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Safety of Avonex Treatment in Multiple Sclerosis Patients With Neutralizing Antibodies to Interferon Beta Therapy

Information source: Biogen
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Multiple Sclerosis

Intervention: low immunogenic interferon-beta-1a (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Biogen

Official(s) and/or principal investigator(s):
Biogen-Idec Investigator, Principal Investigator, Affiliation: neurologyclinicaltrials@biogenidec.com

Summary

This study is to find out the safety and effectiveness of Avonex (interferon-beta-1a) Therapy in patients who have developed neutralizing antibodies during previous interferon-beta treatment

Clinical Details

Official title: A Swedish Multi-Centre, Prospective, Open Label Study: Safety of Avonex Treatment in Multiple Sclerosis Patients Who Are NAB Positive on Previous s.c Interferon Beta Therapy

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

Primary outcome: neutralizing antibody levels will be followed

Secondary outcome:

Proportion of patients with NAb positive titre > 20.

Relative change from baseline (screening) of NAb titre

Change in the annualised relapse rate and number of relapse-free (total and documented relapses) patients

The percentage of patients with a loss of disability of 1.0 (or more) score on the EDSS.

Detailed description: This is a multi-centre, prospective, open label, non-comparative phase IV trial. Eligible patients will receive treatment with IFN-beta-1a AVONEX« 30 mcg i. m. once weekly for 12 months. The patients will be examined clinically and NAb titres will be performed at screening and after 12 months. Adverse event source verification will be performed during the documentation period.

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Relapsing-remitting MS according to Poser criteria(CDMS or LSDMS)30 or MS according

to McDonald criteria

- Disability equivalent to an EDSS of 6. 0 or less at screening

- Neutralizing antibody titre > 20 and <500 in two consecutive NAb tests. One must be

from before screening

- previous treatment with either subcutaneous administered interferon-b-1b (Betaferon®)

or interferon-b-1a (Rebif TM) prior to enrolment

- A priori has been decided to be treated with AVONEX

Exclusion Criteria:

- Is NAb positive on AVONEX

- History of major depression

- Cardiac insufficiency, cardiomyopathy, significant cardiac dysrhythmia, unstable or

advanced ischemic heart disease (NYHA III or IV), or significant 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

- 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

Locations and Contacts

Research Site, Goteborg 416 85, Sweden

Coordinating Research Site, Huddinge, Sweden

Research Site, Joenkoeping 551 85, Sweden

Research Site, Karlstad 651 85, Sweden

Research Site, Stockholm 141 86, Sweden

Additional Information

Starting date: May 2004
Last updated: January 28, 2008

Page last updated: August 20, 2015

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