NCT01361542

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 24, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 27, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

January 26, 2012

Status Verified

January 1, 2012

Enrollment Period

10 months

First QC Date

May 24, 2011

Last Update Submit

January 25, 2012

Conditions

Ankylosing Spondylitis

Keywords

TNFBMDAnkylosing spondylitisbone healthAnti TNF therapyDisease activity

Outcome Measures

Primary Outcomes (1)

  • Increase in bone mineral density and decrease in disease activity

    2 years

Secondary Outcomes (1)

  • Observation of adverse effects of Anti TNF therapy

    2 years

Study Arms (1)

Anti TNF

EXPERIMENTAL

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

Drug: anti TNF alpha agentDrug: Anti TNF alpha therapy

Interventions

anti TNF alpha agentDRUG

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
Anti TNF
Anti TNF alpha therapyDRUG

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

Also known as: REMICADE-infliximab, ENBREL-Etanercept
Anti TNF

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

All India Institute of Medical Sciences

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

Location

Related Publications (1)

  • 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.

    PMID: 15517638RESULT

MeSH Terms

Conditions

Spondylitis, Ankylosing

Interventions

EtanerceptInfliximab

Condition Hierarchy (Ancestors)

Axial SpondyloarthritisSpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesAnkylosisJoint DiseasesArthritis

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc FragmentsImmunoglobulin FragmentsPeptide FragmentsPeptidesAmino Acids, Peptides, and ProteinsImmunoglobulin Constant RegionsImmunoglobulinsImmunoproteinsBlood ProteinsProteinsSerum GlobulinsGlobulinsReceptors, Tumor Necrosis FactorReceptors, CytokineReceptors, ImmunologicReceptors, Cell SurfaceMembrane ProteinsAntibodies, MonoclonalAntibodies

Study Officials

  • Surendra K Sharma, MD, PhD

    All India Institute of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Head

Study Record Dates

First Submitted

May 24, 2011

First Posted

May 27, 2011

Study Start

February 1, 2011

Primary Completion

December 1, 2011

Study Completion

January 1, 2012

Last Updated

January 26, 2012

Record last verified: 2012-01

Locations

IN(1)