Low Dose Rituximab as a First Line Biologic Therapy for the Treatment of DMARD Resistant Patients With Rheumatoid Arthritis

Mashhad University of Medical Sciences44 enrolled

Overview

In this project the investigators decide to evaluate the efficacy and safety of half dose mabthera (it means 500 mg infusion two weeks apart) in conventional drug resistant cases of rheumatoid arthritis. The investigators choose this drug because the use of anti-TNF drugs limited in the investigators refractory patients as the first line drugs because of its cost.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

DMARD Resistant Rheumatoid Arthritis

Interventions

RituximabDRUG

two 500 mg rituximab infusions 2 weeks apart

RituximabDRUG

500mg,two times with two weeks interval

Eligibility

Sex: ALLMin age: 19 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 1987 ACR criteria for classification of RA * 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 hypogammaglobulinemia * 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.

Locations (1)

Rheumatic Diseases Research Center, Mashhad University of Medical Sciences

Mashhad, Razavi Khorasan Province, Iran

Outcomes

Primary Outcomes

change in 28-joint disease activity index( DAS28)

disease activity score 28 formula which caculates based the number of tenderness and swelling of 28 joints and also ESR)

Time frame: Study duration was 6 months and the subjects were assessed for DAS 28 change at baseline, after 2 , 16 and 24 weeks.

Change in European league against rheumatism(EULAR) response criteria

Time frame: Change in EULAR 2,16,24 weeks

Secondary Outcomes

Rituximab side effects

side effects like infusion reaction , paresthesia, itching,hypertension or hypotension,headache and infection.

Time frame: 0,2,16,24 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.