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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-016824-29 | EudraCT Number |
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| Name | Class |
|---|---|
| University of Copenhagen | OTHER |
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The purpose of the study is to determine if Interferon-alfa is effective and safe in multiple sclerosis patients who developed neutralizing antibodies for Interferon-beta.
Patient with NAbs developed during IFN-β therapy do not have any longer beneficial effect of any IFN-β preparation and IFN-β has to be replaced with another therapy that may be less effective or carry along serious adverse effects. Hence, many NAb positive patients wish to continue IFN therapy, and these patients might benefit from treatment with IFN-α as both IFN-α and IFN-β are type I interferons that bind to the same interferon receptor (IFNAR). A full in vivo response to human IFN-α (Multiferon) comparable to that seen after IFN-β induction would suggest that the same therapeutic effect could be obtained with human IFN-α (Multiferon).We measure in vivo response of MxA 9-12 hours after administration of human IFN-α (Multiferon) and four other known IFN response markers measured with rt-PCR.
As controls, NAb negative MS patients with a full in vivo MxA response will be studied.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IFN-alfa | Experimental | One single injection of human leukocyte IFN-α (Multiferon® ) 6 MIU s.c. |
|
| Interferon-beta | Experimental | One single injection of IFN-beta followed by blood test for MxA9.12 hours after injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interferon-beta and human leukocyte Interferon-α | Drug | One single injection of interferon(IFN)- β and one single injection of human leukocyte IFN-α (Multiferon® ) 6 MIU s.c. with 1-7 days follow-up. |
| Measure | Description | Time Frame |
|---|---|---|
| In vivo mRNA MxA response | The primary objective of this study is to compare the in vivo mRNA MxA response to IFN-α with the in vivo mRNA MxA response to IFN-β | 9-12 hours after injection of one dose Interferon-alfa |
| Measure | Description | Time Frame |
|---|---|---|
| Determining response marker: IL10 | The in vivo response to IFN-α of known IFN response marker: interleukin-10 (IL10), | 9-12 hours after adminstration of Interferon-alfa |
| Determining response marker:TRAIL |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Melinda Magyari, M.D. | Danish Multiple Sclerosis Research Center | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25877635 | Derived | Magyari M, Bach Sondergaard H, Sellebjerg F, Soelberg Sorensen P. Preserved in vivo response to interferon-alpha in multiple sclerosis patients with neutralising antibodies against interferon-beta (REPAIR study). Mult Scler Relat Disord. 2013 Apr;2(2):141-6. doi: 10.1016/j.msard.2012.10.001. Epub 2012 Dec 11. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 19, 2013 | |
| Reset | Aug 30, 2013 | |
| Release | Sep 11, 2013 | |
| Reset | Nov 12, 2013 | |
| Release | Nov 18, 2013 | |
| Reset | Jan 6, 2014 | |
| Release | Jan 8, 2014 | |
| Reset | Feb 26, 2014 | |
| Release | Jul 11, 2014 | |
| Reset | Aug 5, 2014 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 19, 2013 | Aug 30, 2013 | |||
| Sep 11, 2013 |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| D016899 | Interferon-beta |
| D000068576 | Interferon beta-1b |
| ID | Term |
|---|---|
| D007370 | Interferon Type I |
| D007372 | Interferons |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
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|
Determining tumor necrosis factor-related apoptosis-inducing ligand (TRAIL)
| 9-12 hours after administration of IFN-alfa |
| Determining response marker IFI27 | Determining IFN-α-inducible protein 27 (IFI27), | 9-12 timer after administration of IFN-alfa |
| Determining response marker:CXCL10 at mRNA level | Determining :Chemokine CXCL10 at mRNA level | 9-12 hours after IFN-alfa administration |
| Changes i Neutralizing antibodies Nabs | Measuring changes in Neutralising antibodies 9-12 hours after treatment with one dose IFN-alfa | 9-12 hours after administration of IFN-alfa |
| Nov 12, 2013 |
| Nov 18, 2013 | Jan 6, 2014 |
| Jan 8, 2014 | Feb 26, 2014 |
| Jul 11, 2014 | Aug 5, 2014 |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D010455 |
| Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |