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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:
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EUCTR |
Last refreshed on:
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14 August 2012 |
Main ID: |
EUCTR2008-003706-33-AT |
Date of registration:
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24/11/2008 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to MS - ORAl CLadribine in Early MS (ORACLE MS) Trial
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Scientific title:
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A Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to MS - ORAl CLadribine in Early MS (ORACLE MS) Trial |
Date of first enrolment:
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02/04/2009 |
Target sample size:
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600 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-003706-33 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
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Phase:
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Countries of recruitment
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Austria
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Belgium
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Bulgaria
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Czech Republic
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Estonia
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Finland
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France
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Germany
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Greece
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Italy
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Norway
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Portugal
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Spain
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Sweden
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United Kingdom
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Be male or female between 18 and 55 years old, inclusive (see Appendix C) 2. Must weigh between 40-120 kg, inclusive 3. Has experienced a single, first clinical event suggestive of MS within 75 days prior to the Screening visit, (clock starts 24 hours after onset). The event must be a new neurological abnormality present for at least 24 hours, either mono- or polysymptomatic 4. Has at least two clinically silent lesions on the T2-weighted MRI scan, at screening, with a size of at least 3 mm, at least one of which is ovoid or periventricular or infratentorial on screening MRI 5. Has EDSS 0 - 5.0 at Screening 6. Has no medical history or evidence of latent tuberculosis infection (LTBI) or active tubercular disease (TB), as evidenced by the Mantoux TB skin test or a comparable sensitive test, according to local regulation guidelines if Mantoux test is not available and/or chest X-ray 7. ALL the hematological parameters must be normal at Screening according to the normal ranges provided by the centralized laboratory performing all the assessments 8. If female, she must: • be neither pregnant nor breast-feeding, nor attempting to conceive and • use a highly effective method of contraception throughout the entire duration of the study and for 90 days following completion of the last dose of study medication. A highly effective method of contraception is defined as those which result in a low failure rate (i.e. less than1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomized partner. For the purpose of this trial, women of childbearing potential are defined as: “All female subjects after puberty unless they are post-menopausal for at least two years, are surgically sterile or are sexually inactive.” 9. If male, he must be willing to use contraception to avoid contributing to pregnancies throughout the entire duration of the study and for 90 days following the last dose of study medication 10. Be willing and able to comply with study procedures for the duration of the study 11. Voluntarily provide written informed consent, including, for USA, subject authorization under Health Insurance Portability and Accountability Act (HIPAA) (see Appendix J), prior to any study-related procedure that is not part of normal medical care, and with the understanding that the subject may withdraw consent at any time without prejudice to their future medical care. 12. Must refuse any treatment already available for CIS such as Interferons and Glatiramer Acetate, entering the Initial Treatment Period of the Study NOTE: Confirmation that the subject is not pregnant must be established by a negative serum human chorionic gonadotropin (hCG) pregnancy test at Screening and a negative urine pregnancy test on Study Day 1. A pregnancy test is not required if the subject is post-menopausal or surgically sterilized. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria: 1. Subject has a diagnosis of multiple sclerosis (per McDonald criteria, 2005) 2. Subject has any other disease that could better explain the subject’s signs and symptoms 3. Subject has complete transverse myelitis or bilateral optic neuritis 4. Subject uses or has used any other approved MS disease modifying drug (DMD) 5. Subject has used any investigational drug or undergone an experimental procedure within 12 weeks prior to SD1. 6. Subject who received oral or systemic corticosteroids or ACTH within 30 days prior to screening MRI. The MRI has to be performed 30 days after the oral or systemic corticosteroids or ACTH treatment. In case this interferes with MRI timing the screening period can be extended accordingly. 