A Study to Assess the Effect of Tocilizumab + Methotrexate on Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis

Phase 3

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: Placebo; Drug: tocilizumab [RoActemra/Actemra]; Drug: Methotrexate

• Registration Number: NCT00106548
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2005-03-25
• Study First Submitted QC: 2005-03-25
• Study First Posted: 2005-03-28
• Study Completion: 2007-10
• Status Verified: 2010-06
• Last Update Submitted: 2010-06-10
• Last Update Posted: 2010-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 623

Inclusion Criteria

• adult patients at least 18 years of age with moderate to severe active RA for at least 6 months;
• inadequate response to a stable dose of MTX;
• patients of reproductive potential must be using reliable methods of contraception.

Exclusion Criteria

• major surgery (including joint surgery) within 8 weeks before entering study, or planned surgery within 6 months after entering study;
• prior treatment failure with an anti-tumor necrosis factor agent;
• women who are pregnant or breast-feeding.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3	Placebo	-
1	tocilizumab [RoActemra/Actemra]	-
2	tocilizumab [RoActemra/Actemra]	-
1	Methotrexate	-
2	Methotrexate	-
3	Methotrexate	-

Primary Outcome Measures

Name	Time	Method
Percentage of patients with ACR 20 response	Week 24

Secondary Outcome Measures

Name	Time	Method
Percentage of patients ACR 50/70 responses; change from baseline in ACR core set components.	Week 24
AEs, laboratory parameters, vital signs	Throughout study