Bosentan in the Treatment of Giant Cell Arteritis
BOSICART
2 other identifiers
interventional
40
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jun 2026
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 24, 2025
CompletedFirst Posted
Study publicly available on registry
May 4, 2025
CompletedStudy Start
First participant enrolled
June 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2029
Study Completion
Last participant's last visit for all outcomes
June 1, 2030
May 6, 2026
April 1, 2026
3 years
March 24, 2025
April 30, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Failure free survival at Week 52
A failure is defined by the occurrence of a relapse or the impossibility to decrease Glucocorticoids according to the predefined scheduled Glucocorticoids scheme.
12 months ( Week 52)
Secondary Outcomes (11)
Proportion of new ischemic event
12 months (Week 52)
Proportion of patients in remission without prednisone
12 months (Week 52)
Proportion of patients in remission with prednisone ≤5 mg/day
12 months (Week 52)
Cumulative dose of prednisone
12 months (Week 52)
Proportion of patient in remission
2 years
- +6 more secondary outcomes
Study Arms (2)
Bosentan + Glucocorticoids
EXPERIMENTALBosentan : 62.5 mg bid for 4 weeks and 125 mg bid during 9 additional weeks Glucocorticoids : prespecified GC tapering schedule
Glucocorticoids
OTHERprespecified GC tapering schedule
Interventions
Bosentan : 62.5 mg twice a day for 4 weeks and 125 mg twice a day during 9 weeks (treatment length 3 months)
Eligibility Criteria
You may qualify if:
- Patients having given their written informed consent prior to participation in the study
- Patients affiliated with social security or CMU (profit or being entitled)
- Diagnosis of GCA, as defined by the revised GCA diagnosis criteria. Patients must satisfy criteria 1-2-3 and 4 (irrespective of time):
- 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)
- At least one of the following:
- unequivocal cranial symptoms of GCA (new onset headache, scalp tenderness, jaw claudication, temporal artery abnormality, ischemia-related vision loss)
- unequivocal symptoms of polymyalgia rheumatica (PMR)
- At least one of the following:
- Temporal artery biopsy (TAB) compatible with the diagnosis of GCA (non-necrotizing vasculitis with a predominance of mononuclear cell infiltration or granulomatous inflammation, usually with multinucleated giant cells)
- Evidence of large vessel vasculitis:
- angio-CT or angio-MRI: thickened and/or contrast-enhanced arteries especially aorta (≥2mm) and epiaortic arteries (≥1mm) and contrast enhanced arteries in T1-weighted sequences
- or PET scan: ≥ grade 2 (from 0 to 3) tracer uptake on large arteries
- At least a sign of active GCA within the 2 weeks prior to randomisation. Active GCA is defined by ESR ≥30 mm/h or CRP ≥10 mg/L and at least one of the following:
- unequivocal cranial symptoms of GCA (new onset localized headache, scalp or temporal artery tenderness, ischemia-related vision loss, or otherwise unexplained mouth or jaw pain upon mastication)
- +2 more criteria
You may not qualify if:
- 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
- Weight \<40 Kg or \> 100 Kg
- Moderate to severe hepatic impairment, i.e., Child-Pugh class B or C. History of chronic alcohol abuse (consumption \> 20 g/day)
- Severe chronic heart failure or severe systolic dysfunction
- Recent (\< 3 months) or incoming surgery requiring a general anaesthesia
- Hypersensitivity to bosentan or one of its excipients
- Prior treatment with any of the following:
- Cell-depleting agents (i.e., anti-CD20)
- Alkylating agents including cyclophosphamide
- Ongoing treatment with glibenclamide, fluconazole and rifampicin. Concomitant administration of both a CYP3A4 inhibitor or a CYP2C9 inhibitor
- Long-course systemic glucocorticoid therapy for other conditions than GCA or PMR
- Laboratory abnormalities: AST or ALT \>3 x upper limit of normal (ULN)
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unité de Recherche Clinique, Entrepôts de données et Pharmacologie GHU Paris Centre
Paris, 75005, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Luc MOUTHON, Pr
Hôpital Cochin, Department of Internal Medicine - 75014, Paris
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 24, 2025
First Posted
May 4, 2025
Study Start (Estimated)
June 1, 2026
Primary Completion (Estimated)
June 1, 2029
Study Completion (Estimated)
June 1, 2030
Last Updated
May 6, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share