18 and older, any sex, with Psoriatic Arthritis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 16Primary· Baseline and Week 16
Percentage of participants with an American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 20% improvement in 78 tender joint count; • ≥ 20% improvement in 76 swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of pain (measured on a 100 mm visual analog scale \[VAS\]); ◦ Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦ Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦ Patient
Group
Value
95% CI
Placebo
19.0
Apremilast 20 mg
30.4
Apremilast 30 mg
38.1
Change From Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) at Week 16Secondary· Baseline and Week 16
The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe,
Group
Value
95% CI
Placebo
-0.086
± 0.0360
Apremilast 20 mg
-0.198
± 0.0364
Apremilast 30 mg
-0.244
± 0.0364
Percentage of Participants With an ACR 20 Response at Week 24Secondary· Baseline and Week 24
Percentage of participants with an American College of Rheumatology 20% (ACR20) response at Week 24. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 20% improvement in 78 tender joint count; • ≥ 20% improvement in 76 swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of pain (measured on a 100 mm visual analog scale \[VAS\]); ◦ Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦ Physician's global assessment of disease activity (measured on a 100 mm VAS)
Group
Value
95% CI
Placebo
13.1
Apremilast 20 mg
25.6
Apremilast 30 mg
35.1
Change From Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) at Week 24Secondary· Baseline and Week 24
The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe,
Group
Value
95% CI
Placebo
-0.076
± 0.0369
Apremilast 20 mg
-0.211
± 0.0373
Apremilast 30 mg
-0.258
± 0.0371
Change From Baseline in 36-item Short Form Health Survey (SF-36) Physical Functioning Domain at Week 16Secondary· Baseline and Week 16
The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning. The physical functioning domain assesses limitations in physical activities because of heal
Group
Value
95% CI
Placebo
1.81
± 0.621
Apremilast 20 mg
3.50
± 0.625
Apremilast 30 mg
4.23
± 0.625
Percentage of Participants With a Modified Psoriatic Arthritis Response Criteria (PsARC) Response at Week 16Secondary· Baseline and Week 16
Modified PsARC response is defined as improvement in at least 2 of the 4 measures, at least one of which must be tender joint count or swollen joint count, and no worsening in any of the 4 measures: • 78 tender joint count, • 76 swollen joint count, • Patient global assessment of disease activity, measured on a 100 mm visual Analog scale (VAS), where 0 mm = lowest disease activity and 100 mm = highest; • Physician global assessment of disease activity, measured on a 100 mm VAS, where 0 mm = lowest disease activity and 100 mm = highest. Improvement or worsening in joint counts is defined as dec
Group
Value
95% CI
Placebo
29.8
Apremilast 20 mg
38.7
Apremilast 30 mg
46.4
Change From Baseline in Patient's Assessment of Pain at Week 16Secondary· Baseline and Week 16
The participant was asked to place a vertical line on a 100-mm visual analog scale on which the left-hand boundary (score = 0 mm) represents "no pain," and the right-hand boundary (score = 100 mm) represents "pain as severe as can be imagined." The distance from the mark to the left-hand boundary was recorded in millimeters.
Group
Value
95% CI
Placebo
-5.7
± 1.83
Apremilast 20 mg
-11.5
± 1.85
Apremilast 30 mg
-13.5
± 1.85
Change From Baseline in Maastricht Ankylosing Spondylitis Entheses Score (MASES) at Week 16Secondary· Baseline and Week 16
The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone): 1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right. The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses.
Group
Value
95% CI
Placebo
-0.9
± 0.30
Apremilast 20 mg
-1.4
± 0.29
Apremilast 30 mg
-1.3
± 0.28
Change From Baseline in Dactylitis Severity Score at Week 16Secondary· Baseline and Week 16
Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet will be rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present.
Group
Value
95% CI
Placebo
-1.4
± 0.28
Apremilast 20 mg
-1.9
± 0.31
Apremilast 30 mg
-1.7
± 0.28
Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 16Secondary· Baseline and Week 16
The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the: • 28 tender joint count (TJC), • 28 swollen joint count (SJC), • Patient's Global Assessment of Disease Activity measured on a 10 cm visual analog scale (VAS), where 0 cm = lowest disease activity and 10 cm = highest; • Physician's Global Assessment of Disease Activity -measured on a 10 cm VAS, where 0 cm = lowest disease activity and 10 cm = highest. The CDAI score ranges from 0 to 76 where lower scores indicate less disease activity. The following thresholds of disease activity have been def
Group
Value
95% CI
Placebo
-3.84
± 0.929
Apremilast 20 mg
-8.24
± 0.926
Apremilast 30 mg
-8.72
± 0.923
Change From Baseline in the Disease Activity Score (DAS28) at Week 16Secondary· Baseline and Week 16
The DAS28 measures the severity of disease at a specific time and is derived from the following variables: • 28 tender joint count • 28 swollen joint count, which do not include the distal interphalangeal (DIP) joints, the hip joint, or the joints below the knee; • C-reactive protein (CRP) • Patient's global assessment of disease activity. DAS28(CRP) scores range from 0 to approximately 10, with the upper bound dependent on the highest possible level of CRP. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 sc
Group
Value
95% CI
Placebo
-0.26
± 0.082
Apremilast 20 mg
-0.73
± 0.082
Apremilast 30 mg
-0.79
± 0.083
Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 16Secondary· Baseline and Week 16
The FACIT-Fatigue scale is a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means "not at all," and 4 means "very much." The FACIT-Fatigue scale score ranges from 0 to 52, with higher scores denoting lower levels of fatigue. A positive change from Baseline score indicates an improvement.
Group
Value
95% CI
Placebo
1.55
± 0.693
Apremilast 20 mg
1.68
± 0.696
Apremilast 30 mg
3.88
± 0.695
Adverse events — posted to ClinicalTrials.gov
Time frame: AE's are reported for the placebo-controlled phase and up to 5 years for all subjects randomized or re-randomized to apremilast at any time during the study. AEs were monitored and collected for 6 years, 4 months, 25 days excluding the end date..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The purpose of this study is to determine whether apremilast is safe and effective in the treatment of patients with psoriatic arthritis, specifically in improving signs and symptoms of psoriatic arthritis (tender and swollen joints, pain, physical function) in treated patients.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT01307423 — Efficacy and Safety Study of Apremilast to Treat Active Psoriatic Arthritis (PsA)
· Phase 3
· completed
NCT01212770 — PALACE 3: Efficacy and Safety Study of Apremilast to Treat Active Psoriatic Arthritis
· Phase 3
· completed
NCT01212757 — PALACE 2: Efficacy and Safety Study of Apremilast to Treat Active Psoriatic Arthritis
· Phase 3
· completed
NCT00773734 — Efficacy and Safety Study of Apremilast (CC-10004) in Subjects With Moderate-to-Severe Plaque-Type Psoriasis (Core Study
· Phase 2
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Amgen
Last refreshed: 19 June 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01172938.