Trial record 19 of 317 for:    biogen | biogen

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

This study has been completed.
Sponsor:
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT00492466
First received: June 25, 2007
Last updated: January 28, 2008
Last verified: January 2008
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 Idec:

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 ] [ Designated as safety issue: Yes ]

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

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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00492466

Locations
Finland
Coordinating Research Site
Turku, Finland
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: NCT00492466     History of Changes
Other Study ID Numbers: RECOVER
Study First Received: June 25, 2007
Last Updated: January 28, 2008
Health Authority: Sweden: Medical Products Agency
Denmark: Danish Medicines Agency
Finland: Finnish Medicines Agency
Norway: Norwegian Medicines Agency

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

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
Immunoglobulins
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
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on August 26, 2014