Investigating if Interferon-Beta Can be Used in Patients With MS After
A Multicentre, Open Label, Non-Comparative Trial Investigating the Recovering of INF-Beta Efficacy in Breakthrough Relapsing-Remitting Multiple Sclerosis Patients With Neutralizing Interferon-Beta Antibodies
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
- Methylprednisolone
Glucocorticoid receptor agonist
What it measured
Main measures
Reduction in the proportion of patients being neutralizing antibody (NAb) positive (titre>20)
Month -1 and after 3, 6, 9, 12, and 15 months
Immune response
Other measures (5)
Change in MxA protein values
Month -1 and after 3, 6, 9, 12, and 15 months
Immune responseChange in binding antibody (Bab) tires
Month -1 and after 3, 6, 9, 12, and 15 months
Proportion of patients with NAb positive titre <5
Month -1 and after 3, 6, 9, 12, and 15 months
Change in annualised relapse rate
at 3, 6, 9, 12, and 15 months
RelapsesThe number of relapse-free patients
at 3, 6, 9, 12, and 15 months
Relapses
Who could take part
Relapsing MS · 18 to 55
Show the full 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
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 if Interferon-beta can recover its effectiveness in patients with Multiple Sclerosis who have previously developed neutralizing antibodies to Interferon-Beta.
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History
Started
Mar 2003
Main results due
Aug 2006
Finished
Aug 2006