Multiple Sclerosis Clinical Trial
Official title:
Characterization of Interferon Beta -1b-Induced Tolerizing Effect in Dendritic Cells
| NCT number | NCT00630721 |
| Other study ID # | 07-0941 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | September 2007 |
| Est. completion date | March 15, 2011 |
| Verified date | October 2018 |
| Source | University of North Carolina, Chapel Hill |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Determine the in-vivo mechanism of action of INF-B-1b as it's mechanisms of action are not completely understood. We propose that high dose exogenous recombinant IFN-B-1b induces tolerizing effect on DC-dependent T-cell differentiation in patients with MS by inducing the expression of SOCS3 in DCs.
| Status | Completed |
| Enrollment | 56 |
| Est. completion date | March 15, 2011 |
| Est. primary completion date | May 15, 2010 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 60 Years |
| Eligibility |
Inclusion Criteria: - Confirmed diagnosis of MS - Age 18-60 years, inclusive - Expanded disability status of 0-6.5 - Give written informed consent prior to any testing under this protocol |
| Country | Name | City | State |
|---|---|---|---|
| United States | University of North Carolina | Chapel Hill | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| University of North Carolina, Chapel Hill |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Determine the effect of IFN-B-1b-induced SOCS3 upregulation in DCs' on their maturation and the capacity to present | 2 years | ||
| Secondary | Characterize the effect of IFN-1b-induced SOCS3 expression in DCs on Th1/Th2 cell differentiation and T-cell cytokine transcription. | 2 years |
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