Skip to main content
OpenTrials
Completed

NCT Number: NCT00305539

HECTHOR: Humira to Spare 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Giant Cell Arteritis Arteritis Autoimmune Diseases Autoimmune Diseases of the Nervous System Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Immune System Diseases Nervous System Diseases Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Vascular Diseases Vasculitis Vasculitis, Central Nervous System

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hôpital Bicêtre

Le Kremlin-Bicêtre, 94270, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Adalimumab

Drug

40 mg sc / for 3 months

Placebo

Drug

placebo

Primary outcomes

  1. 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

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Abbott

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2011
Study completion
2011
First posted
Mar 22, 2006
Registry last updated
Jul 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.