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Trial record 51 of 53 for:    Developmental Disabilities | ( Map: Indiana, United States )

A Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Participants With Active Psoriatic Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03158285
Recruitment Status : Active, not recruiting
First Posted : May 18, 2017
Last Update Posted : August 9, 2019
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Brief Summary:
The primary purpose of this study is to evaluate the efficacy of guselkumab treatment in participants with active psoriatic arthritis (PsA) by assessing the reduction in signs and symptoms of PsA.

Condition or disease Intervention/treatment Phase
Arthritis, Psoriatic Drug: Guselkumab Drug: Placebo Phase 3

Detailed Description:
This is a study of guselkumab in participants with active PsA who are biologically naive and have had inadequate response to standard therapies. It will evaluate the clinical efficacy of guselkumab in the reduction of signs and symptoms, structural damage inhibition and the safety profile of guselkumab in the treatment of PsA. The study will consist of a screening phase (up to 6 weeks), a blinded treatment phase (approximately 100 weeks) including a placebo controlled period from Week 0 to Week 24 and an active treatment period from Week 24 to Week 100 and a safety follow-up phase of 12 weeks after the last administration of study agent. Efficacy, health economics, safety, pharmacokinetics, immunogenicity, biomarker and pharmacogenomics evaluations will be performed in the study at defined schedule.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 741 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Subjects With Active Psoriatic Arthritis
Actual Study Start Date : July 12, 2017
Actual Primary Completion Date : February 25, 2019
Estimated Study Completion Date : December 8, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Guselkumab

Arm Intervention/treatment
Experimental: Group 1: Guselkumab
Participants will receive subcutaneous (SC) guselkumab 100 milligram (mg) once every 4 weeks (q4w) from Week 0 through Week 100.
Drug: Guselkumab
Participants will receive 100 mg of guselkumab as a sterile liquid for SC injection.
Other Name: CNTO 1959

Experimental: Group 2: Guselkumab and Placebo
Participants will receive SC guselkumab 100 mg at Weeks 0 and 4 then once every 8 weeks (q8w) (Weeks 12, 20, 28, 36, 44, 52, 60, 68, 76, 84, 92, and 100) and placebo injections at other visits (Weeks 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, and 96) to maintain the blind.
Drug: Guselkumab
Participants will receive 100 mg of guselkumab as a sterile liquid for SC injection.
Other Name: CNTO 1959

Drug: Placebo
Participants will receive matching placebo as SC injection.

Experimental: Group 3: Placebo Followed by Guselkumab
Participants will receive SC placebo q4w from Week 0 to Week 20 and will cross over at Week 24 to receive SC guselkumab 100 mg q4w from Week 24 through Week 100.
Drug: Guselkumab
Participants will receive 100 mg of guselkumab as a sterile liquid for SC injection.
Other Name: CNTO 1959

Drug: Placebo
Participants will receive matching placebo as SC injection.




Primary Outcome Measures :
  1. Percentage of Participants who Achieve an American College of Rheumatology (ACR) 20 Response at Week 24 [ Time Frame: Week 24 ]
    ACR 20 Response is defined as greater than or equal to (>=) 20 percent improvement from baseline in swollen joint count (66 joints) and tender joint count (68 joints) and >=20 percent improvement from baseline in 3 of following 5 assessments: patient's assessment of pain using Visual Analog Scale (VAS; 0-10, 0 = no pain and 10 = worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 to 10, 0=very well and 10=very poor), physician's global assessment of disease activity using VAS (0=no arthritis activity and 10 = extremely active arthritis), patient'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 serum C-Reactive Protein (CRP).


Secondary Outcome Measures :
  1. Change From Baseline in HAQ-DI Score at Week 24 [ Time Frame: Baseline and Week 24 ]
    The Health Assessment Questionnaire-Disability Index (HAQ-DI) is a 20-question instrument that assesses the 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 to 3 (0=no difficulty and 3=inability to perform a task in that area).

  2. Percentage of Participants who Achieve an ACR 50 Response at Week 24 [ Time Frame: Week 24 ]
    ACR 50 Response is defined as >= 50 percent improvement from baseline in swollen joint count (66 joints) and tender joint count (68 joints) and >=50 percent improvement from baseline in 3 of following 5 assessments: patient's assessment of pain using Visual Analog Scale (VAS; 0-10, 0 = no pain and 10 = worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 to 10, 0=very well and 10=very poor), physician's global assessment of disease activity using VAS (0=no arthritis activity and 10 = extremely active arthritis), patient'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 serum C-Reactive Protein (CRP).

  3. Percentage of Participants With a Psoriasis Response of IGA at Week 24 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline [ Time Frame: 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 of Psoriasis documents the investigator's assessment of the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling using 0 (no evidence), 1 (minimal), 2 (mild), 3 (moderate) and 4 (severe) scale. 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).

  4. Percentage of Participants who Achieve an ACR 20 Response at Week 16 [ Time Frame: Week 16 ]
    ACR 20 Response is defined as >= 20 percent improvement from baseline in swollen joint count (66 joints) and tender joint count (68 joints) and >=20 percent improvement from baseline in 3 of following 5 assessments: patient's assessment of pain using Visual Analog Scale (VAS; 0-10, 0 = no pain and 10 = worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 to 10, 0=very well and 10=very poor), physician's global assessment of disease activity using VAS (0=no arthritis activity and 10 = extremely active arthritis), patient'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 serum C-Reactive Protein (CRP).

  5. Change From Baseline in Modified van der Heijde-Sharp (vdH-S) Score at Week 24 [ Time Frame: Baseline and Week 24 ]
    The vdH-S score is the sum of joint erosion score and joint-space narrowing (JSN) score based on x-rays of both hands and both feet. The total score ranges from 0 to 528 with higher scores indicating more joint damage.

  6. Percentage of Participants With Resolution of Enthesitis at Week 24 Among the Participants With Enthesitis at Baseline [ Time Frame: Week 24 ]
    Enthesitis will be assessed using the Leeds Enthesitis Index (LEI). The LEI was developed to assess enthesitis in participants with PsA, and evaluates the presence or absence of pain by applying local pressure to Lateral epicondyle humerus, left and right, Medial femoral condyle, left and right, and Achilles tendon insertion, left and right. Leeds Enthesitis Index scores ranging from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness).

  7. Percentage of Participants With Resolution of Dactylitis at Week 24 Among the Participants with Dactylitis at Baseline [ Time Frame: Week 24 ]
    The presence and severity of dactylitis will be assessed in both hands and feet using a scoring system from 0 to 3 (0 = no dactylitis, 1 = mild dactylitis, 2 = moderate dactylitis, and 3 = severe dactylitis).

  8. Change From Baseline in Enthesitis Score (based on Leeds Enthesitis Index [LEI]) at Week 24 Among the Participants with Enthesitis at Baseline [ Time Frame: Baseline and Week 24 ]
    Enthesitis will be assessed using the Leeds Enthesitis Index (LEI). The LEI was developed to assess enthesitis in participants with PsA, and evaluates the presence or absence of pain by applying local pressure to Lateral epicondyle humerus, left and right, Medial femoral condyle, left and right, and Achilles tendon insertion, left and right. Leeds Enthesitis Index scores ranging from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness).

  9. Change From Baseline in Dactylitis Score at Week 24 [ Time Frame: Baseline and Week 24 ]
    The presence and severity of dactylitis will be assessed in both hands and feet using a scoring system from 0 to 3 (0 = no dactylitis, 1 = mild dactylitis, 2 = moderate dactylitis, and 3 = severe dactylitis).

  10. Change From Baseline in 36-item Short Form Health Survey (SF-36) Physical Component Summary (PCS) at Week 24 [ Time Frame: Baseline and Week 24 ]
    The SF-36 is a survey of participant health. It consists of 8 individual domains, which are weighted sums of the questions in their section. The 8 domains are: vitality (VT), physical functioning (PF), bodily pain (BP), general health (GH), Role-Physical (RP), Role-Emotional (RE), social functioning (SF) and mental health (MH). Each of these 8 scales (domains) is scored from 0 to 100 with higher scores indicating better health. Based on the scale scores, the summary physical component score (PCS) is derived. Scales contributing most to the scoring of the SF-36 PCS include the PF, RP, BP and GH. Other domains not noted contribute to the scoring but to a lesser degree. The scoring is derived based on an algorithm that has been developed in a software provided by the developer. The summary PCS score is also scaled from 0 to 100 with higher scores indicating better health

  11. Change From Baseline in Disease Activity Score 28 (DAS28) C-reactive Protein (CRP) at Week 24 [ Time Frame: Baseline and Week 24 ]
    The Disease Activity Index Score (DAS28) based on C-Reactive Protein (CRP) is an index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. DAS28(CRP) =0.56×SQRT(tender joints [count:1-28])+0.28×SQRT(swollen joints [count:1-28])+0.36×Ln(CRP value in milligram per Liter [mg/L] +1)+0.014×GH (patient's global assessment of disease activity [arthritis])+0.96. Higher score = more severe disease.

  12. Change From Baseline in SF-36 Mental Component Summary (MCS) at Week 24 [ Time Frame: Baseline and Week 24 ]
    The SF-36 is a survey of participant health. It consists of 8 individual domains, which are weighted sums of the questions in their section. The 8 domains are: vitality (VT), physical functioning (PF), bodily pain (BP), general health (GH), Role-Physical (RP), Role-Emotional (RE), social functioning (SF) and mental health (MH). Each of these 8 scales (domains) is scored from 0 to 100 with higher scores indicating better health. Based on the scale scores, the summary mental component score (MCS) is derived. Scales contributing most to the scoring of the SF-36 MCS include the VT, SF, RE and MH. Other domains not noted contribute to the scoring but to a lesser degree. The scoring is derived based on an algorithm that has been developed in a software provided by the developer. The summary MCS score is also scaled from 0 to 100 with higher scores indicating better health.

  13. Percentage of Participants who Achieve an ACR 50 Response at Week 16 [ Time Frame: Week 16 ]
    ACR 50 Response is defined as >= 50 percent improvement from baseline in swollen joint count (66 joints) and tender joint count (68 joints) and >=50 percent improvement from baseline in 3 of following 5 assessments: patient's assessment of pain using Visual Analog Scale (VAS; 0-10, 0 = no pain and 10 = worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 to 10, 0=very well and 10=very poor), physician's global assessment of disease activity using VAS (0=no arthritis activity and 10 = extremely active arthritis), patient'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 serum C-Reactive Protein (CRP).

  14. Percentage of Participants who Achieve an ACR 70 Response at Week 24 [ Time Frame: Week 24 ]
    ACR 70 Response is defined as >= 70 percent improvement from baseline in swollen joint count (66 joints) and tender joint count (68 joints) and >=70 percent improvement from baseline in 3 of following 5 assessments: patient's assessment of pain using Visual Analog Scale (VAS; 0-10, 0 = no pain and 10 = worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 to 10, 0=very well and 10=very poor), physician's global assessment of disease activity using VAS (0=no arthritis activity and 10 = extremely active arthritis), patient'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 serum C-Reactive Protein (CRP).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have a diagnosis of 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 5 swollen joints and at least 5 tender joints at screening and at baseline, and CRP greater than or equal to (>=) 0.6 milligram per deciLitre (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 (confirmation of sacroiliitis should be performed at the screening visit by a locally performed pelvic x-ray [single anterior-posterior view] unless a pelvic or SI joint x-ray or pelvic magnetic resonance imaging (MRI) has been previously performed. Results must be documented)
  • Have active plaque psoriasis, with at least one psoriatic plaque of >= 2 centimeter (cm) diameter or nail changes consistent with psoriasis or documented history of plaque psoriasis
  • Have active PsA despite previous non-biologic disease-modifying antirheumatic drug (DMARD), apremilast, and/or nonsteroidal anti-inflammatory drug (NSAID) therapy

Exclusion Criteria:

  • Has other inflammatory diseases that might confound the evaluations or benefit of guselkumab therapy, including but not limited to rheumatoid arthritis (RA), axial spondyloarthritis (this does not include a primary diagnosis of PsA with spondylitis), systemic lupus erythematosus, or Lyme disease
  • Has previously received any biologic treatment
  • Has ever received tofacitinib, baricitinib, filgotinib, peficitinib (ASP015K), decernotinib (VX-509), or any other Janus kinase (JAK) inhibitor
  • Has received any systemic immunosuppressants (eg, azathioprine, cyclosporine, 6 thioguanine, mercaptopurine, mycophenolate mofetil, hydroxyurea, tacrolimus) within 4 weeks of the first administration of study agent
  • Is currently receiving 2 or more non-biologic DMARDs (other than methotrexate [MTX], sulfasalazine [SSZ], Hydroxychloroquine [HCQ], leflunomide [LEF]) including, but not limited to chloroquine, gold preparations, and penicillamine within 4 weeks before the first administration of study agent
  • Has received apremilast within 4 weeks prior to the first administration of study agent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03158285


