HECTHOR: Humira to Spare Steroids in Giant Cell Arteritis

Phase 3

Completed

• Conditions: Giant Cell Arteritis
• Interventions: Drug: adalimumab; Drug: placebo

• Registration Number: NCT00305539
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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

Study Timeline

• Study First Submitted: 2006-03-21
• Study First Submitted QC: 2006-03-21
• Study First Posted: 2006-03-22
• Study Start: 2006-05
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-06
• Last Update Posted: 2012-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

Inclusion Criteria

• Age ≥ 50 years
• ACR criteria for Giant cell arteritis (HUNDER 1990)
• Positive Temporal artery biopsy
• Plus standard inclusion criteria for Humira protocols

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	adalimumab	-
2	placebo	placebo

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hôpital Bicêtre; 🇫🇷 Kremlin Bicêtre, France