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Completed

NCT Number: NCT01593332

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

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.

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Key information

Conditions

DMARD Resistant Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

19 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Rheumatic Diseases Research Center, Mashhad University of Medical Sciences

Mashhad, Razavi Khorasan Province, Iran

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Rituximab

Drug

two 500 mg rituximab infusions 2 weeks apart

Other names: Mabthera

Primary outcomes

  1. change in 28-joint disease activity index( DAS28)

    Time frame: 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)

  2. Change in European league against rheumatism(EULAR) response criteria

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

Secondary outcomes

  1. Rituximab side effects

    Time frame: 0,2,16,24 weeks

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

Sponsors and collaborators

Lead sponsor

Mashhad University of Medical Sciences

Other

Collaborators

  • Roche Pharma AG

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
May 8, 2012
Registry last updated
May 8, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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