Efficacy and Safety Study of Apremilast to Treat Active Psoriatic Arthritis (PsA)

Psoriatic Arthritis Clinical Trial

— PALACE4  

Official title:

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Efficacy and Safety Study of Two Doses of Apremilast (CC-10004) in Subjects With Active Psoriatic Arthritis Who Have Not Been Previously Treated With Disease-modifying Antirheumatic Drugs

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01307423
• Other study ID #: CC-10004-PSA-005
• Secondary ID: 2010-020324-22
• Status: Completed
• Phase: Phase 3
• Start date: December 9, 2010
• Est. completion date: August 16, 2017

Study information

• Verified date: April 2020
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• 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 who have not been previously treated with DMARDs. 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: 529
• Est. completion date: August 16, 2017
• Est. primary completion date: February 21, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Subjects must satisfy the following criteria to be enrolled in the study:

1. Male or female, aged = 18 years at time of consent.

2. Must understand and voluntarily sign an informed consent document prior to any study related assessments/procedures being conducted.

3. Able to adhere to the study visit schedule and other protocol requirements.

4. Have a documented diagnosis of Psoriatic Arthritis (PsA, by any criteria) of = 3 months duration.

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

6. Have = 3 swollen AND = 3 tender joints.

7. Have not been previously treated with disease-modifying antirheumatic drugs (DMARDS) (small molecules or biologics)

8. Be receiving treatment on an outpatient basis.

9. If taking oral corticosteroids, must be on a stable dose of prednisone = 10 mg/day or equivalent for at least 1 month prior to screening.

10. If taking nonsteroidal anti-inflammatory drugs (NSAIDs) or narcotic analgesics, must be on stable dose for at least 2 weeks prior to screening and until they have completed the Week 24 study visit.

11. Low potency topical corticosteroids (Appendix M or locally available equivalent) will be allowed as background therapy for treatment of psoriasis on the face, axillae and groin in accordance with the manufacturers' suggested usage during the course of the study. Subjects with scalp psoriasis will be permitted to use coal tar shampoo and/or salicylic acid scalp preparations on scalp lesions. A non-medicated skin emollient (eg, Eucerin cream) will also be permitted for body lesions only. Subjects must not use these treatments within 24 hours prior to the clinic visit.

12. Meet the following laboratory criteria:

• White blood cell count = 3000/mm3 (= 3.0 x 109/L) and < 14,000/mm3 (< 14 x 109/L)
• Platelet count = 100,000/mm3 (= 100 x 109/L)
• Serum creatinine = 1.5 mg/dL(= 132.6 µmol/L)
• Aspartate aminotransferase/Serum glutamic oxaloacetic transaminase (AST/SGOT) and Alanine aminotransferase/Serum glutamic pyruvic transaminase (ALT/SGPT) = 2 x upper limit of normal (ULN)
• Total bilirubin = 2 mg/dL (= 34 µmol/L)
• Hemoglobin = 9 g/dL (= 5.6 mmol/L)
• Hemoglobin A1c = 9.0%

13. Male subjects (including those who have had a vasectomy) who engage in activity in which conception is possible must use barrier contraception (latex condom or any nonlatex condom NOT made out of natural [animal] membrane [eg, polyurethane]) while on IP and for at least 28 days after the last dose of IP.

14. Females of childbearing potential (FCBP) must have a negative pregnancy test at Screening and Baseline. FCBP who engage in activity in which conception is possible must use 2 forms of contraception while on investigational product (IP) and for at least 28 days after the last dose of IP: one highly effective form (ie, hormonal, intrauterine device [IUD], tubal ligation, vasectomized partner) and one additional form (latex condom or any nonlatex condom NOT made out of natural [animal] membrane [eg, polyurethane], diaphragm, sponge). If one highly effective form of contraception cannot be used, then 2 forms of barrier contraception must be used, ie, latex condom or any nonlatex condom NOT made out of natural (animal) membrane (eg, polyurethane) with either of the following: sponge with spermicide or diaphragm with spermicide.

Exclusion Criteria:

1. History of clinically significant (as determined by the Investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic disease, or other major uncontrolled disease.

2. Any condition, including the presence of laboratory abnormalities that places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.

3. Clinically significant abnormality on 12-lead electrocardiography (ECG) at Screening.

4. Pregnant or breast feeding.

5. History of allergy to any component of the IP.

6. Hepatitis B surface antigen positive at screening.

7. Hepatitis C antibody positive at screening.

8. AST/SGOT and/or ALT/SGPT > 1.5 x ULN and total bilirubin > ULN or albumin < lower limit of normal (LLN).

9. History of positive Human Immunodeficiency Virus (HIV), or congenital or acquired immunodeficiency (eg, Common Variable Immunodeficiency Disease).

10. Active tuberculosis or a history of incompletely treated tuberculosis.

11. Clinically significant abnormality based upon chest radiograph with at least PA view (radiograph must be taken within 12 weeks prior to Screening or during the Screening visit). An additional lateral view is strongly recommended but not required.

12. Active substance abuse or a history of substance abuse within 6 months prior to Screening.

13. Bacterial infections requiring treatment with oral or injectable antibiotics, or significant viral or fungal infections, within 4 weeks of Screening. Any treatment for such infections must have been completed at least 4 weeks prior to Screening.

14. Malignancy or history of malignancy (except for treated [ie, cured] basal cell or squamous cell in situ skin carcinomas and treated [ie, cured] cervical intraepithelial neoplasia [CIN] or carcinoma in situ of the cervix).

15. Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following randomization.

16. Erythrodermic, guttate, or pustular psoriasis.

17. Topical therapy for psoriasis, except as noted in the Inclusion Criteria, within 2 weeks of randomization (including but not limited to topical corticosteroids, topical retinoids or vitamin D analog preparations, tacrolimus, pimecrolimus, or anthralin).

18. Rheumatic autoimmune disease other than PsA, including systemic lupus erythematosis (SLE), mixed connective tissue disease (MCTD), scleroderma, or polymyositis.

19. Functional Class IV as defined by the ACR Classification of Functional Status in Rheumatoid Arthritis (Appendix Q).

20. Prior history of or current inflammatory joint disease other than PsA (eg, gout, reactive arthritis, RA, ankylosing spondylitis, Lyme disease).

21. Prior use of disease modifying antirheumatic drugs (DMARDS; small molecules or biologics).

22. Use of the following systemic therapy(ies) within 4 weeks of randomization, including but not limited to corticosteroids (except as noted in inclusion criteria), oral retinoids and fumaric acid esters.

23. Use of phototherapy within 4 weeks of randomization (ie, UVB, PUVA).

24. Previous treatment with any cell depleting therapies, including investigational agents (eg, rituximab, CAMPATH, anti-CD4, anti-CD5, anti-CD3, anti-CD19, and anti-CD20).

25. Treatment with intravenous gamma globulin, plasmapheresis, or Prosorba® column within 6 months of baseline.

26. Any previous treatment with alkylating agents such as cyclophosphamide or chlorambucil, or with total lymphoid irradiation.

27. Prior treatment with apremilast.

28. Use of any investigational drug within 4 weeks of randomization, or 5 pharmacokinetic/ pharmacodynamic half lives, if known (whichever is longer).

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Psoriatic Arthritis

Intervention

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

Locations

Country	Name	City	State
Australia	Eastern Health Clinical School	Box Hill
Australia	Monash Medical Centre	Clayton	Victoria
Australia	Repatriation General Hospital	Daws Park
Australia	Menzies Centre for Population Health Research	Hobart
Australia	Optimus Clinical Research Pty. Ltd	Kogarah
Australia	The Queen Elizabeth Hospital	Woodville
Belgium	UZ Leuven	Leuven
Belgium	CHU de Liege	Liège
Bulgaria	Multiprofile Hospital for Active Treatment Trimontsium	Plovdiv
Bulgaria	17 Diagnostic and Consulting Centre Sofia EOOD	Sofia
Bulgaria	Diagnostic-Consultative Center Sveta Anna	Sofia
Bulgaria	Multiprofile Hospital for Active Treatment Sv. Ivan Rilski	Sofia
Bulgaria	Diagnostic Consulting Center N4	Varna
Canada	Ultranova Skincare	Barrie	Ontario
Canada	William Bensen's Private Practice	Hamilton	Ontario
Canada	Rheumatology Research Associates	Ottawa	Ontario
Canada	Centre de Rhumatologie St-Louis	Sainte Foy	Quebec
Canada	Saskatoon Osteoporosis Centre	Saskatoon	Saskatchewan
Canada	St. Clare's Health Care Corporation of St. John's	St John's	Newfoundland and Labrador
Canada	Wilderman Medical Clinic	Thornhill	Ontario
Canada	Arthritis Research Centre of Canada	Vancouver	British Columbia
Canada	PerCuro Clinical Research	Victoria	British Columbia
Canada	Probity Medical Research Inc	Waterloo	Ontario
Canada	Darryl Toth's Private Practice	Windsor	Ontario
Canada	Manitoba Clinic	Winnipeg	Manitoba
Czechia	Affidea Praha s.r.o	Praha 11
Czechia	Revmatologicky ustav	Praha 2
Czechia	Revmatologicka Ambulance	Praha 4
Czechia	PV - MEDICAL, s.r.o.	Zlin
Estonia	East Tallinn Central Hospital	Tallinn
Estonia	North Estonia Regional Hospital	Tallinn
Estonia	Clinical Research Centre Ltd	Tartu
France	Hotel Dieu	Nantes Cedex 01
France	Groupe Hospitalier Archet I et II	Nice
France	Fondation Hôpital Saint-Joseph	Paris
France	Hopital Lariboisiere	Paris Cedex 10
Hungary	Honvéd Kórház - Állami Egészségügyi Központ	Budapest
Hungary	Qualiclinic kft	Budapest
Hungary	Synexus Magyarország Kft.	Budapest
Hungary	Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum	Debrecen
Hungary	Pest Megyei Flor Ferenc Korhaz	Kistarcsa
Hungary	Principal SMO Kft.	Mako
Hungary	MAV Korhaz es Rendelointezet Szolnok	Szolnok
Italy	Azienda Ospedaliera Universitaria San Martino	Genova
Italy	Ospedale Luigi Sacco	Milano
Italy	AOU della II Universita degli Studi di Napoli	Napoli
Italy	Fondazione PTV Policlinico Tor Vergata	Roma
Italy	Ospedale Civile Maggiore Borgo Trento	Verona
Korea, Republic of	Chungnam National University Hospital	DaeJeon
Korea, Republic of	Gachon University Gil Medical Center	Incheon
Korea, Republic of	Inha University Hosiptal	Incheon
Lithuania	Siauliai Hospital	Siauliai
New Zealand	Waikato hospital	Hamilton
New Zealand	North Shore Hospital	Takapuna
New Zealand	Timaru Hospital	Timaru
Poland	Bytomskie Centrum Medyczne Silesiana Sp. z o.o.	Bialystok
Poland	Szpital Uniwersytecki nr 2 im. Dr Jana Biziela w Bydgoszczy	Bydgoszcz
Poland	Centrum Medyczne Silesiana Sp. z o.o.	Bytom
Poland	Synexus SCM Sp. z o.o.	Gdynia
Poland	Synexus SCM Sp. z o.o.	Katowice
Poland	Niepubliczny Zaklad Opieki Zdrowotnej REUMED	Lublin
Poland	Prywatna Praktyka Lekarska	Poznan
Poland	REUMATIKA-Centrum Reumatologii Niepubliczny Zaklad Opieki Zdrowotnej	Warszawa
Poland	Synexus SCM Sp. z o.o. Oddz. Warszawa	Warszawa
Poland	Synexus SCM Sp. z o.o.	Wroclaw
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	Kemerovo State Medical Academy of Roszdrav	Kemerovo
Russian Federation	Veterans of Wars Regional Clinical Hospital	Kemerovo
Russian Federation	Research Medical Complex Vashe Zdorovie	Kezch
Russian Federation	Krasnoyarsk State Medical Academy	Krasnoyarsk
Russian Federation	City Clinical Hospital #5	Nizhniy Novgorod
Russian Federation	Research Institute of Clinical and Experimental Lymphology	Novosibirsk
Russian Federation	Research Institute of Clinical Immunology	Novosibirsk
Russian Federation	Penza Regional Clinical Hospital n.a. N.N. Burdenko	Penza
Russian Federation	Departmental Hospital at Smolensk Station RZhD JSC	Smolensk
Russian Federation	Tomsk Regional Clinical Hospital	Tomsk
Russian Federation	Regional Clinical Hospital	Vladimir
Russian Federation	Voronezh Regional Clinical Hopsital #1, Voronezh State Medical Academy	Voronezh
Taiwan	Taipei Veterans General Hospital	Taipei
Taiwan	National Taiwan University Hospital	Tapei
United Kingdom	Barnsley Hospital	Barnsley South Yorkshire
United Kingdom	Haywood Hospital	Burslem
United Kingdom	Cannock Chase Hospital	Cannock
United Kingdom	Poole Hospital	Poole
United Kingdom	Southampton General Hospital	Southampton
United States	Atlanta Dermatology, Vein and Research Center, PC	Alpharetta	Georgia
United States	Arthritis and Rheumatology of Georgia	Atlanta	Georgia
United States	Austin Regional Clinic	Austin	Texas
United States	Sonora Clinical Research, LLC	Boise	Idaho
United States	Klein and Associates MD, PA	Cumberland	Maryland
United States	In Vivo Clinical Research	Doral	Florida
United States	Altoona Center for Clinical Research	Duncansville	Pennsylvania
United States	Centre For Rheumatology, Immun. And Arthritis	Fort Lauderdale	Florida
United States	Rheumatology and Immunotherapy Center	Franklin	Wisconsin
United States	Physicians East	Greenville	North Carolina
United States	Klein and Associates MD, PA	Hagerstown	Maryland
United States	Unifour Medical Research Associatets LLC	Hickory	North Carolina
United States	Center for Clinical Studies	Houston	Texas
United States	Houston Medical Research	Houston	Texas
United States	Indiana. University	Indianapolis	Indiana
United States	West Tennessee Research Institute	Jackson	Tennessee
United States	North Florida Dermatology	Jacksonville	Florida
United States	Justus Fiechtner MD PC	Lansing	Michigan
United States	PharmaSeek	Middleton	Wisconsin
United States	Heartland Clinical Research, Inc.	Omaha	Nebraska
United States	Desert Medical Advances	Palm Desert	California
United States	Arizona Research Center	Phoenix	Arizona
United States	Rockford Orthopedic Associates, LLC	Rockford	Illinois
United States	Florida Center for Dermatology, PA	Saint Augustine	Florida
United States	Luckster Enterprises	San Antonio	Texas
United States	The Arthritis Center	Springfield	Illinois
United States	Tampa Medical Group Pa	Tampa	Florida
United States	Center for Clinical Studies	Webster	Texas
United States	Clinical Research Center of Reading, LLP	West Reading	Pennsylvania
United States	Clinical Pharmacology Study Group	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Bulgaria,  Canada,  Czechia,  Estonia,  France,  Hungary,  Italy,  Korea, Republic of,  Lithuania,  New Zealand,  Poland,  Romania,  Russian Federation,  Taiwan,  United Kingdom, 