7. Subject has abnormal total bilirubin, or aspartate aminotransferase (AST) or alanine aminotransferase (ALT) or alkaline phosphatase greater than 2.5 x ULN 8. Subject suffers from current autoimmune disease other than MS 9. Subject suffers from psychiatric illness (including history of, or current, severe depressive disorders and/or suicidal ideation) that in the opinion of the investigator creates undue risk to the subject or could affect compliance with the study protocol 10. Subject suffers from major medical illness such as cardiac (e.g. angina, congestive heart failure or arrhythmia), endocrinologic, hepatic, immunologic, metabolic, renal, pulmonary, gastrointestinal, dermatologic, or other major disease that would preclude the administration of oral cladribine 11. Subject has a history of seizures not adequately controlled by medications 12. Subject has a known allergy to cladribine, IFN-beta, the excipient(s) of the study medications, or to gadolinium-DTPA 13. Has any renal condition that would preclude the administration of gadolinium (e.g. acute or chronic severe renal insufficiency (GFR < 30 mL/min/1.73m2) 14. Has a history of chronic or clinically significant hematological abnormalities 15. History of active or chronic infectious disease or any disease that compromises immune function (e.g. HIV+, HTLV-1, Lyme disease, LTBI or TB, insulin-dependent diabetes). 16. Subject has previously been screened in this study thus signed an informed consent and than withdrawn 17. Subject has received any immunomodulatory or immunosuppressive therapy) at any time prior to SD1, including, but not limited to, the following products: any interferon, glatiramer acetate (Copolymer I), cyclophosphamide, cyclosporine, methotrexate, linomide, azathioprine, mitoxantrone, teriflunomide, laquinimod, cladribine, total lymphoid irradiation, anti-lymphocyte monoclonal antibody treatment (e.g. natalizumab, alemtuzumab/Campath, anti-CD4), intravenous immunoglobuline G (IVIG), cytokines or anti-cytokine therapy 18. Subject has received experimental MS treatment 19. Subject has a history of alcohol or drug abuse 20. Subject has intolerance or any contraindication to both paracetamol (acetaminophen) and ibuprofen 21. Inability to administer subcutaneous injections either by self or by caregiver 22. Has prior or current malignancy (with the exception of in situ basal or squamous cell skin cancer surgically removed without recurrence for at least five years) 23. Have a positive stool heme-occult test at Screening
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Subjects with a first clinical demyelinating event (Clinically Isolated Syndrome (CIS)) at high risk of converting to Multiple Sclerosis (MS) MedDRA version: 9.1
Level: PT
Classification code 10028245
Term: Multiple sclerosis
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Intervention(s)
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Product Name: Cladribine Pharmaceutical Form: Tablet INN or Proposed INN: CLADRIBINE CAS Number: 4291638 Current Sponsor code: 2-CdA Other descriptive name: 2-chloro-2’-deoxy-ß-D-adenosine Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use
Trade Name: Rebif 44 micrograms solution for injection Product Name: Interferon beta-1a FBS-free/HSA-free Pharmaceutical Form: Solution for injection INN or Proposed INN: INTERFERON BETA-1A CAS Number: 9008-11-1 Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 44-
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Primary Outcome(s)
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Secondary Objective: Initial Treatment Period: • Evaluate the effect of 2 dosage regimens of oral cladribine vs. placebo on the time to conversion to MS (from randomization) according to the revised McDonald criteria in subjects with a first clinical demyelinating event at high risk of converting to MS • Evaluate the effect of oral cladribine on selected MRI parameters and disease progression in subjects with a first clinical demyelinating event suggestive of MS • Evaluate the effect of oral cladribine on PASAT, SDMT and BVMT-R as measures of cognition in subjects with a first clinical demyelinating event suggestive of MS • Evaluate the safety and tolerability of treatment with oral cladribine in subjects with a first clinical demyelinating event suggestive of MS • Evaluate the impact of CIS and oral cladribine on select patient-reported outcomes domains of the MSQOL-54, EQ-5D, Health Resource Utilization questionnaire and a treatment satisfaction scale
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Primary end point(s): The primary endpoint for the overall study is time to conversion to CDMS (from randomization), according to the Poser Criteria, defined by either a 2nd attack or a sustained increase in the EDSS score (EDSS = 1 point if baseline was =1 and =4.5, or = 1.5 points if baseline EDSS was 0, or =0.5 point if baseline EDSS was =5, over a period of at least three months).
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Main Objective: The primary objective of this study is to evaluate the effect of oral cladribine on the time to conversion to Clinical Definite Multiple Sclerosis (CDMS) according to the Poser criteria, defined by either a second attack or a sustained increase in EDSS score in subjects with a first clinical demyelinating event at high risk of converting to MS
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Secondary ID(s)
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28821
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2008-003706-33-CZ
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Source(s) of Monetary Support
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Results
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Results available:
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