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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01212757
Other study ID # CC-10004-PSA-003
Secondary ID 2010-018386-32
Status Completed
Phase Phase 3
First received
Last updated
Start date September 27, 2010
Est. completion date January 25, 2017

Study information

Verified date April 2020
Source Amgen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether apremilast is safe and effective in the treatment of patients with psoriatic arthritis.

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 488
Est. completion date January 25, 2017
Est. primary completion date July 26, 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Males or females, aged = 18 years at time of consent.

- Have a diagnosis of Psoriatic Arthritis (PsA, by any criteria) of = 6 months duration.

- Meet the Classification Criteria for Psoriatic Arthritis (CASPAR) PsA at time of screening.

- Must have been inadequately treated by disease-modifying antirheumatic drugs (DMARDs)

- May not have axial involvement alone

- Concurrent Treatment allowed with methotrexate, leflunomide, or sulfasalazine

- Have = 3 swollen AND = 3 tender joints.

- Males & Females must use contraception

- Stable dose of nonsteroidal anti-inflammatory drugs (NSAIDs), narcotics and low dose oral corticosteroids allowed.

Exclusion Criteria:

- Pregnant or breast feeding.

- History of allergy to any component of the investigational product.

- Hepatitis B surface antigen and/or Hepatitis C antibody positive at screening.

- Therapeutic failure on > 3 agents for PsA or > 1 biologic tumor necrosis factor (TNF) blocker

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Apremilast 20mg
Apremilast 20 mg twice daily, orally
Apremilast 30mg
Apremilast 30 mg twice daily, orally
Placebo + 20 mg Apremilast
Placebo + 20 mg Apremilast
Placebo + 30 mg Apremilast
Placebo + 30 mg Apremilast

Locations

Country Name City State
Belgium CHU Brugmann Bruxelles
Belgium UZ Gent Ghent
Belgium UZ Leuven Leuven
Belgium University Hospital of Liege CHU Liege Liège
Bulgaria 17 Diagnostic and Consulting Centre Sofia EOOD Sofia
Bulgaria Diagnostic and Consulting Centre 7 Sofia
Bulgaria Diagnostic-Consultative Center Sveta Anna Sofia
Bulgaria Multiprofile Hospital for Active Treatment Sv. Ivan Rilski Sofia
Bulgaria University Multiprofile Hospital for Active Treatment ACIBADEM City Clinic Sofia Sofia
Bulgaria Diagnostic and Consulting Centre 4 Varna
Canada Anna Jaroszynska Private Practice Burlington Ontario
Canada Rheumatology Research Associates Edmonton Alberta
Canada William Bensen's Private Practice Hamilton Ontario
Canada North Bay Dermatology Center North Bay Ontario
Canada Rheumatology Research Associates Ottawa Ontario
Canada Wilderman Medical Clinic Thornhill Ontario
Canada PerCuro Clinical Research Victoria British Columbia
Canada Darryl Toth's Private Practice Windsor Ontario
Czechia Revmatologie s.r.o. Brno
Czechia MEDIPONT PLUS s.r.o.. Ceske Budejovice
Czechia L.K.N. Arthrocentrum s.r.o. Hlucin
Czechia ARTMEDI UPD s.r.o. Hostivice
Czechia Affidea Praha s.r.o Praha 11
Czechia Revmatologicky ustav Praha 2
Czechia Revmatologicka Ambulance Praha 4
Czechia Revmatologicka Ambulance Sokolov
Czechia PV - MEDICAL, s.r.o. Zlin
Estonia Parnu Hospital Pärnu
Estonia East Tallinn Central Hospital Tallinn
Estonia North Estonia Regional Hospital Tallinn
Estonia Clinical Research Centre Ltd Tartu
Estonia Tartu University Hospital Tartu
France Hopital Universitaire Dupuytren Limoges
France Fondation Hôpital Saint-Joseph Paris
France Groupe Hospitalier Pitié- Salpétrière Paris
France Hopital Lariboisiere Paris
France Centre Hospitalier Lyon Sud Pierre Benite
Germany Charite - Universitätsmedizin Berlin Berlin
Germany Klinikum der Johann-Wolfgang Goethe-Universität Frankfurt
Germany Praxis Karin Rockwitz Goslar
Germany Synexus Clinical Research GmbH Leipzig
Hungary Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum Debrecen
Hungary Pest Megyei Flor Ferenc Korhaz Kistarcsa
Hungary Principal SMO Kft. Makó
Italy Azienda Ospedaliera Universitaria San Martino Genova
Italy Ospedale Luigi Sacco Milano
Italy Seconda Universita degli Studi di Napoli Napoli
Italy IRCCS Policlinico San Matteo Pavia
Italy Universita di Pisa Pisa
Italy Ospedale Civile Maggiore Borgo Trento Verona
Poland NZOZ Osteo-Medic sc A. Racewicz J. Supronik Bialystok
Poland Niepubliczny Zaklad Opieki Zdrowotnej REUMED Lublin
Poland Instytut Reumatologii im. prof. dr hab. med. Eleonory Reicher Warsaw
Poland Wojskowy Instytut Medyczny Warszawa
Poland Synexus SCM Sp. z o.o. Wroclaw
Russian Federation City Clinical Hospital #1 n.a. N.I.Pirogov Moscow
Russian Federation City Clinical Hospital #5 Nizhniy Novgorod
Russian Federation St.Petersburg State Medical Academy n. a. I.I.Mechnikov St. Petersburg
Russian Federation Yaroslavl Regional Clinical Hospital Yaroslavl
South Africa Nelson Mandela School Of Medicine Durban
South Africa Greenacres Hospital Port Elizabeth
South Africa Jacaranda Hospital Pretoria
Spain Hospital Universitario de Canarias La Laguna
Spain Hospital General Carlos Haya Málaga
Spain Hospital Sierrallana Torrelavega
Taiwan Chung Shan Medical University Hospital Taichung
Taiwan Taichung Veterans General Hospital Taichung
Taiwan Cathay General Hospital Taipei
Taiwan Taipei Veterans General Hospital Taipei
Taiwan National Taiwan University Hospital Tapei
United Kingdom Basingstoke and North Hampshire Hospital Basingstoke
United Kingdom Cannock Chase Hospital Cannock
United Kingdom Chapel Allerton Hospital Leeds
United Kingdom Poole Hospital Poole
United Kingdom Great Western Hospital Swindon
United States Michael Bukhalo MD SC Arlington Hts Illinois
United States Arthritis and Rheumatology of Georgia Atlanta Georgia
United States Associated Internal Medical Specialist, PC Battle Creek Michigan
United States Arthritis Care and Diagnostic Center Dallas Texas
United States Baylor Research Institute Dallas Texas
United States Metroplex Clinical Research Center Dallas Texas
United States Denver Arthritis Clinic Denver Colorado
United States Centre For Rheumatology, Immun. And Arthritis Fort Lauderdale Florida
United States Rheumatology and Immunotherapy Center Franklin Wisconsin
United States Vital Research Greensboro North Carolina
United States Unifour Medical Research Associatets LLC Hickory North Carolina
United States Research West Incorporated Kalispell Montana
United States Advanced Rheumatology Lansing Michigan
United States Mayo Clinic Rochester Minnesota
United States University of Rochester Medical Center Rochester New York
United States DMI Research Saint Petersburg Florida
United States Luckster Enterprises San Antonio Texas
United States Seattle Rheumatology Associates Seattle Washington
United States Tacoma Center for Arthritis Research, PS Tacoma Washington
United States University of South Florida Tampa Florida
United States New England Research Associates, LLC Trumbull Connecticut
United States Clinical and Translational Research Center of Alabama, PC Tuscaloosa Alabama
United States Rheumatic Disease Associates Willow Grove Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Belgium,  Bulgaria,  Canada,  Czechia,  Estonia,  France,  Germany,  Hungary,  Italy,  Poland,  Russian Federation,  South Africa,  Spain,  Taiwan,  United Kingdom, 

References & Publications (1)

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

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 16 Percentage of participants with an ACR20 response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • = 20% improvement in 78 tender joint count; • = 20% improvement in 76 swollen joint count; and • = 20% improvement in at least 3 of the 5 following parameters: ?Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); ?Patient's global assessment of disease activity (measured on a 100 mm VAS); ?Physician's global assessment of disease activity (measured on a 100 mm VAS); ?Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); ?C-Reactive Protein. Baseline and Week 16
Secondary 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. Baseline and Week 16
Secondary Percentage of Participants With an ACR 20 Response at Week 24 Percentage of participants with an American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • = 20% improvement in 78 tender joint count; • = 20% improvement in 76 swollen joint count; and • = 20% improvement in at least 3 of the 5 following parameters: ?Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); ?Patient's global assessment of disease activity (measured on a 100 mm VAS); ?Physician's global assessment of disease activity (measured on a 100 mm VAS); ?Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); ?C-Reactive Protein. Baseline and Week 24
Secondary Change From Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) at Week 24 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. Baseline and Week 24
Secondary 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. Baseline and Week 16
Secondary 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. Baseline and Week 16
Secondary 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. Baseline and Week 16
Secondary 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. Baseline and Week 16
Secondary Change From Baseline in Dactylitis Severity Score at Week 16 Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet will be rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present. Baseline and Week 16
Secondary 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. Baseline and Week 16
Secondary 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. Baseline and Week 16
Secondary 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. Baseline and Week 16
Secondary Change From Baseline in 36-item Short Form Health Survey (SF-36) Physical Functioning Domain at Week 24 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. Baseline and Week 24
Secondary 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. Baseline and Week 24
Secondary Change From Baseline in Patient's Assessment of Pain at Week 24 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. Baseline and Week 24
Secondary Change From Baseline in Maastricht Ankylosing Spondylitis Entheses Score (MASES) at Week 24 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. Baseline and Week 24
Secondary 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 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. Baseline and Week 24
Secondary 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. Baseline and Week 24
Secondary 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. Baseline and Week 24
Secondary Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 24 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. Baseline and Week 24
Secondary 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. Baseline and Week 16
Secondary Percentage of Participants With Dactylitis Improvement = 1 Point at Week 16 Percentage of participants with pre-existing dactylitis whose dactylitis severity score improved by = 1 after 16 weeks of treatment. Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present. Baseline and Week 16
Secondary 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. Baseline and Week 16
Secondary 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. Baseline and Week 24
Secondary Percentage of Participants With Dactylitis Improvement = 1 Point at Week 24 Percentage of participants with pre-existing dactylitis whose dactylitis severity score improved by = 1 after 24 weeks of treatment. Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present. Baseline and Week 24
Secondary 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. Baseline and Week 24
Secondary Percentage of Participants With a ACR 50 Response at Week 16 Percentage of participants with an American College of Rheumatology 50% (ACR50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • = 50% improvement in 78 tender joint count; • = 50% improvement in 76 swollen joint count; and • = 50% improvement in at least 3 of the 5 following parameters: o Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); o Patient's global assessment of disease activity (measured on a 100 mm VAS); o Physician's global assessment of disease activity (measured on a 100 mm VAS); o Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); o C-Reactive Protein. Baseline and Week 16
Secondary Percentage of Participants With an ACR 70 Response at Week 16 Percentage of participants with an American College of Rheumatology 70% (ACR70) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • = 70% improvement in 78 tender joint count; • = 70% improvement in 76 swollen joint count; and • = 70% improvement in at least 3 of the 5 following parameters: o Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); o Patient's global assessment of disease activity (measured on a 100 mm VAS); o Physician's global assessment of disease activity (measured on a 100 mm VAS); o Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); o C-Reactive Protein. Baseline and Week 16
Secondary Percentage of Participants With an ACR 50 Response at Week 24 Percentage of participants with an American College of Rheumatology 50% (ACR50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • = 50% improvement in 78 tender joint count; • = 50% improvement in 76 swollen joint count; and • = 50% improvement in at least 3 of the 5 following parameters: o Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); o Patient's global assessment of disease activity (measured on a 100 mm VAS); o Physician's global assessment of disease activity (measured on a 100 mm VAS); o Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); o C-Reactive Protein. Baseline and Week 24
Secondary Percentage of Participants With a ACR 70 Response at Week 24 Percentage of participants with an American College of Rheumatology 70% (ACR70) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • = 70% improvement in 78 tender joint count; • = 70% improvement in 76 swollen joint count; and • = 70% improvement in at least 3 of the 5 following parameters: ? Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); ? Patient's global assessment of disease activity (measured on a 100 mm VAS); ? Physician's global assessment of disease activity (measured on a 100 mm VAS); ? Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); ?C-Reactive Protein. Baseline and Week 24
Secondary 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. Week 16
Secondary Percentage of Participants Achieving a Dactylitis Score of Zero at Week 16 Percentage of participants with pre-existing dactylitis whose dactylitis severity score improves to zero after 16 weeks of treatment. Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present. Week 16
Secondary 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. Week 24
Secondary Percentage of Participants Achieving a Dactylitis Score of Zero at Week 24 Percentage of participants with pre-existing dactylitis whose dactylitis severity score improves to zero after 24 weeks of treatment. Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present. Week 24
Secondary Percentage of Participants With a ACR 20 Response at Week 52 Percentage of participants with an American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • = 20% improvement in 78 tender joint count; • = 20% improvement in 76 swollen joint count; and • = 20% improvement in at least 3 of the 5 following parameters: ?Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); ?Patient's global assessment of disease activity (measured on a 100 mm VAS); ?Physician's global assessment of disease activity (measured on a 100 mm VAS); ?Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); ?C-Reactive Protein. Two-sided 95% confidence interval is based on the Clopper-Pearson method. Baseline and Week 52
Secondary Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Week 52 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. Baseline and Week 52
Secondary Change From Baseline in the SF-36 Physical Functioning Scale Score at Week 52 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. Baseline and Week 52
Secondary Percentage of Participants With a Modified PsARC Response at Week 52 Modified PsARC response is defined as improvement in at least 2 of the 4 measures, at least one of which must be tender joint count or swollen joint count, and no worsening in any of the 4 measures: • 78 tender joint count, • 76 swollen joint count, • Patient global assessment of disease activity, measured on a 100 mm visual Analog scale (VAS), where 0 mm = lowest disease activity and 100 mm = highest; • Physician global assessment of disease activity, measured on a 100 mm VAS, where 0 mm = lowest disease activity and 100 mm = highest. Improvement or worsening in joint counts is defined as decrease or increase, respectively, from baseline by = 30%, and improvement or worsening in global assessments is defined as decrease or increase, respectively, from baseline by = 20 mm VAS. Two-sided 95% confidence interval is based on the Clopper-Pearson method. Baseline and Week 52
Secondary Change From Baseline in the Patient Assessment of Pain at Week 52 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. Baseline and Week 52
Secondary Change From Baseline in Maastricht Ankylosing Spondylitis Entheses Score (MASES) at Week 52 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. Baseline and Week 52
Secondary Change From Baseline in the Dactylitis Severity Score at Week 52 Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet will be rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present. Baseline and Week 52
Secondary 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. Baseline and Week 52
Secondary 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. Baseline and Week 52
Secondary Change From Baseline in the FACIT-Fatigue Scale Score at Week 52 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. Baseline and Week 52
Secondary 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. Baseline and Week 52
Secondary Percentage of Participants With Dactylitis Improvement = 1 Point at Week 52 Percentage of participants with pre-existing dactylitis whose dactylitis severity score improved by = 1 after 52 weeks. Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present. Two-sided 95% confidence interval is based on the Clopper-Pearson method. Baseline and Week 52
Secondary Percentage of Participants Achieving Good or Moderate EULAR Response at Week 52 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. Baseline and Week 52
Secondary Percentage of Participants With an ACR 50 Response at Week 52 Percentage of participants with an American College of Rheumatology 50% (ACR50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • = 50% improvement in 78 tender joint count; • = 50% improvement in 76 swollen joint count; and • = 50% improvement in at least 3 of the 5 following parameters: ? Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); ? Patient's global assessment of disease activity (measured on a 100 mm VAS); ? Physician's global assessment of disease activity (measured on a 100 mm VAS); ? Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); ?C-Reactive Protein. Two-sided 95% confidence interval is based on the Clopper-Pearson method. Baseline and Week 52
Secondary Percentage of Participants With an ACR 70 Response at Week 52 Percentage of participants with an American College of Rheumatology 70% (ACR70) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • = 70% improvement in 78 tender joint count; • = 70% improvement in 76 swollen joint count; and • = 70% improvement in at least 3 of the 5 following parameters: ? Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); ? Patient's global assessment of disease activity (measured on a 100 mm VAS); ? Physician's global assessment of disease activity (measured on a 100 mm VAS); ? Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); ? C-Reactive Protein. Two-sided 95% confidence interval is based on the Clopper-Pearson method. Baseline and Week 52
Secondary 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. Week 52
Secondary Percentage of Participants Achieving a Dactylitis Score of Zero at Week 52 Percentage of participants with pre-existing dactylitis whose dactylitis severity score improves to zero after 52 weeks. Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present. Two-sided 95% confidence interval is based on the Clopper-Pearson method. Week 52
Secondary Number of Participants With Treatment Emergent Adverse Events During the Placebo-Controlled Phase A treatment emergent adverse event (TEAE) is an AE with a start date on or after the date of the first dose of Investigational Product (IP). The severity of each adverse event (AE) and serious AE (SAE) was assessed by the investigator and graded based on a scale from Mild - mild symptoms to Severe AEs (non-serious or serious). A serious adverse event (SAE) is any AE which:
Resulted in death
Was life-threatening
Required inpatient hospitalization or prolongation of existing hospitalization
Resulted in persistent or significant disability/incapacity
Was a congenital anomaly/birth defect
Constituted an important medical event
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)
Secondary Number of Participants With TEAEs During the Apremilast-Exposure 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). The severity of each adverse event (AE) and serious AE (SAE) was assessed by the investigator and graded based on a scale from Mild - mild symptoms to Severe AEs (non-serious or serious). A serious adverse event (SAE) is any AE which:
Resulted in death
Was life-threatening
Required inpatient hospitalization or prolongation of existing hospitalization
Resulted in persistent or significant disability/incapacity
Was a congenital anomaly/birth defect
Constituted an important medical event
Week 0 to week 260; overall median duration of exposure to apremilast 20 mg and 30 mg BID was 198 weeks
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