Evaluating the efficacy and side effects fingolimod in 3 -year follow-up of patients with recurrent forms of multiple sclerosis

Not Applicable

Conditions: Multiple Sclerosis.
Demyelinating diseases of the central nervous system

Registration Number: IRCT201705108323N15

Lead Sponsor: Vice chancellor for research, Kermanshah University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: Male

Target Recruitment: 50

Inclusion Criteria

Age 18-45 years; EDSS score between 0 and 5.5; At least one relapse in the previous year despite treatment with a variety of first-line DMT; At least two relapses in the past two years despite treatment with a variety of first-line DMT; No relapse in the 30 days before starting treatment with fingolimod; Negative pregnancy test for women of childbearing age.
Exclusion criteria: macular edema at baseline;
acute or chronic active bacterial infection, fungal or Viral; Treatment with intravenous corticosteroids within 30 days prior to the start fingolimod; History of treatment with cyclophosphamide or mitoxantrone at any time; Breastfeeding and pregnancy;AST and ALT more than double upper limit of normal; Full or direct bilirubin greater than the upper limit of normal; Creatinine more than 1.7 mg per deciliter; White blood cells below 3500 per cubic millimeter; Lymphocyte count below 800 per cubic millimeter; The presence of uveitis

Exclusion Criteria

Not provided

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Blood pressure. Timepoint: Baseline, every three months for two years. Method of measurement: Blood pressure meter.;White blood cells. Timepoint: Baseline, every three months for two years. Method of measurement: By blood tests in the laboratory.;Progressive multifocal leukoencephalophaty. Timepoint: Baseline, every three months for two years. Method of measurement: Using MRI.;Liver enzymes. Timepoint: Baseline, every three months for two years. Method of measurement: By blood tests in the laboratory.

Secondary Outcome Measures