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Locations
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United States, Alabama
Rheumatology Associates
Birmingham, Alabama, United States, 35205
United States, Arizona
Arizona Arthritis & Rheumatology Associates PC
Glendale, Arizona, United States, 85306
Arizona Arthritis & Rheumatology Research, PLLC
Mesa, Arizona, United States, 85210
United States, Connecticut
Clinical Research Center of Connecticut
Danbury, Connecticut, United States, 06810
United States, Indiana
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, United States, 46256-4697
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, Missouri
Arthritis Consultants
Saint Louis, Missouri, United States, 63141
United States, Texas
Austin Regional Clinic
Austin, Texas, United States, 78731-3146
Bulgaria
Multiprofile Hospital for Active Treatment - Plovdiv
Plovdiv, Bulgaria, 4003
Multiprofile Hosptal for Active Treatment Eurohospital Plovdiv
Plovdiv, Bulgaria, 4004
Medical Center 'Teodora'
Ruse, Bulgaria, 7003
Diagnostic Consulting Center No 17
Sofia, Bulgaria, 1505
Military Medical Academy
Sofia, Bulgaria, 1606
Medical Centre Synexus
Sofia, Bulgaria, 1794
MHAT-Targovishte, AD
Targovishte, Bulgaria, 7700
Czechia
Revmacentrum MUDr. Mostera, s.r.o.
Brno - Zidenice, Czechia, 615 00
Revmaclinic
Brno, Czechia, 61141
MUDr. Rosypalova, s.r.o
Ostrava, Czechia, 70800
Revmatologicka ambulance
Praha 4, Czechia, 14000
Revmatologicky institut
Praha, Czechia, 12850
Medical Plus S.R.O.
Uherske Hradiste, Czechia, 68601
PV-Medical S.R.O
Zlin, Czechia, 76001
Estonia
Parnu Hospital
Parnu, Estonia, 800100
OU Innomedica
Tallinn, Estonia, 10117
East Tallinn Central Hospital
Tallinn, Estonia, 11312
Clinical Research Centre
Tartu, Estonia, 50106
Latvia
Daugavpils Regional Hospital
Daugavpils, Latvia, LV5417
Derma Clinic Riga
Riga, Latvia, LV1003
J Kisis Ltd
Riga, Latvia, LV1003
Orto Clinic Ltd
Riga, Latvia, LV1005
Lithuania
Vakk, Jsc
Kaunas, Lithuania, LT50128
Siauliai Republican Hospital, Public Institution
Siauliai, Lithuania, LT-76231
Central Outpatient Clinic
Vilnius, Lithuania, LT01117
National Osteoporosis Centre
Vilnius, Lithuania, LT09310
Malaysia
Hospital Selayang
Batu Caves, Malaysia, 68100
Hospital Raja Permaisuri Bainun
Ipoh, Malaysia, 30990
Sarawak General Hospital
Kuching, Malaysia, Sarawak
Hospital Melaka
Melaka, Malaysia, 75400
Hospital Putrajaya
Putrajaya, Malaysia, 62250
Hospital Tuanku Jaafar
Seremban, Malaysia, 70300
Poland
Szpital Uniwersytecki Nr 2 w Bydgoszczy
Bydgoszcz, Poland, 85-168
NSZOZ Unica CR
Dabrowka, Poland, 62-069
Centrum Kliniczno Badawcze
Elblag, Poland, 82-300
Centrum Badań Klinicznych PI-House sp. z o.o.
Gdańsk, Poland, 80-546
Centrum Badawcze Wspolczesnej Terapii
Lodz, Poland, 90-242
Centrum Medyczne AMED oddzial w Lodzi
Lodz, Poland, 91-363
NZOZ Lecznica MAK-MED. S.C.
Nadarzyn, Poland, 05-830
Etyka Osrodek Badan Klinicznych
Olsztyn, Poland, 10-117
Centrum Medyczne Hetmańska
Poznań, Poland, 60-218
Lubelskie Centrum Diagnostyczne
Swidnik, Poland, 21-040
Nasz Lekarz Przychodnie Medyczne
Torun, Poland, 87-100
Medycyna Kliniczna
Warsaw, Poland, 00-874
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. prof. dr hab. med. Eleonory Reicher
Warszawa, Poland, 02-637
Centrum Medyczne AMED Warszawa Targowek
Warszawa, Poland, 03-291
Centrum Medyczne WroMedica
Wroclaw, Poland, 51-685
Biogenes Sp. z o. o.
Wrocław, Poland, 53-224
Russian Federation
Chelyabinsk Regional Clinical Dermatovenerological Dispensary
Chelyabinsk, Russian Federation, 454092
Medical and Sanitary Unit "Severstal"
Cherepovets, Russian Federation, 162600
Research Institute of Dermatovenerology, Immunology
Ekaterinburg, Russian Federation, 620076
Regional Clinical Hospital for War Veterans
Kemerovo, Russian Federation, 650000
Medical Centre 'Maximum Health'
Kemerovo, Russian Federation, 650066
Family polyclinic #4
Korolev, Russian Federation, 141060
Krasnodar Clinical Dermatovenerologic Dispensary
Krasnodar, Russian Federation, 350020
Krasnoyarsk State Medical University
Krasnoyarsk, Russian Federation, 660022
Lipetsk Regional Dermatovenerological Dispensary
Lipetsk, Russian Federation, 398005
Moscow State Medical and Stomatological University
Moscow, Russian Federation, 111398
Clinical Diagnostic Center 'Ultramed'
Omsk, Russian Federation, 644024
Orenburg State Medical University
Orenburg, Russian Federation, 460000
Republican Hospital n.a.V.A.Baranov
Petrozavodsk, Russian Federation, 185019
Rostov Regional Clinical Dermatovenerological Dispensary
Rostov, Russian Federation, 344007
Ryazan Regional Clinical Dermatovenerological Dispensary
Ryazan, Russian Federation, 390046
Saratov Regional Clinical Hospital
Saratov, Russian Federation, 410053
Smolensk regional hospital on Smolensk railway station
Smolensk, Russian Federation, 214025
City Clinic №25 - City Rheumatology Centre
St-Petersburg, Russian Federation, 190068
Leningrad region clinical hospital
St-Petersburg, Russian Federation, 194291
Tula Regional Clinical Dermatovenerological Dispensary
Tula, Russian Federation, 300053
Regional Clinical Hospital
Tver, Russian Federation, 170036
Republican Clinical Hospital - G.G. Kuvatov
Ufa, Russian Federation, 450005
Clinical Emergency Hospital n.a. N.V. Solovyev
Yaroslavl, Russian Federation, 150003
Clinical Hospital #3
Yaroslavl, Russian Federation, 150007
Clinical Hospital #10
Yaroslavl, Russian Federation, 150023
Spain
Hosp. Univ. A Coruña
A Coruna, Spain, 15006
Hosp. Univ. de Cruces
Barakaldo, Spain, 48903
Hosp. Univ. de Basurto
Bilbao, Spain, 48013
Hosp. Reina Sofia
Cordoba, Spain, 14004
Hosp. Univ. Infanta Leonor
Madrid, Spain, 28031
Hosp. Univ. Ramon Y Cajal
Madrid, Spain, 28034
Hospital Regional Carlos Haya
Málaga, Spain, 29009
Hosp. de Merida
Mérida, Spain, 06800
H.U. Infanta Sofía
San Sebastián de los Reyes, Spain, 28702
Hosp. Clinico Univ. de Santiago
Santiago de Compostela, Spain, 15706
Hosp. Infanta Luisa
Sevilla, Spain, 41010
Hosp. Unv. de Valme
Sevilla, Spain, 414014
Hosp. Univ. Dr. Peset
Valencia, Spain, 46017
Hosp. Univ. I Politecni La Fe
Valencia, Spain, 46026
Hosp. Do Meixoeiro
Vigo, Spain, 36214
Taiwan
Hualien Tzu Chi Hospital
Hualien City, Taiwan, 970
Chang Gung Memorial Hospital Kaohsiung Branch
Kaohsiung, Taiwan, 833
National Cheng Kung University Medical Center
Tainan, Taiwan, 704
Chang Kung Memorial Hospital
Taipei, Taiwan, 105
Chang-Gung Memorial Hospital, LinKou Branch
Taoyuan, Taiwan, 333
Turkey
Ankara Bilkent City Hospital
Ankara, Turkey, 06800
Hacettepe University Medical Faculty
Ankara, Turkey
Akdeniz University Medical Faculty
Antalya, Turkey, 7059
Uludag University Medical Faculty
Bursa, Turkey, 16059
Osmangazi University Medical Faculty
Eskisehir, Turkey, 26480
Bakirkoy Training and Research Hospital
Istanbul, Turkey, 34147
Marmara University Medical Faculty
Istanbul, Turkey, 34899
Dokuz Eylul Universitesi Tip Fakultesi
Izmir, Turkey, 35340
İzmir Katip Celebi University Medical Faculty Ataturk Training and Research Hospital
Izmir, Turkey, 35360
Ukraine
Municipal Institution Cherkasy Regional Hospital of Cherkasy Regional Council
Cherkasy, Ukraine, 18009
Municipal health care institution Chernihiv Regional Hospital
Chernihiv, Ukraine
Ivano-Frankivsk National Medical University, Ivano-Frankivsk City Clinical Hospital
Ivano-Frankivsk, Ukraine
Communal Institution of Health Kharkiv City multifield hospital №18
Kharkiv, Ukraine, 61029
Kharkiv Railway Clinical Hospital N1 Of Brance 'Health Center'
Kharkiv, Ukraine, 61029
Municipal Institution Regional hospital-center of emergency care and disasters medicine
Kharkiv, Ukraine
State Institution Institute of therapy named after L.T.Malaya AMS Ukraine
Kharkiv, Ukraine
Mi 'Kherson City Clinical Hospital Of E.E. Karabelesh'
Kherson, Ukraine, 73000
Khmelnitckiy regional hospital
Khmelnytsky, Ukraine
City Clinical Hospital No. 2
Kryvyi Rih, Ukraine, 50056
Medical Center 'Consylium Medical'
Kyiv, Ukraine, 04050
Kyiv City Clinical Hospital #3
Kyiv, Ukraine
Kyiv Railway Station Clinical Hospital #2
Kyiv, Ukraine
Kyiv Regional Clinical Hospital
Kyiv, Ukraine
SI National Scientific Center The M.D.Strazhesko Institute of Cardiology of NAMSU
Kyiv, Ukraine
Danylo Halytsky Lviv National Medical University
Lviv, Ukraine
Lviv Communcal City Clinical Hospital #4
Lviv, Ukraine
Multidisciplinary Medical Center of Odessa National Medical University (University Clinic №1)
Odessa, Ukraine, 65026
State Institution Odesa Regional Clinical Hospital
Odessa, Ukraine
Poltava Regional Clinical Hospital HSEI of Ukraine Ukrainian Medical Stomatological Academy
Poltava, Ukraine
Sumy State University
Sumy, Ukraine
Municipal institution of Tepnopil Regional Council 'Ternopil University Hospital'
Ternopil, Ukraine
Ternopil University Hospital
Ternopil, Ukraine
Transcarpathian Regional Clinical Hospital
Uzhgorod, Ukraine
Medical Center LTD Health Clinic Department of Cardiology and Rheumatology
Vinnytsya, Ukraine, 21009
Vinnytsya State Medical University, Vinnytsya Regional Clinical Hospital
Vinnytsya, Ukraine
Zaporizhzhya Regional Clinical Hospital
Zaporizhzhya, Ukraine
Municipal institution Central Clinical Hospital #1 Zhytomir
Zhytomir, Ukraine, 10002
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC

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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT03158285     History of Changes
Other Study ID Numbers: CR108219
CNTO1959PSA3002 ( Other Identifier: Janssen Research & Development, LLC )
2016-001224-63 ( EudraCT Number )
First Posted: May 18, 2017    Key Record Dates
Last Update Posted: August 9, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Arthritis
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs