Status:
COMPLETED
Methotrexate-Inadequate Response Autoinjector Device Sub Study
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to implement a substudy in approximately 120 rheumatoid arthritis (RA) subjects to compare the steady-state serum trough concentration (Cminss), Cmax and area under the cu...
Detailed Description
Study Classification: * Safety: show if the drug is safe under conditions of proposed use * Efficacy: measure of an intervention's influence on a disease or health condition * Safety/Efficacy * Pharm...
Eligibility Criteria
Inclusion
- For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
- Subjects who have been treated in the long term (LT) with open-label SC Abatacept for at least 3 months
- Must continue to meet inclusion criteria specified in main IM101-174 Study Protocol
Exclusion
- Participation in previous device substudy (implemented by Amendment 10)
- Must continue to meet exclusion criteria specified in main IM101-174 Study Protocol
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT01844895
Start Date
April 1 2013
End Date
July 1 2014
Last Update
July 23 2015
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