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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-003024-41 | EudraCT Number | ||
| 2023-503433-21 | Other Identifier | EU CT number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Apremilast | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apremilast | Drug | Oral tablets or liquid suspension |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events | Adverse events will be classified using the Medical Dictionary for Regulatory Activities (MedDRA) classification system. | Up to approximately 4 years |
| Columbia-Suicide Severity rating Scale (C-SSRS) | A questionnaire used to assess suicide risk. | Up to approximately 4 years |
| Tanner Staging | Tanner Staging of sexual development assessment will be used to assess sexual maturity. | Up to approximately 4 years |
| Change from Baseline in Body Weight | Up to approximately 4 years | |
| Change from Baseline in Height | Up to approximately 4 years | |
| Change from Baseline in Body Mass Index (BMI) | Up to approximately 4 years | |
| Number of Participants with Clinically Significant Changes in Vital Signs | Up to approximately 4 years | |
| Number of Participants with Clinically Significant Changes in Laboratory Parameters | Up to approximately 4 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amgen Call Center | Contact | 866-572-6436 | medinfo@amgen.com |
| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General Hospital of Thessaloniki Ippokrateio | Recruiting | Thessaloniki | 54642 | Greece | ||
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| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
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| Meir Medical Center |
| Recruiting |
| Kfar Saba |
| 4428164 |
| Israel |
| Hospital Universitari i Politecnic La Fe | Recruiting | Valencia | Valencia | 46026 | Spain |
| Hospital Universitario Ramon y Cajal | Recruiting | Madrid | 28034 | Spain |
| Hacettepe Universitesi Tip Fakultesi Hastanesi | Recruiting | Ankara | 06100 | Turkey (Türkiye) |
| Istanbul Universitesi Cerrahpasa Tip Fakultesi | Recruiting | Istanbul | 34098 | Turkey (Türkiye) |
| Umraniye Egitim ve Arastirma Hastanesi | Recruiting | Istanbul | 34764 | Turkey (Türkiye) |
| ID | Term |
|---|---|
| D001528 | Behcet Syndrome |
| D001171 | Arthritis, Juvenile |
| D019226 | Oral Ulcer |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D014606 | Uveitis, Anterior |
| D015864 | Panuveitis |
| D014605 | Uveitis |
| D014603 | Uveal Diseases |
| D005128 | Eye Diseases |
| D014657 | Vasculitis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D056660 | Hereditary Autoinflammatory Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D012873 | Skin Diseases, Genetic |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017445 | Skin Diseases, Vascular |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C505730 | apremilast |
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