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

Primary Purpose

Ankylosing Spondylitis

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
anti TNF alpha agent
Anti TNF alpha therapy
Sponsored by
All India Institute of Medical Sciences, New Delhi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Ankylosing Spondylitis focused on measuring TNF, BMD, Ankylosing spondylitis, bone health, Anti TNF therapy, Disease activity

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • All India Institute of Medical Sciences

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Anti TNF

Arm Description

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

Outcomes

Primary Outcome Measures

Increase in bone mineral density and decrease in disease activity

Secondary Outcome Measures

Observation of adverse effects of Anti TNF therapy

Full Information

First Posted
May 24, 2011
Last Updated
January 25, 2012
Sponsor
All India Institute of Medical Sciences, New Delhi
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1. Study Identification

Unique Protocol Identification Number
NCT01361542
Brief Title
Effect Of Anti TNF Alpha Therapy And Their Adverse Effects In Ankylosing Spondylitis In A North Indian Population
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
All India Institute of Medical Sciences, New Delhi

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankylosing Spondylitis
Keywords
TNF, BMD, Ankylosing spondylitis, bone health, Anti TNF therapy, Disease activity

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Anti TNF
Arm Type
Experimental
Arm Description
Anti TNF alpha therapy including either infliximab or etanercept with data obtained before and after the study duration.
Intervention Type
Drug
Intervention Name(s)
anti TNF alpha agent
Other Intervention Name(s)
Infliximab - REMICADE as brand name, Etanercept- ENBREL as brand name
Intervention Description
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
Intervention Name(s)
Anti TNF alpha therapy
Other Intervention Name(s)
REMICADE-infliximab, ENBREL-Etanercept
Intervention Description
Infliximab 3-5 mg/kg as per recommended protocol or Etanercept 50mg/week for 1 year
Primary Outcome Measure Information:
Title
Increase in bone mineral density and decrease in disease activity
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Observation of adverse effects of Anti TNF therapy
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Surendra K Sharma, MD, PhD
Organizational Affiliation
All India Institute of Medical Sciences, New Delhi
Official's Role
Principal Investigator
Facility Information:
Facility Name
All India Institute of Medical Sciences
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110029
Country
India

12. IPD Sharing Statement

Citations:
PubMed Identifier
15517638
Citation
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.
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Effect Of Anti TNF Alpha Therapy And Their Adverse Effects In Ankylosing Spondylitis In A North Indian Population

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