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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01212770
Other study ID # CC-10004-PSA-004
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date September 30, 2010
Est. completion date February 9, 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 and a qualifying psoriasis lesion.

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


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 505
Est. completion date February 9, 2017
Est. primary completion date August 21, 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) criteria for PsA at time of screening.

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

- May not have axial involvement alone

- Concurrent Tx allowed with methotrexate, leflunomide, or sulfasalazine

- Have = 3 swollen AND = 3 tender joints.

- Males & Females must use contraception

- Stable dose of NSAIDs, narcotics and low dose oral corticosteroids allowed.

- Have at least one =2 cm psoriasis lesion

Exclusion Criteria:

- Pregnant or breast feeding.

- History of allergy to any component of the investigational product Hepatitis B surface antigen and/or Hepatitis C antibody positive at screening.

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

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


Locations

Country Name City State
Australia Royal Prince Alfred Hospital Camperdown
Australia Skin Cancer Foundation Carlton
Australia Coff's Clinical Trials Coffs Harbour
Australia Heidelberg Repatriation Hospital Heidelberg
Australia Menzies Centre for Population Health Research Hobart
Australia Optimus Clinical Research Pty. Ltd Kogarah
Australia Coastal Joint Care Maroochydore
Australia The Queen Elizabeth Hospital Woodville
Canada Niagara Peninsula Arthritis Centre Inc. St Catharines Ontario
Canada Alpha Clinical Research, LLC St John's Newfoundland and Labrador
Canada Manna Research Toronto Ontario
Canada Arthritis Research Centre of Canada Vancouver British Columbia
Canada PerCuro Clinical Research Victoria British Columbia
Canada Arthritis Centre Winnipeg Manitoba
Canada Manitoba Clinic Winnipeg Manitoba
Finland Helsingin Reumakeskus Oy Helsinki
Finland Helsingin yliopistollinen keskussairaala Helsinki
Finland Finnish Medical Research Co Pori
France Centre Hospitalier Sud Francilien - Site Gilles de Corbeil Corbeil Essonnes
France Hôtel-Dieu Nantes
France Groupe Hospitalier Archet I et II Nice
France Hopital Larrey Universite Paul Sabatier Toulouse
Germany Charite - Universitätsmedizin Berlin Berlin
Germany Klinische Forschung Berlin - Buch GmbH Berlin
Germany Klinikum der Friedrich-Schiller-Universität Jena Jena
Germany Universitätsmedizin der Johannes Gutenberg-Universität Mainz Mainz
Italy Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi Bologna
Italy Fondazione PTV Policlinico Tor Vergata Roma
Korea, Republic of Hallym University Sacred Heart Hospital Anyang, Kyunggi
Korea, Republic of Chungnam National University Hospital DaeJeon
Korea, Republic of Gachon University Gil Medical Center Incheon
Korea, Republic of Inha University Hosiptal Incheon
Korea, Republic of Seoul National University Hospital Seoul
Korea, Republic of Severance Hospital Seoul
Korea, Republic of Ajou University Hospital Suwon
Lithuania Hospital of Lithuanian University Health and Sciences Kaunas
Lithuania Klaipeda University Hospital Klaipeda
Lithuania Panevezys Hospital Panevezys
Lithuania Siauliai Hospital Siauliai
Poland Gabinet Internistyczno-Reumatologiczny Piotr Adrian Klimiuk Bialystok
Poland Centrum Medyczne Silesiana Sp. z o.o. Bytom
Poland Malopolskie Centrum Medyczne S.C. Kraków
Poland Prywatna Praktyka Lekarska Pawel Hrycaj Poznan
Poland REUMATIKA-Centrum Reumatologii Niepubliczny Zaklad Opieki Zdrowotnej Warszawa
Romania Baia Mare, Emergency County Hospital "Dr. Constantin Opris" Baia Mare
Romania SC Duo Medical SRL Bucharest
Romania Sf. Maria Clinical Hospital Bucharest
Romania Emergency County Clinical Hospital Cluj-Napoca
Romania Sf Apostol Andrei Emergency Clinical County Hospital Galati
Romania C.M.I. Dr. Ciornohuz Adriana Iasi
Russian Federation Sverdlovsk Regional Clinical Hospital 1 Ekaterinburg
Russian Federation Research Medical Complex Vashe Zdorovie Kezch
Russian Federation Research Institute of Clinical and Experimental Lymphology Novosibirsk
Russian Federation Penza Regional Clinical Hospital n.a. N.N. Burdenko Penza
Russian Federation City Hospital 26 St. Petersburg
Slovakia Narodny ustav reumatickych chorob Piestany
Slovakia MUDr. Zuzana Cizmarikova, s.r.o. Poprad,Spisska Sobota
Slovakia REUMEX s.r.o. Rimavska Sobota
Spain Hospital Universitario a Coruna A Coruña
Spain Hospital de Basurto-Osakidetza Bilbao
Spain Hospital Universitario Reina Sofia Córdoba
Spain Hospital Universitario Central de Asturias Oviedo
Spain Hospital Infanta Sofia San Sebastian de los Reyes
Switzerland HFR Fribourg - Hôpital Cantonal Fribourg
Switzerland Chuv Bh-04 Lausanne
Switzerland Kantonsspital St. Gallen St. Gallen
United Kingdom Haywood Hospital Burslem
United Kingdom Southampton General Hospital Southampton
United States Austin Dermatology Associates Austin Texas
United States Austin Regional Clinic Austin Texas
United States Bakersfield Dermatology and Skin Cancer Medical Group Bakersfield California
United States University of Alabama at Birmingham Birmingham Alabama
United States Joao Nascimento, MD Bridgeport Connecticut
United States STAT Research, Inc. Dayton Ohio
United States In Vivo Clinical Research Doral Florida
United States Duke University Medical Center Durham North Carolina
United States Center for Clinical Studies Houston Texas
United States Houston Medical Research Houston Texas
United States Dawes Fretzin Clinical Research Group, LLC Indianapolis Indiana
United States West Tennessee Research Institute Jackson Tennessee
United States Dermatology Research Associates Los Angeles California
United States DermResearch, PLLC Louisville Kentucky
United States Suncoast Clinical Research New Port Richey Florida
United States Rheumatology Associates of Long Island Orlando Florida
United States Desert Medical Advances Palm Desert California
United States Elite Clinical Studies, LLC Phoenix Arizona
United States Advent Clinical Research Pinellas Park Florida
United States Rockford Orthopedic Associates, LLC Rockford Illinois
United States Texas Research Center Sugar Land Texas
United States Catalina Pointe Clinical Research Incorporated Tucson Arizona
United States Clinical Pharmacology Study Group Worcester Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Finland,  France,  Germany,  Italy,  Korea, Republic of,  Lithuania,  Poland,  Romania,  Russian Federation,  Slovakia,  Spain,  Switzerland,  United Kingdom, 

References & Publications (1)

Edwards CJ, Blanco FJ, Crowley J, Birbara CA, Jaworski J, Aelion J, Stevens RM, Vessey A, Zhan X, Bird P. Apremilast, an oral phosphodiesterase 4 inhibitor, in patients with psoriatic arthritis and current skin involvement: a phase III, randomised, contro — 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 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 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 Percentage of Participants Achieving a = 75% Improvement in Psoriasis Area and Severity Index Score (PASI75) at Week 16 The percentage of participants with Baseline psoriasis body surface area (BSA) involvement = 3% who achieved 75% or greater improvement from Baseline in Psoriasis Area and Severity Index (PASI) score after 16 weeks of treatment. The Psoriasis Area and Severity Index (PASI) score is a combination of the intensity of psoriasis, assessed by erythema (reddening), induration (plaque thickness) and desquamation (scaling) scored on a scale from 0 (none) to 4 (very severe), together with the percentage of the area affected, rated on a scale from 0 (no involvement) to 6 (90% to 100% involvement). PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease. 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 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. 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. 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 Percentage of Participants Achieving a = 75% Improvement in Psoriasis Area and Severity Index Score (PASI75) at Week 24 The percentage of participants with Baseline psoriasis body surface area (BSA) involvement = 3% who achieved 75% or greater improvement from Baseline in Psoriasis Area and Severity Index (PASI) score after 24 weeks of treatment. The Psoriasis Area and Severity Index (PASI) score is a combination of the intensity of psoriasis, assessed by erythema (reddening), induration (plaque thickness) and desquamation (scaling) scored on a scale from 0 (none) to 4 (very severe), together with the percentage of the area affected, rated on a scale from 0 (no involvement) to 6 (90% to 100% involvement). PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease. 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 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. 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 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. 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 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. 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: ? 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 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. 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: ? 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 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 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. 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 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. Week 24
Secondary Percentage of Participants With an 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 Percentage of Participants Achieving a = 75% Improvement in Psoriasis Area and Severity Index Score (PASI75) at Week 52 The percentage of participants with Baseline psoriasis body surface area (BSA) involvement = 3% who achieved 75% or greater improvement from Baseline in Psoriasis Area and Severity Index (PASI) score after 52 weeks. The Psoriasis Area and Severity Index (PASI) score is a combination of the intensity of psoriasis, assessed by erythema (reddening), induration (plaque thickness) and desquamation (scaling) scored on a scale from 0 (none) to 4 (very severe), together with the percentage of the area affected, rated on a scale from 0 (no involvement) to 6 (90% to 100% involvement). PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease. Two-sided 95% confidence interval is based on the Clopper-Pearson method. 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 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. 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 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. 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. Two-sided 95% confidence interval is based on the Clopper-Pearson method. 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 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. Week 52
Secondary Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Placebo-Controlled Phase A TEAE is an adverse event (AE) with a start date on or after the date of the first dose of investigational product (IP) and no later than 28 days after the last dose of IP. An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. A serious AE is any AE that results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or constitutes an important medical event. For both AEs and SAEs the investigator assessed the severity of the event according to the grading scale: Mild: asymptomatic or with mild symptoms, Moderate: symptoms causing moderate discomfort or Severe: symptoms causing severe discomfort or pain. 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 Treatment Emergent Adverse Events During the Apremilast Exposure Period A TEAE is an adverse event (AE) with a start date on or after the date of the first dose of investigational product (IP) and no later than 28 days after the last dose of IP. An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. A serious AE is any AE that results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or constitutes an important medical event. For both AEs and SAEs the investigator assessed the severity of the event according to the grading scale: Mild: asymptomatic or with mild symptoms, Moderate: symptoms causing moderate discomfort or Severe: symptoms causing severe discomfort or pain. Week 0 to Week 260; median duration of exposure to apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg BID
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