NCT00491933

Brief Summary

The purpose of this study is to evaluate the value of Quantiferon-TB Gold (QFT-G) assay in the screening for latent tuberculosis infection (LTBI) in rheumatologic patients due to start or on treatment with TNFα antagonists. The results of QFT-G will be compared to tuberculin skin testing (TST) and correlated to clinical and demographic data. The study hypothesis is that the inclusion of QTF-G in the screening strategy will allow a more accurate assessment of LTBI infection.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable rheumatoid-arthritis

Timeline
Completed

Started Jun 2007

Shorter than P25 for not_applicable rheumatoid-arthritis

Geographic Reach
1 country

1 active site

Status
unknown

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

June 1, 2007

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

June 25, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 26, 2007

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

June 26, 2007

Status Verified

June 1, 2007

First QC Date

June 25, 2007

Last Update Submit

June 25, 2007

Conditions

Rheumatoid ArthritisSpondylarthritisTuberculosis

Outcome Measures

Primary Outcomes (2)

  • Concordance between the QFT-G assay and the tuberculin skin test

  • Correlation of the test results to the patient's risk of LTBI

Secondary Outcomes (2)

  • Factors associated with discordance between the TST and the QFT-G test

  • Frequency of indeterminate results

Interventions

Quantiferon-TB Gold assayPROCEDURE
Tuberculin skin testPROCEDURE

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with rheumatological diseases being evaluated for treatment with TNFα antagonists or on treated with TNFα antagonists

You may not qualify if:

  • Unable to sign informed consent
  • Known hypersensitivity to tuberculin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rheumatology Unit, Ospedale L. Sacco Polo Universitario

Milan, 20157, Italy

RECRUITING

Related Publications (3)

  • Gomez-Reino JJ, Carmona L, Valverde VR, Mola EM, Montero MD; BIOBADASER Group. Treatment of rheumatoid arthritis with tumor necrosis factor inhibitors may predispose to significant increase in tuberculosis risk: a multicenter active-surveillance report. Arthritis Rheum. 2003 Aug;48(8):2122-7. doi: 10.1002/art.11137.

    PMID: 12905464BACKGROUND

  • British Thoracic Society Standards of Care Committee. BTS recommendations for assessing risk and for managing Mycobacterium tuberculosis infection and disease in patients due to start anti-TNF-alpha treatment. Thorax. 2005 Oct;60(10):800-5. doi: 10.1136/thx.2005.046797. Epub 2005 Jul 29.

    PMID: 16055611BACKGROUND

  • Ferrara G, Losi M, Meacci M, Meccugni B, Piro R, Roversi P, Bergamini BM, D'Amico R, Marchegiano P, Rumpianesi F, Fabbri LM, Richeldi L. Routine hospital use of a new commercial whole blood interferon-gamma assay for the diagnosis of tuberculosis infection. Am J Respir Crit Care Med. 2005 Sep 1;172(5):631-5. doi: 10.1164/rccm.200502-196OC. Epub 2005 Jun 16.

    PMID: 15961696BACKGROUND

MeSH Terms

Conditions

Arthritis, RheumatoidSpondylarthritisTuberculosis

Interventions

Tuberculin

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesSpondylitisSpinal DiseasesBone DiseasesMycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

Antigens, BacterialBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsAntigensBiological Factors

Study Officials

  • Marco Antivalle, MD

    Ospedale L. Sacco - Polo Universitario, Milano, Italy

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marco Antivalle, MD

CONTACT

+39023904marco.antivalle@fastwebnet.it

Luca Bertani, MD

CONTACT

+39023904luca-bertani@libero.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 25, 2007

First Posted

June 26, 2007

Study Start

June 1, 2007

Study Completion

October 1, 2007

Last Updated

June 26, 2007

Record last verified: 2007-06

Locations

IT(1)