A pilot study of combination monoclonal antibody treatment in early active relapsing-remitting multiple sclerosis using Campath-1H and its non-binding form, SM3. - SM3

Phase 1

• Conditions: Relapsing Remitting Multiple Sclerosis; MedDRA version: 9.1 Level: LLT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis

• Registration Number: EUCTR2005-002305-23-GB
• Lead Sponsor: R&D Addenbrookes Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-01-14
• Study Completion: 2010-03-04
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 0

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

•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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified