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

Biogen

Status and phase

Completed

Phase 4

Conditions

Relapsing-Remitting Multiple Sclerosis

Treatments

Drug: Interferon-beta-1a

Drug: methylprednisolone

Study type

Interventional

Funder types

Industry

Identifiers

NCT00492466

RECOVER

Details and patient eligibility

About

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.

Full 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.

Enrollment

14 patients

Sex

All

Ages

18 to 55 years old

Volunteers

No 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