Status:
COMPLETED
HECTHOR: Humira to Spare Steroids in Giant Cell Arteritis
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Abbott
Conditions:
Giant Cell Arteritis
Eligibility:
All Genders
50+ years
Phase:
PHASE3
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
Eligibility Criteria
Inclusion
- Age ≥ 50 years
- ACR criteria for Giant cell arteritis (HUNDER 1990)
- Positive Temporal artery biopsy
- Plus standard inclusion criteria for Humira protocols
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT00305539
Start Date
May 1 2006
End Date
May 1 2011
Last Update
July 10 2012
Active Locations (1)
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1
Hôpital Bicêtre
Le Kremlin-Bicêtre, France, 94270