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| Sponsor: | Mount Sinai School of Medicine |
|---|---|
| Collaborator: |
National Institute of Neurological Disorders and Stroke (NINDS) |
| Information provided by: | Mount Sinai School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00211887 |
Purpose
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 |
| 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) |
| Enrollment: | 1008 |
| 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
|
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
|
|
2: Active Comparator
Placebo Interferon B1a Weekly vs. Active Glatiramer Acetate
|
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
|
|
3: Active Comparator
Active Interferon B1a Weekly vs. Active Glatiramer Acetate
|
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).
|
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).
Eligibility| 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:
Contacts and Locations
Show 71 Study Locations| Principal Investigator: | Fred Lublin, MD | Mount Sinai School of Medicine |
More Information
| 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 |
| Study First Received: | September 13, 2005 |
| Last Updated: | May 8, 2009 |
| ClinicalTrials.gov Identifier: | NCT00211887 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Multiple Sclerosis Clinical trial treatment trial autoimmune disease |
Relapsing Remitting MS Treatment interferon beta-1a glatiramer acetate |
|
Anti-Infective Agents Interferon Type I, Recombinant Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Multiple Sclerosis, Relapsing-Remitting Pathologic Processes Multiple Sclerosis Therapeutic Uses Interferon beta 1a Growth Inhibitors Angiogenesis Modulating Agents Autoimmune Diseases of the Nervous System Autoimmune Diseases |
Immune System Diseases Demyelinating Diseases Growth Substances Interferons Nervous System Diseases Adjuvants, Immunologic Interferon-beta Sclerosis Immunosuppressive Agents Antiviral Agents Angiogenesis Inhibitors Pharmacologic Actions Copolymer 1 Demyelinating Autoimmune Diseases, CNS |