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Phase II Study of Apremilast (CC-10004) in Adults With in Psoriatic Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00456092
Recruitment Status : Completed
First Posted : April 4, 2007
Results First Posted : October 23, 2019
Last Update Posted : June 19, 2020
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Psoriatic Arthritis
Interventions Drug: Apremilast
Drug: Placebo
Enrollment 204
Recruitment Details Participants were enrolled across 38 sites in Canada, Belgium, Germany, the Netherlands, and the United Kingdom.
Pre-assignment Details Participants were randomized 1:1:1 to either apremilast 40 mg once daily, 20 mg twice daily, or placebo. On Day 85 participants originally randomized to placebo were re-randomized to receive apremilast; participants randomized to apremilast continued on the same dose regimen. Randomization was stratified based on methotrexate use at baseline.
Arm/Group Title Apremilast 40 mg QD Apremilast 20 mg BID Placebo Placebo/Apremilast 40 mg QD Placebo/Apremilast 20 mg BID
Hide Arm/Group Description Participants received 40 mg apremilast orally once a day (QD) for 12 weeks in the Treatment Phase. Participants who entered the Extension Phase continued to receive 40 mg apremilast QD for an additional 12 weeks. The dose of apremilast was titrated starting at 10 mg QD during Days 1 to 3 followed by 20 mg QD during Days 4 to 7 and then 40 mg QD thereafter. A single dose reduction to 20 mg per day was allowed for participants who experienced intolerable adverse effects from study medication. Participants received 20 mg apremilast orally twice a day (BID) for 12 weeks in the Treatment Phase. Participants who entered the Extension Phase continued to receive 20 mg apremilast BID for an additional 12 weeks. The dose of apremilast was titrated starting at 10 mg QD during Days 1 to 3 followed by 20 mg QD during Days 4 to 7 and then 20 mg BID thereafter. A single dose reduction to 20 mg per day was allowed for participants who experienced intolerable adverse effects from study medication. Participants received matching placebo to apremilast orally BID for 12 weeks during the Treatment Phase. Participants who entered the Extension Phase were re-randomized on Day 85 to receive either 40 mg apremilast QD or 20 mg apremilast BID for 12 weeks. Participants who received placebo during the Treatment Phase then received 40 mg apremilast orally QD for 12 weeks during the Extension Phase. The dose of apremilast was titrated starting at 10 mg QD during Days 85 to 87 followed by 20 mg QD during Days 88 to 91 and then 40 mg QD thereafter. A single dose reduction to 20 mg per day was allowed for participants who experienced intolerable adverse effects from study medication. Participants who received placebo during the Treatment Phase then received 20 mg apremilast orally BID for 12 weeks during the Extension Phase. The dose of apremilast was titrated starting at 10 mg QD during Days 85 to 87 followed by 20 mg QD during Days 88 to 91 and then 20 mg BID thereafter. A single dose reduction to 20 mg per day was allowed for participants who experienced intolerable adverse effects from study medication.
Period Title: Extension Phase
Started 46 [1] 40 [1] 0 20 [1] 20 [1]
Completed 35 36 0 19 13
Not Completed 11 4 0 1 7
Reason Not Completed
Grade 2 or Greater AE             2             2             0             0             2
Flare of Psoriatic Arthritis             1             0             0             0             1
Worsening / Not Responding to Study Drug             3             1             0             0             2
Withdrew Consent             2             0             0             0             0
Lost to Follow-up             1             1             0             0             1
Other             2             0             0             1             1
[1]
The Extension Phase was only open to participants enrolled after amendment 1 was in effect.
Period Title: Treatment Phase (12 Weeks)
Started 67 69 68 0 0
Completed 60 55 50 0 0
Not Completed 7 14 18 0 0
Reason Not Completed
Grade 2 or Greater Adverse Event (AE)             3             4             2             0             0
AEs not Included in NCI Terminology             1             2             0             0             0
Intolerability of the Study Drug             2             0             0             0             0
Flare of Psoriasis             0             1             2             0             0
Flare of Psoriatic Arthritis             0             3             3             0             0
Worsening / Not Responding to Study Drug             0             2             7             0             0
Withdrew Consent             0             1             2             0             0
Lost to Follow-up             0             1             1             0             0
Other             1             0             1             0             0
Arm/Group Title Apremilast 40 mg QD Apremilast 20 mg BID Placebo Total
Hide Arm/Group Description Participants received 40 mg apremilast once daily (QD) for 12 weeks in the Treatment Phase. Participants received 20 mg apremilast twice a day (BID) for 12 weeks in the Treatment Phase. Participants received matching placebo to apremilast for 12 weeks during the Treatment Phase. Total of all reporting groups
Overall Number of Baseline Participants 67 69 68 204
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 67 participants 69 participants 68 participants 204 participants
49.9  (11.17) 50.9  (12.58) 51.1  (10.80) 50.6  (11.50)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 67 participants 69 participants 68 participants 204 participants
Female
35
  52.2%
26
  37.7%
36
  52.9%
97
  47.5%
Male
32
  47.8%
43
  62.3%
32
  47.1%
107
  52.5%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 67 participants 69 participants 68 participants 204 participants
White
62
  92.5%
67
  97.1%
68
 100.0%
197
  96.6%
Black
1
   1.5%
0
   0.0%
0
   0.0%
1
   0.5%
Hispanic
1
   1.5%
0
   0.0%
0
   0.0%
1
   0.5%
Asian/Pacific Islander
2
   3.0%
1
   1.4%
0
   0.0%
3
   1.5%
American Indian/Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Other
1
   1.5%
1
   1.4%
0
   0.0%
2
   1.0%
Psoriatic Arthritis Disease Category  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 67 participants 69 participants 68 participants 204 participants
Asymmetrical Oligoarthritis
26
  38.8%
21
  30.4%
20
  29.4%
67
  32.8%
Predominant Spondylitis
4
   6.0%
3
   4.3%
2
   2.9%
9
   4.4%
Symmetric Polyarthritis
32
  47.8%
36
  52.2%
39
  57.4%
107
  52.5%
Arthritis Mutilans
2
   3.0%
0
   0.0%
5
   7.4%
7
   3.4%
Predominant Distal Interphalgeal Involvement
2
   3.0%
9
  13.0%
2
   2.9%
13
   6.4%
Missing/Unknown
1
   1.5%
0
   0.0%
0
   0.0%
1
   0.5%
Duration of Psoriatic Arthritis  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 67 participants 69 participants 68 participants 204 participants
7.6  (8.73) 8.4  (9.77) 7.3  (6.74) 7.8  (8.48)
Pain/Tender Joint Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Joints
Number Analyzed 67 participants 69 participants 68 participants 204 participants
23.2  (17.63) 20.6  (15.90) 21.3  (15.55) 21.7  (16.33)
[1]
Measure Description: The number of tender joints (joints with scores of 1 to 3), rated on a scale of 0 (no pain/tenderness) to 3 (severe pain - tender, winced, withdrew). The joint count included the 68 joints routinely utilized in the American College of Rheumatology (ACR) joint count for evaluation of rheumatoid arthritis, plus 10 additional joints often involved in psoriatic arthritis (the first carpometacarpal [CMC] and the distal interphalangeal [DIP] joints of the fingers) for a total of 78 joints.
Swollen Joint Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Joints
Number Analyzed 67 participants 69 participants 68 participants 204 participants
8.4  (4.94) 10.6  (9.88) 9.5  (9.68) 9.5  (8.51)
[1]
Measure Description: The number of swollen joints noted by the examiner. The joint count included the 66 joints routinely utilized in the American College of Rheumatology (ACR) joint count for evaluation of rheumatoid arthritis, plus 10 additional joints often involved in psoriatic arthritis (the first carpometacarpal [CMC] and the distal interphalangeal [DIP] joints of the fingers) for a total of 76 joints.
Psoriasis Severity   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 67 participants 69 participants 68 participants 204 participants
None
2
   3.0%
7
  10.1%
12
  17.6%
21
  10.3%
Mild
41
  61.2%
47
  68.1%
40
  58.8%
128
  62.7%
Moderate
20
  29.9%
15
  21.7%
11
  16.2%
46
  22.5%
Severe
4
   6.0%
0
   0.0%
5
   7.4%
9
   4.4%
[1]
Measure Description: Psoriasis severity was assessed by the Investigator.
Duration of Psoriasis  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 67 participants 69 participants 68 participants 204 participants
18.3  (13.62) 15.5  (11.66) 15.8  (13.22) 16.5  (12.85)
Methotrexate Use  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 67 participants 69 participants 68 participants 204 participants
Yes
30
  44.8%
30
  43.5%
29
  42.6%
89
  43.6%
No
37
  55.2%
39
  56.5%
39
  57.4%
115
  56.4%
1.Primary Outcome
Title Percentage of Participants With a Modified American College of Rheumatology 20% (ACR 20) Response at Week 12
Hide Description A modified American College of Rheumatology 20% (ACR 20) response was defined as a participant who met the following 3 criteria for improvement from Baseline: • ≥ 20% improvement in 78 tender joint count (includes 10 additional joints often involved in psoriatic arthritis: the first carpometacarpal [CMC] and the distal interphalangeal [DIP] joints of the fingers); • ≥ 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's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]); ◦ C-reactive protein. Participants with no post-baseline ACR scores were considered non-responders.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population which consisted of all randomized participants with at least one of the ACR components assessed at baseline. Last observation carried forward (LOCF) imputation was used.
Arm/Group Title Apremilast 40 mg QD Apremilast 20 mg BID Placebo
Hide Arm/Group Description:
Participants received 40 mg apremilast once daily (QD) for 12 weeks during the Treatment Phase.
Participants received 20 mg apremilast twice a day (BID) for 12 weeks during the Treatment Phase.
Participants received matching placebo to apremilast for 12 weeks during the Treatment Phase.
Overall Number of Participants Analyzed 67 69 68
Measure Type: Number
Unit of Measure: percentage of participants
35.8 43.5 11.8
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Apremilast 40 mg QD, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments A p-value < 0.025 (2-sided) is considered statistically significant, after adjusting for two treatment comparisons using the Bonferroni procedure.
Method Chi-squared, Corrected
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 4.190
Confidence Interval (2-Sided) 95%
1.72 to 10.20
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Apremilast 20 mg BID, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments A p-value < 0.025 (2-sided) is considered statistically significant, after adjusting for two treatment comparisons using the Bonferroni procedure.
Method Chi-squared, Corrected
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 5.770
Confidence Interval (2-Sided) 95%
2.40 to 13.88
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Number of Participants With Adverse Events During the Treatment Phase
Hide Description The severity of each adverse event (AE) was graded based upon the participant's symptoms according to National Cancer Institute (NCI) Common Toxicity Criteria (CTCAE, Version 3.0), on a scale from 1 (Mild AE) to 5 (Death due to AE). Severe AEs are defined as NCI CTCAE grade 3 or higher. AEs related to study drug are those determined by the investigator as suspected to be related to study drug where a temporal relationship of the adverse event to study drug administration made a causal relationship possible, and other medications, therapeutic interventions, or underlying conditions did not provide a sufficient explanation for the observed event. A serious adverse event (SAE) is any AE which: - Resulted in death - Was life-threatening - Required inpatient hospitalization or prolongation of existing hospitalization - Resulted in persistent or significant disability/incapacity - Was a congenital anomaly/birth defect - Constituted an important medical event.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population which consisted of all enrolled participants who received at least 1 dose of study medication.
