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| Phase II Cladribine Add-on to Interferon-beta (IFN-b) Therapy in MS Subjects With Active Disease |
| Link to the ClinicalTrials.gov record | Information obtained from ClinicalTrials.gov on February 14, 2012 |
| Title of trial/grant title | Phase II Cladribine Add-on to Interferon-beta (IFN-b) Therapy in MS Subjects With Active Disease |
| Current status of trial | Active, not recruiting |
| Sponsors and collaborators | EMD Serono |
| Information provided by | EMD Serono |
| ClinicalTrials.gov identifier | NCT00436826 |
| Purpose | The goal of this study is to evaluate the safety, tolerability and effectiveness of oral cladribine when taken in combination with Interferon-beta therapy for the treatment of MS. This study will randomize 200 subjects from approximately 50 sites located world-wide, who have experienced at least one relapse while taking Interferon-beta therapy within 48 weeks prior to Screening, irrespective of disability progression. Secondary progressive multiple sclerosis (SPMS) patients, who are still experiencing relapses, and patients who have received disease modifying drugs (DMDs), other than Interferon-beta therapy, during their MS treatment history, but are currently on Interferon-beta therapy and have experienced active MS symptoms (at least 1 relapse) during the 48 weeks prior to Screening, may also be enrolled. Subjects will be randomised in a 2:1 fashion to receive up to 4 cycles of oral cladribine or matching placebo in combination with Interferon-beta therapy. Subjects who complete the double-blind portion of the study are invited to participate in an open-label extension phase of matching study design. Total participation is 208 weeks. |
| Condition(s) | Multiple Sclerosis |
| Intervention(s) | Drug: Cladribine Drug: Placebo |
| Phase | Phase II |
| Study type and design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment |
| Official title | A Phase II, Multicenter, Randomized, Double Blind, Placebo Controlled, Safety, Tolerability and Efficacy Study of Add-on Cladribine Tablet Therapy With Interferon-beta (IFN-b) Treatment in Multiple Sclerosis Subjects With Active Disease |
| Primary outcome | To evaluate the safety and tolerability of oral cladribine compared to placebo as an add-on therapy to injectable IFN-b treatments in MS subjects with active disease. Quarterly safety review. Efficacy measure at 96 weeks Yes |
| Secondary outcome | To explore the efficacy of oral cladribine as an add-on to IFN-b treatments compared to placebo as an add-on to IFN-b treatments in MS subjects with active disease on: Lesion activity [MRI]; Qualifying relapse rate; Progression of disability At 96 weeks No |
| Study start | December 2006 |
| Minimum age | 18 Years |
| Maximum age | 65 Years |
| Gender | Both |
| Eligibility criteria | Inclusion Criteria: - Be male or female, 18-65 years of age (inclusive); - Weigh between 40-120 kg, inclusive; - Have definite MS, as confirmed by the revised McDonald criteria (Polman, et al. 2005), and have relapsing forms of MS, such as relapsing-remitting or secondary progressive type of disease with superimposed relapses forms (See Appendix I); - Have experienced at least one relapse while receiving IFN-b treatments (Rebif® 44 mcg tiw, sc; Avonexÿ 30 mcg qw, im; or Betaseronÿ 250 mcg qod, sc) for at least 48 weeks (prior to Screening); - Minimum aggregate time on IFN-b therapy is 48-consecutive weeks prior to Screening. Subjects who switched from one IFN-b therapy to another in the 48 weeks preceding Screening may be entered into the study if they have been on a stable regimen of their current IFN-b therapy for a minimum of 3 months prior to Screening. - Be clinically stable (other than MS relapse) during the 28 days preceding Screening; - The following hematological parameters must be normal (as defined below, inclusively) within 28 days of first dosing of blinded study medication at SD 1 (see also Section Error! Reference source not found. for further Hematological Testing and Entry Guidelines): - Hemoglobin = 11.6 - 16.2 G/DL - Leukocytes (total white blood cells [WBC]) = 4.1 - 12.3 x10E3/UL - Absolute lymphocytes = = 1.02 - 3.36 x10E3/UL - Absolute neutrophil count (ANC) = 2.03 - 8.36 x10E3/UL - Platelet count = 140 - 450 x10E3/UL - Have no medical history or evidence of latent tuberculosis infection (LTBI) or active tubercular disease (TB), as evidenced by TB skin test or chest X-ray (see Appendices O, P); - Have an EDSS from 1.0-5.5, inclusive (See Appendix D); - Have no prior exposure to immunosuppressive or