Back to resultsLow Dose Rituximab as a First Line Biologic Therapy for the Treatment of DMARD Resistant Patients With Rheumatoid Arthritis
Primary Purpose
DMARD Resistant Rheumatoid Arthritis
Status
Completed
Phase
Phase 4
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Rituximab
Rituximab
Sponsored by
About this trial
This is an interventional treatment trial for DMARD Resistant Rheumatoid Arthritis focused on measuring Rituximab, Rheumatoid arthritis, Biologics, Anti-tumour necrosis factor, Disease-modifying anti-rheumatic drugs, DAS28, European League Against Rheumatism response
Eligibility 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.
Sites / Locations
- Rheumatic Diseases Research Center, Mashhad University of Medical Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Rituximab
Methotrexate
Arm Description
Outcomes
Primary Outcome Measures
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)
Change in European league against rheumatism(EULAR) response criteria
Secondary Outcome Measures
Rituximab side effects
side effects like infusion reaction , paresthesia, itching,hypertension or hypotension,headache and infection.
Full Information
NCT ID
NCT01593332
First Posted
January 7, 2012
Last Updated
May 5, 2012
Sponsor
Mashhad University of Medical Sciences
Collaborators
Roche Pharma AG
1. Study Identification
Unique Protocol Identification Number
NCT01593332
Brief Title
Low Dose Rituximab as a First Line Biologic Therapy for the Treatment of DMARD Resistant Patients With Rheumatoid Arthritis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
October 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mashhad University of Medical Sciences
Collaborators
Roche Pharma AG
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
DMARD Resistant Rheumatoid Arthritis
Keywords
Rituximab, Rheumatoid arthritis, Biologics, Anti-tumour necrosis factor, Disease-modifying anti-rheumatic drugs, DAS28, European League Against Rheumatism response
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rituximab
Arm Type
Active Comparator
Arm Title
Methotrexate
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Rituximab
Other Intervention Name(s)
Mabthera
Intervention Description
two 500 mg rituximab infusions 2 weeks apart
Intervention Type
Drug
Intervention Name(s)
Rituximab
Other Intervention Name(s)
Mabthera
Intervention Description
500mg,two times with two weeks interval
Primary Outcome Measure Information:
Title
change in 28-joint disease activity index( DAS28)
Description
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.
Title
Change in European league against rheumatism(EULAR) response criteria
Time Frame
Change in EULAR 2,16,24 weeks
Secondary Outcome Measure Information:
Title
Rituximab side effects
Description
side effects like infusion reaction , paresthesia, itching,hypertension or hypotension,headache and infection.
Time Frame
0,2,16,24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Rheumatic Diseases Research Center, Mashhad University of Medical Sciences
City
Mashhad
State/Province
Khorasan Razavi
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Learn more about this trial
Low Dose Rituximab as a First Line Biologic Therapy for the Treatment of DMARD Resistant Patients With Rheumatoid Arthritis
We'll reach out to this number within 24 hrs