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

NCT ID: NCT01361542

Last Updated: 2012-01-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2012-01-31

Brief 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.

Detailed Description

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.

Conditions

Ankylosing Spondylitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Anti TNF

Anti TNF alpha therapy including either infliximab or etanercept with data obtained before and after the study duration.

Group Type: EXPERIMENTAL

anti TNF alpha agent

Intervention Type: 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

Anti TNF alpha therapy

Intervention Type: DRUG

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

Interventions

anti TNF alpha agent

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

Intervention Type: DRUG

Anti TNF alpha therapy

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

Intervention Type: DRUG

Other Intervention Names

Infliximab - REMICADE as brand name; Etanercept- ENBREL as brand name; REMICADE-infliximab; ENBREL-Etanercept

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

All India Institute of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

S.K.SHARMA

Professor and Head

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Surendra K Sharma, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

All India Institute of Medical Sciences

Locations

All India Institute of Medical Sciences

New Delhi, National Capital Territory of Delhi, India

Countries

India

References

Franck H, Meurer T, Hofbauer LC. Evaluation of bone mineral density, hormones, biochemical markers of bone metabolism, and osteoprotegerin serum levels in patients with ankylosing spondylitis. J Rheumatol. 2004 Nov;31(11):2236-41.

Reference Type: RESULT

PMID: 15517638 (View on PubMed)

Other Identifiers

SKS/ASTNF/TB/2011

Identifier Type: -

Identifier Source: org_study_id