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A Study of Guselkumab in Participants With Active Psoriatic Arthritis and an Inadequate Response to Anti-Tumor Necrosis Factor Alpha (Anti-TNF Alpha) Therapy (COSMOS)

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ClinicalTrials.gov Identifier: NCT03796858
Recruitment Status : Recruiting
First Posted : January 8, 2019
Last Update Posted : April 8, 2019
Sponsor:
Information provided by (Responsible Party):
Janssen Pharmaceutica N.V., Belgium

Brief Summary:
The purpose of this study is to evaluate guselkumab efficacy versus placebo in participants with active psoriatic arthritis (PsA) and an inadequate response to Anti-Tumor Necrosis Factor Alpha (TNF-alpha) therapy by assessing the reduction in signs and symptoms of joint disease.

Condition or disease Intervention/treatment Phase
Arthritis, Psoriatic Drug: Guselkumab 100 mg Drug: Placebo Phase 3

Detailed Description:
Psoriatic arthritis is a multi-faceted disease that impacts the joints, soft tissues, and skin, all of which not only results in functional disability and impaired quality of life, but participants with this disease also have increased mortality. Guselkumab is a monoclonal antibody that binds to human interleukin 23 (IL-23) and inhibits IL-23 specific intracellular signaling and subsequent activation and cytokine production. Investigation of guselkumab in this Phase 3b PsA clinical study is supported by the favorable efficacy and safety results from Phase 2 study of guselkumab in PsA and Phase 2 and Phase 3 studies in psoriasis including the subset of participants with PsA. The primary hypothesis is that guselkumab 100 milligram (mg) at Weeks 0, 4, and every 8 weeks (q8w) thereafter is superior to placebo which will be assessed by the proportion of participants achieving an American College of Rheumatology (ACR 20) response at Week 24. The study includes 2 periods: A 24-week double-blind, placebo-controlled period for the primary analysis of the efficacy and safety of guselkumab, compared with placebo and a 32-week active-treatment and safety follow-up period for additional analysis of the efficacy and safety of guselkumab. Safety will be monitored throughout the study (Up to Week 56).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 245 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 3b, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Guselkumab Administered Subcutaneously in Participants With Active Psoriatic Arthritis and an Inadequate Response to Anti-Tumor Necrosis Factor Alpha (Anti-TNFα) Therapy
Actual Study Start Date : March 22, 2019
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : April 30, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Guselkumab

Arm Intervention/treatment
Experimental: Group 1: Guselkumab
Participants will receive guselkumab 100 milligram (mg) Subcutaneous (SC) injection at Weeks 0, 4, 12, 20, 28, 36, and 44 and placebo SC at Week 24 to maintain the blind. At Week 16, Participants who meet the early escape criteria will receive placebo at Week 16 and guselkumab at Week 20, then guselkumab every 8 weeks (q8w).
Drug: Guselkumab 100 mg
Participants will receive guselkumab 100mg as SC injection.
Other Name: CNTO 1959

Drug: Placebo
Participants will receive placebo as SC injection.

Experimental: Group 2: Placebo followed by Guselkumab
Participants will receive placebo SC injection at Weeks 0, 4, 12, and 20, and will crossover to receive guselkumab 100 mg SC injection at Weeks 24, 28, 36, and 44. At Week 16, Participants who meet the early escape criteria will receive guselkumab at Weeks 16 and 20, then guselkumab q8w.
Drug: Guselkumab 100 mg
Participants will receive guselkumab 100mg as SC injection.
Other Name: CNTO 1959

Drug: Placebo
Participants will receive 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 ]
    The ACR 20 Response is defined as greater than or equal to (>=) 20 percent (%) improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >=20 percent improvement in 3 of following 5 assessments: participant's assessment of pain using Visual Analog Scale (VAS; 0-10 millimeter [mm], 0 mm=no pain and 10 mm=worst possible pain), participant's global assessment of disease activity by using VAS (scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS, 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 C-reactive protein (CRP).


Secondary Outcome Measures :
  1. Change from Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24 [ Time Frame: Baseline, Week 24 ]
    The 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). Overall score is computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.

  2. Percentage of Participants who Achieve an ACR 50 Response at Week 24 [ Time Frame: Week 24 ]
    The ACR 50 Response is defined as greater than or equal to (>=) 50 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >=50 percent improvement in 3 of following 5 assessments: participant's assessment of pain using Visual Analog Scale (VAS; 0-10 millimeter [mm], 0 mm=no pain and 10 mm=worst possible pain), participant's global assessment of disease activity by using VAS (scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS, 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 C-reactive protein (CRP).

  3. Change from Baseline in 36-Item Short form Health Survey (SF-36) Physical Component Summary (PCS) Score at Week 24 [ Time Frame: Baseline, Week 24 ]
    The SF-36 is a generic health survey with 36 items that measure functional health and well-being from the participant's perspective. The survey is summarized into 8 dimensions/scales: physical functioning (PF), role-physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role-emotional (RE), and mental health (MH). The physical component summary measure is derived from 4 of the 8 health dimensions (aggregate of PF, RP, BP, and GH scales). The minimum score is 0 and the maximum score is 100. A higher score indicates a better health state.

  4. Percentage of Participants who Achieve Psoriatic Area and Severity Index (PASI) 100 Response at Week 24 [ Time Frame: Week 24 ]
    PASI 100 response is defined as 100% improvement in PASI score from baseline (PASI score of 0). The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI scoring system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease.



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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 intervention 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
  • 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 an inadequate response to anti-TNF alpha therapy, defined as presence of active PsA despite previous treatment with either 1 or 2 anti-TNF alpha agents and either of the following: a) Lack of benefit of an anti-TNF alpha therapy, as documented in the participant history by the treating physician, after at least 12 weeks of etanercept, adalimumab, golimumab, or certolizumab pegol therapy (or biosimilar) and/or at least a 14-week dosage regimen (i.e., at least 4 doses) of infliximab (or biosimilar). Documented lack of benefit may include inadequate improvement in joint counts, physical function, or disease activity, b) Intolerance to an anti-TNF alpha therapy, as documented in the patient history by the treating physician, to etanercept, adalimumab, golimumab, certolizumab pegol, or infliximab (or biosimilars)
  • Be willing to refrain from the use of complementary therapies for PsA or psoriasis including ayurvedic medicine, traditional Taiwanese, Korean, or Chinese medications and acupuncture within 2 weeks before the first study intervention administration and through Week 48

Exclusion Criteria:

  • Has other inflammatory diseases that might confound the evaluations of 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 ever received more than 2 anti-TNF alpha agents
  • Has previously received any biologic treatment (other than anti-TNF Alpha agents), including, but not limited to ustekinumab, abatacept, secukinumab, tildrakizumab, ixekizumab, brodalumab, risankizumab, or other investigative biologic treatment
  • Has previously received tofacitinib, baricitinib, filgotinib, peficitinib (ASP015K), decernotinib (VX 509), or any other a Janus kinase (JAK) inhibitor
  • Has previously received any systemic immunosuppressants (for example, azathioprine, cyclosporine, 6 thioguanine, mercaptopurine, mycophenolate mofetil, hydroxyurea, tacrolimus) within 4 weeks of the first administration of study intervention

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): NCT03796858


Contacts
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Contact: Study Contact 844-434-4210 JNJ.CT@sylogent.com

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Locations
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Belgium
CHU Saint Pierre BXL Recruiting
Brussels, Belgium, 1000
Reuma Clinic Recruiting
Genk, Belgium, 3600
Universitair Ziekenhuis Gent Recruiting
Gent, Belgium, 9000
UZ Leuven Not yet recruiting
Leuven, Belgium, 3000
Bulgaria
Diagnostic - Consulting Center II-Pleven Not yet recruiting
Pleven, Bulgaria, 5800
Medical Center Medconsult-Pleven Not yet recruiting
Pleven, Bulgaria, 5800
Multiprofile Hospital for Active Treatment - Plovdiv Not yet recruiting
Plovdiv, Bulgaria, 4003
Multiprofile Hosptal for Active Treatment Eurohospital Plovdiv Not yet recruiting
Plovdiv, Bulgaria, 4004
Medical Center 'Teodora' Not yet recruiting
Ruse, Bulgaria, 7003
Diagnostic Consulting Center No 17 Not yet recruiting
Sofia, Bulgaria, 1505
Military Medical Academy Not yet recruiting
Sofia, Bulgaria, 1606
France
Hopital Pellegrin Tripode - CHU de Bordeaux Not yet recruiting
Bordeaux, France, 33076
CHU Lapeyronie Not yet recruiting
Montpellier, Herault, France, 34295
Centre Hospitalier Regional d'Orleans (CHRO) - Hopital La Source Not yet recruiting
Orleans, France, 45067
Hopital Lariboisiere Not yet recruiting
Paris, France, 75010
Hôpital Pitié-Salpétrière Not yet recruiting
Paris, France, 75013
Hopital Cochin Not yet recruiting
Paris, France, 75014
Centre Hospitalier Universitaire de Toulouse - Hopital Purpa Not yet recruiting
Toulouse, France, 30159
CHU Trousseau - Service de Rhumatologie Not yet recruiting
Tours, France, 37044
Germany
Charite Universitatsmedizin Berlin - Campus Charite Mitte (CCM), Psoriasis Studienzentrum Not yet recruiting
Berlin, Germany, 10117
Universitatsklinikum Bonn Not yet recruiting
Bonn, Germany, 5105
Rheumatologisches MVZ Dresden GmbH Not yet recruiting
Dresden, Germany, 01109
Universitätsklinikum Düsseldorf Not yet recruiting
Dusseldorf, Germany, 40225
Goethe Universität Frankfurt Not yet recruiting
Frankfurt, Germany, 60590
Hamburger Rheuma Forschungszentrum II Not yet recruiting
Hamburg, Germany, 20095
Medizinische Hochschule Hannover Not yet recruiting
Hannover, Germany, 30625
Rheumazentrum Ruhrgebiet Not yet recruiting
Herne, Germany, 44649
Universitaetsklinikum Koeln Not yet recruiting
Köln, Germany, 50937
Rheumatologische Schwerpunktpraxis Not yet recruiting
Rendsburg, Germany, 24768
Universitätsklinik Tübingen Not yet recruiting
Tübingen, Germany, 72076
Krankenhaus St. Josef Not yet recruiting
Wuppertal, Germany, 42105
Universitätsklinikum Würzburg Not yet recruiting
Würzburg, Germany, 97080
Greece
251 Airforces Hospital Not yet recruiting
Athens, Greece, 115 25
Athens Navy Hospital Not yet recruiting
Athens, Greece, 11521
Laiko General Hospital of Athens Not yet recruiting
Athens, Greece, 11527
General Hospital of Attiki 'KAT' Not yet recruiting
Kifisia, Greece, 14561
General Hospital of Thessaloniki "Agios Pavlos" Not yet recruiting
Thessaloniki, Greece, 55134
424 Military Hospital of Thessaloniki Not yet recruiting
Thessaloniki, Greece, 56429
Hungary
Betegapolo Irgalmas Rend - Budai Irgalmasrendi Korhaz Not yet recruiting
Budapest, Hungary, 1023
Békés Megyei Központi Kórház Pándy Kálmán Tagkórház Not yet recruiting
Gyula, Hungary, 5700
Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókórház Recruiting
Nyiregyhaza, Hungary, 4400
MAV Korhaz es Rendelointezet Recruiting
Szolnok, Hungary, 5000
Fejer Megyei Szent Gyorgy Egyetemi Oktatokorhaz Not yet recruiting
Székesfehérvár, Hungary, 8000
Vital Medical Center Orvosi es Fogaszati Kozpont Recruiting
Veszprem, Hungary, 8200
Israel
Barzilai Medical Center Not yet recruiting
Ashkelon, Israel, 7830604
Bnai Zion Medical Center Not yet recruiting
Hifa, Israel, 31048
Carmel Medical Center Not yet recruiting
Hifa, Israel, 34362
Hadassah Medical Center Not yet recruiting
Jerusalem, Israel, 91120
Sheba Medical Center Not yet recruiting
Ramat Gan, Israel, 5265601
Tel Aviv Sourasky Medical Center Not yet recruiting
Tel Aviv, Israel, 64239
Italy
Azienda Ospedaliera Univ.- Università Degli studi della Campania - Luigi Vanvitelli Not yet recruiting
Napoli, Italy, 80130
Azienda Ospedaliera Universitaria Federico II Not yet recruiting
Napoli, Italy, 80131
AOU di Padova Not yet recruiting
Padova, Italy, 35128
Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone Not yet recruiting
Palermo, Italy, 90127
Ospedale San Carlo Di Potenza - Azienda Ospedaliera Regionale Not yet recruiting
Potenza, Italy, 85100
Policlinico Tor Vergata Not yet recruiting
Roma, Italy, 00133
Complesso Integrato Columbus Not yet recruiting
Rome, Italy, 00168
Humanitas Hospital Not yet recruiting
Rozzano (MI), Italy, 20089
Poland
Szpital Uniwersytecki Nr 2 w Bydgoszczy Not yet recruiting
Bydgoszcz, Poland, 85-168
Centrum Kliniczno Badawcze Recruiting
Elblag, Poland, 82-300
Centrum Terapii Wspolczesnej J. M. Jasnorzewska J. M. Jasnorzewska Spolka Komandytowo-Akcyjna Not yet recruiting
Lodz, Poland, 90-242
Dermed Centrum Medyczne Sp. z o.o Not yet recruiting
Lodz, Poland, 90-265
NZOZ Lecznica MAK-MED. S.C. Not yet recruiting
Nadarzyn, Poland, 05-830
Medycyna Kliniczna Not yet recruiting
Warsaw, Poland, 00-874
Mazowieckie Centrum Reumatologii i Osteoporozy Not yet recruiting
Warszawa, Poland, 04-030
Centrum Medyczne WroMedica Not yet recruiting
Wroclaw, Poland, 51-685
Portugal
Hosp. Garcia de Orta Not yet recruiting
Almada, Portugal, 2805-267
Chbv - Hosp. Infante D. Pedro Not yet recruiting
Aveiro, Portugal, 3814-501
Ccab - Hosp. de Braga Not yet recruiting
Braga, Portugal, 4710-243
Ipr - Inst. Port. de Reumatologia Not yet recruiting
Lisboa, Portugal, 1050-034
Chlo - Hosp. Egas Moniz Not yet recruiting
Lisboa, Portugal, 1349-019
Chln - Hosp. Santa Maria Not yet recruiting
Lisboa, Portugal, 1649-035
Ulsam - Hosp. Conde de Bertiandos Not yet recruiting
Ponte de Lima, Portugal, 4990-041
Chsj - Hosp. Sao Joao Not yet recruiting
Porto, Portugal, 4200-319
Russian Federation
Chelyabinck Regional Clinical Hospital Not yet recruiting
Chelyabinsk, Russian Federation, 454076
Kemerovo State Medical University Not yet recruiting
Kemerovo, Russian Federation, 650000
Family polyclinic #4 Not yet recruiting
Korolev, Russian Federation, 141060
Krasnodar Clinical Dermatovenerologic Dispensary Not yet recruiting
Krasnodar, Russian Federation, 350020
Orenburg State Medical Academy Not yet recruiting
Orenburg, Russian Federation, 460000
Rostov Regional Clinical Dermatovenerological Dispensary Recruiting
Rostov, Russian Federation, 344007
Samara Regional Clinical Hospital Named After V.D.Seredavin Not yet recruiting
Samara, Russian Federation, 443095
Smolensk regional hospital on Smolensk railway station Not yet recruiting
Smolensk, Russian Federation, 214025
Leningrad region clinical hospital Not yet recruiting
St-Petersburg, Russian Federation, 194291
Republican Clinical Hospital - G.G. Kuvatov Not yet recruiting
Ufa, Russian Federation, 450005
Ulyanovsk Regional Clinical Hospital Not yet recruiting
Ulyanovsk, Russian Federation, 432063
Regional Clinical Hospital Not yet recruiting
Velikiy Novgorod, Russian Federation, 173008
Clinical Emergency Hospital n.a. N.V. Solovyev Not yet recruiting
Yaroslavl, Russian Federation, 150003
Clinical Hospital #3 Not yet recruiting
Yaroslavl, Russian Federation, 150007
Spain
Hosp. Univ. A Coruña Not yet recruiting
A Coruña, Spain, 15006
Hosp. Univ. de Cruces Not yet recruiting
Barakaldo, Spain, 48902
Hosp. Univ. Germans Trias I Pujol Recruiting
Barcelona, Spain, 08916
Hosp. Univ. de Basurto Not yet recruiting
Bilbao, Spain, 48013
Hosp. Reina Sofia Recruiting
Córdoba, Spain, 14004
Hosp. Univ. Ramon Y Cajal Not yet recruiting
Madrid, Spain, 28034
Hosp. Univ. Fund. Jimenez Diaz Not yet recruiting
Madrid, Spain, 28040
Hosp. Univ. 12 de Octubre Not yet recruiting
Madrid, Spain, 28041
Hosp. Univ. de Getafe Not yet recruiting
Madrid, Spain, 28905
Hosp. Regional Univ. de Malaga Not yet recruiting
Málaga, Spain, 29009
Hosp. Clinico Univ. de Santiago Recruiting
Santiago de Compostela, Spain, 15706
Hosp. Infanta Luisa Not yet recruiting
Sevilla, Spain, 41010
Hosp. Virgen Del Rocio Not yet recruiting
Sevilla, Spain, 41013
Hosp. Ntra. Sra. de Valme Recruiting
Sevilla, Spain, 41014
Hosp. Do Meixoeiro Not yet recruiting
Vigo, Spain, 36312
Ukraine
Municipal Institution Cherkasy Regional Hospital of Cherkasy Regional Council Not yet recruiting
Cherkasy, Ukraine, 18009
Municipal health care institution Chernihiv Regional Hospital Not yet recruiting
Chernihiv, Ukraine
Ivano-Frankivsk National Medical University, Ivano-Frankivsk City Clinical Hospital Not yet recruiting
Ivano-Frankivsk, Ukraine, 76018
City Multifield Hospital #18, Mechnikov Institute of Microbiology and Immunology of NAMS Not yet recruiting
Kharkiv, Ukraine, 61029
Municipal non-commercial enterprise of Kharkiv Regional Council Regional Clinical Hospital Not yet recruiting
Kharkiv, Ukraine, 61058
Khmelnitckiy regional hospital Not yet recruiting
Khmelnytsky, Ukraine
Kyiv City Clinical Hospital #3, National Medical University Not yet recruiting
Kyiv, Ukraine, 02125
Medical Center 'Consylium Medical' Not yet recruiting
Kyiv, Ukraine, 04050
Kyiv Railway Station Clinical Hospital #2 Not yet recruiting
Kyiv, Ukraine
SI National Scientific Center The M.D.Strazhesko Institute of Cardiology of NAMSU Not yet recruiting
Kyiv, Ukraine
Danylo Halytsky Lviv National Medical University Not yet recruiting
Lviv, Ukraine, 79010
Poltava Regional Clinical Hospital Named After M.V.Sklifosovsk Not yet recruiting
Poltava, Ukraine, 36011
Municipal Institution of Sumy Regional Council Sumy Regional Clinical Hospital Not yet recruiting
Sumy, Ukraine, 40031
Ternopil University Hospital Not yet recruiting
Ternopil, Ukraine, 46002
Medical Center LTD Health Clinic Department of Cardiology and Rheumatology Not yet recruiting
Vinnytsya, Ukraine, 21009
Vinnytsya State Medical University, Vinnytsya Regional Clinical Hospital Not yet recruiting
Vinnytsya, Ukraine, 21018
Municipal institution Central Clinical Hospital #1 Zhytomir Not yet recruiting
Zhytomir, Ukraine, 10002
United Kingdom
Royal National Hospital for Rheumatic Diseases Not yet recruiting
Bath, United Kingdom, BA1 1RL
Cambridge University Hospitals NHS Foundation Trust Not yet recruiting
Cambridge, United Kingdom, CB2 0QQ
Cannock Chase Hospital Not yet recruiting
Cannock, United Kingdom, WS11 5XY
Chapel Allerton Hospital Not yet recruiting
Leeds, United Kingdom, LS7 4SA
Barts Health NHS Trust Whipps Cross University Hospital NHS Trust Not yet recruiting
London, United Kingdom, E11 1NR
Guy's and St Thomas' NHS Foundation Trust - Rheumatoid Arthritis (RA) Clinic Not yet recruiting
London, United Kingdom, SE1 9RS
Central Manchester University Hospitals NHS Foundation Trust Not yet recruiting
Manchester, United Kingdom, M13 9WL
North Tyneside General Hospital Not yet recruiting
Newcastle, United Kingdom, NE29 8NH
Peterborough City Hospital Not yet recruiting
Peterborough, United Kingdom, PE3 9GZ
Haywood Hospital Not yet recruiting
Stoke on Trent, United Kingdom, ST6 7AG
Torbay Hospital-Devon Not yet recruiting
Torquay, United Kingdom, TQ2 7AA
Sponsors and Collaborators
Janssen Pharmaceutica N.V., Belgium
Investigators
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Study Director: Janssen Pharmaceutica N.V., Belgium Clinical Trial Janssen Pharmaceutica N.V., Belgium

Additional Information:
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Responsible Party: Janssen Pharmaceutica N.V., Belgium
ClinicalTrials.gov Identifier: NCT03796858     History of Changes
Other Study ID Numbers: CR108573
2018-003214-41 ( EudraCT Number )
CNTO1959PSA3003 ( Other Identifier: Janssen Pharmaceutica N.V., Belgium )
First Posted: January 8, 2019    Key Record Dates
Last Update Posted: April 8, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials\transparency.

As noted on this site, requests for access to the study data can be submitted through Yale open Access (YODA) Project site at yoda.yale.edu

URL: https://www.janssen.com/clinical-trials/transparency

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Arthritis
Necrosis
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Pathologic Processes
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases