CompletedPhase 2Relapsing MSNCT011712092009-016824-29

What it found

Result in a paper, not read yet

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

What it measured

Main measures

  • In vivo mRNA MxA response

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

    Immune response
  • In 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 response
  • 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

    Immune response
  • Changes 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…

Related trials

History

    1. Started

      Jul 2010

    2. Main results due

      Jun 2011

    3. Finished

      Aug 2011

    Assembled by software from public sources and not checked by people. Each record links to its source. Report an error