Amantiades-Behcets disease Behcets disease
Conditions
Interventions
Randomization between placebo and Tracleer bid 125mg.
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Behcet disease (BD) patients classified according to the criteria according to the International study group for BD 2. BD patients not responding to their usual therapy (BDCAF > 20) 3. Non life -or sight threatening active disease. 3. Adequate birth control measures in women of childbearing age during and for 6 weeks after receiving the last administration. 4. The screening laboratory test results must meet the following criteria: § Hemoglobin >= 6.5 mmol/L. § WBC >= 3.0 x 109/L. § Neutrophils >= 1.5 x 109/L. § Platelets >= 100 x 109/L. § SGOT (AST), SGPT (ALT) and alkaline phosphatase levels must be within 3 times the upper limit of normal (ULN) range for the laboratory conducting the test. § Creatinine clearance > 20 ml/min. 5. Patient must be able to adhere to the study visit schedule and other protocol requirements. 6. The patient must be capable of giving informed consent and the consent must be obtained prior to any screening procedures.
Exclusion criteria
Exclusion criteria: 1. Age 3 times the ULN, Creatinine clearance of
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints · ET-1 levels in relation with BDCAF. · Study of cytokine patterns in relation with therapy and BDCAF. · T cell patterns in relation with therapy and BDCAF. | — |
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint · A decrease in the score in the BDCAF of > 10 in patients with BD with a BDCAF score of > 20. | — |
Countries
Netherlands
Outcome results
None listed