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

Last updated: July 30, 2017
Sponsor: Celltrion
Overall Status: Completed

Phase

3

Condition

Musculoskeletal Diseases

Dermatomyositis (Connective Tissue Disease)

Joint Injuries

Treatment

N/A

Clinical Study ID

NCT01571219
CT-P13 3.2
2011-004468-31
  • Ages 18-75
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient who has completed the scheduled visits, including the End-of-Study Visit, inStudy 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 generalpractitioner or the investigator, the patient will continue to gain benefit fromtreatment in the extension study. Local guidelines for patient treatment will befollowed

Exclusion

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  • Patient who has been withdrawn from Study CT-P13 3.1 for any reason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 issuessuch as serious adverse events (SAEs) or intolerance issues that mean continuation inthis extension study could be detrimental to their health, in the opinion of theinvestigator

  • Patient who plans to participate in a study with an investigational drug during theperiod of this extension study

Study Design

Total Participants: 302
Study Start date:
March 01, 2012
Estimated Completion Date:
July 31, 2013

Connect with a study center

  • Hanyang University Medical Center

    Seoul,
    Korea, Republic of

    Site Not Available

  • Barnsley Hospital

    Barnsley,
    United Kingdom

    Site Not Available

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