A Study of Tocilizumab + DMARDs in Patients With Moderate to Severe Active Rheumatoid Arthritis

Roche

Status and phase: Completed; Phase 3

Conditions: Rheumatoid Arthritis

Treatments: Drug: Standard DMARDs (Disease Modifying Anti Rheumatic Drugs); Drug: tocilizumab [RoActemra/Actemra]

Study type: Interventional

Funder types: Industry

Identifiers

NCT00951275

2009-011105-17

ML22462

Details and patient eligibility

About

This single arm study will assess the effect of tocilizumab + DMARDs (Disease Modifying Anti-Rheumatic Drugs)on improvement of anemia and fatigue in patients with moderate to severe active rheumatoid arthritis. Eligible patients who have had an inadequate response to DMARDs will receive tocilizumab 8mg/kg iv every 4 weeks in combination with standard DMARDs, for 6 months. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Enrollment: 105 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients, >=18 years of age;
• rheumatoid arthritis >=6 months duration;
• DAS28>=3.2;
• inadequate response to prior treatment with a stable dose (>=8 weeks) of DMARD therapy.

Exclusion criteria

• rheumatic autoimmune disease other than rheumatoid arthritis;
• history of or current inflammatory joint disease other than rheumatoid arthritis;
• unsuccessful treatment with an anti-TNF agent;
• previous/concurrent treatment with any cell-depleting therapies.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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105 participants in 1 patient group

1

Experimental group

Treatment:

Drug: tocilizumab [RoActemra/Actemra]

Drug: Standard DMARDs (Disease Modifying Anti Rheumatic Drugs)