Study to Determine if Avonex and Rebif Work Comparably Well in Subjects With Relapsing Multiple Sclerosis (PROOF)
This study has been completed.
Sponsor:
Biogen Idec
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT00599274
First received: January 11, 2008
Last updated: January 26, 2010
Last verified: January 2010
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Purpose
The purpose of this study is to find out if weekly Avonex works as well as three times a week Rebif in subjects with relapsing multiple sclerosis.
| Condition | Intervention |
|---|---|
|
Multiple Sclerosis |
Drug: Interferon beta-1a |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only |
| Official Title: | A Multicenter, Prospective and Retrospective, Long-Term Observational Study of AVONEX® and Rebif® to Determine the Efficacy, Tolerability, and Safety in Subjects With Relapsing Multiple Sclerosis (MS) |
Resource links provided by NLM:
Genetics Home Reference related topics:
multiple sclerosis
MedlinePlus related topics:
Multiple Sclerosis
U.S. FDA Resources
Further study details as provided by Biogen Idec:
| Enrollment: | 136 |
| Study Start Date: | August 2002 |
| Study Completion Date: | May 2003 |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
A
This group was treated with Avonex once a week
|
Drug: Interferon beta-1a
injection once a week
Other Name: Avonex
|
|
B
This group was treated with Rebif three times a week
|
Drug: Interferon beta-1a
injection three times a week
Other Name: Rebif
|
Detailed Description:
This is a Phase 4, multicenter, prospective and retrospective, long-term observational study of Avonex® and Rebif® to determine the efficacy, tolerability, and safety in subjects with relapsing MS.
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
subjects with relapsing remitting Multiple Sclerosis taking AVONEX® or Rebif®.
Criteria
Inclusion Criteria:
- Must have been receiving AVONEX® or Rebif®.
- Must have a confirmed diagnosis of relapsing-remitting MS using the Poser criteria.
- Must have experienced at least 2 relapses within the 3 year period prior to the initiation of treatment.
- Must have an EDSS score of 0.0 to 5.5, inclusive.
Exclusion Criteria:
- History of severe allergic or anaphylactic reaction or hypersensitivity to human albumin, to any interferon, or to other components of the drug formulation.
- History of poorly controlled hypertension and/or other clinically significant major disease.
- History of uncontrolled seizures within the 3 months prior to enrollment.
- History of suicidal ideation or an episode of severe depression within the 3 months prior to enrollment.
- Serious local infection or systemic infection within 8 weeks prior to enrollment.
- Treatment with certain other agents to treat MS symptoms or underlying disease.
- Treatment with any investigational product
- Previous participation in this study.
- Other Protocol-defined inclusion/exclusion criteria may apply.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00599274
Locations
| United States, California | |
| Research Site | |
| Los Angeles, California, United States | |
| Research Site | |
| Walnut Creek, California, United States | |
| United States, Louisiana | |
| Research Site | |
| Shreveport, Louisiana, United States | |
| United States, Massachusetts | |
| Research Site | |
| Worcester, Massachusetts, United States | |
| United States, North Carolina | |
| Research Site | |
| Charlotte, North Carolina, United States | |
| United States, Ohio | |
| Research Site | |
| Columbus, Ohio, United States | |
| United States, Washington | |
| Research Site | |
| Edmonds, Washington, United States | |
| United States, Wisconsin | |
| Research Site | |
| Milwaukee, Wisconsin, United States | |
| Australia | |
| Coordinating Research Site | |
| Woodville, Australia | |
| Austria | |
| Coordinating Research Site | |
| Linz, Austria | |
| Canada, Nova Scotia | |
| Coordinating Research Site | |
| Halifax, Nova Scotia, Canada | |
Sponsors and Collaborators
Biogen Idec
Investigators
| Principal Investigator: | Biogen-Idec Investigator | Biogen Idec |
More Information
No publications provided
| Responsible Party: | Biogen Idec MD, Biogen Idec |
| ClinicalTrials.gov Identifier: | NCT00599274 History of Changes |
| Other Study ID Numbers: | C-862 |
| Study First Received: | January 11, 2008 |
| Last Updated: | January 26, 2010 |
| Health Authority: | United States: Food and Drug Administration Austria: Ethikkommission Australia: Department of Health and Ageing Therapeutic Goods Administration Canada: Health Canada |
Keywords provided by Biogen Idec:
|
Multiple Sclerosis Interferon beta 1a Avonex |
Additional relevant MeSH terms:
|
Multiple Sclerosis Sclerosis 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 Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Immunologic Factors Physiological Effects of Drugs Antineoplastic Agents Adjuvants, Immunologic |
ClinicalTrials.gov processed this record on May 16, 2013