Phase 3
N=488
PALACE 2: Efficacy and Safety Study of Apremilast to Treat Active Psoriatic Arthritis
Psoriatic Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT01212757 ↗Enrolled (actual)
488
Serious AEs
9.4%
Results posted
May 2014
Primary outcome: Primary: Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 16 — 18.9; 37.4; 32.1 percentage of participants — p=0.0060
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Apremilast 20mg (Drug); Apremilast 30mg (Drug); Placebo + 20 mg Apremilast (Drug); Placebo + 30 mg Apremilast (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Amgen
- Primary completion
- Jul 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 16 |
18.9; 37.4; 32.1 | 0.0060 sig |
| SECONDARY Change From Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) at Week 16 |
-0.053; -0.157; -0.193 | 0.0042 sig |
| SECONDARY Percentage of Participants With an ACR 20 Response at Week 24 |
15.7; 31.3; 24.7 | 0.0394 sig |
| SECONDARY Change From Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) at Week 24 |
-0.085; -0.165; -0.206 | 0.0191 sig |
| SECONDARY Change From Baseline in 36-item Short Form Health Survey (SF-36) Physical Functioning Domain at Week 16 |
0.81; 2.17; 2.91 | 0.0237 sig |
| SECONDARY Percentage of Participants With a Modified Psoriatic Arthritis Response Criteria (PsARC) Response at Week 16 |
33.3; 47.9; 48.1 | 0.0065 sig |
| SECONDARY Change From Baseline in Patient's Assessment of Pain at Week 16 |
-7.0; -12.5; -11.9 | 0.0648 |
| SECONDARY Change From Baseline in Maastricht Ankylosing Spondylitis Entheses Score (MASES) at Week 16 |
-1.0; -0.9; -1.4 | 0.3496 |
| SECONDARY Change From Baseline in Dactylitis Severity Score at Week 16 |
-1.1; -0.8; -1.3 | 0.5438 |
| SECONDARY Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 16 |
-3.30; -7.75; -6.81 | 0.0035 sig |
| SECONDARY Change From Baseline in the Disease Activity Score (DAS28) at Week 16 |
-0.27; -0.74; -0.67 | 0.0004 sig |
| SECONDARY Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 16 |
0.63; 0.91; 2.75 | 0.0318 sig |
| SECONDARY Change From Baseline in 36-item Short Form Health Survey (SF-36) Physical Functioning Domain at Week 24 |
1.44; 2.97; 3.30 | 0.0473 sig |
| SECONDARY Percentage of Participants With a Modified Psoriatic Arthritis Response Criteria (PsARC) Response at Week 24 |
24.5; 39.9; 32.1 | 0.1195 |
| SECONDARY Change From Baseline in Patient's Assessment of Pain at Week 24 |
-8.0; -11.5; -9.7 | 0.5067 |
| SECONDARY Change From Baseline in Maastricht Ankylosing Spondylitis Entheses Score (MASES) at Week 24 |
-0.9; -0.9; -1.3 | 0.2719 |
| SECONDARY Change From Baseline in Dactylitis Severity Score at Week 24 |
-1.1; -0.9; -1.4 | 0.3705 |
| SECONDARY Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 24 |
-3.21; -7.71; -6.35 | 0.0097 sig |
| SECONDARY Change From Baseline in the Disease Activity Score (DAS28) at Week 24 |
-0.27; -0.73; -0.65 | 0.0011 sig |
| SECONDARY Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 24 |
0.52; 0.68; 2.65 | 0.0303 sig |
| SECONDARY Percentage of Participants With MASES Improvement ≥ 20% at Week 16 |
52.9; 54.2; 56.4 | 0.6022 |
| SECONDARY Percentage of Participants With Dactylitis Improvement ≥ 1 Point at Week 16 |
59.1; 62.3; 61.6 | 0.7337 |
| SECONDARY Percentage of Participants With Good or Moderate European League Against Rheumatism (EULAR) Response at Week 16 |
31.4; 53.4; 48.8 | 0.0014 sig |
| SECONDARY Percentage of Participants With MASES Improvement ≥ 20% at Week 24 |
51.0; 57.0; 57.4 | 0.3376 |
| SECONDARY Percentage of Participants With Dactylitis Improvement ≥ 1 Point at Week 24 |
62.1; 68.8; 68.5 | 0.3959 |
| SECONDARY Percentage of Participants With Good or Moderate EULAR Response at Week 24 |
21.4; 41.7; 33.3 | 0.0142 sig |
| SECONDARY Percentage of Participants With a ACR 50 Response at Week 16 |
5.0; 14.7; 10.5 | 0.0589 |
| SECONDARY Percentage of Participants With an ACR 70 Response at Week 16 |
0.6; 3.7; 1.2 | 0.5620 |
| SECONDARY Percentage of Participants With an ACR 50 Response at Week 24 |
8.8; 14.1; 11.7 | 0.3629 |
