Study Stopped
Based on analysis of results and consideration of available treatments, the overall benefit to risk profile of ocrelizumab was not favorable in RA.
A Study to Evaluate Ocrelizumab in Combination With Methotrexate Compared With Infliximab Plus Methotrexate in Patients With Active Rheumatoid Arthritis Currently Responding Inadequately to Etanercept or Adalimumab
A PHASE II RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OCRELIZUMAB IN COMBINATION WITH METHOTREXATE, COMPARED TO INFLIXIMAB PLUS METHOTREXATE IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS CURRENTLY RESPONDING INADEQUATELY TO ETANERCEPT OR ADALIMUMAB
2 other identifiers
interventional
28
1 country
53
Brief Summary
This is a Phase II, randomized, active-controlled, double-blind, double-dummy, parallel-group, multicenter study in the United States enrolling patients with active RA. The study will enroll approximately 290 patients at approximately 130 sites.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 rheumatoid-arthritis
Started Mar 2009
Longer than P75 for phase_2 rheumatoid-arthritis
53 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 11, 2008
CompletedFirst Posted
Study publicly available on registry
December 15, 2008
CompletedStudy Start
First participant enrolled
March 5, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 14, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 14, 2012
CompletedResults Posted
Study results publicly available
November 6, 2020
CompletedNovember 6, 2020
October 1, 2020
3.7 years
December 11, 2008
August 27, 2020
October 13, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in DAS28(ESR) at Week 20
Week 20
Secondary Outcomes (7)
Percentage of Participants With Clinical Response of 20% According to ACR Criteria
Baseline up to 30 months
Percentage of Participants With Clinical Response of 50% According to ACR Criteria
Baseline up to 30 months
Percentage of Participants With Clinical Response of 70% According to ACR Criteria
Baseline up to 30 months
European League Against Rheumatism (EULAR) Response Rates
Baseline up to 30 months
Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score
Baseline up to 30 months
- +2 more secondary outcomes
Study Arms (2)
Ocrelizumab 200mg
EXPERIMENTALParticipants received two intravenous (IV) infusions of 200 mg ocrelizumab administered on Day 1 and Day 15 and placebo IV infliximab infusions administered on Day 1, Day 15, Week 6, and Week 14. In addition to the study medication, all patients were to receive methotrexate at a stable dose of 7.5-25 mg/week and folic acid or equivalent at a dose of 5 mg/week to minimize methotrexate toxicity.
Infliximab 5mg/kg
ACTIVE COMPARATORParticipants received four IV infusions of 5 mg/kg infliximab administered on Day 1, Day 15, Week 6, and Week 14 and placebo ocrelizumab infusions administered on Day 1 and Day 15. In addition to the study medication, all patients were to receive methotrexate at a stable dose of 7.5-25 mg/week and folic acid or equivalent at a dose of 5 mg/week to minimize methotrexate toxicity.
Interventions
Eligibility Criteria
You may qualify if:
- Age \>= 18 years
- Current treatment for RA on an outpatient basis
- Active disease
- Currently receiving 50 mg etanercept subcutaneously (SC) every week or 40 mg adalimumab SC every other week.
- Considered by Investigator to be a primary non-responder to their first anti-TNFα treatment for efficacy reasons
You may not qualify if:
- Rheumatic autoimmune disease other than RA, or significant systemic involvement secondary to RA
- History of, or current, inflammatory joint disease other than RA (e.g., gout, reactive arthritis, psoriatic arthritis, seronegative spondyloarthropathy, Lyme disease) or other systemic autoimmune disorder (e.g., systemic lupus erythematosus, inflammatory bowel disease, scleroderma, inflammatory myopathy, mixed connective tissue disease or other overlap syndrome)
- Previous treatment with a any biologic therapy for RA (including investigational products with the exception of etanercept or adalimumab
- Treatment with more than one prior anti-TNFα therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Genentech, Inc.lead
Study Sites (53)
Rheumatology Associates
Birmingham, Alabama, 35205, United States
NEA Baptist Clinic
Jonesboro, Arkansas, 72401, United States
Dr. Brigid Freyne, MD
Murrieta, California, 92563, United States
Agilence Arthritis and Osteoporosis Medical Center, Inc.
