A Study to Evaluate the Impact of Apremilast on Magnetic Resonance Imaging (MRI) Outcomes in Adul… (NCT03783026) | Clinical Trial Compass
CompletedPhase 4
A Study to Evaluate the Impact of Apremilast on Magnetic Resonance Imaging (MRI) Outcomes in Adults With Psoriatic Arthritis
United States123 participantsStarted 2019-02-06
Plain-language summary
This study is designed to assess the efficacy of apremilast, either in monotherapy or with stable methotrexate, on imaging outcomes in adults with active psoriatic arthritis with less than 5 years of disease duration (since diagnosis), and who are naïve to biologic therapies.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Males or females, aged ≥ 18 years at time of consent
✓. For all regions, the local Regulatory Label for treatment with apremilast must be followed.
✓. Must understand and voluntarily sign an informed consent document prior to any study related assessments/procedures being conducted
✓. Able to adhere to the study visit schedule and other protocol requirements
✓. Have a documented diagnosis of PsA of ≥ 3 months AND ≤ 5 years in duration, meeting the Classification Criteria for Psoriatic Arthritis (CASPAR) at the time of Screening Visit
✓. Have ≥ 3 swollen AND ≥ 3 tender joints, with hand involvement (defined as ≥ 1 swollen joint or dactylitis \[each clinically active joint of a dactylitic digit is counted as one joint\]).
✓. Have at least 1 active enthesitis site (one of the Spondyloarthritis Research Consortium of Canada \[SPARCC\] or Leeds Enthesitis Index \[LEI\] sites)
✓. Must not have been treated previously with a tumor necrosis factor (TNF) blocker or other biologic drug for PsA treatment
Exclusion criteria
✕. Contraindication to MRI examination including, but not limited to, intracranial metal clips, heart pacemakers, insulin pumps, implanted hearing aids, neurostimulators, metal hip replacements, profound claustrophobia or inability to lie in the MRI machine in an appropriate position to obtain quality images, history of hypersensitivity to gadolinium contrast agent
✕
What they're measuring
1
Change From Baseline in the Composite Score of BME, Synovitis, and Tenosynovitis Assessed by PsAMRIS at Week 24
. Severe renal impairment (creatinine clearance of less than 30 mL per minute estimated by the Cockroft-Gault equation), which would prevent the use of gadolinium enhancement
✕. History of clinically significant (as determined by the investigator) cardiac, endocrine, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic disease, or other major uncontrolled disease
✕. Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study
✕. Prior history of suicide attempt at any time in the subject's lifetime prior to signing the informed consent, or major psychiatric illness requiring hospitalization within the last 3 years prior to signing the informed consent.
✕. Pregnant or breast feeding
✕. Active substance abuse or a history of substance abuse within 6 months prior to screening
✕. History of allergy or hypersensitivity to any component of the IP