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

Primary Purpose

Relapsing-Remitting Multiple Sclerosis

Status
Completed
Phase
Phase 4
Locations
Finland
Study Type
Interventional
Intervention
Interferon-beta-1a
methylprednisolone
Sponsored by
Biogen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsing-Remitting Multiple Sclerosis focused on measuring Multiple Sclerosis, antibody, Neutralizing antibody, Binding antibody, MxA protein

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Coordinating Research Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

Reduction in the proportion of patients being neutralizing antibody (NAb) positive (titre>20)

Secondary Outcome Measures

Change in MxA protein values
Change in binding antibody (Bab) tires
Proportion of patients with NAb positive titre <5
Change in annualised relapse rate
The number of relapse-free patients

Full Information

First Posted
June 25, 2007
Last Updated
January 28, 2008
Sponsor
Biogen
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1. Study Identification

Unique Protocol Identification Number
NCT00492466
Brief Title
Investigating if Interferon-Beta Can be Used in Patients With MS After They Have Developed Neutralizing Antibodies
Acronym
RECOVER
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
March 2003 (undefined)
Primary Completion Date
August 2006 (Actual)
Study Completion Date
August 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Biogen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsing-Remitting Multiple Sclerosis
Keywords
Multiple Sclerosis, antibody, Neutralizing antibody, Binding antibody, MxA protein

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Interferon-beta-1a
Other Intervention Name(s)
Avonex
Intervention Description
dosage and frequency as per label
Intervention Type
Drug
Intervention Name(s)
methylprednisolone
Intervention Description
dosage and frequency as per Biogen Idec protocol
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Change in MxA protein values
Time Frame
Month -1 and after 3, 6, 9, 12, and 15 months
Title
Change in binding antibody (Bab) tires
Time Frame
Month -1 and after 3, 6, 9, 12, and 15 months
Title
Proportion of patients with NAb positive titre <5
Time Frame
Month -1 and after 3, 6, 9, 12, and 15 months
Title
Change in annualised relapse rate
Time Frame
at 3, 6, 9, 12, and 15 months
Title
The number of relapse-free patients
Time Frame
at 3, 6, 9, 12, and 15 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Biogen-Idec Investigator
Organizational Affiliation
neurologyclinicaltrials@biogenidec.com
Official's Role
Principal Investigator
Facility Information:
Facility Name
Coordinating Research Site
City
Turku
Country
Finland

12. IPD Sharing Statement

Learn more about this trial

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

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