Low Dose Rituximab as a First Line Biologic Therapy for the Treatment of DMARD Resistant Patients With Rheumatoid Arthritis
NCT ID: NCT01593332
Last Updated: 2012-05-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
44 participants
INTERVENTIONAL
2010-07-31
2011-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Rituximab
Rituximab
two 500 mg rituximab infusions 2 weeks apart
Rituximab
500mg,two times with two weeks interval
Methotrexate
Rituximab
two 500 mg rituximab infusions 2 weeks apart
Rituximab
500mg,two times with two weeks interval
Interventions
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Rituximab
two 500 mg rituximab infusions 2 weeks apart
Rituximab
500mg,two times with two weeks interval
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Positive for rheumatoid factor(RF)
* Active RA despite therapy with conventional for at least 3 months as evidenced by DAS 28 \> 3/2
* Patients with active, resistant RA who didn't receive anti TNF agents.
Exclusion Criteria
* Patient with congestive heart failure (classIV)
* Active current bacterial,viral,fungal,myocardial or other infections
* Chronic hepatitis B or hepatitis C carriers
* History of severe allergic reaction to human,humanized or murine monoclonal antibodies
* History of malignancies
* Pregnant women or lactating mothers 8) Patients with Chronic renal failure and hepatic disease.
19 Years
75 Years
ALL
No
Sponsors
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Roche Pharma AG
INDUSTRY
Mashhad University of Medical Sciences
OTHER
Responsible Party
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Kamila Hashemzadeh
assisstant professor
Locations
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Rheumatic Diseases Research Center, Mashhad University of Medical Sciences
Mashhad, Khorasan Razavi, Iran
Countries
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Other Identifiers
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87549
Identifier Type: OTHER
Identifier Source: secondary_id
87549
Identifier Type: -
Identifier Source: org_study_id
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