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PALACE 2: Efficacy and Safety Study of Apremilast to Treat Active Psoriatic Arthritis (PALACE2)

Primary Purpose

Psoriatic Arthritis

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Apremilast 20mg

Apremilast 30mg

Placebo + 20 mg Apremilast

Placebo + 30 mg Apremilast

About this trial

This is an interventional treatment trial for Psoriatic Arthritis focused on measuring Psoriasis, Arthritis, Psoriatic Arthritis, inflammation, skin condition, inflammatory cells, apremilast, CC-10004, phosphodiesterase type 4

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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) PsA 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.

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

Sites / Locations

Clinical and Translational Research Center of Alabama, PC
Denver Arthritis Clinic
New England Research Associates, LLC
Centre For Rheumatology, Immun. And Arthritis
DMI Research
University of South Florida
Arthritis and Rheumatology of Georgia
Michael Bukhalo MD SC
Associated Internal Medical Specialist, PC
Advanced Rheumatology
Mayo Clinic
Research West Incorporated
University of Rochester Medical Center
Vital Research
Unifour Medical Research Associatets LLC
Rheumatic Disease Associates
Metroplex Clinical Research Center
Baylor Research Institute
Arthritis Care and Diagnostic Center
Luckster Enterprises
Seattle Rheumatology Associates
Tacoma Center for Arthritis Research, PS
Rheumatology and Immunotherapy Center
CHU Brugmann
UZ Gent
UZ Leuven
University Hospital of Liege CHU Liege
Diagnostic and Consulting Centre 7
University Multiprofile Hospital for Active Treatment ACIBADEM City Clinic Sofia
17 Diagnostic and Consulting Centre Sofia EOOD
Multiprofile Hospital for Active Treatment Sv. Ivan Rilski
Diagnostic-Consultative Center Sveta Anna
Diagnostic and Consulting Centre 4
Rheumatology Research Associates
PerCuro Clinical Research
Anna Jaroszynska Private Practice
William Bensen's Private Practice
North Bay Dermatology Center
Rheumatology Research Associates
Wilderman Medical Clinic
Darryl Toth's Private Practice
Revmatologie s.r.o.
MEDIPONT PLUS s.r.o..
L.K.N. Arthrocentrum s.r.o.
ARTMEDI UPD s.r.o.
Affidea Praha s.r.o
Revmatologicky ustav
Revmatologicka Ambulance
Revmatologicka Ambulance
PV - MEDICAL, s.r.o.
Parnu Hospital
East Tallinn Central Hospital
North Estonia Regional Hospital
Clinical Research Centre Ltd
Tartu University Hospital
Hopital Universitaire Dupuytren
Hopital Lariboisiere
Fondation Hôpital Saint-Joseph
Groupe Hospitalier Pitié- Salpétrière
Centre Hospitalier Lyon Sud
Charite - Universitätsmedizin Berlin
Klinikum der Johann-Wolfgang Goethe-Universität
Praxis Karin Rockwitz
Synexus Clinical Research GmbH
Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum
Pest Megyei Flor Ferenc Korhaz
Principal SMO Kft.
Azienda Ospedaliera Universitaria San Martino
Ospedale Luigi Sacco
Seconda Universita degli Studi di Napoli
IRCCS Policlinico San Matteo
Universita di Pisa
Ospedale Civile Maggiore Borgo Trento
NZOZ Osteo-Medic sc A. Racewicz J. Supronik
Niepubliczny Zaklad Opieki Zdrowotnej REUMED
Instytut Reumatologii im. prof. dr hab. med. Eleonory Reicher
Wojskowy Instytut Medyczny
Synexus SCM Sp. z o.o.
City Clinical Hospital #1 n.a. N.I.Pirogov
City Clinical Hospital #5
St.Petersburg State Medical Academy n. a. I.I.Mechnikov
Yaroslavl Regional Clinical Hospital
Nelson Mandela School Of Medicine
Greenacres Hospital
Jacaranda Hospital
Hospital Universitario de Canarias
Hospital General Carlos Haya
Hospital Sierrallana
Chung Shan Medical University Hospital
Taichung Veterans General Hospital
Cathay General Hospital
Taipei Veterans General Hospital
National Taiwan University Hospital
Basingstoke and North Hampshire Hospital
Cannock Chase Hospital
Chapel Allerton Hospital
Poole Hospital
Great Western Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

Apremilast 20mg

Apremilast 30mg

Placebo + 20 mg Apremilast

Placebo + 30 mg Apremilast

Arm Description

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

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 + 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 + 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.

Outcomes

Primary Outcome Measures

Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 16

Percentage of participants with an 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.

Secondary Outcome Measures

Change From Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) at Week 16

The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement in functional ability.

Percentage of Participants With an ACR 20 Response at Week 24

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.

Change From Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) at Week 24

Change From Baseline in 36-item Short Form Health Survey (SF-36) Physical Functioning Domain at Week 16

The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning. The physical functioning domain assesses limitations in physical activities because of health problems. A positive change from Baseline score indicates an improvement.

Percentage of Participants With a Modified Psoriatic Arthritis Response Criteria (PsARC) Response at Week 16

Modified PsARC response is defined as improvement in at least 2 of the 4 measures, at least one of which must be tender joint count or swollen joint count, and no worsening in any of the 4 measures: - 78 tender joint count, - 76 swollen joint count, - Patient global assessment of disease activity, measured on a 100 mm visual Analog scale (VAS), where 0 mm = lowest disease activity and 100 mm = highest; - Physician global assessment of disease activity, measured on a 100 mm VAS, where 0 mm = lowest disease activity and 100 mm = highest. Improvement or worsening in joint counts is defined as 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.

Change From Baseline in Patient's Assessment of Pain at Week 16

The participant was asked to place a vertical line on a 100-mm visual analog scale on which the left-hand boundary (score = 0 mm) represents "no pain," and the right-hand boundary (score = 100 mm) represents "pain as severe as can be imagined." The distance from the mark to the left-hand boundary was recorded in millimeters.

Change From Baseline in Maastricht Ankylosing Spondylitis Entheses Score (MASES) at Week 16

The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone): 1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right. The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses.

Change From Baseline in Dactylitis Severity Score at Week 16

Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet will be rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis 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.

Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 16

The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the: - 28 tender joint count (TJC), - 28 swollen joint count (SJC), - Patient's Global Assessment of Disease Activity measured on a 10 cm visual analog scale (VAS), where 0 cm = lowest disease activity and 10 cm = highest; - Physician's Global Assessment of Disease Activity -measured on a 10 cm VAS, where 0 cm = lowest disease activity and 10 cm = highest. The CDAI score ranges from 0-76 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.

Change From Baseline in the Disease Activity Score (DAS28) at Week 16

The DAS28 measures the severity of disease at a specific time and is derived from the following variables: - 28 tender joint count - 28 swollen joint count, which do not include the distal interphalangeal (DIP) joints, the hip joint, or the joints below the knee; - C-reactive protein (CRP) - Patient's global assessment of disease activity. DAS28(CRP) scores range from 0 to approximately 10, with the upper bound dependent on the highest possible level of CRP. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission.

Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 16

The FACIT-Fatigue scale is a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means "not at all," and 4 means "very much." The FACIT-Fatigue scale score ranges from 0 to 52, with higher scores denoting lower levels of fatigue. A positive change from baseline score indicates an improvement.

Change From Baseline in 36-item Short Form Health Survey (SF-36) Physical Functioning Domain at Week 24

Percentage of Participants With a Modified Psoriatic Arthritis Response Criteria (PsARC) Response at Week 24

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.

Change From Baseline in Patient's Assessment of Pain at Week 24

Change From Baseline in Maastricht Ankylosing Spondylitis Entheses Score (MASES) at Week 24

Change From Baseline in Dactylitis Severity Score at Week 24

Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 24

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.

Change From Baseline in the Disease Activity Score (DAS28) at Week 24

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.

Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 24

Percentage of Participants With MASES Improvement ≥ 20% at Week 16

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.

Percentage of Participants With Dactylitis Improvement ≥ 1 Point at Week 16

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 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.

Percentage of Participants With Good or Moderate European League Against Rheumatism (EULAR) Response at Week 16

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.

Percentage of Participants With MASES Improvement ≥ 20% at Week 24

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.

Percentage of Participants With Dactylitis Improvement ≥ 1 Point at Week 24

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 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.

Percentage of Participants With Good or Moderate EULAR Response at Week 24

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.

Percentage of Participants With a ACR 50 Response at Week 16

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: o Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); o Patient's global assessment of disease activity (measured on a 100 mm VAS); o Physician's global assessment of disease activity (measured on a 100 mm VAS); o Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); o C-Reactive Protein.

Percentage of Participants With an ACR 70 Response at Week 16

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: o Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); o Patient's global assessment of disease activity (measured on a 100 mm VAS); o Physician's global assessment of disease activity (measured on a 100 mm VAS); o Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); o C-Reactive Protein.

Percentage of Participants With an ACR 50 Response at Week 24

Percentage of Participants With a ACR 70 Response at Week 24

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.

Percentage of Participants Achieving a MASES Score of Zero at Week 16

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.

Percentage of Participants Achieving a Dactylitis Score of Zero at Week 16

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 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.

Percentage of Participants Achieving a MASES Score of Zero at Week 24

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.

Percentage of Participants Achieving a Dactylitis Score of Zero at Week 24

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 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.

Percentage of Participants With a ACR 20 Response at Week 52

Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Week 52

Change From Baseline in the SF-36 Physical Functioning Scale Score at Week 52

Percentage of Participants With a Modified PsARC Response at Week 52

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.

Change From Baseline in the Patient Assessment of Pain at Week 52

Change From Baseline in Maastricht Ankylosing Spondylitis Entheses Score (MASES) at Week 52

Change From Baseline in the Dactylitis Severity Score at Week 52

Change From Baseline in the CDAI Score at Week 52

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.

Change From Baseline in the DAS28 at Week 52

Change From Baseline in the FACIT-Fatigue Scale Score at Week 52

Percentage of Participants With MASES Improvement ≥ 20% at Week 52

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.

Percentage of Participants With Dactylitis Improvement ≥ 1 Point at Week 52

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 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.

Percentage of Participants Achieving Good or Moderate EULAR Response at Week 52

Percentage of Participants With an ACR 50 Response at Week 52

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.

Percentage of Participants With an ACR 70 Response at Week 52

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.

Percentage of Participants Achieving a MASES Score of Zero at Week 52

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.

Percentage of Participants Achieving a Dactylitis Score of Zero at Week 52

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 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.

Number of Participants With Treatment Emergent Adverse Events During the Placebo-Controlled Phase

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). The severity of each adverse event (AE) and serious AE (SAE) was assessed by the investigator and graded based on a scale from Mild - mild symptoms to Severe AEs (non-serious or serious). A serious adverse event (SAE) is any AE which: Resulted in death Was life-threatening Required inpatient hospitalization or prolongation of existing hospitalization Resulted in persistent or significant disability/incapacity Was a congenital anomaly/birth defect Constituted an important medical event

Number of Participants With TEAEs During the Apremilast-Exposure Period

Full Information

NCT ID

NCT01212757

First Posted

September 29, 2010

Last Updated

April 22, 2020

Sponsor

Amgen

1. Study Identification

Unique Protocol Identification Number

NCT01212757

Brief Title

PALACE 2: Efficacy and Safety Study of Apremilast to Treat Active Psoriatic Arthritis

Acronym

PALACE2

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Completed

Study Start Date

September 27, 2010 (Actual)

Primary Completion Date

July 26, 2012 (Actual)

Study Completion Date

January 25, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Amgen

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to determine whether apremilast is safe and effective in the treatment of patients with psoriatic arthritis. Apremilast is proposed to improve signs and symptoms of psoriatic arthritis (tender and swollen joints, pain, physical function) in treated patients.

Detailed Description

Psoriatic arthritis (PsA) is an inflammatory arthritis that occurs in 6-39% of psoriasis patients. The immunopathogenesis of PsA, which mirrors but is not identical to that seen in psoriatic plaques, reflects a complex interaction among resident dendritic, fibroblastic and endothelial cells, and inflammatory cells attracted to the synovium by cytokines and chemokines. Apremilast (CC-10004) is a novel oral agent that modulates multiple inflammatory pathways through targeted phosphodiesterase type 4 (PDE4) enzyme inhibition. Therefore, apremilast has the potential to be effective in the treatment of PsA.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Psoriatic Arthritis

Keywords

Psoriasis, Arthritis, Psoriatic Arthritis, inflammation, skin condition, inflammatory cells, apremilast, CC-10004, phosphodiesterase type 4

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

488 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Apremilast 20mg

Arm Type

Experimental

Arm Description

Arm Title

Apremilast 30mg

Arm Type

Experimental

Arm Description

Arm Title

Placebo + 20 mg Apremilast

Arm Type

Placebo Comparator

Arm Description

Arm Title

Placebo + 30 mg Apremilast

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Apremilast 20mg

Other Intervention Name(s)

CC-10004

Intervention Description

Apremilast 20 mg twice daily, orally

Intervention Type

Drug

Intervention Name(s)

Apremilast 30mg

Other Intervention Name(s)

CC-10004

Intervention Description

Apremilast 30 mg twice daily, orally

Intervention Type

Drug

Intervention Name(s)

Placebo + 20 mg Apremilast

Other Intervention Name(s)

Placebo, CC-10004

Intervention Description

Placebo + 20 mg Apremilast

Intervention Type

Drug

Intervention Name(s)

Placebo + 30 mg Apremilast

Other Intervention Name(s)

Placebo, CC-10004

Intervention Description

Placebo + 30 mg Apremilast

Primary Outcome Measure Information:

Title

Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 16

Description

Time Frame

Baseline and Week 16

Secondary Outcome Measure Information:

Title

Change From Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) at Week 16

Description

Time Frame

Baseline and Week 16

Title

Percentage of Participants With an ACR 20 Response at Week 24

Description

Time Frame

Baseline and Week 24

Title

Change From Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) at Week 24

Description

Time Frame

Baseline and Week 24

Title

Change From Baseline in 36-item Short Form Health Survey (SF-36) Physical Functioning Domain at Week 16

Description

Time Frame

Baseline and Week 16

Title

Percentage of Participants With a Modified Psoriatic Arthritis Response Criteria (PsARC) Response at Week 16

Description

Time Frame

Baseline and Week 16

Title

Change From Baseline in Patient's Assessment of Pain at Week 16

Description

Time Frame

Baseline and Week 16

Title

Change From Baseline in Maastricht Ankylosing Spondylitis Entheses Score (MASES) at Week 16

Description

Time Frame

Baseline and Week 16

Title

Change From Baseline in Dactylitis Severity Score at Week 16

Description

Time Frame

Baseline and Week 16

Title

Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 16

Description

Time Frame

Baseline and Week 16

Title

Change From Baseline in the Disease Activity Score (DAS28) at Week 16

Description

Time Frame

Baseline and Week 16

Title

Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 16

Description

Time Frame

Baseline and Week 16

Title

Change From Baseline in 36-item Short Form Health Survey (SF-36) Physical Functioning Domain at Week 24

Description

Time Frame

Baseline and Week 24

Title

Percentage of Participants With a Modified Psoriatic Arthritis Response Criteria (PsARC) Response at Week 24

Description

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.

Time Frame

Baseline and Week 24

Title

Change From Baseline in Patient's Assessment of Pain at Week 24

Description

Time Frame

Baseline and Week 24

Title

Change From Baseline in Maastricht Ankylosing Spondylitis Entheses Score (MASES) at Week 24

Description

Time Frame

Baseline and Week 24

Title

Change From Baseline in Dactylitis Severity Score at Week 24

Description

Time Frame

Baseline and Week 24

Title

Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 24

Description

Time Frame

Baseline and Week 24

Title

Change From Baseline in the Disease Activity Score (DAS28) at Week 24

Description

Time Frame

Baseline and Week 24

Title

Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 24

Description

Time Frame

Baseline and Week 24

Title

Percentage of Participants With MASES Improvement ≥ 20% at Week 16

Description

Time Frame

Baseline and Week 16

Title

Percentage of Participants With Dactylitis Improvement ≥ 1 Point at Week 16

Description

Time Frame

Baseline and Week 16

Title

Percentage of Participants With Good or Moderate European League Against Rheumatism (EULAR) Response at Week 16

Description

Time Frame

Baseline and Week 16

Title

Percentage of Participants With MASES Improvement ≥ 20% at Week 24

Description

Time Frame

Baseline and Week 24

Title

Percentage of Participants With Dactylitis Improvement ≥ 1 Point at Week 24

Description

Time Frame

Baseline and Week 24

Title

Percentage of Participants With Good or Moderate EULAR Response at Week 24

Description

Time Frame

Baseline and Week 24

Title

Percentage of Participants With a ACR 50 Response at Week 16

Description

Time Frame

Baseline and Week 16

Title

Percentage of Participants With an ACR 70 Response at Week 16

Description

Time Frame

Baseline and Week 16

Title

Percentage of Participants With an ACR 50 Response at Week 24

Description

Time Frame

Baseline and Week 24

Title

Percentage of Participants With a ACR 70 Response at Week 24

Description

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.

Time Frame

Baseline and Week 24

Title

Percentage of Participants Achieving a MASES Score of Zero at Week 16

Description

Time Frame

Week 16

Title

Percentage of Participants Achieving a Dactylitis Score of Zero at Week 16

Description

Time Frame

Week 16

Title

Percentage of Participants Achieving a MASES Score of Zero at Week 24

Description

Time Frame

Week 24

Title

Percentage of Participants Achieving a Dactylitis Score of Zero at Week 24

Description

Time Frame

Week 24

Title

Percentage of Participants With a ACR 20 Response at Week 52

Description

Time Frame

Baseline and Week 52

Title

Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Week 52

Description

Time Frame

Baseline and Week 52

Title

Change From Baseline in the SF-36 Physical Functioning Scale Score at Week 52

Description

Time Frame

Baseline and Week 52

Title

Percentage of Participants With a Modified PsARC Response at Week 52

Description

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.

Time Frame

Baseline and Week 52

Title

Change From Baseline in the Patient Assessment of Pain at Week 52

Description

Time Frame

Baseline and Week 52

Title

Change From Baseline in Maastricht Ankylosing Spondylitis Entheses Score (MASES) at Week 52

Description

Time Frame

Baseline and Week 52

Title

Change From Baseline in the Dactylitis Severity Score at Week 52

Description

Time Frame

Baseline and Week 52

Title

Change From Baseline in the CDAI Score at Week 52

Description

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.

Time Frame

Baseline and Week 52

Title

Change From Baseline in the DAS28 at Week 52

Description

Time Frame

Baseline and Week 52

Title

Change From Baseline in the FACIT-Fatigue Scale Score at Week 52

Description

Time Frame

Baseline and Week 52

Title

Percentage of Participants With MASES Improvement ≥ 20% at Week 52

Description

Time Frame

Baseline and Week 52

Title

Percentage of Participants With Dactylitis Improvement ≥ 1 Point at Week 52

Description

Time Frame

Baseline and Week 52

Title

Percentage of Participants Achieving Good or Moderate EULAR Response at Week 52

Description

Time Frame

Baseline and Week 52

Title

Percentage of Participants With an ACR 50 Response at Week 52

Description

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.

Time Frame

Baseline and Week 52

Title

Percentage of Participants With an ACR 70 Response at Week 52

Description

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.

Time Frame

Baseline and Week 52

Title

Percentage of Participants Achieving a MASES Score of Zero at Week 52

Description

Time Frame

Week 52

Title

Percentage of Participants Achieving a Dactylitis Score of Zero at Week 52

Description

Time Frame

Week 52

Title

Number of Participants With Treatment Emergent Adverse Events During the Placebo-Controlled Phase

Description

Time Frame

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)

Title

Number of Participants With TEAEs During the Apremilast-Exposure Period

Description

Time Frame

Week 0 to week 260; overall median duration of exposure to apremilast 20 mg and 30 mg BID was 198 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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) PsA 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. 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Organizational Affiliation

Amgen

Official's Role

Study Director

Facility Information:

Facility Name

Clinical and Translational Research Center of Alabama, PC

City

Tuscaloosa

State/Province

Alabama

ZIP/Postal Code

35406

Country

United States

Facility Name

Denver Arthritis Clinic

City

Denver

State/Province

Colorado

ZIP/Postal Code

80230

Country

United States

Facility Name

New England Research Associates, LLC

City

Trumbull

State/Province

Connecticut

ZIP/Postal Code

6611

Country

United States

Facility Name

Centre For Rheumatology, Immun. And Arthritis

City

Fort Lauderdale

State/Province

Florida

ZIP/Postal Code

33334

Country

United States

Facility Name

DMI Research

City

Saint Petersburg

State/Province

Florida

ZIP/Postal Code

33710

Country

United States

Facility Name

University of South Florida

City

Tampa

State/Province

Florida

ZIP/Postal Code

33612

Country

United States

Facility Name

Arthritis and Rheumatology of Georgia

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30342

Country

United States

Facility Name

Michael Bukhalo MD SC

City

Arlington Hts

State/Province

Illinois

ZIP/Postal Code

60005

Country

United States

Facility Name

Associated Internal Medical Specialist, PC

City

Battle Creek

State/Province

Michigan

ZIP/Postal Code

49015

Country

United States

Facility Name

Advanced Rheumatology

City

Lansing

State/Province

Michigan

ZIP/Postal Code

48910

Country

United States

Facility Name

Mayo Clinic

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

Facility Name

Research West Incorporated

City

Kalispell

State/Province

Montana

ZIP/Postal Code

59901

Country

United States

Facility Name

University of Rochester Medical Center

City

Rochester

State/Province

New York

ZIP/Postal Code

14623

Country

United States

Facility Name

Vital Research

City

Greensboro

State/Province

North Carolina

ZIP/Postal Code

27408

Country

United States

Facility Name

Unifour Medical Research Associatets LLC

City

Hickory

State/Province

North Carolina

ZIP/Postal Code

28602

Country

United States

Facility Name

Rheumatic Disease Associates

City

Willow Grove

State/Province

Pennsylvania

ZIP/Postal Code

19090

Country

United States

Facility Name

Metroplex Clinical Research Center

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

Facility Name

Baylor Research Institute

City

Dallas

State/Province

Texas

ZIP/Postal Code

75246-1613

Country

United States

Facility Name

Arthritis Care and Diagnostic Center

City

Dallas

State/Province

Texas

ZIP/Postal Code

75321

Country

United States

Facility Name

Luckster Enterprises

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78232

Country

United States

Facility Name

Seattle Rheumatology Associates

City

Seattle

State/Province

Washington

ZIP/Postal Code

98104

Country

United States

Facility Name

Tacoma Center for Arthritis Research, PS

City

Tacoma

State/Province

Washington

ZIP/Postal Code

98405

Country

United States

Facility Name

Rheumatology and Immunotherapy Center

City

Franklin

State/Province

Wisconsin

ZIP/Postal Code

53132

Country

United States

Facility Name

CHU Brugmann

City

Bruxelles

ZIP/Postal Code

1020

Country

Belgium

Facility Name

UZ Gent

City

Ghent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

UZ Leuven

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

University Hospital of Liege CHU Liege

City

Liège

ZIP/Postal Code

4000

Country

Belgium

Facility Name

Diagnostic and Consulting Centre 7

City

Sofia

ZIP/Postal Code

1233

Country

Bulgaria

Facility Name

University Multiprofile Hospital for Active Treatment ACIBADEM City Clinic Sofia

City

Sofia

ZIP/Postal Code

1407

Country

Bulgaria

Facility Name

17 Diagnostic and Consulting Centre Sofia EOOD

City

Sofia

ZIP/Postal Code

1505

Country

Bulgaria

Facility Name

Multiprofile Hospital for Active Treatment Sv. Ivan Rilski

City

Sofia

ZIP/Postal Code

1612

Country

Bulgaria

Facility Name

Diagnostic-Consultative Center Sveta Anna

City

Sofia

ZIP/Postal Code

1709

Country

Bulgaria

Facility Name

Diagnostic and Consulting Centre 4

City

Varna

ZIP/Postal Code

9010

Country

Bulgaria

Facility Name

Rheumatology Research Associates

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T5M 0H4

Country

Canada

Facility Name

PerCuro Clinical Research

City

Victoria

State/Province

British Columbia

ZIP/Postal Code

V8P5P6

Country

Canada

Facility Name

Anna Jaroszynska Private Practice

City

Burlington

State/Province

Ontario

ZIP/Postal Code

L7L0B7

Country

Canada

Facility Name

William Bensen's Private Practice

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8N1Y2

Country

Canada

Facility Name

North Bay Dermatology Center

City

North Bay

State/Province

Ontario

ZIP/Postal Code

P1B 3Z7

Country

Canada

Facility Name

Rheumatology Research Associates

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1H 1A2

Country

Canada

Facility Name

Wilderman Medical Clinic

City

Thornhill

State/Province

Ontario

ZIP/Postal Code

L4J1W3

Country

Canada

Facility Name

Darryl Toth's Private Practice

City

Windsor

State/Province

Ontario

ZIP/Postal Code

N8W 1E6

Country

Canada

Facility Name

Revmatologie s.r.o.

City

Brno

ZIP/Postal Code

638 00

Country

Czechia

Facility Name

MEDIPONT PLUS s.r.o..

City

Ceske Budejovice

ZIP/Postal Code

370 01

Country

Czechia

Facility Name

L.K.N. Arthrocentrum s.r.o.

City

Hlucin

ZIP/Postal Code

748 01

Country

Czechia

Facility Name

ARTMEDI UPD s.r.o.

City

Hostivice

ZIP/Postal Code

253 01

Country

Czechia

Facility Name

Affidea Praha s.r.o

City

Praha 11

ZIP/Postal Code

148 00

Country

Czechia

Facility Name

Revmatologicky ustav

City

Praha 2

ZIP/Postal Code

128 50

Country

Czechia

Facility Name

Revmatologicka Ambulance

City

Praha 4

ZIP/Postal Code

140 00

Country

Czechia

Facility Name

Revmatologicka Ambulance

City

Sokolov

ZIP/Postal Code

356 01

Country

Czechia

Facility Name

PV - MEDICAL, s.r.o.

City

Zlin

ZIP/Postal Code

760 01

Country

Czechia

Facility Name

Parnu Hospital

City

Pärnu

ZIP/Postal Code

EE-80010

Country

Estonia

Facility Name

East Tallinn Central Hospital

City

Tallinn

ZIP/Postal Code

EE-11412

Country

Estonia

Facility Name

North Estonia Regional Hospital

City

Tallinn

ZIP/Postal Code

EE-13419

Country

Estonia

Facility Name

Clinical Research Centre Ltd

City

Tartu

ZIP/Postal Code

50106

Country

Estonia

Facility Name

Tartu University Hospital

City

Tartu

ZIP/Postal Code

EE-51014

Country

Estonia

Facility Name

Hopital Universitaire Dupuytren

City

Limoges

ZIP/Postal Code

87042

Country

France

Facility Name

Hopital Lariboisiere

City

Paris

ZIP/Postal Code

75010

Country

France

Facility Name

Fondation Hôpital Saint-Joseph

City

Paris

ZIP/Postal Code

75014

Country

France

Facility Name

Groupe Hospitalier Pitié- Salpétrière

City

Paris

ZIP/Postal Code

75651

Country

France

Facility Name

Centre Hospitalier Lyon Sud

City

Pierre Benite

ZIP/Postal Code

69495

Country

France

Facility Name

Charite - Universitätsmedizin Berlin

City

Berlin

ZIP/Postal Code

10117

Country

Germany

Facility Name

Klinikum der Johann-Wolfgang Goethe-Universität

City

Frankfurt

ZIP/Postal Code

60590

Country

Germany

Facility Name

Praxis Karin Rockwitz

City

Goslar

ZIP/Postal Code

38642

Country

Germany

Facility Name

Synexus Clinical Research GmbH

City

Leipzig

ZIP/Postal Code

4103

Country

Germany

Facility Name

Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum

City

Debrecen

ZIP/Postal Code

4032

Country

Hungary

Facility Name

Pest Megyei Flor Ferenc Korhaz

City

Kistarcsa

ZIP/Postal Code

2143

Country

Hungary

Facility Name

Principal SMO Kft.

City

Makó

ZIP/Postal Code

6900

Country

Hungary

Facility Name

Azienda Ospedaliera Universitaria San Martino

City

Genova

ZIP/Postal Code

16132

Country

Italy

Facility Name

Ospedale Luigi Sacco

City

Milano

ZIP/Postal Code

20157

Country

Italy

Facility Name

Seconda Universita degli Studi di Napoli

City

Napoli

ZIP/Postal Code

80130

Country

Italy

Facility Name

IRCCS Policlinico San Matteo

City

Pavia

ZIP/Postal Code

27100

Country

Italy

Facility Name

Universita di Pisa

City

Pisa

ZIP/Postal Code

56126

Country

Italy

Facility Name

Ospedale Civile Maggiore Borgo Trento

City

Verona

ZIP/Postal Code

37126

Country

Italy

Facility Name

NZOZ Osteo-Medic sc A. Racewicz J. Supronik

City

Bialystok

ZIP/Postal Code

15-351

Country

Poland

Facility Name

Niepubliczny Zaklad Opieki Zdrowotnej REUMED

City

Lublin

ZIP/Postal Code

20-582

Country

Poland

Facility Name

Instytut Reumatologii im. prof. dr hab. med. Eleonory Reicher

City

Warsaw

ZIP/Postal Code

02-637

Country

Poland

Facility Name

Wojskowy Instytut Medyczny

City

Warszawa

ZIP/Postal Code

00-909

Country

Poland

Facility Name

Synexus SCM Sp. z o.o.

City

Wroclaw

ZIP/Postal Code

50-088

Country

Poland

Facility Name

City Clinical Hospital #1 n.a. N.I.Pirogov

City

Moscow

ZIP/Postal Code

119049

Country

Russian Federation

Facility Name

City Clinical Hospital #5

City

Nizhniy Novgorod

ZIP/Postal Code

603005

Country

Russian Federation

Facility Name

St.Petersburg State Medical Academy n. a. I.I.Mechnikov

City

St. Petersburg

ZIP/Postal Code

195067

Country

Russian Federation

Facility Name

Yaroslavl Regional Clinical Hospital

City

Yaroslavl

ZIP/Postal Code

150062

Country

Russian Federation

Facility Name

Nelson Mandela School Of Medicine

City

Durban

ZIP/Postal Code

4091

Country

South Africa

Facility Name

Greenacres Hospital

City

Port Elizabeth

ZIP/Postal Code

6057

Country

South Africa

Facility Name

Jacaranda Hospital

City

Pretoria

ZIP/Postal Code

Country

South Africa

Facility Name

Hospital Universitario de Canarias

City

La Laguna

ZIP/Postal Code

38320

Country

Spain

Facility Name

Hospital General Carlos Haya

City

Málaga

ZIP/Postal Code

29009

Country

Spain

Facility Name

Hospital Sierrallana

City

Torrelavega

ZIP/Postal Code

39300

Country

Spain

Facility Name

Chung Shan Medical University Hospital

City

Taichung

ZIP/Postal Code

402

Country

Taiwan

Facility Name

Taichung Veterans General Hospital

City

Taichung

ZIP/Postal Code

40705

Country

Taiwan

Facility Name

Cathay General Hospital

City

Taipei

ZIP/Postal Code

106

Country

Taiwan

Facility Name

Taipei Veterans General Hospital

City

Taipei

ZIP/Postal Code

112

Country

Taiwan

Facility Name

National Taiwan University Hospital

City

Tapei

ZIP/Postal Code

10002

Country

Taiwan

Facility Name

Basingstoke and North Hampshire Hospital

City

Basingstoke

ZIP/Postal Code

RG24 9NA

Country

United Kingdom

Facility Name

Cannock Chase Hospital

City

Cannock

ZIP/Postal Code

WS11 5XY

Country

United Kingdom

Facility Name

Chapel Allerton Hospital

City

Leeds

ZIP/Postal Code

LS7 4SA

Country

United Kingdom

Facility Name

Poole Hospital

City

Poole

ZIP/Postal Code

BH 1 5JB

Country

United Kingdom

Facility Name

Great Western Hospital

City

Swindon

ZIP/Postal Code

SN3 6BB

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

IPD Sharing Time Frame

Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.

IPD Sharing Access Criteria

Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

IPD Sharing URL

http://www.amgen.com/datasharing

Citations:

PubMed Identifier

27422893

Citation

Cutolo M, Myerson GE, Fleischmann RM, Liote F, Diaz-Gonzalez F, Van den Bosch F, Marzo-Ortega H, Feist E, Shah K, Hu C, Stevens RM, Poder A. A Phase III, Randomized, Controlled Trial of Apremilast in Patients with Psoriatic Arthritis: Results of the PALACE 2 Trial. J Rheumatol. 2016 Sep;43(9):1724-34. doi: 10.3899/jrheum.151376. Epub 2016 Jul 15.

Results Reference

background

PubMed Identifier

34536218

Citation

Mease PJ, Gladman DD, Kavanaugh A, McGonagle D, Nash P, Guerette B, Nakasato P, Brunori M, Teng L, McInnes IB. Articular and Extra-Articular Benefits in ACR20 Non-responders at Week 104 Treated With Apremilast: Pooled Analysis of Three Randomized Controlled Trials. Rheumatol Ther. 2021 Dec;8(4):1677-1691. doi: 10.1007/s40744-021-00369-x. Epub 2021 Sep 18.

Results Reference

derived

PubMed Identifier

31909868

Citation

Mease PJ, Gladman DD, Ogdie A, Coates LC, Behrens F, Kavanaugh A, McInnes I, Queiro R, Guerette B, Brunori M, Teng L, Smolen JS. Treatment-to-Target With Apremilast in Psoriatic Arthritis: The Probability of Achieving Targets and Comprehensive Control of Disease Manifestations. Arthritis Care Res (Hoboken). 2020 Jun;72(6):814-821. doi: 10.1002/acr.24134. Epub 2020 May 8.

Results Reference

derived

PubMed Identifier

31077258

Citation

Kavanaugh A, Gladman DD, Edwards CJ, Schett G, Guerette B, Delev N, Teng L, Paris M, Mease PJ. Long-term experience with apremilast in patients with psoriatic arthritis: 5-year results from a PALACE 1-3 pooled analysis. Arthritis Res Ther. 2019 May 10;21(1):118. doi: 10.1186/s13075-019-1901-3.

Results Reference

derived

PubMed Identifier

30018799

Citation

Gladman DD, Kavanaugh A, Gomez-Reino JJ, Wollenhaupt J, Cutolo M, Schett G, Lespessailles E, Guerette B, Delev N, Teng L, Edwards CJ, Birbara CA, Mease PJ. Therapeutic benefit of apremilast on enthesitis and dactylitis in patients with psoriatic arthritis: a pooled analysis of the PALACE 1-3 studies. RMD Open. 2018 Jun 27;4(1):e000669. doi: 10.1136/rmdopen-2018-000669. eCollection 2018.

Results Reference

derived

Learn more about this trial

PALACE 2: Efficacy and Safety Study of Apremilast to Treat Active Psoriatic Arthritis

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