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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00305539

Enrollment

Registered

2006-03-22

Start date

2006-05-31

Completion date

2011-05-31

Last updated

2012-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Giant Cell Arteritis

Keywords

Giant Cell Arteritis, Placebo, Anti-TNF, Multicenter-randomized-trial, Proved GCA according to ACR criteria (HUNDER et al 1990)

Brief 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.

Detailed description

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

Interventions

DRUGadalimumab

40 mg sc / for 3 months

DRUGplacebo

placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
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	1 year

Secondary

Measure	Time frame
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)	1 year
To determine the influence of an initial treatment of 3 months with adalimumab on the percentage of patients relapsing at one year	1 year

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 23, 2026