Effects and Safety of TNF alpha Inhibitors inRefractory Spondyloarthopathies: Observational Study.
Not Applicable
- Conditions
- Health Condition 1: null- Diagnosed cases of Ankylosing Spondylitis (AS) or Psoriatic Arthritis (PA) who are refractory to conventional therapy.
- Registration Number
- CTRI/2018/05/013958
- Lead Sponsor
- Department of Pharmacology Institute of Postgraduate Medical Education and Research Kolkata
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Adult patients of age between 18-60 years of either gender clinically diagnosed as cases of Ankylosing Spondylitis or Psoriatic arthritis who have been advised TNF alpha inhibitor (Infliximab or Adalimumab) therapy as per institutional treatment protocol.
2. Patients who satisfy eligibility criteria for getting TNF alpha inhibitors.
3. Subjects willing to give written informed consent and comply with study related instructions.
Exclusion Criteria
1. Patients of Ankylosing Spondylitis or Psoriatic arthritis having any clinical condition were TNF alpha inhibitor (Infliximab or Adalimumab) therapy is contraindicated.
2. Subjects unwilling to give written informed consent and comply with study related instructions.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method For AS cases 50% reduction in a baseline BASDAI Score (or absolute reduction of 2 out of 10) and favourable Expert Opinion <br/ ><br>For Psoriatic arthritis, reduction in Disease Activity Index for Psoriatic Arthritis (DAPSA) and favourable Expert opinion <br/ ><br>Timepoint: 6 months from the initiation of therapy
- Secondary Outcome Measures
Name Time Method Improvement in both objective and subjective indicators of disease activity and functionTimepoint: 6 months from the initiation of therapy