Juvenile Psoriatic Arthritis
Conditions
Brief summary
The primary endpoint is the achievement of JIA-ACR 30 response at Week 24.
Detailed description
Achievement of JIA-ACR 50/70/90 response at Week 24, Percent change from Baseline in individual components of JIA-CRV at Week 24., Change from Baseline in JADAS-10 and JADAS-27 at Week 24., Achievement of MDA at Week 24 (defined as JADAS-10 of ≤6), Achievement of inactive disease at Week 24 (defined as JADAS-10 of ≤2.7), Change from Baseline in cJADAS-10 and cJADAS-27 at Week 24., Change from Baseline in the Pain-VAS at Week 24, In subjects with PsO (at least 3% BSA at Baseline), achievement of PASI 75/90 at Week 24, In subjects with PsO (at least 3% BSA at Baseline), achievement of the sPGA of PsO of 'clear' or 'almost clear' (0/1) at Week 24., In subjects with PsO (at least 3% BSA at Baseline), change from Baseline in CDLQI at Week 24.
Interventions
Sponsors
AbbVie Deutschland GmbH & Co. KG
Eligibility
Sex/Gender
All
Age
0 Years to 17 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the achievement of JIA-ACR 30 response at Week 24. | — |
Secondary
| Measure | Time frame |
|---|---|
| Achievement of JIA-ACR 50/70/90 response at Week 24, Percent change from Baseline in individual components of JIA-CRV at Week 24., Change from Baseline in JADAS-10 and JADAS-27 at Week 24., Achievement of MDA at Week 24 (defined as JADAS-10 of ≤6), Achievement of inactive disease at Week 24 (defined as JADAS-10 of ≤2.7), Change from Baseline in cJADAS-10 and cJADAS-27 at Week 24., Change from Baseline in the Pain-VAS at Week 24, In subjects with PsO (at least 3% BSA at Baseline), achievement of PASI 75/90 at Week 24, In subjects with PsO (at least 3% BSA at Baseline), achievement of the sPGA of PsO of 'clear' or 'almost clear' (0/1) at Week 24., In subjects with PsO (at least 3% BSA at Baseline), change from Baseline in CDLQI at Week 24. | — |
Countries
France, Germany, Italy, Poland, Spain
Outcome results
None listed