Mild to moderate rheumatoid arthritis MedDRA version: 16.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Sponsors
Roche Austria GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Diagnosis of RA of = 1 years duration (or radiologic evidence of RA if diagnosis of RA 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 =65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effect on disease activity of treatment with TCZ+MTX combination therapy versus TCZ Monotherapy by change in DAS28 score from week 12 (time of randomization) to week 24.;Secondary Objective: - To assess other efficacy parameters such as DAS28 remission CDAI remission, SDAI remission, RADAI-5 remission - To assess quality of life parameters. ;Primary end point(s): - To assess the effect on disease activity of treatment with TCZ+MTX combination therapy versus TCZ Monotherapy with regard to the following primary endpoint in patients with mild to moderate rheumatoid arthritis (RA): - Change in DAS28 score from week 12 (time of randomization) to week 24;Timepoint(s) of evaluation of this end point: At week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Proportion of patients who achieve DAS28 remission at 24 weeks (DAS28 < 2,6) - Proportion of patients who achieve CDAI remission (CDAI < 2,8) at 24 weeks - Proportion of patients who achieve SDAI remission (SDAI < 3,3) at 24 weeks - Proportion of patients who achieve RADAI remission (RADAI-5 score ranging from 0 to 1.4) - Improvement in physical & mental health (HAQ-DI, SF-12, VAS Fatigue) - Incidence of adverse events and serious adverse events during study period - Patients’ satisfaction with treatments (TSQM) ;Timepoint(s) of evaluation of this end point: At week 24 | — |
Countries
Austria
Outcome results
None listed