A Study of RoActemra/Actemra (Tocilizumab) Given Subcutaneously in Combination With Traditional DMARDs in Patients With Moderate to Severe Active Rheumatoid Arthritis

• Conditions: Adult Rheumatoid Arthritis (RA); MedDRA version: 14.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2010-019912-18-BG
• Lead Sponsor: F. Hoffmann-La Roche Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08-25
• Last Update Posted: 27 January 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

- Adult patients, >/=18 years of age

- Moderate to severe rheumatoid arthritis of >/=6 months duration

- Receiving treatment on an outpatient basis

- Swollen joint count (SJC) >/=6 (66 joint count) and tender joint count (TJC) >/=8 (68 joint count) at screening and study start

- On a stable dose of disease-modifying antirheumatic drugs for at least 8 weeks prior to study start
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 480
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 120

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 rheumatoid arthritis, Secondary Sjögren's syndrome with rheumatoid arthritis is allowed

- Functional class IV as defined by the American College of Rheumatology (ACR) Classification of Functional Status in Rheumatoid Arthritis

- Diagnosis of juvenile idiopathic arthritis or juvenile rheumatoid arthritis and/or rheumatoid arthritis before the age of 16 years

- Prior history of or current inflammatory joint disease other than rheumatoid arthritis

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: - Reduction in disease activity according to American College of Rheumatology (ACR) 20 criteria at week 24<br><br>- Safety of treatment with TCZ vs placebo;Secondary Objective: - Prevention of progression of structural damage at Week 24 and Week 48<br>- Improvement of physical function<br>- Long-term safety and efficacy<br>- Pharmacokinetics (PK) and pharmacodynamics (PD) of TCZ SC <br>- Immunogenicity of TCZ SC;Primary end point(s): The proportion of patients with an ACR20 response at week 24.;Timepoint(s) of evaluation of this end point: Week 24

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Prevention of progression of structural damage at Week 24 and 48;<br>Physical function improvement at Week 24;<br>ACR50 and ACR70 at Week 24.<br>;Timepoint(s) of evaluation of this end point: see section E.5.2. above