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

May 5, 2012 updated by: Kamila Hashemzadeh, Mashhad University of Medical Sciences
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Phase 4

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

  • Iran, Islamic Republic of
    • Khorasan Razavi
      • Mashhad, Khorasan Razavi, Iran, Islamic Republic of
        • Rheumatic Diseases Research Center, Mashhad University of Medical Sciences

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

19 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Methotrexate
Drug: Rituximab
two 500 mg rituximab infusions 2 weeks apart
Other Names:
  • Mabthera
Drug: Rituximab
500mg,two times with two weeks interval
Other Names:
  • Mabthera
Active Comparator: Rituximab
Drug: Rituximab
two 500 mg rituximab infusions 2 weeks apart
Other Names:
  • Mabthera
Drug: Rituximab
500mg,two times with two weeks interval
Other Names:
  • Mabthera

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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
Change in EULAR 2,16,24 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

Mashhad University of Medical Sciences

Collaborators

Roche Pharma AG

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

July 1, 2010

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

January 7, 2012

First Submitted That Met QC Criteria

May 5, 2012

First Posted (Estimate)

May 8, 2012

Study Record Updates

Last Update Posted (Estimate)

May 8, 2012

Last Update Submitted That Met QC Criteria

May 5, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 87549 (Other Identifier: DEPUTY OF RESEARCH OF MASHHAD UNIVERSITY OF MEDICAL SCIENCES)

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.

Clinical Trials on DMARD Resistant Rheumatoid Arthritis

Clinical Trials on Rituximab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Qatar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe