REsPonse to Interferon-Alpha in InterfeRon-β Neutralizing Antibody Positive Multiple Sclerosis Patients

• Status: Completed
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Melinda Magyari
• Collaborator: University of Copenhagen
• Treatments: Antibodies; Interferon beta-1b; Interferon-alpha; Interferon-beta; Interferons

Criteria

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