Status:
COMPLETED
REsPonse to Interferon-Alpha in InterfeRon-β Neutralizing Antibody Positive Multiple Sclerosis Patients
Lead Sponsor:
Melinda Magyari
Collaborating Sponsors:
University of Copenhagen
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
Brief Summary
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.
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01171209
Start Date
July 1 2010
End Date
August 1 2011
Last Update
November 30 2012
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