A Study of RoActemra/Actemra (Tocilizumab) Versus Adalimumab in Combination With Methotrexate in Patients With Moderate to Severe Active Rheumatoid Arthritis And an Inadequate Response to Treatment With Only One TNF-Inhibitor

Phase 1

• Conditions: Adult Rheumatoid Arthritis (RA); MedDRA version: 14.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2010-023587-40-DK
• Lead Sponsor: F. Hoffmann-La Roche Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04-12
• Last Update Posted: 31 October 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 700

Inclusion Criteria

- Adult patients, >/= 18 years of age
- Rheumatoid arthritis of >/= 6 months duration (according to ACR criteria)
- Inadequate response due to inefficacy of treatment (at least 3 months) with only one approved TNF-agent other than adalimumab. Depending on the TNF-inhibitor, last dose of TNF-inhibitor should have been 1 to 8 weeks before randomization to the study
- On methotrexate treatment for >/=12 weeks immediately prior to baseline, with stable dose (10-25 mg/week) for the last 8 weeks
- Disease Activity Score (DAS28) >3.2 at baseline
- Oral corticosteroids (/=6 weeks prior to baseline
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 539
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 161

Exclusion Criteria

- Major surgery (including joint surgery) within 8 weeks prior to screening or planned surgery within 6 months following randomization
- Rheumatic autoimmune disease other than rheumatoid arthritis
- Prior history of or current inflammatory joint disease other than rheumatoid arthritis
- Functional class IV (ACR criteria)
- History of severe allergic reaction to human, humanized or murine monoclonal antibodies
- Known active current or history of recurrent infection (including TB)
- Primary or secondary immunodeficiency (history of or currently active)
- Body weight >150 kg
- Previous treatment with any cell-depleting therapies
- Previous treatment with tocilizumab
- Intra-articular or parenteral corticosteroids within 6 weeks prior to baseline

Study & Design

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