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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01925768
Registration number
NCT01925768
Ethics application status
Date submitted
15/08/2013
Date registered
20/08/2013
Date last updated
12/05/2020
Titles & IDs
Public title
Safety and Efficacy Study of Apremilast to Treat Psoriatic Arthritis
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Scientific title
A Phase 3b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) Monotherapy in Subjects With Active Psoriatic Arthritis
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Secondary ID [1]
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CC-10004-PSA-006
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Psoriatic Arthritis
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Condition category
Condition code
Musculoskeletal
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Osteoarthritis
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Inflammatory and Immune System
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Rheumatoid arthritis
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Musculoskeletal
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Apremilast 30 mg
Treatment: Drugs - Placebo
Experimental: Apremilast 30 mg - 30 mg Apremilast tablets administered twice daily (BID) for 24 weeks during the double-blind placebo-controlled phase; followed by 30 mg Apremilast BID for 28 weeks of active treatment phase (up to the 52 week visit); original treatment assignments remain blinded until all participants have completed their 52 week visit or have discontinued. After the Wk 52 visit, all participants in the extension phase will continue to receive treatment with apremilast 30 mg BID until the end of the study (ie, up to Week 104 visit) or until early discontinuation from the trial.
Placebo Comparator: Placebo - Oral placebo BID during the placebo controlled phase weeks 0 to 24; placebo treated participants whose improvement is <10% in both swollen and tender joint counts at Week 16 are eligible for early escape (based on the measure of clinical benefit from their current treatment as evidenced by improvement (or lack of improvement) in 1) the physician (evaluator's) global assessment (EGA), 2) patients pain (pain NRS), 3) the patient global assessments (PGA), and 4) the health assessment questionnaire disability index (HAQ-DI); Placebo-treated patients who early escape are transitioned to apremilast 30 mg PO BID during the active treatment phase up to their Week 52 visit; all those who complete the 52-week treatment phase will enter an open-label extension phase for an additional 52 weeks or until early discontinuation from the trial.
Treatment: Drugs: Apremilast 30 mg
30mg of Apremilast will be orally administered twice daily for 104 weeks
Treatment: Drugs: Placebo
Identically appearing Placebo tablets will be orally administered twice daily for up to 24 weeks
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants Who Achieved an American College of Rheumatology 20% (ACR20) Response at Week 16
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Assessment method [1]
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Percentage of participants with an American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:
= 20% improvement in 78 tender joint count;
= 20% improvement in 76 swollen joint count; and
= 20% improvement in at least 3 of the 5 following parameters:
Patient's self-assessment of pain (measured on a 0 to 10 unit numeric rating scale [NRS]);
Patient's global self-assessment of disease activity (measured on a 0 to 10 unit NRS);
Physician's global assessment of disease activity (measured on a 0 to 10 unit NRS);
Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);
C-Reactive Protein (CRP) Those who withdrew early or who did not have sufficient data at Week 16 were counted as non-responders.
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Timepoint [1]
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Baseline and Week 16
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Secondary outcome [1]
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Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 24
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Assessment method [1]
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HAQ-DI is a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. A higher score indicates worse physical functioning, and a negative change from baseline indicates improvement.
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Timepoint [1]
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Baseline and Week 24
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Secondary outcome [2]
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Percentage of Participants Who Achieved an American College of Rheumatology 20% (ACR20) at Week 24
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Assessment method [2]
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Percentage of participants with an American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:
= 20% improvement in 78 tender joint count;
= 20% improvement in 76 swollen joint count; and
= 20% improvement in at least 3 of the 5 following parameters:
Patient's self-assessment of pain (measured on a 0 to 10 unit numeric rating scale [NRS]);
Patient's global self-assessment of disease activity (measured on a 0 to 10 unit NRS);
Physician's global assessment of disease activity (measured on a 0 to 10 unit NRS);
Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);
C-Reactive Protein (CRP) Those who withdrew early or who did not have sufficient data at Week 16 were counted as non-responders.
