Clinical trial NCT03162796: A Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Participants With Active Psoriatic Arthritis Including Those Previously Treated With Biologic Anti -Tumor Necrosis Factor (TNF) Alpha Agent(s)
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 Including Those Previously Treated With Biologic Anti-TNF Alpha Agents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Arthritis, Psoriatic
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2017-05-22
Enrollment: 383
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: This is a study of guselkumab in participants with active Psoriatic Arthritis (PsA) who had inadequate response to standard therapies. It will evaluate the clinical efficacy of guselkumab in the reduction of signs and symptoms and the safety profile of guselkumab in the treatment of PsA. The study will consists of 4 phases: a screening phase of up to 6 weeks, a blinded treatment phase of approximately 1 year (that is, 52 weeks), including a placebo controlled period from Week 0 to Week 24 and double-blind active treatment period from Week 24 to Week 52, and a safety follow-up phase of 8 weeks after Week 52 (Week 52 to 60) and will be 12 weeks from the last administration of study agent (at Week 48) to the final safety follow-up visit. Efficacy, safety, pharmacokinetic, immunogenicity, and biomarker evaluations will be performed in the study at defined schedule.

Eligibility 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 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 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
* 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 drugs (DMARD), apremilast, and/or nonsteroidal anti-inflammatory drug (NSAID) therapy : Non-biologic DMARD therapy is defined as taking a non-biologic DMARD for at least 3 months or evidence of intolerance; Apremilast therapy is defined as taking apremilast at the marketed dose approved in the country where the study is being conducted for at least 4 months or evidence of intolerance; NSAID therapy is defined as taking an NSAID for at least 4 weeks or evidence of intolerance
* Participants may have been previously treated with up to 2 anti-TNF (tumor necrosis factor) alpha agents (approximately 30 percent \[%\] of the overall study population), and must document the reason for discontinuation

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-TNFalpha 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 any systemic immunosuppressants (for example, azathioprine, cyclosporine, 6 thioguanine, mercaptopurine, mycophenolate mofetil, hydroxyurea, tacrolimus) within 4 weeks of the first administration of study agent
* Has received apremilast within 4 weeks prior to the first administration of study agent
* Has previously received tofacitinib, baricitinib, filgotinib, peficitinib (ASP015K), decernotinib (VX-509), or any other Janus kinase (JAK) inhibitor

Primary outcomes:
measure: Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 24
timeFrame: Week 24
Secondary outcomes:
measure: Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24
timeFrame: Baseline and Week 24
measure: Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 50 Response at Week 24
timeFrame: Week 24
measure: Percentage of Participants With Psoriasis Response of IGA (Score: 0[Cleared] or 1[Minimal] and >=2 Grade Reduction From Baseline) at Week 24 Among Participants With >=3% Body Surface Area (BSA) Psoriatic Involvement and IGA Score of >=2 (Mild) at Baseline
timeFrame: Week 24
measure: Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 16
timeFrame: Week 16
measure: Change From Baseline in Disease Activity Score (DAS28) (C-reactive Protein [CRP]) Score at Week 24
timeFrame: Baseline and Week 24
measure: Percentage of Participants Who Achieve an American College of Rheumatology (ACR) 70 Response at Week 24
timeFrame: Week 24
measure: Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 50 Response at Week 16
timeFrame: Week 16
measure: Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score at Week 24
timeFrame: Baseline and Week 24
measure: Percentage of Participants With Resolution of Enthesitis at Week 24 Among the Participants With Enthesitis at Baseline
