|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Lublin, Fred D., M.D. |
|---|---|
| Collaborator: |
National Institute of Neurological Disorders and Stroke (NINDS) |
| Information provided by: | Lublin, Fred D., M.D. |
| 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: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
|---|---|
|
Active Comparator: 1
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
|
|
Active Comparator: 2
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
|
|
Active Comparator: 3
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: | Fred Lublin, MD, Principal Investigator, CombiRx Clinical Coordinating Center, Mount Sinai School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00211887 History of Changes |
| Other Study ID Numbers: | NS045719, 02-0526, CRC, U01 NS45719 |
| Study First Received: | September 13, 2005 |
| Last Updated: | June 14, 2011 |
| 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 |
|
Multiple Sclerosis Sclerosis Multiple Sclerosis, Relapsing-Remitting Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases Pathologic Processes Interferon-beta Interferons |
Interferon beta 1a Copolymer 1 Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Immunologic Factors Physiological Effects of Drugs Antineoplastic Agents Adjuvants, Immunologic Immunosuppressive Agents |