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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00599274




Registration number
NCT00599274
Ethics application status
Date submitted
11/01/2008
Date registered
23/01/2008
Date last updated
27/01/2010

Titles & IDs
Public title
Study to Determine if Avonex and Rebif Work Comparably Well in Subjects With Relapsing Multiple Sclerosis
Scientific 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)
Secondary ID [1] 0 0
C-862
Universal Trial Number (UTN)
Trial acronym
PROOF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Drugs - Interferon beta-1a
Treatment: Drugs - Interferon beta-1a

A - This group was treated with Avonex once a week

B - This group was treated with Rebif three times a week


Treatment: Drugs: Interferon beta-1a
injection once a week

Treatment: Drugs: Interferon beta-1a
injection three times a week
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2002
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2003
Sample size
Target
Accrual to date
Final
136
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Coordinating Research Site - Woodville
Recruitment postcode(s) [1] 0 0
- Woodville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Louisiana
Country [3] 0 0
United States of America
State/province [3] 0 0
Massachusetts
Country [4] 0 0
United States of America
State/province [4] 0 0
North Carolina
Country [5] 0 0
United States of America
State/province [5] 0 0
Ohio
Country [6] 0 0
United States of America
State/province [6] 0 0
Washington
Country [7] 0 0
United States of America
State/province [7] 0 0
Wisconsin
Country [8] 0 0
Austria
State/province [8] 0 0
Linz
Country [9] 0 0
Canada
State/province [9] 0 0
Nova Scotia

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Biogen
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00599274
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Biogen-Idec Investigator
Address 0 0
Biogen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00599274