An interventional study of anti TNF alpha agent and Anti TNF alpha therapy in Ankylosing Spondylitis, sponsored by All India Institute of Medical Sciences, New Delhi. Completed at 1 site in India. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2012-01-26.
Sponsored by All India Institute of Medical Sciences, New Delhi · Not applicable, Interventional, and Health services research
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.
Ankylosing spondylitis not responding to conventional therapy has been effectively treated with Anti TNF therapy. In addition studies have shown that TNF has a role in osteoporosis of inflammatory diseases. The hypothesis that anti TNF therapy may decrease osteoporosis and tilt bone metabolism to the osteoblastic side has been tested in few studies. These have not been studied in an Indian population. Another great issue in the usage of anti TNF therapy in Indian population is the high incidence of developing infective complications; especially tuberculosis. The investigators are thus studying these in a north Indian population at a tertiary centre. The results would come to important conclusions regarding treatment and in the important issue of tuberculosis screening and prevention.
623 studies on the registry are indexed under Spondylitis; 83 are open to participants now.
This study's enrollment of 24 is below the median of 92 across 349 interventional studies indexed under Spondylitis.
Browse Spondylitis studies →All India Institute of Medical Sciences, New Delhi is the lead sponsor of 146 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Anti TNF alpha therapy including either infliximab or etanercept with data obtained before and after the study duration.
Drug: anti TNF alpha agent · Drug: Anti TNF alpha therapy
Anti TNF alpha therapy included either INFLIXIMAB or ETANERCEPY Infliximab at 3-5 mg/kg at recommended protocols for the duration of the study Etanercept at 50mg weekly for the duration of the study
Also known as: Infliximab - REMICADE as brand name, Etanercept- ENBREL as brand name
Infliximab 3-5 mg/kg as per recommended protocol or Etanercept 50mg/week for 1 year
Also known as: REMICADE-infliximab, ENBREL-Etanercept
Increase in bone mineral density and decrease in disease activity
Time frame: 2 years
Observation of adverse effects of Anti TNF therapy
Time frame: 2 years
This study is completed, as verified in Jan 2012. You cannot join it, but the record below documents what was studied.
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All India Institute of Medical Sciences, New Delhi