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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 30 June 2019
Main ID:  EUCTR2005-002305-23-GB
Date of registration: 14/01/2008
Prospective Registration: Yes
Primary sponsor: R&D Addenbrookes Hospital
Public title: 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
Scientific title: 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
Date of first enrolment: 05/02/2008
Target sample size: 20
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-002305-23
Study type:  Interventional clinical trial of medicinal product
Study design: 
Controlled: yes
Randomised: no
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: no
 
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no
Countries of recruitment
United Kingdom
Contacts
Name:    
Address: 
Telephone:
Email:
Affiliation: 
Name:    
Address: 
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Key inclusion & exclusion 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:
• 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



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Relapsing Remitting Multiple Sclerosis
MedDRA version: 9.1 Level: LLT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis
Intervention(s)

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: equal
Concentration number: 10-

Primary Outcome(s)
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
Primary end point(s): Incidence of anti-alemtuzumab antibodies
Secondary Objective:
Secondary Outcome(s)
Secondary ID(s)
not available
SM3
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date:
Contact:
Results
Results available: Yes
Date Posted: 27/01/2017
Date Completed: 04/03/2010
URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2005-002305-23/results
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