Psoriatic arthritis MedDRA version: 21.0 Level: LLT Classification code 10037160 Term: Psoriatic arthritis System Organ Class: 100000004859
Conditions
Sponsors
Amgen Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males or females, aged = 18 years at time of consent 2. For all regions, the local Regulatory Label for treatment with apremilast must be followed. For example, subjects in the EU must have had inadequate response or intolerance to a prior csDMARD. 3. Must understand and voluntarily sign an informed consent document prior to any study related assessments/procedures being conducted 4. Able to adhere to the study visit schedule and other protocol requirements 5. Have a documented diagnosis of PsA of = 3 months AND = 5 years in duration, meeting the CASPAR criteria for PsA (Appendix B, Taylor, 2006) at the time of Screening Visit 6. 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]). 7. Have at least 1 active enthesitis site (one of the SPARCC or LEI sites) 8. Must not have been treated previously with a TNF blocker or other biologic drug for PsA treatment 9. Must not have been treated with more than 2 csDMARDs 10. Subjects taking csDMARDs, with the exception of MTX, cyclosporine, or LEF (see Section 4.4, Exclusion Criterion 18, 19 and 20), do not require a washout period. However, they must discontinue the csDMARD treatment at least one day prior to their Baseline Visit (ie, Visit 2, Day 1) 11. Subjects who have been previously treated with MTX for < 6 months and who are not on stable doses for at least 3 months will require a 28-day washout prior to the Baseline Visit (ie, Visit 2, Day 1) to participate in the study 12. Subjects who have been previously treated with LEF will require a 12-week washout prior to the Baseline Visit (ie, Visit 2, Day 1), or treatment with cholestyramine, per LEF prescribing label (ie, 8 g cholestyramine 3 times daily for 11 days) 13. Subjects who have been previously treated with cyclosporine will require a 28-day washout prior to the Baseline Visit (ie, Visit 2, Day 1) to participate in the study 14. If taking MTX (= 25 mg/week), continuity of treatment will be allowed if duration of treatment is = 6 months and on a stable dose for at least 3 months prior to the Baseline Visit (ie, Visit 2, Day 1) 15. If taking oral glucocorticoids, must be on a stable dose of prednisone = 10 mg/day or equivalent for at least 4 weeks prior to the Baseline Visit (ie, Visit 2, Day 1) 16. If taking NSAIDs or narcotic analgesics, must be on stable dose for at least 4 weeks prior to Baseline Visit (ie, Visit 2, Day 1) 17. A female of childbearing potential (FCBP)† must have a negative pregnancy test at screening and baseline. While on IP and for at least 28 days after taking the last dose of IP, a FCBP who engages in activity in which conception is possible must use one of the approved contraceptive§ options described below: Option 1: Any one of the following highly effective methods: hormonal contraception (oral, injection, implant, transdermal patch, vaginal ring); intrauterine device; tubal ligation; or partner’s vasectomy; OR Option 2: Male or female condom (latex condom or non-latex condom NOT made out of natural [animal] membrane [for example, polyurethane]); PLUS one additional barrier method: (a) diaphragm with spermicide; (b) cervical cap with spermicide; or (c) contraceptive sponge with spermicide. Note: Option 2 may not be acceptable as a highly effective contraception option in all countries , per local guidelines/ recommendations. † An FCBP is defined as a sexually mature female who
Exclusion criteria
Exclusion criteria: 1. 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. 2. 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 3. History of clinically significant (as determined by the investigator) cardiac, endocrine, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic disease, or other major uncontrolled disease 4. Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study 5. 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. 6. Pregnant or breast feeding 7. Active substance abuse or a history of substance abuse within 6 months prior to screening 8. History of allergy or hypersensitivity to any component of the IP 9. History of are hereditary problems of galactose intolerance, lapp lactose deficiency or glucose malabsorption 10. History of positive human immunodeficiency virus (HIV), or congenital or acquired immunodeficiency (eg, Common Variable Immunodeficiency Disease) 11. Active tuberculosis or a history of incompletely treated tuberculosis 12. Bacterial infections requiring treatment with oral or injectable antibiotics, or significant viral or fungal infections, within 4 weeks of screening. Any treatment for such infections must have been completed and the infection cured, at least 4 weeks prior to screening and no new or recurrent infections prior to the Baseline Visit 13. Malignancy or history of malignancy or myeloproliferative or lymphoproliferative disease within the past 3 years, except for treated (ie, cured) basal cell or squamous cell in situ skin carcinomas; 14. Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following Baseline Visit 15. Rheumatic autoimmune disease other than PsA, including, but not limited to: systemic lupus erythematosus, mixed connective tissue disease, scleroderma, polymyositis, or fibromyalgia 16. Prior history of or current inflammatory joint disease other than PsA (eg, gout, reactive arthritis, RA, ankylosing spondylitis, Lyme disease), which confounds the ability to interpret data from the study 17. Prior treatment with any biologic DMARD 18. Prior treatment with more than 2 csDMARDs 19. Use of the following systemic therapy(ies) within 28 days of the Baseline Visit (ie, Visit 2, Day 1): cyclosporine or other calcineurin inhibitors, glucocorticoids exceeding 10 mg daily prednisone equivalent, as well as mycophenolate. 20. Use of MTX within 4 weeks of the Baseline Visit (ie, Visit 2, Day 1), unless subject is on stable doses for at least 3 months and total treatment duration with MTX is = 6 months 21. Use of LEF within 12 weeks of the Baseline Visit (ie, Visit 2, Day 1), unless subject has taken cholestyramine, 8 g three times daily X 11 days after stopping LEF 22. Previous treatment with a JAK inhibitor (including tyk2 inh
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to evaluate the efficacy of apremilast 30 mg twice a day (BID) on inflammation indices, assessed by magnetic resonance imaging (MRI) of the hand.;Secondary Objective: - The efficacy of apremilast 30 mg BID on imaging outcomes associated with structural progression, assessed by MRI of the hand. - The efficacy of apremilast 30 mg BID on disease activity and functionality, assessed by clinical outcomes - The efficacy of apremilast 30 mg BID on inflammation indices of peripheral arthritis and enthesitis, total (sum of arthritis and enthesitis) and separately, assessed by whole-body MRI (WB-MRI) - The efficacy of apremilast 30 mg BID on The European League Against Rheumatism Psoriatic Arthritis Impact of Disease 12 domains (PsAID-12) - The safety and tolerability of apremilast 30 mg BID;Primary end point(s): Psoriatic Arthritis Magnetic Resonance Imaging Score (PsAMRIS) Inflammation Score of bone marrow edema [BME] + synovitis + tenosynovitis;Timepoint(s) of evaluation of this end point: Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): EFFICACY ENDPOINTS 1. PsAMRIS Inflammation Score of BME + Synovitis + Tenosynovitis 2. PsAMRIS BME + Synovitis 3. PsAMRIS Total Inflammation Score (BME + Synovitis + Tenosynovitis + Periarticular Inflammation) 4. PsAMRIS BME 5. PsAMRIS Synovitis 6. PsAMRIS Tenosynovitis 7. PsAMRIS Periarticular Inflammation 8. PsAMRIS Total Damage Score (erosion + bone proliferation) 9. PsAMRIS Erosion 10. PsAMRIS Bone Proliferation 11. Swollen Joint Count (SJC) 12. Tender Joint Count (TJC) 13. Clinical Disease Activity Index for Psoriatic Arthritis (c-DAPSA) 14. Spondyloarthritis Research Consortium of Canada (SPARCC) 15. Leeds Enthesitis Index (LEI) 16. Enthesitis improvement to 0 17. Leeds Dactylitis Index (LDI) 18. Dactylitis improvement to 0 19. Psoriatic Arthritis Disease Activity Score (PASDAS) 20. Evaluator’s Global Assessment of Disease Activity 21. Subject’s Global Assessment of Disease Activity 22. Subject's Assessment of Pain 23. Health Assessment Questionnaire-Disability Index (HAQ-DI) 24. WB-MRI Peripheral Enthesitis Inflammation Index 25. WB-MRI Peripheral Joints Inflammation Index 26. WB-MRI Total Peripheral Inflammation Index 27. BASDAI 28. The European League Against Rheumatism Psoriatic Arthritis Impact of Disease 12 domains (PsAID-12) SAFETY ENDPOINTS 29. Adverse events (AEs) 30. Discontinuation due to AEs 31. Clinically significant changes in physical examination, vital signs, and/or laboratory findings;Timepoint(s) of evaluation of this end point: #1: Week 48. #2 - #28: Week 24 & 48 #29 - #31: throughout the study | — |
Countries
Austria, Belgium, Canada, Denmark, Germany, Italy, Russian Federation, Spain, Switzerland, United Kingdom, United States
Contacts
Public ContactMedical Information
Amgen (EUROPE) GmbH
Outcome results
None listed