Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
EMEA Post Approval Commitment
This study has been completed.
Sponsored by: EMD Serono
Information provided by: EMD Serono
ClinicalTrials.gov Identifier: NCT00367484
  Purpose

The objectives of the study are:

- comparison of the incidence and time course of the development of neutralizing antibodies (Nabs) to Rebif after 48 weeks of therapy, to historical data from Serono clinical trial databases to assess the safety and tolerability of Rebif®


Condition Intervention Phase
Relapsing Remitting Multiple Sclerosis
Drug: Rebif®
Phase IV

MedlinePlus related topics: Multiple Sclerosis
Drug Information available for: Interferon beta 1a
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • Have MS with two or more relapses in the past two years and is eligible for interferon therapy.
  • Be between 18 and 60 years of age, inclusive.
  • Have given written informed consent, prior to any study related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to their future medical care.
  • Be willing and able to follow all study procedures for the duration of the study.
  • Have an EDSS score less than 6.0
  • If female, she must either

    1. be post menopausal or surgically sterilised; or
    2. use a hormonal contraceptive, intra uterine device, diaphragm with spermicide, or condom with spermicide, for the duration of the study; and
    3. be neither pregnant nor breast feeding. Confirmation that the subject is not pregnant must be established by a negative SERUM hCG pregnancy test between 28 to 7 days before Study Day 0.Urine pregnancy test must be done if serum hCG pregnancy test was performed more than 7 days before Study Day 0. A pregnancy test is not required if the subject is post menopausal or surgically sterilised.

Exclusion Criteria:

  • Prior Interferon beta therapy (either beta-1b or beta-1a).
  • Major medical or psychiatric illness that in the opinion of the investigator creates undue risk to the subject or could affect compliance with the study protocol.
  • Significant immunosuppressive therapy within the 6 months prior to enrolment.
  • Known history of hypersensitivity to natural or recombinant interferon beta, human serum albumin, or any other component of the formulation.
  • Epilepsy with a history of seizures not adequately controlled by treatment.
  • Have greater than Grade 1 toxicity for liver function tests (AST, ALT, GGT or total bilirubin) at the Screening visit
  • Have significant leukopenia (greater than Grade 1 toxicity for total white blood cell count or lymphopenia) at the Screening visit
  • Have had treatment with oral or systemic corticosteroids or ACTH within 1 month of the Screening visit or between the screening visit and study day 0.
  • Cytokine or anti-cytokine therapy within the 3 months prior to the Screening visit or between the screening visit and study day 0.
  • Use of immunomodulatory or immunosuppressive therapy (including but not limited to cyclophosphamide, cyclosporin, methotrexate, azathioprine, linomide) within the 6 months prior to the Screening visit or between the screening visit and study day 0.
  • Have taken intravenous immunoglobulin or glatiramer acetate or mitoxantrone or any investigational drug or experimental procedure within the 3 months prior to the Screening visit or between the screening visit and study day 0.
  • Prior use of cladribine or have received total lymphoid irradiation.
  • Presence of systemic disease that might interfere with patient safety, compliance or evaluation of the condition under study (e.g. poorly controlled insulin-dependent diabetes, Lyme disease, clinically significant cardiac disease, HIV, HTLV-1).

Other concurrent systemic disorders incompatible with the study (at the Investigator’s discretion).

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00367484

Sponsors and Collaborators
EMD Serono
Investigators
Study Director: Manolo Ernesto Beelke, M.D. EMD Serono
  More Information

Full FDA approved prescribing information can be found here  This link exits the ClinicalTrials.gov site

Study ID Numbers: 24810
Study First Received: August 21, 2006
Last Updated: June 11, 2007
ClinicalTrials.gov Identifier: NCT00367484  
Health Authority: France: Institutional Ethical Committee

Study placed in the following topic categories:
Autoimmune Diseases
Multiple Sclerosis
Demyelinating Diseases
Interferon beta 1a
Demyelinating Autoimmune Diseases, CNS
Demyelinating diseases
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Autoimmune Diseases of the Nervous System

Additional relevant MeSH terms:
Pathologic Processes
Immune System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009