A Study of Ocrelizumab Compared to Placebo in Patients With Active Rheumatoid Arthritis Who Don't Have a Response to Anti-TNF-α Therapy (SCRIPT)
Stopped early · Phase 3 · Has a placebo group
Conditions studied: Rheumatoid Arthritis
In brief
This study will evaluate the efficacy and safety of ocrelizumab, compared with placebo, in patients with active rheumatoid arthritis who have an inadequate response to at least one anti-TNF-alpha therapy. Patients will be randomized to receive placebo, 200mg of intravenous ocrelizumab, or 500mg of i.v. ocrelizumab on days 1 and 15. A repeat course of i.v. treatment will be administered at weeks 24 and 26. All patients will receive stable doses of either concomitant methotrexate (7.5-25mg/week) or leflunomide (10-20mg po daily) and may receive additional DMARDs. The treatment period is planned for 48 weeks (until primary analysis) and then participants will enter the open label phase until the drug is commercialized. Target sample size is 1000.
Key facts
- Study ID
- NCT00476996
- Run by
- Genentech, Inc.
- People needed
- 836
- Starts
- 2007-05-15
- Expected to finish
- 2018-05-14
- Last updated by the study team
- 2019-08-12
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Adult patients, ≥ 18 years of age
- Rheumatoid arthritis for at least 3 months
- Inadequate response to previous or current treatment with at least one anti-TNF-alpha agent
- Receiving either leflunomide or methotrexate for ≥ 12 weeks, with a stable dose for the last 4 weeks
- Swollen joint count (SJC) ≥ 4 (66 joint count) and tender joint count (TJC) ≥ 4 (68 joint count) at screening and baseline.
- CRP ≥ 0.6 mg/dL using a high-sensitivity assay.
- Positive rheumatoid factor or positive anti-CCP antibody or both.
You may not qualify if…
- Rheumatic autoimmune disease or inflammatory joint disease, other than RA
- Any surgical procedure in past 12 weeks,or planned within 48 weeks of baseline
Where it is running
- Rheumatology Associates — Birmingham, Alabama, United States
- Rheumatology Associates of North Alabama — Huntsville, Alabama, United States
- Arizona Arthritis & Rheumatology Research, Pllc — Mesa, Arizona, United States
- Arthrocare, Arthritis Care and Research, P.C. — Mesa, Arizona, United States
- Catalina Pointe Clinical Research, Inc. — Tucson, Arizona, United States
- Uni of Arizona Health Science Center; Dept of Rheumatology/Immunology — Tucson, Arizona, United States
- CHI St. Vincent Medical Group Hot Springs — Hot Springs, Arkansas, United States
- Little Rock Diagnostic Clinic — Little Rock, Arkansas, United States
- Allergy & Rheumatology Centre — La Jolla, California, United States
- Private Practice — Long Beach, California, United States
- Valerius Medical Group & Research Ctr of Greater Long Beach — Los Alamitos, California, United States
- Uni of Southern California School of Medicine — Los Angeles, California, United States
- Pacific Arthritis Care Center — Los Angeles, California, United States
- Stanford Uni Medical Center; Divison of Rheumatology — Palo Alto, California, United States
- Ucsd, Dept of Medicine; Rheumatology — San Diego, California, United States
- San Diego Arthritis Med Clnc — San Diego, California, United States
- East Bay Rheumatology — San Leandro, California, United States
- Arthritis Treatment Center of South Bay — Torrance, California, United States
- University of Colorado Cancer Center — Aurora, Colorado, United States
- Arthritis Assoc & Osteoporosis; Ctr of Colorado Springs — Colorado Springs, Colorado, United States
- Arthritis & Osteoporosis Center P.C. — Camden, Connecticut, United States
- New England Research Associates — Trumbull, Connecticut, United States
- Rheumatolgy Consultants of Deleware — Lewes, Delaware, United States
- Javed Rheumatology Associates, Inc. — Newark, Delaware, United States
- Pinnacle Research Group; Llc, Central — Anniston, Alabama, United States
Full record on ClinicalTrials.gov
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