCP joints, and 0 to 230 on aggregate. A negative value for change from Week 24 in bone erosion score indicated an improvement.
Time Frame
Weeks 24, Week 40
Title
Percentage of Participants With Anti-Therapeutic Antibodies (ATA) to TCZ
Description
Percentage of participants with positive results for ATA against TCZ at Baseline and at any of the post-baseline assessment time-points was reported. Participants positive at any post-baseline time points were participants who had no positivity at baseline for the same assay.
Time Frame
Baseline, Post-baseline (assessed at Weeks 12, 24, 36, 52 and at follow up [Week 60])
Title
Mean TCZ Serum Concentration
Time Frame
Baseline, Weeks 12, 24, 36, 52 and follow up (Week 60)
Title
Mean Soluble Interleukin-6 (IL-6) Receptor Concentration
Time Frame
Baseline, Weeks 12, 24, 36, 52 and follow up (Week 60)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Body weight </=150 kg Active moderate to severe rheumatoid arthritis (DAS28 >/=4.4) according to the revised 1987 ACR criteria at screening and baseline (prior to treatment on Day 1) Currently receiving oral MTX for at least 24 weeks and on a stable oral dose of at least 15 mg/week for at least 6 weeks prior to treatment (Day 1), with the following exception: a stable dose of at least 10 mg/week is allowed for participants with a body weight <50 kg or calculated glomerular filtration rate (or creatinine clearance) <60 milliliters per minute (mL/min) History of parenteral (SC or intramuscular [IM]) MTX is allowed, but not within 6 weeks prior to treatment (Day 1). Participants must not have a documented, clinically significant intolerance to oral MTX and must be receiving oral MTX at a dose of 15 mg/week for at least 6 weeks prior to treatment (Day 1) Participants who have received one prior anti-tumor necrosis factor (TNF) must have discontinued etanercept, infliximab, certolizumab, adalimumab, or golimumab for at least 6 months prior to screening Oral corticosteroids must have been </=10 mg/day prednisone (or equivalent) and stable for at least 25 out of 28 days prior to treatment (Day 1) Participants receiving treatment on an outpatient basis Exclusion Criteria: Documented medical history of significant intolerance to oral MTX >/=15 mg/week Participants receiving other (non-MTX) disease modifying anti-rheumatic drugs (DMARDs) within 8 weeks of screening Previous treatment with abatacept, rituximab, tofacitinib, or anakinra Treatment with parenteral corticosteroids within 4 weeks prior to treatment Previous treatment with cell-depleting therapies or alkylating agents Previous treatment with TCZ Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery during the study Rheumatic autoimmune disease other than rheumatoid arthritis Non-rheumatic active autoimmune diseases (for example, inflammatory bowel diseases, psoriasis, multiple sclerosis) Prior history of or current inflammatory joint disease other than rheumatoid arthritis Functional Class IV according to the revised (1987) ACR criteria for rheumatoid arthritis History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies Evidence of significant uncontrolled concomitant diseases; uncontrolled disease states where flares are commonly treated with oral or parenteral corticosteroids Active current or history of recurrent infection, or any major episode of infection requiring hospitalization or treatment with intravenous antibiotics within 4 weeks prior to screening or oral antibiotics within 2 weeks prior to screening Active tuberculosis requiring treatment within the previous 3 years History of or currently active primary or secondary immunodeficiency Pregnant or breast-feeding women Positive for hepatitis B or hepatitis C infection For potential MRI substudy participants: the presence of any metal-containing device or object in the body
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
Uni Of Alabama,Birmingham; Medicine - Rheumatology
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Rheumatology Associates of North Alabama
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Clnical & Translational Reseach Center for Alabama, PC
City
Tuscaloosa
State/Province
Alabama
ZIP/Postal Code
35406
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 & Rheumatology Research, Pllc
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85202
Country
United States
Facility Name
Arizona Arthritis and Rheuma
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85202
Country
United States
Facility Name
Valley Arthritis Care
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85027
Country
United States
Facility Name
Advanced Arthritis Care & Research
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Facility Name
Fort Smith Rheumatology, PC
City
Fort Smith
State/Province
Arkansas
ZIP/Postal Code
72903
Country
United States
Facility Name
CHI St. Vincent Medical Group Hot Springs
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Facility Name
NEA Baptist Clinic
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
Little Rock Diagnostic Clinic
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Medvin Clinical Research
City
Covina
State/Province
California
ZIP/Postal Code
91723
Country
United States
Facility Name
TriWest Research Associates, LLC
City
El Cajon
State/Province
California
ZIP/Postal Code
92020
Country
United States
Facility Name
St. Jude Hospital Yorba Linda DBA St. Joseph
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
CV Mehta MD Medical Corp
City
Hemet
State/Province
California
ZIP/Postal Code
92543
Country
United States
Facility Name
Valerius Medical Group
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720
Country
United States
Facility Name
NRC Research Institute
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
San Diego Arthritis Med Clnc
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
C Michael Neuwelt MD Inc
City
San Leandro
State/Province
California
ZIP/Postal Code
94578
Country
United States
Facility Name
Inland Rheumatology; Clinical Trials, Inc.
