Clinical trial NCT00493077: Safety of Avonex Treatment in Multiple Sclerosis Patients With Neutralizing Antibodies to Interferon Beta Therapy
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
Neutralizing antibodies
Safety
Low immunogenicity
interferon
interferon-beta-1a
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2007-06-27
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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

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 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

Primary outcomes:
measure: neutralizing antibody levels will be followed
timeFrame: 12 months
Secondary outcomes:
measure: Proportion of patients with NAb positive titre > 20.
timeFrame: 12 months
measure: Relative change from baseline (screening) of NAb titre
timeFrame: 12 months
measure: Change in the annualised relapse rate and number of relapse-free (total and documented relapses) patients
timeFrame: 12 months and as needed for relapses
measure: The percentage of patients with a loss of disability of 1.0 (or more) score on the EDSS.
timeFrame: 12 months
Other outcomes:
Locations:
city: Goteborg
country: Sweden
facility: Research Site
city: Huddinge
country: Sweden
facility: Coordinating Research Site
city: Joenkoeping
country: Sweden
facility: Research Site
city: Karlstad
country: Sweden
facility: Research Site
city: Stockholm
country: Sweden
facility: Research Site
Study officials:
affiliation: neurologyclinicaltrials@biogenidec.com
name: Biogen-Idec Investigator
role: PRINCIPAL_INVESTIGATOR
References: