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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00808210
• Other study ID #: ACT4562g
• Secondary ID: GA00931
• Status: Terminated
• Phase: Phase 2
• Start date: March 5, 2009
• Est. completion date: November 14, 2012

Study information

• Verified date: October 2020
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 28
• Est. completion date: November 14, 2012
• Est. primary completion date: November 14, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Infliximab
Intravenous repeating dose
• Methotrexate
Oral or parenteral repeating dose
• Methylprednisolone
Intravenous repeating dose
• Ocrelizumab
Intravenous repeating dose
• Placebo
Intravenous repeating dose

Locations

Country	Name	City	State
United States	Lehigh Valley Physicians Group	Allentown	Pennsylvania
United States	Amarillo Center For Clinical Research	Amarillo	Texas
United States	Billings Clinic	Billings	Montana
United States	Billings Clinic; Research Center	Billings	Montana
United States	Regional Clinical Research	Binghamton	New York
United States	Rheumatology Associates	Birmingham	Alabama
United States	RASF-Clinical Research Center	Boca Raton	Florida
United States	Graves Gilbert Clinic	Bowling Green	Kentucky
United States	Arthritis & Osteoporosis Center	Brooklyn	New York
United States	Arthritis Assoc & Osteoporosis; Ctr of Colorado Springs	Colorado Springs	Colorado
United States	Columbia Arthritis Center (Partnership Practice)	Columbia	South Carolina
United States	Ohio State Univ Med Center	Columbus	Ohio
United States	Robert W. Levin MD - PP	Dunedin	Florida
United States	Barada,Harrell,Toohey&Bellhorn	Durham	North Carolina
United States	Arthritis Associates	Erie	Pennsylvania
United States	Hurley Medical Center	Flint	Michigan
United States	Private Practice - Rosenberg	Florissant	Missouri
United States	Jackson Arthritis Clinic	Flowood	Mississippi
United States	Physicians East Pa	Greenville	North Carolina
United States	Piedmont Arthritis Clinic	Greenville	South Carolina
United States	Arthritis Associates	Hixson	Tennessee
United States	Phillip A Waller MD, PA	Houston	Texas
United States	Institute of Arthritis Research	Idaho Falls	Idaho
United States	Arthritis Associates of Mississippi	Jackson	Mississippi
United States	NEA Baptist Clinic	Jonesboro	Arkansas
United States	Science and Research Institute, Inc.	Jupiter	Florida
United States	Rheumatology, P.C.; Medical Arts Building	Kalamazoo	Michigan
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Fiechtner Research Inc	Lansing	Michigan
United States	Dartmouth-Hitchcock Medical Center, Rheumatology 5C	Lebanon	New Hampshire
United States	Arthritis Res & Treatment	Macon	Georgia
United States	Ramesh Gupta - PP	Memphis	Tennessee
United States	Southwest Rheumatology	Mesquite	Texas
United States	Illinois Bone & Joint Inst.	Morton Grove	Illinois
United States	Dr. Brigid Freyne, MD	Murrieta	California
United States	South Carolina Research Center	Myrtle Beach	South Carolina
United States	Ctr for Inflammatory Disease	Nashville	Tennessee
United States	Oklahoma Medical Research Foundation	Oklahoma City	Oklahoma
United States	Southern Tier Arthritis & Rheumatism	Olean	New York
United States	Westroads Medical Group	Omaha	Nebraska
United States	Buffalo Rheumatology Associates	Orchard Park	New York
United States	Rheumatology Associates of Central Florida	Orlando	Florida
United States	Providence Arthritis Center	Portland	Oregon
United States	Arthritis Center of Reno	Reno	Nevada
United States	Harbin Clinic	Rome	Georgia
United States	Shores Rheumatology	Saint Clair Shores	Michigan
United States	Clayton Medical Research	Saint Louis	Missouri
United States	Texas Arthritis Research Center	San Antonio	Texas
United States	Lovelace Scientific Resources	Sarasota	Florida
United States	Springfield Clinic	Springfield	Illinois
United States	Healthcare Research Consultants	Tulsa	Oklahoma
United States	Agilence Arthritis and Osteoporosis Medical Center, Inc.	Whittier	California
United States	Clinical Pharmacology Study Group	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in DAS28(ESR) at Week 20		Week 20
Secondary	Percentage of Participants With Clinical Response of 20% According to ACR Criteria		Baseline up to 30 months
Secondary	Percentage of Participants With Clinical Response of 50% According to ACR Criteria		Baseline up to 30 months
Secondary	Percentage of Participants With Clinical Response of 70% According to ACR Criteria		Baseline up to 30 months
Secondary	European League Against Rheumatism (EULAR) Response Rates		Baseline up to 30 months
Secondary	Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score		Baseline up to 30 months
Secondary	Change in Fatigue Visual Analog Scale Score (VAS)		Baseline up to 30 months
Secondary	Percentage of Participants With Adverse Events (AEs)		Baseline up to 30 months