City
Upland
State/Province
California
ZIP/Postal Code
91785-1141
Country
United States
Facility Name
Medvin Clinical Research
City
Whittier
State/Province
California
ZIP/Postal Code
90606
Country
United States
Facility Name
University of Colorado Hospital
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Arthritis Assoc & Osteoporosis; Ctr of Colorado Springs
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80920
Country
United States
Facility Name
Denver Arthritis Clinic
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230-7127
Country
United States
Facility Name
Joao Nascimento
City
Bridgeport
State/Province
Connecticut
ZIP/Postal Code
06606
Country
United States
Facility Name
Clinical Research Center of Ct/Ny
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
06810
Country
United States
Facility Name
Arthritis & Osteoporosis Center Pc
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06518
Country
United States
Facility Name
New England Research Associates
City
Trumbull
State/Province
Connecticut
ZIP/Postal Code
06611
Country
United States
Facility Name
Rheumatolgy Consultants of Deleware
City
Lewes
State/Province
Delaware
ZIP/Postal Code
19958
Country
United States
Facility Name
Javed Rheumatology Associates, Inc.
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
Arthritis & Rheumatism; Disease Specialities
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Robert Levin, Md; Research Dept
City
Dunedin
State/Province
Florida
ZIP/Postal Code
34698
Country
United States
Facility Name
Precision Research Organization
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Suncoast Research Group LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33135
Country
United States
Facility Name
South Coast Research Center, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Jeffrey Alper M.D Research
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Facility Name
Rheumatology Associates of Central Florida
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Arthritis and Rheumatology Clinic
City
Orlando
State/Province
Florida
ZIP/Postal Code
32836
Country
United States
Facility Name
Arthritis Center Palm Harbor
City
Palm Harbor
State/Province
Florida
ZIP/Postal Code
34684
Country
United States
Facility Name
Arthritis Rsrch of Florida, Inc.
City
Palm Harbor
State/Province
Florida
ZIP/Postal Code
34684
Country
United States
Facility Name
Pinellas Medical Research - Allegry & Rheumatology Associates, LLC
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33708
Country
United States
Facility Name
Sarasota Arthritis Res Center
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
West Broward Rheumatology Associates, Inc.
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
Facility Name
McIlwain Medical Group
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Burnette & Silverfield, MDS
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
Advanced Clinical Research of Orlando, Inc.
City
Winter Garden
State/Province
Florida
ZIP/Postal Code
34787
Country
United States
Facility Name
North Georgia Rheumatology
City
Duluth
State/Province
Georgia
ZIP/Postal Code
30096
Country
United States
Facility Name
Arthritis Center of North Georgia
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States
Facility Name
North Georgia Rheumatology Group, PC
City
Lawrenceville
State/Province
Georgia
ZIP/Postal Code
30046
Country
United States
Facility Name
Institute of Arthritis Research
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Springfield Clinic
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62703
Country
United States
Facility Name
Indiana Uni Medical Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Diagnostic Rheumatology & Research
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46227
Country
United States
Facility Name
Kansas City Internal Medicine
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66209
Country
United States
Facility Name
Bluegrass Comm Research, Inc.
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40515
Country
United States
Facility Name
Arthritis & Diabetes Clinic, Inc
City
Monroe
State/Province
Louisiana
ZIP/Postal Code
71203
Country
United States
Facility Name
Klein & Associates, M.D., P.A.
