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

NCT01361542 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2012-01-26

No results posted yet for this study

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.

Conditions

Interventions

DRUG

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

DRUG

Anti TNF alpha therapy

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

Sponsors & Collaborators

  • All India Institute of Medical Sciences

    lead OTHER

Principal Investigators

  • Surendra K Sharma, MD, PhD · All India Institute of Medical Sciences

Study Design

Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2011-12-31
Completion
2012-01-31

Countries

  • India

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01361542 on ClinicalTrials.gov