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Efficacy and Safety Study of Apremilast to Treat Active Psoriatic Arthritis (PALACE-1)

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 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) 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

Achieve Clinical Research LLC
Arizona Research Center
UCSD-Thornton Hospital
Stanford University Medical Center
Inland Rheumatology Clinical Trials
Arthritis and Rheumatic Disease Specialties
North Florida Dermatology
Tampa Medical Group Pa
Sonora Clinical Research, LLC
Coeur D'Alene Arthritis Clinic
The Arthritis Center
St. Francis Hospital and Health Centers
The Center for Rheumatology and Bone Research
Justus Fiechtner MD PC
Physicians East
Carolina Bone and Joint
Piedmont Medical Research Associates Inc
Health Research of Oklahoma
Altoona Center for Clinical Research
Clinical Research Center of Reading, LLP
Dermatology Treatment and Research Center
Accurate Clinical Research Inc
Arthritis and Osteoporosis Associates LLP
Center for Clinical Studies
University of Utah
Seattle Rheumatology Associates
Arthritis Northwest Rheumatology
Monash Medical Centre
Eastern Health Clinical School
Repatriation General Hospital
St Vincent's Hospital Melbourne
Emeritus Research
Ordination Wien Dr. Hanusch
Medizinische Universitat Wien
Kaiser-Franz-Josef Spital
Nexus Clinical Research
St. Clare's Health Care Corporation of St. John's
Ultranova Skincare
MAC Research Incorporated
K-W Musculoskeletal Research Inc.
Saint Josephs Healthcare System
Credit Valley Professional Building
The Arthritis Program Research Group Inc.
Toronto Western Hospital
Probity Medical Research Inc
Jude Rodrigues Private Practice
Hospital Maisonneuve - Rosemont
Institut de Rhumatologie de Montreal
Centre de Rhumatologie St-Louis
Centre Hospitalier Universitaire de Sherbrooke-Hospital Fleurimont
Saskatoon Osteoporosis Centre
Ipros - Chr Orleans
Hopital Purpan
Klinikum Duisburg, Wedau Kliniken
Friedrich-Alexander-Universiät Erlangen Nürnberg
Allgemeines Krankenhaus Eilbeck
Rheumazentrum Ruhrgebiet
Praxis Prof. Herbert Kellner
Qualiclinic kft
Synexus Magyarország Kft.
Honvéd Kórház - Állami Egészségügyi Központ
MAV Korhaz es Rendelointezet Szolnok
Veszprém Megyei Önkormányzat Csolnoky Ferenc Kórház-Rendelöintézet
P3 Research
Waikato hospital
Middlemore Clinical Trials
Queen Elizabeth Hospital for Rheumatic Disease
North Shore Hospital
Timaru Hospital
Szpital Uniwersytecki im. Dr A.Jurasza
Szpital Uniwersytecki nr 2 im. Dr Jana Biziela w Bydgoszczy
Synexus SCM Sp. z o.o.
Synexus SCM Sp. z o.o.
Wojewodzki Zespol Reumatologiczny
Synexus SCM Sp. z o.o. Oddz. Warszawa
Kemerovo State Medical Academy
Ryazan I.P. Pavlov State Medical University
Departmental Hospital at Smolensk Station RZhD JSC
Regional Clinical Hospital
Voronezh Regional Clinical Hopsital #1, Voronezh State Medical Academy
Panorama Medical Centre
Groote Schuur Hospital
Chelmsford Medical Centre 2
Clinresco Centres Pty Ltd
The Park
Hospital General Universitario Gregorio Maranon
Hospital Universitario La Paz
Hospital Universitario Marques de Valdecilla
Hospital Clinico Universitario de Santiago
Barnsley Hospital
Colchester General Hospital
West Suffolk Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

Apremilast 20 mg

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 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

Percentage of participants with an American College of Rheumatology 20% (ACR20) response at Week 24. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 20% improvement in 78 tender joint count; • ≥ 20% improvement in 76 swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); ◦ Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦ Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); ◦ C-Reactive Protein.

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 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 to 76 where lower scores indicate less disease activity. The following thresholds of disease activity have been defined for the CDAI: Remission: ≤ 2.8 Low Disease Activity: > 2.8 and ≤ 10 Moderate Disease Activity: > 10 and ≤ 22 High Disease Activity: > 22.

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 SF-36 Physical Function 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 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 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 Domain at Week 52

Percentage of Participants With a Modified PsARC Response at Week 52

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 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 Adverse Events During the Placebo-Controlled Period

A Treatment Emergent Adverse Event (TEAE) is an AE with a start date on or after the date of the first dose of Investigational Product (IP). An AE is any noxious, unintended, or untoward medical occurrence, that may appear or worsen in a participant during the course of study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) was considered an AE. A serious AE (SAE) is any untoward adverse event that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly or birth defect, or a condition that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above.

Number of Participants With Adverse Events During the Apremilast-Exposure Period

A TEAE is an AE with a start date on or after the date of the first dose of Investigational Product (IP) and no later than 28 days after the last dose of IP. An AE is any noxious, unintended, or untoward medical occurrence, that may appear or worsen in a participant during the course of study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) was considered an AE. A serious AE (SAE) is any untoward adverse event that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly or birth defect, or a condition that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above.

Full Information

NCT ID

NCT01172938

First Posted

July 6, 2010

Last Updated

June 18, 2020

Sponsor

Amgen

1. Study Identification

Unique Protocol Identification Number

NCT01172938

Brief Title

Efficacy and Safety Study of Apremilast to Treat Active Psoriatic Arthritis

Acronym

PALACE-1

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

June 2020

Overall Recruitment Status

Completed

Study Start Date

June 2, 2010 (Actual)

Primary Completion Date

April 27, 2012 (Actual)

Study Completion Date

October 27, 2016 (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, specifically in improving 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

504 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Apremilast 20 mg

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 SF-36 Physical Function 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

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 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 Domain 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

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

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 Adverse Events During the Placebo-Controlled Period

Description

Time Frame

Week 0 to Week 16 for placebo participants who entered early escape at Week 16 and up to Week 24 for all other participants (placebo participants who remained on placebo through week 24 and participants randomized to the APR 20 mg BID or APR 30 mg BID)

Title

Number of Participants With Adverse Events During the Apremilast-Exposure Period

Description

Time Frame

Baseline to Week 260; median total exposure to Apremilast was 170 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) 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

Achieve Clinical Research LLC

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35216

Country

United States

Facility Name

Arizona Research Center

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85023

Country

United States

Facility Name

UCSD-Thornton Hospital

City

La Jolla

State/Province

California

ZIP/Postal Code

92093-0943

Country

United States

Facility Name

Stanford University Medical Center

City

Palo Alto

State/Province

California

ZIP/Postal Code

94304-1808

Country

United States

Facility Name

Inland Rheumatology Clinical Trials

City

Upland

State/Province

California

ZIP/Postal Code

91786

Country

United States

Facility Name

Arthritis and Rheumatic Disease Specialties

City

Aventura

State/Province

Florida

ZIP/Postal Code

33180

Country

United States

Facility Name

North Florida Dermatology

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32204

Country

United States

Facility Name

Tampa Medical Group Pa

City

Tampa

State/Province

Florida

ZIP/Postal Code

33614

Country

United States

Facility Name

Sonora Clinical Research, LLC

City

Boise

State/Province

Idaho

ZIP/Postal Code

83702

Country

United States

Facility Name

Coeur D'Alene Arthritis Clinic

City

Coeur d'Alene

State/Province

Idaho

ZIP/Postal Code

83814

Country

United States

Facility Name

The Arthritis Center

City

Springfield

State/Province

Illinois

ZIP/Postal Code

62704

Country

United States

Facility Name

St. Francis Hospital and Health Centers

City

Michigan City

State/Province

Indiana

ZIP/Postal Code

46360

Country

United States

Facility Name

The Center for Rheumatology and Bone Research

City

Wheaton

State/Province

Maryland

ZIP/Postal Code

20902

Country

United States

Facility Name

Justus Fiechtner MD PC

City

Lansing

State/Province

Michigan

ZIP/Postal Code

48910

Country

United States

Facility Name

Physicians East

City

Greenville

State/Province

North Carolina

ZIP/Postal Code

27834

Country

United States

Facility Name

Carolina Bone and Joint

City

Monroe

State/Province

North Carolina

ZIP/Postal Code

28112

Country

United States

Facility Name

Piedmont Medical Research Associates Inc

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27103-3914

Country

United States

Facility Name

Health Research of Oklahoma

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73103

Country

United States

Facility Name

Altoona Center for Clinical Research

City

Duncansville

State/Province

Pennsylvania

ZIP/Postal Code

16635

Country

United States

Facility Name

Clinical Research Center of Reading, LLP

City

West Reading

State/Province

Pennsylvania

ZIP/Postal Code

19610

Country

United States

Facility Name

Dermatology Treatment and Research Center

City

Dallas

State/Province

Texas

ZIP/Postal Code

75230

Country

United States

Facility Name

Accurate Clinical Research Inc

City

Houston

State/Province

Texas

ZIP/Postal Code

77034

Country

United States

Facility Name

Arthritis and Osteoporosis Associates LLP

City

Lubbock

State/Province

Texas

ZIP/Postal Code

79424

Country

United States

Facility Name

Center for Clinical Studies

City

Webster

State/Province

Texas

ZIP/Postal Code

77598

Country

United States

Facility Name

University of Utah

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84132

Country

United States

Facility Name

Seattle Rheumatology Associates

City

Seattle

State/Province

Washington

ZIP/Postal Code

98104

Country

United States

Facility Name

Arthritis Northwest Rheumatology

City

Spokane

State/Province

Washington

ZIP/Postal Code

99204

Country

United States

Facility Name

Monash Medical Centre

City

Clayton

State/Province

Victoria

ZIP/Postal Code

3168

Country

Australia

Facility Name

Eastern Health Clinical School

City

Box Hill

ZIP/Postal Code

3128

Country

Australia

Facility Name

Repatriation General Hospital

City

Daws Park

ZIP/Postal Code

5041

Country

Australia

Facility Name

St Vincent's Hospital Melbourne

City

Fitzroy

ZIP/Postal Code

3065

Country

Australia

Facility Name

Emeritus Research

City

Malvern

ZIP/Postal Code

3145

Country

Australia

Facility Name

Ordination Wien Dr. Hanusch

City

Vienna

ZIP/Postal Code

1060

Country

Austria

Facility Name

Medizinische Universitat Wien

City

Vienna

ZIP/Postal Code

1090

Country

Austria

Facility Name

Kaiser-Franz-Josef Spital

City

Wien

ZIP/Postal Code

1100

Country

Austria

Facility Name

Nexus Clinical Research

City

St John's

State/Province

Newfoundland and Labrador

ZIP/Postal Code

A1A 5E8

Country

Canada

Facility Name

St. Clare's Health Care Corporation of St. John's

City

St John's

State/Province

Newfoundland and Labrador

ZIP/Postal Code

A1C-5B8

Country

Canada

Facility Name

Ultranova Skincare

City

Barrie

State/Province

Ontario

ZIP/Postal Code

L4M 6L2

Country

Canada

Facility Name

MAC Research Incorporated

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8N 2B6

Country

Canada

Facility Name

K-W Musculoskeletal Research Inc.

City

Kitchener

State/Province

Ontario

ZIP/Postal Code

N2M 5N6

Country

Canada

Facility Name

Saint Josephs Healthcare System

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 4V2

Country

Canada

Facility Name

Credit Valley Professional Building

City

Mississauga

State/Province

Ontario

ZIP/Postal Code

L5M 2V8

Country

Canada

Facility Name

The Arthritis Program Research Group Inc.

City

Newmarket

State/Province

Ontario

ZIP/Postal Code

L3Y 3R7

Country

Canada

Facility Name

Toronto Western Hospital

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5T 258

Country

Canada

Facility Name

Probity Medical Research Inc

City

Waterloo

State/Province

Ontario

ZIP/Postal Code

N2J 1C4

Country

Canada

Facility Name

Jude Rodrigues Private Practice

City

Windsor

State/Province

Ontario

ZIP/Postal Code

N8X 5A6

Country

Canada

Facility Name

Hospital Maisonneuve - Rosemont

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H1T 2M4

Country

Canada

Facility Name

Institut de Rhumatologie de Montreal

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H2L 1S6

Country

Canada

Facility Name

Centre de Rhumatologie St-Louis

City

Sainte Foy

State/Province

Quebec

ZIP/Postal Code

G1W 4R4

Country

Canada

Facility Name

Centre Hospitalier Universitaire de Sherbrooke-Hospital Fleurimont

City

Sherbrooke

State/Province

Quebec

ZIP/Postal Code

J1H5N4

Country

Canada

Facility Name

Saskatoon Osteoporosis Centre

City

Saskatoon

State/Province

Saskatchewan

ZIP/Postal Code

S7K 0H6

Country

Canada

Facility Name

Ipros - Chr Orleans

City

Orleans

ZIP/Postal Code

45067

Country

France

Facility Name

Hopital Purpan

City

Toulouse Cedex

ZIP/Postal Code

31009

Country

France

Facility Name

Klinikum Duisburg, Wedau Kliniken

City

Duisburg

ZIP/Postal Code

47055

Country

Germany

Facility Name

Friedrich-Alexander-Universiät Erlangen Nürnberg

City

Erlangen

ZIP/Postal Code

91054

Country

Germany

Facility Name

Allgemeines Krankenhaus Eilbeck

City

Hamburg

ZIP/Postal Code

22081

Country

Germany

Facility Name

Rheumazentrum Ruhrgebiet

City

Herne

ZIP/Postal Code

44652

Country

Germany

Facility Name

Praxis Prof. Herbert Kellner

City

München

ZIP/Postal Code

80639

Country

Germany

Facility Name

Qualiclinic kft

City

Budapest

ZIP/Postal Code

1036

Country

Hungary

Facility Name

Synexus Magyarország Kft.

City

Budapest

ZIP/Postal Code

1036

Country

Hungary

Facility Name

Honvéd Kórház - Állami Egészségügyi Központ

City

Budapest

ZIP/Postal Code

1062

Country

Hungary

Facility Name

MAV Korhaz es Rendelointezet Szolnok

City

Szolnok

ZIP/Postal Code

5000

Country

Hungary

Facility Name

Veszprém Megyei Önkormányzat Csolnoky Ferenc Kórház-Rendelöintézet

City

Veszprém

ZIP/Postal Code

8200

Country

Hungary

Facility Name

P3 Research

City

Crofton Downs

ZIP/Postal Code

6035

Country

New Zealand

Facility Name

Waikato hospital

City

Hamilton

ZIP/Postal Code

3204

Country

New Zealand

Facility Name

Middlemore Clinical Trials

City

New Zealand

ZIP/Postal Code

1640

Country

New Zealand

Facility Name

Queen Elizabeth Hospital for Rheumatic Disease

City

Rotorua

ZIP/Postal Code

3201

Country

New Zealand

Facility Name

North Shore Hospital

City

Takapuna

ZIP/Postal Code

1309

Country

New Zealand

Facility Name

Timaru Hospital

City

Timaru

ZIP/Postal Code

8601

Country

New Zealand

Facility Name

Szpital Uniwersytecki im. Dr A.Jurasza

City

Bydgoszcz

ZIP/Postal Code

85-096

Country

Poland

Facility Name

Szpital Uniwersytecki nr 2 im. Dr Jana Biziela w Bydgoszczy

City

Bydgoszcz

ZIP/Postal Code

85-168

Country

Poland

Facility Name

Synexus SCM Sp. z o.o.

