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

• Status: Completed
• Trial end date: 2006-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Biogen
• Treatments: Antibodies; Immunoglobulins; Interferon beta-1a; Interferon-beta; Interferons; Methylprednisolone; Methylprednisolone acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

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