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

This study has been completed.
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
Kamila Hashemzadeh, Mashhad University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01593332
First received: January 7, 2012
Last updated: May 5, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
DMARD Resistant Rheumatoid Arthritis
Drug: Rituximab
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Mashhad University of Medical Sciences:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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 [ Time Frame: Change in EULAR 2,16,24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rituximab side effects [ Time Frame: 0,2,16,24 weeks ] [ Designated as safety issue: Yes ]
    side effects like infusion reaction , paresthesia, itching,hypertension or hypotension,headache and infection.


Enrollment: 44
Study Start Date: July 2010
Study Completion Date: October 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Rituximab Drug: Rituximab
two 500 mg rituximab infusions 2 weeks apart
Other Name: Mabthera
Drug: Rituximab
500mg,two times with two weeks interval
Other Name: Mabthera
Active Comparator: Methotrexate Drug: Rituximab
two 500 mg rituximab infusions 2 weeks apart
Other Name: Mabthera
Drug: Rituximab
500mg,two times with two weeks interval
Other Name: Mabthera

  Eligibility

Ages Eligible for Study:   19 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01593332

Locations
Iran, Islamic Republic of
Rheumatic Diseases Research Center, Mashhad University of Medical Sciences
Mashhad, Khorasan Razavi, Iran, Islamic Republic of
Sponsors and Collaborators
Mashhad University of Medical Sciences
Roche Pharma AG
  More Information

No publications provided

Responsible Party: Kamila Hashemzadeh, assisstant professor, Mashhad University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01593332     History of Changes
Other Study ID Numbers: 87549, 87549
Study First Received: January 7, 2012
Last Updated: May 5, 2012
Health Authority: Islamic Repablic of Iran:National ethics committee

Keywords provided by Mashhad University of Medical Sciences:
Rituximab
Rheumatoid arthritis
Biologics
Anti-tumour necrosis factor
Disease-modifying anti-rheumatic drugs
DAS28
European League Against Rheumatism response

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Rituximab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on September 16, 2014