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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01593332

Enrollment

Registered

2012-05-08

Start date

2010-07-31

Completion date

2011-10-31

Last updated

2012-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

DMARD Resistant Rheumatoid Arthritis

Keywords

Rituximab, Rheumatoid arthritis, Biologics, Anti-tumour necrosis factor, Disease-modifying anti-rheumatic drugs, DAS28, European League Against Rheumatism response

Brief summary

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.

Interventions

DRUGRituximab

two 500 mg rituximab infusions 2 weeks apart

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
change in 28-joint disease activity index( DAS28)	Study duration was 6 months and the subjects were assessed for DAS 28 change at baseline, after 2 , 16 and 24 weeks.	disease activity score 28 formula which caculates based the number of tenderness and swelling of 28 joints and also ESR)
Change in European league against rheumatism(EULAR) response criteria	Change in EULAR 2,16,24 weeks	—

Secondary

Measure	Time frame	Description
Rituximab side effects	0,2,16,24 weeks	side effects like infusion reaction , paresthesia, itching,hypertension or hypotension,headache and infection.

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026