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HECTHOR: Humira to Spare Steroids in Giant Cell Arteritis

This study has been completed.
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00305539
First received: March 21, 2006
Last updated: July 6, 2012
Last verified: July 2012
History of Changes
  Purpose

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 Intervention Phase
Giant Cell Arteritis
 Drug: adalimumab
Drug: placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

Drug Information available for: Adalimumab
U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

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 [ Time Frame: 1 year ] [ Designated as safety issue: No ]

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) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 69
Study Start Date: May 2006
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Drug: adalimumab
40 mg sc / for 3 months
Other Name: ADALIMUMAB
Placebo Comparator: 2
placebo
 Drug: placebo
placebo
Other Name: placebo

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00305539     History of Changes
Other Study ID Numbers: P041203
Study First Received: March 21, 2006
Last Updated: July 6, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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
Vascular Diseases
Cardiovascular Diseases
Vasculitis
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
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 16, 2013