timeFrame: Week 24
measure: Change From Baseline in Enthesitis Score (Based on LEI) at Week 24 Among the Participants With Enthesitis at Baseline
timeFrame: Baseline and Week 24
measure: Change From Baseline in 36-Item Short Form Health Survey (SF-36) Mental Component Summary (MCS) Score at Week 24
timeFrame: Baseline and Week 24
measure: Percentage of Participants With Resolution of Dactylitis at Week 24 Among the Participants With Dactylitis at Baseline
timeFrame: Week 24
measure: Change From Baseline in Dactylitis Scores at Week 24 Among the Participants With Dactylitis at Baseline
timeFrame: Baseline and Week 24
measure: Percentage of Participants Who Achieved ACR 20 Response by Visit Over Time Through Week 24
timeFrame: Weeks 4, 8, 12, 16, 20 and 24
measure: Percentage of Participants Who Achieved ACR 50 Response by Visit Over Time Through Week 24
timeFrame: Weeks 4, 8, 12, 16, 20 and 24
measure: Percentage of Participants Who Achieved ACR 70 Response by Visit Over Time Through Week 24
timeFrame: Weeks 4, 8, 12, 16, 20 and 24
measure: ACR Components- Swollen Joint Count and Tender Joint Count Through Week 24
timeFrame: Weeks 4, 8, 12, 16, 20 and 24
measure: ACR Components- Patient's Assessment of Pain, Patient's Global Assessment of Disease Activity, Physician's Global Assessment of Disease Activity Through Week 24
timeFrame: Weeks 4, 8, 12, 16, 20 and 24
measure: ACR Component- C-reactive Protein (CRP) Through Week 24
timeFrame: Weeks 4, 8, 12, 16, 20 and 24
measure: ACR Component- Patient's Assessment of Physical Function as Assessed by HAQ-DI Scale Score at Weeks 4, 8, 12, 16, 20 and 24
timeFrame: Weeks 4, 8, 12, 16, 20 and 24
measure: Percent Change From Baseline in ACR Components at Weeks 4, 8, 12, 16, 20 and 24
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20 and 24
measure: Change From Baseline in HAQ-DI Score at Weeks 4, 8, 12, 16, 20 and 24
timeFrame: Baseline, Week 4, 8, 12, 16, 20 and 24
measure: Percentage of Participants Who Achieved a Clinically Meaningful Improvement (>=0.35 Improvement From Baseline) in HAQ-DI Score by Visit Over Time Through Week 24 Among Participants With HAQ-DI Score >=0.35 at Baseline
timeFrame: Week 4, 8, 12, 16, 20 and 24
measure: Percentage of Participants Who Achieved a DAS28 (CRP) Response by Visit Over Time Through Week 24
timeFrame: Weeks 4, 8, 12, 16, 20 and 24
measure: Percentage of Participants Who Achieved a DAS28 (CRP) Remission by Visit Over Time Through Week 24
timeFrame: Week 4, 8, 12, 16, 20 and 24
measure: Change From Baseline in DAS28 (CRP) Score at Weeks 4, 8, 12, 16, 20 and 24
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20 and 24
measure: Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) by Visit Over Time Through Week 24
timeFrame: Weeks 4, 8, 12, 16, 20 and 24
measure: Percentage of Participants Who Achieved Resolution of Enthesitis at Weeks 4, 8, 16, and 24 Among the Participants With Enthesitis at Baseline
timeFrame: Weeks 4, 8, 16, and 24
measure: Change From Baseline in Enthesitis Score at Weeks 4, 8, 16 and 24 Among the Participants With Enthesitis at Baseline
timeFrame: Baseline, Weeks 4, 8, 16 and 24
measure: Percentage of Participants With Resolution of Dactylitis by Visit Over Time Through Week 24 Among the Participants With Dactylitis at Baseline
timeFrame: Weeks 4, 8, 16 and 24
measure: Change From Baseline in Dactylitis Score at Weeks 4, 8, 16 and 24 Among the Participants With Dactylitis at Baseline
timeFrame: Baseline, Weeks 4, 8, 16 and 24
measure: Change From Baseline in the Psoriatic Arthritis Disease Activity (PASDAS) Score at Weeks 8, 16 and 24
timeFrame: Baseline, Weeks 8, 16 and 24
measure: Change From Baseline in Group of Research and Assessment of Psoriasis and Psoriatic Arthritis Composite (GRACE) Score at Weeks 16 and 24
timeFrame: Baseline, Weeks 16 and 24
measure: Change From Baseline in the Disease Activity Index for Psoriatic Arthritis (DAPSA) Score at Weeks 4, 8, 12, 16, 20 and 24
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20 and 24
measure: Percentage of Participants Who Achieved Minimal Disease Activity (MDA) at Weeks 16 and 24
timeFrame: Weeks 16 and Week 24
measure: Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score Through Week 24 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline
timeFrame: Weeks 8, 16 and 24
measure: Change From Baseline in BASDAI Score at Week 8, 16, and Week 24 Among Participants With Spondylitis and Peripheral Arthritis at Baseline
timeFrame: Baseline, Weeks 8, 16, and 24
measure: Percentage of Participants With Low or Very Low Disease Activity Based on Psoriatic Arthritis Disease Activity Score (PASDAS) by Visit Over Time Through Week 24
timeFrame: Weeks 8, 16 and 24
measure: Percentage of Participants With Low Disease Activity Based on Group of Research and Assessment of Psoriasis and Psoriatic Arthritis Composite (GRACE) Score Index by Visit Over Time Through Week 24
timeFrame: Weeks 16 and 24
measure: Percentage of Participants With Low Disease Activity or Remission Based on Disease Activity Index for Psoriatic Arthritis (DAPSA) by Visit Over Time Through Week 24
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20 and 24
measure: Percentage of Participants With Very Low Disease Activity (VLDA) by Visit Over Time Through Week 24
timeFrame: Weeks 16 and 24
measure: Percentage of Participants Who Achieved PASI 75 Response at Weeks 16 and 24 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 at Baseline
timeFrame: Weeks 16 and 24
measure: Percentage of Participants Who Achieved PASI 90 Response at Weeks 16 and 24 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 at Baseline
timeFrame: Weeks 16 and 24
measure: Percentage of Participants Who Achieved PASI 100 Response by Visit Over Time Through Week 24 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 at Baseline
timeFrame: Weeks 16 and 24
measure: Percentage of Participants Who Achieved Both PASI 75 and ACR 20 Responses at Weeks 16 and 24 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline
timeFrame: Weeks 16 and 24
measure: Percentage of Participants Who Achieved Both PASI 75 and Modified PsARC Response by Visit Over Time Through Week 24 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline
timeFrame: Weeks 16 and 24
measure: Percentage of Participants With an IGA Score of 0 (Cleared) at Weeks 16 and 24 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline
timeFrame: Weeks 16 and 24
measure: Change From Baseline in PASI Score at Weeks 16 and 24 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline
timeFrame: Baseline, Weeks 16 and 24
measure: Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) at Weeks 8, 16 and 24
timeFrame: Baseline, Weeks 8, 16 and 24
measure: Change From Baseline in 36-Item Short Form Health Survey (SF-36) Mental Component Summary (MCS) at Weeks 8, 16 and 24
timeFrame: Baseline, Weeks 8, 16 and 24
measure: Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24
timeFrame: Baseline, Week 8, 16 and 24
measure: Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 MCS Score by Visit Over Time Through Week 24
timeFrame: Weeks 8, 16 and 24
measure: Percentage of Participants Who Achieved >=5 Point Improvement From Baseline in SF-36 PCS Score Through Week 24
timeFrame: Weeks 8, 16 and 24
measure: Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 8, 16, and 24
timeFrame: Baseline, Weeks 8, 16 and 24
measure: Percentage of Participants Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score at Weeks 8, 16, and 24
timeFrame: Weeks 8, 16, and 24
measure: Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Scores at Weeks 8, 16 and 24
timeFrame: Baseline, Weeks 8, 16 and 24
measure: Change From Baseline in FACIT-Fatigue Score at Week 24 by ACR 20 Response at Week 24
timeFrame: Baseline and Week 24
measure: Percentage of Participants Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score at Week 24 by ACR 20 Response at Week 24
timeFrame: Week 24
measure: Percentage of Participants Who Achieved an Improvement of >=3 Points From Baseline in PROMIS-29 Domain Scores at Weeks 8, 16, and 24
timeFrame: Weeks 8, 16, and 24
measure: Percentage of Participants Who Achieved an Improvement of >=5 Points From Baseline in PROMIS-29 Domain Scores at Weeks 8, 16, and 24
timeFrame: Weeks 8, 16, and 24
