Clinical Trial: A Study of The Effect of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate on Articular Damage in The Hand in Patients With Moderate to Severe Rheumatoid Arthritis Who Have an Inadequate Response to Non-Biological DMARDs
Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional
Official Title: Open Label Study to Describe the Effect of Tocilizumab in Combination With MTX in the Evolution of Articular Damage (Synovitis/Osteitis and Erosions) Evaluated by MRI in t
Brief Summary: 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.
Detailed Summary:
Sponsor: Hoffmann-La Roche
Current Primary Outcome: 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 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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 [ Time Frame: approximately 2 years ]
Original Secondary Outcome: Same as current
Information By: Hoffmann-La Roche
Dates:
Date Received: June 6, 2013
Date Started: June 2013
Date Completion: June 2015
Last Updated: November 1, 2016
Last Verified: November 2016