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

Effectiveness and side effects of fingolimod in 3-year follow-up of patients with relapsing- remitting multiple sclerosis(RRMS)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT201705108323N15

Enrollment

Registered

2017-06-07

Start date

2013-09-23

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis. Demyelinating diseases of the central nervous system

Interventions

In intervention group patients will receive half-mg biosimilar fingolimod oral capsule daily.

Treatment - Drugs

In intervention group patients will receive half-mg biosimilar fingolimod oral capsule daily

Eligibility

Sex/Gender

Male

Age

18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Masomeh Moaref

Kermanshah University of Medical Sciences

dr_mmoaref@yahoo.com+98 83 3427 3423

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026