measure: Percentage of Participants Who Achieved ACR 20 Response at Weeks 24, 28, 36, 44 and 52
timeFrame: Weeks 24, 28, 36, 44 and 52
measure: Percentage of Participants Who Achieved ACR 50 Response at Weeks 24, 28, 36, 44 and 52
timeFrame: Weeks 24, 28, 36, 44 and 52
measure: Percentage of Participants Who Achieved ACR 70 Response at Weeks 24, 28, 36, 44 and 52
timeFrame: Weeks 24, 28, 36, 44 and 52
measure: Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52
timeFrame: Baseline, Weeks 24, 28, 36, 44 and 52
measure: Change From Baseline in HAQ-DI Score at Weeks 24, 28, 36, 44 and 52
timeFrame: Baseline, Weeks 24, 28, 36, 44 and 52
measure: Percentage of Participants Who Achieved a Clinically Meaningful Improvement (>=0.35 Improvement From Baseline) in HAQ-DI Score at Weeks 24, 28, 36, 44 and 52 Among Participants With HAQ-DI Score >=0.35 at Baseline
timeFrame: Weeks 24, 28, 36, 44 and 52
measure: Change From Baseline in DAS28 (CRP) Score at Weeks 24, 28, 36, 44 and 52
timeFrame: Baseline, Weeks 24, 28, 36, 44 and 52
measure: Percentage of Participants Who Achieved a DAS28 (CRP) Response at Weeks 24, 28, 36, 44 and 52
timeFrame: Weeks 24, 28, 36, 44 and 52
measure: Percentage of Participants Who Achieved a DAS28 (CRP) Remission at Weeks 24, 28, 36, 44 and 52
timeFrame: Weeks 24, 28, 36, 44 and 52
measure: Percentage of Participants Who Maintained a HAQ-DI Response (>=0.35 Improvement From Baseline in HAQ-DI Score) at Week 52 Among Participants Who Achieved a HAQ-DI Response at Week 24
timeFrame: Week 52
measure: Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) at Weeks 24, 28, 36, 44 and 52
timeFrame: Weeks 24, 28, 36, 44 and 52
measure: Change From Baseline in the Disease Activity Index for Psoriatic Arthritis (DAPSA) Score at Weeks 24, 28, 36, 44 and 52
timeFrame: Baseline, Weeks 24, 28, 36, 44 and 52
measure: Percentage of Participants Who Achieved Both PASI 75 and Modified PsARC Response at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 at Baseline
timeFrame: Weeks 24 and 52
measure: Percentage of Participants Who Achieved Both PASI 75 and ACR 20 Responses at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 at Baseline
timeFrame: Weeks 24 and 52
measure: Change From Baseline in PASI Score at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 at Baseline
timeFrame: Baseline, Weeks 24 and 52
measure: Percentage of Participants Who Achieved PASI 75 Response at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 at Baseline
timeFrame: Weeks 24 and 52
measure: Percentage of Participants Who Achieved PASI 90 Response at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 at Baseline
timeFrame: Weeks 24 and 52
measure: Percentage of Participants Who Achieved PASI 100 Response at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 at Baseline
timeFrame: Weeks 24 and 52
measure: Percentage of Participants Who Achieved >=5 Point Improvement From Baseline in SF-36 PCS Score at Weeks 24, 36 and 52
timeFrame: Weeks 24, 36 and 52
measure: Percentage of Participants Who Achieved >=5 Point Improvement From Baseline in SF-36 MCS Score at Weeks 24, 36 and 52
timeFrame: Weeks 24, 36 and 52
measure: Percentage of Participants Who Achieved Minimal Disease Activity (MDA) at Weeks 24 and 52
timeFrame: Weeks 24 and 52
measure: Change From Baseline in Group of Research and Assessment of Psoriasis and Psoriatic Arthritis Composite (GRACE) Score Index at Weeks 24 and 52
timeFrame: Baseline, Weeks 24 and 52
measure: Change From Baseline in Psoriatic Arthritis Disease Activity (PASDAS) Score at Weeks 24 and 52
timeFrame: Baseline, Weeks 24 and 52
measure: Percentage of Participants Who Maintained an ACR 20 Response at Week 52 Among Participants Who Achieved an ACR 20 Response at Week 24
timeFrame: Week 52
measure: Percentage of Participants Who Maintained an ACR 50 Response at Week 52 Among Participants Who Achieved an ACR 50 Response at Week 24
timeFrame: Week 52
measure: Percentage of Participants Who Maintained an ACR 70 Response at Week 52 Among Participants Who Achieved an ACR 70 Response at Week 24
timeFrame: Week 52
