Back to resultsHECTHOR: Humira to Spare Steroids in Giant Cell Arteritis
Primary Purpose
Giant Cell Arteritis
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
adalimumab
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Giant Cell Arteritis focused on measuring Giant Cell Arteritis, Placebo, Anti-TNF, Multicenter-randomized-trial, Proved GCA according to ACR criteria (HUNDER et al 1990)
Eligibility 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
Sites / Locations
- Hôpital Bicêtre
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
1
2
Arm Description
placebo
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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 determine the influence of an initial treatment of 3 months with adalimumab on the percentage of patients relapsing at one year
Full Information
NCT ID
NCT00305539
First Posted
March 21, 2006
Last Updated
July 6, 2012
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Abbott
1. Study Identification
Unique Protocol Identification Number
NCT00305539
Brief Title
HECTHOR: Humira to Spare Steroids in Giant Cell Arteritis
Official Title
HECTHOR: A Pilot Multicenter Double-blind Randomised Study of 3 Months Treatment With Humira Added to Steroids in Giant Cell Arteritis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Abbott
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Giant Cell Arteritis
Keywords
Giant Cell Arteritis, Placebo, Anti-TNF, Multicenter-randomized-trial, Proved GCA according to ACR criteria (HUNDER et al 1990)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
69 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
placebo
Intervention Type
Drug
Intervention Name(s)
adalimumab
Intervention Description
40 mg sc / for 3 months
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xavier Mariette, MD, PhD
Organizational Affiliation
Hôpital Bicêtre, APHP, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Bicêtre
City
Kremlin Bicêtre
ZIP/Postal Code
94270
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
23897775
Citation
Seror R, Baron G, Hachulla E, Debandt M, Larroche C, Puechal X, Maurier F, de Wazieres B, Quemeneur T, Ravaud P, Mariette X. Adalimumab for steroid sparing in patients with giant-cell arteritis: results of a multicentre randomised controlled trial. Ann Rheum Dis. 2014 Dec;73(12):2074-81. doi: 10.1136/annrheumdis-2013-203586. Epub 2013 Jul 29.
Results Reference
derived
Learn more about this trial
HECTHOR: Humira to Spare Steroids in Giant Cell Arteritis
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