patients with relapsing remitting multiple sclerosis MedDRA version: 9.1 Level: LLT Classification code 10028245 Term: Multiple sclerosis
Conditions
Interventions
Trade Name: AZATIOPRINA HEX. 50CPR 50MG BL
Pharmaceutical Form: Tablet
INN or Proposed INN: Azathioprine
CAS Number: 446-86-6
Concentration unit: mg milligram(s)
Concentration type: equal
Concentratio
Sponsors
Universita di Firenze
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: age 18-55 years; diagnosis of multiple sclerosis McDonald criteria 2001 with relapsin remitting course; at least 2 exacerbation in the preceding 2 years;Baseline EDSS score of 1 to 5,5; no clinical relapses within 30 days of study entry;effective method of contraception if women with childbearing potential; signed informed patient 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: immunomodulatory or immunosoppressive tratments in the preceding 6 mounths; steroid therapy in the last 30 days before study entry; concomitant diseases precluding interferon beta or azathioprine treatment; pregnancy or breastfeeding; inability to give the informed consent; pathological conditions interfering with multiple sclerosis evolution; allergy to paracetamol or known intolerance to azathioprine or interferon beta.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to directly compare in patients with relapsing remitting multiple sclerosis azathioprine to Interferon beta efficacy in modifying disease activity.;Secondary Objective: safety profile of azathioprina and interferon beta and their impact on quality of life;Primary end point(s): cumulative relapse count per patient over 2 years. | — |
Countries
Italy
Outcome results
None listed