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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01058005
Recruitment Status : Terminated (Due to significantly slower than expected enrollment, the Sponsor decided to terminate the study.)
First Posted : January 28, 2010
Results First Posted : August 13, 2014
Last Update Posted : September 3, 2014
Elan Pharmaceuticals
Information provided by (Responsible Party):

Brief Summary:
This was a multicenter, randomized, open-label, parallel-group, active-controlled study. Prior to randomization, participants were to have been treated with glatiramer acetate or interferon β-1a (44 μg). Participants were to be randomized to receive natalizumab, interferon β-1a 44 μg, or glatiramer acetate.

Condition or disease Intervention/treatment Phase
Relapsing Remitting Multiple Sclerosis Drug: BG00002 (natalizumab) Drug: interferon beta-1a Drug: glatiramer acetate Phase 3

Detailed Description:
The protocol was amended in 15 March 2011 to discontinue participants' enrollment and efficacy assessments, and to offer the opportunity for participants already enrolled to continue receiving study treatment for their planned participation in the study. The study had been active in several countries for approximately 1 year, and enrollment had been significantly slower than expected. Thus, the decision was made by the Sponsor to terminate the study since current and projected future enrollment rates would not have provided valuable information in a reasonable timeframe. All clinical efficacy and magnetic resonance imaging (MRI) procedures were removed from the protocol, and safety assessments were to be managed through standard of care activities.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : March 2010
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

Arm Intervention/treatment
Experimental: Natalizumab Drug: BG00002 (natalizumab)
300 mg intravenous injection every 4 weeks
Other Name: Tysabri

Active Comparator: Interferon Beta-1a Drug: interferon beta-1a
44 mcg subcutaneous injection 3 times per week
Other Name: Rebif

Active Comparator: Glatiramer Acetate Drug: glatiramer acetate
20 mg subcutaneous injection once daily
Other Name: Copaxone

Primary Outcome Measures :
  1. Incidence of Treatment-emergent Serious Adverse Events (SAEs) [ Time Frame: up to 108 Weeks ]
    An SAE was defined as any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the subject at immediate risk of death (a life-threatening event; however, this does not include an event that, had it occurred in a more severe form, might have caused death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or results in a congenital anomaly/birth defect. An SAE may also have been any other medically important event that, in the opinion of the Investigator, may jeopardize the subject or may require intervention to prevent one of the other outcomes listed in the definition above. See Adverse Events section below for further details.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Key Inclusion Criteria:

  1. Have a diagnosis of relapsing remitting multiple sclerosis (MS) 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 subcutaneous) or interferon beta-1a (44 mcg 3 times per week subcutaneous) 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 (gadolinium [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. Have a documented Expanded Disability Status Scale (EDSS) score between 0.0 and 5.5, inclusive.

Key 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 [HCVAb]) 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 progressive multifocal leukoencephalopathy (PML).

NOTE: Other protocol-defined inclusion/exclusion criteria may apply.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01058005

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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
Maitland, Florida, United States
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, Louisiana
Research Site
New Orleans, Louisiana, United States
United States, Michigan
Research Site
Detroit, Michigan, United States
United States, New York
Research Site
Patchogue, New York, 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, Virginia
Research Site
Norfolk, Virginia, 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
Research Site
Tampere, Finland
Research Site
Strasbourg, Bas-Rhin, France
Research Site
Esztergom, Komárom-Esztergom, Hungary
Research Site
Budapest, Hungary
Research Site
Nyiregyhaza, Hungary
Research Site
Catania, Italy
Research Site
Napoli, Italy
Research Site
Rome, Italy
Research Site
Riga, Latvia
Research Site
Lódz, Lodzkie, Poland
Research Site
Bialystok, Podlaskie, Poland
Research Site
Gdansk, Pomorskie, Poland
Research Site
Ljubljana, Slovenia
Research Site
Alicante, Spain
Research Site
Barcelona, Spain
Research Site
Girona, Spain
Research Site
Madrid, Spain
Research Site
Santa Cruz de Tenerife, Spain
Research Site
Sevilla, Spain
Research Site
Molndal, Sweden
Sponsors and Collaborators
Elan Pharmaceuticals
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Study Director: Medical Director Biogen
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Responsible Party: Biogen Identifier: NCT01058005    
Other Study ID Numbers: 101MS325
First Posted: January 28, 2010    Key Record Dates
Results First Posted: August 13, 2014
Last Update Posted: September 3, 2014
Last Verified: August 2014
Keywords provided by Biogen:
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Interferon beta-1a
Glatiramer Acetate
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic
Immunosuppressive Agents
Antirheumatic Agents