An Extension Study to Demonstrate Long-Term Efficacy and Safety of CT-P13 When Co-administered With Methotrexate in Patient With Rheumatoid Arthritis Who Were Treated With Infliximab (Remicade or CT-P13) in Study CT-P13 3.1

Celltrion Healthcare

Status and phase

Completed

Phase 3

Conditions

Rheumatoid Arthritis

Treatments

Biological: Infliximab

Study type

Interventional

Funder types

Industry

Identifiers

NCT01571219

CT-P13 3.2

2011-004468-31 (EudraCT Number)

Details and patient eligibility

About

CT-P13 (Infliximab) is a monoclonal antibody currently being developed by CELLTRION, Inc. This open-label, single-arm, multicenter, multiple single dose intravenous (IV) infusion, efficacy, and safety extension study of the Phase 3 Study CT-P13 3.1 is designed to assess the long-term efficacy and safety of multiple doses of CT-P13.

Enrollment

302 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient who has completed the scheduled visits, including the End-of-Study Visit, in Study CT-P13 3.1
Patient who has not had any major protocol violation in Study CT-P13 3.1
Patient is permitted to enter the extension study if, in the option of their general practitioner or the investigator, the patient will continue to gain benefit from treatment in the extension study. Local guidelines for patient treatment will be followed

Exclusion criteria

Patient who has been withdrawn from Study CT-P13 3.1 for any reason
Patient who, at the time of providing informed consent, has any ongoing medical issues such as serious adverse events (SAEs) or intolerance issues that mean continuation in this extension study could be detrimental to their health, in the opinion of the investigator
Patient who plans to participate in a study with an investigational drug during the period of this extension study