Arm/Group Title Apremilast 40 mg QD Apremilast 20 mg BID Placebo
Hide Arm/Group Description:
Participants received 40 mg apremilast once daily (QD) for 12 weeks during the Treatment Phase.
Participants received 20 mg apremilast twice a day (BID) for 12 weeks during the Treatment Phase.
Participants received matching placebo to apremilast for 12 weeks during the Treatment Phase.
Overall Number of Participants Analyzed 67 69 68
Measure Type: Count of Participants
Unit of Measure: Participants
All adverse events
58
  86.6%
59
  85.5%
55
  80.9%
Adverse events related to study drug
27
  40.3%
26
  37.7%
26
  38.2%
Severe adverse events
5
   7.5%
4
   5.8%
6
   8.8%
Severe adverse events related to study drug
1
   1.5%
1
   1.4%
1
   1.5%
Serious adverse events
0
   0.0%
4
   5.8%
4
   5.9%
Serious adverse events related to study drug
0
   0.0%
0
   0.0%
1
   1.5%
Discontinued study drug due to adverse event
6
   9.0%
10
  14.5%
7
  10.3%
Discontinued due to AE related to study drug
5
   7.5%
4
   5.8%
1
   1.5%
3.Secondary Outcome
Title Percentage of Participants With a Psoriatic Arthritis Response Criteria (PsARC) Response at Week 12
Hide Description A PsARC response is defined as improvement from Baseline in at least 2 of the following 4 measures, at least 1 of which must be tender joint count or swollen joint count, and no worsening in any of the 4 measures, according to the following: • At least 30% improvement in the 78 tender joint count, • At least 30% improvement in the 76 swollen joint count, • At least 20% improvement in the 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; • At least 20% improvement in the physician global assessment of disease activity, measured on a 100 mm VAS, where 0 mm = lowest disease activity and 100 mm = highest. Participants with no post-baseline PsARC scores were considered non-responders.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population; LOCF imputation was used.
Arm/Group Title Apremilast 40 mg QD Apremilast 20 mg BID Placebo
Hide Arm/Group Description:
Participants received 40 mg apremilast once daily (QD) for 12 weeks during the Treatment Phase.
Participants received 20 mg apremilast twice a day (BID) for 12 weeks during the Treatment Phase.
Participants received matching placebo to apremilast for 12 weeks during the Treatment Phase.
Overall Number of Participants Analyzed 67 69 68
Measure Type: Number
Unit of Measure: percentage of participants
50.7 52.2 22.1
4.Secondary Outcome
Title Percentage of Participants With a Modified ACR 50 Response at Week 12
Hide Description A modified American College of Rheumatology 50% (ACR 50) response was defined as a participant who met the following 3 criteria for improvement from Baseline: • ≥ 50% improvement in 78 tender joint count (includes 10 additional joints often involved in psoriatic arthritis: the first carpometacarpal [CMC] and the distal interphalangeal [DIP] joints of the fingers); • ≥ 50% improvement in 76 swollen joint count; and • ≥ 50% 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's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]); ◦ C-reactive protein. Participants with no post-baseline ACR scores were considered non-responders.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population; LOCF imputation was used.
Arm/Group Title Apremilast 40 mg QD Apremilast 20 mg BID Placebo
Hide Arm/Group Description:
Participants received 40 mg apremilast once daily (QD) for 12 weeks during the Treatment Phase.
Participants received 20 mg apremilast twice a day (BID) for 12 weeks during the Treatment Phase.
Participants received matching placebo to apremilast for 12 weeks during the Treatment Phase.
Overall Number of Participants Analyzed 67 69 68
Measure Type: Number
Unit of Measure: percentage of participants
13.4 17.4 2.9
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Apremilast 40 mg QD, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.056
Comments [Not Specified]
Method Chi-squared, Corrected
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 5.120
Confidence Interval (2-Sided) 95%
1.06 to 24.67
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Apremilast 20 mg BID, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.012
Comments [Not Specified]
Method Chi-squared, Corrected
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 6.950
Confidence Interval (2-Sided) 95%
1.49 to 32.35
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Percentage of Participants With a Modified ACR 70 Response at Week 12
Hide Description A modified American College of Rheumatology 70% (ACR 70) response was defined as a participant who met the following 3 criteria for improvement from Baseline: • ≥ 70% improvement in 78 tender joint count (includes 10 additional joints often involved in psoriatic arthritis: the first carpometacarpal [CMC] and the distal interphalangeal [DIP] joints of the fingers); • ≥ 70% improvement in 76 swollen joint count; and • ≥ 70% 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's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); ◦ C-reactive protein. Participants with no post-baseline ACR scores were considered non-responders.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population; LOCF imputation was used.
Arm/Group Title Apremilast 40 mg QD Apremilast 20 mg BID Placebo
Hide Arm/Group Description:
Participants received 40 mg apremilast once daily (QD) for 12 weeks during the Treatment Phase.
Participants received 20 mg apremilast twice a day (BID) for 12 weeks during the Treatment Phase.
Participants received matching placebo to apremilast for 12 weeks during the Treatment Phase.
Overall Number of Participants Analyzed 67 69 68
Measure Type: Number
Unit of Measure: percentage of participants
7.5 5.8 1.5
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Apremilast 40 mg QD, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.204
Comments [Not Specified]
Method Chi-squared, Corrected
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 5.400
Confidence Interval (2-Sided) 95%
0.61 to 47.54
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Apremilast 20 mg BID, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.371
Comments [Not Specified]
Method Chi-squared, Corrected
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 4.120
Confidence Interval (2-Sided) 95%
0.45 to 37.88
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Percentage of Participants With Good or Moderate European League Against Rheumatism (EULAR) Response Based on Disease Activity Score (DAS28)-CRP(4) at Week 12
Hide Description The DAS28 measures the severity of disease at a specific time. DAS28-CRP(4) is derived from the following 4 variables: • 28 tender joint count, (TJC; does not include the DIP joints, the hip joint, or the joints below the knee) • 28 swollen joint count (SJC) • C-reactive protein (CRP) • Patient's global assessment of disease activity (GH) according to the formula: DAS28-CRP(4) = 0.56*√(TJC28) + 0.28*(SJC28) + 0.36*ln(CRP+1) + 0.014*GH + 0.96. DAS28 scores range from 0 to 9.4, where higher scores indicate more disease activity. A EULAR response reflects an improvement in disease activity based on the DAS-28 score. A Good Response is defined as an improvement (decrease) in the DAS28 > 1.2 from Baseline and a DAS28 score ≤ 3.2. A Moderate Response is defined as either: • an improvement (decrease) in the DAS28 > 0.6 and ≤ 1.2 and a DAS28 score ≤ to 5.1 or, • an improvement (decrease) in the DAS28 > 1.2 and a DAS28 score > 3.2
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population; LOCF imputation was used. Participants with no baseline or post-baseline DAS28-CRP(4) scores were considered non-responders.
Arm/Group Title Apremilast 40 mg QD Apremilast 20 mg BID Placebo
Hide Arm/Group Description:
Participants received 40 mg apremilast once daily (QD) for 12 weeks during the Treatment Phase.
Participants received 20 mg apremilast twice a day (BID) for 12 weeks during the Treatment Phase.
Participants received matching placebo to apremilast for 12 weeks during the Treatment Phase.
Overall Number of Participants Analyzed 67 69 68
Measure Type: Number
Unit of Measure: percentage of participants
49.3 55.1 38.2
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Apremilast 40 mg QD, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.264
Comments [Not Specified]
Method Chi-squared, Corrected
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.568
Confidence Interval (2-Sided) 95%
0.79 to 3.11
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Apremilast 20 mg BID, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.071
Comments [Not Specified]
Method Chi-squared, Corrected
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.980
Confidence Interval (2-Sided) 95%
1.00 to 3.91
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Percentage of Participants With Good or Moderate EULAR Response Based on DAS28-CRP(3) at Week 12
Hide Description The DAS28 measures the severity of disease at a specific time. DAS28-CRP(3) is derived from the following 3 variables: • 28 tender joint count, (does not include the DIP joints, the hip joint, or the joints below the knee) • 28 swollen joint count • C-reactive protein (CRP) according to the formula: DAS28-CRP(3) = [0.56*√(TJC28) + 0.28*√(SJC28) + 0.36*ln(CRP+1)] * 1.10 + 1.15. DAS28 scores range from 0 to 9.4, where higher scores indicate more disease activity. A EULAR response reflects an improvement in disease activity based on the DAS-28 score. A Good Response is defined as an improvement (decrease) in the DAS28 > 1.2 from Baseline and attainment of a DAS28 score ≤ 3.2. A Moderate Response is defined as either: • an improvement (decrease) in the DAS28 > 0.6 and ≤ 1.2 and a DAS28 score ≤ to 5.1 or, • an improvement (decrease) in the DAS28 > 1.2 and a DAS28 score > 3.2
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population; LOCF imputation was used. Participants with no baseline or post-baseline DAS28-CRP(3) scores were considered non-responders.
Arm/Group Title Apremilast 40 mg QD Apremilast 20 mg BID Placebo
Hide Arm/Group Description:
Participants received 40 mg apremilast once daily (QD) for 12 weeks during the Treatment Phase.
Participants received 20 mg apremilast twice a day (BID) for 12 weeks during the Treatment Phase.
Participants received matching placebo to apremilast for 12 weeks during the Treatment Phase.
Overall Number of Participants Analyzed 67 69 68
Measure Type: Number
Unit of Measure: percentage of participants
50.7 44.9 44.1
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Apremilast 40 mg QD, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.549
Comments [Not Specified]
Method Chi-squared, Corrected
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.305
Confidence Interval (2-Sided) 95%
0.66 to 2.57
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Apremilast 20 mg BID, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.000
Comments [Not Specified]
Method Chi-squared, Corrected
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.033
Confidence Interval (2-Sided) 95%
0.53 to 2.03
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Percentage of Participants With DAS28-CRP(4) Score of Mild Disease Activity or In Remission at Week 12
Hide Description The DAS28-CRP(4) measures the severity of disease derived from the following 4 variables: • 28 tender joint count, (does not include the DIP joints, the hip joint, or the joints below the knee) • 28 swollen joint count • C-reactive protein (CRP) • Patient's global assessment of disease activity. DAS28-CRP(4) scores range from 0 to 9.4, where higher scores indicate more disease activity. Mild disease severity is defined as a DAS28-CRP(4) score of ≤ 3.2. In remission is defined as a DAS28-CRP(4) score of ≤ 2.6.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population; LOCF imputation was used. Participants with no post-baseline DAS28-CRP(4) scores were considered non-responders.
Arm/Group Title Apremilast 40 mg QD Apremilast 20 mg BID Placebo
Hide Arm/Group Description:
Participants received 40 mg apremilast once daily (QD) for 12 weeks during the Treatment Phase.
Participants received 20 mg apremilast twice a day (BID) for 12 weeks during the Treatment Phase.
Participants received matching placebo to apremilast for 12 weeks during the Treatment Phase.
Overall Number of Participants Analyzed 67 69 68
Measure Type: Number
Unit of Measure: percentage of participants
38.8 33.3 23.5
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Apremilast 40 mg QD, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.083
Comments [Not Specified]
Method Chi-squared, Corrected
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.060
Confidence Interval (2-Sided) 95%
0.98 to 4.34
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Apremilast 20 mg BID, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.279
Comments [Not Specified]
Method Chi-squared, Corrected
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.630
Confidence Interval (2-Sided) 95%
0.77 to 3.44
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Percentage of Participants With DAS28-CRP(3) Score of Mild Disease Activity or In Remission at Week 12
Hide Description The DAS28-CRP(3) measures the severity of disease derived from the following 3 variables: • 28 tender joint count (does not include the DIP joints, the hip joint, or the joints below the knee) • 28 swollen joint count • C-reactive protein (CRP) DAS28-CRP(3) scores range from 0 to 9.4, where higher scores indicate more disease activity. Mild disease severity is defined as a DAS28-CRP(3) score of ≤ 3.2. In remission is defined as a DAS28-CRP(3) score of ≤ 2.6.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population; LOCF imputation was used. Participants with no post-baseline DAS28-CRP(3) scores were considered non-responders.
Arm/Group Title Apremilast 40 mg QD Apremilast 20 mg BID Placebo
Hide Arm/Group Description:
Participants received 40 mg apremilast once daily (QD) for 12 weeks during the Treatment Phase.
Participants received 20 mg apremilast twice a day (BID) for 12 weeks during the Treatment Phase.
Participants received matching placebo to apremilast for 12 weeks during the Treatment Phase.
Overall Number of Participants Analyzed 67 69 68
Measure Type: Number
Unit of Measure: percentage of participants
40.3 34.8 33.8
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Apremilast 40 mg QD, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.548
Comments [Not Specified]
Method Chi-squared, Corrected
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.320
Confidence Interval (2-Sided) 95%
0.66 to 2.66
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Apremilast 20 mg BID, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.000
Comments [Not Specified]
Method Chi-squared, Corrected
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.040
Confidence Interval (2-Sided) 95%
0.52 to 2.11
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Number of Participants Who Withdrew Prematurely Due to Lack of Efficacy
Hide Description The number of participants who withdrew prematurely from the treatment phase due to lack of efficacy, including flare of psoriasis, flare of psoriatic arthritis or worsening or not responding to study treatment.
Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population
Arm/Group Title Apremilast 40 mg QD Apremilast 20 mg BID Placebo
Hide Arm/Group Description:
Participants received 40 mg apremilast once daily (QD) for 12 weeks during the Treatment Phase.
Participants received 20 mg apremilast twice a day (BID) for 12 weeks during the Treatment Phase.
Participants received matching placebo to apremilast for 12 weeks during the Treatment Phase.
Overall Number of Participants Analyzed 67 69 68
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
6
   8.7%
12
  17.6%
11.Secondary Outcome
Title Number of Participants With Adverse Events Leading to a Dose Reduction
Hide Description The number of participants who were dose reduced during the treatment phase due to adverse events.
Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Apremilast 40 mg QD Apremilast 20 mg BID Placebo
Hide Arm/Group Description:
Participants received 40 mg apremilast once daily (QD) for 12 weeks during the Treatment Phase.
Participants received 20 mg apremilast twice a day (BID) for 12 weeks during the Treatment Phase.
Participants received matching placebo to apremilast for 12 weeks during the Treatment Phase.
Overall Number of Participants Analyzed 67 69 68
Measure Type: Count of Participants
Unit of Measure: Participants
4
   6.0%
4
   5.8%
0
   0.0%
12.Secondary Outcome
Title Maximal ACR Response During the Treatment Phase
Hide Description The ACR-N index score was calculated for each participant at each time point in the study according to the following definition: ACR-N = the lowest of the following 3 values: - percent improvement from Baseline in the 76 swollen joint count, - percent improvement from Baseline in the 78 tender joint count - median percent improvement from Baseline in the following 5 measures ◦ 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's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]); ◦ C-reactive protein. The maximal ACR-N for each participant during the 12-week treatment period was calculated, and represents the maximal ACR response achieved.
Time Frame ACR was measured at Baseline and Weeks 2, 4, 6, 8, 10, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population with non-missing ACR data
Arm/Group Title Apremilast 40 mg QD Apremilast 20 mg BID Placebo
Hide Arm/Group Description:
Participants received 40 mg apremilast once daily (QD) for 12 weeks during the Treatment Phase.
Participants received 20 mg apremilast twice a day (BID) for 12 weeks during the Treatment Phase.
Participants received matching placebo to apremilast for 12 weeks during the Treatment Phase.
Overall Number of Participants Analyzed 65 67 65
Mean (Standard Deviation)
Unit of Measure: percent improvement
22.3  (56.45) 24.2  (37.63) 10.7  (35.42)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Apremilast 40 mg QD, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.136
Comments [Not Specified]
Method ANOVA
Comments ANOVA model with treatment as the factor.
Method of Estimation Estimation Parameter Treatment Difference
Estimated Value 11.58
Estimation Comments Treatment Difference = Apremilast 20 mg BID - Placebo
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Apremilast 20 mg BID, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.080
Comments [Not Specified]
Method ANOVA
Comments ANOVA model with treatment as the factor.
Method of Estimation Estimation Parameter Treatment Difference
Estimated Value 13.53
Estimation Comments Treatment Difference = Apremilast 20 mg BID - Placebo
13.Secondary Outcome
Title Time to ACR 20 Response During the Treatment Phase
Hide Description The Kaplan-Meier estimates of time to ACR 20 response was calculated for participants who had an ACR 20 response at any time during the treatment phase.
Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population with an ACR 20 response during the treatment phase.
Arm/Group Title Apremilast 40 mg QD Apremilast 20 mg BID Placebo
Hide Arm/Group Description:
Participants received 40 mg apremilast once daily (QD) for 12 weeks during the Treatment Phase.
Participants received 20 mg apremilast twice a day (BID) for 12 weeks during the Treatment Phase.
Participants received matching placebo to apremilast for 12 weeks during the Treatment Phase.
Overall Number of Participants Analyzed 37 43 31
Median (95% Confidence Interval)
Unit of Measure: days
29.0
(29.0 to 43.0)
30.0
(29.0 to 57.0)
29.0
(20.0 to 47.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Apremilast 40 mg QD, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.650
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.950
Confidence Interval (2-Sided) 95%
0.745 to 1.211
Estimation Comments Based on a proportional hazards model comparing the hazard functions associated with the treatment and placebo.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Apremilast 20 mg BID, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.283
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.265
Confidence Interval (2-Sided) 95%
0.791 to 2.024
Estimation Comments Based on a proportional hazards model comparing the hazard functions associated with the treatment and placebo.
14.Secondary Outcome
Title Time to ACR 50 Response During the Treatment Phase
Hide Description The Kaplan-Meier estimates of time to ACR 50 response was calculated for participants who had an ACR 50 response at any time during the treatment phase.
Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population who had an ACR 50 response during the treatment phase.
Arm/Group Title Apremilast 40 mg QD Apremilast 20 mg BID Placebo
Hide Arm/Group Description:
Participants received 40 mg apremilast once daily (QD) for 12 weeks during the Treatment Phase.
Participants received 20 mg apremilast twice a day (BID) for 12 weeks during the Treatment Phase.
Participants received matching placebo to apremilast for 12 weeks during the Treatment Phase.
Overall Number of Participants Analyzed 17 18 5
Median (95% Confidence Interval)
Unit of Measure: days
43.0
(29.0 to 61.0)
57.5
(56.0 to 72.0)
15.0
(14.0 to 73.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Apremilast 40 mg QD, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.253
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.337
Confidence Interval (2-Sided) 95%
0.791 to 2.260
Estimation Comments Based on a proportional hazards model comparing the hazard functions associated with the treatment and placebo.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Apremilast 20 mg BID, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.026
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 3.023
Confidence Interval (2-Sided) 95%
1.059 to 8.630
Estimation Comments Based on a proportional hazards model comparing the hazard functions associated with the treatment and placebo.
15.Secondary Outcome
Title Time to ACR 70 Response During the Treatment Phase
Hide Description The Kaplan-Meier estimates of time to ACR 70 response was calculated for participants who had an ACR 70 response at any time during the treatment phase.
Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population with an ACR 70 response during the treatment phase.
Arm/Group Title Apremilast 40 mg QD Apremilast 20 mg BID Placebo
Hide Arm/Group Description:
Participants received 40 mg apremilast once daily (QD) for 12 weeks during the Treatment Phase.
Participants received 20 mg apremilast twice a day (BID) for 12 weeks during the Treatment Phase.
Participants received matching placebo to apremilast for 12 weeks during the Treatment Phase.
Overall Number of Participants Analyzed 7 5 2
Median (95% Confidence Interval)
Unit of Measure: days
62.0
(47.0 to 85.0)
57.0
(43.0 to 85.0)
58.0
(31.0 to 85.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Apremilast 40 mg QD, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.984
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.006
Confidence Interval (2-Sided) 95%
0.457 to 2.215
Estimation Comments Based on a proportional hazards model comparing the hazard functions associated with the treatment and placebo.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Apremilast 20 mg BID, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.836
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.872
Confidence Interval (2-Sided) 95%
0.158 to 4.797
Estimation Comments Based on a proportional hazards model comparing the hazard functions associated with the treatment and placebo.
16.Secondary Outcome
Title Change From Baseline in Dactylitis Severity Score at Week 12
Hide Description Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated on a scale from 0 (no dactylitis) to 3 (severe dactylitis). The dactylitis severity score is the sum of the individual scores for each digit and ranges from 0 to 60.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population; participants with a baseline value and at least 1 post-baseline value in the treatment period are included; LOCF imputation was used.
Arm/Group Title Apremilast 40 mg QD Apremilast 20 mg BID Placebo
Hide Arm/Group Description:
Participants received 40 mg apremilast once daily (QD) for 12 weeks during the Treatment Phase.
Participants received 20 mg apremilast twice a day (BID) for 12 weeks during the Treatment Phase.
Participants received matching placebo to apremilast for 12 weeks during the Treatment Phase.
Overall Number of Participants Analyzed 67 67 67
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.9  (2.39) -1.2  (3.11) -0.2  (3.75)
17.Secondary Outcome
Title Percentage of Participants With Enthesitis
Hide Description Enthesitis is inflammation of the entheses, the sites where tendons or ligaments insert into the bone. Enthesitis is characterized by swelling, pain, and tenderness around the calcaneous, and occasionally by effusion in the bursa associated with this joint. The enthesitis assessment is an evaluation of inflammation at the insertions of the Achilles tendon into the calcaneous and of the plantar fascia into the calcaneous. Inflammation at 1 or more insertions on either the right or left side constituted a positive assessment.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population
Arm/Group Title Apremilast 40 mg QD Apremilast 20 mg BID Placebo
Hide Arm/Group Description:
Participants received 40 mg apremilast once daily (QD) for 12 weeks during the Treatment Phase.
