Open label, multicentric phase IIIb study to evaluate the effect of tocilizumab in combination with DMARDs in the inhibition of progression of synovitis, bone marrow edema, and erosions evaluated by dedicated magnetic resonance imaging (MRI) in the hand of patients with rheumatoid arthritis (RA) - ND

• Conditions: Moderate to severe active rheumatoid arthritis (RA), who are inadequate responders to DMARDs.; MedDRA version: 12.0Level: LLTClassification code 10039073Term: Rheumatoid arthritis

• Registration Number: EUCTR2009-012185-32-IT
• Lead Sponsor: ROCHE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06-25
• Last Update Posted: 7 January 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Men and women ≥ 18 years of age with a diagnosis of RA of ≥ 6 months duration, who are currently experiencing moderate to severe active RA (DAS28 > 3.2) and an inadequate clinical response to a stable dose of non-biologic DMARD therapy - Inclusion criteria 1.Male or non-pregnant, non-nursing female 2.Age ≥ 18 years 3.Patients with diagnosis of RA of ≥ 6 months duration 4.Patients currently experiencing moderate to severe active RA (DAS28 > 3.2) 5.Patients with: SJ ≥ 6; TJ ≥ 8 6.Patients receiving treatment on an outpatient basis 7.Patients with inadequate clinical response to a stable dose of non-biologic DMARD for at least 2 months 8.If patients are receiving an oral corticosteroid, the dose must have been stable for at least 25 out of 28 days prior to treatment (baseline) 9.Subjects 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

Disease-specific 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), systemic sclerosis, polymyositis, or significant systemic involvement secondary to RA (e.g. vasculitis, pulmonary fibrosis or Felty?s syndrome). Patient with interstitial pulmonary fibrosis and still able to tolerate MTX therapy can be included in the study. Patients with secondary Sj?gren?s Syndrome associated with RA can be included in the study 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 wheel chair, 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) Drug-specific criteria: 5.Treatment with any investigational agent within 4 weeks (or 5 half-lives of investigational agent, whichever is longer) before screening 6.Previous inadequate response to treatment with biologic DMARDs Previous biologic treatment allowed if assumed for no more than 1 month and stopped for tolerability reasons at least 6 months before the enrollment in the study. 7.Intraarticular or parenteral corticosteroids within 6 weeks prior to baseline 8.Immunization with a live/attenuated vaccine within 4 weeks prior to baseline 9.Previous treatment with tocilizumab (an exception to this criterion may be granted for single-dose exposure upon application to the sponsor on a case by case basis) 10.Any previous treatment with alkylating agents, such as cyclophosphamide or chlorambucil, or with total lymphoid irradiation Laboratory-specific criteria (at screening): 11.Serum creatinine > 142 &#956;mol/L (1.6 mg/dL) in female patients and > 168 &#956;mol/L (1.9 mg/dL) in male patients 12.ALT (SGPT) or AST (SGOT) > 1.5 ULN (If initial sample yields ALT [SGPT] or AST [SGOT] > 1.5 ULN, a second sample may be taken and tested during the screening period) 13.Platelet count < 100 x 109/L (100,000/mm3) 14.Hemoglobin < 80 g/L (8 g/dL) 15.WBC count <1.0 x 109/L (1000/mm3), ANC < 0.5 x 109/L (500/mm3) 16.ALC < 0.5 x 109/L (500/mm3) 17.Positive hepatitis B surface antigen (HBsAg) or hepatitis C antibody 18.Total bilirubin > ULN (If initial sample yields bilirubin > ULN, a second sample may be taken and tested during the screening period) 19.Triglycerides > 10 mmol/L (> 900 mg/dL) at screening (non-fasted) General medical: 20.Pregnant women or nursing (breastfeeding) mothers 21.Females of child-bearing potential who are not using a reliable method of contraception 22.History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies 23.History of severe or anaphylactic reactions to gadolinium. 24.Chest X-ray evidence of any clinically significant abnormality. 25.Evidence of serious uncontrolled concomitant cardiovascular, nervous system, pulmonary (including obstructive pulmonary disease), renal, hepatic, endocrine (including uncontrolled diabetes mellitus) or GI disease. Et al.

Study & Design

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