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Timepoint [2]
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Baseline and Week 24
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Secondary outcome [3]
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Change From Baseline in the 28-Joint Disease Activity Score Using C-reactive Protein as the Acute-Phase Reactant (DAS28 [CRP]) at Week 24
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Assessment method [3]
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The DAS28 measures the severity of disease at a specific time and is derived from the following variables:
28 tender joint count
28 swollen joint count, which do not include the DIP joints, the hip joint, or the joints below the knee;
C-reactive protein (CRP)
Patient's global assessment of disease activity. DAS28 (CRP) scores range from 0 to 9.4. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission. A higher value indicates higher disease activity, and a negative change from baseline indicates improvement.
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Timepoint [3]
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Baseline and Week 24
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Secondary outcome [4]
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Change From Baseline in the Medical Outcomes Short Form Health Survey (SF-36) V2 Physical Function Domain Score at Week 24
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Assessment method [4]
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The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning. The physical functioning domain assesses limitations in physical activities because of health problems. A positive change from baseline score indicates an improvement.
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Timepoint [4]
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Baseline and Week 24
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Secondary outcome [5]
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Change From Baseline in the 36-item SF-36 Physical Component Summary Score at Week 24
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Assessment method [5]
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The SF-36 (v 2.0) 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 physical component summary (PCS) score includes the physical functioning, role physical, bodily pain, and general health domains. Minimum clinically important difference (MCID) for the scale scores, as well as the PCS and MCS, is defined as a 2.5-point improvement (increase) from baseline. The summary scores range from 0 to 100, with lower scores reflecting more disability, and higher scores reflecting less disability and better health. The 8 domains are regrouped into the PCS and MCS scores.
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Timepoint [5]
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Baseline and Week 24
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Secondary outcome [6]
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Change From Baseline in the Duration of Morning Stiffness at Week 24
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Assessment method [6]
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Morning stiffness was the participant's assessment of how long their morning stiffness lasted after first waking up in the morning, on average, during the previous week. A higher value indicates longer duration, and a negative change from baseline indicates improvement.
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Timepoint [6]
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Baseline and Week 24
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Secondary outcome [7]
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Percentage of Participants With Improved Change in Severity of Morning Stiffness at Week 24
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Assessment method [7]
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Morning stiffness severity was the participant's assessment of how severe their morning stiffness was after first waking up in the morning, on average, during the previous week. The severity was recorded as none, mild, moderate, moderately severe, or very severe. The response of no improvement includes subjects who had no change or worsened. Improvement is defined as the change from baseline of a more severe assessment to less severe assessment.
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Timepoint [7]
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Baseline and Week 24
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Secondary outcome [8]
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Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 16
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Assessment method [8]
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0
HAQ-DI is a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. A higher score indicates worse physical functioning, and a negative change from baseline indicates improvement.
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Timepoint [8]
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Baseline and Week 16
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Secondary outcome [9]
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Change From Baseline in the Disease Activity Score DAS28 (CRP) at Week 16
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Assessment method [9]
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0
The DAS28 measures the severity of disease at a specific time and is derived from the following variables:
28 tender joint count
28 swollen joint count, which do not include the DIP joints, the hip joint, or the joints below the knee;
C-reactive protein (CRP)
Patient's global assessment of disease activity. DAS28 (CRP) scores range from 0 to 9.4. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission. A negative change from baseline indicates improvement.
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Timepoint [9]
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Baseline and Week 16
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Secondary outcome [10]
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Change From Baseline in 36-item Short Form Health Survey (SF-36) V 2 Physical Functioning Domain at Week 16
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Assessment method [10]
0
0
The SF-36 (v 2.0) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning. The physical functioning domain assesses limitations in physical activities because of health problems. A positive change from Baseline score indicates an improvement.
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Timepoint [10]
0
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Baseline and Week 16
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Secondary outcome [11]
0
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Mean Change From Baseline in the Duration of Morning Stiffness at Week 16
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Assessment method [11]
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0
Morning stiffness was the participant's assessment of how long their morning stiffness lasted after first waking up in the morning, on average, during the previous week. A higher value indicates longer duration, and a negative change from baseline indicates improvement.