Whittier, California, 90606, United States
Arthritis Assoc & Osteoporosis; Ctr of Colorado Springs
Colorado Springs, Colorado, 80920, United States
RASF-Clinical Research Center
Boca Raton, Florida, 33486, United States
Robert W. Levin MD - PP
Dunedin, Florida, 34698, United States
Science and Research Institute, Inc.
Jupiter, Florida, 33458, United States
Rheumatology Associates of Central Florida
Orlando, Florida, 32806, United States
Lovelace Scientific Resources
Sarasota, Florida, 34292, United States
Arthritis Res & Treatment
Macon, Georgia, 30281, United States
Harbin Clinic
Rome, Georgia, 30165, United States
Institute of Arthritis Research
Idaho Falls, Idaho, 83404, United States
Illinois Bone & Joint Inst.
Morton Grove, Illinois, 60053, United States
Springfield Clinic
Springfield, Illinois, 62703, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Graves Gilbert Clinic
Bowling Green, Kentucky, 42101, United States
Clinical Pharmacology Study Group
Worcester, Massachusetts, 01610, United States
Hurley Medical Center
Flint, Michigan, 48503, United States
Rheumatology, P.C.; Medical Arts Building
Kalamazoo, Michigan, 49009, United States
Fiechtner Research Inc
Lansing, Michigan, 48910, United States
Shores Rheumatology
Saint Clair Shores, Michigan, 48081, United States
Jackson Arthritis Clinic
Flowood, Mississippi, 39232, United States
Arthritis Associates of Mississippi
Jackson, Mississippi, 39202, United States
Private Practice - Rosenberg
Florissant, Missouri, 63031, United States
Clayton Medical Research
St Louis, Missouri, 63117, United States
Billings Clinic; Research Center
Billings, Montana, 59101, United States
Billings Clinic
Billings, Montana, 59102, United States
Westroads Medical Group
Omaha, Nebraska, 68114, United States
Arthritis Center of Reno
Reno, Nevada, 89502, United States
Dartmouth-Hitchcock Medical Center, Rheumatology 5C
Lebanon, New Hampshire, 03756, United States
Regional Clinical Research
Binghamton, New York, 13905, United States
Arthritis & Osteoporosis Center
Brooklyn, New York, 11201, United States
Southern Tier Arthritis & Rheumatism
Olean, New York, 14760, United States
Buffalo Rheumatology Associates
Orchard Park, New York, 14127, United States
Barada,Harrell,Toohey&Bellhorn
Durham, North Carolina, 27704, United States
Physicians East Pa
Greenville, North Carolina, 27834, United States
Ohio State Univ Med Center
Columbus, Ohio, 43210, United States
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, 73104, United States
Healthcare Research Consultants
Tulsa, Oklahoma, 74135, United States
Providence Arthritis Center
Portland, Oregon, 97213, United States
Lehigh Valley Physicians Group
Allentown, Pennsylvania, 18103, United States
Arthritis Associates
Erie, Pennsylvania, 16508, United States
Columbia Arthritis Center (Partnership Practice)
Columbia, South Carolina, 29204, United States
Piedmont Arthritis Clinic
Greenville, South Carolina, 29601, United States
South Carolina Research Center
Myrtle Beach, South Carolina, 29572, United States
Arthritis Associates
Hixson, Tennessee, 37343, United States
Ramesh Gupta - PP
Memphis, Tennessee, 38119, United States
Ctr for Inflammatory Disease
Nashville, Tennessee, 37205, United States
Amarillo Center For Clinical Research
Amarillo, Texas, 79124, United States
Phillip A Waller MD, PA
Houston, Texas, 77034, United States
Southwest Rheumatology
Mesquite, Texas, 75150, United States
Texas Arthritis Research Center
San Antonio, Texas, 78217, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
At the time of study termination the scope of the statistical analyses was reduced and limited to evaluation of the safety profile.
Results Point of Contact
- Title
- Medical Communications
- Organization
- F. Hoffmann-La Roche Ltd
Study Officials
- STUDY DIRECTOR
Clinical Trials
Genentech, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 11, 2008
First Posted
December 15, 2008
Study Start
March 5, 2009
Primary Completion
November 14, 2012
Study Completion
November 14, 2012
Last Updated
November 6, 2020
Results First Posted
November 6, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will share
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/members/ourmembers/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research\_and\_development/who\_we\_are\_how\_we\_work/clinical\_trials/our\_commitment\_to\_data\_sharing.htm).