Status:
TERMINATED
Study Evaluating Efficacy / Safety of Etanercept + Methotrexate Compared to Usual Treatment in Moderate RA Subjects
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
To assess comparative radiographic efficacy, clinical efficacy and safety of etanercept (ETN) + methotrexate (MTX) with usual disease-modifying anti-rheumatic drug (DMARD) treatment in subjects with m...
Eligibility Criteria
Inclusion
- Meet the 1987 ACR Revised Criteria for Rheumatoid Arthritis.
- Documented evidence, confirmed by a blinded 3rd party assessor, of at least one erosion observed by X-ray at randomization based on X-ray taken at the screening visit.
- Have received MTX as stable dose for 28 days prior to the screening visit.
Exclusion
- Previous treatment with ETN, infliximab, adalimumab, other Tumor necrosis factor (TNF) -a inhibitors, anakinra or other biological agents.
- Receipt of any DMARD, other than MTX, within 28 days before screening.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
141 Patients enrolled
Trial Details
Trial ID
NCT00706797
Start Date
September 1 2008
End Date
May 1 2010
Last Update
June 21 2011
Active Locations (45)
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1
Ostrava, Czechia, 722 00
2
Prague, Czechia, 128-50
3
Prague, Czechia, 140-59
4
Amiens, France, 80054