A Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis Who Have an Inadequate Response to DMARDs or Anti-TNF

Roche

Status and phase: Completed; Phase 3

Conditions: Rheumatoid Arthritis

Treatments: Drug: tocilizumab [RoActemra/Actemra]

Study type: Interventional

Funder types: Industry

Identifiers

NCT01326962

ML22726

Details and patient eligibility

About

This open-label, single arm study will evaluate the safety and efficacy of RoActemra/Actemra (tocilizumab) in patients with active, moderate to severe rheumatoid arthritis who have an inadequate response to disease-modifying antirheumatic drugs (DMARDs) or anti-TNF. Patients will receive RoActemra/Actemra at a dose of 8 mg/kg (max 800 mg) intravenously every 4 weeks for a total of 6 infusions. Non-biologic DMARD therapy may be continued throughout the study. Anticipated time on study treatment is 24 weeks.

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients, >/= 18 years of age
• Active moderate to severe rheumatoid arthritis of >/= 6 months duration
• >/=1 non-biologic DMARD and/or anti-TNF therapy at stable dose for >/=8 weeks at any time prior to study treatment
• Inadequate clinical response to non-biologic DMARD or anti-TNF therapy
• Oral corticosteroids must be at stable dose for at least 25 out of 28 days prior to first dose of study drug

Exclusion criteria

• Pregnant or lactating women
• Major surgery (including joint surgery) within 8 weeks prior to screening or major surgery planned within 6 months of enrolment
• Rheumatic autoimmune disease other than RA
• Functional class IV (ACR classification)
• Prior history of or current joint disease other than RA
• Intraarticular or parenteral corticosteroids within 6 weeks prior to baseline
• Previous treatment with RoActemra/Actemra
• Known active current or history of recurrent infection
• History of or currently active primary or secondary immunodeficiency
• Active tuberculosis requiring treatment within the previous 3 years
• Positive for HIV

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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28 participants in 1 patient group

Single Arm

Experimental group

Treatment:

Drug: tocilizumab [RoActemra/Actemra]