A Study of Tocilizumab in Combination With DMARD Therapy in Patients With Active Rheumatoid Arthritis.

Rheumatoid Arthritis Clinical Trial

Official title:

A Randomized, Double Blind Study of Safety and Reduction in Signs and Symptoms During Treatment With Tocilizumab Versus Placebo, in Combination With DMARD Therapy, in Patients With Active Rheumatoid Arthritis and Inadequate Response to Current DMARD Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00773461
• Other study ID #: ML21753
• Status: Completed
• Phase: Phase 3
• First received: October 15, 2008
• Last updated: October 7, 2013
• Start date: October 2008
• Est. completion date: July 2010

Study information

• Verified date: October 2013
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

This 2 arm study will compare the safety and efficacy, with regard to reduction of signs and symptoms, of tocilizumab versus placebo, both in combination with DMARDs, in patients with active rheumatoid arthritis who currently have an inadequate response to DMARD therapy. Patients will be randomized 2:1 to receive tocilizumab 8mg/kg iv or placebo iv every 4 weeks, in conjunction with stable DMARD therapy. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 209
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• adult patients, 18-70 years of age;

• rheumatoid arthritis for >= 6 months;

• receiving permitted DMARDs, at a stable dose, for >= 8 weeks prior to baseline;

• current inadequate clinical response to DMARDs.

Exclusion Criteria:

• major surgery, including joint surgery, within 8 weeks before entering study, or planned major surgery within 6 months following randomization;

• rheumatic autoimmune disease or inflammatory joint disease other than rheumatoid arthritis;

• unsuccessful treatment with an anti-TNF agent;

• previous treatment with tocilizumab.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• tocilizumab [RoActemra/Actemra]
8mg/kg iv every 4 weeks for 24 weeks
• Placebo
iv every 4 weeks for 24 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with ACR20 response		Week 24	No
Secondary	Proportion of patients with ACR50 and ACR70		Week 24	No
Secondary	Mean change from baseline in individual parameters of ACR core set		Week 24	No
Secondary	Mean change from baseline in a) HAQ-DI, b) FACIT fatigue score, c) rheumatoid factor, d) hemoglobin		Week 24	No
Secondary	Time to onset of ACR20, 50 and 70		Throughout study	No
Secondary	Proportion of patients achieving a) DAS28 <3.2 and b) DAS28 <2.6		Throughout study	No