Participants received 20 mg apremilast twice a day (BID) for 12 weeks during the Treatment Phase.
Participants received matching placebo to apremilast for 12 weeks during the Treatment Phase.
Overall Number of Participants Analyzed 67 69 68
Measure Type: Number
Unit of Measure: percentage of participants
Achilles tendon into the calcaneous: Baseline 22.4 21.7 35.3
Achilles tendon into the calcaneous: Week 12 20.9 17.4 17.6
Plantar fascia into the calcaneous: Baseline 26.9 26.1 14.7
Plantar fascia into the calcaneous: Week 12 19.4 21.7 17.6
18.Secondary Outcome
Title Time to Relapse of Psoriatic Arthritis During the Observational Follow-up Phase
Hide Description Relapse of psoriatic arthritis was defined as a 50% loss of the maximal ACR improvement during the Observation Phase in participants who received apremilast and achieved at least an ACR 20 at their Final Treatment Phase/Early Termination Visit. The time to relapse during the Observational Phase was calculated from the time of maximum ACR reduction and from the date of the Final Treatment Phase visit. Participants classified as responders who did not relapse were censored at the day of the last follow-up.
Time Frame From Week 12 to end of 28-day observational follow-up (1) and from the date of maximal ACR during the 12-week Treatment Phase until the end of the 28-day observational follow-up phase (2).
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received apremilast and with an ACR 20 response at the Week 12 (or Early Termination) visit who did not enroll in the Extension Phase.
Arm/Group Title Apremilast 40 mg QD Apremilast 20 mg BID
Hide Arm/Group Description:
Participants received 40 mg apremilast once daily (QD) for 12 weeks during the Treatment Phase.
Participants received 20 mg apremilast twice a day (BID) for 12 weeks during the Treatment Phase.
Overall Number of Participants Analyzed 7 11
Median (95% Confidence Interval)
Unit of Measure: days
1. From Week 12
16.0
(15.0 to 29.0)
15.0
(14.0 to 29.0)
2. From Date of Maximal ACR Response
43.0
(34.0 to 73.0)
29.0
(22.0 to 43.0)
19.Secondary Outcome
Title Number of Participants Who Relapsed During the Observational Follow-up Phase
Hide Description Relapse of psoriatic arthritis was defined as a 50% loss of the maximal ACR improvement during the Observation Phase in participants who received apremilast and achieved at least an ACR 20 at their Final Treatment Phase/Early Termination Visit.
Time Frame 28-day observational follow-up period following Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received apremilast with an ACR 20 response at the Week 12 (or Early Termination) visit who did not enroll in the Extension Phase.
Arm/Group Title Apremilast 40 mg QD Apremilast 20 mg BID
Hide Arm/Group Description:
Participants received 40 mg apremilast once daily (QD) for 12 weeks during the Treatment Phase.
Participants received 20 mg apremilast twice a day (BID) for 12 weeks during the Treatment Phase.
Overall Number of Participants Analyzed 7 11
Measure Type: Count of Participants
Unit of Measure: Participants
5
  71.4%
9
  81.8%
20.Secondary Outcome
Title Change From Baseline in Short Form 36 (SF-36) Summary Physical and Mental Component Scores at Week 12
Hide Description The Medical Outcome SF 36-Item Health Survey, Version 2 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). The summary physical health score included the following subscales: physical functioning, role-physical, bodily pain, and general health. The summary mental health score included other subscales: vitality, social functioning, role-emotional, and mental health. Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10, where higher scores are associated with better functioning/quality of life. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale. A higher change from baseline indicates an improvement in better health results or functioning.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population; participants with a baseline value and at least 1 post-baseline value in the treatment period are included; LOCF imputation was used.
Arm/Group Title Apremilast 40 mg QD Apremilast 20 mg BID Placebo
Hide Arm/Group Description:
Participants received 40 mg apremilast once daily (QD) for 12 weeks during the Treatment Phase.
Participants received 20 mg apremilast twice a day (BID) for 12 weeks during the Treatment Phase.
Participants received matching placebo to apremilast for 12 weeks during the Treatment Phase.
Overall Number of Participants Analyzed 65 64 61
Mean (Standard Deviation)
Unit of Measure: units on a scale
Mental Component 1.0  (8.01) 3.4  (7.18) -0.8  (8.39)
Physical Component 2.1  (5.94) 2.4  (7.89) 0.8  (6.24)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Apremilast 40 mg QD, Placebo
Comments Mental Component
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.308
Comments [Not Specified]
Method ANOVA
Comments ANOVA model including treatment group, methotrexate use, and baseline score.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 1.4
Estimation Comments Adjusted mean difference (Apremilast-Placebo) was based on the ANOVA model described above.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Apremilast 20 mg BID, Placebo
Comments Mental Component
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method ANOVA
Comments ANOVA model including treatment group, methotrexate use, and baseline score.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 4.1
Estimation Comments Adjusted mean difference (Apremilast-Placebo) was based on the ANOVA model described above.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Apremilast 40 mg QD, Placebo
Comments Physical Component
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.182
Comments [Not Specified]
Method ANOVA
Comments ANOVA model including treatment group, methotrexate use, and baseline score.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 1.6
Estimation Comments Adjusted mean difference (Apremilast-Placebo) was based on the ANOVA model described above.
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Apremilast 20 mg BID, Placebo
Comments Physical Component
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.026
Comments [Not Specified]
Method ANOVA
Comments ANOVA model including treatment group, methotrexate use, and baseline score.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 2.7
Estimation Comments Adjusted mean difference (Apremilast-Placebo) was based on the ANOVA model described above.
21.Secondary Outcome
Title Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 12
Hide Description The DLQI is a validated, self-administered, 10-item questionnaire that measures the impact of skin disease on participants' quality of life, based on recall over the past week. Domains include symptoms, feelings, daily activities, leisure, work, personal relationships, and treatment. Each question is answered on a scale from 0 (not at all) to 3 (very much). The total score ranges from 0 to 30 where a higher score indicates that a participant's dermatological condition has a greater impact on their daily life.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population; participants with a baseline value and at least 1 post-baseline value in the treatment period are included; LOCF imputation was used.
Arm/Group Title Apremilast 40 mg QD Apremilast 20 mg BID Placebo
Hide Arm/Group Description:
Participants received 40 mg apremilast once daily (QD) for 12 weeks during the Treatment Phase.
Participants received 20 mg apremilast twice a day (BID) for 12 weeks during the Treatment Phase.
Participants received matching placebo to apremilast for 12 weeks during the Treatment Phase.
Overall Number of Participants Analyzed 67 67 64
Mean (Standard Deviation)
Unit of Measure: units on a scale
-2.6  (5.96) -1.8  (4.29) -0.3  (4.82)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Apremilast 40 mg QD, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.016
Comments [Not Specified]
Method ANOVA
Comments ANOVA model using treatment group, methotrexate use, and interaction of treatment group and methotrexate use as factors.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -2.1
Estimation Comments The adjusted mean difference (Apremilast-Placebo) is based on an ANOVA model described above.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Apremilast 20 mg BID, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.105
Comments [Not Specified]
Method ANOVA
Comments ANOVA model using treatment group, methotrexate use, and interaction of treatment group and methotrexate use as factors.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -1.4
Estimation Comments The adjusted mean difference (Apremilast-Placebo) is based on an ANOVA model described above.
22.Secondary Outcome
Title Change From Baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12
Hide Description The HAQ-DI is a self-administered instrument consisting of 20 questions in eight categories of functioning which represent a comprehensive set of functional activities - dressing, rising, eating, walking, hygiene, reach, grip, and usual activities. Each item asks over the past week whether a particular task can be performed. For each item, there is a four-level difficulty scale that is scored from 0 to 3, representing normal (no difficulty) (0), some difficulty (1), much difficulty (2), and unable to do (3). The eight category scores are averaged into an overall HAQ-DI score on a scale from zero (no disability) to three (completely disabled).
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population; participants with a baseline value and at least 1 post-baseline value in the treatment period are included; LOCF imputation was used.
Arm/Group Title Apremilast 40 mg QD Apremilast 20 mg BID Placebo
Hide Arm/Group Description:
Participants received 40 mg apremilast once daily (QD) for 12 weeks during the Treatment Phase.
Participants received 20 mg apremilast twice a day (BID) for 12 weeks during the Treatment Phase.
Participants received matching placebo to apremilast for 12 weeks during the Treatment Phase.
Overall Number of Participants Analyzed 67 69 67
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.2  (0.39) -0.2  (0.35) -0.1  (0.39)
23.Secondary Outcome
Title Change From Baseline in the Functional Assessment of Chronic Illness Therapy for Fatigue (FACIT-F) at Week 12
Hide Description The FACIT-Fatigue is a 13 item self-administered questionnaire that assesses both the physical and functional consequences of fatigue based on recall during the past 7 days. Each question is answered on a 5-point scale, where 0 means "not at all," and 4 means "very much." The total score ranges from 0 to 52 with higher scores representing less fatigue.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population; participants with a baseline value and at least 1 post-baseline value in the treatment period are included; LOCF imputation was used.
Arm/Group Title Apremilast 40 mg QD Apremilast 20 mg BID Placebo
Hide Arm/Group Description:
Participants received 40 mg apremilast once daily (QD) for 12 weeks during the Treatment Phase.
Participants received 20 mg apremilast twice a day (BID) for 12 weeks during the Treatment Phase.
Participants received matching placebo to apremilast for 12 weeks during the Treatment Phase.
Overall Number of Participants Analyzed 67 67 64
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.3  (9.46) 4.1  (8.78) 0.5  (8.03)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Apremilast 40 mg QD, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.028
Comments [Not Specified]
Method ANOVA
Comments ANOVA model with treatment, methotrexate use, and interaction of treatment group and methotrexate use as factors and baseline score as the covariate.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 3.3
Estimation Comments The adjusted mean difference (Apremilast-Placebo) is based on an ANOVA model described above.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Apremilast 20 mg BID, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method ANOVA
Comments ANOVA model with treatment, methotrexate use, and interaction of treatment group and methotrexate use as factors with baseline score as the covariate.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 4.3
Estimation Comments The adjusted mean difference (Apremilast-Placebo) is based on an ANOVA model described above.
24.Secondary Outcome
Title Number of Participants With Adverse Events During the Extension Phase
Hide Description The severity of each adverse event (AE) was graded based upon the participant's symptoms according to National Cancer Institute (NCI) Common Toxicity Criteria (CTCAE, Version 3.0), on a scale from 1 (Mild AE) to 5 (Death due to AE). Severe AEs are defined as NCI CTCAE grade 3 or higher. AEs related to study drug are those determined by the investigator as suspected to be related to study drug where a temporal relationship of the adverse event to study drug administration made a causal relationship possible, and other medications, therapeutic interventions, or underlying conditions did not provide a sufficient explanation for the observed event. A serious adverse event (SAE) is any AE which: - Resulted in death - Was life-threatening - Required inpatient hospitalization or prolongation of existing hospitalization - Resulted in persistent or significant disability/incapacity - Was a congenital anomaly/birth defect - Constituted an important medical event.
Time Frame Weeks 12 to 24 (Extension Phase)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population; participants who entered the Extension Phase.
Arm/Group Title Apremilast 40 mg QD Apremilast 20 mg BID Placebo/Apremilast 40 mg QD Placebo/Apremilast 20 mg BID
Hide Arm/Group Description:
Participants who received apremilast 40 mg QD during the Treatment Phase continued to receive apremilast 40 mg QD for an additional 12 weeks during the Extension Phase.
Participants who received apremilast 20 mg BID during the Treatment Phase continued to receive apremilast 20 mg BID for an additional 12 weeks during the Extension Phase.
Participants who received placebo during the Treatment Phase then received 40 mg apremilast orally QD for 12 weeks during the Extension Phase.
Participants who received placebo during the Treatment Phase then received 20 mg apremilast orally BID for 12 weeks during the Extension Phase.
Overall Number of Participants Analyzed 46 40 20 20
Measure Type: Count of Participants
Unit of Measure: Participants
All adverse events
30
  65.2%
29
  72.5%
16
  80.0%
11
  55.0%
Adverse events related to study drug
12
  26.1%
8
  20.0%
4
  20.0%
4
  20.0%
Severe adverse events
5
  10.9%
3
   7.5%
3
  15.0%
4
  20.0%
Serious adverse events
2
   4.3%
3
   7.5%
1
   5.0%
1
   5.0%
Serious adverse events related to study drug
0
   0.0%
0
   0.0%
0
   0.0%
1
   5.0%
Discontinued study drug due to adverse event
3
   6.5%
2
   5.0%
0
   0.0%
3
  15.0%
Discontinued due to AE related to study drug
1
   2.2%
1
   2.5%
0
   0.0%
1
   5.0%
25.Secondary Outcome
Title Percentage of Participants With a Psoriatic Arthritis Response Criteria (PsARC) Response at Week 24
Hide Description A PsARC response is defined as improvement from Baseline in at least 2 of the following 4 measures, at least 1 of which must be tender joint count or swollen joint count, and no worsening in any of the 4 measures: • At least 30% improvement in the 78 tender joint count, • At least 30% improvement in the 76 swollen joint count, • At least 20% improvement in the 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; • At least 20% improvement in the physician global assessment of disease activity, measured on a 100 mm VAS, where 0 mm = lowest disease activity and 100 mm = highest. Participants with missing data were considered non-responders.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants enrolled in the Extension Phase; LOCF imputation was used.
Arm/Group Title Apremilast 40 mg QD Apremilast 20 mg BID Placebo/Apremilast 40 mg QD Placebo/Apremilast 20 mg BID
Hide Arm/Group Description:
Participants who received apremilast 40 mg QD during the Treatment Phase continued to receive apremilast 40 mg QD for an additional 12 weeks during the Extension Phase.
Participants who received apremilast 20 mg BID during the Treatment Phase continued to receive apremilast 20 mg BID for an additional 12 weeks during the Extension Phase.
Participants who received placebo during the Treatment Phase then received 40 mg apremilast orally QD for 12 weeks during the Extension Phase.
Participants who received placebo during the Treatment Phase then received 20 mg apremilast orally BID for 12 weeks during the Extension Phase.
Overall Number of Participants Analyzed 46 40 20 20
Measure Type: Number
Unit of Measure: percentage of participants
26.1 20.0 55.0 40.0
26.Secondary Outcome
Title Percentage of Participants With a Modified ACR 20 Response at Week 24
Hide Description A modified ACR 20 response was defined as a participant who met the following 3 criteria for improvement: • ≥ 20% improvement in 78 tender joint count (includes 10 additional joints often involved in psoriatic arthritis: the first carpometacarpal [CMC] and the distal interphalangeal [DIP] joints of the fingers); • ≥ 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 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's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]); ◦ C-reactive protein. Response at Week 24 was measured as improvement from Baseline (Day 1) and from Week 12 (Day 85). Participants with no post-baseline ACR scores were considered non-responders.
Time Frame Baseline (Day 1), Week 12 (Day 85) and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants enrolled in the Extension Phase; LOCF imputation was used. For the analysis of response from Week 12 (Day 85), participants with a tender or swollen joint count of 0 at Day 85 were excluded.
Arm/Group Title Apremilast 40 mg QD Apremilast 20 mg BID Placebo/Apremilast 40 mg QD Placebo/Apremilast 20 mg BID
Hide Arm/Group Description:
Participants who received apremilast 40 mg QD during the Treatment Phase continued to receive apremilast 40 mg QD for an additional 12 weeks during the Extension Phase.
Participants who received apremilast 20 mg BID during the Treatment Phase continued to receive apremilast 20 mg BID for an additional 12 weeks during the Extension Phase.
Participants who received placebo during the Treatment Phase then received 40 mg apremilast orally QD for 12 weeks during the Extension Phase.
Participants who received placebo during the Treatment Phase then received 20 mg apremilast orally BID for 12 weeks during the Extension Phase.
Overall Number of Participants Analyzed 46 40 20 20
Measure Type: Number
Unit of Measure: percentage of participants
Response From Baseline Number Analyzed 46 participants 40 participants 20 participants 20 participants
43.5 42.5 45.0 40.0
Response From Week 12 Number Analyzed 30 participants 34 participants 13 participants 18 participants
16.7 14.7 15.4 16.7
27.Secondary Outcome
Title Percentage of Participants With a Modified ACR 50 Response at Week 24
Hide Description A modified ACR 50 response was defined as a participant who met the following 3 criteria for improvement: • ≥ 50% improvement in 78 tender joint count (includes 10 additional joints often involved in psoriatic arthritis: the first carpometacarpal [CMC] and the distal interphalangeal [DIP] joints of the fingers); • ≥ 50% improvement in 76 swollen joint count; and • ≥ 50% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of pain (measured on a 100 mm 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's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]); ◦ C-reactive protein. Response at Week 24 was measured as improvement from Baseline (Day 1) and from Week 12 (Day 85). Participants with no post-baseline ACR scores were considered non-responders.
Time Frame Baseline (Day 1), Week 12 (Day 85) and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants enrolled in the Extension Phase; LOCF imputation was used. For the analysis of response from Week 12 (Day 85), participants with a tender or swollen joint count of 0 at Day 85 were excluded.
Arm/Group Title Apremilast 40 mg QD Apremilast 20 mg BID Placebo/Apremilast 40 mg QD Placebo/Apremilast 20 mg BID
Hide Arm/Group Description:
Participants who received apremilast 40 mg QD during the Treatment Phase continued to receive apremilast 40 mg QD for an additional 12 weeks during the Extension Phase.
Participants who received apremilast 20 mg BID during the Treatment Phase continued to receive apremilast 20 mg BID for an additional 12 weeks during the Extension Phase.
Participants who received placebo during the Treatment Phase then received 40 mg apremilast orally QD for 12 weeks during the Extension Phase.
Participants who received placebo during the Treatment Phase then received 20 mg apremilast orally BID for 12 weeks during the Extension Phase.
Overall Number of Participants Analyzed 46 40 20 20
Measure Type: Number
Unit of Measure: percentage of participants
Response From Baseline Number Analyzed 46 participants 40 participants 20 participants 20 participants
23.9 22.5 20.0 15.0
Response From Week 12 Number Analyzed 31 participants 34 participants 13 participants 18 participants
9.7 5.9 15.4 5.6
28.Secondary Outcome
Title Percentage of Participants With a Modified ACR 70 Response at Week 24
Hide Description A modified ACR 70 response was defined as a participant who met the following 3 criteria for improvement: • ≥ 70% improvement in 78 tender joint count (includes 10 additional joints often involved in psoriatic arthritis: the first carpometacarpal [CMC] and the distal interphalangeal [DIP] joints of the fingers); • ≥ 70% improvement in 76 swollen joint count; and • ≥ 70% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of pain (measured on a 100 mm 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's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]); ◦ C-reactive protein. Response at Week 24 was measured as improvement from Baseline (Day 1). Participants with no post-baseline ACR scores were considered non-responders.
Time Frame Baseline (Day 1) and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants enrolled in the Extension Phase; LOCF imputation was used.
Arm/Group Title Apremilast 40 mg QD Apremilast 20 mg BID Placebo/Apremilast 40 mg QD Placebo/Apremilast 20 mg BID
Hide Arm/Group Description:
Participants who received apremilast 40 mg QD during the Treatment Phase continued to receive apremilast 40 mg QD for an additional 12 weeks during the Extension Phase.
Participants who received apremilast 20 mg BID during the Treatment Phase continued to receive apremilast 20 mg BID for an additional 12 weeks during the Extension Phase.
Participants who received placebo during the Treatment Phase then received 40 mg apremilast orally QD for 12 weeks during the Extension Phase.
Participants who received placebo during the Treatment Phase then received 20 mg apremilast orally BID for 12 weeks during the Extension Phase.
Overall Number of Participants Analyzed 46 40 20 20
Measure Type: Number
Unit of Measure: percentage of participants
13.0 17.5 15.0 5.0
29.Secondary Outcome
Title Percentage of Participants With Good or Moderate EULAR Response Based on DAS28-CRP(4) at Week 24
Hide Description The DAS28 measures the severity of disease at a specific time. DAS28-CRP(4) is derived from the following 4 variables: • 28 tender joint count, (does not include the DIP joints, the hip joint, or the joints below the knee) • 28 swollen joint count • C-reactive protein • Patient's global assessment of disease activity according to the formula: DAS28-CRP(4) = 0.56*√(TJC28) + 0.28*(SJC28) + 0.36*ln(CRP+1) + 0.014*GH + 0.96. DAS28 scores range from 0 to 9.4, where higher scores indicate more disease activity. A EULAR response reflects an improvement in disease activity based on the DAS-28 score. A Good Response is defined as an improvement (decrease) in the DAS28 > 1.2 from Baseline and attainment of a DAS28 score ≤ 3.2. A Moderate Response is defined as either: • an improvement (decrease) in the DAS28 > 0.6 and ≤ 1.2 and a DAS28 score ≤ to 5.1 or, • an improvement (decrease) in the DAS28 > 1.2 and a DAS28 score > 3.2
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants enrolled in the Extension Phase; LOCF imputation was used.
Arm/Group Title Apremilast 40 mg QD Apremilast 20 mg BID Placebo/Apremilast 40 mg QD Placebo/Apremilast 20 mg BID
Hide Arm/Group Description:
Participants who received apremilast 40 mg QD during the Treatment Phase continued to receive apremilast 40 mg QD for an additional 12 weeks during the Extension Phase.
Participants who received apremilast 20 mg BID during the Treatment Phase continued to receive apremilast 20 mg BID for an additional 12 weeks during the Extension Phase.
Participants who received placebo during the Treatment Phase then received 40 mg apremilast orally QD for 12 weeks during the Extension Phase.
Participants who received placebo during the Treatment Phase then received 20 mg apremilast orally BID for 12 weeks during the Extension Phase.
Overall Number of Participants Analyzed 46 40 20 20
Measure Type: Number
Unit of Measure: percentage of participants
67.4 60.0 70.0 50.0
30.Secondary Outcome
Title Percentage of Participants With Good or Moderate EULAR Response Based on DAS28-CRP(3) at Week 24
Hide Description The DAS28 measures the severity of disease at a specific time. DAS28-CRP(3) is derived from the following 3 variables: • 28 tender joint count, (does not include the DIP joints, the hip joint, or the joints below the knee) • 28 swollen joint count • C-reactive protein (CRP) according to the formula: DAS28-CRP(3) = [0.56*√(TJC28) + 0.28*√(SJC28) + 0.36*ln(CRP+1)] * 1.10 + 1.15. DAS28 scores range from 0 to 9.4, where higher scores indicate more disease activity. A EULAR response reflects an improvement in disease activity based on the DAS-28 score. A Good Response is defined as an improvement (decrease) in the DAS28 > 1.2 from Baseline and attainment of a DAS28 score ≤ 3.2. A Moderate Response is defined as either: • an improvement (decrease) in the DAS28 > 0.6 and ≤ 1.2 and a DAS28 score ≤ to 5.1 or, • an improvement (decrease) in the DAS28 > 1.2 and a DAS28 score > 3.2
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants enrolled in the Extension Phase; LOCF imputation was used.
Arm/Group Title Apremilast 40 mg QD Apremilast 20 mg BID Placebo/Apremilast 40 mg QD Placebo/Apremilast 20 mg BID
Hide Arm/Group Description:
Participants who received apremilast 40 mg QD during the Treatment Phase continued to receive apremilast 40 mg QD for an additional 12 weeks during the Extension Phase.
Participants who received apremilast 20 mg BID during the Treatment Phase continued to receive apremilast 20 mg BID for an additional 12 weeks during the Extension Phase.
Participants who received placebo during the Treatment Phase then received 40 mg apremilast orally QD for 12 weeks during the Extension Phase.
Participants who received placebo during the Treatment Phase then received 20 mg apremilast orally BID for 12 weeks during the Extension Phase.
Overall Number of Participants Analyzed 46 40 20 20
Measure Type: Number
Unit of Measure: percentage of participants
60.9 67.5 65.0 55.0
31.Secondary Outcome
Title Maximal ACR Response During the Extension Period
Hide Description The ACR-N index score was calculated for each participant at each time point in the study according to the following definition: ACR-N = the lowest of the following 3 values: • percent improvement from Baseline in the 76 swollen joint count, • percent improvement from Baseline in the 78 tender joint count • median percent improvement from Baseline in the following 5 measures ◦ 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's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]); ◦ C-reactive protein. The maximal ACR-N for each participant during the 12-week extension period was calculated, and represents the maximal ACR response achieved.
Time Frame ACR was measured at Baseline and Weeks 16, 20 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants enrolled in the Extension Phase with non-missing ACR data
Arm/Group Title Apremilast 40 mg QD Apremilast 20 mg BID Placebo/Apremilast 40 mg QD Placebo/Apremilast 20 mg BID
Hide Arm/Group Description:
Participants who received apremilast 40 mg QD during the Treatment Phase continued to receive apremilast 40 mg QD for an additional 12 weeks during the Extension Phase.
Participants who received apremilast 20 mg BID during the Treatment Phase continued to receive apremilast 20 mg BID for an additional 12 weeks during the Extension Phase.
Participants who received placebo during the Treatment Phase then received 40 mg apremilast orally QD for 12 weeks during the Extension Phase.
Participants who received placebo during the Treatment Phase then received 20 mg apremilast orally BID for 12 weeks during the Extension Phase.
Overall Number of Participants Analyzed 44 39 20 17
Mean (Standard Deviation)
Unit of Measure: percent improvement
29.1  (40.86) 30.4  (36.77) 23.3  (32.11) 34.2  (31.16)
32.Secondary Outcome
Title Time to ACR 20 Response During the Study
Hide Description Time to ACR 20 was measured from the first dose of apremilast to the first time a participant achieved an ACR 20 response in the treatment or extension phase. The Kaplan-Meier estimates of time to ACR 20 response were calculated for participants who had an ACR 20 response at any time during the study.
Time Frame Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants enrolled in the Extension Phase with an ACR 20 response at any time during the study
Arm/Group Title Apremilast 40 mg QD Apremilast 20 mg BID Placebo/Apremilast 40 mg QD Placebo/Apremilast 20 mg BID
Hide Arm/Group Description:
Participants who received apremilast 40 mg QD during the Treatment Phase continued to receive apremilast 40 mg QD for an additional 12 weeks during the Extension Phase.
Participants who received apremilast 20 mg BID during the Treatment Phase continued to receive apremilast 20 mg BID for an additional 12 weeks during the Extension Phase.
Participants who received placebo during the Treatment Phase then received 40 mg apremilast orally QD for 12 weeks during the Extension Phase.
Participants who received placebo during the Treatment Phase then received 20 mg apremilast orally BID for 12 weeks during the Extension Phase.
Overall Number of Participants Analyzed 31 29 4 6
Median (95% Confidence Interval)
Unit of Measure: days
43.0
(29.0 to 44.0)
43.0
(29.0 to 59.0)
34.0
(29.0 to 55.0)
55.5
(29.0 to 57.0)
33.Secondary Outcome
Title Time to ACR 50 Response During the Treatment and Extension Phase
Hide Description Time to ACR 50 response was measured from the first dose of apremilast to the first time a participant achieved an ACR 50 response in the treatment or extension phase. The Kaplan-Meier estimates of time to ACR 50 response were calculated for participants who had an ACR 50 response at any time during the study.
Time Frame Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants enrolled in the Extension Phase with an ACR 50 response at any time during the study
Arm/Group Title Apremilast 40 mg QD Apremilast 20 mg BID Placebo/Apremilast 40 mg QD Placebo/Apremilast 20 mg BID
Hide Arm/Group Description:
Participants who received apremilast 40 mg QD during the Treatment Phase continued to receive apremilast 40 mg QD for an additional 12 weeks during the Extension Phase.
Participants who received apremilast 20 mg BID during the Treatment Phase continued to receive apremilast 20 mg BID for an additional 12 weeks during the Extension Phase.
Participants who received placebo during the Treatment Phase then received 40 mg apremilast orally QD for 12 weeks during the Extension Phase.
Participants who received placebo during the Treatment Phase then received 20 mg apremilast orally BID for 12 weeks during the Extension Phase.
Overall Number of Participants Analyzed 18 16 2 3
Median (95% Confidence Interval)
Unit of Measure: days
71.0
(44.0 to 110.0)
58.5
(56.0 to 86.0)
84.5
(84.0 to 85.0)
55.0
(23.0 to 57.0)
34.Secondary Outcome
Title Time to ACR 70 Response During the Treatment and Extension Phase
Hide Description Time to ACR 70 response was measured from the first dose of apremilast to the first time a participant achieved an ACR 70 response in the treatment or extension phase. The Kaplan-Meier estimates of time to ACR 70 response were calculated for participants who had an ACR 70 response at any time during the study.
Time Frame Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants enrolled in the Extension Phase with an ACR 70 response at any time during the study
Arm/Group Title Apremilast 40 mg QD Apremilast 20 mg BID Placebo/Apremilast 40 mg QD Placebo/Apremilast 20 mg BID
Hide Arm/Group Description:
Participants who received apremilast 40 mg QD during the Treatment Phase continued to receive apremilast 40 mg QD for an additional 12 weeks during the Extension Phase.
Participants who received apremilast 20 mg BID during the Treatment Phase continued to receive apremilast 20 mg BID for an additional 12 weeks during the Extension Phase.
Participants who received placebo during the Treatment Phase then received 40 mg apremilast orally QD for 12 weeks during the Extension Phase.
Participants who received placebo during the Treatment Phase then received 20 mg apremilast orally BID for 12 weeks during the Extension Phase.
Overall Number of Participants Analyzed 9 7 0 0
Median (95% Confidence Interval)
Unit of Measure: days
138.0
(85.0 to 169.0)
85.0
(57.0 to 141.0)
35.Secondary Outcome
Title Change From Baseline and Week 12 in Dactylitis Severity Score at Week 24
Hide Description Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated on a scale from 0 (no dactylitis) to 3 (severe dactylitis). The dactylitis severity score is the sum of the individual scores for each digit and ranges from 0 to 60. Change in the dactylitis severity score was assessed from Baseline (Day 1) and from Week 12 (Day 85).
Time Frame Baseline, Week 12 and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants enrolled in the Extension Phase with a baseline/Week 12 value and at least 1 post-baseline value in the extension period; LOCF imputation was used.
Arm/Group Title Apremilast 40 mg QD Apremilast 20 mg BID Placebo/Apremilast 40 mg QD Placebo/Apremilast 20 mg BID
Hide Arm/Group Description:
Participants who received apremilast 40 mg QD during the Treatment Phase continued to receive apremilast 40 mg QD for an additional 12 weeks during the Extension Phase.
Participants who received apremilast 20 mg BID during the Treatment Phase continued to receive apremilast 20 mg BID for an additional 12 weeks during the Extension Phase.
Participants who received placebo during the Treatment Phase then received 40 mg apremilast orally QD for 12 weeks during the Extension Phase.
Participants who received placebo during the Treatment Phase then received 20 mg apremilast orally BID for 12 weeks during the Extension Phase.
Overall Number of Participants Analyzed 46 39 20 18
Mean (Standard Deviation)
Unit of Measure: units on a scale
Change from Baseline Number Analyzed 46 participants 39 participants 20 participants 18 participants
-0.4  (3.47) -1.5  (3.13) -1.8  (4.94) 0.1  (1.08)
Change from Week 12 Number Analyzed 45 participants 39 participants 20 participants 18 participants
0.3  (3.07) -0.2  (1.97) -0.3  (0.98) -0.8  (2.39)
36.Secondary Outcome
Title Percentage of Participants With Enthesitis in the Extension Phase
Hide Description Enthesitis is inflammation of the entheses, the sites where tendons or ligaments insert into the bone. Enthesitis is characterized by swelling, pain, and tenderness around the calcaneous, and occasionally by effusion in the bursa associated with this joint. The enthesitis assessment is an evaluation of inflammation at the insertions of the Achilles tendon into the calcaneous and of the plantar fascia into the calcaneous. Inflammation at 1 or more insertions on either the right or left side constituted a positive assessment.
Time Frame Week 12 and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants enrolled in the Extension Phase
Arm/Group Title Apremilast 40 mg QD Apremilast 20 mg BID Placebo/Apremilast 40 mg QD Placebo/Apremilast 20 mg BID
Hide Arm/Group Description:
Participants who received apremilast 40 mg QD during the Treatment Phase continued to receive apremilast 40 mg QD for an additional 12 weeks during the Extension Phase.
