Trial record 2 of 275 for:
biogen | biogen
Open-Label Safety Extension Study of Avonex
This study has been completed.
Sponsor:
Biogen Idec
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT00915460
First received: June 5, 2009
Last updated: NA
Last verified: June 2009
History: No changes posted
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Sclerosis |
Drug: Interferon beta-1a (Avonex) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label |
| Official Title: | 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 |
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:
Primary Outcome 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. [ Time Frame: The study duration is 7 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- 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. [ Time Frame: The study duration is 7 months ] [ Designated as safety issue: No ]
| Enrollment: | 408 |
| Study Start Date: | September 1999 |
| Study Completion Date: | July 2003 |
| Primary Completion Date: | June 2003 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Patients previously enrolled in BIogen Idec study C95-812.
|
Drug: Interferon beta-1a (Avonex)
dosage and frequency as per Biogen Idec protocol
Other Name: Avonex
|
|
Experimental: 2
Patients previously enrolled in Biogen Idec study C96-823.
|
Drug: Interferon beta-1a (Avonex)
dosage and frequency as per Biogen Idec protocol
Other Name: Avonex
|
|
Experimental: 3
Patients previously enrolled in Biogen Idec study C97-830.
|
Drug: Interferon beta-1a (Avonex)
dosage and frequency as per Biogen Idec protocol
Other Name: Avonex
|
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Biogen Idec MD, Biogen Idec |
| ClinicalTrials.gov Identifier: | NCT00915460 History of Changes |
| Other Study ID Numbers: | C-98-838 |
| Study First Received: | June 5, 2009 |
| Last Updated: | June 5, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Biogen Idec:
|
Multiple Sclerosis Avonex Interferon beta-1a patients at high risk to develop multiple sclerosis |
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 22, 2013