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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/NCT01172938
Registration number
NCT01172938
Ethics application status
Date submitted
6/07/2010
Date registered
30/07/2010
Date last updated
19/06/2020
Titles & IDs
Public title
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
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Secondary ID [1]
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CC-10004-PSA-002
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Universal Trial Number (UTN)
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Trial acronym
PALACE-1
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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 + 20 mg Apremilast
Treatment: Drugs - Placebo + 30 mg Apremilast
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 30mg - 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 + 20 mg Apremilast
Placebo + 20 mg Apremilast
Treatment: Drugs: Placebo + 30 mg Apremilast
Placebo + 30 mg Apremilast
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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 at Week 24. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • = 20% improvement in 78 tender joint count; • = 20% improvement in 76 swollen joint count; and • = 20% improvement in at least 3 of the 5 following parameters: ? Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); ? Patient's global assessment of disease activity (measured on a 100 mm VAS); ? Physician's global assessment of disease activity (measured on a 100 mm VAS); ? 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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Change From Baseline in Patient's Assessment of Pain at Week 16
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Assessment method [6]
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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 [6]
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Baseline and Week 16
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Secondary outcome [7]
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Change From Baseline in Maastricht Ankylosing Spondylitis Entheses Score (MASES) at Week 16
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Assessment method [7]
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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 [7]
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Baseline and Week 16
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Secondary outcome [8]
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Change From Baseline in Dactylitis Severity Score at Week 16
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Assessment method [8]
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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 [8]
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Baseline and Week 16
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Secondary outcome [9]
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Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 16
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Assessment method [9]
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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 to 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 [9]
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Baseline and Week 16
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Secondary outcome [10]
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Change From Baseline in the Disease Activity Score (DAS28) at Week 16
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Assessment method [10]
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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 [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 Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 16
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Assessment method [11]
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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. A positive change from Baseline score indicates an improvement.
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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 SF-36 Physical Function at Week 24
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Assessment method [12]
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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 [12]
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Baseline and Week 24
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Secondary outcome [13]
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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 [13]
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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 [13]
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Baseline and Week 24
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Secondary outcome [14]
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Change From Baseline in Patient's Assessment of Pain at Week 24
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Assessment method [14]
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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 [14]
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Baseline and Week 24
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Secondary outcome [15]
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Change From Baseline in Maastricht Ankylosing Spondylitis Entheses Score (MASES) at Week 24
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Assessment method [15]
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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 [15]
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Baseline and Week 24
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Secondary outcome [16]
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Change From Baseline in Dactylitis Severity Score at Week 24
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Assessment method [16]
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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 [16]
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Baseline and Week 24
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Secondary outcome [17]
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Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 24
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Assessment method [17]
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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 [17]
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Baseline and Week 24
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Secondary outcome [18]
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Change From Baseline in the Disease Activity Score (DAS28) at Week 24
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Assessment method [18]
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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 [18]
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Baseline and Week 24
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Secondary outcome [19]
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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 [19]
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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 [19]
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Baseline and Week 24
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Secondary outcome [20]
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Percentage of Participants With MASES Improvement = 20% at Week 16
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Assessment method [20]
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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 [20]
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Baseline and Week 16
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Secondary outcome [21]
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Percentage of Participants With Dactylitis Improvement = 1 Point at Week 16
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Assessment method [21]
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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 [21]
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Baseline and Week 16
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Secondary outcome [22]
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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 [22]
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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 [22]
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Baseline and Week 16
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Secondary outcome [23]
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Percentage of Participants With MASES Improvement = 20% at Week 24
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Assessment method [23]
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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 [23]
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Baseline and Week 24
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Secondary outcome [24]
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Percentage of Participants With Dactylitis Improvement = 1 Point at Week 24
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Assessment method [24]
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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 [24]
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Baseline and Week 24
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Secondary outcome [25]
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Percentage of Participants With Good or Moderate EULAR Response at Week 24
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Assessment method [25]
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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 [25]
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Baseline and Week 24
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Secondary outcome [26]
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Percentage of Participants With a ACR 50 Response at Week 16
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Assessment method [26]
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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 [26]
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Baseline and Week 16
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Secondary outcome [27]
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Percentage of Participants With an ACR 70 Response at Week 16
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Assessment method [27]
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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 [27]
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Baseline and Week 16
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Secondary outcome [28]
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Percentage of Participants With an ACR 50 Response at Week 24
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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 24
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Secondary outcome [29]
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Percentage of Participants With a ACR 70 Response at Week 24
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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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Baseline and week 24
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Secondary outcome [30]
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Percentage of Participants Achieving a MASES Score of Zero at Week 16
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Assessment method [30]
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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.
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Timepoint [30]
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0
Week 16
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Secondary outcome [31]
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Percentage of Participants Achieving a Dactylitis Score of Zero at Week 16
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Assessment method [31]
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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.
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Timepoint [31]
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0
Week 16
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Secondary outcome [32]
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Percentage of Participants Achieving a MASES Score of Zero at Week 24
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Assessment method [32]
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 [32]
0
0
Week 24
Query!
Secondary outcome [33]
0
0
Percentage of Participants Achieving a Dactylitis Score of Zero at Week 24
Query!
Assessment method [33]
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 [33]
0
0
Week 24
Query!
Secondary outcome [34]
0
0
Percentage of Participants With a ACR 20 Response at Week 52
Query!
Assessment method [34]
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.
Query!
Timepoint [34]
0
0
Baseline and Week 52
Query!
Secondary outcome [35]
0
0
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Week 52
Query!
Assessment method [35]
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 [35]
0
0
Baseline and Week 52
Query!
Secondary outcome [36]
0
0
Change From Baseline in the SF-36 Physical Functioning Domain at Week 52
Query!
Assessment method [36]
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 [36]
0
0
Baseline and Week 52
Query!
Secondary outcome [37]
0
0
Percentage of Participants With a Modified PsARC Response at Week 52
Query!
Assessment method [37]
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 [37]
0
0
Baseline and Week 52
Query!
Secondary outcome [38]
0
0
Change From Baseline in the Patient Assessment of Pain at Week 52
Query!
Assessment method [38]
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 [38]
0
0
Baseline and Week 52
Query!
Secondary outcome [39]
0
0
Change From Baseline in Maastricht Ankylosing Spondylitis Entheses Score (MASES) at Week 52
Query!
Assessment method [39]
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 [39]
0
0
Baseline and week 52
Query!
Secondary outcome [40]
0
0
Change From Baseline in the Dactylitis Severity Score at Week 52
Query!
Assessment method [40]
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 [40]
0
0
Baseline and Week 52
Query!
Secondary outcome [41]
0
0
Change From Baseline in the CDAI Score at Week 52
Query!
Assessment method [41]
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 [41]
0
0
Baseline and Week 52
Query!
Secondary outcome [42]
0
0
Change From Baseline in the DAS28 at Week 52
Query!
Assessment method [42]
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 [42]
0
0
Baseline and Week 52
Query!
Secondary outcome [43]
0
0
Change From Baseline in the FACIT-Fatigue Scale Score at Week 52
Query!
Assessment method [43]
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 [43]
0
0
Baseline and Week 52
Query!
Secondary outcome [44]
0
0
Percentage of Participants With MASES Improvement = 20% at Week 52
Query!
Assessment method [44]
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 [44]
0
0
Baseline and Week 52
Query!
Secondary outcome [45]
0
0
Percentage of Participants With Dactylitis Improvement = 1 Point at Week 52
Query!
Assessment method [45]
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 [45]
0
0
Baseline and Week 52
Query!
Secondary outcome [46]
0
0
Percentage of Participants Achieving Good or Moderate EULAR Response at Week 52
Query!
Assessment method [46]
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.
Query!
Timepoint [46]
0
0
Baseline and Week 52
Query!
Secondary outcome [47]
0
0
Percentage of Participants With an ACR 50 Response at Week 52
Query!
Assessment method [47]
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 [47]
0
0
Baseline and Week 52
Query!
Secondary outcome [48]
0
0
Percentage of Participants With an ACR 70 Response at Week 52
Query!
Assessment method [48]
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 [48]
0
0
Baseline and Week 52
Query!
Secondary outcome [49]
0
0
Percentage of Participants Achieving a MASES Score of Zero at Week 52
Query!
Assessment method [49]
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 [49]
0
0
Week 52
Query!
Secondary outcome [50]
0
0
Percentage of Participants Achieving a Dactylitis Score of Zero at Week 52
Query!
Assessment method [50]
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 [50]
0
0
Week 52
Query!
Secondary outcome [51]
0
0
Number of Participants With Adverse Events During the Placebo-Controlled Period
Query!
Assessment method [51]
0
0
A Treatment Emergent Adverse Event (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.
Query!
Timepoint [51]
0
0
Week 0 to Week 16 for placebo participants who entered early escape 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 [52]
0
0
Number of Participants With Adverse Events During the Apremilast-Exposure Period
Query!
Assessment method [52]
0
0
A TEAE is an 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 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.
Query!
Timepoint [52]
0
0
Baseline to Week 260; median total exposure to Apremilast was 170 weeks
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) at time of
screening.
- Must have been inadequately treated by disease-modifying antirheumatic drugs (DMARDs)
- May not have axial involvement alone
- Concurrent treatment allowed with methotrexate, leflunomide, or sulfasalazine
- Have = 3 swollen AND = 3 tender joints.
- Males & Females must use contraception
- Stable dose of nonsteroidal anti-inflammatory drugs (NSAIDs), narcotics and low dose
oral corticosteroids allowed.
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
2/06/2010
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
27/10/2016
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
504
Query!
Recruitment in Australia
Recruitment state(s)
VIC
Query!
Recruitment hospital [1]
0
0
Monash Medical Centre - Clayton
Query!
Recruitment hospital [2]
0
0
Eastern Health Clinical School - Box Hill
Query!
Recruitment hospital [3]
0
0
Repatriation General Hospital - Daws Park
Query!
Recruitment hospital [4]
0
0
St Vincent's Hospital Melbourne - Fitzroy
Query!
Recruitment hospital [5]
0
0
Emeritus Research - Malvern
Query!
Recruitment postcode(s) [1]
0
0
3168 - Clayton
Query!
Recruitment postcode(s) [2]
0
0
3128 - Box Hill
Query!
Recruitment postcode(s) [3]
0
0
5041 - Daws Park
Query!
Recruitment postcode(s) [4]
0
0
3065 - Fitzroy
Query!
Recruitment postcode(s) [5]
0
0
3145 - Malvern
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
Florida
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Idaho
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
Maryland
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Michigan
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
Oklahoma
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Pennsylvania
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Texas
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Utah
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Washington
Query!
Country [16]
0
0
Austria
Query!
State/province [16]
0
0
Vienna
Query!
Country [17]
0
0
Austria
Query!
State/province [17]
0
0
Wien
Query!
Country [18]
0
0
Canada
Query!
State/province [18]
0
0
Newfoundland and Labrador
Query!
Country [19]
0
0
Canada
Query!
State/province [19]
0
0
Ontario
Query!
Country [20]
0
0
Canada
Query!
State/province [20]
0
0
Quebec
Query!
Country [21]
0
0
Canada
Query!
State/province [21]
0
0
Saskatchewan
Query!
Country [22]
0
0
France
Query!
State/province [22]
0
0
Orleans
Query!
Country [23]
0
0
France
Query!
State/province [23]
0
0
Toulouse Cedex
Query!
Country [24]
0
0
Germany
Query!
State/province [24]
0
0
Duisburg
Query!
Country [25]
0
0
Germany
Query!
State/province [25]
0
0
Erlangen
Query!
Country [26]
0
0
Germany
Query!
State/province [26]
0
0
Hamburg
Query!
Country [27]
0
0
Germany
Query!
State/province [27]
0
0
Herne
Query!
Country [28]
0
0
Germany
Query!
State/province [28]
0
0
München
Query!
Country [29]
0
0
Hungary
Query!
State/province [29]
0
0
Budapest
Query!
Country [30]
0
0
Hungary
Query!
State/province [30]
0
0
Szolnok
Query!
Country [31]
0
0
Hungary
Query!
State/province [31]
0
0
Veszprém
Query!
Country [32]
0
0
New Zealand
Query!
State/province [32]
0
0
Crofton Downs
Query!
Country [33]
0
0
New Zealand
Query!
State/province [33]
0
0
Hamilton
Query!
Country [34]
0
0
New Zealand
Query!
State/province [34]
0
0
New Zealand
Query!
Country [35]
0
0
New Zealand
Query!
State/province [35]
0
0
Rotorua
Query!
Country [36]
0
0
New Zealand
Query!
State/province [36]
0
0
Takapuna
Query!
Country [37]
0
0
New Zealand
Query!
State/province [37]
0
0
Timaru
Query!
Country [38]
0
0
Poland
Query!
State/province [38]
0
0
Bydgoszcz
Query!
Country [39]
0
0
Poland
Query!
State/province [39]
0
0
Gdynia
Query!
Country [40]
0
0
Poland
Query!
State/province [40]
0
0
Katowice
Query!
Country [41]
0
0
Poland
Query!
State/province [41]
0
0
Sopot
Query!
Country [42]
0
0
Poland
Query!
State/province [42]
0
0
Warszawa
Query!
Country [43]
0
0
Russian Federation
Query!
State/province [43]
0
0
Kemerovo
Query!
Country [44]
0
0
Russian Federation
Query!
State/province [44]
0
0
Ryazan
Query!
Country [45]
0
0
Russian Federation
Query!
State/province [45]
0
0
Smolensk
Query!
Country [46]
0
0
Russian Federation
Query!
State/province [46]
0
0
Vladimir
Query!
Country [47]
0
0
Russian Federation
Query!
State/province [47]
0
0
Voronezh
Query!
Country [48]
0
0
South Africa
Query!
State/province [48]
0
0
Cape Town
Query!
Country [49]
0
0
South Africa
Query!
State/province [49]
0
0
Durban
Query!
Country [50]
0
0
South Africa
Query!
State/province [50]
0
0
Johannesburg
Query!
Country [51]
0
0
South Africa
Query!
State/province [51]
0
0
Pinelands
Query!
Country [52]
0
0
Spain
Query!
State/province [52]
0
0
Madrid
Query!
Country [53]
0
0
Spain
Query!
State/province [53]
0
0
Santander
Query!
Country [54]
0
0
Spain
Query!
State/province [54]
0
0
Santiago de Compostela
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Country [55]
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United Kingdom
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State/province [55]
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Barnsley South Yorkshire
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Country [56]
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United Kingdom
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State/province [56]
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Colchester
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Country [57]
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United Kingdom
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State/province [57]
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Edmunds
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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
Ethics application status
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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, specifically in improving 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/NCT01172938
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Trial related presentations / publications
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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 public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01172938
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