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Trial record 1 of 2 for:    combirx
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Combination Therapy in Patients With Relapsing-Remitting Multiple Sclerosis (MS)CombiRx

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Fred Lublin, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT00211887
First received: September 13, 2005
Last updated: March 6, 2014
Last verified: March 2014
Results First Received: June 25, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Factorial Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Relapsing Remitting Multiple Sclerosis
Interventions: Drug: Interferon beta 1-a
Drug: glatiramer acetate
Other: placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The trial enrolled participants from January 2005 through April 2009. The trial was conducted in 68 sites, both private practice and academic, in the USA and Canada.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
1129 participants assessed for eligibility. 121 excluded due to recent activity (16), <2 exacerbations (14), other medical exclusions (14), inconclusive for RRMS (12), abnormal lab value (10), cannot have Gd (5), EDSS>5.5 (2), and other reason (46).

Reporting Groups
  Description
IFN + GA Interferon beta-1a 30µg intramuscularly weekly and glatiramer acetate (GA) 20mg daily
Interferon Beta 1a Interferon beta-1a 30µg intramuscularly weekly
Glatiramer Acetate glatiramer acetate 20mg daily

Participant Flow:   Overall Study
    IFN + GA     Interferon Beta 1a     Glatiramer Acetate  
STARTED     499     250     259  
COMPLETED     397     194     223  
NOT COMPLETED     102     56     36  
Adverse Event                 8                 4                 6  
Death                 1                 1                 1  
Lost to Follow-up                 28                 13                 9  
Non-medical reason                 31                 14                 8  
Other medical reason                 15                 11                 7  
Side effects                 19                 13                 5  



  Baseline Characteristics
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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.
No text entered.

Reporting Groups
  Description
IFN + GA Interferon beta-1a intramuscularly weekly and glatiramer acetate daily
IFB-1a Interferon beta-1a
Glatiramer glatiramer acetate
Total Total of all reporting groups

Baseline Measures
    IFN + GA     IFB-1a     Glatiramer     Total  
Number of Participants  
[units: participants]
  499     250     259     1008  
Age  
[units: years]
Mean ± Standard Deviation
  37.1  ± 9.4     37.6  ± 10.2     39.0  ± 9.5     37.7  ± 9.7  
Gender  
[units: participants]
       
Female     372     173     185     730  
Male     127     77     74     278  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   ARR - PDEs   [ Time Frame: Baseline to Month 36 ]

2.  Secondary:   Confirmed Progression on the Expanded Disability Status Scale   [ Time Frame: Baseline to Month 36 ]

3.  Secondary:   Change in the Multiple Sclerosis Functional Composite   [ Time Frame: Baseline to month 36 ]

4.  Secondary:   Change in MRI Composite Score   [ Time Frame: Baseline to month 36 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
absence of a comparative randomized placebo only group


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Fred D. Lublin
Organization: Icahn School of Medicine at Mount Sinai
phone: 212-241-6854
e-mail: fred.lublin@mssm.edu


Publications of Results:
Publications automatically indexed to this study:

Responsible Party: Fred Lublin, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT00211887     History of Changes
Other Study ID Numbers: GCO 02-0526, 02-0526, CRC, U01NS045719
Study First Received: September 13, 2005
Results First Received: June 25, 2013
Last Updated: March 6, 2014
Health Authority: United States: Food and Drug Administration