Assessment of the Clinical and Ultrasound Response to Apremilast by Clinical Evaluation and by a … (NCT03191539) | Clinical Trial Compass
UnknownPhase 3
Assessment of the Clinical and Ultrasound Response to Apremilast by Clinical Evaluation and by a Joint-periarticular-nail Ultrasound Index in Patients With Active Psoriatic Arthritis
56 participantsStarted 2017-11-02
Plain-language summary
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
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Adults 18 years of age or older with Psoriatic Arthritis (PsA) according to Classification Criteria for Psoriatic Arthritis (CASPAR) criteria at the time of selection, with involvement of hands and/or feet with active clinical disease (more than two swollen joints)
* Present 2 or more joints with ultrasound synovitis at the screening visit
* Present 1 or more entheses affected as shown by ultrasound at the screening visit
* Accept and sign the informed consent of the study
* Ability to comply with all tests and visits of specified protocol and have a permanent address.
* Women of childbearing potential must have a negative pregnancy test at the baseline visit. Women of childbearing potential who participate in the study should use one of the following contraceptive methods throughout the trial and for at least 28 days after taking the last dose of study medication.
* Approved contraceptive options are:
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:
* Concomitant treatment wi…