Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been terminated.
(Due to significantly slower than expected enrollment, the Sponsor decided to terminate the study.)
Sponsor:
Collaborator:
Elan Pharmaceuticals
Information provided by (Responsible Party):
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01058005
First received: January 26, 2010
Last updated: August 18, 2014
Last verified: August 2014
  Purpose

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 Intervention Phase
Relapsing Remitting Multiple Sclerosis
Drug: BG00002 (natalizumab)
Drug: interferon beta-1a
Drug: 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 Serious Adverse Events (SAEs) [ Time Frame: up to 108 Weeks ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 84
Study Start Date: March 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: 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

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.

  Eligibility

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

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.

  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
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
Finland
Research Site
Tampere, Finland
France
Research Site
Strasbourg, Bas-Rhin, France
Hungary
Research Site
Esztergom, Komárom-Esztergom, Hungary
Research Site
Budapest, Hungary
Research Site
Nyiregyhaza, Hungary
Italy
Research Site
Catania, Italy
Research Site
Napoli, Italy
Research Site
Rome, 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
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
Sweden
Research Site
Molndal, Sweden
Sponsors and Collaborators
Biogen Idec
Elan Pharmaceuticals
Investigators
Study Director: Medical Director Biogen Idec
  More Information

No publications provided

Responsible Party: Biogen Idec
ClinicalTrials.gov Identifier: NCT01058005     History of Changes
Other Study ID Numbers: 101MS325
Study First Received: January 26, 2010
Results First Received: July 23, 2014
Last Updated: August 18, 2014
Health Authority: Sweden: Medical Products Agency
Spain: Spanish Agency of Medicines
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
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes
Copolymer 1
Interferon beta 1a
Interferon-beta
Interferons
Adjuvants, Immunologic
Anti-Infective Agents
Antineoplastic Agents
Antiviral Agents
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014