HECTHOR: Humira to Spare Steroids in Giant Cell Arteritis

Assistance Publique - Hôpitaux de Paris69 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Giant Cell Arteritis

Interventions

adalimumabDRUG

40 mg sc / for 3 months

placeboDRUG

placebo

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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

Locations (1)

Hôpital Bicêtre

Le Kremlin-Bicêtre, France

Outcomes

Primary Outcomes

To determine the influence of an initial treatment of 3 months with adalimumab, 40 mg every other week, in the percentage of patients achieving at 6 months (week 26), a decrease in their corticosteroid treatment to a dose equal or lower than 0,1 mg/kg

Time frame: 1 year

Secondary Outcomes

To determine the influence of an initial treatment of 3 months with adalimumab on the total dose of corticosteroids determined by AUC (area under the curve)

Time frame: 1 year

To determine the influence of an initial treatment of 3 months with adalimumab on the percentage of patients relapsing at one year

Time frame: 1 year

Data from ClinicalTrials.gov

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