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NCT Number: NCT01361542

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

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.

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Key information

Conditions

Ankylosing Spondylitis Ankylosis Arthritis Axial Spondyloarthritis Bone Diseases Joint Diseases Musculoskeletal Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis Spondylitis, Ankylosing

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

All India Institute of Medical Sciences

New Delhi, National Capital Territory of Delhi, 110029, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who are fulfilling the Modified New York Criteria(1984) for the diagnosis of Ankylosing Spondylitis
  • Age ≥ 18 years
  • Patients who have been planned to be started on anti Tnf alpha agents.
  • Patients who have given consent for the study.

Exclusion criteria

  • Patients with other coexistent rheumatologic diseases.
  • Patients who have previously received anti TNF alpha agents in the past 1 year.
  • Patients who are receiving other medications that may significantly alter the bone metabolism (like steroids, bisphosphonates, estrogen replacement therapy etc)
  • Patients with any contraindications against the usage of anti TNF alpha agents (Active/ chronic infections, liver dysfunction, demyelinating diseases, pregnancy etc)
  • Patients with other definite risk factors for osteoporosis like chronic alcoholism, smoking, endocrine disorders etc

Treatment and study plan

anti TNF alpha agent

Drug

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

Other names: Infliximab - REMICADE as brand name, Etanercept- ENBREL as brand name

Anti TNF alpha therapy

Drug

Infliximab 3-5 mg/kg as per recommended protocol or Etanercept 50mg/week for 1 year

Other names: REMICADE-infliximab, ENBREL-Etanercept

Primary outcomes

  1. Increase in bone mineral density and decrease in disease activity

    Time frame: 2 years

Secondary outcomes

  1. Observation of adverse effects of Anti TNF therapy

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

All India Institute of Medical Sciences

Other

Registry information

Official study title

Effect Of Anti TNF Alpha Therapy On Disease Activity And Bone Health, And Their Adverse Effects In Ankylosing Spondylitis In A North Indian Population

Important dates

Study start
2011
Primary completion
2011
Study completion
2012
First posted
May 27, 2011
Registry last updated
Jan 26, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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