REPAIR
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Treatment tested
- Interferon beta
- HUMAN LEUCOCYTE INTERFERON-ALPHA
Compared with
- Interferon beta-1a
Interferon alpha/beta receptor agonist
- Interferon beta-1b
Interferon alpha/beta receptor agonist
What it measured
Main measures
In vivo mRNA MxA response
9-12 hours after injection of one dose Interferon-alfa
Immune responseIn vivo mRNA MxA-respons efter en injektion med IFN-α sammenlignet med in vivo mRNA MxA-responset efter en injektion med IFN-β efter besøget ved screenings-/baselinebesøget.
Immune response
Other measures (5)
Determining response marker: IL10
9-12 hours after adminstration of Interferon-alfa
Immune responseDetermining response marker:TRAIL
9-12 hours after administration of IFN-alfa
Determining response marker IFI27
9-12 timer after administration of IFN-alfa
Determining response marker:CXCL10 at mRNA level
9-12 hours after IFN-alfa administration
Immune responseChanges i Neutralizing antibodies Nabs
9-12 hours after administration of IFN-alfa
Immune response
Who could take part
Relapsing MS · 18 to 55
Inclusion Criteria: * The subject must give written informed consent prior to any study related activities * Subject age must be between 18 and 55 (both included) * The subject must have MS according to McDonald criteria * The subject must have disability equivalent to EDSS of 5.5 or less * The subject must have been treated with any IFN-β preparation for at least 12 months at any time * The subject must have been shown to be NAb positive and without no in vivo mRNA MxA response within the last 12 months * The subject must be prepared and considered able to follow the protocol Exclusion Criteria: * The subject must not have conditions that might give rise to similar symptoms as MS * The subject must not have received any immunomodulatory or immunosuppressive treatment (other than IFN-β or glatiramer acetate) 6 months prior to the screening visit * The subject must not have received mitoxantrone, cyclophosphamide, treosulphane, natalizumab, daclizumab, rituximab, alemtuzumab, cladribine, or any experimental therapy at any time * The subject must not have undergone previous total body irradiation, total lymphoid irradiation, stem cell treatment, autologous bone marrow transplantation or allogenic bone marrow transplantation. * The subject must not have received treatment with glucocorticoids or ATCH later than 2 month prior to the screening visit * The subject must not have alcohol and drug dependency * The subject must not have cardiac or renal insufficiency * The subject must not have any systemic disease that can influence the subject's safety or compliance * Subjects may be male or female. Women of child-bearing potential must be sexually inactive or practice a medically acceptable method of birth control. Acceptable methods include oral contraceptive, contraceptive patch, long-acting injectable contraceptive, or double-barrier method (condom or IUD with spermicide) * The subject must not have known or suspected allergy to IFN-α * The subject must not have participated in any other study within 3 months prior to the screening visit
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Loading reviews and guidelines…
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History
Started
Jul 2010
Main results due
Jun 2011
Finished
Aug 2011
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