Status:
COMPLETED
Long-Term Efficacy and Safety of CT-P10 in Patients With RA
Lead Sponsor:
Celltrion
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
This is an open-label, single-arm, multicenter, efficacy, and safety maintenance study of the Phase 1 Study CT-P10 1.1. This study is designed to assess the long-term efficacy and safety of CT-P10 co-...
Eligibility Criteria
Inclusion
- Patient has disease improvement (moderate or good response) according to Disease Activity Score using 28 joint counts (DAS28) during the last course of treatment in Study CT-P10 1.1.
- Patient has completed all of the scheduled visits in the Study CT-P10 1.1 Main Study Period, including the Core Study Period and/or Extension Study Period.
Exclusion
- Patient has been withdrawn from Study CT-P10 1.1 for any reason.
- Patient has, at the time of providing informed consent, any current medical issues such as serious adverse events (SAEs) or current or previous intolerance issues that mean continuation in this maintenance study could be detrimental to their health, in the opinion of the investigator.
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
87 Patients enrolled
Trial Details
Trial ID
NCT01873443
Start Date
May 1 2013
End Date
October 1 2014
Last Update
November 26 2015
Active Locations (1)
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1
Inha University College of Medicine Hospital
Incheon, South Korea