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

Celltrion Healthcare

Status and phase

Completed

Phase 1

Conditions

Rheumatoid Arthritis

Treatments

Drug: Rituximab, MTX, folic acid

Study type

Interventional

Funder types

Industry

Identifiers

NCT01873443

CT-P10 1.3

2012-005502-21 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment

87 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

Patient has been withdrawn from Study CT-P10 1.1 for any reason.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.