Official Title: “A Randomized, Double-Blind Study of Safety and Reduction in Signs and Symptoms During Treatment With Tocilizumab Versus Placebo, in Combination With Methotrexate, in Patients With Moderate to Severe Active Rheumatoid Arthritis and Inadequate Response to Anti-TNF Therapy”

This 3 arm study will compare the safety and efficacy, with regard to reduction of signs and symptoms, of tocilizumab versus placebo in combination with methotrexate (MTX) in patients with moderate to severe active rheumatoid arthritis (RA) currently on MTX therapy, and who have had an inadequate response to prior therapy with an anti-tumor necrosis factor (anti-TNF) agent. Patients will be randomized to receive tocilizumab 4mg/kg iv, tocilizumab 8mg/kg or placebo iv, every 4 weeks. All patients will also receive methotrexate 10-25mg/week. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: tocilizumab
  • 4mg/kg iv every 4 weeks
• Drug: tocilizumab
  • 8mg/kg iv every 4 weeks
• Drug: Placebo
  • iv every 4 weeks
• Drug: Methotrexate
  • 10-25mg weekly

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Experimental: 2
• Placebo Comparator: 3

Primary Measures

• Percentage of patients with ACR 20 response
  • Time Frame: Week 24
    Safety Issue?: No
• AEs, laboratory parameters, vital signs, ECGs.
  • Time Frame: Throughout study
    Safety Issue?: No

Secondary Measures

• Percentage of patients with ACR 50 and ACR 70 responses
  • Time Frame: Week 24
    Safety Issue?: No
• Mean changes in parameters of ACR core set
  • Time Frame: Week 24
    Safety Issue?: No

Inclusion Criteria:

• adult patients at least 18 years of age with moderate to severe active RA for at least 6 months;
• inadequate response to current anti-rheumatic therapies, including MTX;
• inadequate response or intolerance to treatment with 1 or more anti-TNF therapies within 1 year of entering study;
• on stable MTX for at least 8 weeks before entering study;
• patients of reproductive potential must be using reliable methods of contraception.

Exclusion Criteria:

• major surgery (including joint surgery) within 8 weeks before screening, or planned major surgery within 6 months after entering study;
• women who are pregnant or breast-feeding.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Hoffmann-La Roche

Overall Clinical Trial Officials and Contacts

Clinical Trials Study Director Hoffmann-La Roche, +1 973 235 5000  

Information obtained from ClinicalTrials.gov on October 06, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00106522

Study ID Number: WA18062

ClinicalTrials.gov Identifier: NCT00106522

Health Authority: United States: Food and Drug Administration