Guselkumab in Active Psoriatic Arthritis Participants With Inadequate Response/Intolerance to One Prior Anti-TNF Alpha Agent (SOLSTICE)
Last Updated   April 24, 2024 - 21:02
OVERVIEW
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Gender
all -
Age
years -
Phase
phase 3The drug or treatment is given to large groups of people to confirm its effectiveness, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely. -
Sites
sites -
Status
Recruiting
SUMMARY
PsA is a chronic, immune-mediated inflammatory disease characterized by peripheral joint inflammation, enthesitis, dactylitis, axial disease, and the skin lesions associated with psoriasis. Guselkumab is a fully human monoclonal antibody (mAb) that binds to p19 protein subunit of interleukin (IL)-23 and blocks the binding of extracellular IL-23 to the cell surface IL-23 receptor, inhibiting IL-23 specific intracellular signaling, subsequent activation, and cytokine production. The primary hypothesis of this study is that guselkumab is superior to placebo as assessed by the proportion of participants who had an inadequate response (IR) and/or intolerance to one prior anti-tumor necrosis factor (anti-TNF) achieving an American College of Rheumatology 20 (ACR 20) response at Week 24. This study will consist of a screening phase (up to 6 weeks), blinded treatment phase (approximately up to 2 years), which includes a placebo-controlled period from Week 0 to Week 24, and an active-controlled treatment phase from Week 24 to Week 100, and safety follow-up phase (Week 112). Safety assessments will include physical examinations, vital signs, height, weight, electrocardiograms, and clinical safety laboratory assessments. The total duration of the study will be up to 118 weeks.
CONDITIONS
- Arthritis, Psoriatic
ELIGIBILITY
Inclusion Criteria:
* Have a diagnosis of active psoriatic arthritis (PsA) for at least 6 months before the first administration of study agent and meet Classification criteria for Psoriatic Arthritis (CASPAR) at screening
* Have active PsA as defined by: at least 3 swollen joints and at least 3 tender joints at screening and at baseline; and C-reactive protein (CRP) greater than or equal to (>=) 0.3 milligrams per deciliter (mg/dL) at screening from the central laboratory
* Have at least one of the following PsA subsets: distal interphalangeal joint involvement, polyarticular arthritis with absence of rheumatoid nodules, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis
* Have active plaque psoriasis, with at least one psoriatic plaque of >= 2 centimeters (cm) diameter and/or nail changes consistent with psoriasis, or documented history of plaque psoriasis
* Have an inadequate response and/or intolerance to anti-tumor necrosis factor alpha (TNF alpha) therapy, defined as presence of active PsA despite previous treatment with one prior anti-TNF alpha agent
Exclusion Criteria:
* Has other inflammatory diseases that might confound the evaluations of benefit of guselkumab therapy in the treatment of PsA, including but not limited to rheumatoid arthritis, ankylosing spondylitis/nonradiographic axial spondyloarthritis, systemic lupus erythematosus, or Lyme disease
* Has received more than 1 prior anti-tumor necrosis factor (TNF) alpha agent (or biosimilars)
* Has ever received Janus kinase (JAK) inhibitor including but not limited to tofacitinib, baricitinib, filgotinib, peficitinib, decernotinib, upadacitinib or any other investigational JAK inhibitor
* Has received any systemic immunosuppressants (example, azathioprine, cyclosporine, 6 thioguanine, mercaptopurine, mycophenolate mofetil, hydroxyurea, tacrolimus) within 4 weeks of the first administration of study intervention
* Has known allergies, hypersensitivity, or intolerance to guselkumab or its excipients
* Has a history of chronic or recurrent infectious disease, including but not limited to chronic renal infection, chronic chest infection (example, bronchiectasis), recurrent urinary tract infection (example, recurrent pyelonephritis or chronic non-remitting cystitis), fungal infection (example, mucocutaneous candidiasis), or open, draining, or infected skin wounds or ulcers
DETAILS
PsA is a chronic, immune-mediated inflammatory disease characterized by peripheral joint inflammation, enthesitis, dactylitis, axial disease, and the skin lesions associated with psoriasis. Guselkumab is a fully human monoclonal antibody (mAb) that binds to p19 protein subunit of interleukin (IL)-23 and blocks the binding of extracellular IL-23 to the cell surface IL-23 receptor, inhibiting IL-23 specific intracellular signaling, subsequent activation, and cytokine production. The primary hypothesis of this study is that guselkumab is superior to placebo as assessed by the proportion of participants who had an inadequate response (IR) and/or intolerance to one prior anti-tumor necrosis factor (anti-TNF) achieving an American College of Rheumatology 20 (ACR 20) response at Week 24. This study will consist of a screening phase (up to 6 weeks), blinded treatment phase (approximately up to 2 years), which includes a placebo-controlled period from Week 0 to Week 24, and an active-controlled treatment phase from Week 24 to Week 100, and safety follow-up phase (Week 112). Safety assessments will include physical examinations, vital signs, height, weight, electrocardiograms, and clinical safety laboratory assessments. The total duration of the study will be up to 118 weeks.
LOCATIONS
Country (14) | City or Province (169) | Status |
United States | Albuquerque, NM Albuquerque Center for Rheumatology |
RECRUITING
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United States | Baltimore, MD Johns Hopkins University |
RECRUITING
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United States | Bay Pines, FL Bay Pines VA Healthcare System |
RECRUITING
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United States | Beckley, WV Rheumatology and Pulmonary Clinic |
RECRUITING
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United States | Birmingham, AL Rheumatology Associates |
COMPLETED
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United States | Charlotte, NC DJL Clinical Research, PLLC |
RECRUITING
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United States | Chicago, IL Great Lakes Clinical Trials |
COMPLETED
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United States | Clearwater, FL Clinical Research of West Florida |
RECRUITING
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United States | Colleyville, TX Precision Comprehensive Clinical Research Solutions |
RECRUITING
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United States | Corpus Christi, TX Adriana Pop Moody MD Clinic PA |
COMPLETED
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United States | Dallas, TX Metroplex Clinical Research Center |
COMPLETED
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United States | Danbury, CT Clinical Research Center of Connecticut |
COMPLETED
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United States | DeBary, FL Omega Research Consultants |
RECRUITING
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United States | Eagan, MN St. Paul Rhuematology P A |
RECRUITING
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United States | Flagstaff, AZ Arizona Arthritis and Rheumatology Research PLLC |
RECRUITING
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United States | Fort Worth, TX Precision Comprehensive Clinical Research Solutions |
COMPLETED
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United States | Hagerstown, MD Klein And Associates M D P A |
RECRUITING
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United States | Huntington Beach, CA Newport Huntington Medical Group |
RECRUITING
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United States | Lansing, MI Great Lakes Center of Rheumatology |
RECRUITING
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United States | Las Cruces, NM Arthritis and Osteoperosis Associates of New Mexico |
COMPLETED
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United States | Lubbock, TX West Texas Clinical Research |
RECRUITING
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United States | Memphis, TN Dr. Ramesh Gupta |
RECRUITING
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United States | Mesa, AZ Arizona Arthritis and Rheumatology Research PLLC |
COMPLETED
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United States | Mesquite, TX Southwest Rheumatology Research LLC |
COMPLETED
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United States | Monroe, LA The Arthritis and Diabetes Clinic |
RECRUITING
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United States | Ocoee, FL Advanced Clinical Research of Orlando |
RECRUITING
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United States | Okemos, MI Arthritis and Rheumatology Center of MI |
RECRUITING
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United States | Oklahoma City, OK Health Research of Oklahoma |
COMPLETED
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United States | Oklahoma City, OK Rheumatology Associates of Oklahoma |
RECRUITING
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United States | Orchard Park, NY Buffalo Rheumatology and Medicine PLLC |
RECRUITING
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United States | Phoenix, AZ Arizona Arthritis and Rheumatology Research PLLC |
RECRUITING
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United States | Phoenix, AZ Arizona Arthritis and Rheumatology Research PLLC |
RECRUITING
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United States | Plano, TX Texas Rheumatology Care |
RECRUITING
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United States | Plantation, FL Integral Rheumatology And Immunology Specialists |
RECRUITING
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United States | Saint Clair Shores, MI Clinical Research Institute of Michigan, LLC |
COMPLETED
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United States | Saint Louis, MO Arthritis Consultants |
COMPLETED
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United States | Searcy, AR Unity Health-White County Medical Center |
COMPLETED
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United States | Skokie, IL Clinic of Robert Hozman |
RECRUITING
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United States | Spokane, WA Arthritis Northwest PLLC |
COMPLETED
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United States | Sun City, AZ Arizona Arthritis and Rheumatology Associates |
RECRUITING
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United States | Tampa, FL Clinical Research of West Florida |
RECRUITING
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United States | The Woodlands, TX Advanced Rheumatology of Houston |
RECRUITING
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United States | Thousand Oaks, CA Medvin Clinical Research |
COMPLETED
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United States | Tomball, TX DM Clinical Research |
RECRUITING
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United States | Tucson, AZ Southern Arizona VA Healthcare System |
RECRUITING
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United States | Tujunga, CA Medvin Clinical Research |
RECRUITING
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United States | Vandalia, OH STAT Research, Inc. |
COMPLETED
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United States | Voorhees, NJ Arthritis Rheumatic And Back Disease Associates |
RECRUITING
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United States | Waco, TX Arthritis & Osteoporosis Clinic |
RECRUITING
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United States | Zephyrhills, FL Florida Medical Clinic, P.A. |
RECRUITING
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Ukraine | Cherkasy Communal Noncommercial Enterprise Cherkasy Regional Hospital of Cherkasy Regional Council |
TERMINATED
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Ukraine | Kharkiv Municipal non-commercial enterprise of Kharkiv Regional Council Regional Clinical Hospital |
COMPLETED
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Ukraine | Khmelnytsky Khmelnitckiy regional hospital |
COMPLETED
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Ukraine | Kryvyi Rih City Clinical Hospital No. 2 |
TERMINATED
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Ukraine | Kyiv Kyiv City Clinical Hospital #3 |
COMPLETED
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Ukraine | Kyiv Kyiv Railway Clinical Hospital #2 Of Branch 'Health Center' Of The Company 'Ukrainian Railway' |
COMPLETED
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Ukraine | Kyiv Medical Center 'Consylium Medical' |
COMPLETED
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Ukraine | Kyiv Medical Center LLC 'Harmony of Beauty' |
TERMINATED
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Ukraine | Kyiv Medical Center of 'Institute of Rheumatology', LLC |
COMPLETED
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Ukraine | Kyiv SI National Scientific Center Institute of Cardiology of M.D. Strazhesko of NAMS of Ukraine |
COMPLETED
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Ukraine | Lutsk Volyn Regional Clinical Hospital |
COMPLETED
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Ukraine | Odessa LLC Medical House |
TERMINATED
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Ukraine | Poltava ME Poltava Regional Clinical Hospital named after M.V. Sklifosovsky of Poltava Regional Consuil |
SUSPENDED
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Ukraine | Vinnytsya Vinnitsia Regional Clinical Hospital n.a. M. I. Pyrogov |
TERMINATED
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Ukraine | Zaporizhzhya Medical Center LLC 'Modern Clinic' |
SUSPENDED
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Turkey | Adana Adana City Hospital |
RECRUITING
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Turkey | Ankara Ankara Bilkent City Hospital |
RECRUITING
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Turkey | Ankara Gulhane Training and Research Hospital |
RECRUITING
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Turkey | Ankara Hacettepe University Medical Faculty |
RECRUITING
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Turkey | Antalya Akdeniz University Medical Faculty |
RECRUITING
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Turkey | Bursa Uludag University Medical Faculty |
RECRUITING
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Turkey | Denizli Pamukkale University Medical Faculty |
RECRUITING
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Turkey | Eskisehir Osmangazi University Medical Faculty |
COMPLETED
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Turkey | Istanbul Istanbul University Cerrahpasa Medical Faculty |
COMPLETED
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Turkey | Istanbul Istanbul University Istanbul Medical Faculty |
COMPLETED
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Turkey | Istanbul Kartal Dr Lutfi Kirdar sehir Hastanesi |
RECRUITING
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Turkey | Istanbul Marmara University Medical Faculty |
RECRUITING
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Turkey | Kocaeli Kocaeli University Medical Faculty |
COMPLETED
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Turkey | Konya Necmettin Erbakan University Meram Medical Faculty |
RECRUITING
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Spain | Barakaldo Hosp. Univ. de Cruces |
RECRUITING
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Spain | Madrid, MD Hosp. Quiron Madrid Pozuelo |
RECRUITING
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Spain | Madrid, MD Hosp. Univ. de La Princesa |
RECRUITING
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Spain | Málaga Hosp. Regional Univ. de Malaga |
RECRUITING
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Spain | Santiago de Compostela Clinica Gaias |
RECRUITING
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Spain | Sevilla Hosp. Quiron Sagrado Corazon |
RECRUITING
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Spain | Valencia, VC Hosp. Clinico Univ. de Valencia |
RECRUITING
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Russia | Barnaul Altay Medical State University |
SUSPENDED
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Russia | Chelyabinsk Chelyabinck Regional Clinical Hospital |
TERMINATED
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Russia | Chelyabinsk Chelyabinsk Regional Clinical Dermatovenerological Dispensary |
SUSPENDED
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Russia | Kemerovo Kemerovo State Medical University |
SUSPENDED
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Russia | Kemerovo LLL Medical Center Revma-Med |
SUSPENDED
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Russia | Korolev LLC Family Outpatient Clinic # 4 |
COMPLETED
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Russia | Krasnodar Krasnodar Clinical Dermatovenerologic Dispensary |
SUSPENDED
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Russia | Krasnoyarsk Regional SBI of PH Krasnoyarsk Regional Clinical hospital #20 named after I.S. Berzon |
TERMINATED
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Russia | Moscow Clinical-Diagnostic Center Euromedservice, JSC |
TERMINATED
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Russia | Moscow FGBU Research Institute of Rheumatology named V.A.Nasonova |
TERMINATED
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Russia | Moscow GBUZ of Moscow Region 'Moscow Region SRI n.a. Vladimirskyi' |
SUSPENDED
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Russia | Orenburg GBOU VPO Orenburg State Medical University |
TERMINATED
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Russia | Rostov Rostov Regional Clinical Dermatovenerological Dispensary |
SUSPENDED
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Russia | Saratov Saratov Regional Clinical Hospital |
TERMINATED
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Russia | Smolensk Smolensk regional hospital on Smolensk railway station |
TERMINATED
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Russia | St. Petersburg St. Petersburg GBUZ Clinical Reumatological Hospital 25 |
TERMINATED
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Russia | St. Petersburg X7 Clinical Research Company Limited |
TERMINATED
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Russia | Tolyatti GBUZ of Samara Region 'Tolyatti City Clinical Hospital 5' |
TERMINATED
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Russia | Tula Tula Regional Clinical Dermatovenerological Dispensary |
TERMINATED
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Russia | Ufa Republican Clinical Hospital - G.G. Kuvatov |
COMPLETED
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Puerto Rico | San Juan FDI Clinical Research |
RECRUITING
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Puerto Rico | San Juan GCM Medical Group |
RECRUITING
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Puerto Rico | San Juan Mindful Medical Research |
RECRUITING
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Poland | Bytom Nzoz Bif Med |
COMPLETED
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Poland | Elblag Centrum Kliniczno Badawcze |
RECRUITING
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Poland | Krakow Centrum Medyczne Promed |
COMPLETED
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Poland | Krakow Malopolskie Badania Kliniczne Sp z o o |
RECRUITING
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Poland | Krakow Malopolskie Centrum Kliniczne |
RECRUITING
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Poland | Lodz Centrum Terapii Wspolczesnej J M Jasnorzewska Spolka Komandytowo Akcyjna |
RECRUITING
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Poland | Lodz Dermed Centrum Medyczne Sp z o o |
RECRUITING
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Poland | Nadarzyn NZOZ Lecznica MAK MED S C |
RECRUITING
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Poland | Nowa Sol Twoja Przychodnia - Centrum Medyczne Nowa Sol |
RECRUITING
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Poland | Poznan Centrum Medyczne |
RECRUITING
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Poland | Poznan Twoja Przychodnia |
RECRUITING
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Poland | Swidnik Lubelskie Centrum Diagnostyczne |
COMPLETED
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Poland | Warsaw MICS Centrum Medyczne Warszawa |
RECRUITING
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Poland | Warszawa Centrum Medyczne Reuma Park |
RECRUITING
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Poland | Warszawa Rheuma-Medicus, Zaklad Opieki Zdrowotnej |
RECRUITING
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Poland | Wrocław WroMedica I.Bielicka, A.Strzałkowska s.c. |
RECRUITING
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Malaysia | Batu Caves, SL Hospital Selayang |
COMPLETED
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Malaysia | George Town Hospital Pulau Pinang |
COMPLETED
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Malaysia | Ipoh, PK Hospital Raja Permaisuri Bainun |
RECRUITING
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Malaysia | Seremban, NS Hospital Tuanku Jaafar |
COMPLETED
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Israel | Haifa, H Bnai Zion Medical Center |
RECRUITING
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Israel | Haifa, H Rambam Health Care Campus |
RECRUITING
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Israel | Hifa, H Carmel Medical Center |
RECRUITING
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Israel | Kfar-Sava Meir Medical Center |
COMPLETED
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Israel | Ramat Gan Sheba Medical Center |
RECRUITING
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Hungary | Budapest Betegapolo Irgalmas Rend - Budai Irgalmasrendi Korhaz |
RECRUITING
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Hungary | Budapest Uno Medical Trials Ltd. |
RECRUITING
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Hungary | Debrecen Debreceni Egyetem, Kenézy Gyula Egyetemi Oktatókórház |
COMPLETED
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Hungary | Gyula Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz |
RECRUITING
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Hungary | Kistarcsa Pest Megyei Flor Ferenc Korhaz |
RECRUITING
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Hungary | Szeged Szegedi Tudományegyetem, ÁOK, Szent-Györgyi Albert Klinikai Központ |
RECRUITING
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Hungary | Szekesfehervar Fejer Varmegyei Szent Gyorgy Egyetemi Oktatokorhaz |
RECRUITING
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Hungary | Veszprem Vital Medical Center Orvosi es Fogaszati Kozpont |
RECRUITING
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Czechia | Breclav RHEUMA s r o |
RECRUITING
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Czechia | Hlucin L K N Arthrocentrum |
RECRUITING
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Czechia | Ostrava MUDr Rosypalova s r o |
RECRUITING
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Czechia | Pardubice Arthrohelp S.R.O. |
RECRUITING
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Czechia | Praha 2 Revmatologicky ustav |
RECRUITING
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Czechia | Uherske Hradiste Medical Plus S R O |
RECRUITING
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Czechia | Zlin PV Medical S R O |
COMPLETED
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Bulgaria | Pleven UMHAT 'Dr. Georgi Stranski', EAD |
RECRUITING
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Bulgaria | Plovdiv Medical Center Unimed Plovdiv |
RECRUITING
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Bulgaria | Plovdiv UMHAT Kaspela |
RECRUITING
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Bulgaria | Ruse, 18 Diagnosis-consulting centre-1 |
RECRUITING
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Bulgaria | Sfia UMHAT St. Ivan Rilski |
RECRUITING
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Bulgaria | Sofia ASIMP Rheumatology Centre St Irina EOOD |
RECRUITING
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Bulgaria | Sofia Medical Centre Synexus |
COMPLETED
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Bulgaria | Sofia Military Medical Academy |
COMPLETED
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Bulgaria | Sofia University Multiprofile Hospital Sofiamed Sofia |
COMPLETED
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Australia | Hobart, TAS Southern Clinical Research |
TERMINATED
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Australia | Liverpool, NSW Liverpool Hospital |
TERMINATED
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Australia | Melbourne, VIC Eastern Health - Box Hill Hospital |
TERMINATED
|
Australia | Melbourne, VIC Skin Health Institute Inc. |
TERMINATED
|
Argentina | Buenos Aires, B Centro Privado de Medicina Familiar |
RECRUITING
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Argentina | Buenos Aires, B Cosultorios Reumatologógicos Pampa |
RECRUITING
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Argentina | Buenos Aires, B Hospital Central Militar Cirujano Mayor Dr Cosme Argerich |
RECRUITING
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Argentina | Ciudad Autonoma de Buenos Aires, B CIPREC |
RECRUITING
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Argentina | Ciudad Autónoma de Buenos Aires, B OMI |
RECRUITING
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Argentina | Ciudad de Mendoza Instituto de Reumatología Mendoza |
RECRUITING
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Argentina | San Miguel De Tucuman Centro de Investigaciones Medicas Tucuman |
RECRUITING
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