A phase II, randomised, open-label, three-arm study comparing low-and high-dose Campath® (MabCampath®) and high-dose Rebif® in patients with early, active relapsing-remitting Multiple Sclerosis (MS)
- Conditions
- Relapsing-remitting multiple sclerosisMusculoskeletal DiseasesMultiple sclerosis
- Registration Number
- ISRCTN87885087
- Lead Sponsor
- ILEX Oncology, Inc. (USA)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 334
1. Signed, written informed consent
2. Male or non-pregnant, non-lactating female patients, 18 to 50 years of age (inclusive)
3. Diagnosis of MS per McDonald's update of the Poser criteria, including cranial Magnetic Resonance Imaging (MRI) consistent with those criteria
4. Onset of first symptoms within 3 years prior to screening
5. Expanded Disability Status Scale (EDSS) score 0.0 - 3.0 (inclusive) at the screening and baseline visits
6. At least two clinical episodes of MS in the 2 years prior to study entry (i.e., the initial event if within 2 years of study entry plus greater than or equal to one relapse, or greater than or equal to two relapses if the initial event was between 2 and 3 years prior to study entry)
7. In addition to the clinical criteria (3 to 6 above), greater than or equal to one enhancing lesion on any one of the up to four screening gadolinium-enhanced MRI brain scans during a maximum 3-month run-in period (inclusive of the Month 0 baseline scan)
1. Previous immunotherapy for MS other than steroids, including treatment with interferons, intravenous immunoglobulin, glatiramer acetate, and mitoxantrone
2. Personal history of thyroid autoimmune disease
3. Personal history of clinically significant autoimmune disease (e.g., inflammatory bowel disease, diabetes, lupus, severe asthma)
4. History of thyroid carcinoma (previous thyroid adenoma is acceptable and is not to be considered an exclusion criterion)
5. History of malignancy (except for basal cell skin carcinoma in which situation the patient is eligible only if disease-free for more or equal to 5 years)
6. Any disability acquired from trauma or another illness that, in the opinion of the investigator, could interfere with evaluation of disability due to MS
7. Previous treatment with Campath®
8. History of anaphylaxis following exposure to humanized monoclonal antibodies
9. Inability to undergo MRI with gadolinium administration
10. Female patients with childbearing potential with a positive serum pregnancy test at screening or baseline. (NB: Serum pregnancy testing will be performed on each occasion)
11. Male and female patients who do not agree to use effective contraceptive method(s) during the study
12. Impaired renal function (i.e., serum creatinine larger or equal to 2 times the institutional Upper Limit of Normal [ULN])
13. Untreated Major Depressive Disorder (MDD)
14. Epileptic seizures that are not adequately controlled by treatment
15. Suicidal ideation
16. 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
17. Abnormal CD4 count or significantly abnormal thyroid function; presence of anti-Thyroid Stimulating Hormone (TSH) receptor antibodies; known seropositivity for Human Immunodeficiency Virus (HIV)
18. Intolerance of pulsed corticosteroids, especially a history of steroid psychosis
19. Presence of a monoclonal paraprotein
20. Patients who, in the opinion of the investigator, have any form of MS other than relapsing-remitting
21. Patients currently participating in a clinical trial of an experimental or unapproved/unlicensed therapy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method