Is IFN-beta Treatment in MS Useful After a Washout Period in Patients With Neutralizing Antibodies to Interferon Beta (RENeu)
This study has been completed.
Sponsor:
Biogen Idec
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT00493116
First received: June 25, 2007
Last updated: June 7, 2012
Last verified: July 2011
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Purpose
This study is to find out if Interferon-beta (IFN-beta) can recover its effectiveness after a washout period in patients with Multiple Sclerosis who have previously developed neutralizing antibodies to Interferon-Beta
| Condition | Intervention | Phase |
|---|---|---|
|
Relapsing-Remitting Multiple Sclerosis |
Drug: Interferon-beta-1a Drug: methylprednisolone |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Multi-Centre, Open Label Study to Investigate the Recovery of IFN-beta Efficacy in Relapsing-Remitting Multiple Sclerosis Patients With Neutralising IFN-beta Antibodies and Reduced Bioavailability |
Resource links provided by NLM:
Genetics Home Reference related topics:
multiple sclerosis
MedlinePlus related topics:
Multiple Sclerosis
Drug Information available for:
Prednisolone
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone
Prednisolone sodium phosphate
Prednisolone phosphate
Prednisolone sodium succinate
Methylprednisolone sodium succinate
Interferon
Interferon Beta-1a
U.S. FDA Resources
Further study details as provided by Biogen Idec:
Primary Outcome Measures:
- return of bioavailability of AVONEX (interferon-beta-1a) as measured by induction of MxA mRNA [ Time Frame: screening and every 3 months from month 6 to month 27 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Proportion of patients becoming neutralizing antibody negative [ Time Frame: screening and every 3 months from month 3 to month 27 ] [ Designated as safety issue: No ]
- proportion of patients becoming neutralizing antibody positive after treatment with AVONEX [ Time Frame: at baseline and every three months ] [ Designated as safety issue: No ]
- proportion of patents relapse free [ Time Frame: months 6, 12, 18 and 24 ] [ Designated as safety issue: No ]
- total relapses [ Time Frame: 27 months ] [ Designated as safety issue: No ]
- proportion of patients with an increase in EDSS of 1 point [ Time Frame: screening, 3, 9, 15, 21, and 27 months ] [ Designated as safety issue: No ]
- Brain atrophy and cumulative number of enlarging T2 lesions on MRI [ Time Frame: months 0, 12, and 27 ] [ Designated as safety issue: No ]
| Enrollment: | 20 |
| Study Start Date: | October 2003 |
| Study Completion Date: | December 2009 |
| Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: Interferon-beta-1a
dosage and frequency as per Biogen Idec protocol
Other Name: Avonex
Drug: methylprednisolone
dosage and frequency as per Biogen Idec protocol
|
Detailed Description:
This is an explorative multi-centre, open label, non-comparative trial investigating whether it is possible to recover IFN-beta efficacy in breakthrough relapsing-remitting multiple sclerosis patients with high titres of neutralizing IFN-beta antibodies.
Prior to enrollment, treated MS subjects must have been on interferon-beta-1a or interferon-beta-1b for a minimum of 12 months and have reduced bioavailability as defined by the relative expression of MxA mRNA/GAPDH.
Subjects will complete a washout period with concurrent methylprednisolone 500mg PO daily for 3 days every month until they become Neutralizing Antibody negative. Subjects will then be challenged with AVONEX 30mcg IM weekly. Bioavailability will be measured every three months to determine return of biological activity. Clinical and MRI parameters, safety and tolerability will be compared to baseline to determine efficacy.
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Must have been receiving interferon-beta-1a or interferon-beta-1b for a minimum of 12 consecutive months prior to enrollment
- Relapsing-Remitting Multiple Sclerosis according to Poser or McDonald criteria
- EDSS score of 6 or less
- NAB titre >or equal to 20 via CPE assay or >or equal to 100 via MxA Protein assay measured at least 24 hours after last interferon-beta injection on two consecutive tests at least 3 months apart
- Reduced bioavailability (relative expression of MxA mRNA/GAPDH
Exclusion Criteria:
- History of severe allergic or anaphylactic reaction to human albumin, to any interferon, Methylprednisolone or to any other component of study drugs
- Clinically significant systemic illness
- History of poorly controlled hypertension, diabetes, or osteoporosis
- History of uncontrolled seizures within 3 months of enrollment
- History of Depression or suicidal ideation within 3 months of enrollment
- Serious local infection (abscess or cellulitis) or systemic infection within 8 weeks of study
- abnormal screening blood tests
Contacts and Locations More Information
No publications provided
| Responsible Party: | Biogen Idec MD, Biogen Idec |
| ClinicalTrials.gov Identifier: | NCT00493116 History of Changes |
| Other Study ID Numbers: | AUS-8001 |
| Study First Received: | June 25, 2007 |
| Last Updated: | June 7, 2012 |
| Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration |
Keywords provided by Biogen Idec:
|
recovery of efficacy MxA protein neutralizing antibodies Multiple sclerosis |
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 Antibodies Interferon-beta Interferon beta 1a Interferons Methylprednisolone Hemisuccinate |
Prednisolone Methylprednisolone acetate Prednisolone acetate Methylprednisolone Prednisolone hemisuccinate Prednisolone phosphate Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antiviral Agents Anti-Infective Agents Therapeutic Uses Antineoplastic Agents Anti-Inflammatory Agents Antiemetics |
ClinicalTrials.gov processed this record on June 13, 2013