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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 16 December 2017
Main ID:  NCT01571219
Date of registration: 23/03/2012
Prospective Registration: Yes
Primary sponsor: Celltrion
Public title: 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
Scientific title: An Open-Label, Single-Arm, 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 CP-P13) in Study CT-P13 3.1
Date of first enrolment: March 2012
Target sample size: 302
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT01571219
Study type:  Interventional
Study design:  Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 3
Countries of recruitment
Korea, Republic of United Kingdom
Contacts
Name:     Dae Hyun Yoo, M.D., Ph.D.
Address: 
Telephone:
Email:
Affiliation:  Hanyang University
Key inclusion & exclusion criteria

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- Patient who has been withdrawn from Study CT-P13 3.1 for any reason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



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis
Intervention(s)
Biological: Infliximab
Primary Outcome(s)
Long term efficacy evaluated by American College of Rheumatology(ACR) criteria and Long term safety evaluated by immunogenicity and clinical laboratory test [Time Frame: Up to week 40]
Secondary Outcome(s)
Secondary ID(s)
2011-004468-31
CT-P13 3.2
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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