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Multiple SclerosisPhase 2REPAIRNCT01171209

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

A Phase 2 study testing Interferon-beta and human leukocyte Interferon-α in people with Multiple Sclerosis, run by Melinda Magyari.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Multiple Sclerosis
What is being tested?
Interferon-beta and human leukocyte Interferon-α
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
No sites listed yet
Study dates
Jul 2010to Aug 2011
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
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  • 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

About this study

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.

Read the 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 along serious adverse effects. Hence, many NAb positive patients wish to continue IFN therapy, and these patients might benefit from treatment with IFN-α as both IFN-α and IFN-β are type I interferons that bind to the same interferon receptor (IFNAR). A full in vivo response to human IFN-α (Multiferon) comparable to that seen after IFN-β induction would suggest that the same therapeutic effect could be obtained with human IFN-α (Multiferon).We measure in vivo response of MxA 9-12 hours after administration of human IFN-α (Multiferon) and four other known IFN response markers measured with rt-PCR.

As controls, NAb negative MS patients with a full in vivo MxA response will be studied.

Being tested
Interferon-beta and human leukocyte Interferon-α
Keywords
MS
Medical subject headings
Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Interferon-beta and human leukocyte Interferon-αDrug

    Also called IFN-beta : Rebif, Betaferon, IFN-alfa: Multiferon®

    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.

Study groups in NCT01171209
Study groupRoleWhat they receive
IFN-alfaExperimentalOne single injection of human leukocyte IFN-α (Multiferon® ) 6 MIU s.c.
Receives: Drug: Interferon-beta and human leukocyte Interferon-α
Interferon-betaExperimentalOne single injection of IFN-beta followed by blood test for MxA9.12 hours after injection
Receives: Drug: Interferon-beta and human leukocyte Interferon-α

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 9-12 hours after injection of one dose Interferon-alfa

Secondary outcomes (5)

  1. Determining response marker: IL10

    The in vivo response to IFN-α of known IFN response marker: interleukin-10 (IL10),

    Measured: 9-12 hours after adminstration of Interferon-alfa

  2. Determining response marker:TRAIL

    Determining tumor necrosis factor-related apoptosis-inducing ligand (TRAIL)

    Measured: 9-12 hours after administration of IFN-alfa

  3. Determining response marker IFI27

    Determining IFN-α-inducible protein 27 (IFI27),

    Measured: 9-12 timer after administration of IFN-alfa

  4. Determining response marker:CXCL10 at mRNA level

    Determining :Chemokine CXCL10 at mRNA level

    Measured: 9-12 hours after IFN-alfa administration

  5. Changes i Neutralizing antibodies Nabs

    Measuring changes in Neutralising antibodies 9-12 hours after treatment with one dose IFN-alfa

    Measured: 9-12 hours after administration of IFN-alfa

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jul 2010 (estimated)
  2. Study startJul 2010
  3. Primary completionJun 2011
  4. Study completionAug 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01171209
Sponsor's protocol ID
2009-016824-29
Other IDs
2009-016824-29, 2009
Acronym
REPAIR
Status last verified
Nov 2012
First submitted
8 Jul 2010
Last updated
30 Nov 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 25877635

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Interferon-beta and human leukocyte Interferon-α in people with Multiple Sclerosis, run by Melinda Magyari.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

In vivo mRNA MxA response (time frame: 9-12 hours after injection of one dose Interferon-alfa). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01171209, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2012.

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