This open-label, single arm study will evaluate the effect of RoActemra/Actemra in combination with methotrexate on articular damage in the hand (synovitis/osteitis and erosions) in patients with moderate to severe rheumatoid arthritis who have an inadequate response to non-biological disease-modifying ante-rheumatic drugs (DMARDs). Patients will receive RoActemra/Actemra 8 mg/kg intravenously every 4 weeks for 24 weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
stable dose
8 mg/kg intravenously every 4 weeks, 24 weeks
Change in extent and degree of synovitis in the hand assessed by MRI according to the OMERACT RAMRIS scale
Time frame: from baseline to Week 24
Radiological changes in the hand according to the modified Sharp scale
Time frame: from baseline to Week 24
Change in Ritchie articular index
Time frame: from baseline to Week 24
Proportion of patients with American College of Rheumatology (ACR 20/50/70) response at Weeks 12 and 24
Time frame: Weeks 12 and 24
Change in pain: Visual analogue scale (VAS)
Time frame: from baseline to Week 24
Change in disability: Stanford Health Assessment Questionnaire
Time frame: from baseline to Week 24
Change in FACIT-fatigue questionnaire
Time frame: from baseline to Week 24
Change in disease activity: Disease activity score 28 - erythrocyte sedimentation rate (DAS28-ESR)
Time frame: from baseline to Week 28
Change in C-reactive protein
Time frame: from baseline to Week 24
Change in immunologic parameters: Rheumatic factor/anti-CCP
Time frame: from baseline to Week 24
Safety: Incidence of adverse events
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Time frame: approximately 2 years