Clinical Trial: New Immunomodulatory Therapy Strategies in Chronic Reactive Arthritis
Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional
Official Title: New Immunomodulatory Therapy Strategies in Chronic Reactive Arthritis: Immunostimulation Plus Antibiotic Versus Immunosuppression Plus Antibiotic Versus Conventional Stand
Brief Summary:
- to investigate, whether one of the two alternative therapy strategies (antibiotic plus immunostimulation versus antibiotic plus immunosuppression) in chronic reactive arthritis is therapeutical superior to conventionel standardtherapy (DMARD).
- to investigate, whether one or more of the different therapy strategies cause an altered detection of bacterial DNA in the joint or colon.
- to measure the antigen-specific and -unspecific immune response (predominantly t-cell response) during therapy and correlate it with the clinical course.
- to gain knowledge from these analyses and the clinical course concerning the pathogenesis and the point of attack for possible therapies in chronic reactive arthritis.
- to compare cytokine-profiles of CD4- and CD8-positive T-cells from patients treated with infliximab to those treated with etanercept.
Detailed Summary:
Studybackground Enteric reactive arthritis (ReA) is an extraintestinal manifestation of an infection of colon mucosa caused by enterobacteria. At least in the chronic courses of ReA a bacterial persistence can be assumed which is most likely to be located in colon mucosa or colon associated lymph nodes. The persistence of bacteria might be in consequence of an insufficient t-helper-immune-response.
On the other hand the persistence of the pathogen itself could be harmless and the local immune-pathology could be caused by a hypersensitivity immune response The project in hand shall assess whether 1.) immune stimulation or immune suppression is the best therapy for chronic reactive arthritis and 2.) enteric reactive arthritis is based on bacterial persistence or a hypersensitivity immune response.
By gaining these data we hope to be able to draw conclusions concerning the pathogenesis and therapies of other infections that affect the mucosa.
ReA occurs after infection of the intestine (enteric ReA) or after urogenital infection caused by chlamydia (urogenital ReA). Both forms of ReA are pathogenetically und immunogenically closely related and are treated as one entity.
Patients who are enrolled in the trial with enteric ReA (colon as possible location of bacterial persistence), not those with urogenital ReA (location of bacterial persistence not known) undergo colonoscopy before and after treatment-period to obtain colon biopsies for further work up.
Patients with knee involvement (arthritis of knee) undergo arthroscopy before and after treatment-period to obtain synovial biopsies for further work up.
Recently collected data for
Sponsor: Charite University, Berlin, Germany
Current Primary Outcome:
- change in intensity of pain (VAS pain, scale 0-10)
- change in funcion (WOMAC)
Original Primary Outcome: Same as current
Current Secondary Outcome:
- decrease of CRP/ESR
- change of cytokine response
- change of DNA detection
- number of swollen and tender joints
- number of entheseal localisations
- improvement of quality of life, „Short form 36“ (SF-36)
- BASDAI (disease activity index)
- Reduction of NSAIDs
- Patient`s global (scale 0-10).
- Physician`s global (scale 0-10).
Original Secondary Outcome: Same as current
Information By: Charite University, Berlin, Germany
Dates:
Date Received: October 24, 2005
Date Started: January 2003
Date Completion:
Last Updated: September 7, 2006
Last Verified: September 2006
