Clinical trial NCT01307423: Efficacy and Safety Study of Apremilast to Treat Active Psoriatic Arthritis (PsA)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriatic Arthritis
Keywords: psoriasis
Arthritis
Psoriatic Arthritis
inflammation
skin condition
inflammatory cells
apremilast
CC-10004
phosphodiesterase type 4
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2011-03-02
Enrollment: 529
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Psoriatic arthritis (PsA) is an inflammatory arthritis that occurs in 6-39% of psoriasis patients. The immunopathogenesis of PsA, which mirrors but is not identical to that seen in psoriatic plaques, reflects a complex interaction among resident dendritic, fibroblastic and endothelial cells, and inflammatory cells attracted to the synovium by cytokines and chemokines. Apremilast (CC-10004) is a novel oral agent that modulates multiple inflammatory pathways through targeted phosphodiesterase type 4 (PDE4) enzyme inhibition. Therefore, apremilast has the potential to be effective in the treatment of PsA.

Eligibility criteria: 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).

Primary outcomes:
measure: Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 16
timeFrame: Baseline and Week 16
Secondary outcomes:
measure: Change From Baseline in Health Assessment Questionnaire- Disability Index [HAQ-DI]) at Week 16
timeFrame: Baseline and Week 16
measure: Percentage of Participants With an ACR 20 Response at Week 24
timeFrame: Baseline and Week 24
measure: Change From Baseline in Health Assessment Questionnaire- Disability Index [HAQ-DI]) at Week 24
timeFrame: Baseline and Week 24
measure: Change From Baseline in 36-item Short Form Health Survey (SF-36) Physical Functioning Domain at Week 16
timeFrame: Baseline and Week 16
measure: Percentage of Participants With a Modified Psoriatic Arthritis Response Criteria (PsARC) Response at Week 16
timeFrame: Baseline and Week 16
measure: Change From Baseline in Patient's Assessment of Pain at Week 16
timeFrame: Baseline and Week 16
measure: Change From Baseline in Maastricht Ankylosing Spondylitis Entheses Score (MASES) at Week 16
timeFrame: Baseline and Week 16
measure: Change From Baseline in Dactylitis Severity Score at Week 16
timeFrame: Baseline to Week 16
measure: Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 16
timeFrame: Baseline and Week 16
measure: Change From Baseline in the Disease Activity Score (DAS28) After 16 Weeks of Treatment
timeFrame: Baseline and Week 16
measure: Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 16
timeFrame: Baseline and Week 16
measure: Change From Baseline in 36-item Short Form Health Survey (SF-36) Physical Functioning Domain at Week 24
timeFrame: Baseline and Week 24
measure: Percentage of Participants With a Modified Psoriatic Arthritis Response Criteria (PsARC) Response at Week 24
timeFrame: Baseline and Week 24
measure: Change From Baseline in Participants Assessment of Pain at Week 24
timeFrame: Baseline and Week 24
measure: Change From Baseline in Maastricht Ankylosing Spondylitis Entheses Score (MASES) at Week 24
timeFrame: Baseline and Week 24
measure: Change From Baseline in Dactylitis Severity Score at Week 24
timeFrame: Baseline and Week 24
measure: Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 24
timeFrame: Baseline and Week 24
measure: Change From Baseline in Disease Activity Score (DAS 28) at Week 24
timeFrame: Baseline and Week 24
measure: Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 24
timeFrame: Baseline and Week 24
measure: Percentage of Participants With ≥ 20% Improvement in Maastricht Ankylosing Spondylitis Entheses Score at Week 16
timeFrame: Baseline and Week 16
measure: Percentage of Participants With Dactylitis Improvement ≥ 1 Point at Week 16
timeFrame: Baseline and Week 16
measure: Percentage of Participants With Good or Moderate European League Against Rheumatism (EULAR) Response at Week 16
timeFrame: Baseline and Week 16
measure: Percentage of Participants With MASES Improvement ≥ 20% at Week 24
timeFrame: Baseline and Week 24
measure: Percentage of Participants With Dactylitis Improvement ≥ 1 Point at Week 24
timeFrame: Baseline and Week 24
measure: Percentage of Participants With Good or Moderate EULAR Response at Week 24
timeFrame: Baseline and Week 24
measure: Percentage of Participants With a ACR 50 Response at Week 16
timeFrame: Baseline and Week 16
measure: Percentage of Participants With a ACR 70 Response at Week 16
timeFrame: Baseline and Week 16
measure: Percentage of Participants With a ACR 50 Response at Week 24
timeFrame: Baseline and Week 24
measure: Percentage of Participants With a ACR 70 Response at Week 24
