Phase 4
N=123
A Study to Evaluate the Impact of Apremilast on Magnetic Resonance Imaging (MRI) Outcomes in Adults With Psoriatic Arthritis
Psoriatic Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT03783026 ↗Enrolled (actual)
123
Serious AEs
4.9%
Results posted
Dec 2022
Primary outcome: Primary: Change From Baseline in the Composite Score of BME, Synovitis, and Tenosynovitis Assessed by PsAMRIS at Week 24 — -2.32 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Apremilast (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Amgen
- Primary completion
- Oct 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Composite Score of BME, Synovitis, and Tenosynovitis Assessed by PsAMRIS at Week 24 |
-2.32 | — |
| SECONDARY Change From Baseline in the Composite Score of BME, Synovitis, and Tenosynovitis Assessed by PsAMRIS at Week 48 |
-2.91 | — |
| SECONDARY Change From Baseline in the Composite Score of BME and Synovitis Assessed by PsAMRIS at Weeks 24 and 48 |
-1.19; -1.54 | — |
| SECONDARY Change From Baseline in the PsAMRIS Total Inflammation Score at Weeks 24 and 48 |
-3.62; -4.35 | — |
| SECONDARY Change From Baseline in Bone Marrow Edema Assessed by PsAMRIS at Weeks 24 and 48 |
-0.22; -0.39 | — |
| SECONDARY Change From Baseline in Synovitis Assessed by PsAMRIS at Weeks 24 and 48 |
-0.47; -0.65 | — |
| SECONDARY Change From Baseline in Tenosynovitis Assessed by PsAMRIS at Weeks 24 and 48 |
-0.64; -0.78 | — |
| SECONDARY Change From Baseline in Periarticular Inflammation Assessed by PsAMRIS at Weeks 24 and 48 |
-0.49; -0.59 | — |
| SECONDARY Change From Baseline in the PsAMRIS Total Damage Score at Weeks 24 and 48 |
0.22; 0.50 | — |
| SECONDARY Change From Baseline in Bone Erosion Assessed by PsAMRIS at Weeks 24 and 48 |
-0.01; 0.03 | — |
| SECONDARY Change From Baseline in Bone Proliferation Assessed by PsAMRIS at Weeks 24 and 48 |
0.01; 0.02 | — |
| SECONDARY Change From Baseline in Swollen Joint Count (SJC) at Weeks 24 and 48 |
-5.8; -6.3 | — |
| SECONDARY Change From Baseline in Tender Joint Count (TJC) at Weeks 24 and 48 |
-7.9; -8.4 | — |
| SECONDARY Change From Baseline in the Clinical Disease Activity Index for Psoriatic Arthritis (c-DAPSA) Score at Weeks 24 and 48 |
-15.3; -17.2 | — |
| SECONDARY Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index at Weeks 24 and 48 in Participants With Pre-existing Enthesopathy |
-1.8; -2.3 | — |
| SECONDARY Change From Baseline in the Leeds Enthesitis Index (LEI) at Weeks 24 and 48 in Participants With Pre-existing Enthesopathy |
-1.3; -1.5 | — |
| SECONDARY Percentage of Participants With Baseline SPARCC Enthesitis Whose Enthesitis Improved to 0 at Weeks 24 and 48 |
46.9; 57.0 | — |
| SECONDARY Percentage of Participants With Baseline LEI Enthesitis Whose Enthesitis Improved to 0 at Weeks 24 and 48 |
56.4; 62.3 | — |
| SECONDARY Change From Baseline in Leeds Dactylitis Index (LDI) at Weeks 24 and 48 in Participants With Pre-existing Dactylitis |
-34.38; -38.71 | — |
| SECONDARY Percentage of Participants With Baseline Dactylitis Whose Dactylitis Count Improved to 0 at Weeks 24 and 48 |
89.2; 93.3 | — |
| SECONDARY Change From Baseline in the Psoriatic Arthritis Disease Activity Score (PASDAS) at Weeks 24 and 48 |
-1.752; -1.833 | — |
| SECONDARY Change From Baseline in the Evaluator's Global Assessment of Disease Activity at Weeks 24 and 48 |
-2.7; -2.8 | — |
| SECONDARY Change From Baseline in the Patient's Global Assessment of Disease Activity at Weeks 24 and 48 |
-1.3; -1.6 | — |
| SECONDARY Change From Baseline in the Subject's Assessment of Pain at Weeks 24 and 48 |
-1.4; -2.0 | — |
| SECONDARY Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) at Weeks 24 and 48 |
-0.293; -0.383 | — |
| SECONDARY Change From Baseline in Whole Body MRI (WB-MRI) Peripheral Enthesitis Inflammation Index at Weeks 24 and 48 |
-0.17; -0.52 | — |
| SECONDARY Change From Baseline in the WB-MRI Peripheral Joints Inflammation Index at Weeks 24 and 48 |
-3.38; -3.58 | — |
| SECONDARY Change From Baseline in the WB-MRI Total Peripheral Inflammation Index at Weeks 24 and 48 |
-3.49; -4.06 | — |
| SECONDARY Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Weeks 24 and 48 |
-1.94; -2.01 | — |
| SECONDARY Change From Baseline in the Psoriatic Arthritis Impact of Disease 12 Domain Questionnaire (PsAID-12) at Weeks 24 and 48 |
-1.352; -1.612 | — |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) |
95; 60; 6; 6; 0; 12 | — |
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.
Eligibility Criteria
Inclusion Criteria
Subjects must satisfy the following criteria to be enrolled in the study:
- 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
- Must not have been treated with more than 2 conventional synthetic disease-modifying antirheumatic drugs (csDMARDs)
- Subjects taking csDMARDs, with the exception of methotrexate (MTX), cyclosporine, or leflunomide (LEF), 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)
- 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 to participate in the study
- Subjects who have been previously treated with LEF will require a 12-week washout prior to the Baseline Visit, or treatment with cholestyramine, per LEF prescribing label (ie, 8 g cholestyramine 3 times daily for 11 days)
- Subjects who have been previously treated with cyclosporine will require a 28-day washout prior to the Baseline Visit to participate in the study
- 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
- 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
- If taking nonsteroidal anti-inflammatory drugs (NSAIDs) or narcotic analgesics, must be on stable dose for at least 4 weeks prior to Baseline Visit
- A female of childbearing potential (FCBP) must have a negative pregnancy test at screening and baseline. While on investigational product (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.
- Must be in general good health (except for PsA) as judged by the investigator, based on medical history, physical examination, and clinical laboratories. (Note: The definition of good health means a subject does not have uncontrolled significant comorbid conditions).
Exclusion Criteria
The presence of any of the following will exclude a subject from enrollment:
- 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
Data sourced from ClinicalTrials.gov (NCT03783026). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.