Differential Immune Effects of Natalizumab
This study has been completed.
Sponsor:
Cantonal Hospital of St. Gallen
Information provided by:
Cantonal Hospital of St. Gallen
ClinicalTrials.gov Identifier:
NCT00859482
First received: March 10, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
| Tracking Information | |||||
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| First Received Date ICMJE | March 10, 2009 | ||||
| Last Updated Date | March 10, 2009 | ||||
| Start Date ICMJE | July 2006 | ||||
| Primary Completion Date | July 2007 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Function of T regulatory cells [ Time Frame: at month 3 ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
Change in distinct immune cell lines [ Time Frame: month 3 ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Differential Immune Effects of Natalizumab | ||||
| Official Title ICMJE | A Phase IV Study to Investigate Differential Immune Effects of Natalizumab | ||||
| Brief Summary | Natalizumab is a humanized monoclonal antibody directed against Very Late Activation Antigene 4 (VLA-4) and has a potent effect on disease activity in multiple sclerosis (MS). A blockade of VLA-4 with natalizumab may not only interfere with autoimmunological processes but also with central nervous system (CNS) immune surveillance. |
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| Detailed Description | Longitudinal ex vivo and in vitro study to determine the effect of natalizumab on frequency of distinct immune cells and on the frequency and suppressive function of natural CD4+CD25+ regulatory T cells (Tregs). |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples Without DNA Description: full blodd |
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| Sampling Method | Probability Sample | ||||
| Study Population | Patients initiating natalizumab for treatment of relapsing remitting MS |
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| Condition ICMJE | Multiple Sclerosis, Relapsing Remitting | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 27 | ||||
| Completion Date | July 2007 | ||||
| Primary Completion Date | July 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 65 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00859482 | ||||
| Other Study ID Numbers ICMJE | Ntz-Tregs1 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Norman Putzki, MD, Cantonal Hospital St. Gallen | ||||
| Study Sponsor ICMJE | Cantonal Hospital of St. Gallen | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Cantonal Hospital of St. Gallen | ||||
| Verification Date | March 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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