Long-Term Efficacy and Safety of CT-P10 in Patients With RA

Sponsor
Celltrion
Study ID
NCT01873443
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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-administered with MTX and folic acid in patients with RA who have completed the scheduled visits in Study CT-P10 1.1

Key Dates

Start date
May 31, 2013
Status verified
May 2015
Primary completion
Oct 31, 2014
Completion
Oct 31, 2014

Study Design

Enrollment
87 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Rituximab, MTX, folic acid

Primary Outcome Measure

Efficacy evaluation by ACR criteria and safety evaluation by hypersensitivity monitoring [ Time Frame: 8 week interval ]

Related Studies