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Investigating if Interferon-Beta Can be Used in Patients With MS After They Have Developed Neutralizing Antibodies (RECOVER)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00492466
First Posted: June 27, 2007
Last Update Posted: January 30, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Biogen
  Purpose
This study is to find out if Interferon-beta can recover its effectiveness 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: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicentre, Open Label, Non-Comparative Trial Investigating the Recovering of INF-Beta Efficacy in Breakthrough Relapsing-Remitting Multiple Sclerosis Patients With Neutralizing Interferon-Beta Antibodies

Resource links provided by NLM:


Further study details as provided by Biogen:

Primary Outcome Measures:
  • Reduction in the proportion of patients being neutralizing antibody (NAb) positive (titre>20) [ Time Frame: Month -1 and after 3, 6, 9, 12, and 15 months ]

Secondary Outcome Measures:
  • Change in MxA protein values [ Time Frame: Month -1 and after 3, 6, 9, 12, and 15 months ]
  • Change in binding antibody (Bab) tires [ Time Frame: Month -1 and after 3, 6, 9, 12, and 15 months ]
  • Proportion of patients with NAb positive titre <5 [ Time Frame: Month -1 and after 3, 6, 9, 12, and 15 months ]
  • Change in annualised relapse rate [ Time Frame: at 3, 6, 9, 12, and 15 months ]
  • The number of relapse-free patients [ Time Frame: at 3, 6, 9, 12, and 15 months ]

Enrollment: 14
Study Start Date: March 2003
Study Completion Date: August 2006
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Interferon-beta-1a
dosage and frequency as per label
Other Name: Avonex
Drug: methylprednisolone
dosage and frequency as per Biogen Idec protocol

Detailed Description:

This is a multi-center, open Label, non-comparative Phase IV trial. Eligible Patients will receive treatment with Interferon-beta-1a (AVONEX) 30mcg I.M. once weekly for up to 12 months.

In the wash-out period prior to commencing treatment with AVONEX, patients will receive treatment with intermittent Methylprednisolone 500 mg PO Daily for three consecutive days at monthly intervals.

The patients will be examined clinically and laboratory tests will be performed at screening (month -1) and after 3, 9, and 15 months.

Neutralizing antibody(NAb)titres and Binding antibody(BAb)titres as well as MxA protein levels will be evaluated at screening/baseline (month -1/0) and after 3, 6, 9, 12, and 15 months.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Relapsing remitting Multiple Sclerosis according to Poser criteria (CDMS or LDMS) or Multiple Sclerosis according to McDonald criteria
  • Disability equivalent to EDSS of 6.0 or less
  • Clinical activity defined as at least one relapse rate within the last 12 months
  • NAb titre >20 (measured at least 48 hours after last interferon-beta injection
  • has been treated with subcutaneously administered interferon-beta-1b or interferon-beta-1a (Rebif) for at least 24 hours before enrollment

Exclusion Criteria:

  • Any condition that might give rise to similar symptoms as MS
  • Immunomodulatory therapy other than interferon-beta-1a or interferon-beta-1b or any immunosuppressive treatment six months prior to inclusion into the trial
  • Treatment with glucocorticoids or ACTH less than one month prior to inclusion into the trial
  • History of major depression
  • Alcohol or drug dependency
  • Cardiac insufficiency, cardiomyopathy, significant cardiac dysrhythmia, unstable or advanced ischemic heart disease (NYHA III or IV)
  • 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
  • Gastro-intestinal ulcers, gastritis, or dyspepsia
  • 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00492466


Locations
Finland
Coordinating Research Site
Turku, Finland
Sponsors and Collaborators
Biogen
Investigators
Principal Investigator: Biogen-Idec Investigator neurologyclinicaltrials@biogenidec.com
  More Information

Responsible Party: biogen Idec MD, Biogen Idec
ClinicalTrials.gov Identifier: NCT00492466     History of Changes
Other Study ID Numbers: RECOVER
First Submitted: June 25, 2007
First Posted: June 27, 2007
Last Update Posted: January 30, 2008
Last Verified: January 2008

Keywords provided by Biogen:
Multiple Sclerosis
antibody
Neutralizing antibody
Binding antibody
MxA protein

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Antibodies
Immunoglobulins
Interferon-beta
Interferon beta-1a
Antibodies, Blocking
Interferons
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Anti-Inflammatory Agents
Antiemetics