Study Stopped
Due to significantly slower than expected enrollment, the Sponsor decided to terminate the study.
Study Evaluating Rebif, Copaxone, and Tysabri for Active Multiple Sclerosis
SURPASS
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
1 other identifier
interventional
84
13 countries
42
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Mar 2010
42 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 26, 2010
CompletedFirst Posted
Study publicly available on registry
January 28, 2010
CompletedStudy Start
First participant enrolled
March 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedResults Posted
Study results publicly available
August 13, 2014
CompletedSeptember 3, 2014
August 1, 2014
2.1 years
January 26, 2010
July 23, 2014
August 18, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of Treatment-emergent Serious Adverse Events (SAEs)
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.
up to 108 Weeks
Study Arms (3)
Natalizumab
EXPERIMENTALInterferon Beta-1a
ACTIVE COMPARATORGlatiramer Acetate
ACTIVE COMPARATORInterventions
300 mg intravenous injection every 4 weeks
44 mcg subcutaneous injection 3 times per week
20 mg subcutaneous injection once daily
Eligibility Criteria
You may qualify if:
- Have a diagnosis of relapsing remitting multiple sclerosis (MS) as defined by the revised McDonald Committee criteria (Polman 2005).
- 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
- Be naïve to natalizumab.
- Have a documented Expanded Disability Status Scale (EDSS) score between 0.0 and 5.5, inclusive.
You may not qualify if:
- 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.
- Have known intolerance, contraindication to, or history of non-compliance with, the use of glatiramer acetate or interferon beta-1a.
- 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.
- 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.
- 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.
- 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.
- 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).
- Known history of human immunodeficiency virus (HIV).
- 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 \[HBcAb\]).
- History of transplantation or any anti-rejection therapy.
- History of progressive multifocal leukoencephalopathy (PML).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biogenlead
- Elan Pharmaceuticalscollaborator
Study Sites (42)
Research Site
Cullman, Alabama, United States
Research Site
Phoenix, Arizona, United States
Research Site
Fort Collins, Colorado, United States
Research Site
Maitland, Florida, United States
Research Site
St. Petersburg, Florida, United States
Research Site
Tampa, Florida, United States
Research Site
Atlanta, Georgia, United States
Research Site
Lexington, Kentucky, United States
Research Site
New Orleans, Louisiana, United States
Research Site
Detroit, Michigan, United States
Research Site
Patchogue, New York, United States
Research Site
Charlotte, North Carolina, United States
Research Site
Akron, Ohio, United States
Research Site
Franklin, Tennessee, United States
Research Site
Knoxville, Tennessee, United States
Research Site
Round Rock, Texas, United States
Research Site
Norfolk, Virginia, United States
Research Site
Kirkland, Washington, United States
Research Site
Morgantown, West Virginia, United States
Research Site
Fitzroy, Victoria, Australia
Research Site
Gatineau, Quebec, Canada
Research Site
Pardubice, Czechia
Research Site
Tampere, Finland
Research Site
Strasbourg, Bas-Rhin, France
Research Site
Esztergom, Komárom-Esztergom, Hungary
Research Site
Budapest, Hungary
Research Site
Nyíregyháza, Hungary
Research Site
Catania, Catania, Italy
Research Site
Napoli, Italy
Research Site
Rome, Italy
Research Site
Riga, Latvia
Research Site
Bialystok, Podlaskie Voivodeship, Poland
Research Site
Gdansk, Pomeranian Voivodeship, Poland
Research Site
Lódz, Łódź Voivodeship, Poland
Research Site
Ljubljana, Slovenia
Research Site
Barcelona, Barcelona, Spain
Research Site
Alicante, Spain
Research Site
Girona, Spain
Research Site
Madrid, Spain
Research Site
Santa Cruz de Tenerife, Spain
Research Site
Seville, Spain
Research Site
Mölndal, Sweden
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Due to early termination of the study and the small size of the study population, there was insufficient power for efficacy and safety analyses. Only serious adverse events were to be captured and reported under the protocol.
Results Point of Contact
- Title
- Biogen Idec Study Medical Director
- Organization
- Biogen Idec
Study Officials
- STUDY DIRECTOR
Medical Director
Biogen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 26, 2010
First Posted
January 28, 2010
Study Start
March 1, 2010
Primary Completion
April 1, 2012
Study Completion
April 1, 2012
Last Updated
September 3, 2014
Results First Posted
August 13, 2014
Record last verified: 2014-08