Identification of Cytokine Profiles and T Cell Subsets Among Immunosuppressed Patients at Risk of Developing Active Tuberculosis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2005 by Hvidovre University Hospital.
Recruitment status was  Recruiting
Copenhagen Hospital Corporation
The Danish Rheumatism Association
Danish Lung Association
Information provided by:
Hvidovre University Hospital Identifier:
First received: January 31, 2006
Last updated: February 27, 2006
Last verified: December 2005
The purpose of this study is to identify differences in TB specific immune responses among immunosuppressed patients latently infected with TB and patients with active TB.

HIV Infections
Rheumatoid Arthritis

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Longitudinal

Resource links provided by NLM:

Further study details as provided by Hvidovre University Hospital:

Estimated Enrollment: 60
Study Start Date: November 2005
Estimated Study Completion Date: September 2008
Detailed Description:

Immunosuppressed patients latently infected with TB are at higher risk of developing active TB than patients with normal immune functions. Especially two patient categories are at risk: HIV positives and patients receiving TNF-a blocking medication. Existing methods of diagnosis and surveillance of latent TB infection can not identify who will develop active TB and who can control the infection. There is a need for better understanding of TB specific immune functions,as we believe deficient TB specific immune reactions is a key in reactivation of latent TB infection.

In this study we follow groups of latent TB infected patients with either rheumatoid arthritis or HIV. We follow the patients during treatment with TNF-a blocking medication, HAART treatment or prophylactic TB medication. Results are correlated to patients with active TB, latent TB and healthy controls.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Latent TB infection + rheumatid arthritis
  • Latent TB infection + HIV
  • Active TB

Exclusion Criteria:

  • Age < 18yrs
  • Pregnancy
  • Patients not able to understand the given information
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00285441

Contact: Morten Ruhwald, MD +45 36323632
Contact: Pernille Ravn, MD, Ph.d. +45 36323632

Infectious disease department University Hospital Hvidovre Recruiting
Copenhagen, Denmark, 2650
Sponsors and Collaborators
Hvidovre University Hospital
Copenhagen Hospital Corporation
The Danish Rheumatism Association
Danish Lung Association
Principal Investigator: Morten Ruhwald, MD University Hospital Hvidovre
  More Information

Additional Information: Identifier: NCT00285441     History of Changes
Other Study ID Numbers: KF-01-278477 
Study First Received: January 31, 2006
Last Updated: February 27, 2006
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by Hvidovre University Hospital:

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Actinomycetales Infections
Autoimmune Diseases
Bacterial Infections
Connective Tissue Diseases
Gram-Positive Bacterial Infections
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Mycobacterium Infections
Rheumatic Diseases processed this record on May 23, 2016