MedTrace Logo

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

NCT01873443 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 87

Last updated 2015-11-26

No results posted yet for this study

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

Conditions

Interventions

DRUG

Rituximab, MTX, folic acid

Rituximab IV 1000mg MTX 10\~25mg/week Folic acid at least 5mg/week

Sponsors & Collaborators

Principal Investigators

  • DaeHyun Yoo, Ph.D · Hanyang University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2014-10-31
Completion
2014-10-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01873443 on ClinicalTrials.gov