A study to evaluate safety, tolerability and efficacy of a biosimilar Etanercept in India.
Phase 4
- Conditions
- Health Condition 1: null- Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS), Psoriatic Arthritis(PsA) , Plaque Psoriasis, Juvenile Idiopathic Arthritis (JIA)
- Registration Number
- CTRI/2016/11/007466
- Lead Sponsor
- Cipla Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 200
Inclusion Criteria
1.Patients or their legally acceptable representative willing to give a written informed consent.
2.Males or Females having definite diagnosis of their rheumatoid arthritis (RA), ankylosing spondylitis (AS), psoriatic arthritis of 18 years and above or plaque psoriasis of 8 years and above or juvenile idiopathic arthritis of 2 years and above.
Exclusion Criteria
1. Known allergy and hypersensitivity to Etanercept or any other component of medication.
2. Any known contradictions to Etanercept.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety <br/ ><br>â?¢Incidence and nature of adverse events <br/ ><br>â?¢Incidence of drug related adverse events. <br/ ><br>Timepoint: 24 weeks
- Secondary Outcome Measures
Name Time Method The ACR 20 (20% improvement from baseline) <br/ ><br>The ACR 50 (50% improvement from baseline) <br/ ><br>Defined as 20 to 50 % improvement from baseline in <br/ ><br>a.Tender joint count <br/ ><br>b.Swollen joint count <br/ ><br>c. -Physicianâ??s global assessment of disease activity <br/ ><br>d. -Patientâ??s global assessment of disease activity <br/ ><br>e. -Patientâ??s assessment of physical function using the disability domain of the HAQ (Indian Health Assessment Questionnaire) indexTimepoint: 24 weeks