Open-Label Safety Extension Study of Avonex
An Open-Label Safety Extension Study of AVONEX® (Interferon Beta-1a) Treatment in Subjects Who Completed Biogen Studies C95-812, C96-823, or C97-830
What it found
We found no results in the registry or in papers.
This trial finished 23 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Interferon beta-1a
Interferon alpha/beta receptor agonist
What it measured
Main measures
The primary objective of this study is to collect data on serious adverse events which occur during extended treatment with AVONEX in subjects at high risk for developing MS and in subjects with secondary progressive MS.
The study duration is 7 months
Safety
Other measures (1)
To monitor the occurrence of diagnosed clinically definite multiple sclerosis (CDMS) in subjects who enter this study at high risk for developing MS following an initial demyelinating event.
The study duration is 7 months
Who could take part
MS (type not specified)
Show the full criteria
Inclusion criteria
* Must have completed (as defined below) one of the following Biogen AVONEX® clinical studies and meet the other criteria indicated. * Subjects enrolled from studies C95-812 and C97-830 must have completed their respective study within 12 months prior to enrollment in C98-838. Subjects enrolled from study C96-823 must have completed the study within 24 months prior to enrollment in C98-838. * have not been diagnosed with any other disease that accounts for their neurologic symptoms.
Exclusion criteria
* History of any significant cardiac, hepatic, pulmonary, or renal disease; immune deficiency; or other medical conditions that would preclude therapy with interferon beta. * History of severe allergic or anaphylactic reactions or history of hypersensitivity to human albumin. * History of seizure within the 3 months prior to enrollment. * Abnormal laboratory results at the screening visit: * History of suicidal ideation or an episode of severe depression within the 3 months prior to enrollment into this study. Other inclusion and exclusion criteria apply as per Biogen Idec Protocol
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
To collect data on serious adverse events which occur during extended treatment with Avonex in subjects at high risk for developing multiple sclerosis (MS) and in subjects with secondary progressive MS.
Loading reviews and guidelines…
Related trials
- An Observational Study to Learn About the Interferon-beta Exposure of
Running, not recruiting
Still running
- US PROmyBETAapp2.0: A Study to Learn More About the Medication Usage a
Completed
No results found
- PROmyBETAappGame: a Study to Learn More About the Medication Usage & P
Completed
No results found
- EPID Multiple Sclerosis Pregnancy Study
Completed
No results found
- Comparison Study of PF530 and Betaferon in Healthy Subjects
Phase 1 · Completed
No results found
- Study to Evaluate the Pharmacokinetic Profiles of BIIB017 (Peginterfer
Phase 1 · Completed
Paper found, not read
History
Started
Sept 1999
Main results due
Jun 2003
Finished
Jul 2003