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Sponsors and Collaborators: |
Mount Sinai School of Medicine National Institute of Neurological Disorders and Stroke (NINDS) |
Information provided by: | National Institute of Neurological Disorders and Stroke (NINDS) |
ClinicalTrials.gov Identifier: | NCT00211887 |
This is for a randomized clinical trial (RCT) to determine if the combined use of interferon beta-1a (IFN) and glatiramer acetate (GA) is a measurably better therapy than either agent used individually in patients with relapsing-remitting (RR) multiple sclerosis (MS).
Condition | Intervention | Phase |
Relapsing Remitting Multiple Sclerosis |
Drug: Interferon beta 1-a Drug: glatiramer acetate Other: placebo |
Phase III |
MedlinePlus related topics: | Multiple Sclerosis |
ChemIDplus related topics: | Interferon alfa-2b Interferons Interferon beta Interferon-beta Interferon beta 1a Copolymer 1 |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Factorial Assignment, Safety/Efficacy Study |
Official Title: | A Multi-Center, Double-Blind, Randomized Study Comparing the Combined Use of Interferon Beta-1a and Glatiramer Acetate to Either Agent Alone in Patients With Relapsing-Remitting Multiple Sclerosis (CombiRx) |
Estimated Enrollment: | 1000 |
Study Start Date: | January 2005 |
Estimated Study Completion Date: | July 2012 |
Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Active Comparator
Active Interferon B1a Weekly vs. Placebo Glatiramer Acetate
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Drug: Interferon beta 1-a
The single agent arm is divided into two groups, IFN and GA providing for 3 treatment arms: IFN IM and GA SC (50% of the patients), IFN IM and placebo SC (25% of the patients) and GA SC and placebo IM (25% of the patients).
Other: placebo
an inactive substance
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2: Active Comparator
Placebo Interferon B1a Weekly vs. Active Glatiramer Acetate
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Drug: glatiramer acetate
The single agent arm is divided into two groups, IFN and GA providing for 3 treatment arms: IFN IM and GA SC (50% of the patients), IFN IM and placebo SC (25% of the patients) and GA SC and placebo IM (25% of the patients).
Other: placebo
an inactive substance
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3: Active Comparator
Active Interferon B1a Weekly vs. Active Glatiramer Acetate
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Drug: Interferon beta 1-a
The single agent arm is divided into two groups, IFN and GA providing for 3 treatment arms: IFN IM and GA SC (50% of the patients), IFN IM and placebo SC (25% of the patients) and GA SC and placebo IM (25% of the patients).
Drug: glatiramer acetate
The single agent arm is divided into two groups, IFN and GA providing for 3 treatment arms: IFN IM and GA SC (50% of the patients), IFN IM and placebo SC (25% of the patients) and GA SC and placebo IM (25% of the patients).
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This is a multicenter, double blind, randomized trial examining combination therapy versus single agent therapy with three-year follow-up on the last patient randomized. All patients will remain on therapy until the last patient completes the study. All patients will then be transitioned, based on the findings, to open label of combination with continued follow-up or some recommendation about single agent therapy. While the study design benefits from having two arms of single agent therapy to examine the important question of whether there are differences between the single agents, the primary interest is in combination therapy. Therefore, a two-group combination versus single agent concept was used - splitting the population into single agent and combination therapy equally. The single agent arm is divided into two groups, IFN and GA providing for 3 treatment arms: IFN IM and GA SC (50% of the patients), IFN IM and placebo SC (25% of the patients) and GA SC and placebo IM (25% of the patients).
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Abnormal screening blood tests exceeding any of the limits defined below:
Contact: Michele Weber, MS | 866-848-3088 |
Show 71 Study Locations |
Mount Sinai School of Medicine |
National Institute of Neurological Disorders and Stroke (NINDS) |
Principal Investigator: | Fred Lublin, MD | Mount Sinai School of Medicine |
Responsible Party: | Mount Sinai School of Medicine ( Fred Lublin, MD, Principal Investigator, CombiRx Clinical Coordinating Center ) |
Study ID Numbers: | NS045719, 02-0526, CRC, U01 NS45719 |
First Received: | September 13, 2005 |
Last Updated: | September 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00211887 |
Health Authority: | United States: Food and Drug Administration |
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