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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)

This study has been terminated.
(Based on analysis of results and consideration of available treatments, the overall benefit to risk profile of ocrelizumab was not favorable in RA.)
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by:
Genentech
ClinicalTrials.gov Identifier:
NCT00476996
First received: May 18, 2007
Last updated: June 25, 2010
Last verified: June 2010
History of Changes

May 18, 2007
June 25, 2010
May 2007
October 2010   (final data collection date for primary outcome measure)
Percentage of patients with ACR20 responses [ Time Frame: Weeks 24 and 48 ] [ Designated as safety issue: No ]
Percentage of patients with clinical response of 20%, 50%, and 70% according to ACR criteria (ACR20, ACR50, and ACR70) and the components of this outcome
Complete list of historical versions of study NCT00476996 on ClinicalTrials.gov Archive Site
  • Proportion of patients with a major clinical response [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
  • Proportion of patients achieving Disease Activity Score (DAS28) remission [ Time Frame: Weeks 24 and 48 ] [ Designated as safety issue: No ]
  • Change in DAS28 from baseline [ Time Frame: Weeks 24 and 48 ] [ Designated as safety issue: No ]
  • EULAR response rates [ Time Frame: Weeks 24 and 48 ] [ Designated as safety issue: No ]
  • Proportion of patients achieving an ACR50 response [ Time Frame: Weeks 24 and 48 ] [ Designated as safety issue: No ]
  • Proportion of patients achieving an ACR70 response [ Time Frame: Weeks 24 and 48 ] [ Designated as safety issue: No ]
  • Proportion of patients with a reduction in the HAQ-DI score [ Time Frame: Weeks 24 and 48 ] [ Designated as safety issue: No ]
  • Disease activity scores 28 (DAS 28)
  • European League Against Rheumatism (EULAR) response rate
  • Modified Sharp score of hand and feet radiographs
  • Health Assessments Questionnaire - Disability Index (HAQ-DI) score
  • SF-36 and FACIT Fatigue Scale scores
  • Modified BPI, disease status and activity limitation questions on the CRF
  • Incidence of adverse events graded according to the NCI CTC AE (Version 3.0)
  • Incidence of clinical laboratory abnormalities
  • Incidence of human anti-human (ocrelizumab) antibodies (HAHA)
Not Provided
Not Provided
 
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)
A Randomized, Double-Blind, Parallel Group, International Study to Evaluate the Safety and Efficacy of Ocrelizumab Compared to Placebo in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to at Least One Anti-TNF-α Therapy

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 anticipated time on study treatment is 1-2 years. Target sample size is 1000.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Rheumatoid Arthritis
  • Drug: leflunomide
    Oral repeating dose
  • Drug: methotrexate
    Oral or parenteral repeating dose
  • Drug: ocrelizumab
    Intravenous repeating dose (200mg)
  • Drug: ocrelizumab
    Intravenous repeating dose (500mg)
  • Drug: placebo
    Intravenous repeating dose
  • Experimental: 1
    Interventions:
    • Drug: leflunomide
    • Drug: methotrexate
    • Drug: ocrelizumab
  • Experimental: 2
    Interventions:
    • Drug: leflunomide
    • Drug: methotrexate
    • Drug: ocrelizumab
  • Placebo Comparator: 3
    Interventions:
    • Drug: leflunomide
    • Drug: methotrexate
    • Drug: placebo
Tak PP, Mease PJ, Genovese MC, Kremer J, Haraoui B, Tanaka Y, Bingham CO 3rd, Ashrafzadeh A, Travers H, Safa-Leathers S, Kumar S, Dummer W. Safety and efficacy of ocrelizumab in patients with rheumatoid arthritis and an inadequate response to at least one tumor necrosis factor inhibitor: results of a forty-eight–week randomized, double-blind, placebo-controlled, parallel-group phase III trial. Arthritis Rheum. 2012 Feb;64(2):360-70.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
1000
Not Provided
October 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult patients, ≥ 18 years of age
  • Rheumatoid arthritis for ≥ 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

Exclusion Criteria:

  • Rheumatic autoimmune disease or inflammatory joint disease, other than RA
  • Any surgical procedure in past 12 weeks,or planned within 48 weeks of baseline
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00476996
ACT3986g, WA20495
Not Provided
Clinical Trials Posting Group, Genentech, Inc.
Genentech
Roche Pharma AG
Study Director: Wolfgang Dummer, M.D. Genentech
Genentech
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP