Phase
Condition
Psoriatic Arthritis
Joint Injuries
Arthritis And Arthritic Pain
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Males or females, 18 years and older at time of consent.
Must understand and voluntarily sign an informed consent document prior to any studyrelated assessments/procedures being conducted.
Able to adhere to the study visit schedule and other protocol requirements.
Have a documented diagnosis of psoriatic arthritis (by any criteria) of at least 3months' duration
Meet the classification criteria for psoriatic arthritis (CASPAR) at the time ofscreening.
Have at least 3 swollen AND at least 3 tender joints.
Must have high sensitivity C-Reactive Protein (hs-CRP) of at least 0.5 mg/dL atscreening and at baseline.
Must be receiving treatment on an outpatient basis.
Must be tumor necrosis factor (TNF) blocker naive and other Biologic naïve fordermatologic and rheumatic conditions
Subjects taking disease modifying anti-rheumatoid drugs (DMARDs), with the exceptionof cyclosporine and leflunomide (see 7.3. Exclusion Criteria 20, 21), do not require awashout, however, they must discontinue the DMARD treatment at least one day prior totheir baseline visit (ie, Visit 2, Day 0)
Subjects who have been previously treated with leflunomide will require a 12-weekwashout or treatment with the cholestyramine, per leflunomide prescribing label (ie. 8g cholestyramine 3 times daily for 11 days.
Subjects who have been previously treated with cyclosporine will require a 4-weekwashout prior to randomization to participate in the study
If taking oral corticosteroids, must be on a stable dose of prednisone less than orequal to 10 mg/day or equivalent for at least 30 days prior to baseline visit (ie, Day
If taking nonsteroidal anti-inflammatory drugs (NSAIDs) or narcotic analgesics, mustbe on stable dose for at least 30 days prior to baseline visit (ie, Day 0) and untilthey have completed the Week 24 study visit.
Must meet the following laboratory criteria:
White blood cell count greater than 3000/mm^3 (greater than 3.0 X 10^9/L) andless than 14,000/mm^3 (less than 14 X 10^9/L)
Platelet count at least 100,000/mm^3 (at least 100 X 10^9/L)
Serum creatinine less than or equal to 1.5 mg/dL (less than or equal to 132.6 μmol/L)
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than orequal to twice upper limit of normal (ULN). If initial test shows ALT or ASTgreater than 2 times the ULN, one repeat test is allowed during the screeningperiod.
Total bilirubin less than or equal to 2 mg/dL (less than or equal to 34 μmol/L)or Albumin greater than LLN. If initial test result is greater than 2 mg/dL, onerepeat test is allowed during the screening period.
Hemoglobin at least 9 g/dL (at least 5.6 mmol/L)
Hemoglobin A1c less than or equal to 9.0%
All females of childbearing potential (FCBP) must use one of the approvedcontraceptive options as described below while on investigational product and for atleast 28 days after administration of the last dose of the investigational product. At the time of study entry, and at any time during the study when a female subject ofchildbearing potential's contraceptive measures or ability to become pregnant changes,the investigator will educate the subject regarding contraception options and thecorrect and consistent use of effective contraceptive methods in order to successfullyprevent pregnancy. Females of childbearing potential must have a negative pregnancy test at Screening andBaseline. All FCBP subjects who engage in activity in which conception is possiblemust use one of the approved contraceptive options described below: Option 1: Any one of the following highly effective methods: hormonal contraception (oral, injection, implant, transdermal patch, vaginal ring); intrauterine device (IUD); tubal ligation; or partner's vasectomy; OR Option 2: Male or female condom (latex condom or non latex condom NOT made out of natural [animal] membrane [forexample, polyurethane]; PLUS one additional barrier method: (a) diaphragm withspermicide; (b) cervical cap with spermicide; or (c) contraceptive sponge withspermicide.
Male subjects (including those who have had a vasectomy) who engage in activity inwhich conception is possible must use barrier contraception (male latex condom ornonlatex condom NOT made out of natural [animal] membrane [for example, polyurethane])while on investigational product and for at least 28 days after the last dose ofinvestigational product.
Exclusion
Exclusion Criteria:
History of clinically significant (as determined by the investigator) cardiac,endocrine, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic,immunologic disease, or other major uncontrolled disease.
Any condition, including the presence of laboratory abnormalities, which places thesubject at unacceptable risk if he/she were to participate in the study or confoundsthe ability to interpret data from the study.
Clinically significant abnormality on a 12-lead electrocardiogram (ECG) at Screening.
Pregnant or breast feeding.
History of allergy to any component of the investigational product.
Hepatitis B surface antigen positive at screening.
Hepatitis C antibody positive at screening.
History of positive human immunodeficiency virus (HIV), or congenital or acquiredimmunodeficiency (eg, Common Variable Immunodeficiency Disease).
Active tuberculosis or a history of incompletely treated tuberculosis.
Clinically significant abnormality based upon chest radiograph with at leastposterior-anterior (PA) view (the radiograph must be taken within 12 weeks prior toScreening or during the Screening visit). An additional lateral view is stronglyrecommended but not required.
Active substance abuse or a history of substance abuse within 6 months prior toScreening.
Bacterial infections requiring treatment with oral or injectable antibiotics, orsignificant viral or fungal infections, within 4 weeks of Screening. Any treatment forsuch infections must have been completed and the infection cured, at least 4 weeksprior to Screening.
Malignancy or history of malignancy, except for:
treated [ie, cured] basal cell or squamous cell in situ skin carcinomas;
treated [ie, cured] cervical intraepithelial neoplasia [CIN] or carcinoma in situof the cervix with no evidence of recurrence within the previous 5 years.
Major surgery (including joint surgery) within 8 weeks prior to screening or plannedmajor surgery within 6 months following randomization.
Erythrodermic, guttate, or generalized pustular psoriasis at randomization.
Rheumatic autoimmune disease other than PsA, including, but not limited to: systemiclupus erythematosis (SLE), mixed connective tissue disease (MCTD), scleroderma,polymyositis, or fibromyalgia.
Functional Class IV, as defined by the American College of Rheumatology (ACR)Classification of Functional Status in Rheumatoid Arthritis.
Prior history of or current inflammatory joint disease other than PsA (eg, gout,reactive arthritis, rheumatoid arthritis (RA), ankylosing spondylitis, Lyme disease).
Prior treatment with more than one non-biologic DMARD
Use of the following systemic therapy(ies) within 4 weeks of randomization:cyclosporine or other calcineurin inhibitors, corticosteroids exceeding 10 mg dailyprednisone equivalent, as well as other oral agents such as retinoids, mycophenolate,thioguanine, hydroxyurea, sirolimus, tacrolimus.
Use of leflunomide within 12 weeks of randomization, unless subject has takencholestyramine, 8g TID (three times a day) x 11 days after stopping leflunomide.
Previous treatment with biologic agents for rheumatic diseases such as, but notlimited to: adalimumab, abatacept, canakinumab, etanercept, golimumab, infliximab,rilonacept, certolizumab pegol, or tocilizumab.
Previous treatment with biologic agents for dermatologic diseases such as alefacept,anti-TNFs (eg etanercept, adalinumab) or ustekinumab.
Previous treatment with tofacitinib, Anti IL-17 agents or secukinumab
Previous treatment with any cell depleting therapies, including investigational agents (eg, rituximab, alemtuzumab, ocrelizumab, alemtuzumab, anti-CD4, anti-CD5, anti-CD3,anti-CD19, and anti-CD20).
Treatment with intravenous gamma globulin, plasmapheresis, or Prosorba® column
Any previous treatment with alkylating agents such as cyclophosphamide orchlorambucil, or with total lymphoid irradiation.
Prior treatment with any non-biologic DMARDS other than methotrexate, sulfasalazine,chloroquine, hydroxychloroquine, azathioprine, fumeric acid esters, cyclosporine, orleflunomide
Prior treatment with apremilast, or participation in a clinical study, involvingapremilast
Use of any investigational drug within 4 weeks of randomization, or 5 pharmacokinetic/pharmacodynamic half lives, if known (whichever is longer).
Study Design
Study Description
Connect with a study center
Westmead Hospital
Westmead, New South Wales 2145
AustraliaSite Not Available
Menzies Research Institute
Hobart, Tasmania 7000
AustraliaSite Not Available
Colin Bayliss Research and Teaching Unit
Victoria Park, Western Australia 6100
AustraliaSite Not Available
Eastern Health Clinical School
Box Hill, 3128
AustraliaSite Not Available
Royal Prince Alfred Hospital
Camperdown, 2050
AustraliaSite Not Available
Menzies Centre for Population Health Research
Hobart,, 7000
AustraliaSite Not Available
Optimus Clinical Research Pty. Ltd
Kogarah, 2217
AustraliaSite Not Available
Coastal Joint Care
Maroochydore, 4558
AustraliaSite Not Available
Westmead Cancer Care Center
Westmead, NSW, 2145
AustraliaSite Not Available
Manna Research
Vancouver, British Columbia V6J 1S3
CanadaSite Not Available
Manitoba Clinic
Winnipeg, Manitoba R3A1M3
CanadaSite Not Available
Karma Clinical Trials
Saint John's, Newfoundland and Labrador A1A 4Y3
CanadaSite Not Available
Nexus Clinical Research
St John's, Newfoundland and Labrador A1A 5E8
CanadaSite Not Available
MAC Research Incorporated
Hamilton, Ontario L8N 2B6
CanadaSite Not Available
Rheumatology Research Associates
Ottawa, Ontario K1H 1A2
CanadaSite Not Available
Arthur Karasik Private Practice
Toronto, Ontario M9C 5N2
CanadaSite Not Available
Manna Research
Toronto, Ontario M9W4L6
CanadaSite Not Available
Jude Rodrigues Private Practice
Windsor, Ontario N8X 5A6
CanadaSite Not Available
Groupe de Recherche en Maladies Osseuses Inc.
Quebec City, Quebec G1V 3M7
CanadaSite Not Available
CHUL du CHU de Quebec
Quebec, G1V 4G2
CanadaSite Not Available
Revmatologicky Ustav
Praha, Praha, hlavní mesto 125 8
Czech RepublicSite Not Available
ARTMEDI UPD s.r.o.
Hostivice, Praha-západ 253 01
Czech RepublicSite Not Available
Revmatologicky ustav
Praha 2, 128 50
CzechiaSite Not Available
Revmatologicka Ambulance
Praha 4, 140 00
CzechiaSite Not Available
Revmatologicka Ambulance
Sokolov, 356 01
CzechiaSite Not Available
PV - MEDICAL, s.r.o.
Zlin, 760 01
CzechiaSite Not Available
East Tallinn Central Hospital
Tallinn, EE-11412
EstoniaSite Not Available
Innomedica Medical and Research Centre
Tallinn, EE-10117
EstoniaSite Not Available
Clinical Research Centre Ltd
Tartu, 50106
EstoniaSite Not Available
Qualiclinic kft
Budapest, 1036
HungarySite Not Available
Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum
Debrecen, 4032
HungarySite Not Available
MAV Korhaz es Rendelointezet Szolnok
Szolnok, 5000
HungarySite Not Available
Veszprém Megyei Önkormányzat Csolnoky Ferenc Kórház-Rendelöintézet
Veszprém, 8200
HungarySite Not Available
Middlemore Hospital
Otahuhu, Auckland 1640
New ZealandSite Not Available
Waikato hospital
Hamilton, 3204
New ZealandSite Not Available
Middlemore Clinical Trials
Manukau, 1640
New ZealandSite Not Available
Timaru Hospital
Timaru, 8601
New ZealandSite Not Available
Covamed SRL
Sfantu Gheorghe, Covasna 520052
RomaniaSite Not Available
Sf. Maria Clinical Hospital
Bucharest, 011172
RomaniaSite Not Available
Emergency County Clinical Hospital
Cluj-Napoca, 400006
RomaniaSite Not Available
Sf Apostol Andrei Emergency Clinical County Hospital
Galati, 800578
RomaniaSite Not Available
SC Covamed SRL
Sfantu Gheorghe, Covasna, 520052
RomaniaSite Not Available
Research Medical Complex Vashe Zdorovie
Kazan, 420103
Russian FederationSite Not Available
Nizhniy Novgorod State Medical Academy
Nizhny Novgorod, 603005
Russian FederationSite Not Available
Penza Regional Clinical Hospital n.a. N.N. Burdenko
Penza, 440026
Russian FederationSite Not Available
Departmental Hospital at Smolensk Station RZhD JSC
Smolensk, 214025
Russian FederationSite Not Available
Yaroslavl Regional Clinical Hospital
Yaroslavl, 150062
Russian FederationSite Not Available
Clinresco Centre
Johannesburg, Gauteng 1619
South AfricaSite Not Available
Jacaranda Hospital
Pretoria, Gauteng 181
South AfricaSite Not Available
Panorama Medical Centre
Cape Town, Western Cape 7500
South AfricaSite Not Available
Hospital Universitario de Canarias
La Cuesta, Canarias 38330
SpainSite Not Available
Hospital Universitario Vall d'Hebron
Badalona, Cataluña 08035
SpainSite Not Available
Hospital Universitari de Bellvitge
Hospitalet de Llobregat, Cataluña 08907
SpainSite Not Available
Hospital Universitario a Coruna
A Coruña, 15006
SpainSite Not Available
Hospital Vall d'Hebron
Barcelona, 08035
SpainSite Not Available
Hospital Universitari de Bellvitge
Barcelona, Hospitalet De Llobregat, 08907
SpainSite Not Available
Hospital de Basurto-Osakidetza
Bilbao, 48013
SpainSite Not Available
Hospital Universitario de Canarias
La Laguna, 38320
SpainSite Not Available
Hospital Universitario La Paz
Madrid, 28046
SpainSite Not Available
Hospital General de Malaga
Malaga, 29009
SpainSite Not Available
Hospital General Carlos Haya
Málaga, 29009
SpainSite Not Available
Corporacion Sanitaria Parc Tauli
Sabadell, 08208
SpainSite Not Available
Hospital Clinico Universitario de Santiago
Santiago de Compostela, 15706
SpainSite Not Available
Achieve Clinical Research LLC
Birmingham, Alabama 35216
United StatesSite Not Available
Desert Medical Advances
Palm Desert, California 92260
United StatesSite Not Available
Bay Area Arthritis and Osteoporosis
Brandon, Florida 33511
United StatesSite Not Available
Health Point Medical Group
Brandon, Florida 33511
United StatesSite Not Available
Palmetto Medical Research
Hialeah, Florida 33016
United StatesSite Not Available
Jeffrey Alper MD Research
Naples, Florida 34102
United StatesSite Not Available
Suncoast Clinical Research
New Port Richey, Florida 34652
United StatesSite Not Available
University of South Florida
Tampa, Florida 33612-4799
United StatesSite Not Available
Coeur D'Alene Arthritis Clinic
Coeur d'Alene, Idaho 83814
United StatesSite Not Available
Rockford Orthopedic Associates, LLC
Rockford, Illinois 61107
United StatesSite Not Available
Advanced Rheumatology
Lansing, Michigan 48910
United StatesSite Not Available
Research West Incorporated
Kalispell, Montana 59901
United StatesSite Not Available
Heartland Clinical Research, Inc.
Omaha, Nebraska 68134
United StatesSite Not Available
Physicians East
Greenville, North Carolina 27834
United StatesSite Not Available
Piedmont Medical Research Associates Inc
Winston-Salem, North Carolina 27103-3914
United StatesSite Not Available
Altoona Center for Clinical Research
Duncansville, Pennsylvania 16635
United StatesSite Not Available
West Tennessee Research Institute
Jackson, Tennessee 38305
United StatesSite Not Available
Ramesh C Gupta MD
Memphis, Tennessee 38119
United StatesSite Not Available
Austin Regional Clinic
Austin, Texas 78731
United StatesSite Not Available
Baylor Research Institute
Dallas, Texas 75231
United StatesSite Not Available
Houston Medical Research
Houston, Texas 77090
United StatesSite Not Available
Arthritis and Osteoporosis Associates LLP
Lubbock, Texas 79424
United StatesSite Not Available
University of Utah
Salt Lake City, Utah 84132
United StatesSite Not Available
Tacoma Center for Arthritis Research, PS
Tacoma, Washington 98405
United StatesSite Not Available
Mountain State Clinical Research
Clarksburg, West Virginia 26301
United StatesSite Not Available
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