A Study of Tocilizumab in Combination With Disease-Modifying Anti-Rheumatic Drugs (DMARDs) in Participants With Moderate to Severe Active Rheumatoid Arthritis With an Inadequate Response to DMARDs

Roche

Status and phase: Completed; Phase 3

Conditions: Rheumatoid Arthritis

Treatments: Drug: Tocilizumab; Drug: DMARDs

Study type: Interventional

Funder types: Industry

Identifiers

NCT00996606

2009-012185-32

ML22413

Details and patient eligibility

About

This open-label, single-arm study will evaluate the efficacy and safety of tocilizumab in combination with DMARDs in participants with moderate to severe active rheumatoid arthritis who have an inadequate response to DMARDs. Participants will receive tocilizumab as 8 milligrams per kilogram (mg/kg) via intravenous (IV) infusion every 4 weeks in addition to their current DMARD therapy.

Enrollment: 58 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Moderate to severe active RA of ≥6 months duration
• DAS28 >3.2
• Inadequate response to a stable dose of non-biologic DMARD for ≥2 months
• Those receiving oral corticosteroids must have been at stable dose for ≥25 days in the 28 days prior to first study treatment

Exclusion criteria

• Rheumatic autoimmune disease other than RA
• History of or current inflammatory joint disease other than RA
• Previous treatment with alkylating agents or total lymphoid irradiation
• Intra-articular or parenteral corticosteroids within 6 weeks prior to Baseline
• Previous treatment with any cell-depleting therapies
• American College of Rheumatology (ACR) Functional Class IV

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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58 participants in 1 patient group

Tocilizumab in Active RA

Experimental group

Description:

Participants with active RA will receive tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions will be given from Baseline to Week 44, and participants will be assessed through Week 48.

Treatment:

Drug: DMARDs

Drug: Tocilizumab