A Study of Apremilast in Children With Oral Ulcers Associated With Behçet's Disease or Juvenile Psoriatic Arthritis
Behçet's Disease, Juvenile Psoriatic Arthritis
About this trial
This is an interventional treatment trial for Behçet's Disease focused on measuring Oral Ulcers, Behçet's Disease, Juvenile Psoriatic Arthritis, Apremilast, AMG 407, Otezla
Eligibility Criteria
Inclusion Criteria: Informed consent / assent obtained Must have completed Week 52 on treatment on core study Age and sex specific body mass index (BMI) no lower in range than the 5th percentile on Centers for Disease Control (CDC growth chart) Willing to adhere to study visit schedule and protocol requirements Must have acceptable benefit/risk for continued treatment with apremilast Exclusion Criteria: Answer "yes" to any question on C-SSRS at Week 52 visit of core study Scheduled surgery or other interventions that would interrupt study participation Female participants of childbearing potential unwilling to use protocol specified method of contraception during treatment and for 30 days after last dose Female participants planning to become pregnant while on study through 30 days after last dose Female participants of childbearing potential with positive pregnancy test at Week 0 Known sensitivity to any products to be administered during dosing Not likely to be available to complete all protocol-required study visits
Sites / Locations
- Hospital Universitari i Politecnic La FeRecruiting
- Hospital Universitario Ramon y CajalRecruiting
- Umraniye Egitim ve Arastirma HastanesiRecruiting
Arms of the Study
Arm 1
Experimental
Apremilast
Participants with a weight between ≥ 12 kg to < 20 kg will receive apremilast 10 mg BID (twice a day), participants with a weight between ≥ 20 kg to < 50 kg will receive 20 mg BID, and participants with a weight ≥ 50 kg will receive apremilast 30 mg BID.