EUCTR2016-004819-12-IT
Active, not recruiting
Phase 1
Discontinuation of first-line disease modifying treatment (DMT) in long-term full responders MS patients: a multicentre randomized clinical trial. - Full Responders
OSPEDALE SAN RAFFAELE0 sites300 target enrollmentJanuary 20, 2022
ConditionsRelapsing-Remitting multiple sclerosis (RR-MS),MedDRA version: 21.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
DrugsBETAFERON - 15 FLACONCINI 0.25 MG + 15 FLACONCINI 2 MLAVONEX - 30 MCG (6 MILIONI UI) POLVERE E SOLVENTE PER SOLUZIONE INIETTABILE 4 FLACONI CON DISPOSITIVO BIOSET + 4 SIRINGHE PRERIEMPITE USO INTRAMUSCOLARECOPAXONE - 40 MG/ML SOLUZIONE INIETTABILE IN SIRINGA PRERIEMPITA 12 SIRINGHE PRERIEMPITE DA 1 ML CON AGOREBIF - 44 MCG(12 MILIONI UI) -SOLUZ INIETTABILE- USO SOTTOCUTANEO-PENNA PRERIEMPITA 0.5 ML (24 MILIONI UI/ML)12 PENNE PRERIEMPITE
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Relapsing-Remitting multiple sclerosis (RR-MS),
- Sponsor
- OSPEDALE SAN RAFFAELE
- Enrollment
- 300
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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.
Outcomes
Primary Outcomes
Not specified
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