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| Tracking Information | |||||
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| First Received Date ICMJE | December 19, 2002 | ||||
| Last Updated Date | July 13, 2009 | ||||
| Start Date ICMJE | December 2002 | ||||
| Primary Completion Date | September 2007 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
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| Change History | Complete list of historical versions of study NCT00050778 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Descriptive Information | |||||
| Brief Title ICMJE | A Phase II Study Comparing Low- and High-Dose Alemtuzumab and High-Dose Rebif® in Patients With Early, Active Relapsing-Remitting Multiple Sclerosis | ||||
| Official Title ICMJE | A Phase II, Randomized, Open-Label, Three-Arm Study Comparing Low- and High Dose Alemtuzumab and High-Dose Subcutaneous Interferon Beta-1a (Rebif®) in Patients With Early, Active Relapsing-Remitting Multiple Sclerosis | ||||
| Brief Summary | This is a Phase II, randomized, open-label, three-arm study comparing two different doses of alemtuzumab and Rebif® in patients with early, active relapsing-remitting Multiple Sclerosis (MS) who have not been previously treated with MS therapies other than steroids. |
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| Detailed Description | The aims of treatment for multiple sclerosis (MS) therapy are to prevent the progression of disease and accumulation of long-term disability. The hypothesis underlying this study is that aggressive treatment of inflammation in the brain early in the course of MS will protect the patient from disease progression and accumulating disability. This protocol compares two different doses of alemtuzumab and Rebif® to evaluate the kind of side effects that patients experience and to evaluate wich drug is better at:
Patients who receive alemtuzumab during the initial 36-month treatment period may be eligible for additional alemtuzumab retreatment on either a fixed or an as-needed schedule to evaluate:
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| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE | Multiple Sclerosis, Relapsing-Remitting | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | 334 | ||||
| Estimated Completion Date | June 2013 | ||||
| Primary Completion Date | September 2007 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 50 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States, Croatia, Poland, Russian Federation, United Kingdom | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00050778 | ||||
| Responsible Party | Medical Monitor, Genzyme Corporation | ||||
| Study ID Numbers ICMJE | CAMMS223 | ||||
| Study Sponsor ICMJE | Genzyme | ||||
| Collaborators ICMJE | Bayer | ||||
| Investigators ICMJE |
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| Information Provided By | Genzyme | ||||
| Verification Date | June 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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