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21740
Country
United States
Facility Name
New England Medical Center; Dept. of Medicine, Div. of Rheumatology
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Phase Iii Clinical Research
City
Fall River
State/Province
Massachusetts
ZIP/Postal Code
02720
Country
United States
Facility Name
Mansfield Medical Center
City
Mansfield
State/Province
Massachusetts
ZIP/Postal Code
02048
Country
United States
Facility Name
Reliant Medical Group, Inc; Rheumatology
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
Facility Name
UMass Memorial Medical Center
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
Facility Name
Clinical Pharmacology Study Group
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01610
Country
United States
Facility Name
Advanced Rheumatology, PC
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48910
Country
United States
Facility Name
Fiechtner Research Inc
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48910
Country
United States
Facility Name
Nisus Research/Northern Michigan Hospital
City
Petoskey
State/Province
Michigan
ZIP/Postal Code
49770
Country
United States
Facility Name
Shores Rheumatology
City
Saint Clair Shores
State/Province
Michigan
ZIP/Postal Code
48081
Country
United States
Facility Name
St. Luke's Hospital Association of Duluth
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
Facility Name
St. Paul Rheumatology
City
Eagan
State/Province
Minnesota
ZIP/Postal Code
55121
Country
United States
Facility Name
Arthritis and Osteoporosis; Treatment and Research Center
City
Flowood
State/Province
Mississippi
ZIP/Postal Code
39232
Country
United States
Facility Name
Jackson Arthritis Clinic
City
Flowood
State/Province
Mississippi
ZIP/Postal Code
39232
Country
United States
Facility Name
David S Rosenberg
City
Florissant
State/Province
Missouri
ZIP/Postal Code
63031
Country
United States
Facility Name
Clinical Research Consultants,LLC
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Clayton Medical Research
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63117
Country
United States
Facility Name
Arthritis Consultants
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
G. T. Kelly, MD
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Rheumatology Research Group
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Nashua Rheumatology - Foundation Medical Partners
City
Nashua
State/Province
New Hampshire
ZIP/Postal Code
03060
Country
United States
Facility Name
Arthritis and Osteoporosis Associates
City
Manalapan
State/Province
New Jersey
ZIP/Postal Code
07726
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
Arthritis Rheumatic & Back Disease Associates
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Facility Name
Cooper Cancer Institute
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Facility Name
Albuquerque Clinical Trials
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Arthritis and Osteoporosis Associates of New Mexico
City
Las Cruces
State/Province
New Mexico
ZIP/Postal Code
88011
Country
United States
Facility Name
The Center for Rheumatology
City
Albany
State/Province
New York
ZIP/Postal Code
12203
Country
United States
Facility Name
Arthritis & Osteoporosis Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11201
Country
United States
Facility Name
Manhasset Rheumatology
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Manhattan Medical Reserach
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Buffalo Rheumatology Associates
City
Orchard Park
State/Province
New York
ZIP/Postal Code
14127
Country
United States
Facility Name
Office of Premier Chatpar Md
City
Plainview
State/Province
New York
ZIP/Postal Code
11803
Country
United States
Facility Name
Rheumatology Associates of Long Island
City
Smithtown
State/Province
New York
ZIP/Postal Code
11787
Country
United States
Facility Name
Arthritis Health Associates
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Asheville Arthritis & Osteoporosis Center, PA
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28803
Country
United States
Facility Name
Carolina Bone & Joint P.A.
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
Triangle Orthopaedics Associates, P.A.
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27704
Country
United States
Facility Name
Medication Management
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27408
Country
United States
Facility Name
PMG Research of Hickory LLC
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28602
Country
United States
Facility Name
Cape Fear Arthritis Care
City
Leland
State/Province
North Carolina
ZIP/Postal Code
28451
Country
United States
Facility Name
Shanahan Rheumatology & Immunology, PLLC
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27617
Country
United States
Facility Name
St. Alexius Medical Center; Arthritis Clinic
City
Bismarck
State/Province
North Dakota
ZIP/Postal Code
58501
Country
United States
Facility Name
Odyssey Research Services; Main Medical Building
City
Bismarck
State/Province
North Dakota
ZIP/Postal Code
58507
Country
United States
Facility Name
Crystal Arthritis Center, Inc.
City
Akron
State/Province
Ohio
ZIP/Postal Code
44333
Country
United States
Facility Name
Cincinnati Rheumatic Disease Study Group
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
University Hospitals Case Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Facility Name
Ohio State University; Rheumatology; Immun/Rheum
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43203
Country
United States
Facility Name
Columbus Arthritis Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
STAT Research Inc
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45417
Country
United States
Facility Name
Paramount Medical Research
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Facility Name
Clinical Research Source, Inc.
