drugset / Trial / NCT01361542

Effect Of Anti TNF Alpha Therapy And Their Adverse Effects In Ankylosing Spondylitis In A North Indian Population

NCT01361542

NaSingle-groupOpen-labelHealth-services research

Summary

Ankylosing Spondylitis (AS) is a chronic painful progressive inflammatory arthritis of unknown etiology primarily affecting the spine and sacroiliac joints. In addition to formation of new bone leading to syndesmophytes and ankylosis; osteoporosis is also a prominent feature in AS-thus showing the paradox of new bone formation at abnormal sites coexisting with reduced bone mass \& increased fracture risk. Osteoporosis is a common complication of AS, with an incidence between 18.7% and 62%. TNF alpha has a central role in disturbing this balance in bone metabolism--resulting in accelerated alveolar bone loss and decreased strength- i.e. osteoporosis. The investigators hypothesis that anti TNF therapy is effective in active AS resistant to conventional therapy and helps in improving the bone density and over all bone health.

Timeline

Start
2011-02
Primary completion
2011-12
Completion
2012-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Etanercept Protein / enzyme biologic 50 mg
Subject Infliximab Monoclonal antibody 3 mg/kg
Subject Infliximab Monoclonal antibody 5 mg/kg