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Data Sheet of Clinical Trial C.T DATA SHEET OF CLINICAL TRIAL C.T. No 024-15 CLINICAL TRIAL REGISTRATION (EC) I. SPONSOR INFORMATION Foreign National TYPE OF INSTITUTION II. CLINICAL TRIAL GENERAL INFORMATION 1. CLINICAL TRIAL IDENTIFICATION Scientific Title: A PHASE 3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE CONTROLLED, PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF RPC1063 ADMINISTERED ORALLY TO RELAPSING MULTIPLE SCLEROSIS PATIENTS Public Title: PHASE 3 CLINICAL TRIAL OF RPC1063 FOR PATIENTS WITH RELAPSING MULTIPLE SCLEROSIS Secundary ID(s): WHO UTN: PER-024-15 Protocol Code: RPC01-301 Clinicaltrials.gov: NA EUDRACT N°: NA 1 1-2 2 2-3 Study clinical phase: 3 4 Clinical Trial Total Duration: 30 months No Aplica 0(exploratory trials) Enrolment start date in Peru (Initial) 30/06/2015 Worldwide enrolment start date (dd/ (dd/mm/aaaa): 31/12/2014 mm/aaaa): Enrolment start date in Peru (Posterior) (dd/mm/aaaa): Without starting enrollment In enrollment Peru enrolment status : Enrollment stopped Enrollment closed Other 2. CLINICAL TRIAL GOALS AND DESIGN Randomnized Simple Non randomnized Double Assignation method Type of blinding No aplica Triple Open Single arm Parallel Crossed Factorial Assignation Others: ____________________ Study Design Double-Blind. Double-Dummy, Active Controlled, Parallel Group Study Purpose To assess whether the clinical efficacy of RPC1063 is superior to interferon (IFN) &#946;-1a (Avonex®) in reducing the rate of clinical relapses in patients with RMS. 3. STUDY INTERVENTION Indicate if the product is being developed as: Pharmaceutical product Medical device Herbal product Type of research product Galenic product Complementary product Dietary product and sweetener Other: ____________________ Research product identification N° Product name Generic name Product type ATC 1 RPC1063 Ozanimod Producto en investigación de origen L04 - Agentes inmunosupresores químico N° Comparator name Generic name Product type ATC 1 Interferon Beta 1a MAS Ritonavir/ Avonex y Ritonavir/Lopinavir Medicamento L03 - Inmunoestimulantes Lopinavir Página 1 de 4 Intervention(s) description: N° of Group Name Type of group Intervention(s) description participants Subjects' treatment time 30 months Subjects' follow up time 28 days 4. Study Population Inclusion Criteria: 1. 1. MS, as diagnosed by the revised 2010 McDonald criteria 2. Exhibiting a relapsing clinical course consistent with RMS and history of brain MRI lesions consistent with MS 3. Ages 18-55 years 4. EDSS score between 0 and 5.0 at baseline 5. Meet one of the following disease activity criteria: At least 1 documented relapse within the last 12 months prior to screening, OR at least 1 documented relapse occurred within the last 24 months prior to screening and documented evidence of at least 1 GdE lesion on brain MRI within the last 12 months prior to randomization 6. No history of relapse with onset from 30 days prior to screening until randomization 7. Ability to provide written informed consent 8. Patients of reproduction potential must practice an acceptable method of birth control (see protocol) during study participation and for 30 days after their last dose of treatment of study medication or true sexual abstinence (see protocol) 9. Patients must have documentation of positive Varicella zoster virus (VZV) IgG antibody status or complete VZV vaccination at least 30 days prior to randomization. Exclusion Criteria: 1. 1. Primary progressive MS at screening 2. Disease duration of more than 15 years in patients with an EDSS &#8804;2.0 3. Contraindications to MRI or Gadolinium contrast 4. Incompatibility with beta IFN use 5. Pregnancy, lactation, or a positive serum beta human chorionic gonadotropin (&#946;-hCG) measured during screening 6. Clinically relevant hepatic, neurological, pulmonary, ophthalmological, endocrine, renal, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult 7. Specific cardiac conditions are excluded 8. Resting heart rate less than 55 bpm at Screening 9. Diabetes mellitus type 1, or uncontrolled diabetes mellitus type 2 with hemoglobin A1c >9% , or diabetic patients with significant co- morbid conditions such as retinopathy or nephropathy 10. History of uveitis 11. Known active bacterial, viral, fungal, mycobacterial infection, or other infection (including tuberculosis [TB] or atypical mycobacterial disease 12. History or known presence of recurrent or chronic infection (e.g., hepatitis A, B, or C, human immunodeficiency virus (HIV), syphilis, TB); recurring urinary tract infections could be allowed 13. History of cáncer 14. Suicide attempts in the past or current signs of major depression 15. History of alcohol or drug abuse within 1 year prior to randomization 16. History of or currently active primary or secondary immunodeficiency Studied Condition: N/A Studied Condition G35Multiple Sclerosis Medical speciality : Neurology classification(CIE-10): • Argentina • Croacia • Portugal • Canada • España • Reino Unido • Colombia • Estonia • Rumania • Mexico • Georgia • Rusia Countries where the enrolment is • Peru • Holanda • Suecia conducted: • Estados Unidos • Hungria • Ucrania • Alemania • Letonia • Nueva Zelanda • Bielorrusia • Lituania • Serbia • Bosnia-Herzeg. • Moldavia • Bulgaria • Polonia Number of participants per gender 37 >Number of subjects to be included (Initial): 1200 in all the countries: Number of participants per gender 0 (Posterior): Population to be included by gender Women Men Both Healthy volunteers Yes No Subordinate Groups Yes No Indigenous or native people Yes No Minors Yes No Indicate if the study population Subjects with disabilities to grant consent includes: Yes No Women of childbearing age Yes No Pregnant women Yes No Women during labor, puerperium or lactation Yes No Fetus Yes No Adults(18-64 years) Yes No Elderly (>= 65 years) Yes No Under 18 years Yes No - In Utero Yes No Range of age of subjects to be - Preterm newborn infants (up to gestational age < 37 weeks) included: Yes No - Newborns (0-27 days) Yes No - Infants and toddlers (28 days-23months) Yes No - Children (2 - 11 years) Yes No Página 2 de 4 - Adolescents (12 - 17 years) Yes No 5. EVALUATION CRITERIA Primary Evaluation Criteria N° Evaluation criteria name Method of measurement Time point for the measurement Secondary Evaluation Criteria N° Evaluation criteria name Method of measurement Time point for the measurement 6. DATA MONITORING Existence of the Data Monitoring ¿Interim analysis is planned? Yes No Committee(CMD) Yes No III. INFORMATION FROM THE FINANCING SOURCE 1. INFORMATION FROM THE FINANCING SOURCE Sponsor Name 2. Sponsor Responsibilities Institution Name Responsibility Inform to the OGITT of the NIH when the first subject is enrolled in Peru, and the end date of enrollment in the country. Submit progress reports to the National Health Institute during the execution of the Clinical Trial. Submit to the OGITT of the NIH the final reports as well as the results, conclusions, and publication of the clinical trial. Notify to the OGITT of the NIH the adverse events and deviations as established in the Clinical Trials Regulation. Inform and describe the reasons for a suspension and cancellation of the clinical trial. Provide the facilities for the inspection of the execution of the clinical trial by the staff of the General Office of Research and Technology Transfer (OGITT) of the National Institute of Health. False IV. RESEARCH SITE, PRINCIPAL INVESTIGATOR, ETHICS COMMITTEE Research Site 1 of 2 1. RESEARCH SITE WHERE THE CLINICAL TRIAL WILL BE CONDUCTED CLINICA CENTENARIO PERUANO JAPONESA - CLÍNICA RCI N°: 00687 Research site: CENTENARIO PERUANO JAPONESA 2. PRINCIPAL INVESTIGATOR Full name: Liliana, Rodriguez Kadota 3. CO-INVESTIGATOR 4. INSTITUTIONAL RESEARCH ETHICS COMMITTEE (CIEI) THAT APPROVED THE TRIAL FOR THE SITE UNIVERSIDAD DE SAN MARTIN DE PORRES - Comité Institucional de RCIEI N°: 00018 Ethics Committe Name: Ética en investigación de la Facultad de Medicina Humana de Universidad San Martín de Porres Approval date: 15/12/2014 End approval date: 15/12/2015 CONTACT DATA (Legal Representative of CIEI) [email protected] - Full Name: Segundo Amador, Vargas Guerra E-mail: [email protected] Av. Alameda del Corregidor N° 1531 Telephone number: 3652300 anexo 1600 Address: - Urb. Los Sirios III Etapa (Lima - Lima - La Molina) Research Site 2 of 2 1. RESEARCH SITE WHERE THE CLINICAL TRIAL WILL BE CONDUCTED PENSAC - Centro de Investigaciones RCI N°: 01038 Research site: Médicas 2. PRINCIPAL INVESTIGATOR Full name: Edwin Javier, Pretell Alva 3. CO-INVESTIGATOR 4. INSTITUTIONAL RESEARCH ETHICS COMMITTEE (CIEI) THAT APPROVED THE TRIAL FOR THE SITE Página 3 de 4 UNIVERSIDAD DE SAN MARTIN DE PORRES - Comité Institucional de RCIEI N°: 00018 Ethics Committe Name: Ética en investigación de la Facultad de Medicina Humana de Universidad San Martín de Porres Approval date: 15/12/2014 End approval date: 15/12/2015 CONTACT DATA (Legal Representative of CIEI) [email protected] - Full Name: Segundo Amador, Vargas Guerra E-mail: [email protected] Av. Alameda del Corregidor N° 1531 Telephone number: 3652300 anexo 1600 Address: - Urb. Los Sirios III Etapa (Lima - Lima - La Molina) VI. SHARED USE OF CLINICAL TRIAL DATA (ANONIMIZED INDIVIDUAL DATA) ¿Is there a plan for sharing of Yes No Not decided deidentified individual clinical trial participant-level data (IPD) to other In case the answer is affirmative, describe the Plan: researchers (including data dictionaries)? None Study protocol Statistical Analysis Plan Informed consent form Additional information that will be Clinical Study Report shared Others _______________ (Inglés) Describe briefly when this information will be available and how it can be obtained. N/A URL N/A DOI N/A Clinical Trial Registration Date 04-09-2015 00:00 Most recent Clinical Trial Update N/A VII. CLINICAL TRIAL CONTACT PERSONS INFORMATION DATA OF THE CONTACT PERSON(s) FOR CONSULTATIONS ABOUT THE CLINICAL TRIAL Full Name Email Telephone Type of queries to be resolved VIII. AUTORIZATION STATUS RESOLUCIÓN DIRECTORAL Document Document Date 04/09/2015 687-2015 Observations Instituto Nacional de Salud - 01/10/2021 6:18 a.m. Página 4 de 4.
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