measure: Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score at Weeks 24 and 52 Among Participants With Spondylitis and Peripheral Arthritis as Their Primary Arthritic Presentation of PsA
timeFrame: Weeks 24 and 52
measure: Percentage of Participants With Resolution of Enthesitis at Weeks 24, 36, 44 and 52 Among the Participants With Enthesitis at Baseline
timeFrame: Weeks 24, 36, 44 and 52
measure: Percentage of Participants With Resolution of Dactylitis at Weeks 24, 36, 44 and 52 Among Participants With Dactylitis at Baseline
timeFrame: Weeks 24, 36, 44 and 52
measure: Change From Baseline in Enthesitis Score (Based on SPARCC) at Weeks 24, 36, 44 and 52 Among the Participants With Enthesitis at Baseline
timeFrame: Baseline, Weeks 24, 36, 44 and 52
measure: Change From Baseline in Enthesitis Score (Based on LEI) at Weeks 24, 36, 44 and 52 Among the Participants With Enthesitis at Baseline
timeFrame: Baseline, Weeks 24, 36, 44 and 52
measure: Change From Baseline in Dactylitis Score at Weeks 24, 36, 44 and 52 Among the Participants With Dactylitis at Baseline
timeFrame: Baseline, Weeks 24, 36, 44 and 52
measure: Percentage of Participants With an IGA Score of 0 (Cleared) or 1 (Cleared) at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 at Baseline
timeFrame: Weeks 24 and 52
measure: Change From Baseline in SF-36 Physical Component Summary (PCS) Score at Weeks 24, 36 and 52
timeFrame: Baseline, Weeks 24, 36 and 52
measure: Change From Baseline in SF-36 Mental Component Summary (MCS) Score at Weeks 24, 36 and 52
timeFrame: Baseline, Weeks 24, 36 and 52
measure: Change From Baseline in Norm Based Scores of SF-36 Scales at Week 24, 36 and 52
timeFrame: Baseline, Weeks 24, 36 and 52
measure: Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 24, 36 and 52
timeFrame: Baseline, Weeks 24, 36 and 52
measure: Percentage of Participants Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score at Weeks 24, 36 and 52
timeFrame: Weeks 24, 36 and 52
measure: Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Scores at Weeks 24, 36 and 52
timeFrame: Baseline, Weeks 24, 36 and 52
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Rheumatology Associates
state: Alabama
city: Glendale
country: United States
facility: Arizona Arthritis & Rheumatology Associates PC
state: Arizona
city: Mesa
country: United States
facility: Arizona Arthritis & Rheumatology Research, PLLC
state: Arizona
city: Danbury
country: United States
facility: Clinical Research Center of Connecticut
state: Connecticut
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research Group, LLC
state: Indiana
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Saint Louis
country: United States
facility: Arthritis Consultants
state: Missouri
city: Freehold
country: United States
facility: Arthritis and Osteoporosis Associates
state: New Jersey
city: Austin
country: United States
facility: Austin Regional Clinic
state: Texas
city: Geelong
country: Australia
facility: Barwon Rheumatology Services
city: Hobart
country: Australia
facility: Southern Clinical Research
city: Liverpool
country: Australia
facility: Liverpool Hospital
city: Maroochydore
country: Australia
facility: Rheumatology Research Unit
city: Melbourne
country: Australia
facility: Eastern Health - Box Hill Hospital
city: Woodville South
country: Australia
facility: Queen Elizabeth Hospital
city: St. John's
country: Canada
facility: Eastern Regional Health Authority, St. Clare's Mercy Hospital
state: Newfoundland and Labrador
city: Barrie
country: Canada
facility: The Waterside Clinic
state: Ontario
city: Hamilton
country: Canada
facility: Dermatrials Research
state: Ontario
city: Peterborough
country: Canada
facility: Skin Centre for Dermatology
state: Ontario
city: Waterloo
country: Canada
facility: K. Papp Clinical Research
state: Ontario
city: Quebec
country: Canada
facility: G.R.M.O. (Groupe de recherche en maladies osseuses) Inc.
city: Brno
country: Czechia
facility: Revmaclinic
city: Ostrava
country: Czechia
facility: MUDr. Rosypalova, s.r.o
city: Praha 4
country: Czechia
facility: Revmatologicka ambulance
city: Praha
country: Czechia
facility: Revmatologicky ustav
city: Uherske Hradiste
country: Czechia
facility: Medical Plus S.R.O.
city: Zlin
country: Czechia
facility: PV-Medical S.R.O
city: Berlin
country: Germany
facility: ISA GmbH
city: Frankfurt
country: Germany
facility: Universitatsklinikum Frankfurt
city: Hamburg
country: Germany
facility: MVZ Rheuma
city: Herne
country: Germany
facility: Rheumazentrum Ruhrgebiet
city: Wuppertal
country: Germany
facility: Krankenhaus St. Josef
city: Budapest
country: Hungary
facility: Orszagos Reumatologia es Fizioterapias Intezet
city: Budapest
country: Hungary
facility: Magyar Honvedseg Egeszsegugyi Kozpont
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont
city: Kistarcsa
country: Hungary
facility: Pest Megyei Flor Ferenc Korhaz
city: Szombathely
country: Hungary
facility: Martinus Medicus Health Center
city: Bundang
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Hanyang University Hospital for rheumatic Diseases
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea Seoul St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: SMG - SNU Boramae Medical Center
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
city: Batu Caves
country: Malaysia
facility: Hospital Selayang
city: Georgetown
country: Malaysia
facility: Hospital Pulau Pinang
city: Ipoh
country: Malaysia
facility: Hospital Raja Permaisuri Bainun
city: Melaka
country: Malaysia
facility: Hospital Melaka
city: Seremban
country: Malaysia
facility: Hospital Tuanku Jaafar
city: Bialystok
country: Poland
facility: Nzoz Osteo-Medic
city: Bydgoszcz
country: Poland
facility: Szpital Uniwersytecki Nr 2 w Bydgoszczy
city: Dabrowka
country: Poland
facility: NSZOZ Unica CR
city: Elblag
country: Poland
facility: Centrum Kliniczno Badawcze J. Brzezicki, B. Gornikiewicz-Brzezicka Lekarze Spolka Partnerska
city: Olsztyn
country: Poland
facility: Etyka Osrodek Badan Klinicznych
city: Poznań
country: Poland
facility: Centrum Medyczne Hetmańska
city: Torun
country: Poland
facility: Nasz Lekarz Przychodnie Medyczne
city: Warsaw
country: Poland
facility: Medycyna Kliniczna
city: Warszawa
country: Poland
facility: Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. prof. dr hab. med. Eleonory Reicher
city: Wroclaw
country: Poland
facility: Centrum Medyczne WroMedica
city: Wroclaw
country: Poland
facility: Nzoz Biogenes Sp. Z O. O.
city: Chelyabinsk
country: Russian Federation
facility: Chelyabinsk Regional Clinical Dermatovenerological Dispensary
city: Cherepovets
country: Russian Federation
facility: Medical and Sanitary Unit ''Severstal''
city: Ekaterinburg
country: Russian Federation
facility: Research Institute of Dermatovenerology, Immunology
city: Krasnoyarsk
country: Russian Federation
facility: Krasnoyarsk State Medical University
city: Lipetsk
country: Russian Federation
facility: Lipetsk Regional Dermatovenerological Dispensary
city: Rostov
country: Russian Federation
facility: Rostov Regional Clinical Dermatovenerological Dispensary
city: Ryazan
country: Russian Federation
facility: Ryazan Regional Clinical Dermatovenerological Dispensary
city: Ufa
country: Russian Federation
facility: Republican Clinical Hospital - G.G. Kuvatov
city: Yaroslavl
country: Russian Federation
facility: Clinical Emergency Hospital n.a. N.V. Solovyev
city: Yaroslavl
country: Russian Federation
facility: Clinical Hospital #10
city: A Coruna
country: Spain
facility: Hosp. Univ. A Coruña
city: Barcelona
country: Spain
facility: Hosp. Del Mar
city: Madrid
country: Spain
facility: Hosp. Gral. Univ. Gregorio Marañon
city: Madrid
country: Spain
facility: Hosp. Univ. Ramon Y Cajal
city: Málaga
country: Spain
facility: Hospital Regional Carlos Haya
city: Santiago de Compostela
country: Spain
facility: Hosp. Clinico Univ. de Santiago
city: Sevilla
country: Spain
facility: Hosp. Infanta Luisa
city: Sevilla
country: Spain
facility: Hosp. Unv. de Valme
city: Valencia
country: Spain
facility: Hosp. de Manises
city: Hualien City
country: Taiwan
facility: Hualien Tzu Chi Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Veterans General Hospital
city: Kaohsiung
country: Taiwan
facility: Chang Gung Memorial Hospital Kaohsiung Branch
