Safety of Avonex Treatment in Multiple Sclerosis Patients With Neutralizing Antibodies to Interferon Beta Therapy (SAFE)
This study has been completed.
Sponsor:
Biogen Idec
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT00493077
First received: June 25, 2007
Last updated: January 28, 2008
Last verified: January 2008
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Purpose
This study is to find out the safety and effectiveness of Avonex (interferon-beta-1a) Therapy in patients who have developed neutralizing antibodies during previous interferon-beta treatment
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Sclerosis |
Drug: low immunogenic interferon-beta-1a |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Swedish Multi-Centre, Prospective, Open Label Study: Safety of Avonex Treatment in Multiple Sclerosis Patients Who Are NAB Positive on Previous s.c Interferon Beta Therapy |
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:
- neutralizing antibody levels will be followed [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Proportion of patients with NAb positive titre > 20. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
- Relative change from baseline (screening) of NAb titre [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
- Change in the annualised relapse rate and number of relapse-free (total and documented relapses) patients [ Time Frame: 12 months and as needed for relapses ] [ Designated as safety issue: No ]
- The percentage of patients with a loss of disability of 1.0 (or more) score on the EDSS. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
| Enrollment: | 3 |
| Study Start Date: | May 2004 |
| Study Completion Date: | May 2006 |
| Primary Completion Date: | May 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: low immunogenic interferon-beta-1a
dosage and frequency as per Biogen Idec protocol
Other Name: Avonex
|
Detailed Description:
This is a multi-centre, prospective, open label, non-comparative phase IV trial. Eligible patients will receive treatment with IFN-beta-1a AVONEX® 30 mcg i.m. once weekly for 12 months.The patients will be examined clinically and NAb titres will be performed at screening and after 12 months. Adverse event source verification will be performed during the documentation period.
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Relapsing-remitting MS according to Poser criteria(CDMS or LSDMS)30 or MS according to McDonald criteria
- Disability equivalent to an EDSS of 6.0 or less at screening
- Neutralizing antibody titre > 20 and <500 in two consecutive NAb tests. One must be from before screening
- previous treatment with either subcutaneous administered interferon-b-1b (Betaferon®) or interferon-b-1a (Rebif TM) prior to enrolment
- A priori has been decided to be treated with AVONEX
Exclusion Criteria:
- Is NAb positive on AVONEX
- History of major depression
- Cardiac insufficiency, cardiomyopathy, significant cardiac dysrhythmia, unstable or advanced ischemic heart disease (NYHA III or IV), or significant hypertension (BP > 180/110 mmHg)
- Renal insufficiency defined as serum creatinine > 1.5 times the upper normal reference limit
- Any systemic disease that can influence the patient's safety and compliance, or the evaluation of the disability
- Women who are pregnant, breast-feeding or have the possibility for pregnancy during the trial. To avoid pregnancy, women have to be postmenopausal, surgical sterile, sexually inactive or practice reliable contraceptives
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00493077
Locations
| Sweden | |
| Research Site | |
| Goteborg, Sweden, 416 85 | |
| Coordinating Research Site | |
| Huddinge, Sweden | |
| Research Site | |
| Joenkoeping, Sweden, 551 85 | |
| Research Site | |
| Karlstad, Sweden, 651 85 | |
| Research Site | |
| Stockholm, Sweden, 141 86 | |
Sponsors and Collaborators
Biogen Idec
Investigators
| Principal Investigator: | Biogen-Idec Investigator | neurologyclinicaltrials@biogenidec.com |
More Information
No publications provided
| Responsible Party: | biogen Idec MD, Biogen Idec |
| ClinicalTrials.gov Identifier: | NCT00493077 History of Changes |
| Other Study ID Numbers: | SAFE |
| Study First Received: | June 25, 2007 |
| Last Updated: | January 28, 2008 |
| Health Authority: | Sweden: Medical Products Agency |
Keywords provided by Biogen Idec:
|
Multiple Sclerosis Neutralizing antibodies Safety |
Low immunogenicity interferon interferon-beta-1a |
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 June 18, 2013