Relapsing Remitting Multiple Sclerosis MedDRA version: 9.1 Level: LLT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis
Conditions
Sponsors
R&D Addenbrookes Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Male or non-pregnant, non-lactating female patients, 18 to 50 years of age (inclusive) • Diagnosis of MS using McDonald’s criteria29, including diagnostic MRI • Onset of first MS symptoms within 6 years prior to screening • EDSS 30 score 0.0 to 6.0 (inclusive) at the screening visit • At least 3 clinical episodes of MS in the 2 years prior to study entry 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: • Detectable anti-Campath-1H antibodies • Personal history of clinically significant autoimmune disease (e.g., inflammatory bowel disease, diabetes, lupus, severe asthma) • History of thyroid carcinoma (previous thyroid adenoma is acceptable and is not to be considered an exclusion criterion) • History of malignancy (except for basal cell skin carcinoma in which situation the patient is eligible only if disease-free for ?5 years) • History of anaphylaxis following exposure to humanized monoclonal antibodies • Inability to undergo MRI with gadolinium administration (for the MRI sub-cohort) • Female patients with childbearing potential and a positive serum pregnancy test within 2 weeks prior to randomization. (NB: Pregnancy testing will be performed on each occasion.) • Male and female patients who do not agree to use effective contraceptive method(s) during the study • 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 • Abnormal CD4 count or significantly abnormal thyroid function • Intolerance of pulsed corticosteroids, especially a history of steroid psychosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to assess the ability of SM3 to tolerise patients with multiple sclerosis to the therapeutic antibody alemtuzumab. The incidence of anti-alemtuzumab antibodies following two doses of alemtuzumab alone will be compared with that achieved by two doses of alemtuzumab preceded by SM3;Secondary Objective: ;Primary end point(s): Incidence of anti-alemtuzumab antibodies | — |
Countries
United Kingdom
Outcome results
None listed