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Main
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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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4 January 2022 |
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Main ID: |
EUCTR2007-001162-32-CZ |
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Date of registration:
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31/03/2008 |
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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 Phase 3 Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Patients with Relapsing-Remitting Multiple Scleroris Who Have Relapsed On Therapy - CARE MS-II
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Scientific title:
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A Phase 3 Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Patients with Relapsing-Remitting Multiple Scleroris Who Have Relapsed On Therapy - CARE MS-II |
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Date of first enrolment:
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30/07/2008 |
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Target sample size:
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573 |
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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:2007-001162-32 |
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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: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: yes
Cross over: no
Other: yes
Other trial design description: rater-blinded
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Austria
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Belgium
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Czech Republic
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Denmark
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France
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Germany
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Italy
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Netherlands
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Poland
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Spain
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Sweden
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United Kingdom
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
• Signed informed consent form (ICF)
• Age 18 to 55 years old (inclusive) as of the date the ICF is signed
• Diagnosis of MS per update of McDonald criteria
• Onset of MS symptoms (as determined by a neurologist, at present or retrospectively) within 10 years of the date the ICF is signed
• EDSS score 0.0 to 5.0 (inclusive) at Screening
• >/= 2 MS attacks (first episode or relapse occurring in the 24 months prior to the date the ICF is signed, with >/= 1 attack in the 12 months prior to the date the ICF is signed, with objective neurological signs confirmed by a physician, nurse practitioner, or other Genzyme-approved health-care provider. The objective signs may be identified retrospectively.
• >/= 1 MS attack (relapse) during treatment with a beta interferon therapy or glatiramer acetate after having been on that therapy for >6 months within 10 years of the date the ICF is signed
• MRI scan demonstrating white matter lesions attributable to MS and meeting at least 1 of the following criteria, as determined by the neurologist or a radiologist: >/= 9 T2 lesions at least 3 mm in any axis or a gadolinium-enhancing lesion at least 3 mm in any axis plus >/1 brain T2 lesions or a spinal cord lesion consistent with MS plus >/1 brain T2 lesions
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:
• Previous treatment with alemtuzumab • Current participation in another clinical study or previous participation in CAMMS323 • Treatment with natalizumab, methotrexate, azathioprine, or cyclosporine in the past 6 months. Patients who received one of these medications more than 6 months before the date the ICF is signed may be eligible for study entry if approval is granted by Genzyme • Previous treatment with mitoxantrone, cyclophosphamide, cladribine, rituximab or any other immunosuppressant or cytotoxic therapy (other than steroids) • Previous treatment with any investigational medication unless prior approval is granted by the sponsor and the patient completes washout (Prior treatment with herbal medications or nutritional supplements is permitted) • Any progressive form of MS • History of malignancy, except basal skin cell carcinoma • Any disability acquired from trauma or another illness that, in the opinion of the Investigator, could interfere with evaluation of disability due to MS • Previous hypersensitivity reaction to any immunoglobulin product • Known allergy or intolerance to interferon beta, human albumin, or mannitol • Intolerance of pulsed corticosteroids, especially a history of steroid psychosis • Inability to self-administer SC injections or receive SC injections from caregiver • Inability to undergo MRI with gadolinium administration • Confirmed platelet, CD4+, CD8+, B-cell, absolute neutrophil count
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-
Trade Name: Rebif
Pharmaceutical Form: Solution for injection
INN or Proposed INN: INTERFERON BETA-1A
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 44-
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Primary Outcome(s)
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Secondary Objective: Secondary objectives of the CAMMS32400507 trial are:
- Proportion of patients who are relapse free at Year 2
- Change from baseline in EDSS
- Acquisition of disability as measured by change from baseline in MSFC
- Percent change from baseline in MRI-T2-hyperintense lesion volume at Year 2
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Main Objective: The main objectives of study CAMMS32400507 is to compare the safety and efficacy of 2 annual cycles of 12 mg/day intravenous (IV) alemtuzumab to 3-times weekly subcutaneous (SC) interferon beta-1a (Rebif) in patients with active relapsing-remitting multiple sclerosis (RRMS) who have experienced at least 1 relapse during prior treatment with an interferon beta or glatiramer acetate, after having received that therapy for > 6 months
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Primary end point(s): The study will be considered to have met its primary efficacy objectives if a statistically significant difference between alemtuzumab and sc interferon-beta-1a groups is observed for time to SAD or relapse rate
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Secondary ID(s)
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not available
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2007-001162-32-GB
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CAMMS 32400507
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 30/07/2008
Contact:
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