HECTHOR: Humira to Spare Steroids in Giant Cell Arteritis

Giant Cell Arteritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00305539
• Other study ID #: P041203
• Status: Completed
• Phase: Phase 3
• First received: March 21, 2006
• Last updated: July 6, 2012
• Start date: May 2006
• Est. completion date: May 2011

Study information

• Verified date: July 2012
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arteritis
• Giant Cell Arteritis
• Polymyalgia Rheumatica

Intervention

Drug:
• adalimumab
40 mg sc / for 3 months
• placebo
placebo

Locations

Country	Name	City	State
France	Hôpital Bicêtre	Kremlin Bicêtre

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Abbott

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes
Secondary	To determine the influence of an initial treatment of 3 months with adalimumab on the percentage of patients relapsing at one year		1 year	Yes