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.

• Register: RPEC
• Last refreshed on: 4 September 2023
• Main ID: PER-005-12
• Date of registration: 29/05/2012
• Prospective Registration: Yes
• Primary sponsor: Celltrion, Inc.,
• Public title: 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.
• 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 PATIENTS WITH RHEUMATOID ARTHRITIS WHO WERE TREATED WITH INFLIXIMAB (REMICADE OR CT-P13) IN STUDY CT-P13 3.1.
• Target sample size: 22
• URL: https://www.ins.gob.pe/ensayosclinicos/rpec/recuperarECPBNuevoEN.asp?numec=005-12
• Study type: Interventional
• Study design: OPEN-LABEL, SNGLE-ARM, MULTICENTER, MULTIPLE SINGLE-DOSE INTRAVENOUS (IV) INFUSION, EFFICACY, AND SAFETY EXTENSION STUDY.
• Phase: III

Countries of recruitment

Australia, Austria, Bahamas, Belarus, Denmark, Germany, Malasya, Qatar, Santo Tome and Principe, Somalia, St. Lucia, Syria

Contacts

• Name: ANDRES PALMA BAYONA
• Affiliation: PPD Peru S.A.C.

• Name: LUIS QUEIJA MELENDEZ
• Affiliation: PPD Peru S.A.C.

Key inclusion & exclusion criteria

Inclusion criteria:
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

Exclusion criteria:
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


Age minimum: 18
Age maximum: 75
Gender: --

Intervention(s)

SCREENING WILL TAKE PLACE BETWEEN DOSE 9 (WEEK 54) IN STUDY CT-P13 3.1 AND DOSE 10 (WEEK 62; FIRST DOSE IN THE EXTENSION PERIOD). PATIENTS WHO MEET ALL INCLUSION CRITERIA AND NONE OF THE EXCLUSION CRITERIA AND WHO AGREE TO CONTINUE IN THE EXTENSION PERIODWILL RECEIVE CT-P13 EVERY 8 WEEKS (TOTAL OF UP TO 6 DOSES). METHOTREXATE BETWEEN 12.5 TO 25 MG/WEEK, ORAL OR OARENTERAL DOSE, AND FOLIC (≥5 MG/WEEK WILL BE ADMINISTERED THROUGHOUT THE DURATION OF THE STUDY. PATIENTS MAY BE PREMEDICATED WITH AN ANTIHISTAMINE (CHLORPHENIRAMINE 2 TO 4 MG OR EQUIVALENT DOSE OF EQUIVALENT ANTIHISTAMINE) 30 TO 60 MINUTES PRIOR TO THE START OF STUDY TREATMENT INFUSION AT THE INVESTIGATOR´S DISCRETION. PATIENTS WILL COMPLY WITH ALL APPROPIATE VISITS AND ASSESSMENTS. A DOSE VISIT WINDOW OF ± 7 DAYS IS ALLOWED.
THE PERIOD OF THE STUDY WILL BE UNBLINDED AND CONSIST OF A FURTHER 6 DOSES OF STUDY TREATMENT DURING WHICH TIME THE STUDY TREATMENT WILL BE ADMINISTERED EVERY 8 WEEKS (WEEKS 62, 70, 78, 86, 94 AND 102). ALL PATIENTS WILL HAVE TO PROVIDE INFORMED CONSENT TO EITHER SWITCH FROM REMICADE REFERENCE PRODUCT IN STUDY CT-P13 3.1 TO CT-P13 IN THE EXTENSION PERIOD OR TO MAINTAIN TREATMEN WITH CT-P13 IN THE EXTENSION PERIOD. EACH DOSE WILL CONSIST OF A SINGLE-DOSE ADMINISTRATION OF ATUDY TREATMENT CO-ADMINISTERED WITH METHOTREXATE AND FOLIC ACID AND FOLLOWED BY AN OFF-DOSE PERIOD OF 8 WEEKS.
PATIENTS WIIL RETURN TO THE STUDY CENTER AT PREDEFINED TIME INTERVALSFOR CLINIAL ASSESSMENTS AND BLOOD SAMPLING

Source(s) of Monetary Support

CELLTRION, INC.

Ethics review

Status: Approved
Approval date: 03/01/2012
Contact:

[e-mail]

Comite Institucional de Etica en Investigacion de la Asociacion Benefica Prisma

616-5500 Anx. 246

[e-mail]

Status: Approved
Approval date: 03/01/2012
Contact:

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Via Libre

4331396

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Status: Approved
Approval date: 31/05/2012
Contact:

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Hospital Maria Auxiliadora

9275-9021

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