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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/NCT01212770
Registration number
NCT01212770
Ethics application status
Date submitted
29/09/2010
Date registered
1/10/2010
Date last updated
6/05/2020
Titles & IDs
Public title
PALACE 3: Efficacy and Safety Study of Apremilast to Treat Active Psoriatic Arthritis
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Scientific title
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Efficacy and Safety Study of Two Doses of Apremilast (CC-10004) in Subjects With Active Psoriatic Arthritis and a Qualifying Psoriasis Lesion
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Secondary ID [1]
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CC-10004-PSA-004
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Universal Trial Number (UTN)
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Trial acronym
PALACE 3
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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 20mg
Treatment: Drugs - Apremilast 30mg
Treatment: Drugs - Placebo
Experimental: Apremilast 20 mg - 20 mg Apremilast tablets administered twice daily for 24 weeks during the placebo-controlled phase followed by 20 mg Apremilast tablets administered twice daily for up to 4.5 years in the active treatment / long-term safety phase
Experimental: Apremilast 30 mg - 30 mg Apremilast tablets administered twice a day for 24 weeks during the placebo-controlled phase followed by 30 mg Apremilast tablets administered twice a day for up to 4.5 years in the active treatment / long-term safety phase orally twice daily
Placebo Comparator: Placebo + 20 mg Apremilast - Placebo + 20 mg Apremilast tablets administered twice daily for 24 weeks during the placebo-controlled phase followed by 20 mg Apremilast tablets administered twice daily for up to 4.5 years in the active treatment / long-term safety phase. Subjects who do not have at least 20% improvement in their swollen and tender joint counts at Week 16 will escape to 20 mg Apremilast twice daily at Week 16
Placebo Comparator: Placebo + 30 mg Apremilast - Placebo + 30 mg Apremilast tablets administered twice daily for 24 weeks during the placebo-controlled phase followed by 30 mg Apremilast tablets administered twice daily for up to 4.5 years in the active treatment / long-term safety phase. Subjects who do not have at least 20% improvement in their swollen and tender joint counts at Week 16 will escape to 30 mg Apremilast twice daily at Week 16.
Treatment: Drugs: Apremilast 20mg
Apremilast 20 mg twice daily, orally
Treatment: Drugs: Apremilast 30mg
Apremilast 30 mg twice daily, orally
Treatment: Drugs: Placebo
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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 With 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 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.
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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 16
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Assessment method [1]
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The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement in functional ability.
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Timepoint [1]
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Baseline and Week 16
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Secondary outcome [2]
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Percentage of Participants With an ACR 20 Response 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 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.
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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 Health Assessment Questionnaire- Disability Index (HAQ-DI) at Week 24
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Assessment method [3]
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The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement in functional ability.
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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 36-item Short Form Health Survey (SF-36) Physical Functioning Domain at Week 16
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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 16
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Secondary outcome [5]
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Percentage of Participants With a Modified Psoriatic Arthritis Response Criteria (PsARC) Response at Week 16
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Assessment method [5]
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Modified PsARC response is defined as improvement in at least 2 of the 4 measures, at least one of which must be tender joint count or swollen joint count, and no worsening in any of the 4 measures: • 78 tender joint count, • 76 swollen joint count, • Patient global assessment of disease activity, measured on a 100 mm visual Analog scale (VAS), where 0 mm = lowest disease activity and 100 mm = highest; • Physician global assessment of disease activity, measured on a 100 mm VAS, where 0 mm = lowest disease activity and 100 mm = highest. Improvement or worsening in joint counts is defined as decrease or increase, respectively, from baseline by = 30%, and improvement or worsening in global assessments is defined as decrease or increase, respectively, from baseline by = 20 mm VAS.
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Timepoint [5]
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Baseline and Week 16
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Secondary outcome [6]
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Percentage of Participants Achieving a = 75% Improvement in Psoriasis Area and Severity Index Score (PASI75) at Week 16
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Assessment method [6]
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The percentage of participants with Baseline psoriasis body surface area (BSA) involvement = 3% who achieved 75% or greater improvement from Baseline in Psoriasis Area and Severity Index (PASI) score after 16 weeks of treatment. The Psoriasis Area and Severity Index (PASI) score is a combination of the intensity of psoriasis, assessed by erythema (reddening), induration (plaque thickness) and desquamation (scaling) scored on a scale from 0 (none) to 4 (very severe), together with the percentage of the area affected, rated on a scale from 0 (no involvement) to 6 (90% to 100% involvement). PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease.
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Timepoint [6]
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Baseline and Week 16
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Secondary outcome [7]
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Change From Baseline in Patient's Assessment of Pain at Week 16
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Assessment method [7]
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The participant was asked to place a vertical line on a 100-mm visual analog scale on which the left-hand boundary (score = 0 mm) represents "no pain," and the right-hand boundary (score = 100 mm) represents "pain as severe as can be imagined." The distance from the mark to the left-hand boundary was recorded in millimeters.
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Timepoint [7]
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Baseline and Week 16
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Secondary outcome [8]
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Change From Baseline in Maastricht Ankylosing Spondylitis Entheses Score (MASES) at Week 16
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Assessment method [8]
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The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone): 1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right. The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses.
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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 Dactylitis Severity Score at Week 16
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Assessment method [9]
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Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present.
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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 Clinical Disease Activity Index (CDAI) at Week 16
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Assessment method [10]
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The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the: • 28 tender joint count (TJC), • 28 swollen joint count (SJC), • Patient's Global Assessment of Disease Activity measured on a 10 cm visual analog scale (VAS), where 0 cm = lowest disease activity and 10 cm = highest; • Physician's Global Assessment of Disease Activity -measured on a 10 cm VAS, where 0 cm = lowest disease activity and 10 cm = highest. The CDAI score ranges from 0-76 where lower scores indicate less disease activity. The following thresholds of disease activity have been defined for the CDAI: Remission: = 2.8 Low Disease Activity: > 2.8 and = 10 Moderate Disease Activity: > 10 and = 22 High Disease Activity: > 22.
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Timepoint [10]
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Baseline and Week 16
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Secondary outcome [11]
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Change From Baseline in the Disease Activity Score (DAS28) at Week 16
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Assessment method [11]
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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 distal interphalangeal (DIP) joints, the hip joint, or the joints below the knee; • C-reactive protein (CRP) • Patient's global assessment of disease activity. DAS28(CRP) scores range from 0 to approximately 10, with the upper bound dependent on the highest possible level of CRP. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission.
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Timepoint [11]
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Baseline and Week 16
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Secondary outcome [12]
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Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 16
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Assessment method [12]
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The FACIT-Fatigue scale is a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means "not at all," and 4 means "very much." The FACIT-Fatigue scale score ranges from 0 to 52, with higher scores denoting lower levels of fatigue.
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Timepoint [12]
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Baseline and Week 16
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Secondary outcome [13]
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Change From Baseline in 36-item Short Form Health Survey (SF-36) Physical Functioning Domain at Week 24
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Assessment method [13]
0
0
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 [13]
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Baseline and Week 24
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Secondary outcome [14]
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Percentage of Participants With a Modified Psoriatic Arthritis Response Criteria (PsARC) Response at Week 24
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Assessment method [14]
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Modified PsARC response is defined as improvement in at least 2 of the 4 measures, at least one of which must be tender joint count or swollen joint count, and no worsening in any of the 4 measures: • 78 tender joint count, • 76 swollen joint count, • Patient global assessment of disease activity, measured on a 100 mm visual Analog scale (VAS), where 0 mm = lowest disease activity and 100 mm = highest; • Physician global assessment of disease activity, measured on a 100 mm VAS, where 0 mm = lowest disease activity and 100 mm = highest. Improvement or worsening in joint counts is defined as decrease or increase, respectively, from baseline by = 30%, and improvement or worsening in global assessments is defined as decrease or increase, respectively, from baseline by = 20 mm VAS.
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Timepoint [14]
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Baseline and Week 24
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Secondary outcome [15]
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Percentage of Participants Achieving a = 75% Improvement in Psoriasis Area and Severity Index Score (PASI75) at Week 24
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Assessment method [15]
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The percentage of participants with Baseline psoriasis body surface area (BSA) involvement = 3% who achieved 75% or greater improvement from Baseline in Psoriasis Area and Severity Index (PASI) score after 24 weeks of treatment. The Psoriasis Area and Severity Index (PASI) score is a combination of the intensity of psoriasis, assessed by erythema (reddening), induration (plaque thickness) and desquamation (scaling) scored on a scale from 0 (none) to 4 (very severe), together with the percentage of the area affected, rated on a scale from 0 (no involvement) to 6 (90% to 100% involvement). PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease.
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Timepoint [15]
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Baseline and Week 24
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Secondary outcome [16]
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Change From Baseline in Patient's Assessment of Pain at Week 24
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Assessment method [16]
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The participant was asked to place a vertical line on a 100-mm visual analog scale on which the left-hand boundary (score = 0 mm) represents "no pain," and the right-hand boundary (score = 100 mm) represents "pain as severe as can be imagined." The distance from the mark to the left-hand boundary was recorded in millimeters.
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Timepoint [16]
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Baseline and week 24
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Secondary outcome [17]
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Change From Baseline in Maastricht Ankylosing Spondylitis Entheses Score (MASES) at Week 24
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Assessment method [17]
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0
The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone): 1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right. The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses.
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Timepoint [17]
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Baseline and week 24
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Secondary outcome [18]
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Change From Baseline in Dactylitis Severity Score at Week 24
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Assessment method [18]
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0
Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet will be rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present.
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Timepoint [18]
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0
Baseline and Week 24
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Secondary outcome [19]
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0
Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 24
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Assessment method [19]
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0
The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the: • 28 tender joint count (TJC), • 28 swollen joint count (SJC), • Patient's Global Assessment of Disease Activity measured on a 10 cm visual analog scale (VAS), where 0 cm = lowest disease activity and 10 cm = highest; • Physician's Global Assessment of Disease Activity -measured on a 10 cm VAS, where 0 cm = lowest disease activity and 10 cm = highest. The CDAI score ranges from 0-76 where lower scores indicate less disease activity. The following thresholds of disease activity have been defined for the CDAI: Remission: = 2.8; Low Disease Activity: > 2.8 and = 10; Moderate Disease Activity: > 10 and = 22; High Disease Activity: > 22.
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Timepoint [19]
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Baseline and Week 24
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Secondary outcome [20]
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Change From Baseline in the Disease Activity Score (DAS28) at Week 24
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Assessment method [20]
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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 approximately 10, with the upper bound dependent on the highest possible level of CRP. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission.
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Timepoint [20]
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0
Baseline and Week 24
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Secondary outcome [21]
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Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 24
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Assessment method [21]
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0
The FACIT-Fatigue scale is a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means "not at all," and 4 means "very much." The FACIT-Fatigue scale score ranges from 0 to 52, with higher scores denoting lower levels of fatigue. A positive change from baseline score indicates an improvement.
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Timepoint [21]
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Baseline and Week 24
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Secondary outcome [22]
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Percentage of Participants With MASES Improvement = 20% at Week 16
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Assessment method [22]
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Percentage of participants with pre-existing enthesopathy whose MASES improved by = 20% from Baseline after 16 weeks of treatment. The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone): 1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right. The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses.
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Timepoint [22]
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Baseline and Week 16
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Secondary outcome [23]
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Percentage of Participants With Dactylitis Improvement = 1 Point at Week 16
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Assessment method [23]
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Percentage of participants with pre-existing dactylitis whose dactylitis severity score improved by = 1 after 16 weeks of treatment. Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present.
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Timepoint [23]
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Baseline and Week 16
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Secondary outcome [24]
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Percentage of Participants With Good or Moderate European League Against Rheumatism (EULAR) Response at Week 16
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Assessment method [24]
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A EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS-28 score. A Good Response is defined as an improvement (decrease) in the DAS28 of more than 1.2 compared with Baseline and attainment of a DAS28 score less than or equal to 3.2. A Moderate Response is defined as either: • an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 and attainment of a DAS28 score of less than or equal to 5.1 or, • an improvement (decrease) in the DAS28 of more than 1.2 and attainment of a DAS28 score of greater than 3.2.
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Timepoint [24]
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Baseline and Week 16
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Secondary outcome [25]
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Percentage of Participants With MASES Improvement = 20% at Week 24
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Assessment method [25]
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Percentage of participants with pre-existing enthesopathy whose MASES improved by = 20% from Baseline after 24 weeks of treatment. The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone): 1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right. The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses.
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Timepoint [25]
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0
Baseline and Week 24
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Secondary outcome [26]
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Percentage of Participants With Dactylitis Improvement = 1 Point at Week 24
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Assessment method [26]
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Percentage of participants with pre-existing dactylitis whose dactylitis severity score improved by = 1 after 24 weeks of treatment. Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present.
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Timepoint [26]
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0
Baseline and Week 24
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Secondary outcome [27]
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Percentage of Participants With Good or Moderate EULAR Response at Week 24
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Assessment method [27]
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EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS-28 score. A Good Response is defined as an improvement (decrease) in the DAS28 of more than 1.2 compared with Baseline and attainment of a DAS28 score less than or equal to 3.2. A Moderate Response is defined as either: • an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 and attainment of a DAS28 score of less than or equal to 5.1 or, • an improvement (decrease) in the DAS28 of more than 1.2 and attainment of a DAS28 score of greater than 3.2.
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Timepoint [27]
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Baseline and Week 24
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Secondary outcome [28]
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Percentage of Participants With a ACR 50 Response at Week 16
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Assessment method [28]
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Percentage of participants with an American College of Rheumatology 50% (ACR50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • = 50% improvement in 78 tender joint count; • = 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.
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Timepoint [28]
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Baseline and Week 16
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Secondary outcome [29]
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Percentage of Participants With an ACR 70 Response at Week 16
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Assessment method [29]
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Percentage of participants with an American College of Rheumatology 70% (ACR70) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • = 70% improvement in 78 tender joint count; • = 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.
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Timepoint [29]
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0
Baseline and Week 16
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Secondary outcome [30]
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0
Percentage of Participants With an ACR 50 Response at Week 24
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Assessment method [30]
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Percentage of participants with an American College of Rheumatology 50% (ACR50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • = 50% improvement in 78 tender joint count; • = 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.
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Timepoint [30]
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0
Baseline and Week 24
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Secondary outcome [31]
0
0
Percentage of Participants With a ACR 70 Response at Week 24
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Assessment method [31]
0
0
Percentage of participants with an American College of Rheumatology 70% (ACR70) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • = 70% improvement in 78 tender joint count; • = 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.
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Timepoint [31]
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0
Baseline and Week 24
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Secondary outcome [32]
0
0
Percentage of Participants Achieving a MASES Score of Zero at Week 16
Query!
Assessment method [32]
0
0
Percentage of participants with pre-existing enthesopathy whose MASES improves to 0 after 16 weeks of treatment. The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone): 1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right. The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses.
Query!
Timepoint [32]
0
0
Week 16
Query!
Secondary outcome [33]
0
0
Percentage of Participants Achieving a Dactylitis Score of Zero at Week 16
Query!
Assessment method [33]
0
0
Percentage of participants with pre-existing dactylitis whose dactylitis severity score improves to zero after 16 weeks of treatment. Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present.
Query!
Timepoint [33]
0
0
Week 16
Query!
Secondary outcome [34]
0
0
Percentage of Participants Achieving a MASES Score of Zero at Week 24
Query!
Assessment method [34]
0
0
Percentage of participants with pre-existing enthesopathy whose MASES improves to 0 after 24 weeks of treatment. The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone): 1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right. The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses.
Query!
Timepoint [34]
0
0
Week 24
Query!
Secondary outcome [35]
0
0
Percentage of Participants Achieving a Dactylitis Score of Zero at Week 24
Query!
Assessment method [35]
0
0
Percentage of participants with pre-existing dactylitis whose dactylitis severity score improves to zero after 24 weeks of treatment. Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present.
Query!
Timepoint [35]
0
0
Week 24
Query!
Secondary outcome [36]
0
0
Percentage of Participants With an ACR 20 Response at Week 52
Query!
Assessment method [36]
0
0
Percentage of participants with an American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • = 20% improvement in 78 tender joint count; • = 20% improvement in 76 swollen joint count; and • = 20% improvement in at least 3 of the 5 following parameters: ? Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); ? Patient's global assessment of disease activity (measured on a 100 mm VAS); ? Physician's global assessment of disease activity (measured on a 100 mm VAS); ? Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); ? C-Reactive Protein. Two-sided 95% confidence interval is based on the Clopper-Pearson method.
Query!
Timepoint [36]
0
0
Baseline and Week 52
Query!
Secondary outcome [37]
0
0
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Week 52
Query!
Assessment method [37]
0
0
The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement in functional ability.
Query!
Timepoint [37]
0
0
Baseline and Week 52
Query!
Secondary outcome [38]
0
0
Change From Baseline in the SF-36 Physical Functioning Scale Score at Week 52
Query!
Assessment method [38]
0
0
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.
Query!
Timepoint [38]
0
0
Baseline and Week 52
Query!
Secondary outcome [39]
0
0
Percentage of Participants With a Modified PsARC Response at Week 52
Query!
Assessment method [39]
0
0
Modified PsARC response is defined as improvement in at least 2 of the 4 measures, at least one of which must be tender joint count or swollen joint count, and no worsening in any of the 4 measures: • 78 tender joint count, • 76 swollen joint count, • Patient global assessment of disease activity, measured on a 100 mm visual Analog scale (VAS), where 0 mm = lowest disease activity and 100 mm = highest; • Physician global assessment of disease activity, measured on a 100 mm VAS, where 0 mm = lowest disease activity and 100 mm = highest. Improvement or worsening in joint counts is defined as decrease or increase, respectively, from baseline by = 30%, and improvement or worsening in global assessments is defined as decrease or increase, respectively, from baseline by = 20 mm VAS. Two-sided 95% confidence interval is based on the Clopper-Pearson method.
Query!
Timepoint [39]
0
0
Baseline and Week 52
Query!
Secondary outcome [40]
0
0
Percentage of Participants Achieving a = 75% Improvement in Psoriasis Area and Severity Index Score (PASI75) at Week 52
Query!
Assessment method [40]
0
0
The percentage of participants with Baseline psoriasis body surface area (BSA) involvement = 3% who achieved 75% or greater improvement from Baseline in Psoriasis Area and Severity Index (PASI) score after 52 weeks. The Psoriasis Area and Severity Index (PASI) score is a combination of the intensity of psoriasis, assessed by erythema (reddening), induration (plaque thickness) and desquamation (scaling) scored on a scale from 0 (none) to 4 (very severe), together with the percentage of the area affected, rated on a scale from 0 (no involvement) to 6 (90% to 100% involvement). PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease. Two-sided 95% confidence interval is based on the Clopper-Pearson method.
Query!
Timepoint [40]
0
0
Baseline and Week 52
Query!
Secondary outcome [41]
0
0
Change From Baseline in the Patient Assessment of Pain at Week 52
Query!
Assessment method [41]
0
0
The participant was asked to place a vertical line on a 100-mm visual analog scale on which the left-hand boundary (score = 0 mm) represents "no pain," and the right-hand boundary (score = 100 mm) represents "pain as severe as can be imagined." The distance from the mark to the left-hand boundary was recorded in millimeters.
Query!
Timepoint [41]
0
0
Baseline and Week 52
Query!
Secondary outcome [42]
0
0
Change From Baseline in Maastricht Ankylosing Spondylitis Entheses Score (MASES) at Week 52
Query!
Assessment method [42]
0
0
The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone): 1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right. The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses.
Query!
Timepoint [42]
0
0
Baseline and Week 52
Query!
Secondary outcome [43]
0
0
Change From Baseline in the Dactylitis Severity Score at Week 52
Query!
Assessment method [43]
0
0
Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet will be rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present.
Query!
Timepoint [43]
0
0
Baseline and Week 52
Query!
Secondary outcome [44]
0
0
Change From Baseline in the CDAI Score at Week 52
Query!
Assessment method [44]
0
0
The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the: •28 tender joint count (TJC), •28 swollen joint count (SJC), •Patient's Global Assessment of Disease Activity measured on a 10 cm visual analog scale (VAS), where 0 cm = lowest disease activity and 10 cm = highest; •Physician's Global Assessment of Disease Activity -measured on a 10 cm VAS, where 0 cm = lowest disease activity and 10 cm = highest. The CDAI score ranges from 0-76 where lower scores indicate less disease activity. The following thresholds of disease activity have been defined for the CDAI: Remission: = 2.8 Low Disease Activity: > 2.8 and = 10 Moderate Disease Activity: > 10 and = 22 High Disease Activity: > 22.
Query!
Timepoint [44]
0
0
Baseline and Week 52
Query!
Secondary outcome [45]
0
0
Change From Baseline in the DAS28 at Week 52
Query!
Assessment method [45]
0
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 approximately 10, with the upper bound dependent on the highest possible level of CRP. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission.
Query!
Timepoint [45]
0
0
Baseline and Week 52
Query!
Secondary outcome [46]
0
0
Change From Baseline in the FACIT-Fatigue Scale Score at Week 52
Query!
Assessment method [46]
0
0
The FACIT-Fatigue scale is a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means "not at all," and 4 means "very much." The FACIT-Fatigue scale score ranges from 0 to 52, with higher scores denoting lower levels of fatigue. A positive change from baseline score indicates an improvement.
Query!
Timepoint [46]
0
0
Baseline and Week 52
Query!
Secondary outcome [47]
0
0
Percentage of Participants With MASES Improvement = 20% at Week 52
Query!
Assessment method [47]
0
0
Percentage of participants with pre-existing enthesopathy whose MASES improved by = 20% from Baseline after 52 weeks. The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone): 1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right. The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses. Two-sided 95% confidence interval is based on the Clopper-Pearson method.
Query!
Timepoint [47]
0
0
Baseline and Week 52
Query!
Secondary outcome [48]
0
0
Percentage of Participants With Dactylitis Improvement = 1 Point at Week 52
Query!
Assessment method [48]
0
0
Percentage of participants with pre-existing dactylitis whose dactylitis severity score improved by = 1 after 52 weeks. Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present. Two-sided 95% confidence interval is based on the Clopper-Pearson method.
Query!
Timepoint [48]
0
0
Baseline and Week 52
Query!
Secondary outcome [49]
0
0
Percentage of Participants Achieving Good or Moderate EULAR Response at Week 52
Query!
Assessment method [49]
0
0
A EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS-28 score. A Good Response is defined as an improvement (decrease) in the DAS28 of more than 1.2 compared with Baseline and attainment of a DAS28 score less than or equal to 3.2. A Moderate Response is defined as either: • an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 and attainment of a DAS28 score of less than or equal to 5.1 or, • an improvement (decrease) in the DAS28 of more than 1.2 and attainment of a DAS28 score of greater than 3.2. Two-sided 95% confidence interval is based on the Clopper-Pearson method.
Query!
Timepoint [49]
0
0
Baseline and Week 52
Query!
Secondary outcome [50]
0
0
Percentage of Participants With an ACR 50 Response at Week 52
Query!
Assessment method [50]
0
0
Percentage of participants with an American College of Rheumatology 50% (ACR50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • = 50% improvement in 78 tender joint count; • = 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. Two-sided 95% confidence interval is based on the Clopper-Pearson method.
Query!
Timepoint [50]
0
0
Baseline and Week 52
Query!
Secondary outcome [51]
0
0
Percentage of Participants With an ACR 70 Response at Week 52
Query!
Assessment method [51]
0
0
Percentage of participants with an American College of Rheumatology 70% (ACR70) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • = 70% improvement in 78 tender joint count; • = 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. Two-sided 95% confidence interval is based on the Clopper-Pearson method.
Query!
Timepoint [51]
0
0
Baseline and Week 52
Query!
Secondary outcome [52]
0
0
Percentage of Participants Achieving a MASES Score of Zero at Week 52
Query!
Assessment method [52]
0
0
Percentage of participants with pre-existing enthesopathy whose MASES improves to 0 after 24 weeks. The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone): 1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right. The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses. Two-sided 95% confidence interval is based on the Clopper-Pearson method.
Query!
Timepoint [52]
0
0
Week 52
Query!
Secondary outcome [53]
0
0
Percentage of Participants Achieving a Dactylitis Score of Zero at Week 52
Query!
Assessment method [53]
0
0
Percentage of participants with pre-existing dactylitis whose dactylitis severity score improves to zero after 52 weeks. Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present. Two-sided 95% confidence interval is based on the Clopper-Pearson method.
Query!
Timepoint [53]
0
0
Week 52
Query!
Secondary outcome [54]
0
0
Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Placebo-Controlled Phase
Query!
Assessment method [54]
0
0
A TEAE is an adverse event (AE) with a start date on or after the date of the first dose of investigational product (IP) and no later than 28 days after the last dose of IP. An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. A serious AE is any AE that results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or constitutes an important medical event. For both AEs and SAEs the investigator assessed the severity of the event according to the grading scale: Mild: asymptomatic or with mild symptoms, Moderate: symptoms causing moderate discomfort or Severe: symptoms causing severe discomfort or pain.
Query!
Timepoint [54]
0
0
Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants (placebo participants who remained on placebo through week 24 and participants randomized to the APR 20 mg BID or APR 30 mg BID)
Query!
Secondary outcome [55]
0
0
Number of Participants With Treatment Emergent Adverse Events During the Apremilast Exposure Period
Query!
Assessment method [55]
0
0
A TEAE is an adverse event (AE) with a start date on or after the date of the first dose of investigational product (IP) and no later than 28 days after the last dose of IP. An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. A serious AE is any AE that results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or constitutes an important medical event. For both AEs and SAEs the investigator assessed the severity of the event according to the grading scale: Mild: asymptomatic or with mild symptoms, Moderate: symptoms causing moderate discomfort or Severe: symptoms causing severe discomfort or pain.
Query!
Timepoint [55]
0
0
Week 0 to Week 260; median duration of exposure to apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg BID
Query!
Eligibility
Key inclusion criteria
- Males or females, aged = 18 years at time of consent.
- Have a diagnosis of Psoriatic Arthritis (PsA, by any criteria) of = 6 months duration.
- Meet the Classification Criteria for Psoriatic Arthritis (CASPAR) criteria for PsA at
time of screening.
- Must have been inadequately treated by disease-modifying antirheumatic drugs (DMARDs)
- May not have axial involvement alone
- Concurrent Tx allowed with methotrexate, leflunomide, or sulfasalazine
- Have = 3 swollen AND = 3 tender joints.
- Males & Females must use contraception
- Stable dose of NSAIDs, narcotics and low dose oral corticosteroids allowed.
- Have at least one =2 cm psoriasis lesion
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
- Pregnant or breast feeding.
- History of allergy to any component of the investigational product Hepatitis B surface
antigen and/or Hepatitis C antibody positive at screening.
- Therapeutic failure on > 3 agents for PsA or > 1 biologic tumor necrosis factor (TNF)
blocker
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)
Query!
Masking / blinding
Blinded (masking used)
Query!
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
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
30/09/2010
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
9/02/2017
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
505
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
0
0
Royal Prince Alfred Hospital - Camperdown
Query!
Recruitment hospital [2]
0
0
Skin Cancer Foundation - Carlton
Query!
Recruitment hospital [3]
0
0
Coff's Clinical Trials - Coffs Harbour
Query!
Recruitment hospital [4]
0
0
Heidelberg Repatriation Hospital - Heidelberg
Query!
Recruitment hospital [5]
0
0
Menzies Centre for Population Health Research - Hobart
Query!
Recruitment hospital [6]
0
0
Optimus Clinical Research Pty. Ltd - Kogarah
Query!
Recruitment hospital [7]
0
0
Coastal Joint Care - Maroochydore
Query!
Recruitment hospital [8]
0
0
The Queen Elizabeth Hospital - Woodville
Query!
Recruitment postcode(s) [1]
0
0
2050 - Camperdown
Query!
Recruitment postcode(s) [2]
0
0
3053 - Carlton
Query!
Recruitment postcode(s) [3]
0
0
2450 - Coffs Harbour
Query!
Recruitment postcode(s) [4]
0
0
3081 - Heidelberg
Query!
Recruitment postcode(s) [5]
0
0
7000 - Hobart
Query!
Recruitment postcode(s) [6]
0
0
2217 - Kogarah
Query!
Recruitment postcode(s) [7]
0
0
4558 - Maroochydore
Query!
Recruitment postcode(s) [8]
0
0
5011 - Woodville
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arizona
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
California
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Connecticut
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Florida
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Illinois
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Indiana
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Kentucky
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Massachusetts
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
North Carolina
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Ohio
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Tennessee
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Texas
Query!
Country [14]
0
0
Canada
Query!
State/province [14]
0
0
British Columbia
Query!
Country [15]
0
0
Canada
Query!
State/province [15]
0
0
Manitoba
Query!
Country [16]
0
0
Canada
Query!
State/province [16]
0
0
Newfoundland and Labrador
Query!
Country [17]
0
0
Canada
Query!
State/province [17]
0
0
Ontario
Query!
Country [18]
0
0
Finland
Query!
State/province [18]
0
0
Helsinki
Query!
Country [19]
0
0
Finland
Query!
State/province [19]
0
0
Pori
Query!
Country [20]
0
0
France
Query!
State/province [20]
0
0
Corbeil Essonnes
Query!
Country [21]
0
0
France
Query!
State/province [21]
0
0
Nantes
Query!
Country [22]
0
0
France
Query!
State/province [22]
0
0
Nice
Query!
Country [23]
0
0
France
Query!
State/province [23]
0
0
Toulouse
Query!
Country [24]
0
0
Germany
Query!
State/province [24]
0
0
Berlin
Query!
Country [25]
0
0
Germany
Query!
State/province [25]
0
0
Jena
Query!
Country [26]
0
0
Germany
Query!
State/province [26]
0
0
Mainz
Query!
Country [27]
0
0
Italy
Query!
State/province [27]
0
0
Bologna
Query!
Country [28]
0
0
Italy
Query!
State/province [28]
0
0
Roma
Query!
Country [29]
0
0
Korea, Republic of
Query!
State/province [29]
0
0
Anyang, Kyunggi
Query!
Country [30]
0
0
Korea, Republic of
Query!
State/province [30]
0
0
DaeJeon
Query!
Country [31]
0
0
Korea, Republic of
Query!
State/province [31]
0
0
Incheon
Query!
Country [32]
0
0
Korea, Republic of
Query!
State/province [32]
0
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Seoul
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Korea, Republic of
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Suwon
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Lithuania
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Kaunas
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Lithuania
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Klaipeda
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Lithuania
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Panevezys
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Lithuania
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Siauliai
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Poland
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Bialystok
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Poland
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Bytom
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Poland
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Kraków
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Poland
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Poznan
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Poland
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Warszawa
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Romania
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Baia Mare
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Romania
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Bucharest
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Romania
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Cluj-Napoca
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Romania
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Galati
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Romania
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Iasi
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Country [48]
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Russian Federation
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Ekaterinburg
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Country [49]
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Russian Federation
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Kezch
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Country [50]
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Russian Federation
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Novosibirsk
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Russian Federation
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Penza
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Russian Federation
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St. Petersburg
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Country [53]
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Slovakia
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Piestany
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Slovakia
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Poprad,Spisska Sobota
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Slovakia
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Rimavska Sobota
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Spain
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A Coruña
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Spain
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Bilbao
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Spain
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Córdoba
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Spain
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Oviedo
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Spain
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San Sebastian de los Reyes
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Switzerland
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Fribourg
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Switzerland
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Lausanne
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Country [63]
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Switzerland
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St. Gallen
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United Kingdom
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Burslem
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Country [65]
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United Kingdom
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Southampton
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Amgen
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Address
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Ethics approval
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Summary
Brief summary
The purpose of this study is to determine whether apremilast is safe and effective in the
treatment of patients with psoriatic arthritis and a qualifying psoriasis lesion.
Apremilast is proposed to improve signs and symptoms of psoriatic arthritis (tender and
swollen joints, pain, physical function) in treated patients.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01212770
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Public notes
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Contacts
Principal investigator
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MD
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Address
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Amgen
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01212770
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