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States
Facility Name
Arthritis Care Center Oklahoma
City
Ardmore
State/Province
Oklahoma
ZIP/Postal Code
73401
Country
United States
Facility Name
Arthritis and Rheumatology; Center of Oklahoma PLLC
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Health Research of Oklahoma, Llc
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Lynn Health Science Inst.
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Oklahoma Center For Arthritis Therapy & Research
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Healthcare Research Consultants
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74135
Country
United States
Facility Name
Altoona Center For Clinical Research
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Arthritis Associates
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16508
Country
United States
Facility Name
Arthritis Group
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19152
Country
United States
Facility Name
Advanced Rheumatology & Arthritis Research Center
City
Wexford
State/Province
Pennsylvania
ZIP/Postal Code
15090
Country
United States
Facility Name
Clinical Research Center of Reading
City
Wyomissing
State/Province
Pennsylvania
ZIP/Postal Code
19610
Country
United States
Facility Name
Emkey Arthritis & Osteoporosis
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
Columbia Arthritis Center (Partnership Practice)
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29204
Country
United States
Facility Name
Piedmont Arthritis Clinic
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29601
Country
United States
Facility Name
West Tennessee Research Institute
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
Ramesh Gupta - PP
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Amarillo Center For Clinical Research
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79124
Country
United States
Facility Name
Austin Regional Clinic
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Lovelace Scientific Resources Inc.
City
Austin
State/Province
Texas
ZIP/Postal Code
78758
Country
United States
Facility Name
Diagnostic Group
City
Beaumont
State/Province
Texas
ZIP/Postal Code
77701
Country
United States
Facility Name
AOCBV
City
College Station
State/Province
Texas
ZIP/Postal Code
77845
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
Arthritis Care & Diagnostic Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231-4406
Country
United States
Facility Name
Metroplex Clinical Research
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Rheumatic Disease Clin Res Ctr
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
IntraFusion Researh Network
City
Houston
State/Province
Texas
ZIP/Postal Code
77007
Country
United States
Facility Name
Houston Inst. For Clinical Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
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 Management
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
NextGen Clinical Research Inc
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Arthiritis & Osteoporosis Centre of South Texas
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78232
Country
United States
Facility Name
Arthritis Clinic Of Central Texas
City
San Marcos
State/Province
Texas
ZIP/Postal Code
78666
Country
United States
Facility Name
Crossroads Clinical Research, LLC
City
Victoria
State/Province
Texas
ZIP/Postal Code
77901
Country
United States
Facility Name
Arthritis & Osteoporosis Clinic
City
Waco
State/Province
Texas
ZIP/Postal Code
76710
Country
United States
Facility Name
South Puget Sound Clinical Research
City
Olympia
State/Province
Washington
ZIP/Postal Code
98502
Country
United States
Facility Name
Arthritis Northwest, Spokane
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Wenatchee Valley Hospital & Clinics
City
Wenatchee
State/Province
Washington
ZIP/Postal Code
98801
Country
United States
Facility Name
Mountain State Clinical Research
City
Clarksburg
State/Province
West Virginia
ZIP/Postal Code
26301
Country
United States
Facility Name
Rheumatic Disease Center
City
Glendale
State/Province
Wisconsin
ZIP/Postal Code
53217
Country
United States
Facility Name
Lakeshore Orthopedics
City
Manitowoc
State/Province
Wisconsin
ZIP/Postal Code
54220
Country
United States
Facility Name
Gundersen Clinic Ltd;Sec. Rheumatology/Dept. of Internal Med
City
Onalaska
State/Province
Wisconsin
ZIP/Postal Code
54605
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29575803
Citation
Kremer JM, Rigby W, Singer NG, Birchwood C, Gill D, Reiss W, Pei J, Michalska M. Sustained Response Following Discontinuation of Methotrexate in Patients With Rheumatoid Arthritis Treated With Subcutaneous Tocilizumab: Results From a Randomized, Controlled Trial. Arthritis Rheumatol. 2018 Aug;70(8):1200-1208. doi: 10.1002/art.40493. Epub 2018 Jun 14.
Results Reference
derived

Learn more about this trial

A Study of the Impact of Methotrexate (MTX) Discontinuation on the Efficacy of Subcutaneous (SC) Tocilizumab (TCZ) With MTX

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