Status:
COMPLETED
Comparison of Clinical Effects of Rituximab and Glatiramer Acetate in Secondary Progressive Multiple Sclerosis Patients
Lead Sponsor:
Isfahan University of Medical Sciences
Conditions:
Secondary Progressive Multiple Sclerosis
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this study is to compare expanded disability status scale, annualized relapse rate, Gad-enhanced brain lesions, and side effects after administration of rituximab and glatiramer acetate...
Detailed Description
Multiple sclerosis (MS) is an autoimmune inflammatory demyelinative disease of central nervous system. Active secondary progressive MS means progressive accumulation of disability after an initial rel...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2019
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT03315923
Start Date
December 1 2017
End Date
March 1 2019
Last Update
May 23 2019
Active Locations (1)
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1
Kashani Hospital
Isfahan, Iran, 8174673461