Phase 3 N=505 Randomized Quadruple-blind Treatment

PALACE 3: Efficacy and Safety Study of Apremilast to Treat Active Psoriatic Arthritis

Psoriatic Arthritis

Bottom Line

View on ClinicalTrials.gov: NCT01212770 ↗

Enrolled (actual)

505

Serious AEs

10.6%

Results posted

May 2014

Primary outcome: Primary: Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 16 — 18.3; 28.4; 40.7 percentage of participants — p=<0.0001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Apremilast 20mg (Drug); Apremilast 30mg (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Amgen
Primary completion: Aug 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 16	18.3; 28.4; 40.7	<0.0001 sig
SECONDARY Change From Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) at Week 16	-0.065; -0.131; -0.192	0.0073 sig
SECONDARY Percentage of Participants With an ACR 20 Response at Week 24	15.4; 26.6; 31.1	0.0007 sig
SECONDARY Change From Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) at Week 24	-0.053; -0.137; -0.192	0.0050 sig
SECONDARY Change From Baseline in 36-item Short Form Health Survey (SF-36) Physical Functioning Domain at Week 16	1.14; 2.29; 3.47	0.0053 sig
SECONDARY Percentage of Participants With a Modified Psoriatic Arthritis Response Criteria (PsARC) Response at Week 16	27.2; 37.9; 52.7	<0.0001 sig
SECONDARY Percentage of Participants Achieving a ≥ 75% Improvement in Psoriasis Area and Severity Index Score (PASI75) at Week 16	7.9; 20.9; 22.2	0.0062 sig
SECONDARY Change From Baseline in Patient's Assessment of Pain at Week 16	-4.9; -8.6; -12.7	0.0021 sig
SECONDARY Change From Baseline in Maastricht Ankylosing Spondylitis Entheses Score (MASES) at Week 16	-0.7; -0.7; -1.0	0.5349
SECONDARY Change From Baseline in Dactylitis Severity Score at Week 16	-1.3; -1.7; -2.1	0.0720
SECONDARY Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 16	-2.76; -4.61; -7.70	0.0001 sig
SECONDARY Change From Baseline in the Disease Activity Score (DAS28) at Week 16	-0.28; -0.54; -0.74	0.0001 sig
SECONDARY Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 16	1.18; 1.86; 3.72	0.0049 sig
SECONDARY Change From Baseline in 36-item Short Form Health Survey (SF-36) Physical Functioning Domain at Week 24	1.03; 2.71; 3.37	0.0043 sig
SECONDARY Percentage of Participants With a Modified Psoriatic Arthritis Response Criteria (PsARC) Response at Week 24	23.1; 32.0; 44.3	< 0.0001 sig
SECONDARY Percentage of Participants Achieving a ≥ 75% Improvement in Psoriasis Area and Severity Index Score (PASI75) at Week 24	11.2; 22.2; 25.6	0.0099 sig
SECONDARY Change From Baseline in Patient's Assessment of Pain at Week 24	-4.4; -8.2; -10.9	0.0080 sig
SECONDARY Change From Baseline in Maastricht Ankylosing Spondylitis Entheses Score (MASES) at Week 24	-0.7; -1.0; -1.1	0.2761
SECONDARY Change From Baseline in Dactylitis Severity Score at Week 24	-1.3; -1.7; -2.3	0.0399 sig
SECONDARY Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 24	-2.53; -5.18; -7.81	< 0.0001 sig
SECONDARY Change From Baseline in the Disease Activity Score (DAS28) at Week 24	-0.27; -0.57; -0.75	0.0001 sig
SECONDARY Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 24	0.83; 2.01; 3.27	0.0078 sig
SECONDARY Percentage of Participants With MASES Improvement ≥ 20% at Week 16	53.2; 48.5; 54.5	0.7585
SECONDARY Percentage of Participants With Dactylitis Improvement ≥ 1 Point at Week 16	59.2; 66.2; 71.3	0.1303
SECONDARY Percentage of Participants With Good or Moderate European League Against Rheumatism (EULAR) Response at Week 16	29.0; 40.2; 51.5	< 0.0001 sig
SECONDARY Percentage of Participants With MASES Improvement ≥ 20% at Week 24	51.4; 51.5; 54.5	0.5731
SECONDARY Percentage of Participants With Dactylitis Improvement ≥ 1 Point at Week 24	60.6; 67.6; 73.8	0.1172
