At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 104 enrolled
Drug / intervention
Abatacept +1 moredrug
Likely dose
Abatacept 10 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Multi-Center, Open Label Study to Assess Early Response to Abatacept With Background Methotrexate Using Power Doppler Ultrasonography in Patients With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate
In Brief
A Phase 3 clinical trial evaluating Abatacept and Methotrexate for Rheumatoid Arthritis. Completed, enrolled 104 participants across 21 sites in 8 countries.
Detailed Summary
The purpose of the study is to assess early signs of response to abatacept+methotrexate in metacarpophalangeal joints in both hands using power Doppler ultrasonography in patients with active rheumatoid arthritis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesDenmark, France, Germany, Hungary, Italy, Norway, Spain, United Kingdom
Collaborators--
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 2008
Enrollment StartDec 2008
Primary CompletionOct 2011
TodayJul 2026
First PostedOct 7, 2008
Enrollment StartDec 1, 2008
Primary CompletionOct 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 17.7 years ago
Interventions
Abataceptdrug
Abatacept, 10 mg/kg, solution given intravenously on Days 1, 15, 29,57, 85, 113, 141, and 169
Methotrexatedrug
Methotrexate administered in a dose of 15 mg/week or higher for at least 3 months and at a stable dose for at least 28 days prior to baseline