Study Evaluating Rebif, Copaxone, and Tysabri for Active Multiple Sclerosis (SURPASS)

This study has been terminated.
(Majority of subjects who enrolled in the extension of the study had received on average 12 months of treatment.)
Sponsor:
Collaborator:
Elan Pharmaceuticals
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01058005
First received: January 26, 2010
Last updated: September 12, 2013
Last verified: September 2012
  Purpose

Protocol version 5 of this study will be conducted to continue providing study treatment in fulfillment of the commitments made in Versions 1 through 4 of the protocol.


Condition Intervention Phase
Relapsing Remitting Multiple Sclerosis
Drug: Natalizumab
Biological: Interferon Beta-1a
Biological: Glatiramer acetate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: A Multicenter, Randomized, Open-Label, Parallel-Group, Active-Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon Beta-1a) to Natalizumab in Subjects With Relapsing Remitting Multiple Sclerosis

Resource links provided by NLM:


Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • Incidence of treatment emergent SAEs [ Time Frame: 108 Weeks ] [ Designated as safety issue: Yes ]

Enrollment: 84
Study Start Date: February 2010
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Natalizumab Drug: Natalizumab
300 mg IV every 4 weeks
Other Name: Tysabri
Active Comparator: Interferon Beta-1a Biological: Interferon Beta-1a
44 mcg subcutaneous 3 times per week
Other Name: Rebif
Active Comparator: Glatiramer acetate Biological: Glatiramer acetate
20 mg subcutaneous once daily
Other Name: Copaxone

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Have a diagnosis of relapsing remitting multiple sclerosis as defined by the revised McDonald Committee criteria (Polman 2005).
  2. Must have been treated with a stable regimen of either glatiramer acetate (20 mg per day SC) or interferon beta-1a (44 mcg 3 times per week) as their principal first therapy for MS for 6 to 18 months prior to randomization. (Note: prior treatment with another MS therapy of ≤30 days total duration is not exclusionary [e.g. titration to 44 mcg is allowed]).
  3. Have had disease activity within 12 months prior to screening while on therapy; disease activity must be observed after a minimum of 6 months on therapy. Qualifying disease activity is defined as:

    • One or more clinical relapses OR
    • Two or more new MRI lesions (Gd+ and/or T2 hyperintense) For inclusion purposes: (a) a relapse is defined as neurologic signs and/or symptoms documented in the medical record by a neurologist and of sufficient duration to be determined by the Investigator or the Treating Physician as consistent with an MS relapse or (b) MRI activity must be verified by the central reader center.
  4. Be naïve to natalizumab.
  5. Be between the ages of 18 and 60, inclusive at the time of informed consent.
  6. Have a documented EDSS score between 0.0 and 5.5, inclusive.

Exclusion Criteria:

  1. Have a diagnosis of primary progressive, secondary progressive, or progressive relapsing MS (as defined by Lublin and Reingold, 1996). These conditions require the presence of continuous clinical disease worsening over a period of at least 3 months. Patients with these conditions may also have superimposed relapses, but are distinguished from relapsing-remitting patients by the lack of clinically stable periods or clinical improvement.
  2. Have known intolerance, contraindication to, or history of non-compliance with, the use of glatiramer acetate or interferon beta-1a.
  3. Have had an MS exacerbation (relapse) within 30 days prior to randomization AND/OR the patient has not stabilized from a previous relapse, in the opinion of the Investigator, prior to randomization.
  4. The patient is considered by the Investigator to be immunocompromised based on medical history, physical examination, laboratory testing, or due to prior immunosuppressive or immunomodulating treatment.
  5. Subjects for whom MRI is contraindicated, i.e., have pacemakers or other contraindicated implanted metal devices, have suffered or are at risk for side effects from gadolinium (Gd), or have claustrophobia that cannot be medically managed.
  6. History of any clinically significant (as determined by the Investigator) cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, or other major disease that would preclude participation in a clinical trial.
  7. History of malignant disease, including solid tumors and hematologic malignancies (with the exception of basal cell and squamous cell carcinomas of the skin that have been completely excised and are considered cured).
  8. Known history of Human Immunodeficiency Virus (HIV).
  9. Positive test result for Hepatitis C virus (test for hepatitis C virus antibody [HCV Ab]) or hepatitis B virus (test for hepatitis B surface antigen [HBsAg] and/or hepatitis B core antibody [HBcAb]).
  10. History of transplantation or any anti-rejection therapy.
  11. History of PML
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01058005

  Hide Study Locations
Locations
United States, Alabama
Research Site
Cullman, Alabama, United States
United States, Arizona
Research Site
Phoenix, Arizona, United States
United States, Colorado
Research Site
Fort Collins, Colorado, United States
United States, Florida
Research Site
Saint Petersburg, Florida, United States
Research Site
Tampa, Florida, United States
United States, Georgia
Research Site
Atlanta, Georgia, United States
United States, Kentucky
Research Site
Lexington, Kentucky, United States
United States, Michigan
Research Site
Detroit, Michigan, United States
United States, North Carolina
Research Site
Charlotte, North Carolina, United States
United States, Ohio
Research Site
Akron, Ohio, United States
United States, Tennessee
Research Site
Franklin, Tennessee, United States
Research Site
Knoxville, Tennessee, United States
United States, Texas
Research Site
Round Rock, Texas, United States
United States, Washington
Research Site
Kirkland, Washington, United States
United States, West Virginia
Research Site
Morgantown, West Virginia, United States
Australia, Victoria
Research Site
Fitzroy, Victoria, Australia
Canada, Quebec
Research Site
Gatineau, Quebec, Canada
Czech Republic
Research Site
Pardubice, Czech Republic
Hungary
Research Site
Esztergom, Komárom-Esztergom, Hungary
Research Site
Budapest, Hungary
Italy
Research Site
Catania, Italy
Research Site
Napoli, Italy
Latvia
Research Site
Riga, Latvia
Poland
Research Site
Lódz, Lodzkie, Poland
Research Site
Bialystok, Podlaskie, Poland
Research Site
Gdansk, Pomorskie, Poland
Slovenia
Research Site
Ljubljana, Slovenia
Spain
Research Site
Barcelona, Spain
Research Site
Girona, Spain
Research Site
Sevilla, Spain
Sweden
Research Site
Göteborg, Sweden
Sponsors and Collaborators
Biogen Idec
Elan Pharmaceuticals
  More Information

No publications provided

Responsible Party: Biogen Idec, Medical Director, Biogen Idec, Inc
ClinicalTrials.gov Identifier: NCT01058005     History of Changes
Other Study ID Numbers: 101MS325
Study First Received: January 26, 2010
Last Updated: September 12, 2013
Health Authority: Sweden: Medicinal Products Agency
Spain: Spanish Medicines Agency
Italy: Ministry of Health
Czech Republic: State Institute for Drug Control
Poland: Ministry of Health
Hungary: National Institute of Pharmacy
Canada: Health Canada
Latvia: State Agency of Medicines
United States: Food and Drug Administration

Keywords provided by Biogen Idec:
MS

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Interferon beta 1a
Interferon-beta
Interferons
Copolymer 1
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic
Immunosuppressive Agents

ClinicalTrials.gov processed this record on August 01, 2014