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