References & Publications (1)

Mease PJ, Kavanaugh A, Ogdie A, Wells AF, Bergman M, Gladman DD, Richter S, Teng L, Jardon S, Smolen JS. Baseline Disease Activity Predicts Achievement of cDAPSA Treatment Targets With Apremilast: Phase III Results in DMARD-naïve Patients With Psoriatic Arthritis. J Rheumatol. 2022 Apr 15. pii: jrheum.210906. doi: 10.3899/jrheum.210906. [Epub ahead of print] — 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	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 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 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). SF-36 domain scores were first calculated to range from 0 to100 and then transformed to norm-based scores (the norm-based scores in the US general population have an average of 50 and a standard deviation of 10). Norm-based scores were used in analyses, with higher scores indicating 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=lowest disease activity and 100=highest; • Physician global assessment of disease activity, measured on a 100 mm VAS, where 0=lowest disease activity and 100=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 Achilles 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 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 to 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) After 16 Weeks of Treatment	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 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). SF-36 domain scores were first calculated to range from 0 to100 and then transformed to norm-based scores (the norm-based scores in the US general population have an average of 50 and a standard deviation of 10). Norm-based scores were used in analyses, with higher scores indicating 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=lowest disease activity and 100=highest; • Physician global assessment of disease activity, measured on a 100 mm VAS, where 0=lowest disease activity and 100=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 Participants 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 Achilles 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 Disease Activity Score (DAS 28) 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 = 20% Improvement in Maastricht Ankylosing Spondylitis Entheses Score 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 Achilles 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	The EULAR response criteria classify each subject as a good, moderate or non-responder to treatment based on the degree of improvement from baseline and the level of disease activity at the endpoint. EULAR response is derived using the individual subject's DAS28 as the measure of severity of disease. Good or moderate response is defined as follows: Good response: DAS28 at the time point = 3.2 and improvement from baseline > 1.2 Moderate response: DAS28 at the time point > 3.2 and improvement from baseline > 1.2, or DAS28 at the time point = 5.1 and improvement from baseline > 0.6 and = 1.2	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 Achilles 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	The EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on th DAS-28. Good or moderate response is defined as follows: Good response: DAS28 at the time point = 3.2 and improvement from baseline > 1.2 Moderate response: DAS28 at the time point > 3.2 and improvement from baseline > 1.2, or DAS28 at the time point = 5.1 and improvement from baseline > 0.6 and = 1.2 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 a 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 a 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 With Pre-existing Enthesopathy Whose Maastricht Ankylosing Spondylitis Entheses Score Improves to 0 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 Achilles 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 Pre-existing Dactylitis Whose Dactylitis Severity Score Improves to 0 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.	Baseline and 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 Achilles 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 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.	Baseline and 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 changes from Baseline in the overall score indicate improvement in functional ability.	Baseline and Week 52
Secondary	Change From Baseline in the SF-36v2 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	Measure Description: Modified PsARC response is defined as improvement in at least 2 of the 4 measures, at least one of which must be tender joint count or swollen joint count, and no worsening in any of the 4 measures: • 78 tender joint count, • 76 swollen joint count, • Patient global assessment of disease activity, measured on a 100 mm visual Analog scale (VAS), where 0=lowest disease activity and 100=highest; • Physician global assessment of disease activity, measured on a 100 mm VAS, where 0=lowest disease activity and 100=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 Participants Assessment of Pain Using the Visual Analog Scale 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 Achilles 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 Achilles 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 Pre-existing Dactylitis Whose Dactylitis Severity Score Improves From Baseline by = 1 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	The EULAR response criteria classify each subject as a good, moderate or non-responder to treatment based on the degree of improvement from baseline and the level of disease activity at the endpoint. EULAR response is derived using the individual subject's DAS28 as the measure of severity of disease. A Good response is defined as follows: Good response: DAS28 at the time point = 3.2 and improvement from baseline > 1.2 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: o 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	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 With Pre-existing Enthesopathy Whose MASES Improves From Baseline to 0 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 Achilles 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 was based on the Clopper-Pearson method.	Baseline and Week 52
Secondary	Percentage of Participants With Pre-existing Dactylitis Whose Dactylitis Severity Score Improves From Baseline to 0 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 and ranges from 0 to 20. Two-sided 95% confidence interval is based on the Clopper-Pearson method.	Baseline and Week 52
Secondary	Number of Participants With Treatment Emergent Adverse Events 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 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 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 168.93 weeks and 229.36 weeks for apremilast 30 mg BID