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NCT06878404Active, not recruitingPhase 3

A Study to Evaluate the Efficacy and Safety of JNJ-77242113 (Icotrokinra) in Biologic-naïve Participants With Active Psoriatic Arthritis

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of JNJ-77242113 for the Treatment of Biologic-naïve Participants With Active Psoriatic Arthritis

Source: ClinicalTrials.gov · Last updated 3 Nov 2026

Brief summary (registry, in English)

The purpose of this study is to evaluate the efficacy of icotrokinra compared to placebo in participants with active psoriatic arthritis (PsA) by assessing the reduction in signs and symptoms of PsA.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
552 (actual)
First submitted
13 Mar 2025
Start date
21 Feb 2025
Primary completion date
25 May 2026
Lead sponsor
Janssen Research & Development, LLC
NCT number
NCT06878404
EU CT number
2023-509239-19-00

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 552
  • From 21 Feb 2025 to the primary completion date, 25 May 2026
  • 154 sites in 16 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Has previously received any biologic disease-modifying antirheumatic drugs (DMARDs) for PsA or psoriasis

Other illness

  • Has a history or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic (with the exception of PsA), psychiatric, genitourinary, or metabolic disturbances
  • Has known allergies, hypersensitivity, or intolerance to icotrokinra or its excipients
  • Has other inflammatory diseases that might confound the evaluations of benefit of icotrokinra therapy, including but not limited to rheumatoid arthritis (RA), systemic lupus erythematosus, or lyme disease

Other

  • Participants with fibromyalgia or osteoarthritis symptoms that, in the investigator's opinion, would have potential to interfere with efficacy assessments

Who the study is looking for

  • Have a diagnosis of psoriatic arthritis (PsA) for at least 3 months before the first administration of study intervention and meet classification criteria for psoriatic arthritis (CASPAR) at screening
  • Have active PsA as defined by: (a) At least 3 swollen joints and at least 3 tender joints at screening and at baseline (b) C-reactive protein (CRP) greater than or equal to (\>=) 0.1 milligrams per deciliter (mg/dL) at screening from the central laboratory
  • Have at least 1 of the PsA subsets: distal interphalangeal joint involvement, polyarticular arthritis with absence of rheumatoid nodules, arthritis mutilans, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis
  • Have active plaque psoriasis with at least one psoriatic plaque of \>= 2 cm diameter or nail changes consistent with psoriasis
  • A female participant of childbearing potential must have a negative highly sensitive serum pregnancy test (Beta-hCG) at screening and a negative urine pregnancy test at Week 0 prior to administration of study intervention

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (154)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hospital Central Militar Cirujano Mayor Dr Cosme Argerich
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Buenos AiresArgentinaUnknown status
Cosultorios Reumatologógicos Pampa
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Buenos AiresArgentinaUnknown status
Mindout Research
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Buenos AiresArgentinaUnknown status
Arsema
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Ciudad de Buenos AiresArgentinaUnknown status
Centro Medico Privado de Reumatologia Tucuman
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Ciudad de San Miguel de TucumanArgentinaUnknown status
Consultora Integral de Salud SRL
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CórdobaArgentinaUnknown status
MR Medicina Reumatologica
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San FernandoArgentinaUnknown status
Instituto Medico De Alta Complejidad (IMAC)
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San IsidroArgentinaUnknown status
Ipswich Hospital
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IpswichAustraliaUnknown status
Rheumatology Research Unit
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MaroochydoreAustraliaUnknown status
BJC Health
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ParramattaAustraliaUnknown status
Queen Elizabeth Hospital
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South WoodvilleAustraliaUnknown status
Royal Darwin Hospital
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TiwiAustraliaUnknown status
Medical Center MedTech Services Ltd.
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HaskovoBulgariaActive, not recruiting
Medical Center Exacta Medica OOD
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PlevenBulgariaActive, not recruiting
Medical center "Artmed" LTD
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PlovdivBulgariaActive, not recruiting
Medical Center Teodora EOOD
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RuseBulgariaActive, not recruiting
Beijing Tong Ren Hospital, Capital Medical University
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BeijingChinaUnknown status
Peking University Third Hospital
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BeijingChinaUnknown status
The First Bethune Hospital of Jilin University
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ChangchunChinaUnknown status
Xiangya Hospital Central South University
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ChangshaChinaUnknown status
Sichuan Provincial Peoples Hospital
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ChengduChinaUnknown status
West China Hospital,Sichuan University
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ChengduChinaUnknown status
The First Affiliated Hospital of Chongqing Medical University
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ChongqingChinaUnknown status
Nanfang Hospital of Southern Medical Hospital
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GuangzhouChinaUnknown status
The Affiliated Hospital of Guizhou Medical University
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GuiyangChinaUnknown status
Linyi City People Hospital
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LinyiChinaUnknown status
The Second Affiliated Hospital of Nanchang University
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NanchangChinaUnknown status
Jiangxi Provincial Peoples Hospital
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NanchangChinaUnknown status
Affiliated Hospital of Nantong University
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NantongChinaUnknown status
Pingxiang People's Hospital
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PingxiangChinaUnknown status
Shanghai Skin Disease Hospital
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ShanghaiChinaUnknown status
Huashan Hospital, Fudan University
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ShanghaiChinaUnknown status
Shenzhen People's Hospital
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ShenzhenChinaUnknown status
The Third Hospital of Hebei Medical University
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ShijiazhuangChinaUnknown status
Second Affiliated Hospital of Soochow University
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SuzhouChinaUnknown status
Shanxi Bethune Hospital
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TaiyuanChinaUnknown status
The First Affiliated Hospital of Wenzhou Medical University
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WenzhouChinaUnknown status
The Second Affiliated Hospital of Xi'an Jiaotong University
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Xi'anChinaUnknown status
Affiliated Hospital of Jiangsu University
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ZhenjiangChinaUnknown status
Rheuma s.r.o.
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BřeclavCzechiaActive, not recruiting
Revmatologie s.r.o.
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Brno-SeverCzechiaActive, not recruiting
Revmacentrum MUDr Mostera s r o
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Brno-ŽideniceCzechiaActive, not recruiting
L.K.N. Arthrocentrum, s.r.o.
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HlučínCzechiaActive, not recruiting
Revimex pro s.r.o.
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KarvinaCzechiaActive, not recruiting
CCR Ostrava s.r.o.
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Moravska Ostrava A PrivozCzechiaActive, not recruiting
MUDr. Rosypalova s.r.o.
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PorubaCzechiaActive, not recruiting
Fakultni nemocnice v Motole
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PragueCzechiaActive, not recruiting
Revmatologicky Ustav
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Prague 2CzechiaActive, not recruiting
Fakultni Thomayerova nemocnice
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Prague 4CzechiaActive, not recruiting
MUDr. Zuzana Stejfova
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Praha 4CzechiaActive, not recruiting
MEDICAL PLUS s.r.o.
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Uherské HradištěCzechiaActive, not recruiting
PV Medical Services s.r.o.
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ZlínCzechiaActive, not recruiting
Thermalsole und Schwefelbad Bentheim GmbH
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Bad BentheimGermanyActive, not recruiting
Charite Universitaetsmedizin Berlin KöR
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BerlinGermanyActive, not recruiting
ISA - Interdisciplinary Study Association GmbH
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BerlinGermanyActive, not recruiting
Technische Universitaet Dresden
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DresdenGermanyActive, not recruiting
Medical Center- University of Freiburg
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Freiburg im BreisgauGermanyActive, not recruiting
MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH
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HamburgGermanyActive, not recruiting
St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr
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HerneGermanyActive, not recruiting
Studienzentrum Dr. Schwarz
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LangenauGermanyActive, not recruiting
Johannes Wesling Klinikum Minden
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MindenGermanyActive, not recruiting
Eberhard Karls Universitaet Tuebingen
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TuebingenGermanyActive, not recruiting
Region Midtjylland
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Aarhus NDenmarkActive, not recruiting
Esbjerg Og Grindsted Sygehus
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EsbjergDenmarkActive, not recruiting
Frederiksberg Hospital
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FrederiksbergDenmarkActive, not recruiting
Region Midtjylland
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HerningDenmarkActive, not recruiting
Odense University Hospital
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SvendborgDenmarkActive, not recruiting
Lillebaelt Hospital
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VejleDenmarkActive, not recruiting
Complexo Hospitalario Universitario A Coruña
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A CoruñaSpainActive, not recruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainActive, not recruiting
Hospital Universitario Reina Sofia
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CórdobaSpainActive, not recruiting
Hospital Universitario 12 de Octubre
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MadridSpainActive, not recruiting
Hospital Universitario Regional de Málaga
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MálagaSpainActive, not recruiting
Parc Tauli Hospital Universitari
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SabadellSpainActive, not recruiting
Hospital Universitario Marqués de Valdecilla
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SantanderSpainActive, not recruiting
Hospital Universitario Virgen De La Macarena
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SevillaSpainActive, not recruiting
Hospital Quironsalud Infanta Luisa
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SevillaSpainActive, not recruiting
Hospital Quironsalud Sagrado Corazon
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SevillaSpainActive, not recruiting
University Hospital Virgen Del Rocio S.L.
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SevillaSpainActive, not recruiting
Prince of Wales Hospital
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Hong KongHong Kong SAR ChinaUnknown status
Qualiclinic Kft.
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BudapestHungaryActive, not recruiting
Betegapolo Irgalmasrend Budai Irgalmasrendi Korhaz
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Budapest IIHungaryActive, not recruiting
Revita Kft.
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Budapest IIHungaryActive, not recruiting
Obudai Egeszseguegyi Centrum Kft.
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Budapest IIIHungaryActive, not recruiting
Uno Medical Trials Kft.
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Budapest XVHungaryActive, not recruiting
University of Debrecen
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DebrecenHungaryActive, not recruiting
Bekes Varmegyei Koezponti Korhaz
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GyulaHungaryActive, not recruiting
Obudai Egeszseguegyi Centrum Kft.
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KaposvarHungaryActive, not recruiting
University of Szeged
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SzegedHungaryActive, not recruiting
Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz
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SzekesfehervarHungaryActive, not recruiting
Szolnoki Mav Korhaz Es Rendelointezet
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SzolnokHungaryActive, not recruiting
Vital-Medicina Kft.
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VeszpremHungaryActive, not recruiting
Marengo CIMS Hospital
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AhmedabadIndiaUnknown status
Apollo Hospitals
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BhubaneswarIndiaUnknown status
Nizams Institute of Medical Sciences
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HyderabadIndiaUnknown status
Apollo Multispeciality Hospital Ltd
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KolkataIndiaUnknown status
Kokilaben Dhirubhai Ambani Hsp And Med Research Inst
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MumbaiIndiaUnknown status
JSS Hospital
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MysuruIndiaUnknown status
Indraprastha Apollo Hospital
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New DelhiIndiaUnknown status
All India Institute of Medical Sciences
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New DelhiIndiaUnknown status
Fortis Hospital
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NoidaIndiaUnknown status
SIDS Hospital & Research Centre
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SuratIndiaUnknown status
Fukuoka University Hospital
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FukuokaJapanUnknown status
Kagawa University Hospital
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Kita-gunJapanUnknown status
Nagoya City University Hospital
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NagoyaJapanUnknown status
Maeshima Rheumatology Clinic
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ŌitaJapanUnknown status
Public Interest Incorporated Foundation Nipoon Life Saiseikai Nippon Life Hospital
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OsakaJapanUnknown status
Sasebo Chuo Hospital
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SaseboJapanUnknown status
Tohoku University Hospital
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SendaiJapanUnknown status
Teikyo University Hospital
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tabashi CityJapanUnknown status
Kyorin University Hospital
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TokyoJapanUnknown status
Mie University Hospital
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TsuJapanUnknown status
Osteo Medic s.c. Artur Racewicz Jerzy Supronik
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BialystokPolandActive, not recruiting
Clinicmed Daniluk Nowak Sp. k.
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BialystokPolandActive, not recruiting
Specderm Poznanska sp.j.
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BialystokPolandActive, not recruiting
Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy
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BydgoszczPolandActive, not recruiting
Pratia S.A.
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CracowPolandActive, not recruiting
Malopolskie Badania Kliniczne Sp. z o.o.
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CracowPolandActive, not recruiting
Centrum Medyczne All-Med Badania Kliniczne
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CracowPolandActive, not recruiting
Centrum Kliniczno-Badawcze J.Brzezicki B.Gornikiewicz-Brzezicka Lekarze sp.p.
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ElblagPolandActive, not recruiting
Ambulatorium Sp. z o.o.
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ElblagPolandActive, not recruiting
Pratia S.A.
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GdyniaPolandActive, not recruiting
Specjalistyczny Gabinet Dermatologiczny Aplikacyjno Badawczy Marek Brzewski Paweł Brzewski s.c.
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KrakowPolandActive, not recruiting
DERMED Centrum Medyczne Sp. z o.o.
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LodzPolandActive, not recruiting
Reumed Sp. z o.o.
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LublinPolandActive, not recruiting
NZOZ Lecznica MAK MED S C
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NadarzynPolandActive, not recruiting
Etyka Osrodek Badan Klinicznych Tomasz Pesta S.K.A.
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OlsztynPolandActive, not recruiting
Medicover Integrated Clinical Services Sp. z o.o.
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TorunPolandActive, not recruiting
Klinika Reuma Park Sp. z o.o. S.K.
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WarsawPolandActive, not recruiting
Medicover Integrated Clinical Services Sp. z o.o.
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WarsawPolandActive, not recruiting
Centrum Medyczne Oporow
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WroclawPolandActive, not recruiting
dermMedica Sp. z o.o
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WroclawPolandActive, not recruiting
Phramongkutklao Hospital
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BangkokThailandUnknown status
Rajavithi Hospital
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BangkokThailandUnknown status
Siriraj Hospital
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BangkokThailandUnknown status
Saraburi Hospital
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Changwat Sara BuriThailandUnknown status
Phra Nakhon Si Ayutthaya Hospital
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Phra Nakhon Si AyutthayaThailandUnknown status
Songklanagarind Hospital
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SongkhlaThailandUnknown status
National Taiwan University Hospital Hsin Chu Branch
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HsinchuTaiwanUnknown status
Chang Gung Memorial Hospital
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Kaohsiung CityTaiwanUnknown status
National Cheng Kung University Hospital
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TainanTaiwanUnknown status
Chi Mei Medical Center Yong Kang
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TainanTaiwanUnknown status
Taipei Veterans General Hospital
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TaipeiTaiwanUnknown status
Linkou Chang Gung Memorial Hospital
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TaoyuanTaiwanUnknown status
Arthritis and Rheumatology Research Institute
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AllenUnited StatesUnknown status
Joint and Muscle Research Institute
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CharlotteUnited StatesUnknown status
Omega Research Consultants
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DeBaryUnited StatesUnknown status
Altoona Center For Clinical Research
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DuncansvilleUnited StatesUnknown status
Naiara Alvarez MD Integrative Rheumatology of South TX
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HarlingenUnited StatesUnknown status
Arthritis and Rheumatism Associates ARA Jonesboro
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JonesboroUnited StatesUnknown status
Integral Rheumatology And Immunology Specialists
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PlantationUnited StatesUnknown status
Clinical Research of West Florida
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TampaUnited StatesUnknown status
Willow Rheumatology and Wellness PLLC
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WillowbrookUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.