Clinical trial NCT00206635: Betaseron 16-Year Long-Term Follow-Up (LTF) in Patients With Relapsing-Remitting Multiple Sclerosis
Official title: A Long-term Follow up of Patients Enrolled in the Pivotal Study of Betaseron® (Interferon Beta 1b) in Relapsing-remitting Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2005-09-21
Enrollment: 432
Sex: ALL
Minimum age (years): 33
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Original pivotal trial population of Betaseron pivotal study (1989-1993)

Brief summary: The purpose of this follow-up study is to look carefully at the long-term course of multiple sclerosis (MS) and possibly the long-term effects of Betaseron in the patients who were previously enrolled in the original North American study that led to the marketing approval of Betaseron.

Detailed description: This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.Bayer HealthCare Pharmaceuticals, Inc. is the sponsor of the trial.

Eligibility criteria: Inclusion Criteria:

* Patients in North America have to have been previously enrolled in the original Betaseron trial from 1988-1993
* Be able to understand the consent form (or have a guardian who can)

Exclusion Criteria:

* North American patients cannot be included if they have not participated in the original Betaseron trial from 1988-1993

Primary outcomes:
measure: Description of long term course of disease
timeFrame: 16 years
Secondary outcomes:
measure: Comparison to natural history cohort
timeFrame: 16 years
Other outcomes:
Locations:
city: Many Locations
country: United States
state: Alabama
city: Many Locations
country: United States
state: Arizona
city: Many Locations
country: United States
state: California
city: Many Locations
country: United States
state: Illinois
city: Many Locations
country: United States
state: Maryland
city: Many Locations
country: United States
state: Pennsylvania
city: Many Locations
country: Canada
state: British Columbia
city: Many Locations
country: Canada
state: Ontario
city: Many Locations
country: Canada
state: Quebec
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Ebers GC, Traboulsee A, Li D, Langdon D, Reder AT, Goodin DS, Bogumil T, Beckmann K, Wolf C, Konieczny A; Investigators of the 16-year Long-Term Follow-Up Study. Analysis of clinical outcomes according to original treatment groups 16 years after the pivotal IFNB-1b trial. J Neurol Neurosurg Psychiatry. 2010 Aug;81(8):907-12. doi: 10.1136/jnnp.2009.204123. Epub 2010 Jun 19.
citation: Reder AT, Ebers GC, Traboulsee A, Li D, Langdon D, Goodin DS, Bogumil T, Beckmann K, Konieczny A; Investigators of the 16-Year Long-Term Follow-Up Study. Cross-sectional study assessing long-term safety of interferon-beta-1b for relapsing-remitting MS. Neurology. 2010 Jun 8;74(23):1877-85. doi: 10.1212/WNL.0b013e3181e240d0.
citation: Goodin DS, Traboulsee A, Knappertz V, Reder AT, Li D, Langdon D, Wolf C, Beckmann K, Konieczny A, Ebers GC; 16-Year Long Term Follow-up Study Investigators. Relationship between early clinical characteristics and long term disability outcomes: 16 year cohort study (follow-up) of the pivotal interferon beta-1b trial in multiple sclerosis. J Neurol Neurosurg Psychiatry. 2012 Mar;83(3):282-7. doi: 10.1136/jnnp-2011-301178. Epub 2011 Dec 21.
citation: Goodin DS, Jones J, Li D, Traboulsee A, Reder AT, Beckmann K, Konieczny A, Knappertz V; 16-Year Long-Term Follow-up Study Investigators. Establishing long-term efficacy in chronic disease: use of recursive partitioning and propensity score adjustment to estimate outcome in MS. PLoS One. 2011;6(11):e22444. doi: 10.1371/journal.pone.0022444. Epub 2011 Nov 30.