HECTHOR: Humira to Spare Steroids in Giant Cell Arteritis

Sponsor
Assistance Publique - Hôpitaux de Paris
Study ID
NCT00305539
Phase
PHASE3
Status
Completed

Conditions

  • Giant Cell Arteritis

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • adalimumab — DRUG
    40 mg sc / for 3 months
  • placebo — DRUG
    placebo

Study Details

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.

Key Dates

Start date
May 31, 2006
Status verified
Jul 2012
Primary completion
May 31, 2011
Completion
May 31, 2011

Study Design

Enrollment
69 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: 1
  • Placebo Comparator: 2
    placebo

Primary Outcome Measure

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 ]

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