Overview

HECTHOR: Humira to Spare Steroids in Giant Cell Arteritis

Status:
Completed
Trial end date:
2011-05-01
Target enrollment:
0
Participant gender:
All
Summary
Hypothesis: In giant cell arteritis (GCA), a short initial treatment with anti-TNF may allow a faster decrease of steroids dosage and therefore avoid some of the adverse events of steroids.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborator:
Abbott
Treatments:
Adalimumab
Criteria
Inclusion Criteria:

- Age ≥ 50 years

- ACR criteria for Giant cell arteritis (HUNDER 1990)

- Positive Temporal artery biopsy

- Plus standard inclusion criteria for Humira protocols

Exclusion Criteria:

- Prednisone treatment for a different disease at a dose >15 mg/day

- Corticoid treatment for GCA more than 10 days

- GCA treatment with prednisone > 1 mg/kg whatever period of time

- GCA treatment with an anti-TNF, MTX, cyclosporine, cyclophosphamide, dapsone or
steroid bolus

- Recent, permanent or transient visual loss due to GCA and the presence of any specific
visual abnormality (diplopia, hallucination)

- Plus standard exclusion criteria for Humira protocols