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

NCT01171209 | Completed Phase 2 DMC

• 1 other identifier: 2009-016824-29
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Multiple Sclerosis

Keywords

MS

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Determining response marker: IL10

  9-12 hours after adminstration of Interferon-alfa

• Determining 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

• Changes i Neutralizing antibodies Nabs

  9-12 hours after administration of IFN-alfa

Study Arms (2)

IFN-alfa

EXPERIMENTAL

One single injection of human leukocyte IFN-α (Multiferon® ) 6 MIU s.c.

Drug: Interferon-beta and human leukocyte Interferon-α

Interferon-beta

EXPERIMENTAL

One single injection of IFN-beta followed by blood test for MxA9.12 hours after injection

Drug: Interferon-beta and human leukocyte Interferon-α

Interventions

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.

Also known as: IFN-beta : Rebif, Betaferon, IFN-alfa: Multiferon®

IFN-alfa; Interferon-beta

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Melinda Magyari: lead
• University of Copenhagen: collaborator

Related Publications (1)

• 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.

  PMID: 25877635 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Interferon-beta; Interferon beta-1b

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Melinda Magyari, M.D.

  Danish Multiple Sclerosis Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: July 8, 2010
• First Posted: July 28, 2010
• Study Start: July 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: August 1, 2011
• Last Updated: November 30, 2012

Record last verified: 2012-11