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

May 22, 2019 updated by: Vahid Shaygannejad, Isfahan University of Medical Sciences

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

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 among patients with active secondary progressive multiple sclerosis during a one year follow up through a randomized clinical trial.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 relapsing course which is also associated with clinical relapses and/or new/enlarged Gad-enhanced brain lesions. This form of the disease leads to high rates of morbidity and mortality among patients. Different immunosuppressive and immunomodulatory agents are recommended by researchers to decrease relapses and improve disability among MS patients. The effect of these medications on different phenotypes of MS are mostly investigated solely and very small number of comparative studies are conducted to evaluate the superiority of these medications on each other.

Glatiramer acetate is one of the known MS medications which is being used to control relapses from a long time ago and different clinical trials have shown its partial efficacy among MS patients. On the other hand, rituximab is one of the medications which is recently suggested for treatment of MS and currently phase II clinical trials are conducted to evaluate the efficacy of this medication among patients. As previously stated, there is a lack of clinical trials to compare the efficacy of suggested medications among secondary progressive patients. To fill this gap, we aimed to compare the efficacy of these two medications on disability, annualized relapse rate, and Gad-enhanced brain lesions among patients with active secondary progressive MS through a randomized clinical trial during a one-year follow-up period.

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 53 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rituximab
Patients in this group will receive 1g of rituximab in 500 cc normal saline serum through intravenous infusion as one treatment course. The treatment course will be repeated in 6 months. Along with rituximab, 100 mg methylprednisolone, 10 mg chlorpheniramine, and 500 mg acetaminophen will also be injected to decrease side effects of rituximab.
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.
Other Names:
  • Zytux®
Experimental: Glatiramer acetate
Patients in this group will receive 40 mg of glatiramer acetate three times per week through subcutaneous injection.
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.
Other Names:
  • Osvimer®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disability measured by Expanded Disability Status Scale
Time Frame: one year
expanded disability status scale will be measured in the baseline and after 12 months of intervention. This scale measures the disability of patients with a score, ranging from 0 (normal neurological exam) to 10 (death due to MS). This score is assigned to the patient by the neurologist and after neurological examination. The patient will be given a score in this scale according to the observed disability. The scores will be compared at the end of study.
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Drug Reactions
Time Frame: one year
adverse drug reactions will be observed closely and reported during the intervention. We will compare the number of adverse drug reactions in two groups. Also, adverse drug reactions will be described by details in each group.
one year
number of Gadolinium-enhanced brain lesions and neuroimaging findings
Time Frame: one year
patients will undergo brain MRI before and after the study and number of Gad-enhanced brain lesions will compared before and after intervention.
one year
Annualized relapse rate
Time Frame: one year
annualized relapse rate will be measured in the baseline (according to patients' history in the last year) and after 12 months of intervention.
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Isfahan University of Medical Sciences

Investigators

  • Study Chair: Vahid Shaygannejad, M.D., Isfahan University of Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2017

Primary Completion (Actual)

February 1, 2019

Study Completion (Actual)

March 1, 2019

Study Registration Dates

First Submitted

October 17, 2017

First Submitted That Met QC Criteria

October 17, 2017

First Posted (Actual)

October 20, 2017

Study Record Updates

Last Update Posted (Actual)

May 23, 2019

Last Update Submitted That Met QC Criteria

May 22, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 396514

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

We may share the individual participant data (anonymously) on request of qualified investigators.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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