Status:
COMPLETED
Safety, Tolerability and Efficacy Study of the New Medication ASK8007 to Treat Patients With Rheumatoid Arthritis
Lead Sponsor:
Astellas Pharma Inc
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to investigate the safety and tolerability of the new medication ASK8007, and to study whether it has a beneficial effect on joint inflammation in patients with rheumatoid...
Eligibility Criteria
Inclusion
- meet the American Rheumatism Association (ARA) 1987 revised criteria for the classification of RA (also referred to as the American College of Rheumatology \[ACR\] criteria);
- being treated with an adequate dose (to the discretion of the local physicians) of either MTX or leflunomide (LEF)or sulfasalazine (SS2) for at least 4 months prior to baseline of which the last 6 weeks before baseline were at a stable dose;
- have active poly-arthritis (i.e. active rheumatoid arthritis as defined in detail in the protocol)
Exclusion
- have been treated with any registered or non-registered investigational drug in the context of a clinical intervention study during the last 3 months before baseline;
- have been treated with TNFα-blockers within a certain period of time (defined for each medication) before baseline;
- have been treated with any DMARD other than MTX, LEF or SS2 during the last month before baseline;
- documented evidence for the presence of clinically severe, unstable, or uncontrollable renal, hepatic, respiratory, hematological, genitourinary, cardiovascular, endocrine, neurological, psychiatric, or other medical illness which would, in the opinion of the investigator, put the patient at safety risk or mask measures of efficacy.
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT00411424
Start Date
September 1 2007
End Date
June 1 2009
Last Update
March 21 2013
Active Locations (10)
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1
Leuven, Belgium, 3000
2
Budapest, Hungary, 1027
3
Dublin, Ireland
4
Amsterdam, Netherlands