HECTHOR: Humira to Spare Steroids in Giant Cell Arteritis

Assistance Publique - Hôpitaux de Paris

Status and phase: Completed; Phase 3

Conditions: Giant Cell Arteritis

Treatments: Drug: placebo; Drug: adalimumab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00305539

P041203

Details and patient eligibility

About

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.

Full description

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

Enrollment: 69 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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69 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Treatment:

Drug: adalimumab

2

Placebo Comparator group

Description:

placebo

Treatment:

Drug: placebo