CTRI/2017/08/009321
Completed
Phase 2
ong term effectiveness of Rituximab (RTX) in patients of rheumatoid arthritis (RA) with active disease despite supervised standard rheumatology care (with methotrexate as a pivotal drug) - CRD/RTX/2016/001
CENTER FOR RHEUMATIC DISEASES0 sites60 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Health Condition 1: null- Rheumatoid arthritisHealth Condition 2: M057- Rheumatoid arthritis with rheumatoid factor without organ or systems involvement
- Sponsor
- CENTER FOR RHEUMATIC DISEASES
- Enrollment
- 60
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Age 18\-70 years
- •2\.Seropositive RA and fulfilling the requirements of 2010 American College of Rheumatology ACR/EULAR classification criteria for RA
- •3\.Disease duration between 6 months and 5 years.
- •4\.Patients with \>\= 6 tender joints and \>\= 4 swollen joints (based on 66 swollen joints and 68 painful joints) and a DAS28 (ESR) score \>\= 3\.2
- •5\.Ambulant and standard ACR functional class I, II or III
- •6\.Patients must be able to understand and comply with instructions
- •7\.Men and women of child bearing potential must be using adequate birth control measures and agree to continue such precautions for 6 months after receiving the last dose
- •8\.Menopausal females must have experienced their last period more than 12 months prior to study entry to be classified as not of child bearing potential
- •9\.The screening laboratory tests must meet the following criteria:
- •Haemoglobin \>\=8\.0 g/dL; WBC \>\=3\.5 x 109/L; Neutrophils \>\= 1\.5 x 109/L; Lymphocytes \< 1000/mm3; Platelets \>\= 100 x 109/L; Serum transaminase not \>\= 2 times the upper limit of normal; Serum creatinine not \>\= 1\.7 mg/dL
Exclusion Criteria
- •1\.Patients with contraindications to Rituximab use
- •2\.Patients with hypersensitivity to Rituximab or any of its components
- •3\.Patients who have received any Biologic DMARD in past 6 months
- •4\.Prior use of disease modifying anti rheumatic drugs, other than methotrexate, hydroycholoroquine or sulfasalazine within 4 weeks prior to screening
- •5\.Patients suffering from acute or chronic, disseminated or localized (bacterial/fungal/viral) infections (except fungal nail bed infection) or sepsis or patients with a history of recurring infections or at increased risk of developing infections or sepsis.
- •6\.Patients presently suffering from tuberculosis
Outcomes
Primary Outcomes
Not specified
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