Recruiting
Sponsor ID
20190531
A Study of Apremilast in Children With Oral Ulcers Associated With Behçet’s Disease or Juvenile Psoriatic Arthritis
Study Details
The primary objective of this study is to evaluate the long-term safety of apremilast in subjects 2 years of age or older with oral ulcers associated with Behçets disease or 5 years of age or older with active juvenile psoriatic arthritis that have completed Study 20190530 or Study 20190529.
Protocol Summary
Primary Outcome Measures
Number of Participants with Adverse Events
Timeframe: Up to approximately 4 years
Columbia-Suicide Severity rating Scale (C-SSRS)
Timeframe: Up to approximately 4 years
Tanner Staging
Timeframe: Up to approximately 4 years
Change from Baseline in Body Weight
Timeframe: Up to approximately 4 years
Change from Baseline in Height
Timeframe: Up to approximately 4 years
Change from Baseline in Body Mass Index (BMI)
Timeframe: Up to approximately 4 years
Number of Participants with Clinically Significant Changes in Vital Signs
Timeframe: Up to approximately 4 years
Number of Participants with Clinically Significant Changes in Laboratory Parameters
Timeframe: Up to approximately 4 years
Secondary Outcome Measures
Not Available
Locations
Location
Hospital Universitari i Politecnic La Fe
Valencia, Comunidad Valenciana, Spain, 46026
Status
Recruiting
Location
Hospital Universitario Ramon y Cajal
Madrid, Madrid, Spain, 28034
Status
Recruiting
Location
Meir Medical Center
Kfar Saba, Israel, 4428164
Status
Recruiting
Location
General Hospital of Thessaloniki Ippokrateio
Thessaloniki, Greece, 54642
Status
Recruiting
Location
Istanbul Universitesi Cerrahpasa Tip Fakultesi
Istanbul, Turkey, 34098
Status
Recruiting
Location
Umraniye Egitim ve Arastirma Hastanesi
Istanbul, Turkey, 34764
Status
Recruiting
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