A Randomized, Double-blind, Parallel Group Study of the Safety and Effect on Clinical Outcome of Tocilizumab SC Versus Tocilizumab IV, in Combination With Traditional Disease Modifying Anti-rheumatic Drugs (DMARDs), in Patients With Moderate to Severe Active Rheumatoid Arthritis

Not Applicable

• Conditions: -M05; M05

• Registration Number: PER-083-10
• Lead Sponsor: F. HOFFMANN-LA ROCHE LTD.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-12-07
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 24

Inclusion Criteria

• Adult participants, ≥ 18 years of age
• Rheumatoid arthritis of ≥ 6 months duration, according to American College of Rheumatology (ACR) criteria
• Swollen joint count (SJC) ≥ 4 (66 joint count), tender joint count (TJC) ≥ 4 (68 joint count) at screening and baseline
• Inadequate response to current DMARD therapy
• Permitted DMARDs must be at stable dose for ≥ 8 weeks prior to baseline
• Oral corticosteroids (≤ 10 mg/day prednisone or equivalent) and NSAIDs (up to maximum recommended dose) must be at stable dose for ≥ 4 weeks prior to baseline

Exclusion Criteria

• Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following randomization
• Rheumatic autoimmune disease other than RA
• Functional class IV (ACR classification)
• Diagnosis of juvenile idiopathic arthritis (JIA) or juvenile rheumatoid arthritis (JRA) and/or RA before the age of 16
• Prior history of or current inflammatory joint disease other than RA
• Intra-articular or parenteral corticosteroids within 4 weeks prior to baseline
• Previous treatment with tocilizumab
• Active current or history of recurrent infection

Study & Design

• Study Type: Interventional
• Study Design: Not specified