Biological Efficacy of Interferon ß Therapy in Patients with Multiple Sclerosis

Phase 1

• Conditions: To correlate bioactivity of IFNß reflected by level of MxA expression and clinical course of MS To measure expression of MxA protein in patients treated with IFNß depending on NAbs statusNAbs positive cohorts will be correlated NAbs titer with level of MxA expression, respectively if the MxA decrease is not preceding NAbs positivity. The MxA induction test will be tested.

• Registration Number: EUCTR2011-001956-12-CZ
• Lead Sponsor: niversity Hospital Motol

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-05-04
• Last Update Posted: 21 August 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 85

Inclusion Criteria

Male and female 18-55 years old
Diagnosis of multiple sclerosis established with Mc Donald criteria(2005) or clinically isolated syndrom suspected of the next MS development.
Patients starting IFNß treatment
Effective contraception in male and in female patients of childbearing potential has been introduced.
Willingness to accept the plan of the study and compliance with the study.
No active major organ disease especially of hepatic or thyroid origin.
Patient has given written informed consent to participate in the study.

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 85
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Age less than 18 or more than 55.
Noneffective contraception method or pregnancy planning.
Active major organ disease, especially hepatic or endocrinologic.
Cooperation of the subject cannot be ensured.
History of alcohol or drug abuse within 2 years prior to study entry.
Severe depression
Pregnancy

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: The principal objective of our study is a prospective assesment of clinical efficacy of INFß treatement correlated to MxA.;Secondary Objective: The correlation of the titer of neutralizing antibodies(NAbs) and MxA.<br>To adress the issue of detecting the NAbs negative patients with repeatedly measured lower than cutoff levels of MxA.To find primary INFß nonresponders with the test of MxA induction in these patients.;Primary end point(s): The principal objective of our study is a prospective assesment of clinical efficacy of INFß treatement correlated to MxA.<br><br>;Timepoint(s) of evaluation of this end point: 4 years

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The correlation of the titer of neutralizing antibodies(NAbs) and MxA.<br>To adress the issue of detecting the NAbs negative patients with repeatedly measured lower than cutoff levels of MxA.To find primary INFß nonresponders with the test of MxA induction in these patients.<br>;Timepoint(s) of evaluation of this end point: 2 years