Status:
COMPLETED
Study Comparing The Effect On Disease Activity When Reducing Or Discontinuing Etanercept In Subjects With RA
Lead Sponsor:
Pfizer
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This study involves Rheumatoid Arthritis patients in regular clinical setting who are already on etanercept treatment and are in remission or in a low disease activity (LDA) state, and is intended to ...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Subject has a current DAS28 equal to or less than 3.2.
- Subject is currently receiving treatment with etanercept, either 25 mg twice weekly or 50 mg once weekly, for a minimum of 14 months at baseline
- Subject is currently receiving oral, sc or intramuscular methotrexate once weekly, 7.5 mg/week to 25 mg/week and at a stable dose for a minimum of 4 months at baseline.
- Exclusion Criteria:
- Subject has earlier had an attempt of discontinuing etanercept for reasons of remission or low disease activity state.
- Subject has received any disease-modifying anti-rheumatic drug, other than methotrexate, within one month before baseline.
- Subject has had a dose of prednisone (or equivalent) \>7.5 mg/day or has received intra-articular, intravenous, intramuscular, or subcutaneous corticosteroid within one month of baseline.
Exclusion
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
91 Patients enrolled
Trial Details
Trial ID
NCT00858780
Start Date
January 1 2009
End Date
June 1 2012
Last Update
September 11 2013
Active Locations (16)
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1
Pfizer Investigational Site
Glostrup Municipality, Denmark, DK-2600
2
Pfizer Investigational Site
Hellerup, Denmark, 2900
3
Pfizer Investigational Site
Jyväskylä, Finland, Finland, 40620
4
Pfizer Investigational Site
Helsinki, Finland, FI-00029 HUS