atalizumab de-escalation to interferon-beta-1b in patients withrelapsing-remitting multiple sclerosis: A multicenter study

• Conditions: relapse-remitting multiple sclerosis; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2012-004040-30-AT
• Lead Sponsor: Ospedale Regionale di Lugano

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03-12
• Last Update Posted: 27 October 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

· Female or male patients with relapsing-remitting forms of multiple
sclerosis (according to McDonald's criteria);
· Age between 18 and 70 years;
· Natalizumab-treatment for at least 12 months following the current Swiss guidelines for treatment initiation;
· Treated with a disease-modifying therapy other than interferon beta-1b for at least 12 months before natalizumab was initiated;
· Never treated with interferon beta-1b;
· Eligible patients are clinically stable (free from relapses and 6-month confirmed disability progression for at least 6 months) while on natalizumab-treatment and do not show any Gd-enhancement on their last MRI performed while on Tysabri;
· In eligible patients MRI were performed in the past as following
a) 6-18 months prior to natalizumab-treatment
b) at natalizumab start
c) 12 months after natalizumab initiation;
· Good records with regard to clinical disease activity (relapse rate,
EDSS progression) in the year prior to natalizumab and during
natalizumab;
· Patients who decide to stop natalizumab treatment after a careful
benefit/risk assessment. Risk for PML increases with duration of
natalizumab exposure, pretreatment with an immunosuppressant
agent or serological status of anti-JC-virus positivity;
· Patients, who in context with cessation of natalizumab have decided, after a careful benefit/risk assessment, to continue treatment of their MS with Interferon beta-1b;
· Women of potential childbearing with active contraceptive methods;
· Patients who are willing to undergo study procedures;
· Patients who are willing to undergo MRI;
· Patients who are willing and able to sign informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 36
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 36

Exclusion Criteria

· Patients who have previously entered this study;
· Natalizumab-treatment for less than 12 months following the current Swiss guidelines for treatment initiation;
· Prior treatment with interferon beta-1b (ever interferon beta-1b);
· Sign of clinical disease activity within the 6 months;
· One or more relapses and/or 6-month confirmed disability
progression during the 6 months prior to the study;
· Secondary progressive MS;
· Primary progressive MS;
· Pregnancy - Serum pregnancy test at screening visit positive- or
breast feeding;
· Uncontrolled, clinically significant heart diseases, such as
arrhythmias, angina, or uncompensated congestive heart failure;
· History of severe depression or attempted suicide or current suicidal
ideation;
· Medical or psychiatric conditions that compromise the ability to give informed consent, to comply with the protocol, or to complete the study;
· Uncontrolled seizure disorder;
· Myopathy or clinically significant liver disease;
· Inability, in the opinion of the principal investigator or staff, to comply with protocol requirements for the duration of the study;
· Known hypersensitivity to interferon-beta or other human proteins including albumin;
· Any contraindication for MRI or contrast administration;
· A history of drug abuse in the 6 months prior to screening;
· Treatment with any of the following in the 30 days before day 1:
systemic corticosteroids, ACTH, or other investigational drugs;
· Participation in any other study involving investigational or marketed products, concomitantly or within 30 days prior to entry in the study;
· Current participation on other clinical trials;
· Treatment with drugs which might interfere with the evaluation of
study drugs during the study protocol such as immunomodulants,
immunosuppressives other than interferon beta-1b;
· Likelihood of requiring treatment during the study period with drugs not permitted by the study protocol such as immunomodulants, immunosuppressives other than interferon beta-1b.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified