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PALACE 3: Efficacy and Safety Study of Apremilast to Treat Active Psoriatic Arthritis (PALACE 3)

Primary Purpose

Psoriatic Arthritis

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Apremilast 20mg

Apremilast 30mg

Placebo

About this trial

This is an interventional treatment trial for Psoriatic Arthritis focused on measuring Psoriatic Arthritis, Psoriasis, 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) criteria for PsA at time of screening.
Must have been inadequately treated by disease-modifying antirheumatic drugs (DMARDs)
May not have axial involvement alone
Concurrent Tx allowed with methotrexate, leflunomide, or sulfasalazine
Have ≥ 3 swollen AND ≥ 3 tender joints.
Males & Females must use contraception
Stable dose of NSAIDs, narcotics and low dose oral corticosteroids allowed.
Have at least one ≥2 cm psoriasis lesion

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

University of Alabama at Birmingham
Elite Clinical Studies, LLC
Catalina Pointe Clinical Research Incorporated
Bakersfield Dermatology and Skin Cancer Medical Group
Dermatology Research Associates
Desert Medical Advances
Joao Nascimento, MD
In Vivo Clinical Research
Suncoast Clinical Research
Rheumatology Associates of Long Island
Advent Clinical Research
Rockford Orthopedic Associates, LLC
Dawes Fretzin Clinical Research Group, LLC
DermResearch, PLLC
Clinical Pharmacology Study Group
Duke University Medical Center
STAT Research, Inc.
West Tennessee Research Institute
Austin Dermatology Associates
Austin Regional Clinic
Center for Clinical Studies
Houston Medical Research
Texas Research Center
Royal Prince Alfred Hospital
Skin Cancer Foundation
Coff's Clinical Trials
Heidelberg Repatriation Hospital
Menzies Centre for Population Health Research
Optimus Clinical Research Pty. Ltd
Coastal Joint Care
The Queen Elizabeth Hospital
Arthritis Research Centre of Canada
PerCuro Clinical Research
Manitoba Clinic
Arthritis Centre
Alpha Clinical Research, LLC
Niagara Peninsula Arthritis Centre Inc.
Manna Research
Helsingin Reumakeskus Oy
Helsingin yliopistollinen keskussairaala
Finnish Medical Research Co
Centre Hospitalier Sud Francilien - Site Gilles de Corbeil
Hôtel-Dieu
Groupe Hospitalier Archet I et II
Hopital Larrey Universite Paul Sabatier
Charite - Universitätsmedizin Berlin
Klinische Forschung Berlin - Buch GmbH
Klinikum der Friedrich-Schiller-Universität Jena
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi
Fondazione PTV Policlinico Tor Vergata
Hallym University Sacred Heart Hospital
Chungnam National University Hospital
Inha University Hosiptal
Gachon University Gil Medical Center
Seoul National University Hospital
Severance Hospital
Ajou University Hospital
Hospital of Lithuanian University Health and Sciences
Klaipeda University Hospital
Panevezys Hospital
Siauliai Hospital
Gabinet Internistyczno-Reumatologiczny Piotr Adrian Klimiuk
Centrum Medyczne Silesiana Sp. z o.o.
Malopolskie Centrum Medyczne S.C.
Prywatna Praktyka Lekarska Pawel Hrycaj
REUMATIKA-Centrum Reumatologii Niepubliczny Zaklad Opieki Zdrowotnej
Baia Mare, Emergency County Hospital "Dr. Constantin Opris"
SC Duo Medical SRL
Sf. Maria Clinical Hospital
Emergency County Clinical Hospital
Sf Apostol Andrei Emergency Clinical County Hospital
C.M.I. Dr. Ciornohuz Adriana
Sverdlovsk Regional Clinical Hospital 1
Research Medical Complex Vashe Zdorovie
Research Institute of Clinical and Experimental Lymphology
Penza Regional Clinical Hospital n.a. N.N. Burdenko
City Hospital 26
Narodny ustav reumatickych chorob
MUDr. Zuzana Cizmarikova, s.r.o.
REUMEX s.r.o.
Hospital Universitario a Coruna
Hospital de Basurto-Osakidetza
Hospital Universitario Reina Sofia
Hospital Universitario Central de Asturias
Hospital Infanta Sofia
HFR Fribourg - Hôpital Cantonal
Chuv Bh-04
Kantonsspital St. Gallen
Haywood Hospital
Southampton General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

Apremilast 20 mg

Apremilast 30 mg

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 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.

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

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.

Percentage of Participants Achieving a ≥ 75% Improvement in Psoriasis Area and Severity Index Score (PASI75) at Week 16

The percentage of participants with Baseline psoriasis body surface area (BSA) involvement ≥ 3% who achieved 75% or greater improvement from Baseline in Psoriasis Area and Severity Index (PASI) score after 16 weeks of treatment. The Psoriasis Area and Severity Index (PASI) score is a combination of the intensity of psoriasis, assessed by erythema (reddening), induration (plaque thickness) and desquamation (scaling) scored on a scale from 0 (none) to 4 (very severe), together with the percentage of the area affected, rated on a scale from 0 (no involvement) to 6 (90% to 100% involvement). PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease.

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 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.

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.

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

Percentage of Participants Achieving a ≥ 75% Improvement in Psoriasis Area and Severity Index Score (PASI75) at Week 24

The percentage of participants with Baseline psoriasis body surface area (BSA) involvement ≥ 3% who achieved 75% or greater improvement from Baseline in Psoriasis Area and Severity Index (PASI) score after 24 weeks of treatment. The Psoriasis Area and Severity Index (PASI) score is a combination of the intensity of psoriasis, assessed by erythema (reddening), induration (plaque thickness) and desquamation (scaling) scored on a scale from 0 (none) to 4 (very severe), together with the percentage of the area affected, rated on a scale from 0 (no involvement) to 6 (90% to 100% involvement). PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease.

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

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.

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 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.

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 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.

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: ◦ 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 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: ◦ 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 With an ACR 50 Response at Week 24

Percentage of Participants With a ACR 70 Response at Week 24

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 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.

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 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.

Percentage of Participants With an 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

Percentage of Participants Achieving a ≥ 75% Improvement in Psoriasis Area and Severity Index Score (PASI75) at Week 52

The percentage of participants with Baseline psoriasis body surface area (BSA) involvement ≥ 3% who achieved 75% or greater improvement from Baseline in Psoriasis Area and Severity Index (PASI) score after 52 weeks. The Psoriasis Area and Severity Index (PASI) score is a combination of the intensity of psoriasis, assessed by erythema (reddening), induration (plaque thickness) and desquamation (scaling) scored on a scale from 0 (none) to 4 (very severe), together with the percentage of the area affected, rated on a scale from 0 (no involvement) to 6 (90% to 100% involvement). PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease. Two-sided 95% confidence interval is based on the Clopper-Pearson method.

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

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 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 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.

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 ACR 70 Response at Week 52

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 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.

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

A TEAE is an adverse event (AE) with a start date on or after the date of the first dose of investigational product (IP) and no later than 28 days after the last dose of IP. An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. A serious AE is any AE that results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or constitutes an important medical event. For both AEs and SAEs the investigator assessed the severity of the event according to the grading scale: Mild: asymptomatic or with mild symptoms, Moderate: symptoms causing moderate discomfort or Severe: symptoms causing severe discomfort or pain.

Number of Participants With Treatment Emergent Adverse Events During the Apremilast Exposure Period

Full Information

NCT ID

NCT01212770

First Posted

September 29, 2010

Last Updated

April 22, 2020

Sponsor

Amgen

1. Study Identification

Unique Protocol Identification Number

NCT01212770

Brief Title

PALACE 3: Efficacy and Safety Study of Apremilast to Treat Active Psoriatic Arthritis

Acronym

PALACE 3

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 and a Qualifying Psoriasis Lesion

Study Type

Interventional

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Completed

Study Start Date

September 30, 2010 (Actual)

Primary Completion Date

August 21, 2012 (Actual)

Study Completion Date

February 9, 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 and a qualifying psoriasis lesion. Apremilast is proposed to improve signs and symptoms of psoriatic arthritis (tender and swollen joints, pain, physical function) in treated patients.

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

Psoriatic Arthritis, Psoriasis, 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

505 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Apremilast 20 mg

Arm Type

Experimental

Arm Description

Arm Title

Apremilast 30 mg

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

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

Percentage of Participants Achieving a ≥ 75% Improvement in Psoriasis Area and Severity Index Score (PASI75) 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

Time Frame

Baseline and Week 24

Title

Percentage of Participants Achieving a ≥ 75% Improvement in Psoriasis Area and Severity Index Score (PASI75) at Week 24

Description

The percentage of participants with Baseline psoriasis body surface area (BSA) involvement ≥ 3% who achieved 75% or greater improvement from Baseline in Psoriasis Area and Severity Index (PASI) score after 24 weeks of treatment. The Psoriasis Area and Severity Index (PASI) score is a combination of the intensity of psoriasis, assessed by erythema (reddening), induration (plaque thickness) and desquamation (scaling) scored on a scale from 0 (none) to 4 (very severe), together with the percentage of the area affected, rated on a scale from 0 (no involvement) to 6 (90% to 100% involvement). PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease.

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

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 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

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 an 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

Time Frame

Baseline and Week 52

Title

Percentage of Participants Achieving a ≥ 75% Improvement in Psoriasis Area and Severity Index Score (PASI75) at Week 52

Description

The percentage of participants with Baseline psoriasis body surface area (BSA) involvement ≥ 3% who achieved 75% or greater improvement from Baseline in Psoriasis Area and Severity Index (PASI) score after 52 weeks. The Psoriasis Area and Severity Index (PASI) score is a combination of the intensity of psoriasis, assessed by erythema (reddening), induration (plaque thickness) and desquamation (scaling) scored on a scale from 0 (none) to 4 (very severe), together with the percentage of the area affected, rated on a scale from 0 (no involvement) to 6 (90% to 100% involvement). PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease. Two-sided 95% confidence interval is based on the Clopper-Pearson method.

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

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.

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

Time Frame

Baseline and Week 52

Title

Percentage of Participants With an ACR 70 Response at Week 52

Description

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 (TEAEs) 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 Treatment Emergent Adverse Events During the Apremilast Exposure Period

Description

Time Frame

Week 0 to Week 260; median duration of exposure to apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg BID

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) criteria for PsA at time of screening. Must have been inadequately treated by disease-modifying antirheumatic drugs (DMARDs) May not have axial involvement alone Concurrent Tx allowed with methotrexate, leflunomide, or sulfasalazine Have ≥ 3 swollen AND ≥ 3 tender joints. Males & Females must use contraception Stable dose of NSAIDs, narcotics and low dose oral corticosteroids allowed. Have at least one ≥2 cm psoriasis lesion 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

University of Alabama at Birmingham

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35294

Country

United States

Facility Name

Elite Clinical Studies, LLC

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85018

Country

United States

Facility Name

Catalina Pointe Clinical Research Incorporated

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85704

Country

United States

Facility Name

Bakersfield Dermatology and Skin Cancer Medical Group

City

Bakersfield

State/Province

California

ZIP/Postal Code

93309

Country

United States

Facility Name

Dermatology Research Associates

City

Los Angeles

State/Province

California

ZIP/Postal Code

90045

Country

United States

Facility Name

Desert Medical Advances

City

Palm Desert

State/Province

California

ZIP/Postal Code

92260

Country

United States

Facility Name

Joao Nascimento, MD

City

Bridgeport

State/Province

Connecticut

ZIP/Postal Code

6606

Country

United States

Facility Name

In Vivo Clinical Research

City

Doral

State/Province

Florida

ZIP/Postal Code

33166

Country

United States

Facility Name

Suncoast Clinical Research

City

New Port Richey

State/Province

Florida

ZIP/Postal Code

34652

Country

United States

Facility Name

Rheumatology Associates of Long Island

City

Orlando

State/Province

Florida

ZIP/Postal Code

32806

Country

United States

Facility Name

Advent Clinical Research

City

Pinellas Park

State/Province

Florida

ZIP/Postal Code

33781

Country

United States

Facility Name

Rockford Orthopedic Associates, LLC

City

Rockford

State/Province

Illinois

ZIP/Postal Code

61107

Country

United States

Facility Name

Dawes Fretzin Clinical Research Group, LLC

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46256

Country

United States

Facility Name

DermResearch, PLLC

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40217

Country

United States

Facility Name

Clinical Pharmacology Study Group

City

Worcester

State/Province

Massachusetts

ZIP/Postal Code

01605

Country

United States

Facility Name

Duke University Medical Center

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

Facility Name

STAT Research, Inc.

City

Dayton

State/Province

Ohio

ZIP/Postal Code

45417

Country

United States

Facility Name

West Tennessee Research Institute

City

Jackson

State/Province

Tennessee

ZIP/Postal Code

38305

Country

United States

Facility Name

Austin Dermatology Associates

City

Austin

State/Province

Texas

ZIP/Postal Code

78705

Country

United States

Facility Name

Austin Regional Clinic

City

Austin

State/Province

Texas

ZIP/Postal Code

78731

Country

United States

Facility Name

Center for Clinical Studies

City

Houston

State/Province

Texas

ZIP/Postal Code

77065

Country

United States

Facility Name

Houston Medical Research

City

Houston

State/Province

Texas

ZIP/Postal Code

77090

Country

United States

Facility Name

Texas Research Center

City

Sugar Land

State/Province

Texas

ZIP/Postal Code

77479

Country

United States

Facility Name

Royal Prince Alfred Hospital

City

Camperdown

ZIP/Postal Code

2050

Country

Australia

Facility Name

Skin Cancer Foundation

City

Carlton

ZIP/Postal Code

3053

Country

Australia

Facility Name

Coff's Clinical Trials

City

Coffs Harbour

ZIP/Postal Code

2450

Country

Australia

Facility Name

Heidelberg Repatriation Hospital

City

Heidelberg

ZIP/Postal Code

3081

Country

Australia

Facility Name

Menzies Centre for Population Health Research

City

Hobart

ZIP/Postal Code

7000

Country

Australia

Facility Name

Optimus Clinical Research Pty. Ltd

City

Kogarah

ZIP/Postal Code

2217

Country

Australia

Facility Name

Coastal Joint Care

City

Maroochydore

ZIP/Postal Code

4558

Country

Australia

Facility Name

The Queen Elizabeth Hospital

City

Woodville

ZIP/Postal Code

5011

Country

Australia

Facility Name

Arthritis Research Centre of Canada

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V5Z1L7

Country

Canada

Facility Name

PerCuro Clinical Research

City

Victoria

State/Province

British Columbia

ZIP/Postal Code

V8P5P6

Country

Canada

Facility Name

Manitoba Clinic

City

Winnipeg

State/Province

Manitoba

ZIP/Postal Code

R3A1M3

Country

Canada

Facility Name

Arthritis Centre

City

Winnipeg

State/Province

Manitoba

ZIP/Postal Code

R3A1M4

Country

Canada

Facility Name

Alpha Clinical Research, LLC

City

St John's

State/Province

Newfoundland and Labrador

ZIP/Postal Code

A1B 4S8

Country

Canada

Facility Name

Niagara Peninsula Arthritis Centre Inc.

City

St Catharines

State/Province

Ontario

ZIP/Postal Code

L2N 7E4

Country

Canada

Facility Name

Manna Research

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M9W4L6

Country

Canada

Facility Name

Helsingin Reumakeskus Oy

City

Helsinki

ZIP/Postal Code

FI-00120

Country

Finland

Facility Name

Helsingin yliopistollinen keskussairaala

City

Helsinki

ZIP/Postal Code

FI-00290

Country

Finland

Facility Name

Finnish Medical Research Co

City

Pori

ZIP/Postal Code

FI-28100

Country

Finland

Facility Name

Centre Hospitalier Sud Francilien - Site Gilles de Corbeil

City

Corbeil Essonnes

ZIP/Postal Code

91106

Country

France

Facility Name

Hôtel-Dieu

City

Nantes

ZIP/Postal Code

44093

Country

France

Facility Name

Groupe Hospitalier Archet I et II

City

Nice

ZIP/Postal Code

6002

Country

France

Facility Name

Hopital Larrey Universite Paul Sabatier

City

Toulouse

ZIP/Postal Code

31000

Country

France

Facility Name

Charite - Universitätsmedizin Berlin

City

Berlin

ZIP/Postal Code

10117

Country

Germany

Facility Name

Klinische Forschung Berlin - Buch GmbH

City

Berlin

ZIP/Postal Code

13125

Country

Germany

Facility Name

Klinikum der Friedrich-Schiller-Universität Jena

City

Jena

ZIP/Postal Code

7740

Country

Germany

Facility Name

Universitätsmedizin der Johannes Gutenberg-Universität Mainz

City

Mainz

ZIP/Postal Code

55131

Country

Germany

Facility Name

Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi

City

Bologna

ZIP/Postal Code

40138

Country

Italy

Facility Name

Fondazione PTV Policlinico Tor Vergata

City

Roma

ZIP/Postal Code

133

Country

Italy

Facility Name

Hallym University Sacred Heart Hospital

City

Anyang, Kyunggi

ZIP/Postal Code

431070

Country

Korea, Republic of

Facility Name

Chungnam National University Hospital

City

DaeJeon

ZIP/Postal Code

301-721

Country

Korea, Republic of

Facility Name

Inha University Hosiptal

City

Incheon

ZIP/Postal Code

400-711

Country

Korea, Republic of

Facility Name

Gachon University Gil Medical Center

City

Incheon

ZIP/Postal Code

405760

Country

Korea, Republic of

Facility Name

Seoul National University Hospital

City

Seoul

ZIP/Postal Code

03080

Country

Korea, Republic of

Facility Name

Severance Hospital

City

Seoul

ZIP/Postal Code

120-752

Country

Korea, Republic of

Facility Name

Ajou University Hospital

City

Suwon

ZIP/Postal Code

443-721

Country

Korea, Republic of

Facility Name

Hospital of Lithuanian University Health and Sciences

City

Kaunas

ZIP/Postal Code

LT-50009

Country

Lithuania

Facility Name

Klaipeda University Hospital

City

Klaipeda

ZIP/Postal Code

LT-5808

Country

Lithuania

Facility Name

Panevezys Hospital

City

Panevezys

ZIP/Postal Code

LT-35144

Country

Lithuania

Facility Name

Siauliai Hospital

City

Siauliai

ZIP/Postal Code

LT-76231

Country

Lithuania

Facility Name

Gabinet Internistyczno-Reumatologiczny Piotr Adrian Klimiuk

City

Bialystok

ZIP/Postal Code

15-099

Country

Poland

Facility Name

Centrum Medyczne Silesiana Sp. z o.o.

City

Bytom

ZIP/Postal Code

41-902

Country

Poland

Facility Name

Malopolskie Centrum Medyczne S.C.

City

Kraków

ZIP/Postal Code

30-510

Country

Poland

Facility Name

Prywatna Praktyka Lekarska Pawel Hrycaj

City

Poznan

ZIP/Postal Code

61-397

Country

Poland

Facility Name

REUMATIKA-Centrum Reumatologii Niepubliczny Zaklad Opieki Zdrowotnej

City

Warszawa

ZIP/Postal Code

02-653

Country

Poland

Facility Name

Baia Mare, Emergency County Hospital "Dr. Constantin Opris"

City

Baia Mare

ZIP/Postal Code

430031

Country

Romania

Facility Name

SC Duo Medical SRL

City

Bucharest

ZIP/Postal Code

10584

Country

Romania

Facility Name

Sf. Maria Clinical Hospital

City

Bucharest

ZIP/Postal Code

11172

Country

Romania

Facility Name

Emergency County Clinical Hospital

City

Cluj-Napoca

ZIP/Postal Code

400006

Country

Romania

Facility Name

Sf Apostol Andrei Emergency Clinical County Hospital

City

Galati

ZIP/Postal Code

800578

Country

Romania

Facility Name

C.M.I. Dr. Ciornohuz Adriana

City

Iasi

ZIP/Postal Code

700127

Country

Romania

Facility Name

Sverdlovsk Regional Clinical Hospital 1

City

Ekaterinburg

ZIP/Postal Code

620102

Country

Russian Federation

Facility Name

Research Medical Complex Vashe Zdorovie

City

Kezch

ZIP/Postal Code

214025

Country

Russian Federation

Facility Name

Research Institute of Clinical and Experimental Lymphology

City

Novosibirsk

ZIP/Postal Code

630117

Country

Russian Federation

Facility Name

Penza Regional Clinical Hospital n.a. N.N. Burdenko

City

Penza

ZIP/Postal Code

440026

Country

Russian Federation

Facility Name

City Hospital 26

City

St. Petersburg

ZIP/Postal Code

196247

Country

Russian Federation

Facility Name

Narodny ustav reumatickych chorob

City

Piestany

ZIP/Postal Code

921 12

Country

Slovakia

Facility Name

MUDr. Zuzana Cizmarikova, s.r.o.

City

Poprad,Spisska Sobota

ZIP/Postal Code

058 01

Country

Slovakia

Facility Name

REUMEX s.r.o.

City

Rimavska Sobota

ZIP/Postal Code

979 01

Country

Slovakia

Facility Name

Hospital Universitario a Coruna

City

A Coruña

ZIP/Postal Code

15006

Country

Spain

Facility Name

Hospital de Basurto-Osakidetza

City

Bilbao

ZIP/Postal Code

48013

Country

Spain

Facility Name

Hospital Universitario Reina Sofia

City

Córdoba

ZIP/Postal Code

14004

Country

Spain

Facility Name

Hospital Universitario Central de Asturias

City

Oviedo

ZIP/Postal Code

33006

Country

Spain

Facility Name

Hospital Infanta Sofia

City

San Sebastian de los Reyes

ZIP/Postal Code

28702

Country

Spain

Facility Name

HFR Fribourg - Hôpital Cantonal

City

Fribourg

ZIP/Postal Code

1708

Country

Switzerland

Facility Name

Chuv Bh-04

City

Lausanne

ZIP/Postal Code

1011

Country

Switzerland

Facility Name

Kantonsspital St. Gallen

City

St. Gallen

ZIP/Postal Code

9007

Country

Switzerland

Facility Name

Haywood Hospital

City

Burslem

ZIP/Postal Code

ST6 7AG

Country

United Kingdom

Facility Name

Southampton General Hospital

City

Southampton

ZIP/Postal Code

SO16 6YD

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

26792812

Citation

Edwards CJ, Blanco FJ, Crowley J, Birbara CA, Jaworski J, Aelion J, Stevens RM, Vessey A, Zhan X, Bird P. Apremilast, an oral phosphodiesterase 4 inhibitor, in patients with psoriatic arthritis and current skin involvement: a phase III, randomised, controlled trial (PALACE 3). Ann Rheum Dis. 2016 Jun;75(6):1065-73. doi: 10.1136/annrheumdis-2015-207963. Epub 2016 Jan 20.

Results Reference

result

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

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