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| Name | Class |
|---|---|
| Celgene Corporation | INDUSTRY |
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This study aims to evaluate more objectively, through an imaging technique such as ultrasound, changes in joints and entheses of patients with active psoriatic arthritis (PAs) who will start treatment with Apremilast after the failure of other therapies such as synthetic DMARD (metrotrexato , Leflunomide ...).
The hypothesis of the study is that the technique of ultrasound can demonstrate the efficacy of Apremilast in the treatment of patients with active PAs
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Apremilast | Experimental | 30 mg of Apremilast twice a day during 52 weeks. During the first 6 days will be a dose escalation as the following: Day 1: 10 mg daily Day 2: 10 mg day- 10 mg night Day 3: 10 mg day- 20 mg night Day 4: 20mg day- 20mg night Day 5: 20 mg day- 30 mg night Day 6: 30 mg day- 30 mg night |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apremilast | Drug | 30 mg twice a day during 52 weeks. In the first 6 days will be a dose escalation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in the ultrasound index | Reduction in the ultrasound index at 12 months after the introduction of Apremilast in the study patients | screening visit, baseline visit, visit 1 month, visit 6 months, visit 9 months and visit 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Activity Score (DAS 28) | screening visit, baseline visit, visit 1 month, visit 6 months, visit 9 months and visit 12 months | |
| Psoriasis activity and severity index (PASI) | screening visit, baseline visit, visit 1 month, visit 6 months, visit 9 months and visit 12 months |
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Inclusion Criteria:
Option 1: Any of the following: hormonal contraceptives (e.g., birth control pills, injection, implant, transdermal patch, vaginal ring); intrauterine device (IUD); tubal ligation; or her partner has had a vasectomy OR Option 2: Male or female condom (a latex condom or non-latex condom but NOT made of natural membrane [animal, e.g., polyurethane]) AND one of the following additional barrier methods: a) diaphragm with spermicide; B) cervical cap with spermicide; or c) contraceptive sponge with spermicide.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Juan José de AgustÃn de Oro, MD | Contact | 93 489 30 00 | jjdagust@vhebron.net |
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| Leeds Enthesitis Index (LEI) | screening visit, baseline visit, visit 1 month, visit 6 months, visit 9 months and visit 12 months |
| Number of tender and swollen joints assessed by (Number of Tender Joints (NTJ) ) | screening visit, baseline visit, visit 1 month, visit 6 months, visit 9 months and visit 12 months |
| Patient Visual Analog Scale (VAS) for pain | screening visit, baseline visit, visit 1 month, visit 6 months, visit 9 months and visit 12 months |
| Ultrasonic nail injuries | screening visit, baseline visit, visit 1 month, visit 6 months, visit 9 months and visit 12 months |
| Clinical Disease Activity Index (CDAI) | screening visit, baseline visit, visit 1 month, visit 6 months, visit 9 months and visit 12 months |
| Simple Disease Activity Index (SDAI) | screening visit, baseline visit, visit 1 month, visit 6 months, visit 9 months and visit 12 months |
| Number of tender and swollen joints assessed by (Number os swollen joints (NSJ)) | screening visit, baseline visit, visit 1 month, visit 6 months, visit 9 months and visit 12 months |
| doctor Visual Analog Scale (VAS) for pain | screening visit, baseline visit, visit 1 month, visit 6 months, visit 9 months and visit 12 months |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C505730 | apremilast |
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