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:
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT00673920
First received: May 5, 2008
Last updated: June 28, 2013
Last verified: June 2013
  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 ]

Enrollment: 314
Study Start Date: April 2008
Primary Completion Date: July 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00673920

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: NCT00673920     History of Changes
Other Study ID Numbers: ACT4394g, WA20496
Study First Received: May 5, 2008
Last Updated: June 28, 2013
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 September 16, 2014