SECONDARY Percentage of Participants With Good or Moderate EULAR Response at Week 24	20.1; 32.0; 42.5	< 0.0001 sig
SECONDARY Percentage of Participants With a ACR 50 Response at Week 16	8.3; 12.4; 15.0	0.0520
SECONDARY Percentage of Participants With an ACR 70 Response at Week 16	2.4; 4.7; 3.6	0.5154
SECONDARY Percentage of Participants With an ACR 50 Response at Week 24	7.7; 13.6; 16.2	0.0180 sig
SECONDARY Percentage of Participants With a ACR 70 Response at Week 24	3.6; 4.1; 5.4	0.4230
SECONDARY Percentage of Participants Achieving a MASES Score of Zero at Week 16	24.8; 19.6; 20.5	0.4707
SECONDARY Percentage of Participants Achieving a Dactylitis Score of Zero at Week 16	35.2; 40.8; 41.3	0.4175
SECONDARY Percentage of Participants Achieving a MASES Score of Zero at Week 24	28.4; 20.6; 27.7	0.9463
SECONDARY Percentage of Participants Achieving a Dactylitis Score of Zero at Week 24	36.6; 45.1; 46.3	0.2321
SECONDARY Percentage of Participants With an ACR 20 Response at Week 52	59.3; 58.2; 56.0; 63.0	—
SECONDARY Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Week 52	-0.34; -0.34; -0.33; -0.35	—
SECONDARY Change From Baseline in the SF-36 Physical Functioning Scale Score at Week 52	7.76; 6.87; 5.68; 5.87	—
SECONDARY Percentage of Participants With a Modified PsARC Response at Week 52	81.1; 75.8; 71.6; 79.0	—
SECONDARY Percentage of Participants Achieving a ≥ 75% Improvement in Psoriasis Area and Severity Index Score (PASI75) at Week 52	33.3; 28.6; 28.6; 39.1	—
SECONDARY Change From Baseline in the Patient Assessment of Pain at Week 52	-19.9; -19.1; -14.9; -18.7	—
SECONDARY Change From Baseline in Maastricht Ankylosing Spondylitis Entheses Score (MASES) at Week 52	-2.5; -2.2; -2.2; -1.9	—
SECONDARY Change From Baseline in the Dactylitis Severity Score at Week 52	-3.1; -3.8; -2.9; -3.6	—
SECONDARY Change From Baseline in the CDAI Score at Week 52	-13.54; -12.38; -12.86; -14.14	—
SECONDARY Change From Baseline in the DAS28 at Week 52	-1.28; -1.29; -1.21; -1.41	—
SECONDARY Change From Baseline in the FACIT-Fatigue Scale Score at Week 52	6.72; 5.66; 4.78; 6.20	—
SECONDARY Percentage of Participants With MASES Improvement ≥ 20% at Week 52	73.5; 75.0; 77.3; 71.3	—
SECONDARY Percentage of Participants With Dactylitis Improvement ≥ 1 Point at Week 52	95.5; 92.3; 88.5; 91.8	—
SECONDARY Percentage of Participants Achieving Good or Moderate EULAR Response at Week 52	64.8; 73.1; 69.4; 74.8	—
SECONDARY Percentage of Participants With an ACR 50 Response at Week 52	28.3; 31.8; 25.2; 30.2	—
SECONDARY Percentage of Participants With an ACR 70 Response at Week 52	20.8; 14.9; 9.2; 10.4	—
SECONDARY Percentage of Participants Achieving a MASES Score of Zero at Week 52	44.1; 43.8; 33.3; 36.8	—
SECONDARY Percentage of Participants Achieving a Dactylitis Score of Zero at Week 52	68.2; 80.8; 75.0; 68.9	—
SECONDARY Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Placebo-Controlled Phase	83; 100; 104; 33; 50; 62	—
SECONDARY Number of Participants With Treatment Emergent Adverse Events During the Apremilast Exposure Period	194; 64; 209; 98; 11; 111	—

Summary

The purpose of this study is to determine whether apremilast is safe and effective in the treatment of patients with psoriatic arthritis and a qualifying psoriasis lesion. 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) criteria for PsA at time of screening.
Must have been inadequately treated by disease-modifying antirheumatic drugs (DMARDs)
May not have axial involvement alone
Concurrent Tx allowed with methotrexate, leflunomide, or sulfasalazine
Have ≥ 3 swollen AND ≥ 3 tender joints.
Males & Females must use contraception
Stable dose of NSAIDs, narcotics and low dose oral corticosteroids allowed.
Have at least one ≥2 cm psoriasis lesion

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01212770). 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.