Participants who received apremilast 20 mg BID during the Treatment Phase continued to receive apremilast 20 mg BID for an additional 12 weeks during the Extension Phase.
Participants who received placebo during the Treatment Phase then received 40 mg apremilast orally QD for 12 weeks during the Extension Phase.
Participants who received placebo during the Treatment Phase then received 20 mg apremilast orally BID for 12 weeks during the Extension Phase.
Overall Number of Participants Analyzed 46 40 20 20
Measure Type: Number
Unit of Measure: percentage of participants
Achilles tendon into the calcaneous: Week 12 17.4 15.0 20.0 20.0
Achilles tendon into the calcaneous: Week 24 19.6 15.0 0.0 15.0
Plantar fascia into the calcaneous:Week 12 15.2 17.5 25.0 10.0
Plantar fascia into the calcaneous: Week 24 13.0 7.5 0.0 10.0
37.Secondary Outcome
Title Time to Relapse of Psoriatic Arthritis After Extension Phase
Hide Description Relapse of psoriatic arthritis was defined as a 50% loss of the maximal ACR improvement during the Follow-up Phase in participants who achieved at least an ACR 20 at their Final Extension Phase (Week 24)/Early Termination Visit. The time to relapse during the Follow-up Phase was calculated from the time of maximum ACR reduction and from the date of the Final Extension Phase visit. Participants classified as responders who did not relapse were censored at the day of the last follow-up.
Time Frame From Week 24 to the end of the 28-day follow-up (1) and from the date of maximal ACR until the end of the 28-day follow-up phase (2).
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with an ACR 20 response at the Week 24 (or Early Termination) visit and entered the Follow-up Phase after the Extension Phase
Arm/Group Title Apremilast 40 mg QD Apremilast 20 mg BID Placebo/Apremilast 40 mg QD Placebo/Apremilast 20 mg BID
Hide Arm/Group Description:
Participants who received apremilast 40 mg QD during the Treatment Phase continued to receive apremilast 40 mg QD for an additional 12 weeks during the Extension Phase.
Participants who received apremilast 20 mg BID during the Treatment Phase continued to receive apremilast 20 mg BID for an additional 12 weeks during the Extension Phase.
Participants who received placebo during the Treatment Phase then received 40 mg apremilast orally QD for 12 weeks during the Extension Phase.
Participants who received placebo during the Treatment Phase then received 20 mg apremilast orally BID for 12 weeks during the Extension Phase.
Overall Number of Participants Analyzed 20 17 2 3
Median (95% Confidence Interval)
Unit of Measure: days
1. From Week 12
31.0 [1] 
(29.0 to NA)
32.0
(29.0 to 38.0)
16.0 [1] 
(NA to NA)
29.0 [1] 
(15.0 to NA)
2. From Date of Maximal ACR Response
85.0 [1] 
(57.0 to NA)
111 [1] 
(41.0 to NA)
16.0 [1] 
(NA to NA)
29.0 [1] 
(15.0 to NA)
[1]
Could not be estimated due to the low number of events
38.Secondary Outcome
Title Number of Participants Who Relapsed After the Extension Phase
Hide Description Relapse of psoriatic arthritis was defined as a 50% loss of the maximal ACR improvement during the Follow-up Phase in participants who achieved at least an ACR 20 at their Final Extension Phase/Early Termination Visit.
Time Frame Week 24 to Week 28 (28-day follow-up period)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with an ACR 20 response at the Week 24 (or Early Termination) visit and entered the Follow-up Phase after the Extension Phase
Arm/Group Title Apremilast 40 mg QD Apremilast 20 mg BID Placebo/Apremilast 40 mg QD Placebo/Apremilast 20 mg BID
Hide Arm/Group Description:
Participants who received apremilast 40 mg QD during the Treatment Phase continued to receive apremilast 40 mg QD for an additional 12 weeks during the Extension Phase.
Participants who received apremilast 20 mg BID during the Treatment Phase continued to receive apremilast 20 mg BID for an additional 12 weeks during the Extension Phase.
Participants who received placebo during the Treatment Phase then received 40 mg apremilast orally QD for 12 weeks during the Extension Phase.
Participants who received placebo during the Treatment Phase then received 20 mg apremilast orally BID for 12 weeks during the Extension Phase.
Overall Number of Participants Analyzed 20 17 2 3
Measure Type: Number
Unit of Measure: participants
8 8 1 2
39.Secondary Outcome
Title Change From Baseline and Week 12 in SF-36 at Week 24
Hide Description The Medical Outcome SF 36-Item Health Survey, Version 2 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). The summary physical health score included the following subscales: physical functioning, role-physical, bodily pain, and general health. The summary mental health score included other subscales: vitality, social functioning, role-emotional, and mental health. Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10, where higher scores are associated with better functioning/quality of life. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale. A higher change from baseline indicates an improvement in better health results or functioning.
Time Frame Baseline (Day 1), Week 12 (Day 85) and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants enrolled in the Extension Phase with a Baseline/Week 12 value and at least 1 post-baseline value in the extension period; LOCF imputation was used.
Arm/Group Title Apremilast 40 mg QD Apremilast 20 mg BID Placebo/Apremilast 40 mg QD Placebo/Apremilast 20 mg BID
Hide Arm/Group Description:
Participants who received apremilast 40 mg QD during the Treatment Phase continued to receive apremilast 40 mg QD for an additional 12 weeks during the Extension Phase.
Participants who received apremilast 20 mg BID during the Treatment Phase continued to receive apremilast 20 mg BID for an additional 12 weeks during the Extension Phase.
Participants who received placebo during the Treatment Phase then received 40 mg apremilast orally QD for 12 weeks during the Extension Phase.
Participants who received placebo during the Treatment Phase then received 20 mg apremilast orally BID for 12 weeks during the Extension Phase.
Overall Number of Participants Analyzed 43 36 20 18
Mean (Standard Deviation)
Unit of Measure: units on a scale
Mental Component: Change from Baseline Number Analyzed 41 participants 36 participants 20 participants 18 participants
0.2  (9.08) 1.4  (8.92) -2.7  (12.20) -1.0  (14.00)
Mental Component: Change from Week 12 Number Analyzed 43 participants 34 participants 20 participants 18 participants
-1.1  (8.14) -2.4  (9.35) -2.5  (10.60) -3.4  (10.61)
Physical Component: Change from Baseline Number Analyzed 41 participants 36 participants 20 participants 18 participants
3.2  (6.68) 4.4  (7.74) 1.8  (9.50) 4.2  (9.99)
Physical Component: Change from Week 12 Number Analyzed 43 participants 34 participants 20 participants 18 participants
0.3  (6.10) 1.0  (6.60) -0.1  (8.50) 2.5  (7.81)
40.Secondary Outcome
Title Change From Baseline and Week 12 in Dermatology Life Quality Index (DLQI) at Week 24
Hide Description The DLQI is a validated, self-administered, 10-item questionnaire that measures the impact of skin disease on participants' quality of life, based on recall over the past week. Domains include symptoms, feelings, daily activities, leisure, work, personal relationships, and treatment. Each question is answered on a scale from 0 (not at all) to 3 (very much) The total score ranges from 0 to 30 where a higher score indicates that a participant's dermatological condition has a greater impact on their daily life.
Time Frame Baseline (Day 1), Week 12 (Day 85) and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants enrolled in the Extension Phase with a Baseline/Week 12 value and at least 1 post-baseline value in the extension period; LOCF imputation was used.
Arm/Group Title Apremilast 40 mg QD Apremilast 20 mg BID Placebo/Apremilast 40 mg QD Placebo/Apremilast 20 mg BID
Hide Arm/Group Description:
Participants who received apremilast 40 mg QD during the Treatment Phase continued to receive apremilast 40 mg QD for an additional 12 weeks during the Extension Phase.
Participants who received apremilast 20 mg BID during the Treatment Phase continued to receive apremilast 20 mg BID for an additional 12 weeks during the Extension Phase.
Participants who received placebo during the Treatment Phase then received 40 mg apremilast orally QD for 12 weeks during the Extension Phase.
Participants who received placebo during the Treatment Phase then received 20 mg apremilast orally BID for 12 weeks during the Extension Phase.
Overall Number of Participants Analyzed 43 37 20 18
Mean (Standard Deviation)
Unit of Measure: units on a scale
Change from Baseline -3.0  (7.36) -1.5  (4.08) -2.6  (4.78) -1.9  (5.50)
Change from Week 12 -0.0  (5.72) -0.1  (3.54) -1.2  (2.07) -2.0  (6.25)
41.Secondary Outcome
Title Change From Baseline and Week 12 in the Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 24
Hide Description The HAQ-DI is a self-administered instrument consisting of 20 questions in eight categories of functioning which represent a comprehensive set of functional activities - dressing, rising, eating, walking, hygiene, reach, grip, and usual activities. Each item asks over the past week whether a particular task can be performed. For each item, there is a four-level difficulty scale that is scored from 0 to 3, representing normal (no difficulty) (0), some difficulty (1), much difficulty (2), and unable to do (3). The eight category scores are averaged into an overall HAQ-DI score on a scale from zero (no disability) to three (completely disabled).
Time Frame Baseline (Day 1), Week 12 (Day 85) and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants enrolled in the Extension Phase with a Baseline/Week 12 value and at least 1 post-baseline value in the extension period; LOCF imputation was used.
Arm/Group Title Apremilast 40 mg QD Apremilast 20 mg BID Placebo/Apremilast 40 mg QD Placebo/Apremilast 20 mg BID
Hide Arm/Group Description:
Participants who received apremilast 40 mg QD during the Treatment Phase continued to receive apremilast 40 mg QD for an additional 12 weeks during the Extension Phase.
Participants who received apremilast 20 mg BID during the Treatment Phase continued to receive apremilast 20 mg BID for an additional 12 weeks during the Extension Phase.
Participants who received placebo during the Treatment Phase then received 40 mg apremilast orally QD for 12 weeks during the Extension Phase.
Participants who received placebo during the Treatment Phase then received 20 mg apremilast orally BID for 12 weeks during the Extension Phase.
Overall Number of Participants Analyzed 46 40 20 18
Mean (Standard Deviation)
Unit of Measure: units on a scale
Change from Baseline Number Analyzed 46 participants 40 participants 20 participants 18 participants
-0.1  (0.45) -0.2  (0.37) -0.1  (0.61) -0.2  (0.59)
Change from Week 12 Number Analyzed 46 participants 40 participants 20 participants 17 participants
0.0  (0.37) -0.0  (0.23) -0.0  (0.46) -0.2  (0.44)
42.Secondary Outcome
Title Change From Baseline in the Functional Assessment of Chronic Illness Therapy for Fatigue (FACIT-F) at Week 24
Hide Description The FACIT-Fatigue is a 13 item self-administered questionnaire that assesses both the physical and functional consequences of fatigue based on recall during the past 7 days. Each question is answered on a 5-point scale, where 0 means "not at all," and 4 means "very much." The total score ranges from 0 to 52 with higher scores representing less fatigue.
