drugset / Trial / NCT00244179

New Immunomodulatory Therapy Strategies in Chronic Reactive Arthritis

NCT00244179

RandomizedParallel-groupOpen-labelEct

Summary

1. 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). 2. to investigate, whether one or more of the different therapy strategies cause an altered detection of bacterial DNA in the joint or colon. 3. to measure the antigen-specific and -unspecific immune response (predominantly t-cell response) during therapy and correlate it with the clinical course. 4. 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. 5. to compare cytokine-profiles of CD4- and CD8-positive T-cells from patients treated with infliximab to those treated with etanercept.

Timeline

Start
2003-01
Primary completion
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Infliximab Monoclonal antibody 1 mg/kg
Subject Infliximab Monoclonal antibody 5 mg/kg
Subject Infliximab Monoclonal antibody 10 mg/kg
Subject Leflunomide Small molecule
Subject Methotrexate Small molecule
Subject Sulfasalazine Small molecule
Subject interferon gamma Protein / enzyme biologic 50 ug Subcutaneous
Subject interferon gamma Protein / enzyme biologic 100 ug Subcutaneous
Subject interferon gamma Protein / enzyme biologic 150 ug Subcutaneous

Indications