A Study to Assess the Safety and Efficacy of Tocilizumab 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 Monotherapy Versus Methotrexate Monotherapy in Patients With Moderate to Severe Active Rheumatoid Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00109408
• Other study ID #: WA17824
• Status: Completed
• Phase: Phase 3
• First received: April 27, 2005
• Last updated: November 1, 2016
• Start date: July 2005
• Est. completion date: December 2007

Study information

• Verified date: November 2016
• 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 2 arm study will assess the safety and efficacy of tocilizumab monotherapy versus methotrexate in patients with active rheumatoid arthritis (RA). Patients will be randomized to receive tocilizumab 8mg/kg iv every 4 weeks plus placebo po weekly, or methotrexate 7.5-20mg po weekly plus placebo iv every 4 weeks. The anticipated time on study treatment is 3-12 months and the target sample size is 500+ individuals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 673
• Est. completion date: December 2007
• Est. primary completion date: December 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 active RA for at least 3 months;

• 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 major surgery within 6 months after entering study;

• treatment with methotrexate (MTX) within 6 months of entering study;

• patients who have stopped previous MTX treatment due to toxicity or lack of response;

• 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

Intervention

Drug:
• Methotrexate
7.5-20mg po weekly
• tocilizumab [RoActemra/Actemra]
8mg/kg iv every 4 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Canada,  China,  Denmark,  France,  Israel,  Italy,  Lithuania,  Mexico,  Norway,  Peru,  Portugal,  Serbia,  Slovenia,  South Africa,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients with ACR 20 response		Week 24	No
Secondary	Percentage of patients with ACR 20 response		Week 8	No
Secondary	Percentage of patients with ACR 50 and ACR 70 responses		Week 24	No
Secondary	Mean change in parameters of ACR core set		Week 24	No
Secondary	AEs, laboratory parameters, vital signs.		Throughout study	No