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Timepoint [11]
0
0
Baseline and Week 16
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Secondary outcome [12]
0
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Percentage of Participants Whose Severity of Morning Stiffness at Week 16 Improved From Baseline
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Assessment method [12]
0
0
Morning stiffness severity was the participant's assessment of how severe their morning stiffness was after first waking up in the morning, on average, during the previous week. The severity was recorded as none, mild, moderate, moderately severe, or very severe. Improvement is defined as the change from baseline of a more severe assessment to less severe assessment. Full Analysis Set; Participants who discontinued early prior to Week 16 and those who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders.
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Timepoint [12]
0
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Baseline and Week 16
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Secondary outcome [13]
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Percentage of Participants Who Achieved an American College of Rheumatology 20% (ACR20) Response at Weeks 2, 4, 6, 8, 12 and 20
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Assessment method [13]
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Percentage of participants with an American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:
= 20% improvement in 78 tender joint count;
= 20% improvement in 76 swollen joint count; and
= 20% improvement in at least 3 of the 5 following parameters:
Patient's self-assessment of pain (measured on a 0 to 10 unit numeric rating scale [NRS]);
Patient's global self-assessment of disease activity (measured on a 0 to 10 unit NRS);
Physician's global assessment of disease activity (measured on a 0 to 10 unit NRS);
Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);
C-Reactive Protein (CRP)
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Timepoint [13]
0
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Baseline and at Weeks 2, 4, 6, 8, 12 and 20
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Secondary outcome [14]
0
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Percentage of Participants Who Achieved an American College of Rheumatology 20% (ACR20) Response at Weeks 52 and 104
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Assessment method [14]
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Percentage of participants with an American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:
= 20% improvement in 78 tender joint count;
= 20% improvement in 76 swollen joint count; and
= 20% improvement in at least 3 of the 5 following parameters:
Patient's self-assessment of pain (measured on a 0 to 10 unit numeric rating scale [NRS]);
Patient's global self-assessment of disease activity (measured on a 0 to 10 unit NRS);
Physician's global assessment of disease activity (measured on a 0 to 10 unit NRS);
Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);
C-Reactive Protein (CRP)
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Timepoint [14]
0
0
Baseline and Weeks 52 and 104
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Secondary outcome [15]
0
0
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Weeks 52 and 104
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Assessment method [15]
0
0
HAQ-DI is a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. A higher score indicates worse physical functioning, and a negative change from baseline indicates improvement.
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Timepoint [15]
0
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Baseline and Weeks 52 and 104
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Secondary outcome [16]
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Change From Baseline in the Disease Activity Score (DAS28) at Week 52 and 104
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Assessment method [16]
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0
The DAS28 measures the severity of disease at a specific time and is derived from the following variables:
28 tender joint count
28 swollen joint count, which do not include the DIP joints, the hip joint, or the joints below the knee;
C-reactive protein (CRP)
Patient's global assessment of disease activity. DAS28 (CRP) scores range from 0 to 9.4. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission. A negative change from baseline indicates improvement.
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Timepoint [16]
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Baseline and Weeks 52 and 104
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Secondary outcome [17]
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Change From Baseline in 36-item SF-36 (V2.0) Physical Functioning Domain Score at Weeks 52 and 104
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Assessment method [17]
0
0
The SF-36 (v 2.0) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning. The physical functioning domain assesses limitations in physical activities because of health problems. A positive change from Baseline score indicates an improvement.
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Timepoint [17]
0
0
Baseline and Weeks 52 and 104
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Secondary outcome [18]
0
0
Change From Baseline in the Duration of Morning Stiffness at Weeks 52 and 104
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Assessment method [18]
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0
Morning stiffness was the participant's assessment of how long their morning stiffness lasted after first waking up in the morning, on average, during the previous week. A higher value indicates longer duration, and a negative change from baseline indicates improvement.
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Timepoint [18]
0
0
Baseline and Weeks 52 and 104
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Secondary outcome [19]
0
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Percentage of Participants Whose Severity of Morning Stiffness at Week 52 and 104 Improved From Baseline
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Assessment method [19]
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0
Morning stiffness severity was the participant's assessment of how severe their morning stiffness was after first waking up in the morning, on average, during the previous week. The severity was recorded as none, mild, moderate, moderately severe, or very severe. Improvement is defined as the change from baseline of a more severe assessment to less severe assessment.
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Timepoint [19]
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0
Baseline and Weeks 52 and 104
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Secondary outcome [20]
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Number of Participants With Treatment Emergent Adverse Events (TEAE) During the 24 Week Placebo Controlled Phase
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Assessment method [20]
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A TEAE is an AE with a start date on or after the date of the first dose of Investigational Product (IP). An AE is any noxious, unintended, or untoward medical occurrence, that may appear or worsen in a participant during the course of study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) was considered an AE. A serious AE (SAE) is any untoward adverse event that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly or birth defect, or a condition that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above.
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Timepoint [20]
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Date of first dose of study drug to Week 24; median duration of exposure during placebo controlled phase was 24.14 weeks
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Secondary outcome [21]
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Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Apremilast-Exposure Period
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Assessment method [21]
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0
A TEAE is an AE with a start date on or after the date of the first dose of Investigational Product (IP). An AE is any noxious, unintended, or untoward medical occurrence, that may appear or worsen in a participant during the course of study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) was considered an AE. A serious AE (SAE) is any untoward adverse event that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly or birth defect, or a condition that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above.
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Timepoint [21]
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Start of lst dose of IP up to week 104: Weeks 0 to104 for those initially randomized to APR 30 mg BID, Weeks 16 -104 for PBO-treated patients who EE to APR at Week 16 and from Weeks 24-104 for PBO-treated patients who transitioned to APR at Week 24
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Eligibility
Key inclusion criteria
1. Males or females, 18 years and older at time of consent.
2. Must understand and voluntarily sign an informed consent document prior to any study
related assessments/procedures being conducted.
3. Able to adhere to the study visit schedule and other protocol requirements.
4. Have a documented diagnosis of psoriatic arthritis (by any criteria) of at least 3
months' duration
5. Meet the classification criteria for psoriatic arthritis (CASPAR) at the time of
screening.
6. Have at least 3 swollen AND at least 3 tender joints.
7. Must have high sensitivity C-Reactive Protein (hs-CRP) of at least 0.5 mg/dL at
screening and at baseline.
8. Must be receiving treatment on an outpatient basis.
9. Must be tumor necrosis factor (TNF) blocker naive and other Biologic naïve for
dermatologic and rheumatic conditions
10. Subjects taking disease modifying anti-rheumatoid drugs (DMARDs), with the exception
of cyclosporine and leflunomide (see 7.3.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion Criteria 20, 21), do not require a
washout, however, they must discontinue the DMARD treatment at least one day prior to
their baseline visit (ie, Visit 2, Day 0)
11. Subjects who have been previously treated with leflunomide will require a 12-week
washout or treatment with the cholestyramine, per leflunomide prescribing label (ie. 8
g cholestyramine 3 times daily for 11 days.
12. Subjects who have been previously treated with cyclosporine will require a 4-week
washout prior to randomization to participate in the study
13. If taking oral corticosteroids, must be on a stable dose of prednisone less than or
equal to 10 mg/day or equivalent for at least 30 days prior to baseline visit (ie, Day
0)
14. If taking nonsteroidal anti-inflammatory drugs (NSAIDs) or narcotic analgesics, must
be on stable dose for at least 30 days prior to baseline visit (ie, Day 0) and until
they have completed the Week 24 study visit.
15. Must meet the following laboratory criteria:
- White blood cell count greater than 3000/mm^3 (greater than 3.0 X 10^9/L) and
less than 14,000/mm^3 (less than 14 X 10^9/L)
- Platelet count at least 100,000/mm^3 (at least 100 X 10^9/L)
- Serum creatinine less than or equal to 1.5 mg/dL (less than or equal to 132.6
µmol/L)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or
equal to twice upper limit of normal (ULN). If initial test shows ALT or AST
greater than 2 times the ULN, one repeat test is allowed during the screening
period.
- Total bilirubin less than or equal to 2 mg/dL (less than or equal to 34 µmol/L)
or Albumin greater than LLN. If initial test result is greater than 2 mg/dL, one
repeat test is allowed during the screening period.
- Hemoglobin at least 9 g/dL (at least 5.6 mmol/L)
- Hemoglobin A1c less than or equal to 9.0%
16. All females of childbearing potential (FCBP) must use one of the approved
contraceptive options as described below while on investigational product and for at
least 28 days after administration of the last dose of the investigational product.
At the time of study entry, and at any time during the study when a female subject of
childbearing potential's contraceptive measures or ability to become pregnant changes,
the investigator will educate the subject regarding contraception options and the
correct and consistent use of effective contraceptive methods in order to successfully
prevent pregnancy.
Females of childbearing potential must have a negative pregnancy test at Screening and
Baseline. All FCBP subjects who engage in activity in which conception is possible
must use one of the approved contraceptive options described below:
Option 1: Any one of the following highly effective methods: hormonal contraception
(oral, injection, implant, transdermal patch, vaginal ring); intrauterine device
(IUD); tubal ligation; or partner's vasectomy; OR Option 2: Male or female condom
(latex condom or non latex condom NOT made out of natural [animal] membrane [for
example, polyurethane]; PLUS one additional barrier method: (a) diaphragm with
spermicide; (b) cervical cap with spermicide; or (c) contraceptive sponge with
spermicide.
17. Male subjects (including those who have had a vasectomy) who engage in activity in
which conception is possible must use barrier contraception (male latex condom or
nonlatex condom NOT made out of natural [animal] membrane [for example, polyurethane])
while on investigational product and for at least 28 days after the last dose of
investigational product.
1. History of clinically significant (as determined by the investigator) cardiac,
endocrine, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic,
immunologic disease, or other major uncontrolled disease.
2. Any condition, including the presence of laboratory abnormalities, which places the
subject at unacceptable risk if he/she were to participate in the study or confounds
the ability to interpret data from the study.
3. Clinically significant abnormality on a 12-lead electrocardiogram (ECG) at Screening.
4. Pregnant or breast feeding.
5. History of allergy to any component of the investigational product.
6. Hepatitis B surface antigen positive at screening.
7. Hepatitis C antibody positive at screening.
8. History of positive human immunodeficiency virus (HIV), or congenital or acquired
immunodeficiency (eg, Common Variable Immunodeficiency Disease).
9. Active tuberculosis or a history of incompletely treated tuberculosis.
10. Clinically significant abnormality based upon chest radiograph with at least
posterior-anterior (PA) view (the radiograph must be taken within 12 weeks prior to
Screening or during the Screening visit). An additional lateral view is strongly
recommended but not required.
11. Active substance abuse or a history of substance abuse within 6 months prior to
Screening.
12. Bacterial infections requiring treatment with oral or injectable antibiotics, or
significant viral or fungal infections, within 4 weeks of Screening. Any treatment for
such infections must have been completed and the infection cured, at least 4 weeks
prior to Screening.
13. Malignancy or history of malignancy, except for:
1. treated [ie, cured] basal cell or squamous cell in situ skin carcinomas;
2. treated [ie, cured] cervical intraepithelial neoplasia [CIN] or carcinoma in situ
of the cervix with no evidence of recurrence within the previous 5 years.
14. Major surgery (including joint surgery) within 8 weeks prior to screening or planned
major surgery within 6 months following randomization.
15. Erythrodermic, guttate, or generalized pustular psoriasis at randomization.
16. Rheumatic autoimmune disease other than PsA, including, but not limited to: systemic
lupus erythematosis (SLE), mixed connective tissue disease (MCTD), scleroderma,
polymyositis, or fibromyalgia.
17. Functional Class IV, as defined by the American College of Rheumatology (ACR)
Classification of Functional Status in Rheumatoid Arthritis.
18. Prior history of or current inflammatory joint disease other than PsA (eg, gout,
reactive arthritis, rheumatoid arthritis (RA), ankylosing spondylitis, Lyme disease).
19. Prior treatment with more than one non-biologic DMARD
20. Use of the following systemic therapy(ies) within 4 weeks of randomization:
cyclosporine or other calcineurin inhibitors, corticosteroids exceeding 10 mg daily
prednisone equivalent, as well as other oral agents such as retinoids, mycophenolate,
thioguanine, hydroxyurea, sirolimus, tacrolimus.
21. Use of leflunomide within 12 weeks of randomization, unless subject has taken
cholestyramine, 8g TID (three times a day) x 11 days after stopping leflunomide.
22. Previous treatment with biologic agents for rheumatic diseases such as, but not
limited to: adalimumab, abatacept, canakinumab, etanercept, golimumab, infliximab,
rilonacept, certolizumab pegol, or tocilizumab.
23. Previous treatment with biologic agents for dermatologic diseases such as alefacept,
anti-TNFs (eg etanercept, adalinumab) or ustekinumab.
24. Previous treatment with tofacitinib, Anti IL-17 agents or secukinumab
25. Previous treatment with any cell depleting therapies, including investigational agents
(eg, rituximab, alemtuzumab, ocrelizumab, alemtuzumab, anti-CD4, anti-CD5, anti-CD3,
anti-CD19, and anti-CD20).
26. Treatment with intravenous gamma globulin, plasmapheresis, or Prosorba® column
27. Any previous treatment with alkylating agents such as cyclophosphamide or
chlorambucil, or with total lymphoid irradiation.
28. Prior treatment with any non-biologic DMARDS other than methotrexate, sulfasalazine,
chloroquine, hydroxychloroquine, azathioprine, fumeric acid esters, cyclosporine, or
leflunomide
29. Prior treatment with apremilast, or participation in a clinical study, involving
apremilast
30. Use of any investigational drug within 4 weeks of randomization, or 5 pharmacokinetic/
pharmacodynamic half lives, if known (whichever is longer).
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Query!
Query!
Query!
Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
4/09/2013
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
17/11/2016
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Sample size
Target
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Accrual to date
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Final
219
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Recruitment in Australia
Recruitment state(s)
WA
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Recruitment hospital [1]
0
0
Colin Bayliss Research and Teaching Unit - Victoria Park
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Recruitment hospital [2]
0
0
Eastern Health Clinical School - Box Hill
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Recruitment hospital [3]
0
0
Royal Prince Alfred Hospital - Camperdown
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Recruitment hospital [4]
0
0
Menzies Centre for Population Health Research - Hobart,
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Recruitment hospital [5]
0
0
Optimus Clinical Research Pty. Ltd - Kogarah
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Recruitment hospital [6]
0
0
Coastal Joint Care - Maroochydore
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Recruitment hospital [7]
0
0
Westmead Cancer Care Center - Westmead, NSW
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Recruitment postcode(s) [1]
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0
6100 - Victoria Park
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Recruitment postcode(s) [2]
0
0
3128 - Box Hill
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Recruitment postcode(s) [3]
0
0
2050 - Camperdown
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Recruitment postcode(s) [4]
0
0
7000 - Hobart,
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Recruitment postcode(s) [5]
0
0
2217 - Kogarah
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Recruitment postcode(s) [6]
0
0
4558 - Maroochydore
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Recruitment postcode(s) [7]
0
0
2145 - Westmead, NSW
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
Alabama
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Country [2]
0
0
United States of America
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State/province [2]
0
0
California
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Country [3]
0
0
United States of America
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State/province [3]
0
0
Florida
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Country [4]
0
0
United States of America
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State/province [4]
0
0
Idaho
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Illinois
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Michigan
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Country [7]
0
0
United States of America
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State/province [7]
0
0
Montana
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Country [8]
0
0
United States of America
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State/province [8]
0
0
Nebraska
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Country [9]
0
0
United States of America
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State/province [9]
0
0
North Carolina
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Country [10]
0
0
United States of America
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State/province [10]
0
0
Pennsylvania
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Country [11]
0
0
United States of America
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State/province [11]
0
0
Tennessee
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Country [12]
0
0
United States of America
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State/province [12]
0
0
Texas
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Country [13]
0
0
United States of America
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State/province [13]
0
0
Utah
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Country [14]
0
0
United States of America
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State/province [14]
0
0
West Virginia
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Country [15]
0
0
Canada
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State/province [15]
0
0
British Columbia
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Country [16]
0
0
Canada
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State/province [16]
0
0
Manitoba
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Country [17]
0
0
Canada
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State/province [17]
0
0
Newfoundland and Labrador
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Country [18]
0
0
Canada
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State/province [18]
0
0
Ontario
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Country [19]
0
0
Canada
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State/province [19]
0
0
Quebec
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Country [20]
0
0
Czechia
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State/province [20]
0
0
Praha 2
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Country [21]
0
0
Czechia
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State/province [21]
0
0
Praha 4
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Country [22]
0
0
Czechia
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State/province [22]
0
0
Sokolov
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Country [23]
0
0
Czechia
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State/province [23]
0
0
Zlin
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Country [24]
0
0
Estonia
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State/province [24]
0
0
Tallinn
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Country [25]
0
0
Estonia
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State/province [25]
0
0
Tartu
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Country [26]
0
0
Hungary
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State/province [26]
0
0
Budapest
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Country [27]
0
0
Hungary
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State/province [27]
0
0
Debrecen
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Country [28]
0
0
Hungary
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State/province [28]
0
0
Szolnok
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Country [29]
0
0
Hungary
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State/province [29]
0
0
Veszprém
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Country [30]
0
0
New Zealand
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State/province [30]
0
0
Hamilton
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Country [31]
0
0
New Zealand
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State/province [31]
0
0
Manukau
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Country [32]
0
0
New Zealand
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State/province [32]
0
0
Timaru
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Country [33]
0
0
Romania
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State/province [33]
0
0
Bucharest
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Country [34]
0
0
Romania
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State/province [34]
0
0
Cluj-Napoca
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Country [35]
0
0
Romania
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State/province [35]
0
0
Galati
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Country [36]
0
0
Romania
Query!
State/province [36]
0
0
Sfantu Gheorghe, Covasna
Query!
Country [37]
0
0
Russian Federation
Query!
State/province [37]
0
0
Kazan
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Country [38]
0
0
Russian Federation
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State/province [38]
0
0
Penza
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Country [39]
0
0
Russian Federation
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State/province [39]
0
0
Smolensk
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Country [40]
0
0
Russian Federation
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State/province [40]
0
0
Yaroslavl
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Country [41]
0
0
Spain
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State/province [41]
0
0
A Coruña
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Country [42]
0
0
Spain
Query!
State/province [42]
0
0
Barcelona, Hospitalet De Llobregat
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Country [43]
0
0
Spain
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State/province [43]
0
0
Barcelona
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Country [44]
0
0
Spain
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State/province [44]
0
0
Bilbao
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Country [45]
0
0
Spain
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State/province [45]
0
0
La Laguna
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Country [46]
0
0
Spain
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State/province [46]
0
0
Madrid
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Country [47]
0
0
Spain
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State/province [47]
0
0
Málaga
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Country [48]
0
0
Spain
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State/province [48]
0
0
Sabadell
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Country [49]
0
0
Spain
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State/province [49]
0
0
Santiago de Compostela
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Amgen
Query!
Address
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Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
The purpose of this study is to determine whether apremilast is safe and effective for
treating patients with psoriatic arthritis.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT01925768
Query!
Trial related presentations / publications
Nash P, Ohson K, Walsh J, Delev N, Nguyen D, Teng L, Gomez-Reino JJ, Aelion JA; ACTIVE investigators. Early and sustained efficacy with apremilast monotherapy in biological-naive patients with psoriatic arthritis: a phase IIIB, randomised controlled trial (ACTIVE). Ann Rheum Dis. 2018 May;77(5):690-698. doi: 10.1136/annrheumdis-2017-211568. Epub 2018 Jan 17.
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Public notes
Query!
Contacts
Principal investigator
Name
0
0
MD
Query!
Address
0
0
Amgen
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Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01925768
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