timeFrame: Baseline and Week 24
measure: Percentage of Participants With Pre-existing Enthesopathy Whose Maastricht Ankylosing Spondylitis Entheses Score Improves to 0 at Week 16
timeFrame: Baseline and Week 16
measure: Percentage of Participants With Pre-existing Dactylitis Whose Dactylitis Severity Score Improves to 0 at Week 16
timeFrame: Baseline and Week 16
measure: Percentage of Participants Achieving a MASES Score of Zero at Week 24
timeFrame: Baseline and Week 24
measure: Percentage of Participants Achieving a Dactylitis Score of Zero at Week 24
timeFrame: Baseline and Week 24
measure: Percentage of Participants With a ACR 20 Response at Week 52
timeFrame: Baseline and Week 52
measure: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Week 52
timeFrame: Baseline and Week 52
measure: Change From Baseline in the SF-36v2 Physical Functioning Scale Score at Week 52
timeFrame: Baseline and Week 52
measure: Percentage of Participants With a Modified PsARC Response at Week 52
timeFrame: Baseline and Week 52
measure: Change From Baseline in the Participants Assessment of Pain Using the Visual Analog Scale at Week 52
timeFrame: Baseline and Week 52
measure: Change From Baseline in Maastricht Ankylosing Spondylitis Entheses Score (MASES) at Week 52
timeFrame: Baseline and Week 52
measure: Change From Baseline in the Dactylitis Severity Score at Week 52
timeFrame: Baseline and Week 52
measure: Change From Baseline in the CDAI Score at Week 52
timeFrame: Baseline and Week 52
measure: Change From Baseline in the DAS28 at Week 52
timeFrame: Baseline and Week 52
measure: Change From Baseline in the FACIT-Fatigue Scale Score at Week 52
timeFrame: Baseline and Week 52
measure: Percentage of Participants With MASES Improvement ≥ 20% at Week 52
timeFrame: Baseline and Week 52
measure: Percentage of Participants With Pre-existing Dactylitis Whose Dactylitis Severity Score Improves From Baseline by ≥ 1 at Week 52
timeFrame: Baseline and Week 52
measure: Percentage of Participants Achieving Good or Moderate EULAR Response at Week 52
timeFrame: Baseline and Week 52
measure: Percentage of Participants With an ACR 50 Response at Week 52
timeFrame: Baseline and Week 52
measure: Percentage of Participants With an ACR 70 Response at Week 52
timeFrame: Baseline and Week 52
measure: Percentage of Participants With Pre-existing Enthesopathy Whose MASES Improves From Baseline to 0 at Week 52
timeFrame: Baseline and Week 52
measure: Percentage of Participants With Pre-existing Dactylitis Whose Dactylitis Severity Score Improves From Baseline to 0 at Week 52
timeFrame: Baseline and Week 52
measure: Number of Participants With Treatment Emergent Adverse Events During the Placebo Controlled Phase
timeFrame: 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)
measure: Number of Participants With Treatment Emergent Adverse Events During the Apremilast Exposure Period
timeFrame: 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
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Research Center
state: Arizona
city: Palm Desert
country: United States
facility: Desert Medical Advances
state: California
city: Doral
country: United States
facility: In Vivo Clinical Research
state: Florida
city: Fort Lauderdale
country: United States
facility: Centre For Rheumatology, Immun. And Arthritis
state: Florida
city: Jacksonville
country: United States
facility: North Florida Dermatology
state: Florida
city: Saint Augustine
country: United States
facility: Florida Center for Dermatology, PA
state: Florida
city: Tampa
country: United States
facility: Tampa Medical Group Pa
state: Florida
city: Alpharetta
country: United States
facility: Atlanta Dermatology, Vein and Research Center, PC
state: Georgia
city: Atlanta
country: United States
facility: Arthritis and Rheumatology of Georgia
state: Georgia
city: Boise
country: United States
facility: Sonora Clinical Research, LLC
state: Idaho
city: Rockford
country: United States
facility: Rockford Orthopedic Associates, LLC
state: Illinois
city: Springfield
country: United States
facility: The Arthritis Center
state: Illinois
city: Indianapolis
country: United States
facility: Indiana. University
state: Indiana
city: Cumberland
country: United States
facility: Klein and Associates MD, PA
state: Maryland
city: Hagerstown
country: United States
facility: Klein and Associates MD, PA
state: Maryland
city: Worcester
country: United States
facility: Clinical Pharmacology Study Group
state: Massachusetts
city: Lansing
country: United States
facility: Justus Fiechtner MD PC
state: Michigan
city: Omaha
country: United States
facility: Heartland Clinical Research, Inc.
state: Nebraska
city: Greenville
country: United States
facility: Physicians East
state: North Carolina
city: Hickory
country: United States
facility: Unifour Medical Research Associatets LLC
state: North Carolina
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: West Reading
country: United States
facility: Clinical Research Center of Reading, LLP
state: Pennsylvania
city: Jackson
country: United States
facility: West Tennessee Research Institute
state: Tennessee
city: Austin
country: United States
facility: Austin Regional Clinic
state: Texas
city: Houston
country: United States
facility: Center for Clinical Studies
state: Texas
city: Houston
country: United States
facility: Houston Medical Research
state: Texas
city: San Antonio
country: United States
facility: Luckster Enterprises
state: Texas
city: Webster
country: United States
facility: Center for Clinical Studies
state: Texas
city: Franklin
country: United States
facility: Rheumatology and Immunotherapy Center
state: Wisconsin
city: Middleton
country: United States
facility: PharmaSeek
state: Wisconsin
city: Clayton
country: Australia
facility: Monash Medical Centre
state: Victoria
city: Box Hill
country: Australia
facility: Eastern Health Clinical School
city: Daws Park
country: Australia
facility: Repatriation General Hospital
city: Hobart
country: Australia
facility: Menzies Centre for Population Health Research
city: Kogarah
country: Australia
facility: Optimus Clinical Research Pty. Ltd
city: Woodville
country: Australia
facility: The Queen Elizabeth Hospital
city: Leuven
country: Belgium
facility: UZ Leuven
city: Liège
country: Belgium
facility: CHU de Liege
city: Plovdiv
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment Trimontsium
city: Sofia
country: Bulgaria
facility: 17 Diagnostic and Consulting Centre Sofia EOOD
city: Sofia
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment Sv. Ivan Rilski
city: Sofia
country: Bulgaria
facility: Diagnostic-Consultative Center Sveta Anna
city: Varna
country: Bulgaria
facility: Diagnostic Consulting Center N4
city: Vancouver
country: Canada
facility: Arthritis Research Centre of Canada
state: British Columbia
city: Victoria
country: Canada
facility: PerCuro Clinical Research
state: British Columbia
city: Winnipeg
country: Canada
facility: Manitoba Clinic
state: Manitoba
city: St John's
country: Canada
facility: St. Clare's Health Care Corporation of St. John's
state: Newfoundland and Labrador
city: Barrie
country: Canada
facility: Ultranova Skincare
state: Ontario
city: Hamilton
country: Canada
facility: William Bensen's Private Practice
state: Ontario
city: Ottawa
country: Canada
facility: Rheumatology Research Associates
state: Ontario
city: Thornhill
country: Canada
facility: Wilderman Medical Clinic
state: Ontario
city: Waterloo
country: Canada
facility: Probity Medical Research Inc
state: Ontario
city: Windsor
country: Canada
facility: Darryl Toth's Private Practice
state: Ontario
city: Sainte Foy
country: Canada
facility: Centre de Rhumatologie St-Louis
state: Quebec
city: Saskatoon
country: Canada
facility: Saskatoon Osteoporosis Centre
state: Saskatchewan
city: Praha 11
country: Czechia
facility: Affidea Praha s.r.o
city: Praha 2
country: Czechia
facility: Revmatologicky ustav
city: Praha 4
country: Czechia
facility: Revmatologicka Ambulance
city: Zlin
country: Czechia
facility: PV - MEDICAL, s.r.o.
city: Tallinn
country: Estonia
facility: East Tallinn Central Hospital
city: Tallinn
country: Estonia
facility: North Estonia Regional Hospital
city: Tartu
country: Estonia
facility: Clinical Research Centre Ltd
city: Nantes Cedex 01
country: France
facility: Hotel Dieu
city: Nice
country: France
facility: Groupe Hospitalier Archet I et II
city: Paris Cedex 10
country: France
facility: Hopital Lariboisiere
city: Paris
country: France
facility: Fondation Hôpital Saint-Joseph
city: Budapest
country: Hungary
facility: Qualiclinic kft
city: Budapest
country: Hungary
facility: Synexus Magyarország Kft.
city: Budapest
country: Hungary
facility: Honvéd Kórház - Állami Egészségügyi Központ
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum
city: Kistarcsa
country: Hungary
facility: Pest Megyei Flor Ferenc Korhaz
city: Mako
country: Hungary
facility: Principal SMO Kft.
city: Szolnok
country: Hungary
facility: MAV Korhaz es Rendelointezet Szolnok
city: Genova
country: Italy
facility: Azienda Ospedaliera Universitaria San Martino
city: Milano
country: Italy
facility: Ospedale Luigi Sacco
city: Napoli
country: Italy
facility: AOU della II Universita degli Studi di Napoli
city: Roma
country: Italy
facility: Fondazione PTV Policlinico Tor Vergata
city: Verona
country: Italy
facility: Ospedale Civile Maggiore Borgo Trento
city: DaeJeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Incheon
country: Korea, Republic of
facility: Inha University Hosiptal
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Siauliai
country: Lithuania
facility: Siauliai Hospital
city: Hamilton
country: New Zealand
facility: Waikato hospital
city: Takapuna
country: New Zealand
facility: North Shore Hospital
city: Timaru
country: New Zealand
facility: Timaru Hospital
city: Bialystok
country: Poland
facility: Bytomskie Centrum Medyczne Silesiana Sp. z o.o.
city: Bydgoszcz
country: Poland
facility: Szpital Uniwersytecki nr 2 im. Dr Jana Biziela w Bydgoszczy
city: Bytom
country: Poland
facility: Centrum Medyczne Silesiana Sp. z o.o.
city: Gdynia
country: Poland
facility: Synexus SCM Sp. z o.o.
city: Katowice
country: Poland
facility: Synexus SCM Sp. z o.o.
city: Lublin
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej REUMED
city: Poznan
country: Poland
facility: Prywatna Praktyka Lekarska
city: Warszawa
country: Poland
facility: REUMATIKA-Centrum Reumatologii Niepubliczny Zaklad Opieki Zdrowotnej
city: Warszawa
country: Poland
facility: Synexus SCM Sp. z o.o. Oddz. Warszawa
city: Wroclaw
country: Poland
facility: Synexus SCM Sp. z o.o.
city: Bucharest
country: Romania
facility: Sf. Maria Clinical Hospital
city: Cluj-Napoca
country: Romania
facility: Emergency County Clinical Hospital
city: Galati
country: Romania
facility: Sf Apostol Andrei Emergency Clinical County Hospital
city: Iasi
country: Romania
facility: C.M.I. Dr. Ciornohuz Adriana
city: Kemerovo
country: Russian Federation
facility: Veterans of Wars Regional Clinical Hospital
city: Kemerovo
country: Russian Federation
facility: Kemerovo State Medical Academy of Roszdrav
city: Kezch
country: Russian Federation
facility: Research Medical Complex Vashe Zdorovie
city: Krasnoyarsk
country: Russian Federation
facility: Krasnoyarsk State Medical Academy
city: Nizhniy Novgorod
country: Russian Federation
facility: City Clinical Hospital #5
city: Novosibirsk
country: Russian Federation
facility: Research Institute of Clinical Immunology
city: Novosibirsk
country: Russian Federation
facility: Research Institute of Clinical and Experimental Lymphology
city: Penza
country: Russian Federation
facility: Penza Regional Clinical Hospital n.a. N.N. Burdenko
city: Smolensk
country: Russian Federation
facility: Departmental Hospital at Smolensk Station RZhD JSC
city: Tomsk
country: Russian Federation
facility: Tomsk Regional Clinical Hospital
city: Vladimir
country: Russian Federation
facility: Regional Clinical Hospital
city: Voronezh
country: Russian Federation
facility: Voronezh Regional Clinical Hopsital #1, Voronezh State Medical Academy
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Tapei
country: Taiwan
facility: National Taiwan University Hospital
city: Barnsley South Yorkshire
country: United Kingdom
facility: Barnsley Hospital
city: Burslem
country: United Kingdom
facility: Haywood Hospital
city: Cannock
country: United Kingdom
facility: Cannock Chase Hospital
city: Poole
country: United Kingdom
facility: Poole Hospital
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: 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-naive Patients With Psoriatic Arthritis. J Rheumatol. 2022 Jul;49(7):694-699. doi: 10.3899/jrheum.210906. Epub 2022 Apr 15.
citation: Wells AF, Edwards CJ, Kivitz AJ, Bird P, Guerette B, Delev N, Paris M, Teng L, Aelion JA. Apremilast monotherapy for long-term treatment of active psoriatic arthritis in DMARD-naive patients. Rheumatology (Oxford). 2022 Mar 2;61(3):1035-1043. doi: 10.1093/rheumatology/keab449.
citation: Wells AF, Edwards CJ, Kivitz AJ, Bird P, Nguyen D, Paris M, Teng L, Aelion JA. Apremilast monotherapy in DMARD-naive psoriatic arthritis patients: results of the randomized, placebo-controlled PALACE 4 trial. Rheumatology (Oxford). 2018 Jul 1;57(7):1253-1263. doi: 10.1093/rheumatology/key032.