Phase 4
N=308
Efficacy, Safety, and Tolerability Study of Apremilast to Treat Early Oligoarticular Psoriatic Arthritis.
Arthritis, Psoriatic
Bottom Line
View on ClinicalTrials.gov: NCT03747939 ↗Enrolled (actual)
308
Serious AEs
5.0%
Results posted
Jan 2024
Primary outcome: Primary: Percentage of Participants Who Achieved a Clinical State of Minimal Disease Activity (MDA-Joints) Response at Week 16 — 16.0; 33.9 percentage of participants — p=0.0008
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Apremilast (CC-10004) (Drug); Apremilast (CC-10004) Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Amgen
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Achieved a Clinical State of Minimal Disease Activity (MDA-Joints) Response at Week 16 |
16.0; 33.9 | 0.0008 sig |
| SECONDARY Percentage of Participants Who Achieved Remission or Low Disease Activity at Week 16 Based on Clinical Activity in Psoriatic Arthritis (cDAPSA) |
51.8; 70.2 | 0.0017 sig |
| SECONDARY Percentage of Participants With SJC ≤ 1 at Week 16 |
69.0; 74.0 | 0.3539 |
| SECONDARY Percentage of Participants With TJC ≤ 1 at Week 16 |
44.4; 66.2 | 0.0003 sig |
| SECONDARY Percentage of Participants With Patient's Global Assessments of Disease Activity Score of ≤ 20 mm in the VAS at Week 16 |
19.1; 30.4 | 0.0286 sig |
| SECONDARY Percentage of Participants With an Assessment of Pain Score ≤ 15 mm in VAS at Week 16 |
13.1; 29.4 | 0.0022 sig |
| SECONDARY Change From Baseline in Psoriatic Arthritis Impact of Disease 12-item for Clinical Trials (PsAID-12) Questionnaire Score at Week 16 |
-0.42; -1.45 | <0.0001 sig |
| SECONDARY Percentage of Participants With a Good or Moderate Psoriatic Arthritis Disease Activity (PASDAS) Score at Week 16 |
42.7; 59.9 | 0.0043 sig |
Summary
This clinical study will test the effects of a drug called apremilast in oligoarticular psoriatic arthritis with less than 5 years of disease duration. In previous studies, apremilast has been shown to be safe and efficacious in reducing signs and symptoms of psoriatic arthritis, as well as improving physical function. This study will compare the effects of apremilast to placebo on psoriatic arthritis subjects in which the number of affected joints is limited (greater than 1 but less or equal to 4). About 285 patients worldwide will take part in this study.
Eligibility Criteria
Inclusion Criteria
- ≥ 18 yrs, male or female subject
- Subjects must have signs and symptoms of PsA ≤5 years duration at the time of the Screening Visit
- SJC AND TJC must be >1 and ≤ 4
- For all regions, the local Regulatory Label for treatment with apremilast must be followed.
- Stable doses of protocol-allowed PsA medications
- General good health (except for psoriatic arthritis) 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).
- Comply with protocol-required contraception measures
- Subject meets the Classification Criteria for Psoriatic Arthritis [CASPAR] Criteria for PsA at the Screening visit
Exclusion Criteria
- Prior use of >2 csDMARD to treat PsA
- Prior exposure to a JAK-inhibitor and/or a biologic DMARD.
- Use of intra-articular (IA) or intra-muscular (IM) glucocorticoid injection within 8 weeks before the Baseline Visit.
- Use of leflunomide within 12 weeks of randomization. Subjects who stopped leflunomide and completed 11 days of treatment with cholestyramine (8 g, 3 x daily) prior to the Baseline Visit may enter the study.
- Prior use of cyclosporine.
- Prior treatment with apremilast, or participation in a clinical study, involving apremilast.
- Use of any investigational drug within 4 weeks of the Baseline Visit, or 5 pharmacokinetic/pharmacodynamic half-lives, if known (whichever is longer).
Data sourced from ClinicalTrials.gov (NCT03747939). 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.