Health Condition 1: null- Rheumatoid arthritis Health Condition 2: M057- Rheumatoid arthritis with rheumatoid factor without organ or systems involvement
Conditions
Interventions
Intervention1: Rituximab: Rituximab is a standard of care B cell depleting biological DMARD
Control Intervention1: NOT APPLICABLE: NOT APPLICABLE
Sponsors
CENTER FOR RHEUMATIC DISEASES
Eligibility
Inclusion 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 = 100 x 109/L; Serum transaminase not >= 2 times the upper limit of normal; Serum creatinine not >= 1.7 mg/dL
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients achieving ACR 50 response at 24 weeks after the second or third rituximab infusionTimepoint: Proportion of patients achieving ACR 50 response at 24 weeks after the second or third rituximab infusion | — |
Secondary
| Measure | Time frame |
|---|---|
| ACR 20 & 70 improvement Changes from Baseline in the DAS 28 index and EULAR (European League for Rheumatism) response (disease status) Changes from Baseline in HAQ (modified Stanford health assessment) and RAPS (RA pain scale) Changes from baseline in C-Reactive protein (CRP) Safety evaluation & incidence of Adverse events (AE) and Serious adverse events (SAEs) at all study endpoints Withdrawal rate at study end points Timepoint: Week 24 and week 48 | — |
Countries
India
Contacts
Public ContactDR ARVIND CHOPRA
CENTRE FOR RHEUMATIC DISEASES
Outcome results
None listed