HECTHOR: Humira to Spare Steroids in Giant Cell Arteritis

NCT00305539 | Completed Phase 3

• 1 other identifier: P041203
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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.

Conditions

Giant Cell Arteritis

Keywords

Giant Cell Arteritis; Placebo; Anti-TNF; Multicenter-randomized-trial; Proved GCA according to ACR criteria (HUNDER et al 1990)

Outcome Measures

Primary Outcomes (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

  1 year

Secondary Outcomes (2)

• 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

Study Arms (2)

1

ACTIVE COMPARATOR

Drug: adalimumab

2

PLACEBO COMPARATOR

placebo

Drug: placebo

Interventions

adalimumab DRUG

40 mg sc / for 3 months

1

placebo DRUG

placebo

2

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 50 years
• ACR criteria for Giant cell arteritis (HUNDER 1990)
• Positive Temporal artery biopsy

You may not qualify if:

• 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)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Abbott: collaborator

Study Sites (1)

Hôpital Bicêtre

Le Kremlin-Bicêtre, 94270, France

Location

Related Publications (1)

• 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.

  PMID: 23897775 DERIVED

MeSH Terms

Conditions

Giant Cell Arteritis

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

Vasculitis, Central Nervous System; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arteritis; Vasculitis; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Xavier Mariette, MD, PhD

  Hôpital Bicêtre, APHP, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2006
• First Posted: March 22, 2006
• Study Start: May 1, 2006
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: July 10, 2012

Record last verified: 2012-07

Locations

FR (1)