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

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: NCT00211887
Recruitment Status : Completed
First Posted : September 21, 2005
Results First Posted : April 3, 2014
Last Update Posted : April 3, 2014
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Fred Lublin, Mount Sinai School of Medicine

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Relapsing Remitting Multiple Sclerosis
Interventions: Drug: Interferon beta 1-a
Drug: glatiramer acetate
Other: placebo

  Participant Flow

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
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

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
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 
Overall Participants Analyzed 
[Units: Participants]
 499   250   259   1008 
[Units: Years]
Mean (Standard Deviation)
 37.1  (9.4)   37.6  (10.2)   39.0  (9.5)   37.7  (9.7) 
[Units: Participants]
Female   372   173   185   730 
Male   127   77   74   278 

  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

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

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

Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: Fred Lublin, Mount Sinai School of Medicine Identifier: NCT00211887     History of Changes
Other Study ID Numbers: GCO 02-0526
U01NS045719 ( U.S. NIH Grant/Contract )
First Submitted: September 13, 2005
First Posted: September 21, 2005
Results First Submitted: June 25, 2013
Results First Posted: April 3, 2014
Last Update Posted: April 3, 2014