cytotoxic agents (with the exception of steroids for MS flare management, or intravenous immunoglobulin-G [IVIG] after allowed wash-out periods. Exclusion Criteria: - Have primary progressive MS or secondary progressive MS without relapses forms; - Have prior or current malignancy other than medically documented complete excision of basal cell skin cancer no less than 5 years prior to Screening; - Have a history of chronic or clinically significant hematological abnormalities; - Prior use of cladribine, mitoxantrone, campath-1h, cyclophosphamide, azathioprine, methotrexate, daclizumab, natalizumab, lymphoid irradiation, bone marrow transplantation or myelosuppressive/cytotoxic therapy; - Use of cytokine or anti-cytokine therapy or plasmapheresis within 3 months prior to Study Day 1; - Treatment with intravenous immunoglobulin-G (IVIG) within 30 days of Screening; - Treatment with oral or parenteral corticosteroids within 2 weeks of Screening; - Treatment with adrenocorticotropic hormone within 28 days prior to Study Day 1; - Use of any investigational drug (other than Rebif® New Formulation [RNF]) or experimental procedure within 6 months prior to Study Day 1; - Subject has inadequate liver function, defined by a total bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT) or alkaline phosphatase > 2.5 times the upper limit of the normal values; - Subject suffers from major medical illness such as cardiac, endocrinologic, hepatic, immunologic (other than MS), metabolic, renal, pulmonary, gastrointestinal, dermatologic, or other major disease that would preclude the administration of oral cladribine. - Subject suffers from major 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; - History of active or chronic infectious disease or any disease which compromises immune function (e.g. HIV+, HTLV-1, Lyme disease, LTBI or TB); - Have an allergy or hypersensitivity to gadolinium, to cladribine or any of its excipients, or IFN-b or any of its excipient(s); - Have any renal condition that would preclude the administration of gadolinium (e.g. acute or chronic severe renal insufficiency (GFR < 30mL/min/1.73m2); - Have a positive stool heme-occult test at Screening (see also Section Error! Reference source not found. for further Heme-Occult Testing and Entry Guidelines); - Subject has a history of seizures not adequately controlled by treatment. |
| Locations | Alabama, United States Research Site Cullman Alabama Arizona, United States Research Site Phoenix Arizona Arizona, United States Research Site Scottsdale Arizona California, United States Research Site Los Angeles California Colorado, United States Research Site Boulder Colorado Colorado, United States Research Site Fort Collins Colorado Florida, United States Research Site Tampa Florida Georgia, United States Research Site Atlanta Georgia Illinois, United States Research Site Peoria Illinois Massachusetts, United States Research Site Boston Massachusetts Massachusetts, United States US Medical Information Rockland Massachusetts 02370 Missouri, United States Research Site St Louis Missouri New Jersey, United States Research Site Newark New Jersey New Mexico, United States Research Site Albuquerque New Mexico North Carolina, United States Research Site Charlote North Carolina North Carolina, United States Research Site Winston-Salem North Carolina Pennsylvania, United States Research Site Bethlehem Pennsylvania Pennsylvania, United States Research Site Philadelphia Pennsylvania Tennessee, United States Research Site Nashville Tennessee Texas, United States Research Site Houston Texas Texas, United States Research Site Round Rock Texas Vermont, United States Research Site Burlington Vermont Italy Research Site Fidenza Italy Research Site Milan Italy Research Site Napoli Italy Research Site Rome Russian Federation Research Site Arkhangelsk Russian Federation Research Site Kazan Russian Federation Research Site Moscow Russian Federation Research Site Novosibirsk Russian Federation Research Site Samara Russian Federation Research Site Smolensk Russian Federation Research Site St. Petersburg Spain Research Site Alicante Spain Research site Barcelona Spain Research Site Bilbao Spain Research Site Madrid Spain Research Site Malaga Spain Research Site Santiago Spain Research Site Seville |
| Study ID numbers | 26593 |
| Last updated | January 19, 2012 |
| Record first received | February 15, 2007 |
| ClinicalTrials.gov identifier | NCT00436826 |
| Download date | Information obtained from ClinicalTrials.gov on February 14, 2012 |
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