Bosentan in the Treatment of Giant Cell Arteritis
ConditionGiant Cell Arteritis (GCA)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age50+
SponsorAssistance Publique - Hôpitaux de Paris
About this trial
The purpose of this study is to determine whether a treatment with 3 months of bosentan associated to standard therapy might be superior to glucocorticoids alone in term of failure free survival at 12 months
Eligibility criteria
Qualifiers
Patients having given their written informed consent prior to participation in the study
Patients affiliated with social security or CMU (profit or being entitled)
Age ≥50 years at disease onset
History of erythrocyte sedimentation rate (ESR) ≥ 50 mm/h or CRP ≥ 20 mg/L (not mandatory if TAB is positive: see below)
Disqualifiers
Patients under maintenance of justice, wardship or legal guardianship
Patient unable to give written informed consent prior to participation in the study
Patients included in other investigational therapeutic study within the previous 3 months
Patients suspected not to be observant to the proposed treatments
Trial design
Treatments tested in this trial
- Bosentan
- Glucocorticoids
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
Assistance Publique - Hôpitaux de Paris
Lead sponsor
URC-CIC Paris Descartes Necker Cochin
Collaborator
Source ClinicalTrials.gov