Randomized placebo-controlled study to evaluate the safety and efficacy of adding tocilizumab (TCZ) to methotrexate (MTX) versus switching to TCZ (placebo-controlled), with possible addition of other disease-modifying anti-rheumatic drugs (DMARDs), in patients with active rheumatoid arthritis who have inadequately responded to prior MTX treatment. - ND

Conditions: Adult patients with active moderate to severe (DAS28 > 4.4) rheumatoid arthritis (RA) who have inadequately responded to prior conventional MTX treatment and have not been treated with any biologic agent before.
MedDRA version: 9.1Level: LLTClassification code 10003268Term: Arthritis rheumatoid

Registration Number: EUCTR2008-001847-20-IT

Lead Sponsor: ROCHE

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 470

Inclusion Criteria

1. Male or non-pregnant, non-nursing female 2. > 18 years of age 3. Body weight < 150 kg 4. Patients currently experiencing active moderate to severe RA (DAS28 > 4.4) according to the revised 1987 ACR criteria for the diagnosis of RA 5. Radiographic evidence of at least one joint with definite erosion attributable to RA as determined by the central reading site. Any joint of the hands, feet or wrists can be considered with the exception of distal interphalangeal joints of the hands 6. Patients currently receiving MTX for at least 12 weeks and who have received MTX at a stable dose of at least 15 mg/week for at least 6 weeks prior to treatment (day 1), with the following exception: 10 mg instead of 15 mg is acceptable in patients with a body weight < 50 kg, low grade toxicity to MTX (such as nausea), or calculated glomerular filtration rate (or creatinine clearance) < 60 mL/min 7. If patients are receiving an oral corticosteroid, the dose must have been < 10 mg/day prednisone (or equivalent) and stable for at least 25 out of 28 days prior to treatment (day 1) 8. Patients receiving treatment on an outpatient basis 9. Patients able and willing to give written informed consent and comply with the requirements of the study protocol
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following randomization 2. Rheumatic autoimmune disease other than RA, including systemic lupus erythematosus (SLE), mixed connective tissue disease (MCTD), scleroderma, polymyositis, or significant systemic involvement secondary to RA (e.g. vasculitis, pulmonary fibrosis or Felty?s syndrome). Patients with interstitial pulmonary fibrosis and still able to tolerate MTX therapy are permitted. Sjögren?s Syndrome with RA is permitted 3. Functional class IV as defined by the ACR Classification of Functional Status in RA (largely or wholly incapacitated with patient bedridden or confined to wheelchair, permitting little or no self-care) 4. Prior history of or current inflammatory joint disease other than RA (e.g. gout, reactive arthritis, psoriatic arthritis, seronegative spondyloarthropathy, Lyme disease)