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
Results First Received: July 23, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label
Condition: Relapsing Remitting Multiple Sclerosis
Interventions: Drug: BG00002 (natalizumab)
Drug: interferon beta-1a
Drug: glatiramer acetate

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Natalizumab 300 mg intravenous injection every 4 weeks
Interferon Beta-1a 44 mcg subcutaneous injection 3 times per week
Glatiramer Acetate 20 mg subcutaneous injection once daily

Participant Flow:   Overall Study
    Natalizumab     Interferon Beta-1a     Glatiramer Acetate  
STARTED     38     25     21  
Dosed With Study Treatment     36     22     17  
COMPLETED     0     0     1  
NOT COMPLETED     38     25     20  
Adverse Event                 0                 2                 1  
Physician Decision                 2                 2                 0  
Withdrawal by Subject                 4                 5                 11  
Withdrawn Due to Study Termination                 27                 13                 7  
Reason Missing                 5                 3                 1  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who received at least 1 dose of study medication.

Reporting Groups
  Description
Natalizumab 300 mg intravenous injection every 4 weeks
Interferon Beta-1a 44 mcg subcutaneous injection 3 times per week
Glatiramer Acetate 20 mg subcutaneous injection once daily
Total Total of all reporting groups

Baseline Measures
    Natalizumab     Interferon Beta-1a     Glatiramer Acetate     Total  
Number of Participants  
[units: participants]
  36     22     17     75  
Age  
[units: years]
Mean ± Standard Deviation
  35.8  ± 9.51     39.0  ± 10.0     37.6  ± 13.16     37.1  ± 10.52  
Gender  
[units: participants]
       
Female     30     16     13     59  
Male     6     6     4     16  



  Outcome Measures

1.  Primary:   Incidence of Treatment-emergent Serious Adverse Events (SAEs)   [ Time Frame: up to 108 Weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Biogen Idec Study Medical Director
Organization: Biogen Idec
e-mail: clinicaltrials@biogenidec.com


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