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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. |
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Register:
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EUCTR |
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Last refreshed on:
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30 June 2019 |
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Main ID: |
EUCTR2005-002305-23-GB |
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Date of registration:
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14/01/2008 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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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
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Scientific title:
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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 |
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Date of first enrolment:
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05/02/2008 |
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Target sample size:
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20 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-002305-23 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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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
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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United Kingdom
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Relapsing Remitting Multiple Sclerosis
MedDRA version: 9.1
Level: LLT
Classification code 10063399
Term: Relapsing-remitting multiple sclerosis
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Intervention(s)
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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-
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Primary Outcome(s)
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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
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Primary end point(s): Incidence of anti-alemtuzumab antibodies
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Secondary Objective:
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Secondary ID(s)
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not available
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SM3
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date:
Contact:
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