A Study to Evaluate Ocrelizumab Compared With Placebo in Patients With Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate Therapy (FEATURE)
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:
Genentech
Collaborator:
Roche Pharma AG
Information provided by:
Genentech
ClinicalTrials.gov Identifier:
NCT00673920
First received: May 5, 2008
Last updated: June 25, 2010
Last verified: June 2010
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Purpose
This study will evaluate the efficacy and safety of ocrelizumab, compared to placebo, in patients with active rheumatoid arthritis who have an inadequate response to methotrexate therapy. Patients will be randomized 2:2:1 to receive 1) infusions of ocrelizumab 200mg iv on Days 1 and 15, 2) infusions of ocrelizumab 400mg iv on Day 1 and placebo iv on Day 15, or 3) infusions of placebo iv on Days 1 and 15. At the end of the placebo-controlled treatment period at 24 weeks, patients in groups 1 and 3 will be re-randomized to receive either a single infusion of 400mg iv ocrelizumab or 2 infusions of 200mg iv ocrelizumab, and group 2 will receive a second single infusion of 400mg iv ocrelizumab. All patients will receive a stable dose of concomitant methotrexate (7.5-25mg/week) throughout the study. The anticipated time on study treatment is 1-2 years. Target number of patients to be enrolled in this trial is 300.
| Condition | Intervention | Phase |
|---|---|---|
|
Rheumatoid Arthritis |
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 Given As a Single Infusion or Dual Infusion Compared With Placebo in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate Therapy |
Resource links provided by NLM:
Further study details as provided by Genentech:
Primary Outcome Measures:
- Percentage of patients with ACR20 response [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- ACR50, ACR70, DAS28, Eular response rate, SF-36, FACIT-Fatigue score, comparison of AE rates after single and dual infusions of ocrelizumab [ Time Frame: Weeks 24 and 48 ] [ Designated as safety issue: No ]
- AEs and lab parameters; PK and PD parameters after single and dual infusions of ocrelizumab [ Time Frame: Length of Study ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 300 |
| Study Start Date: | April 2008 |
| Estimated Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: methotrexate
Oral or parenteral repeating dose
Drug: ocrelizumab
Intravenous repeating dose
|
| Experimental: 2 |
Drug: methotrexate
Oral or parenteral repeating dose
Drug: ocrelizumab
Intravenous repeating dose
|
| Placebo Comparator: 3 |
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
- Active rheumatoid arthritis
- Inadequate treatment with any DMARD other than methotrexate
Exclusion criteria:
- Rheumatic autoimmune disease or inflammatory joint disease other than rheumatoid arthritis
- Concurrent treatment with any DMARD other than methotrexate
- Previous treatment with any cell-depleting therapies
- Any surgical procedure in past 12 weeks, or planned within 48 weeks after baseline
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Clinical Trials Posting Group, Genentech, Inc. |
| ClinicalTrials.gov Identifier: | NCT00673920 History of Changes |
| Other Study ID Numbers: | ACT4394g, WA20496 |
| Study First Received: | May 5, 2008 |
| Last Updated: | June 25, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Genentech:
|
RA |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Methotrexate 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 May 21, 2013