Time Frame Baseline (Day 1), Week 12 (Day 85) and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants enrolled in the Extension Phase with a Baseline/Week 12 value and at least 1 post-baseline value in the extension period; LOCF imputation was used.
Arm/Group Title Apremilast 40 mg QD Apremilast 20 mg BID Placebo/Apremilast 40 mg QD Placebo/Apremilast 20 mg BID
Hide Arm/Group Description:
Participants who received apremilast 40 mg QD during the Treatment Phase continued to receive apremilast 40 mg QD for an additional 12 weeks during the Extension Phase.
Participants who received apremilast 20 mg BID during the Treatment Phase continued to receive apremilast 20 mg BID for an additional 12 weeks during the Extension Phase.
Participants who received placebo during the Treatment Phase then received 40 mg apremilast orally QD for 12 weeks during the Extension Phase.
Participants who received placebo during the Treatment Phase then received 20 mg apremilast orally BID for 12 weeks during the Extension Phase.
Overall Number of Participants Analyzed 43 37 20 18
Mean (Standard Deviation)
Unit of Measure: units on a scale
Change from Baseline 4.4  (9.76) 5.9  (7.76) 1.3  (11.23) 1.3  (12.34)
Change from Week 12 -0.3  (8.56) 0.1  (6.19) -2.4  (9.05) -1.3  (13.10)
Time Frame Adverse events are reported for the 12-week placebo-controlled phase, including AEs that occurred during the 28-day observational follow-up, and for up to 24 weeks for all participants who were randomized or re-randomized to apremilast at any time during the study.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Week 12: Apremilast 40 mg QD Week 12: Apremilast 20 mg BID Week 12: Placebo Week 24: Apremilast 40 mg QD Week 24: Apremilast 20 mg BID
Hide Arm/Group Description Participants received 40 mg apremilast once daily (QD) for 12 weeks during the Treatment Phase. Participants received 20 mg apremilast twice a day (BID) for 12 weeks during the Treatment Phase. Participants received matching placebo to apremilast for 12 weeks during the Treatment Phase. Participants who received 40 mg QD apremilast, regardless of when the apremilast exposure started (at Week 0, or 12), up until Week 24. Participants who received 20 mg apremilast BID, regardless of when the apremilast exposure started (at Week 0, 12), up until Week 24.
All-Cause Mortality
Week 12: Apremilast 40 mg QD Week 12: Apremilast 20 mg BID Week 12: Placebo Week 24: Apremilast 40 mg QD Week 24: Apremilast 20 mg BID
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Week 12: Apremilast 40 mg QD Week 12: Apremilast 20 mg BID Week 12: Placebo Week 24: Apremilast 40 mg QD Week 24: Apremilast 20 mg BID
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/67 (0.00%)   4/69 (5.80%)   6/68 (8.82%)   3/87 (3.45%)   8/89 (8.99%) 
Cardiac disorders           
Sinus tachycardia  1  0/67 (0.00%)  1/69 (1.45%)  0/68 (0.00%)  0/87 (0.00%)  1/89 (1.12%) 
Hypertensive heart disease  1  0/67 (0.00%)  0/69 (0.00%)  0/68 (0.00%)  0/87 (0.00%)  1/89 (1.12%) 
Gastrointestinal disorders           
Nausea  1  0/67 (0.00%)  0/69 (0.00%)  2/68 (2.94%)  0/87 (0.00%)  0/89 (0.00%) 
Vomiting  1  0/67 (0.00%)  0/69 (0.00%)  1/68 (1.47%)  0/87 (0.00%)  0/89 (0.00%) 
Hepatobiliary disorders           
Biliary colic  1  0/67 (0.00%)  1/69 (1.45%)  0/68 (0.00%)  0/87 (0.00%)  1/89 (1.12%) 
Hyperbilirubinaemia  1  0/67 (0.00%)  1/69 (1.45%)  0/68 (0.00%)  0/87 (0.00%)  1/89 (1.12%) 
Infections and infestations           
Abdominal abscess  1  0/67 (0.00%)  0/69 (0.00%)  0/68 (0.00%)  0/87 (0.00%)  1/89 (1.12%) 
Wound infection  1  0/67 (0.00%)  0/69 (0.00%)  0/68 (0.00%)  0/87 (0.00%)  1/89 (1.12%) 
Injury, poisoning and procedural complications           
Fall  1  0/67 (0.00%)  0/69 (0.00%)  1/68 (1.47%)  0/87 (0.00%)  0/89 (0.00%) 
Tibia fracture  1  0/67 (0.00%)  0/69 (0.00%)  0/68 (0.00%)  1/87 (1.15%)  0/89 (0.00%) 
Musculoskeletal and connective tissue disorders           
Arthralgia  1  0/67 (0.00%)  0/69 (0.00%)  1/68 (1.47%)  0/87 (0.00%)  0/89 (0.00%) 
Intervertebral disc degeneration  1  0/67 (0.00%)  1/69 (1.45%)  0/68 (0.00%)  0/87 (0.00%)  1/89 (1.12%) 
Osteoarthritis  1  0/67 (0.00%)  0/69 (0.00%)  0/68 (0.00%)  0/87 (0.00%)  1/89 (1.12%) 
Psoriatic arthropathy  1  0/67 (0.00%)  0/69 (0.00%)  1/68 (1.47%)  0/87 (0.00%)  0/89 (0.00%) 
Synovitis  1  0/67 (0.00%)  0/69 (0.00%)  0/68 (0.00%)  0/87 (0.00%)  1/89 (1.12%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Oral neoplasm  1  0/67 (0.00%)  0/69 (0.00%)  0/68 (0.00%)  0/87 (0.00%)  1/89 (1.12%) 
Squamous cell carcinoma of skin  1  0/67 (0.00%)  0/69 (0.00%)  0/68 (0.00%)  1/87 (1.15%)  0/89 (0.00%) 
Uterine leiomyoma  1  0/67 (0.00%)  0/69 (0.00%)  1/68 (1.47%)  0/87 (0.00%)  0/89 (0.00%) 
Neoplasm prostate  1  0/67 (0.00%)  0/69 (0.00%)  0/68 (0.00%)  0/87 (0.00%)  1/89 (1.12%) 
Nervous system disorders           
Balance disorder  1  0/67 (0.00%)  0/69 (0.00%)  1/68 (1.47%)  0/87 (0.00%)  0/89 (0.00%) 
Parkinson's disease  1  0/67 (0.00%)  0/69 (0.00%)  0/68 (0.00%)  1/87 (1.15%)  0/89 (0.00%) 
Social circumstances           
Pregnancy of partner  1  0/67 (0.00%)  1/69 (1.45%)  0/68 (0.00%)  0/87 (0.00%)  1/89 (1.12%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Week 12: Apremilast 40 mg QD Week 12: Apremilast 20 mg BID Week 12: Placebo Week 24: Apremilast 40 mg QD Week 24: Apremilast 20 mg BID
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   45/67 (67.16%)   44/69 (63.77%)   42/68 (61.76%)   63/87 (72.41%)   62/89 (69.66%) 
Gastrointestinal disorders           
Diarrhoea  1  18/67 (26.87%)  14/69 (20.29%)  7/68 (10.29%)  23/87 (26.44%)  14/89 (15.73%) 
Nausea  1  15/67 (22.39%)  12/69 (17.39%)  10/68 (14.71%)  23/87 (26.44%)  14/89 (15.73%) 
Abdominal pain upper  1  4/67 (5.97%)  7/69 (10.14%)  3/68 (4.41%)  5/87 (5.75%)  8/89 (8.99%) 
Vomiting  1  4/67 (5.97%)  4/69 (5.80%)  3/68 (4.41%)  5/87 (5.75%)  6/89 (6.74%) 
Abdominal pain  1  2/67 (2.99%)  4/69 (5.80%)  1/68 (1.47%)  2/87 (2.30%)  4/89 (4.49%) 
General disorders           
Fatigue  1  11/67 (16.42%)  6/69 (8.70%)  6/68 (8.82%)  11/87 (12.64%)  7/89 (7.87%) 
Infections and infestations           
Nasopharyngitis  1  8/67 (11.94%)  8/69 (11.59%)  14/68 (20.59%)  23/87 (26.44%)  18/89 (20.22%) 
Upper respiratory tract infection  1  4/67 (5.97%)  2/69 (2.90%)  0/68 (0.00%)  4/87 (4.60%)  3/89 (3.37%) 
Influenza  1  3/67 (4.48%)  0/69 (0.00%)  1/68 (1.47%)  5/87 (5.75%)  2/89 (2.25%) 
Rhinitis  1  0/67 (0.00%)  2/69 (2.90%)  0/68 (0.00%)  0/87 (0.00%)  5/89 (5.62%) 
Musculoskeletal and connective tissue disorders           
Psoriatic arthropathy  1  5/67 (7.46%)  7/69 (10.14%)  8/68 (11.76%)  10/87 (11.49%)  13/89 (14.61%) 
Back pain  1  2/67 (2.99%)  1/69 (1.45%)  4/68 (5.88%)  4/87 (4.60%)  1/89 (1.12%) 
Nervous system disorders           
Headache  1  15/67 (22.39%)  13/69 (18.84%)  11/68 (16.18%)  17/87 (19.54%)  17/89 (19.10%) 
Dizziness  1  7/67 (10.45%)  3/69 (4.35%)  3/68 (4.41%)  7/87 (8.05%)  3/89 (3.37%) 
Migraine  1  2/67 (2.99%)  6/69 (8.70%)  0/68 (0.00%)  3/87 (3.45%)  6/89 (6.74%) 
Respiratory, thoracic and mediastinal disorders           
Oropharyngeal pain  1  1/67 (1.49%)  1/69 (1.45%)  4/68 (5.88%)  2/87 (2.30%)  1/89 (1.12%) 
Cough  1  0/67 (0.00%)  1/69 (1.45%)  4/68 (5.88%)  0/87 (0.00%)  3/89 (3.37%) 
Skin and subcutaneous tissue disorders           
Pruritus  1  5/67 (7.46%)  2/69 (2.90%)  1/68 (1.47%)  5/87 (5.75%)  4/89 (4.49%) 
Psoriasis  1  1/67 (1.49%)  3/69 (4.35%)  3/68 (4.41%)  4/87 (4.60%)  6/89 (6.74%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results from a center cannot be submitted for publication before results of multicenter study are published unless it is more than 1 year since study completion. Then, Investigator can publish if manuscript is submitted to Celgene 60 days prior to submission. If Celgene decides publication would hinder drug development, Investigator must delay submission for up to 90 days. Investigator must delete confidential information before submission or defer publication to permit patent applications.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Associate Director, Clinical Trials Disclosure
Organization: Celgene Corporation
Phone: 1-888-260-1599
EMail: clinicaltrialdisclosure@celgene.com
Layout table for additonal information
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00456092    
Other Study ID Numbers: CC-10004-PSA-001
First Submitted: April 2, 2007
First Posted: April 4, 2007
Results First Submitted: August 27, 2018
Results First Posted: October 23, 2019
Last Update Posted: June 19, 2020