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

Relapsing-Remitting Multiple Sclerosis Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00492466
• Other study ID #: RECOVER
• Status: Completed
• Phase: Phase 4
• First received: June 25, 2007
• Last updated: January 28, 2008
• Start date: March 2003
• Est. completion date: August 2006

Study information

• Verified date: January 2008
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products AgencyDenmark: Danish Medicines AgencyFinland: Finnish Medicines AgencyNorway: Norwegian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: August 2006
• Est. primary completion date: August 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Relapsing-Remitting Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• Interferon-beta-1a
dosage and frequency as per label
• methylprednisolone
dosage and frequency as per Biogen Idec protocol

Locations

Country	Name	City	State
Finland	Coordinating Research Site	Turku

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in the proportion of patients being neutralizing antibody (NAb) positive (titre>20)		Month -1 and after 3, 6, 9, 12, and 15 months	Yes
Secondary	Change in MxA protein values		Month -1 and after 3, 6, 9, 12, and 15 months	Yes
Secondary	Change in binding antibody (Bab) tires		Month -1 and after 3, 6, 9, 12, and 15 months	Yes
Secondary	Proportion of patients with NAb positive titre <5		Month -1 and after 3, 6, 9, 12, and 15 months	Yes
Secondary	Change in annualised relapse rate		at 3, 6, 9, 12, and 15 months	Yes
Secondary	The number of relapse-free patients		at 3, 6, 9, 12, and 15 months	Yes