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Effects and Safety of TNF alpha Inhibitors in Refractory Spondyloarthopathies: Observational Study.

Effectiveness and Safety Profile of TNF alpha Inhibitors in Refractory Spondyloarthopathies: An Observational Study.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2018/05/013958
Enrollment
30
Registered
2018-05-18
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Diagnosed cases of Ankylosing Spondylitis (AS) or Psoriatic Arthritis (PA) who are refractory to conventional therapy.

Interventions

None listed

Sponsors

Department of Pharmacology Institute of Postgraduate Medical Education and Research Kolkata
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
For AS cases 50% reduction in a baseline BASDAI Score (or absolute reduction of 2 out of 10) and favourable Expert Opinion For Psoriatic arthritis, reduction in Disease Activity Index for Psoriatic Arthritis (DAPSA) and favourable Expert opinion Timepoint: 6 months from the initiation of therapy

Secondary

MeasureTime frame
Improvement in both objective and subjective indicators of disease activity and functionTimepoint: 6 months from the initiation of therapy

Countries

India

Contacts

Public ContactDr Pradipta Das

Institute of Postgraduate Medical Education and Research,Kolkata

drsupchat@gmail.com3322234135

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026