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HECTHOR: Humira to Spare Steroids in Giant Cell Arteritis

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ClinicalTrials.gov Identifier: NCT00305539
Recruitment Status : Completed
First Posted : March 22, 2006
Last Update Posted : July 10, 2012
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Giant Cell Arteritis Drug: adalimumab Drug: placebo Phase 3

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 69 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: HECTHOR: A Pilot Multicenter Double-blind Randomised Study of 3 Months Treatment With Humira Added to Steroids in Giant Cell Arteritis
Study Start Date : May 2006
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Adalimumab

Arm Intervention/treatment
Active Comparator: 1 Drug: adalimumab
40 mg sc / for 3 months

Placebo Comparator: 2
placebo
Drug: placebo
placebo




Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]
  2. 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 ]


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00305539


Locations
France
Hôpital Bicêtre
Kremlin Bicêtre, France, 94270
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Abbott
Investigators
Principal Investigator: Xavier Mariette, MD, PhD Hôpital Bicêtre, APHP, France

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00305539     History of Changes
Other Study ID Numbers: P041203
First Posted: March 22, 2006    Key Record Dates
Last Update Posted: July 10, 2012
Last Verified: July 2012

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Giant Cell Arteritis
Placebo
Anti-TNF
Multicenter-randomized-trial
Proved GCA according to ACR criteria (HUNDER et al 1990)

Additional relevant MeSH terms:
Arteritis
Giant Cell Arteritis
Polymyalgia Rheumatica
Vasculitis
Vascular Diseases
Cardiovascular Diseases
Vasculitis, Central Nervous System
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Skin Diseases, Vascular
Skin Diseases
Autoimmune Diseases
Immune System Diseases
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents