A Study of Ixekizumab (LY2439821) Versus Adalimumab in Participants With Psoriatic Arthritis
Study Purpose
The main purpose of this study is to evaluate the effectiveness and safety of ixekizumab versus adalimumab in participants with psoriatic arthritis (PsA) who are biologic disease-modifying anti-rheumatic drugs (DMARD) naive.
Recruitment Criteria
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Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
|
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
| Eligible Ages | 18 Years and Over |
| Gender | All |
Inclusion Criteria:
- Presents with established diagnosis of active psoriatic arthritis for at least 6 months, and currently meets Classification for Psoriatic Arthritis (CASPAR) criteria - Active PsA defined as the presence of at least 3 tender and at least 3 swollen joints - Presence of active plaque psoriasis with a BSA ≥3% - Men must agree to use a reliable method of birth control or remain abstinent during the study - Women must agree to use reliable birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment - Have had an inadequate response when treated with 1 or more conventional synthetic disease-modifying antirheumatic drugs (csDMARDs)Exclusion Criteria:
- Current or prior use of biologic agents for treatment of Ps or PsA - Evidence of active inflammatory arthritic syndromes or spondyloarthropathies other than PsA - Have participated in any study with interleukin 17 (IL-17) antagonists, including ixekizumab - Serious disorder or illness other than psoriatic arthritis - Serious infection within the last 3 months - Women who are breastfeedingTrial Details
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Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT03151551 |
|
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 4 |
|
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Eli Lilly and Company |
|
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) |
| Principal Investigator Affiliation | Eli Lilly and Company |
|
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
| Overall Status | Recruiting |
| Countries | Argentina, Australia, Austria, Belgium, Canada, Denmark, Finland, France, Germany, Hungary, India, Israel, Italy, Mexico, Netherlands, Poland, South Africa, Spain, Sweden, Switzerland, Ukraine, United Kingdom |
|
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Psoriatic Arthritis |
| Study Website: | View Trial Website |
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
International Sites
Status
Active, not recruiting
Address
Atencion Integral en Reumatología
Ciudad Autonoma de Buenos Aire, Buenos Aires, C1426AAL
Site Contact
Status
Active, not recruiting
Address
Clinica Adventista de Belgrano
Ciudad de Buenos Aires, Buenos Aires, C1430EGF
Site Contact
Status
Active, not recruiting
Address
CER Instituto Medico
Quilmes, Buenos Aires, B1878DVC
Site Contact
Status
Active, not recruiting
Address
Instituto de Asist Reumatologica Integral
San Fernando, Buenos Aires, B1646DBM
Site Contact
Status
Active, not recruiting
Address
Centro Medico Privado de Reumatologia
San Miguel de Tucuman, Tucuman, T4000AXL
Site Contact
Status
Active, not recruiting
Address
Organizacion Medica de Investigacion - OMI
Ciudad Autonoma de Buenos Aire, , C1015ABO
Site Contact
Status
Active, not recruiting
Address
Instituto Centenario
Ciudad Autonoma de Buenos Aire, , C1204AAD
Site Contact
Status
Active, not recruiting
Address
Hospital Ramos Mejia
Ciudad Autonoma de Buenos Aire, , C1221ADC
Site Contact
Status
Active, not recruiting
Address
Centro de Medicina Familiar Mindout Research
Ciudad Autonoma de Buenos Aire, , C1417EYG
Site Contact
Status
Active, not recruiting
Address
CENUDIAB
Ciudad Autonoma de Buenos Aire, , C1440AAD
Site Contact
Status
Active, not recruiting
Address
Consultora Integral de Salud S.R.L.
Cordoba, , 5004
Site Contact
Status
Active, not recruiting
Address
Centro Polivalente de Asistencia e Inv. Clinica CER-San Juan
San Juan, , J5402DIL
Site Contact
Status
Active, not recruiting
Address
Combined Rheumatology Practice (CRP)
Kogarah, New South Wales, 2217
Site Contact
Status
Active, not recruiting
Address
Rheumatology, The Queen Elizabeth Hospital
Woodville South, South Australia, 5011
Site Contact
Status
Active, not recruiting
Address
Southern Clinical Research Pty Ltd
Hobart, Tasmania, 7000
Site Contact
Status
Active, not recruiting
Address
Emeritus Research
Camberwell, Victoria, 3124
Site Contact
Status
Active, not recruiting
Address
St Vincents Hospital Melbourne
Fitzroy, Victoria, 3065
Site Contact
Status
Active, not recruiting
Address
Zentrum für klinische Studien Dr. Ursula Hanusch GmbH
Wien, , 1060
Site Contact
Status
Active, not recruiting
Address
Rheuma-Zentrum Wien Oberlaa
Wien, , 1100
Site Contact
Status
Active, not recruiting
Address
Universitair Ziekenhuis Gent
Gent, , 9000
Site Contact
Status
Active, not recruiting
Address
Saint Joseph Hospital
Gilly, , 6060
Site Contact
Status
Active, not recruiting
Address
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
Leuven, , 3000
Site Contact
Status
Active, not recruiting
Address
Hopital Ambroise Pare
Mons, , 7000
Site Contact
Status
Active, not recruiting
Address
The Waterside Clinic
Barrie, Ontario, L4M 6L2
Site Contact
Status
Active, not recruiting
Address
SKiN Center for Dermatology
Peterborough, Ontario, K9J 5K2
Site Contact
Status
Active, not recruiting
Address
Centre de Recherche Musculo-Squelettique
Trois-Rivieres, Quebec, G8Z 1Y2
Site Contact
Status
Recruiting
Address
Polmed Research Inc.
Saskatoon, Saskatchewan, S7K 0H6
Site Contact
Status
Active, not recruiting
Address
Group de recherche en maladies osseuses
Quebec, , G1V 3M7
Site Contact
Status
Active, not recruiting
Address
Frederiksberg Hospital
Frederiksberg, Hovedstaden, 2000
Site Contact
Status
Active, not recruiting
Address
Aalborg Universitetshospital - Psykiatrien
Aalborg, , 9000
Site Contact
Status
Active, not recruiting
Address
Helsinki University Hospital, HYKS
Helsinki, , 00029
Site Contact
Status
Active, not recruiting
Address
Kiljava Medical Research
Hyvinkaa, , 05800
Site Contact
Status
Active, not recruiting
Address
Terveystalo Kouvola
Kouvola, , 45100
Site Contact
Status
Active, not recruiting
Address
Turun Yliopistollinen Keskussairaala
Turku, , 20521
Site Contact
Status
Active, not recruiting
Address
Hôpital Trousseau, CHRU de Tours
Chambray-lès-Tours, , 37170
Site Contact
Status
Active, not recruiting
Address
Centre Hospitalier de Vendee Les Oudairies
La Roche Sur Yon, , 85025
Site Contact
Status
Active, not recruiting
Address
Hopital Edouard Herriot
Lyon Cedex 03, , 69003
Site Contact
Status
Active, not recruiting
Address
Centre hospitalier universitaire Lapeyronie
Montpellier Cedex 5, , 34295
Site Contact
Status
Active, not recruiting
Address
Nouvel Hôpital Orléans La Source
Orleans CEDEX 2, , 45067
Site Contact
Status
Active, not recruiting
Address
Hôpital Pierre-Paul Riquet
Toulouse cedex 9, , 31059
Site Contact
Status
Active, not recruiting
Address
Klinikum der Universität München
München, Bayern, 80336
Site Contact
Status
Active, not recruiting
Address
Klinikum der Johann Wolfgang Goethe-Universität Frankfurt
Frankfurt am Main, Hessen, 60590
Site Contact
Status
Active, not recruiting
Address
Rheumazentrum Ratingen
Ratingen, Nordrhein-Westfalen, 40878
Site Contact
Status
Active, not recruiting
Address
HRF Hamburger Rheuma Forschungszentrum
Hamburg, , 20095
Site Contact
Status
Active, not recruiting
Address
Allergo-Derm Bakos Kft
Szolnok, Jasz-Nagykun-Szolnok, 5000
Site Contact
Status
Active, not recruiting
Address
Obudai Egeszsegugyi Centrum Kft
Budapest, , 1036
Site Contact
Status
Active, not recruiting
Address
UNO Medical Trials Kft.
Budapest, , 1135
Site Contact
Status
Active, not recruiting
Address
Vital Medical Center
Veszprem, , 8200
Site Contact
Status
Active, not recruiting
Address
Care Hospital
Hyderabad, Andhra Pradesh, 500035
Site Contact
Status
Active, not recruiting
Address
King George Hospital
Visakhapatnam, Andhra Pradesh, 530002
Site Contact
Status
Active, not recruiting
Address
Sir Ganga Ram Hospital
New Delhi, Delhi, 110060
Site Contact
Status
Active, not recruiting
Address
Panchshil Hospital
Ahmedabad, Gujarat, 380005
Site Contact
Status
Active, not recruiting
Address
Byramjee Jeejeebhoy Medical College & Civil Hospital
Ahmedabad, Gujarat, 380016
Site Contact
Status
Active, not recruiting
Address
Shalby Hospital
Ahmedabad, Gujarat, 532004
Site Contact
Status
Active, not recruiting
Address
Government Medical College & Sir Sayajirao General Hospital
Vadodara, Gujarat, 390001
Site Contact
Status
Active, not recruiting
Address
Artemis Hospital
Gurgaon, Haryana, 122001
Site Contact
Status
Active, not recruiting
Address
Narayana Hrudayalaya Hospital
Bangalore, Karnataka, 560099
Site Contact
Status
Active, not recruiting
Address
Kokilaben Dhirubhai Ambani Hospital &Medical Research Inst.
Mumbai, Maharashtra, 400053
Site Contact
Status
Active, not recruiting
Address
Ruby Hall Clinic and Grant Medical Foundation
Pune, Maharashtra, 411001
Site Contact
Status
Active, not recruiting
Address
Krishna Institute of Medical Sciences Ltd.
Secunderabad, Telengana, 500003
Site Contact
Status
Active, not recruiting
Address
Apollo Gleneagles Hospitals
Kolkata, West Bengal, 700054
Site Contact
Status
Active, not recruiting
Address
Barzilai Medical Center
Ashkelon, , 78278
Site Contact
Status
Active, not recruiting
Address
Rambam Medical Center
Haifa, , 3109601
Site Contact
Status
Active, not recruiting
Address
Carmel Medical Center
Haifa, , 3436212
Site Contact
Status
Active, not recruiting
Address
Meir Medical Center
Kfar Saba, , 4428164
Site Contact
Status
Active, not recruiting
Address
Rabin Medical Center
Petach Tikva, , 4941492
Site Contact
Status
Active, not recruiting
Address
Sheba Medical Center
Ramat Gan, , 5266202
Site Contact
Status
Active, not recruiting
Address
Tel Aviv Sourasky Medical Center
Tel Aviv, , 6423906
Site Contact
Status
Active, not recruiting
Address
Assaf Harofeh Medical Center
Zerifin, , 6093000
Site Contact
Status
Active, not recruiting
Address
Istituto Clinico Humanitas
Rozzano, Milano, 20089
Site Contact
Status
Active, not recruiting
Address
Istituto Ortopedico Rizzoli
Bologna, , 40136
Site Contact
Status
Active, not recruiting
Address
Presidio Ospedaliero Vittorio Emanuele
Catania, , 95124
Site Contact
Status
Active, not recruiting
Address
Fondazione Universitaria degli Studi G D'Annunzio
Chieti, , 66100
Site Contact
Status
Active, not recruiting
Address
Policlinico di Tor Vergata
Roma, , 00133
Site Contact
Status
Active, not recruiting
Address
Complesso Integrato Columbus
Roma, , 00168
Site Contact
Status
Active, not recruiting
Address
Ospedale Policlinico Giambattista Rossi, Borgo Roma
Verona, , 37134
Site Contact
Status
Active, not recruiting
Address
Centro Medico del Angel S.C.
Mexicali, Baja California, 21100
Site Contact
Status
Active, not recruiting
Address
Ctro Inv en Artritis y Osteoporosis SC
Mexicali, Baja California, 21200
Site Contact
Status
Active, not recruiting
Address
CIMAB S.A. de C.V.
Torreon, Coahuila, 27000
Site Contact
Status
Active, not recruiting
Address
Grupo Médico CAMINO S.C.
México City, Distrito Federal, 03310
Site Contact
Status
Active, not recruiting
Address
Clínica Enfermedades Crónicas y Procedimientos Especiales SC
Morelia, Michoacan, 58249
Site Contact
Status
Active, not recruiting
Address
Centro Investigacion de Tratam Innovadores de Sinaloa SC
Culiacan, Sinaloa, 80000
Site Contact
Status
Active, not recruiting
Address
Cemdeicy S.C.P.
Merida, Yucatán, 97130
Site Contact
Status
Active, not recruiting
Address
RM Pharma Specialists S.A. de C.V.
Distrito Federal, , 3100
Site Contact
Status
Active, not recruiting
Address
Antonius Ziekenhuis
Sneek, , 8601 ZK
Site Contact
Status
Active, not recruiting
Address
NZOZ Centrum Reumatologiczne Ind. Prak.
Elblag, , 82-300
Site Contact
Status
Active, not recruiting
Address
"Dermed" Centrum Medyczne Sp. z o.o.
Lodz, , 90-265
Site Contact
Status
Active, not recruiting
Address
Twoja Przychodnia-Centrum Medyczne Nowa Sol
Nowa Sol, , 67100
Site Contact
Status
Active, not recruiting
Address
Rheuma Medicus Zakład Opieki Zdrowotnej
Warsaw, , 02-118
Site Contact
Status
Active, not recruiting
Address
DermMEDICA Sp. z o.o.
Wroclaw, , 51-318
Site Contact
Status
Active, not recruiting
Address
Greenacres Hospital
Port Elizabeth, Eastern Cape, 6045
Site Contact
Status
Active, not recruiting
Address
Clinresco Centres (Pt) Ltd
Johannesburg, Gauteng, 1619
Site Contact
Status
Active, not recruiting
Address
Suite 509 Umhlanga Netcare Medical Centre
Durban, KwaZulu-Natal, 4319
Site Contact
Status
Active, not recruiting
Address
Arthritis Clinical Research Trial Unit
Pinelands, Western Cape, 7405
Site Contact
Status
Active, not recruiting
Address
Winelands Medical Research Centre
Stellenbosch, Western Cape, 7600
Site Contact
Status
Active, not recruiting
Address
St Augustines Hospital
Durban, , 4001
Site Contact
Status
Active, not recruiting
Address
Suite 209A Jakaranda Hospital
Pretoria, , 0002
Site Contact
Status
Active, not recruiting
Address
Hospital Marina Baixa
La Vila Joiosa, Alicante, 03570
Site Contact
Status
Active, not recruiting
Address
Hospital Clinico Universitario de Santiago
Santiago de Compostela, La Coruna, 15706
Site Contact
Status
Active, not recruiting
Address
Hospital Del Sagrado Coraz
Barcelona, , 08029
Site Contact
Status
Active, not recruiting
Address
Complexo Hospitalario Universitario A Coruña, CHUAC
La Coruna, , 15006
Site Contact
Status
Active, not recruiting
Address
Hospital Infanta Luisa
Sevilla, , 41010
Site Contact
Status
Active, not recruiting
Address
Reumatologikliniken Västmanlands Sjukhus
Västerås, Västmanland, 72189
Site Contact
Status
Active, not recruiting
Address
Reumatologiska Kliniken Skånes universitetssjukhus Malmö
Malmo, , 205 02
Site Contact
Status
Active, not recruiting
Address
Centrum för reumatologi
Stockholm, , 102 35
Site Contact
Status
Active, not recruiting
Address
Reumatologiska Kliniken Karolinska Universitetssjukhuset Solna
Stockholm, , 171 76
Site Contact
Status
Active, not recruiting
Address
Kantonsspital St. Gallen
St. Gallen, Sankt Gallen, 9007
Site Contact
Status
Active, not recruiting
Address
HUG-Hôpitaux Universitaires de Genève
Genève, , 1206
Site Contact
Status
Active, not recruiting
Address
Regional Clinical Hospital Center for Emergency medical care
Kharkiv, ,
Site Contact
Status
Active, not recruiting
Address
National Scientific Center "Strazhesko institute of cardio"
Kyiv, , 03680
Site Contact
Status
Active, not recruiting
Address
Kyiv City Clinical Hospital #3
Kyiv, ,
Site Contact
Status
Active, not recruiting
Address
Multifield Medical Center of Odesa NMU (University Clinic#1)
Odesa, , 65026
Site Contact
Status
Active, not recruiting
Address
Municipal Institution of Ternopil Regional Council
Ternopil, , 46002
Site Contact
Status
Active, not recruiting
Address
Vinnytsya Regional Clinical Hospital
Vinnytsya, , 21018
Site Contact
Status
Active, not recruiting
Address
Regional Clinical Hospital of Zaporizhzhia
Zaporizhzhia, , 69600
Site Contact
Status
Active, not recruiting
Address
Addenbrookes Hospital
Cambridge, Cambridgeshire, CB2 0QQ
Site Contact
Status
Active, not recruiting
Address
Royal Cornwall Hospital
Truro, Cornwall, TR1 3LJ
Site Contact
Status
Active, not recruiting
Address
Southampton General Hospital
Southampton, Hants, SO16 6YD
Site Contact
Status
Active, not recruiting
Address
Wythenshawe Hospital
Wythenshawe, Manchester, M23 9LT
Site Contact
Status
Active, not recruiting
Address
Wishaw General Hospital
Wishaw, North Lanarkshire, ML2 0DP
Site Contact
Status
Active, not recruiting
Address
Western General Hospital
Edinburgh, Scotland, EH4 2XU
Site Contact
Status
Active, not recruiting
Address
Whipps Cross University Hospital
London, Surrey, E11 1NR
Site Contact
Status
Active, not recruiting
Address
North Tyneside General Hospital
North Shields, Tyneside, NE29 8NH
Site Contact
Status
Active, not recruiting
Address
The Dudley Group NHS Foundation Trust
Dudley, West Midlands, DY1 2HQ
Site Contact
Status
Active, not recruiting
Address
New Cross Hospital
Wolverhampton, West Midlands, WV10 0QP
Site Contact
Status
Active, not recruiting
Address
St Lukes Hospital
Bradford, West Yorkshire, BD5 0NA
Site Contact
Status
Active, not recruiting
Address
The Great Western Hospital
Swindon, Wiltshire, SN3 6BB
Site Contact
