SOLSTICE: Guselkumab in Active Psoriatic Arthritis Participants With Inadequate Response/Intolerance to One Prior Anti-TNF Alpha Agent
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy of guselkumab treatment in participants with active psoriatic arthritis (PsA) and inadequate response (IR) and/or intolerance to a prior anti-tumor necrosis factor (TNF) by assessing the reduction in signs and symptoms of PsA.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Group 1: Guselkumab and Placebo Participants will receive guselkumab and placebo subcutaneously (SC) to maintain the blind. |
Drug: Guselkumab
Participants will receive guselkumab as SC injection.
Other Names:
Drug: Placebo
Participants will receive matching placebo as SC injection.
|
| Experimental: Group 2: Guselkumab Participants will receive guselkumab SC. |
Drug: Guselkumab
Participants will receive guselkumab as SC injection.
Other Names:
|
| Experimental: Group 3: Placebo Followed by Guselkumab Participants will receive placebo SC and will cross over to receive guselkumab SC. |
Drug: Guselkumab
Participants will receive guselkumab as SC injection.
Other Names:
Drug: Placebo
Participants will receive matching placebo as SC injection.
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants Who Achieve an American College of Rheumatology (ACR) 20 Response at Week 24 [Week 24]
The ACR 20 Response is defined as greater than or equal to (>=) 20 percent (%) improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints) and >=20 percent (%) improvement from baseline in 3 of following 5 assessments: participant's assessment of pain using Visual Analog Scale (VAS; 0-100 millimeter [mm], 0 mm=no pain and 100 mm=worst possible pain), participant's global assessment of disease activity by using VAS (scale ranges from 0 mm to 100 mm, [0 mm= very well to 100 mm= very poor]), physician's global assessment of disease activity using VAS (scale ranges from 0 to 100), [0 = no arthritis to 100 = extremely active arthritis], participant's assessment of physical function measured by Health Assessment Questionnaire-disability Index (HAQ-DI, defined as a 20-question instrument assessing 8 functional areas. The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and CRP.
Secondary Outcome Measures
- Percentage of Participants who Achieve a Psoriasis Response of IGA Psoriasis Score of 0 or 1 and >=2 Grade Reduction From Baseline at Week 24 Among Participants With >=3% Body Surface Area (BSA) Psoriatic Involvement and IGA Score of >=2 at Baseline [Week 24]
Psoriasis response is defined as an Investigator's Global Assessment (IGA) psoriasis score of 0 (cleared) or 1 (minimal) and >=2- grade reduction from baseline. The IGA documents the investigator's assessment of the participants psoriasis and lesions are graded for induration, erythema and scaling, each using a 5-point scale: 0 (no evidence), 1 (minimal), 2 (mild), 3 (moderate), and 4 (severe). The IGA score of psoriasis is based upon the average of induration, erythema and scaling scores. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
- Percentage of Participants who Achieve PASI 90 Response at Week 24 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline [Week 24]
Psoriasis Area and Severity Index (PASI) is a tool to assess and grade severity of psoriasis and response to therapy. In PASI, body is divided into 4 areas: head, trunk, upper extremities, lower extremities. Each area is assessed separately for percentage of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90 to 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severity. PASI numeric score range from 0 (no psoriasis) to 72. Higher scores indicate more severe disease. A PASI 90 response: >=90% improvement in PASI score from baseline.
- Change From Baseline in HAQ-DI Score at Week 24 [Baseline and Week 24]
HAQ-DI score assess functional status of participant. It is 20 question instrument that assess degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0=indicating no difficulty, to 3=indicating inability to perform a task in that area. Total HAQ score is average of the computed categories scores ranging from 0-3 where 0=least difficulty and 3=extreme difficulty. Lower scores are indicative of better functioning. Negative change from baseline indicates improvement of physical function.
- Change From Baseline in 36-item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score at Week 24 [Baseline and Week 24]
SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health), which yielded a PCS with score range 0-100 (higher score-better quality of life) and a Mental Component Summary (MCS) with score range 0-100 (higher score-better quality of life) in addition to subscale scores. The PCS scores are normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. A positive change indicates improvement while a negative change indicates worsening of health status and quality of life.
- Change From Baseline in Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-F) Score at Week 24 [Baseline and Week 24]
The FACIT-F is a questionnaire that assesses self-reported tiredness, weakness, and difficulty conducting usual activities due to fatigue. The subscale consists 13-item instrument to measure fatigue. Each of the 13 items has a set of five response categories: Not at all (=0), A little bit (=1), Somewhat (=2), Quite a bit (=3) and Very much (=4). A total FACIT-Fatigue subscale score is calculated as the sum of the 13 item scores (reserved scores [4 - score]) and ranges from 0 to 52, with a higher score indicating less fatigue. Positive changes from baseline indicate improvement of fatigue. Items are reverse scored when appropriate to provide a scale in which higher scores represent better functioning or less fatigue.
- Percentage of Participants Achieving Minimal Disease Activity (MDA) at Week 24 [Week 24]
MDA is considered achieved if at least 5 of the following 7 criteria were met at the analysis visit: tender joint count <=1; swollen joint count <=1; psoriasis activity and severity index <=1; patient's pain VAS score of <=15; patient's global disease activity VAS (arthritis and psoriasis) score of <=20; HAQ-DI <=0.5; and tender entheseal points <=1.
- Percentage of Participants who Achieve ACR 20 Response at Week 16 [Week 16]
ACR 20 response: >=20% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >=20% improvement from baseline in 3 of 5 assessments: patient's assessment of pain using visual analog scale (VAS; 0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by Disability Index of Health Assessment Questionnaire (HAQ-DI; 20-question instrument assessing 8 functional areas; range: 0-3, 0=indicating no difficulty, 3=indicating inability to perform task in that area), and CRP.
- Percentage of Participants who Achieve ACR 50 Response at Week 16 [Week 16]
ACR 50 response is defined as >=50% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >=50% improvement from baseline in 3 of 5 assessments: patient's assessment of pain using visual analog scale (VAS; 0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI; a 20-question instrument assessing 8 functional areas; range: 0-3, 0=no difficulty, 3=inability to perform a task in that area), and CRP.
- Percentage of Participants who Achieve ACR 50 Response at Week 24 [Week 24]
ACR 50 response is defined as >=50 percent (%) improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >=50% improvement from baseline in 3 of 5 assessments: patient's assessment of pain using visual analog scale (VAS; 0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI; a 20-question instrument assessing 8 functional areas; range: 0-3, 0=no difficulty, 3=inability to perform a task in that area), and CRP.
- Percentage of Participants who Achieve ACR 70 Response at Week 24 [Week 24]
ACR 70 response is defined as >= 70% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >=70% improvement from baseline in 3 of 5 assessments: patient's assessment of pain using visual analog scale (VAS; 0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI; a 20-question instrument assessing 8 functional areas; range: 0-3, 0=no difficulty, 3=inability to perform a task in that area), and CRP.
- Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Reasonably Related AEs, as a Measure of Safety and Tolerability [Up to 60 weeks]
Percentage of participants with AEs, SAEs reasonably related AEs will be assessed. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect, and suspects transmission of any infectious agent via a medicinal product. Reasonably related AEs are those AEs which are judged related to study treatment by the investigator.
- Percentage of Participants With AEs leading to Discontinuation of Study Intervention [Up to 60 weeks]
Percentage of participants with AEs leading to discontinuation of study intervention will be reported.
- Percentage of Participants With Infections [Up to 60 weeks]
Percentage of participants with infections will be reported.
- Percentage of Participants With Injection-site Reactions [Up to 48 weeks]
Percentage of participants with injection-site reactions will be reported. An injection-site reaction is any adverse reaction at a subcutaneous (SC) study intervention injection-site.
- Percentage of Participants With Change from Baseline in Clinical Laboratory Abnormalities [Up to 60 weeks]
Percentage of participants with change from baseline in clinical laboratory abnormalities including chemistry and hematology will be reported.
- Percentage of participants With Laboratory Abnormalities With Maximum Toxicity Grades as per Common Terminology Criteria for Adverse Events (CTCAE) Toxicity [Up to 60 weeks]
Percentage of participants with laboratory abnormalities (hematology, chemistry) with maximum toxicity grades as per CTCAE will be reported. Grade refers to the severity of the AE as follows: Grade 1- Mild, asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2- Moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental Activities of Daily Living (ADL); Grade 3- Severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated, disabling, limiting self-care ADL; Grade 4- Life-threatening consequences, urgent intervention indicated; Grade 5- Death related to AE.
- Serum Guselkumab Concentration [Up to 60 weeks]
Serum guselkumab concentration will be measured.
- Percentage of Participants With Anti-guselkumab Antibodies [Up to 60 weeks]
Percentage of participants with anti-guselkumab antibodies to guselkumab will be reported.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Arthritis Associates | Birmingham | Alabama | United States | 32505 |
| 2 | Arizona Arthritis and Rheumatology Research, PLLC | Flagstaff | Arizona | United States | 86001-6218 |
| 3 | Arizona Arthritis and Rheumatology Research, PLLC | Mesa | Arizona | United States | 85210 |
| 4 | Arizona Arthritis and Rheumatology Research, PLLC | Phoenix | Arizona | United States | 85032 |
| 5 | Arizona Arthritis and Rheumatology Research, PLLC | Phoenix | Arizona | United States | 85037 |
| 6 | Arizona Arthritis & Rheumatology Associates | Sun City | Arizona | United States | 85351 |
| 7 | Southern Arizona VA Healthcare System | Tucson | Arizona | United States | 85723 |
| 8 | Medvin Clinical Research | Covina | California | United States | 91722 |
| 9 | Newport Huntington Medical Group | Huntington Beach | California | United States | 92648 |
| 10 | Medvin Clinical Research | Thousand Oaks | California | United States | 91360 |
| 11 | Medvin Clinical Research | Tujunga | California | United States | 91042 |
| 12 | Clinical Research Center of Connecticut | Danbury | Connecticut | United States | 06810 |
| 13 | Bay Pines VA Healthcare System | Bay Pines | Florida | United States | 33744 |
| 14 | Clinical Research of West Florida | Clearwater | Florida | United States | 33765 |
| 15 | The Center for Arthritis and Rheumatic Diseases | Miami | Florida | United States | 33173 |
| 16 | Integral Rheumatology & Immunology Specialists | Plantation | Florida | United States | 33324 |
| 17 | Clinical Research of West Florida | Tampa | Florida | United States | 33606 |
| 18 | Florida Medical Clinic, P.A. | Zephyrhills | Florida | United States | 33542 |
| 19 | Great Lakes Clinical Trials | Chicago | Illinois | United States | 60640 |
| 20 | Clinic of Robert Hozman | Skokie | Illinois | United States | 60076 |
| 21 | The Arthritis and Diabetes Clinic | Monroe | Louisiana | United States | 71203 |
| 22 | Johns Hopkins University | Baltimore | Maryland | United States | 21224 |
| 23 | Klein & Associates, M.D., P.A. | Hagerstown | Maryland | United States | 21740 |
| 24 | Clinical Pharmacology Study Group | Worcester | Massachusetts | United States | 01605 |
| 25 | University of Michigan | Ann Arbor | Michigan | United States | 48109 |
| 26 | Clinical Research Institute of Michigan, LLC | Saint Clair Shores | Michigan | United States | 48081 |
| 27 | St. Paul Rhuematology, P.A. | Eagan | Minnesota | United States | 55121 |
| 28 | Arthritis Consultants | Saint Louis | Missouri | United States | 63141 |
| 29 | Arthritis Rheumatic And Back Disease Associates | Voorhees | New Jersey | United States | 08043 |
| 30 | Albuquerque Center for Rheumatology | Albuquerque | New Mexico | United States | 87102 |
| 31 | Arthritis and Osteoperosis Associates of New Mexico | Las Cruces | New Mexico | United States | 88011 |
| 32 | VA NY Harbor Healthcare System | Brooklyn | New York | United States | 11209 |
| 33 | Buffalo Rheumatology and Medicine PLLC | Orchard Park | New York | United States | 14127 |
| 34 | DJL Clinical Research, PLLC | Charlotte | North Carolina | United States | 28210 |
| 35 | STAT Research, Inc. | Vandalia | Ohio | United States | 45377 |
| 36 | Health Research of Oklahoma | Oklahoma City | Oklahoma | United States | 73103 |
| 37 | Dr. Ramesh Gupta | Memphis | Tennessee | United States | 38119 |
| 38 | Tekton Research Inc. | Austin | Texas | United States | 78745 |
| 39 | Precision Comprehensive Clinical Research Solutions | Colleyville | Texas | United States | 76034 |
| 40 | Adriana Pop Moody MD Clinic PA | Corpus Christi | Texas | United States | 78404 |
| 41 | Metroplex Clinical Research Center | Dallas | Texas | United States | 75231 |
| 42 | Precision Comprehensive Clinical Research Solutions | Fort Worth | Texas | United States | 76107 |
| 43 | Precision Comprehensive Clinical Research Solutions | Grapevine | Texas | United States | 76051 |
| 44 | Southwest Rheumatology Research LLC | Mesquite | Texas | United States | 75150 |
| 45 | DM Clinical Research | Tomball | Texas | United States | 77375 |
| 46 | Arthritis & Osteoporosis Clinic | Waco | Texas | United States | 76710 |
| 47 | Arthritis Northwest PLLC | Spokane | Washington | United States | 99204 |
| 48 | Rheumatology & Pulmonary Clinic | Beckley | West Virginia | United States | 25801 |
| 49 | Rheumatology Dept, University of Melbourne Clinical School, Western Hospital | Footscray | Australia | 3011 | |
| 50 | Southern Clinical Research | Hobart | Australia | 7000 | |
| 51 | Liverpool Hospital | Liverpool | Australia | 2170 | |
| 52 | Skin Health Institute Inc. | Melbourne | Australia | 3053 | |
| 53 | Eastern Health - Box Hill Hospital | Melbourne | Australia | 3128 | |
| 54 | UMHAT 'Dr. Georgi Stranski', EAD | Pleven | Bulgaria | 5804 | |
| 55 | Medical Center Unimed Plovdiv | Plovdiv | Bulgaria | 4001 | |
| 56 | UMHAT Kaspela | Plovdiv | Bulgaria | 4001 | |
| 57 | UMHAT St. Ivan Rilski | Sfia | Bulgaria | 1612 | |
| 58 | Military Medical Academy | Sofia | Bulgaria | 1606 | |
| 59 | ASIMP Rheumatology Centre "St Irina" EOOD | Sofia | Bulgaria | 1750 | |
| 60 | University Multiprofile Hospital Sofiamed Sofia | Sofia | Bulgaria | 1770 | |
| 61 | Medical Centre Synexus | Sofia | Bulgaria | 1794 | |
| 62 | Medical Centre 'New Rehabilitation Centre' | Stara Zagora | Bulgaria | 6000 | |
| 63 | DDC Sv. Ivan Rilski OOD | Targovishte | Bulgaria | 7700 | |
| 64 | L.K.N Arthrocentrum | Hlucin | Czechia | 748 01 | |
| 65 | MUDr. Rosypalova, s.r.o | Ostrava | Czechia | 70800 | |
| 66 | Arthrohelp S.R.O. | Pardubice | Czechia | 53002 | |
| 67 | Revmatologicky ustav | Praha 2 | Czechia | 128 50 | |
| 68 | Medical Plus S.R.O. | Uherske Hradiste | Czechia | 68601 | |
| 69 | PV-Medical S.R.O | Zlin | Czechia | 76001 | |
| 70 | Betegapolo Irgalmas Rend - Budai Irgalmasrendi Korhaz | Budapest | Hungary | 1023 | |
| 71 | Debreceni Egyetem, Kenézy Gyula Egyetemi Oktatókórház | Debrecen | Hungary | 4031 | |
| 72 | Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz | Gyula | Hungary | 5700 | |
| 73 | Pest Megyei Flor Ferenc Korhaz | Kistarcsa | Hungary | 2143 | |
| 74 | Szegedi Tudományegyetem, ÁOK, Szent-Györgyi Albert Klinikai Központ | Szeged | Hungary | 6725 | |
| 75 | Fejer Megyei Szent Gyorgy Egyetemi Oktatokorhaz | Székesfehérvár | Hungary | H-8000 | |
| 76 | Vital Medical Center Orvosi es Fogaszati Kozpont | Veszprem | Hungary | 8200 | |
| 77 | Barzilai Medical Center | Ashkelon | Israel | 7830604 | |
| 78 | Bnai Zion Medical Center | Haifa | Israel | 31048 | |
| 79 | Carmel Medical Center | Hifa | Israel | 34362 | |
| 80 | Meir Medical Center | Kfar-Sava | Israel | 4428164 | |
| 81 | Sheba Medical Center | Ramat Gan | Israel | 5265601 | |
| 82 | Hospital Selayang | Batu Caves | Malaysia | 68100 | |
| 83 | Hospital Pulau Pinang | George Town | Malaysia | 10990 | |
| 84 | Hospital Raja Permaisuri Bainun | Ipoh | Malaysia | 30450 | |
| 85 | Hospital Tuanku Jaafar | Seremban | Malaysia | 70300 | |
| 86 | Nzoz Bif-Med | Bytom | Poland | 41-902 | |
| 87 | Centrum Kliniczno Badawcze | Elblag | Poland | 82-300 | |
| 88 | Malopolskie Centrum Kliniczne | Krakow | Poland | 30-149 | |
| 89 | Centrum Medyczne Promed | Krakow | Poland | 31-513 | |
| 90 | Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna | Lodz | Poland | 90-242 | |
| 91 | Dermed Centrum Medyczne Sp. z o.o | Lodz | Poland | 90-265 | |
| 92 | NZOZ Lecznica MAK-MED. S.C. | Nadarzyn | Poland | 05-830 | |
| 93 | Centrum Medyczne | Poznan | Poland | 61-113 | |
| 94 | Lubelskie Centrum Diagnostyczne | Swidnik | Poland | 21-040 | |
| 95 | Medycyna Kliniczna | Warsaw | Poland | 00-874 | |
| 96 | Rheuma-Medicus, Zaklad Opieki Zdrowotnej | Warszawa | Poland | 02-118 | |
| 97 | WroMedica I.Bielicka, A.Strzałkowska s.c. | Wrocław | Poland | 51-685 | |
| 98 | GCM Medical Group | San Juan | Puerto Rico | 00917 | |
| 99 | Mindful Medical Research | San Juan | Puerto Rico | 00918 | |
| 100 | FDI Clinical Research | San Juan | Puerto Rico | 00927 | |
| 101 | Altay Medical State University | Barnaul | Russian Federation | 656038 | |
| 102 | Chelyabinck Regional Clinical Hospital | Chelyabinsk | Russian Federation | 454076 | |
| 103 | Chelyabinsk Regional Clinical Dermatovenerological Dispensary | Chelyabinsk | Russian Federation | 454092 | |
| 104 | Chita State Medical Academy | Chita | Russian Federation | 672090 | |
| 105 | JSC Family Therapy Center | Ekaterinburg | Russian Federation | 620043 | |
| 106 | Research Institute of Dermatovenerology, Immunology | Ekaterinburg | Russian Federation | 620076 | |
| 107 | Regional Clinical Diagnostic Center of Udmurtia Region | Izhevsk | Russian Federation | 426009 | |
| 108 | Kemerovo State Medical University | Kemerovo | Russian Federation | 650000 | |
| 109 | LLL Medical Center Revma-Med | Kemerovo | Russian Federation | 650070 | |
| 110 | Kirov State Medical Academy | Kirov | Russian Federation | 610027 | |
| 111 | LLC Family Outpatient Clinic # 4 | Korolev | Russian Federation | 141060 | |
| 112 | Krasnodar Clinical Dermatovenerologic Dispensary | Krasnodar | Russian Federation | 350020 | |
| 113 | Regional SBI of PH Krasnoyarsk Regional Clinical hospital #20 named after I.S. Berzon | Krasnoyarsk | Russian Federation | 660123 | |
| 114 | Moscow State Medical and Stomatological University | Moscow | Russian Federation | 111398 | |
| 115 | Clinical-Diagnostic Center Euromedservice, JSC | Moscow | Russian Federation | 115419 | |
| 116 | FGBU Research Institute of Rheumatology named V.A.Nasonova | Moscow | Russian Federation | 115522 | |
| 117 | GBUZ of Moscow Region 'Moscow Region SRI n.a. Vladimirskyi' | Moscow | Russian Federation | 129110 | |
| 118 | Novgorod Regional Clinical Hospital n.a. N.A. Semashko | Nizhniy Novgorod | Russian Federation | 603126 | |
| 119 | FSEI HPE Privolzhsky Medical Research University | Nizhny Novgorod | Russian Federation | 603005 | |
| 120 | Llc Ultramed | Omsk | Russian Federation | 644024 | |
| 121 | BUZ Regional Clinical Hospital | Omsk | Russian Federation | 644111 | |
| 122 | GBOU VPO Orenburg State Medical University | Orenburg | Russian Federation | 460000 | |
| 123 | Rostov Regional Clinical Dermatovenerological Dispensary | Rostov | Russian Federation | 344007 | |
| 124 | Saratov Regional Clinical Hospital | Saratov | Russian Federation | 410053 | |
| 125 | Smolensk regional hospital on Smolensk railway station | Smolensk | Russian Federation | 214025 | |
| 126 | Leningrad region clinical hospital | St-Petersburg | Russian Federation | 194291 | |
| 127 | St. Petersburg GBUZ Clinical Reumatological Hospital 25 | St. Petersburg | Russian Federation | 190068 | |
| 128 | Dermatovenerological Dispensary #10 | St. Petersburg | Russian Federation | 194021 | |
| 129 | X7 Clinical Research Company Limited | St. Petersburg | Russian Federation | 194156 | |
| 130 | Eco-safety Ltd | St. Petersburg | Russian Federation | 196143 | |
| 131 | GBUZ of Samara Region 'Tolyatti City Clinical Hospital 5' | Tolyatti | Russian Federation | 445846 | |
| 132 | Tula Regional Clinical Dermatovenerological Dispensary | Tula | Russian Federation | 300053 | |
| 133 | Regional Clinical Hospital | Tver | Russian Federation | 170036 | |
| 134 | Republican Clinical Hospital - G.G. Kuvatov | Ufa | Russian Federation | 450005 | |
| 135 | Clinical Emergency Hospital n.a. N.V. Solovyev | Yaroslavl | Russian Federation | 150003 | |
| 136 | Clinical Hospital #3 | Yaroslavl | Russian Federation | 150007 | |
| 137 | Regional Clinical Hospital | Yaroslavl | Russian Federation | 150062 | |
| 138 | Gulhane Training and Research Hospital | Ankara | Turkey | 06010 | |
| 139 | Ankara Bilkent City Hospital | Ankara | Turkey | 06800 | |
| 140 | Hacettepe University Medical Faculty | Ankara | Turkey | 6100 | |
| 141 | Akdeniz University Medical Faculty | Antalya | Turkey | 7059 | |
| 142 | Uludag University Medical Faculty | Bursa | Turkey | 16059 | |
| 143 | Istanbul University Istanbul Medical Faculty | Istanbul | Turkey | 34093 | |
| 144 | Istanbul University Cerrahpasa Medical Faculty | Istanbul | Turkey | 34098 | |
| 145 | Marmara University Medical Faculty | Istanbul | Turkey | 34899 | |
| 146 | Kocaeli University Medical Faculty | Kocaeli | Turkey | 41380 | |
| 147 | Necmettin Erbakan University Meram Medical Faculty | Konya | Turkey | 42080 | |
| 148 | Communal Noncommercial Enterprise Cherkasy Regional Hospital of Cherkasy Regional Council | Cherkasy | Ukraine | 18009 | |
| 149 | Ivano-Frankivsk National Medical University, Ivano-Frankivsk City Clinical Hospital | Ivano-Frankivsk | Ukraine | 76018 | |
| 150 | Municipal Institution Of Health Care Kharkiv City Policlinic # 24 | Kharkiv | Ukraine | 61064 | |
| 151 | Municipal Institution Regional hospital-center of emergency care and disasters medicine | Kharkiv | Ukraine | 61204 | |
| 152 | Mi 'Kherson City Clinical Hospital Of E.E. Karabelesh' | Kherson | Ukraine | 73000 | |
| 153 | Khmelnitckiy regional hospital | Khmelnytsky | Ukraine | 29000 | |
| 154 | City Clinical Hospital No. 2 | Kryvyi Rih | Ukraine | 50056 | |
| 155 | Medical Center LLC 'Harmony of Beauty' | Kyiv | Ukraine | 01135 | |
| 156 | Medical Center of 'Institute of Rheumatology', LLC | Kyiv | Ukraine | 02081 | |
| 157 | Kyiv City Clinical Hospital #3 | Kyiv | Ukraine | 02125 | |
| 158 | Kyiv Railway Clinical Hospital #2 Of Branch 'Health Center' Of The Company 'Ukrainian Railway' | Kyiv | Ukraine | 03049 | |
| 159 | SI National Scientific Center Institute of Cardiology of M.D. Strazhesko of NAMS of Ukraine | Kyiv | Ukraine | 03680 | |
| 160 | Medical Center 'Consylium Medical' | Kyiv | Ukraine | 04050 | |
| 161 | Municipal Non-Profit Enterprise of Kyiv Regional Council 'Kyiv regional Clinical Hospital' | Kyiv | Ukraine | 04107 | |
| 162 | Volyn Regional Clinical Hospital | Lutsk | Ukraine | 43005 | |
| 163 | Municipal Non-profit Enterprise 'Odesa Regional Clinical Hospital' Odesa Regional Council | Odessa | Ukraine | 65025 | |
| 164 | LLC Medical House | Odessa | Ukraine | 65026 | |
| 165 | ME Poltava Regional Clinical Hospital named after M.V. Sklifosovsky of Poltava Regional Consuil | Poltava | Ukraine | 36011 | |
| 166 | Municipal institution of Tepnopil Regional Council 'Ternopil University Hospital' | Ternopil | Ukraine | 46002 | |
| 167 | Vinnitsia Regional Clinical Hospital n.a. M. I. Pyrogov | Vinnytsya | Ukraine | 21018 | |
| 168 | Communal Institution City Clinical Hospital #6 Of Zaporizhzhya City | Zaporizhzhya | Ukraine | 69035 | |
| 169 | Medical Center LLC 'Modern Clinic' | Zaporizhzhya | Ukraine | 69600 |
Sponsors and Collaborators
- Janssen Research & Development, LLC
Investigators
- Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CR109039
- 2021-000482-32
- CNTO1959PSA3005