Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Bosentan

    Drug

    Bosentan : 62.5 mg twice a day for 4 weeks and 125 mg twice a day during 9 weeks (treatment length 3 months)

  • Glucocorticoids

    Drug

    prespecified GC tapering schedule

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Bosentan + GlucocorticoidsExperimental treatment 1 intervention
Group B: GlucocorticoidsOther 1 intervention

Trial outcomes

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.

Time frame
12 months ( Week 52)

Secondary outcomes

1

Proportion of new ischemic event

Time frame
12 months (Week 52)
2

Proportion of patients in remission without prednisone

Proportion of patients in remission without prednisone

Time frame
12 months (Week 52)
3

Proportion of patients in remission with prednisone ≤5 mg/day

Time frame
12 months (Week 52)
4

Cumulative dose of prednisone

Time frame
12 months (Week 52)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assistance Publique - Hôpitaux de Paris

Lead sponsor

URC-CIC Paris Descartes Necker Cochin

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: