Discontinuation of first-line disease modifying treatment (DMT) in long-term full responders MS patients

Phase 1

• Conditions: Relapsing-Remitting multiple sclerosis (RR-MS),; MedDRA version: 21.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2016-004819-12-IT
• Lead Sponsor: OSPEDALE SAN RAFFAELE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-01-20
• Last Update Posted: 7 February 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

- patients with relapsing remitting multiple sclerosis
- males and females patients
- free from attacks and MRI active lesions in the last 4 years
- patients who require the discontinuation of DMT
- age between 18-55 years
- EDSS < 5.0
- women in childbearing age who use a contraceptive method
- patients negative to HIV blood examination
- patients negative to both HCV and HBV blood examination
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 230
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 70

Exclusion Criteria

- previous use of immunosuppressive treatments
- previous use of any experimental disease modifying treatments
- clinically relevant systemic diseases
- pregnancy

For IFNß-treated group:
- history of hypersensitivity to natural or recombinant interferon, human albumin, or any other component of the IFNß formulation
- history of depression and/or suicidal ideation
- active liver disease

For GA-treated group:
- history of hypersensitivity to GA or mannitol.

Study & Design

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