HECTHOR: Humira to Spare Steroids in Giant Cell Arteritis

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00305539
• Date of registration: 21/03/2006
• Prospective Registration: Yes
• Primary sponsor: Assistance Publique - Hôpitaux de Paris
• Public title: HECTHOR: Humira to Spare Steroids in Giant Cell Arteritis
• Scientific title: HECTHOR: A Pilot Multicenter Double-blind Randomised Study of 3 Months Treatment With Humira Added to Steroids in Giant Cell Arteritis
• Date of first enrolment: May 2006
• Target sample size: 69
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00305539
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

France

Contacts

• Name: Xavier Mariette, MD, PhD
• Affiliation: Hôpital Bicêtre, APHP, France

Key inclusion & exclusion criteria

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



Age minimum: 50 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Giant Cell Arteritis

Intervention(s)

Drug: adalimumab

Drug: placebo

Primary Outcome(s)

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 Outcome(s)

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]

Secondary ID(s)

P041203

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Abbott