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
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ClinicalTrials.gov Identifier: NCT01571219 |
Recruitment Status :
Completed
First Posted : April 5, 2012
Last Update Posted : August 1, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Rheumatoid Arthritis | Biological: Infliximab | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 302 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official 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 |
Study Start Date : | March 2012 |
Actual Primary Completion Date : | July 2013 |
Actual Study Completion Date : | July 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: CT-P13 |
Biological: Infliximab
CT-P13(3mg/kg) administered as a 2-hour IV infusion per dose co-administered with methotrexate between 12.5 to 25 mg/week, oral or parenteral dose (dose and route must be maintained from Study CT-P13 3.1 and be maintained from the beginning to the end of the extension study) and folic acid(≥5mg/week, oral dose) |
- 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 ]

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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- Patient who has been withdrawn from Study CT-P13 3.1 for any reason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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01571219
Korea, Republic of | |
Hanyang University Medical Center | |
Seoul, Korea, Republic of |
Study Director: | Dae Hyun Yoo, M.D., Ph.D. | Hanyang University |
Responsible Party: | Celltrion |
ClinicalTrials.gov Identifier: | NCT01571219 |
Other Study ID Numbers: |
CT-P13 3.2 2011-004468-31 ( EudraCT Number ) |
First Posted: | April 5, 2012 Key Record Dates |
Last Update Posted: | August 1, 2017 |
Last Verified: | July 2017 |
RA Biosimilar |
Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases |
Autoimmune Diseases Immune System Diseases Infliximab Dermatologic Agents Gastrointestinal Agents Antirheumatic Agents |