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 is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT00476996
First received: May 18, 2007
Last updated: January 6, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Rheumatoid Arthritis
Drug: leflunomide
Drug: methotrexate
Drug: ocrelizumab
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Genentech:

Primary Outcome Measures:
  • Percentage of patients with ACR20 responses [ Time Frame: Weeks 24 and 48 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 840
Study Start Date: May 2007
Estimated Study Completion Date: December 2014
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: leflunomide
Oral repeating dose
Drug: methotrexate
Oral or parenteral repeating dose
Drug: ocrelizumab
Intravenous repeating dose (200mg)
Experimental: 2 Drug: leflunomide
Oral repeating dose
Drug: methotrexate
Oral or parenteral repeating dose
Drug: ocrelizumab
Intravenous repeating dose (500mg)
Placebo Comparator: 3 Drug: leflunomide
Oral repeating dose
Drug: methotrexate
Oral or parenteral repeating dose
Drug: placebo
Intravenous repeating dose

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00476996

Sponsors and Collaborators
Genentech
Roche Pharma AG
Investigators
Study Director: Wolfgang Dummer, M.D. Genentech
  More Information

Additional Information:
No publications provided by Genentech

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT00476996     History of Changes
Other Study ID Numbers: ACT3986g, WA20495
Study First Received: May 18, 2007
Last Updated: January 6, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech:
RA
SCRIPT
anti-CD20
CD20

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
Leflunomide
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on April 22, 2014