Status:
COMPLETED
A Study of Glucocorticoid Use to Evaluate Systematic Methylprednisolone Reduction in Patients With Rheumatoid Arthritis on Background RoActemra/Actemra (Tocilizumab) (ACT-ALONE)
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This open-label, single-arm study will assess the use of glucocorticoids (GC) in daily clinical practice and will evaluate the dose reduction of glucocorticoids once low disease activity is achieved i...
Eligibility Criteria
Inclusion
- Non-interventional phase
- Adult patients, \>/=18 years of age
- Moderate to severe active rheumatoid arthritis defined as Disease Activity Score using 28-joint count (DAS28) \>/=5.1
- Patients with inadequate clinical response to a current treatment with 2 or more non-biologic disease-modifying anti-rheumatic drugs (DMARDs), one of them being methotrexate (MTX) optimally administered during a period of more than 3 months or inadequate response to a current anti-TNF therapy
- Current use of oral glucocorticoids started at least 4 weeks prior to enrolment Interventional phase
- Patients enrolled in the non-interventional phase
- Patients with low disease activity defined as DAS28 \</=3.2 at Visit 2
- Use of oral glucocorticoids with methylprednisolone equivalent dose of \>/=1mg and \</=20mg/day at Visit 2
Exclusion
- Non-interventional \& interventional phase
- Rheumatic autoimmune disease other than rheumatoid arthritis, or significant systemic involvement secondary to rheumatoid arthritis
- Functional class IV as defined by the American College of Rheumatology (ACR) Classification of Functional Status in rheumatoid arthritis
- Prior history or current inflammatory joint disease other than rheumatoid arthritis (e.g. gout)
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT01219933
Start Date
January 1 2011
End Date
March 1 2013
Last Update
January 19 2015
Active Locations (16)
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1
Aalst, Belgium, 9300
2
Bruges, Belgium, 8000
3
Brussels, Belgium, 1020
4
Brussels, Belgium, 1070