How Side Effects of Avonex Are Affected by Gradually Increasing to Full Dose vs Starting at Full Dose (TODAY)
This study has been terminated.
(Terminated due to poor recruitment)
Sponsor:
Biogen Idec
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT00574041
First received: December 12, 2007
Last updated: September 2, 2008
Last verified: September 2008
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Purpose
This study is to find out if starting at low dose Avonex and slowly increasing to full dose will improve flu like symptoms as a side effect of Avonex treatment.
| Condition | Intervention | Phase |
|---|---|---|
|
Relapsing Remitting Multiple Sclerosis |
Drug: Interferon beta-1a |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | An Open-Label Study to Examine the Difference in Tolerability Associated With Titration Of Dose on Initiation of Avonex therapY (TODAY) |
Resource links provided by NLM:
Further study details as provided by Biogen Idec:
Primary Outcome Measures:
- To assess the mean severity of episodes of FLS during the 4 week titration phase [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- To assess the mean severity and duration of FLS episodes in post-titration phase [ Time Frame: throughout study ] [ Designated as safety issue: Yes ]
| Enrollment: | 19 |
| Study Start Date: | June 2007 |
| Study Completion Date: | February 2008 |
| Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
titrated dose of Avonex
|
Drug: Interferon beta-1a
injected, once a week
Other Name: Avonex
|
|
Active Comparator: 2
full dose Avonex
|
Drug: Interferon beta-1a
injected, once a week
Other Name: Avonex
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Diagnosis of clinically-definite relapsing-remitting multiple sclerosis
Exclusion Criteria:
- Any Product Information-specified contraindications to interferon-beta therapy, or other medical factors which, in the opinion of the investigator, make the subject unsuitable for interferon-beta therapy
- Use of AVONEX, but not other interferon therapies, in the 3 months prior to randomisation into the study
- A clinically significant infectious illness (e.g., cellulitis, abscess, pneumonia, septicemia) within 30 days prior to randomisation.
- History of seizure in the 3 months prior to randomisation
- History of suicidal ideation or severe depression within the 3 months prior to randomisation.
- Other inclusion and exclusion criteria may apply per study protocol
Contacts and Locations More Information
No publications provided
| Responsible Party: | Biogen Idec MD, Biogen Idec |
| ClinicalTrials.gov Identifier: | NCT00574041 History of Changes |
| Other Study ID Numbers: | AUS-8002 |
| Study First Received: | December 12, 2007 |
| Last Updated: | September 2, 2008 |
| Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration |
Keywords provided by Biogen Idec:
|
Multiple Sclerosis Avonex side effects flu like symptoms |
Additional relevant MeSH terms:
|
Multiple Sclerosis Sclerosis Multiple Sclerosis, Relapsing-Remitting 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 19, 2013