| SECONDARY Percentage of Participants With a ACR 70 Response at Week 24 |
3.1; 5.5; 2.5 | 0.7273 |
| SECONDARY Percentage of Participants Achieving a MASES Score of Zero at Week 16 |
23.1; 29.0; 20.8 | 0.7023 |
| SECONDARY Percentage of Participants Achieving a Dactylitis Score of Zero at Week 16 |
40.9; 42.9; 41.1 | 0.9698 |
| SECONDARY Percentage of Participants Achieving a MASES Score of Zero at Week 24 |
24.0; 29.9; 22.8 | 0.8424 |
| SECONDARY Percentage of Participants Achieving a Dactylitis Score of Zero at Week 24 |
40.9; 44.2; 46.6 | 0.4811 |
| SECONDARY Percentage of Participants With a ACR 20 Response at Week 52 |
53.3; 47.5; 52.9; 52.6 | — |
| SECONDARY Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Week 52 |
-0.208; -0.310; -0.192; -0.330 | — |
| SECONDARY Change From Baseline in the SF-36 Physical Functioning Scale Score at Week 52 |
4.13; 5.97; 4.05; 4.97 | — |
| SECONDARY Percentage of Participants With a Modified PsARC Response at Week 52 |
78.3; 73.3; 72.4; 74.6 | — |
| SECONDARY Change From Baseline in the Patient Assessment of Pain at Week 52 |
-15.6; -16.0; -13.5; -12.9 | — |
| SECONDARY Change From Baseline in Maastricht Ankylosing Spondylitis Entheses Score (MASES) at Week 52 |
-2.5; -2.5; -1.7; -2.1 | — |
| SECONDARY Change From Baseline in the Dactylitis Severity Score at Week 52 |
-1.9; -2.1; -1.8; -1.8 | — |
| SECONDARY Change From Baseline in the CDAI Score at Week 52 |
-13.66; -13.13; -12.03; -14.38 | — |
| SECONDARY Change From Baseline in the DAS28 at Week 52 |
-1.18; -1.18; -1.11; -1.30 | — |
| SECONDARY Change From Baseline in the FACIT-Fatigue Scale Score at Week 52 |
1.97; 4.95; 2.45; 4.38 | — |
| SECONDARY Percentage of Participants With MASES Improvement ≥ 20% at Week 52 |
72.5; 79.5; 70.0; 69.2 | — |
| SECONDARY Percentage of Participants With Dactylitis Improvement ≥ 1 Point at Week 52 |
95.7; 88.9; 80.7; 85.0 | — |
| SECONDARY Percentage of Participants Achieving Good or Moderate EULAR Response at Week 52 |
70.0; 64.5; 68.0; 67.5 | — |
| SECONDARY Percentage of Participants With an ACR 50 Response at Week 52 |
30.5; 27.4; 26.7; 18.6 | — |
| SECONDARY Percentage of Participants With an ACR 70 Response at Week 52 |
16.9; 14.3; 9.8; 6.8 | — |
| SECONDARY Percentage of Participants Achieving a MASES Score of Zero at Week 52 |
42.5; 41.0; 40.0; 37.2 | — |
| SECONDARY Percentage of Participants Achieving a Dactylitis Score of Zero at Week 52 |
78.3; 77.8; 57.9; 65.0 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events During the Placebo-Controlled Phase |
72; 106; 96; 28; 53; 57 | — |
| SECONDARY Number of Participants With TEAEs During the Apremilast-Exposure Period |
202; 53; 207; 102; 5; 100 | — |
Summary
The purpose of this study is to determine whether apremilast is safe and effective in the treatment of patients with psoriatic arthritis.
Apremilast is proposed to improve signs and symptoms of psoriatic arthritis (tender and swollen joints, pain, physical function) in treated patients.
Eligibility Criteria
Inclusion Criteria
- Males or females, aged ≥ 18 years at time of consent.
- Have a diagnosis of Psoriatic Arthritis (PsA, by any criteria) of ≥ 6 months duration.
- Meet the Classification Criteria for Psoriatic Arthritis (CASPAR) PsA at time of screening.
- Must have been inadequately treated by disease-modifying antirheumatic drugs (DMARDs)
- May not have axial involvement alone
- Concurrent Treatment allowed with methotrexate, leflunomide, or sulfasalazine
- Have ≥ 3 swollen AND ≥ 3 tender joints.
- Males & Females must use contraception
- Stable dose of nonsteroidal anti-inflammatory drugs (NSAIDs), narcotics and low dose oral corticosteroids allowed.
Exclusion Criteria
- Pregnant or breast feeding.
- History of allergy to any component of the investigational product.
- Hepatitis B surface antigen and/or Hepatitis C antibody positive at screening.
- Therapeutic failure on > 3 agents for PsA or > 1 biologic tumor necrosis factor (TNF) blocker
Data sourced from ClinicalTrials.gov (NCT01212757). 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.