A study of saftey and efficacy of Tocilizumab (TCZ) in combination with Methotrexate (MTX) versus Tocilizumab Monotherapy in patients with mild to moderate rheumatoid arthritis, who have not adequately responded to their current treatment with MTX.

Conditions: Mild to moderate rheumatoid arthritis
MedDRA version: 16.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Registration Number: EUCTR2011-001863-39-AT

Lead Sponsor: Roche Austria GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

- Diagnosis of RA of = 1 years duration (or radiologic evidence of RA if diagnosis of RA < 1 year) and mild to moderate disease activity at screening (defined as DAS 28 = 4,5 and > 2,6)
- Patients currently receiving MTX for at least 12 weeks and who have received MTX at a stable dose of at least 15mg/week for at least 6 weeks prior to treatment (day 1).
Patients with a history of parenteral (subcutaneous or intramuscular) MTX prior to baseline are eligible. However, prior to treatment (day 1) these patients must have been on a stable dose of oral MTX of at least 15 mg/week for at least 6 weeks
- Age = 18 years.
- Body weight < 150kg
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 120
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

- Rheumatic autoimmune disease other than RA
- Functional class IV as defined by the ACR Classification of Functional Status in RA
- Treatment with a biologic agent at any time prior to baseline.
- Treatment with traditional non-biologic DMARDs other than MTX within 1 month (for leflunomide 3 months) prior to baseline
- History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies
- Evidence of serious uncontrolled concomitant cardiovascular, nervous system, pulmonary (including obstructive pulmonary disease), renal, hepatic, endocrine (including uncontrolled diabetes mellitus) or GI disease
- Known active current or history of recurrent bacterial, viral, fungal, mycobacterial or other infections