HECTHOR: Humira to Spare Steroids in Giant Cell Arteritis

HECTHOR: A Pilot Multicenter Double-blind Randomised Study of 3 Months Treatment With Humira Added to Steroids in Giant Cell Arteritis

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.

The protocol consists of a SC injection of adalimumab or placebo every 2 weeks for 10 weeks added to steroids

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