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

Sponsor
Hoffmann-La Roche
Study ID
NCT01878318
Phase
PHASE4
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

First listed
Jun 14, 2013
Start date
Jun 30, 2013
Status verified
Nov 2016
Primary completion
Jun 30, 2015
Completion
Jun 30, 2015

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: RoActemra/Actemra

Primary Outcome Measure

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 ]

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