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

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 Active Rheumatoid Arthritis and Inadequate Response to Anti-TNF Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00106522
• Other study ID #: WA18062
• Status: Completed
• Phase: Phase 3
• First received: March 25, 2005
• Last updated: November 1, 2016
• Start date: May 2005
• Est. completion date: November 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 499
• Est. completion date: November 2007
• Est. primary completion date: November 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 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.

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:
• Methotrexate
10-25mg weekly
• Placebo
iv every 4 weeks
• tocilizumab [RoActemra/Actemra]
8mg/kg iv every 4 weeks
• tocilizumab [RoActemra/Actemra]
4mg/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,  Australia,  Belgium,  Canada,  France,  Germany,  Iceland,  Italy,  Mexico,  Netherlands,  Puerto Rico,  Sweden,  Switzerland,  United Kingdom, 

Outcome

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