AN OPEN-LABEL, SINGLE-ARM, EXTENSION STUDY TO DEMONSTRATE LONG-TERM EFFICACY AND SAFETY OF CT-P13 WHEN CO-ADMINISTERED WITH METHOTREXATE IN PATIENTS WITH RHEUMATOID ARTHRITIS WHO WERE TREATED WITH INFLIXIMAB (REMICADE OR CT-P13) IN STUDY CT-P13 3.1.
- Registration Number
- PER-005-12
- Lead Sponsor
- Celltrion, Inc.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- Not specified
- Target Recruitment
- 11
EACH PATIENT MUST MEET ALL THE FOLLOWING CRITERIA TO BE ENROLLED IN THIS STUDY:
1. PATIENT WHO HAS COMPLETED THE SCHEDULED VISITS, NCLUDING THE END-OF-STUDY VISIT, IN STUDY CT-P13 3.1.
2. PATIENT WHO HAS NOT HAD ANY MAJOR PROTOCOL VIOLATION IN STUDY CT-P13 3.1.
3. PATIENT IS PERMITTED TO ENTER THE EXTENSION STUDY IF, IN THE OPINION 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.
4. PATIENT (OR LEGAL GUARDIANS, IF APLICABLE) IS INFORMED OF THE FULL NATURE AND PURPOSE OF THE STUDY, INCLUDING POSSIBLE RISKS AND SIDE EFFECTS, AND GIVEN AMPLE TIME AND OPPORTUNITY TO READ AND UNDERSTAND THIS INFORMATION, AND HAS SIGNED AND DATED THE WRITTEN INFORMED CONSENT BEFORE INCLUSION IN THE EXTENSION STUDY.
5. BOTH MALE AND FEMALE PATIENTS AND THEIR PARTNERS OF CHILDBEARING POTENCIAL MUST AGREE TO USE 2 MEDICALLY ACCEPTED METHODS OF CONTRACEPTION (EG. BARRIER CONTRACEPTIVES [MALE CONDOM, FEMALE CONDOM, OR DIAPHRAGM WITH A SPERMICIDAL GEL], HORMONAL CONTRACEPTIVES [IMPLANTS, INJECTABLES, COMBINATION ORAL CONTRACEPTIVES, TRANSDERMAL PATCHES, OR CONTRACEPTIVE RINGS], AND INTRAUTERINE DEVICES) DURING THE COURSE OF THE STUDY AND FOR 6 MONTHS FOLLOWING DISCONTINUATION OF STUDY TREATMENT (EXCLUDING WOMEN WHO ARE NOT OF CHILDBEARING POTENTIAL AND MEN WHO HAVE BEEN STERILIZED).
6. BOTH MALE AND FEMALE PATIENTS AN THEIR PARTNERS OF CHILDBEARING POTENTIAL
PATIENTS MEETING ANY OF THE FOLLOWING CRITERIA WILL BE EXCLUDED FROM THE STUDY:
1. PATIENT WHO HAS BEEN WITHDRAWN FROM STUDY CT-P13 3.1 FOR ANY REASON.
2. PATIENT WHO, AT THE TIME OF PROVIDING INFORMED CONSENT, HAS ANY ONGOING MEDICAL ISSUES SUCH AS SERIOUS ADVERSE EVENTS (SAEs) OR INTOLERANCE ISSUES HAT MEAN CONTINUATION IN THIS EXTENSION STUDY COULD BE DETRIMENTAL TO THEIR HEALTH, IN THE OPINION OF THE INVESTIGADOR.
3. PATIENT WHO PLANS TO PARTICIPATE IN A STUDY WITH AN INVESTIGATIONAL DRUG DURING THE PERIOD OF THIS EXTENSION STUDY.
4. FEMALE PATIENT WHO IS PLANNING TO BECOME PREGNANT OR BREASTFEED WITHIN THE PERIOD OF THE STUDY.
5. PATIENT WHO PLANS TO RECEIVE OR LIVE-ATTENUATED VACCINATION OR WHO IS SCHEDULED TO RECEIVE A LIVE OR LIVE-ATTENUATED VACCINATION DURING THE PERIOD OF THIS STUDY. KILLED VACCINES ARE ACCEPTABLE DURING THE STUDY.
6. PATIENT WHO, IN THE OPININ OF THEIR GENERAL PRACTITIONER OR INVESTIGATOR, SHOULD NOT PARTICIPATE IN THIS EXTENSION STUDY FOR WHATEVER REASON.
7. PATIENT WHO IS RECEIVING ANY SURGICAL PROCEDURE, INCLUDING BONE OR JOINT SURGERY OR SYNOVECTOMY (INCLUDING JOINT FUSION OR REPLACEMENT) WITHIN 12 WEEKS PRIOR TO THE TIME OF PROVIDING INFORMED CONSENT OR PLANNED WITHIN 6 MONTHS AFTER THE TIME OF PROVIDING INFORMED CONSENT.
8. PATIENT WHO, AT THE TIME OF PROVIDING INFORMED CONSENT, IS TAKING, IS PLANNING TO TAKE, OR IS REQUIRED TO TAKE DURING THE COURSE OF THIS STUDY ANY OF THE FOLLOWING CONCOMITANT MEDICATIONS:
. CORTICOSTEROIDS
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method