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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00106548
• Other study ID #: WA17822
• Status: Completed
• Phase: Phase 3
• First received: March 25, 2005
• Last updated: June 10, 2010
• Est. completion date: October 2007

Study information

• Verified date: June 2010
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 623
• Est. completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis
• Signs and Symptoms

Intervention

Drug:
• tocilizumab [RoActemra/Actemra]
4mg/kg iv / month
• tocilizumab [RoActemra/Actemra]
8mg/kg iv / month
• Placebo
iv / month
• Methotrexate
10-25mg/week

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

Argentina,  Australia,  Austria,  Brazil,  Bulgaria,  Canada,  China,  France,  Germany,  Hungary,  Israel,  Italy,  Mexico,  Singapore,  Slovakia,  Switzerland,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients with ACR 20 response		Week 24	No
Secondary	Percentage of patients ACR 50/70 responses; change from baseline in ACR core set components.		Week 24	No
Secondary	AEs, laboratory parameters, vital signs		Throughout study	No