Relapsing Remitting Multiple Sclerosis MedDRA version: 9.1 Level: LLT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis
Conditions
Interventions
Trade Name: MabCampath ®
Product Name: Alemtuzumab
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Alemtuzumab
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: eq
Sponsors
Genzyme Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Signed informed consent form (ICF) • Age 18 to 50 years old (inclusive) as of the date the ICF is signed • Diagnosis of MS per update of McDonald criteria, and cranial MRI scan demonstrating white matter lesions attributable to MS within 5 years of Screening • Onset of MS symptoms (as determined by a neurologist, either at present or retrospectively) within 5 years of the date the ICF is signed • EDSS score of 0.0 to 3.0 (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. 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: • Current participation in another clinical study • Received prior therapy for MS other than corticosteroids, eg, alemtuzumab, interferons, IV immunoglobulin, glatiramer acetate, natalizumab, and mitoxantrone • Exposure to azathioprine, cladribine, cyclophosphamide, cyclosporine A, methotrexate, or any other immunosuppressive agent other than systemic corticosteroid treatment • Received treatment with a monoclonal antibody for any reason • Previous treatment with any investigational medication, ie drug has not been approved at any dose or for any indication (Prior treatment with herbal medications or nutritional supplements is permitted.) • Has 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 • CD4+, CD8+ B-cell count, absolute neutrophil count < LLN at Screening (see protocol) • Absolute neutrophil count <LLN at Screening • Known bleeding disorder (eg, dysfibrinogenemia, factor IX deficiency, hemophilia, Von Willebrand’s disease, disseminated intravascular coagulation (DIC), fibrinogen deficiency, or 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, severe psoriasis • Presence of anti-thyroid stimulating hormone (TSH) receptor (TSHR) antibodies (ie, above the 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 that would, in the opinion of the Investigator, compromise patient safety or interfere with the interpretation of study results, eg, current peptic ulcer disease or other condi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of study CAMMS323 is to compare the safety and efficacy of 2 annual cycles of IV alemtuzumab to 3-times weekly SC administration of interferon beta-1a. ;Secondary Objective: Secondary objectives of the CAMMS323 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;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 observed for time to SAD or relapse rate | — |
Countries
Czech Republic, France, Germany, Poland, Sweden, United Kingdom
Outcome results
None listed