Comparison of Clinical Effects of Rituximab and Glatiramer Acetate in Secondary Progressive Multiple Sclerosis Patients

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

84

Participants

Timeline

Start Date

December 1, 2017

Primary Completion Date

February 1, 2019

Study Completion Date

March 1, 2019

Conditions
Secondary Progressive Multiple Sclerosis
Interventions
DRUG

Rituximab

Patients will receive 1 g of rituximab (two vials of Zytux 500 mg/50 ml) in 500 cc normal saline serum through intravenous infusion as one treatment cycle. This cycle will be repeated every 6 months. Along with rituximab, patients will receive 100 mg of methylprednisolone, 10 mg of chlorpheniramine, and 500 mg of acetaminophen. Before each cycle, patients will be evaluated regarding complete blood count (CBC)-diff, blood urea nitrogen (BUN), Cr, and liver function tests.

DRUG

Glatiramer Acetate

Patients will receive 40 mg of glatiramer acetate three times per week through subcutaneous injection. Patients will undergo electrocardiography before starting the treatment to find any abnormal finding. Also, lab tests will be checked for them prior to the treatment, including CBC-diff, BUN, Cr, and liver function tests.

Trial Locations (1)

8174673461

Kashani Hospital, Isfahan

All Listed Sponsors
lead

Isfahan University of Medical Sciences

OTHER

NCT03315923 - Comparison of Clinical Effects of Rituximab and Glatiramer Acetate in Secondary Progressive Multiple Sclerosis Patients | Biotech Hunter | Biotech Hunter