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

Sponsor

Mashhad University of Medical Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT01593332

Collaborator

Roche Pharma AG (Industry)

Enrollment

Location

Arms

Duration (Months)

2.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
DMARD Resistant Rheumatoid Arthritis	Drug: Rituximab Drug: Rituximab	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

44 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Study Start Date :

Jul 1, 2010

Actual Primary Completion Date :

Sep 1, 2011

Actual Study Completion Date :

Oct 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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
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

Arm

Intervention/Treatment

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

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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

Rituximab side effects [0,2,16,24 weeks]
side effects like infusion reaction , paresthesia, itching,hypertension or hypotension,headache and infection.

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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.