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

NCT01593332 | Completed Phase 4 DMC

• 1 other identifier: 87549
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

DMARD Resistant Rheumatoid Arthritis

Keywords

Rituximab; Rheumatoid arthritis; Biologics; Anti-tumour necrosis factor; Disease-modifying anti-rheumatic drugs; DAS28; European League Against Rheumatism response

Outcome Measures

Primary Outcomes (2)

• 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)

  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

  Change in EULAR 2,16,24 weeks

Secondary Outcomes (1)

• Rituximab side effects

  0,2,16,24 weeks

Study Arms (2)

Rituximab

ACTIVE COMPARATOR

Drug: Rituximab

Methotrexate

ACTIVE COMPARATOR

Drug: Rituximab

Interventions

Rituximab DRUG

two 500 mg rituximab infusions 2 weeks apart

Also known as: Mabthera

Methotrexate; Rituximab

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mashhad University of Medical Sciences: lead
• Roche Pharma AG: collaborator

Study Sites (1)

Rheumatic Diseases Research Center, Mashhad University of Medical Sciences

Mashhad, Khorasan Razavi, Iran

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assisstant professor

Study Record Dates

• First Submitted: January 7, 2012
• First Posted: May 8, 2012
• Study Start: July 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: October 1, 2011
• Last Updated: May 8, 2012

Record last verified: 2012-05

Locations

IR (1)