Safety of Avonex Treatment in Multiple Sclerosis Patients With Neutral
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
What it found
We found no results in the registry or in papers.
This trial finished 20 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Interferon beta-1a
Interferon alpha/beta receptor agonist
What it measured
Main measures
neutralizing antibody levels will be followed
12 months
Immune response
Other measures (4)
Proportion of patients with NAb positive titre > 20.
12 months
Relative change from baseline (screening) of NAb titre
12 months
Change in the annualised relapse rate and number of relapse-free (total and documented relapses) patients
12 months and as needed for relapses
RelapsesThe percentage of patients with a loss of disability of 1.0 (or more) score on the EDSS.
12 months
Disability progression
Who could take part
Relapsing MS · 18 to 55
Show the full 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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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
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History
Started
May 2004
Main results due
May 2006
Finished
May 2006