City

Gdynia

ZIP/Postal Code

81-384

Country

Poland

Facility Name

Synexus SCM Sp. z o.o.

City

Katowice

ZIP/Postal Code

Poland

Country

Poland

Facility Name

Wojewodzki Zespol Reumatologiczny

City

Sopot

ZIP/Postal Code

81-759

Country

Poland

Facility Name

Synexus SCM Sp. z o.o. Oddz. Warszawa

City

Warszawa

ZIP/Postal Code

01-192

Country

Poland

Facility Name

Kemerovo State Medical Academy

City

Kemerovo

ZIP/Postal Code

650066

Country

Russian Federation

Facility Name

Ryazan I.P. Pavlov State Medical University

City

Ryazan

ZIP/Postal Code

390026

Country

Russian Federation

Facility Name

Departmental Hospital at Smolensk Station RZhD JSC

City

Smolensk

ZIP/Postal Code

214025

Country

Russian Federation

Facility Name

Regional Clinical Hospital

City

Vladimir

ZIP/Postal Code

600023

Country

Russian Federation

Facility Name

Voronezh Regional Clinical Hopsital #1, Voronezh State Medical Academy

City

Voronezh

ZIP/Postal Code

394066

Country

Russian Federation

Facility Name

Panorama Medical Centre

City

Cape Town

ZIP/Postal Code

7500

Country

South Africa

Facility Name

Groote Schuur Hospital

City

Cape Town

ZIP/Postal Code

7925

Country

South Africa

Facility Name

Chelmsford Medical Centre 2

City

Durban

ZIP/Postal Code

4001

Country

South Africa

Facility Name

Clinresco Centres Pty Ltd

City

Johannesburg

ZIP/Postal Code

1619

Country

South Africa

Facility Name

The Park

City

Pinelands

ZIP/Postal Code

7700

Country

South Africa

Facility Name

Hospital General Universitario Gregorio Maranon

City

Madrid

ZIP/Postal Code

28007

Country

Spain

Facility Name

Hospital Universitario La Paz

City

Madrid

ZIP/Postal Code

28046

Country

Spain

Facility Name

Hospital Universitario Marques de Valdecilla

City

Santander

ZIP/Postal Code

39008

Country

Spain

Facility Name

Hospital Clinico Universitario de Santiago

City

Santiago de Compostela

ZIP/Postal Code

15706

Country

Spain

Facility Name

Barnsley Hospital

City

Barnsley South Yorkshire

ZIP/Postal Code

S75 2EP

Country

United Kingdom

Facility Name

Colchester General Hospital

City

Colchester

ZIP/Postal Code

CO4 5JL

Country

United Kingdom

Facility Name

West Suffolk Hospital

City

Edmunds

ZIP/Postal Code

IP33 2QZ

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

25593233

Citation

Kavanaugh A, Mease PJ, Gomez-Reino JJ, Adebajo AO, Wollenhaupt J, Gladman DD, Hochfeld M, Teng LL, Schett G, Lespessailles E, Hall S. Longterm (52-week) results of a phase III randomized, controlled trial of apremilast in patients with psoriatic arthritis. J Rheumatol. 2015 Mar;42(3):479-88. doi: 10.3899/jrheum.140647. Epub 2015 Jan 15.

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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.

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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.

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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.

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30018799

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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.

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Kavanaugh A, Mease PJ, Gomez-Reino JJ, Adebajo AO, Wollenhaupt J, Gladman DD, Lespessailles E, Hall S, Hochfeld M, Hu C, Hough D, Stevens RM, Schett G. Treatment of psoriatic arthritis in a phase 3 randomised, placebo-controlled trial with apremilast, an oral phosphodiesterase 4 inhibitor. Ann Rheum Dis. 2014 Jun;73(6):1020-6. doi: 10.1136/annrheumdis-2013-205056. Epub 2014 Mar 4.

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Efficacy and Safety Study of Apremilast to Treat Active Psoriatic Arthritis

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