To assess the efficacy and safety of Etanercept in patients with spondylarthropathy and refractory heel enthesitis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
24
50 mg injection once weekly
placebo
Unnamed facility
Arles, France
Unnamed facility
Avignon, France
Unnamed facility
Bordeaux, France
Unnamed facility
Grenoble, France
Normalized Net Incremental Area Under the Curve (AUC) for Patient Global Assessment of Disease Activity (PGA) Between Randomization and Week 12
PGA was measured using a 100mm Visual Analog Scale (VAS) ranging from 0=very good to 100=very bad. The normalized net incremental area under the curve of the PGA is the area between the baseline and the PGA curve as a function of time (week 2, 4, 8, 12). AUC was computed using the linear trapezoidal method. All the areas above the baseline and under the curve are positive and all the area below the baseline and above the curve are negative. The net incremental AUC is the sum of these areas. This result is then divided by the study duration of the patients. (negative value = improvement).
Time frame: 12 weeks
Change From Baseline in Patient Global Assessment of Disease Activity Score at Week 12
The patient global assessment of disease activity was measured using a 100mm Visual Analog Scale (VAS) ranging from 0=very good to 100=very bad. Change=12 week score minus baseline score. A negative score indicates an improvement in disease activity and a positive score indicates worsening.
Time frame: Baseline and 12 weeks
Number of Patients Achieving a 50% Response on the Patient Global Assessment of Disease Activity
A response is defined as at least a 50% improvement (decrease) from baseline in the patient global assessment of disease activity. The patient global assessment of disease activity was measured using a 100mm Visual Analog Scale (VAS) ranging from 0=very good to 100=very bad.
Time frame: 12 weeks
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Unnamed facility
Montpellier, France
Unnamed facility
Nice, France
Unnamed facility
Orléans, France
Unnamed facility
Paris (Bichat), France
Unnamed facility
Paris (cochin), France
Unnamed facility
Paris (Pitie Salpetriere), France
...and 5 more locations