Rituximab in treatment of Rheumatoid arthritis in Indian patients
- Conditions
- Health Condition 1: null- Rheumatoid arthritisHealth Condition 2: M057- Rheumatoid arthritis with rheumatoid factor without organ or systems involvement
- Registration Number
- CTRI/2017/08/009321
- Lead Sponsor
- CENTER FOR RHEUMATIC DISEASES
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method ACR 20 & 70 improvement <br/ ><br>Changes from Baseline in the DAS 28 index and EULAR (European League for Rheumatism) response (disease status) <br/ ><br>Changes from Baseline in HAQ (modified Stanford health assessment) and RAPS (RA pain scale) <br/ ><br>Changes from baseline in C-Reactive protein (CRP) <br/ ><br>Safety evaluation & incidence of Adverse events (AE) and Serious adverse events (SAEs) at all study endpoints <br/ ><br>Withdrawal rate at study end points <br/ ><br>Timepoint: Week 24 and week 48