Relapsing Remitting Multiple Sclerosis MedDRA version: 9.1 Level: LLT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis
Conditions
Sponsors
Genzyme Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Signed informed consent form (ICF) • Age 18 to 55 years old (inclusive) as of the date the ICF is signed • Diagnosis of MS per update of McDonald criteria • Onset of MS symptoms (as determined by a neurologist, at present or retrospectively) within 10 years of the date the ICF is signed • EDSS score 0.0 to 5.0 (inclusive) at Screening • >/= 2 MS attacks (first episode or relapse occurring in the 24 months prior to the date the ICF is signed, with >/= 1 attack in the 12 months prior to the date the ICF is signed, with objective neurological signs confirmed by a physician, nurse practitioner, or other Genzyme-approved health-care provider. The objective signs may be identified retrospectively. • >/= 1 MS attack (relapse) during treatment with a beta interferon therapy or glatiramer acetate after having been on that therapy for >6 months within 10 years of the date the ICF is signed • MRI scan demonstrating white matter lesions attributable to MS and meeting at least 1 of the following criteria, as determined by the neurologist or a radiologist: >/= 9 T2 lesions at least 3 mm in any axis or a gadolinium-enhancing lesion at least 3 mm in any axis plus >/1 brain T2 lesions or a spinal cord lesion consistent with MS plus >/1 brain T2 lesions 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
Exclusion criteria: • Previous treatment with alemtuzumab • Current participation in another clinical study or previous participation in CAMMS323 • Treatment with natalizumab, methotrexate, azathioprine, or cyclosporine in the past 6 months. Patients who received one of these medications more than 6 months before the date the ICF is signed may be eligible for study entry if approval is granted by Genzyme • Previous treatment with mitoxantrone, cyclophosphamide, cladribine, rituximab or any other immunosuppressant or cytotoxic therapy (other than steroids) • Previous treatment with any investigational medication unless prior approval is granted by the sponsor and the patient completes washout (Prior treatment with herbal medications or nutritional supplements is permitted) • Any progressive form of MS • History of malignancy, except basal skin cell carcinoma • Any disability acquired from trauma or another illness that, in the opinion of the Investigator, could interfere with evaluation of disability due to MS • Previous hypersensitivity reaction to any immunoglobulin product • Known allergy or intolerance to interferon beta, human albumin, or mannitol • Intolerance of pulsed corticosteroids, especially a history of steroid psychosis • Inability to self-administer SC injections or receive SC injections from caregiver • Inability to undergo MRI with gadolinium administration • Confirmed platelet, CD4+, CD8+, B-cell, absolute neutrophil count <LLN at Screening if abnormal cell counts return to within normal limits eligibility may be reassessed (see protocol) • Known bleeding disorder (eg, dysfibrinogenemia, factor IX deficiency, hemophilia, Von Willebrand’s disease disseminated intravascular coagulation [DIC], fibrinogen deficiency, clotting factor deficiency) • Seropositivity for human immunodeficiency virus (HIV) • Significant autoimmune disease including but not limited to; immune cytopenias, rheumatoid arthritis, systemic lupus erythematosus, other connective tissue disorders, vasculitis, inflammatory bowel disease, sever psoriasis • Presence of anti thyroid stimulating hormone (TSH) receptor (TSHR) antibodies (ie, above LLN) • Active infection, eg, deep-tissue infection, that the Investigator considers sufficiently serious to preclude study participation • In the Investigator’s opinion, is at high risk for infection (eg, indwelling catheter, dysphagia with aspiration, decubitus ulcer, history of prior aspiration pneumonia or recurrent urinary tract infection) • Latent tuberculosis unless effective anti-tuberculosis therapy has been completed, or active tuberculosis. More specific guidance on tuberculosis testing and patient eligibility is provided in the Study Operations Manual (SOM) • Infection with hepatitis C virus • Past or present hepatitis B infection (positive hepatitis B serology) • Of childbearing potential with a positive serum pregnancy test, pregnant, or lactating • Unwilling to agree to use a reliable and acceptable contraceptive method throughout the study period (fertile patients only). Reliable and effective contraceptive method(s): include intrauterine device (IUD), hormonal-based contraception, surgical sterilization, abstinence, or double-barrier contraception (condom and occlusive cap (diaphragm or cervical cap with spermicide) • Major psychiatric disorder that is not adequately controlled by treatment • Epileptic seizures that are not adequately controlled by treatment • Major systemic disease or other illness tha
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The study will be considered to have met its primary efficacy objectives if a statistically significant difference between alemtuzumab and sc interferon-beta-1a groups is observed for time to SAD or relapse rate;Main Objective: The main objectives of study CAMMS32400507 is to compare the safety and efficacy of 2 annual cycles of 12 mg/day intravenous (IV) alemtuzumab to 3-times weekly subcutaneous (SC) interferon beta-1a (Rebif) in patients with active relapsing-remitting multiple sclerosis (RRMS) who have experienced at least 1 relapse during prior treatment with an interferon beta or glatiramer acetate, after having received that therapy for > 6 months; Secondary Objective: Secondary objectives of the CAMMS32400507 trial are: - Proportion of patients who are relapse free at Year 2 - Change from baseline in EDSS - Acquisition of disability as measured by change from baseline in MSFC - Percent change from baseline in MRI-T2-hyperintense lesion volume at Year 2 | — |
Countries
Austria, Belgium, Czech Republic, Denmark, France, Germany, Italy, Netherlands, Poland, Spain, Sweden, United Kingdom
Outcome results
None listed