Giant Cell Arteritis and Anakinra Trial
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Giant Cell Arteritis
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 51 years and 125 years
- Gender
- Both males and females
Description
Side assumptions investigators made are that the patients receiving anakinra in add-on therapy will have: a time and a complete remission rate respectively shorter and higher, fewer relapses and a decrease of the total consumption of prednisone over a 12- month follow-up. This controlled study is th...
Side assumptions investigators made are that the patients receiving anakinra in add-on therapy will have: a time and a complete remission rate respectively shorter and higher, fewer relapses and a decrease of the total consumption of prednisone over a 12- month follow-up. This controlled study is the first to assess the inhibition of the IL- 1 pathway in the GCA with anakinra in add-on therapy with corticosteroids in patients newly diagnosed or on relapse. The purpose of this work is to support the following proof of concept of the addition of anakinra to corticosteroid therapy in the treatment of GCA: potential synergies of this association and intrinsic therapeutic action of anakinra in patient newly diagnosed, and this without loss of opportunity for patients that will benefit all of the reference treatment. The other originality of this study is to demonstrate the steroid-sparing effect of targeting interleukin -1, which is per se a therapeutic and nosologic innovation for this disease. Finally, ancillary biological studies will clarify the mode of action of the anti-cytokine therapy and identify markers of response to this biotherapy.
Tracking Information
- NCT #
- NCT02902731
- Collaborators
- Hôpital Claude-Huriez
- Amiens University Hospital
- University Hospital, Rouen
- University Hospital, Limoges
- Central Hospital Saint Quentin
- Valenciennes Hospital, Valenciennes, FRANCE
- Investigators
- Principal Investigator: Achille AOUBA, MD PHD CHU CAEN