A Study of RoActemra/Actemra (Tocilizumab) in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to DMARDs (REMISSION)

Roche

Status and phase: Completed; Phase 3

Conditions: Rheumatoid Arthritis

Treatments: Drug: tocilizumab [RoActemra/Actemra]

Study type: Interventional

Funder types: Industry

Identifiers

NCT01610791

ML22638

Details and patient eligibility

About

This open label, single arm study will assess the safety and efficacy of RoActemra/Actemra (tocilizumab) in patients with moderate to severe active rheumatoid arthritis who have an inadequate response to disease-modifying antirheumatic drugs (DMARDs). Patients will receive RoActemra/Actemra at a dose of 8 mg/kg intravenously every 4 weeks for 24 weeks (6 infusions).

Enrollment: 121 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients, >/= 18 years of age
• Moderate to severe active rheumatoid arthritis (DAS28 > 3.2 at screening)
• Inadequate response to DMARDs
• Body weight < 150 kg

Exclusion criteria

• Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months of enrollment
• Rheumatic autoimmune disease other than RA
• American College of Rheumatology (ACR) functional class IV
• Prior history of or current inflammatory joint disease other than RA
• Previous treatment with any biologic drug that is used in the treatment of RA
• Intraarticular or parenteral corticosteroids within 6 weeks prior to baseline
• Pregnant or lactating women
• Active current or history of recurrent infection, active TB within the previous 3 years, HIV infection

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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121 participants in 1 patient group

Single Arm

Experimental group

Treatment:

Drug: tocilizumab [RoActemra/Actemra]