Clinical Trial: HECTHOR: Humira to Spare Steroids in Giant Cell Arteritis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary: The protocol consists of a SC injection of adalimumab or placebo every 2 weeks for 10 weeks added to steroids
Sponsor: Assistance Publique - Hôpitaux de Paris

Current Primary Outcome: 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 ]

Original Primary Outcome: 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

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome:

  • - 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)
  • - To assess safety of a treatment of 3 months with adalimumab, 40 mg every other week, in giant cell arteritis
  • - To determine the influence of an initial treatment of 3 months with adalimumab on the percentage of patients relapsing at one year


Information By: Assistance Publique - Hôpitaux de Paris

Dates:
Date Received: March 21, 2006
Date Started: May 2006
Date Completion:
Last Updated: July 6, 2012
Last Verified: July 2012