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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03315923
• Date of registration: 17/10/2017
• Prospective Registration: Yes
• Primary sponsor: Isfahan University of Medical Sciences
• Public title: Comparison of Clinical Effects of Rituximab and Glatiramer Acetate in Secondary Progressive Multiple Sclerosis Patients
• Scientific title: Comparison of Expanded Disability Status Scale, Gad-enhanced Brain Lesions, Annualized Relapse Rate, and Side Effects Between Active Secondary Progressive Multiple Sclerosis Patients on Rituximab and Glatiramer Acetate
• Date of first enrolment: December 1, 2017
• Target sample size: 84
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03315923
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2/Phase 3

Countries of recruitment

Iran, Islamic Republic of

Contacts

• Name: Vahid Shaygannejad, M.D.
• Affiliation: Isfahan University of Medical Sciences

Key inclusion & exclusion criteria

Inclusion Criteria:

- age between 18 and 55 years old

- diagnosis of active secondary progressive multiple sclerosis based on the latest
McDonald criteria in 2010

- experiencing at least one relapse during the last year

- expanded disability status scale =5

- diagnosis of secondary progressive MS for at least one year

- maintaining pregnancy prevention methods for women in reproductive ages

- filling the written informed consent prior to enrollment

Exclusion Criteria:

- diagnosis of other subtypes of MS, including relapsing-remitting MS and primary
progressive MS and inactive form of the disease

- experiencing relapse during the 30 days before starting the study

- receiving systemic corticosteroid therapy during the last 30 days

- undergoing plasmapheresis or receiving intravenous immunoglobulin during the last 1
months

- history of other demyelinative diseases of central nervous system such as
neuromyelitis optica spectrum disorders

- history of other autoimmune diseases such as systemic lupus erythematosus, sjogren's
syndrome, antiphospholipid syndrome, and behcet's disease

- presence of chronic or recurrent infections such as hepatitis B, hepatitis C, or
syphilis

- pregnancy or lactation

- receiving live attenuated viral vaccines during the last 4 weeks

- history of cardiac arrhythmia, angina pectoris, or other cardiac diseases

- history of immunodeficiency syndromes such as HIV

- white blood cell count <2500 or lymphocyte count <400

- history of brain and spinal malignancies

- history of severe allergic reactions or anaphylaxis to monoclonal antibodies

- presence of active bacterial, viral, fungal, mycobacterial, or other infections

- alcohol or drug abuse during the last two years

- unable to undergo MRI

- presence of uncontrolled cardiac, respiratory, renal, hepatic, endocrine, or
gastrointestinal disease

- presence of encephalopathy due to infectious (such as herpes, syphilis, ...) or
metabolic (vitamin B12 deficiency) reasons

- history of bone marrow transplant, whole body radiotherapy, or other treatments
leading to reduction of lymphocytes

- Cr>1.4 in women and >1.6 in men

- aspartate transaminase and alanine transaminase 2.5 times higher than the normal
amount

- platelet count <100000

- Hb <8.5



Age minimum: 18 Years
Age maximum: 55 Years
Gender: All

Health Condition(s) or Problem(s) studied

Secondary Progressive Multiple Sclerosis

Intervention(s)

Drug: Glatiramer Acetate

Drug: Rituximab

Primary Outcome(s)

Disability measured by Expanded Disability Status Scale [Time Frame: one year]

Secondary Outcome(s)

Annualized relapse rate [Time Frame: one year]

number of Gadolinium-enhanced brain lesions and neuroimaging findings [Time Frame: one year]

Adverse Drug Reactions [Time Frame: one year]

Secondary ID(s)

396514

Source(s) of Monetary Support

Please refer to primary and secondary sponsors