city: Taichung
country: Taiwan
facility: Chung Shan Medical University Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Medical Center
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Chang Kung Memorial Hospital
city: Taoyuan
country: Taiwan
facility: Chang-Gung Memorial Hospital, LinKou Branch
city: Chernihiv
country: Ukraine
facility: Municipal health care institution Chernihiv Regional Hospital
city: Ivano-Frankivsk
country: Ukraine
facility: Ivano-Frankivsk National Medical University, Ivano-Frankivsk City Clinical Hospital
city: Kharkiv
country: Ukraine
facility: Communal Institution of Health Kharkiv City multifield hospital №18
city: Kharkiv
country: Ukraine
facility: Municipal Institution Regional hospital-center of emergency care and disasters medicine
city: Khmelnytsky
country: Ukraine
facility: Khmelnitckiy regional hospital
city: Kyiv
country: Ukraine
facility: Clinic of SI 'NSC 'The M.D.Strazhesko Institute of Cardiology' of NAMS of Ukraine'
city: Kyiv
country: Ukraine
facility: Kyiv Railway Station Clinical Hospital #2
city: Lviv
country: Ukraine
facility: Danylo Halytsky Lviv National Medical University
city: Odessa
country: Ukraine
facility: Municipal Non-profit Enterprise 'Odesa Regional Clinical Hospital' Odesa Regional Council
city: Ternopil
country: Ukraine
facility: Municipal institution of Tepnopil Regional Council 'Ternopil University Hospital'
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References:
citation: Orbai AM, Coates LC, Deodhar A, Helliwell PS, Ritchlin CT, Leibowitz E, Kollmeier AP, Hsia EC, Xu XL, Sheng S, Jiang Y, Liu Y, Han C. Meaningful Improvement in General Health Outcomes with Guselkumab Treatment for Psoriatic Arthritis: Patient-Reported Outcomes Measurement Information System-29 Results from a Phase 3 Study. Patient. 2022 Nov;15(6):657-668. doi: 10.1007/s40271-022-00588-6. Epub 2022 Jun 30.
citation: Coates LC, Ritchlin CT, Gossec L, Helliwell PS, Rahman P, Kollmeier AP, Xu XL, Shawi M, Karyekar CS, Contre C, Noel W, Sheng S, Wang Y, Xu S, Mease PJ. Guselkumab provides sustained domain-specific and comprehensive efficacy using composite indices in patients with active psoriatic arthritis. Rheumatology (Oxford). 2023 Feb 1;62(2):606-616. doi: 10.1093/rheumatology/keac375.
citation: Ritchlin CT, Mease PJ, Boehncke WH, Tesser J, Schiopu E, Chakravarty SD, Kollmeier AP, Xu XL, Shawi M, Jiang Y, Sheng S, Wang Y, Xu S, Merola JF, McInnes IB, Deodhar A. Sustained and improved guselkumab response in patients with active psoriatic arthritis regardless of baseline demographic and disease characteristics: pooled results through week 52 of two phase III, randomised, placebo-controlled studies. RMD Open. 2022 Mar;8(1):e002195. doi: 10.1136/rmdopen-2022-002195.
citation: Rahman P, Mease PJ, Helliwell PS, Deodhar A, Gossec L, Kavanaugh A, Kollmeier AP, Hsia EC, Zhou B, Lin X, Shawi M, Karyekar CS, Han C. Guselkumab demonstrated an independent treatment effect in reducing fatigue after adjustment for clinical response-results from two phase 3 clinical trials of 1120 patients with active psoriatic arthritis. Arthritis Res Ther. 2021 Jul 14;23(1):190. doi: 10.1186/s13075-021-02554-3.
citation: Sweet K, Song Q, Loza MJ, McInnes IB, Ma K, Leander K, Lakshminarayanan V, Franks C, Cooper P, Siebert S. Guselkumab induces robust reduction in acute phase proteins and type 17 effector cytokines in active psoriatic arthritis: results from phase 3 trials. RMD Open. 2021 May;7(2):e001679. doi: 10.1136/rmdopen-2021-001679.
citation: Rahman P, Ritchlin CT, Helliwell PS, Boehncke WH, Mease PJ, Gottlieb AB, Kafka S, Kollmeier AP, Hsia EC, Xu XL, Shawi M, Sheng S, Agarwal P, Zhou B, Ramachandran P, Zhuang Y, McInnes IB. Pooled Safety Results Through 1 Year of 2 Phase III Trials of Guselkumab in Patients With Psoriatic Arthritis. J Rheumatol. 2021 Dec;48(12):1815-1823. doi: 10.3899/jrheum.201532. Epub 2021 May 1.
citation: McGonagle D, McInnes IB, Deodhar A, Schett G, Shawi M, Kafka S, Karyekar CS, Kollmeier AP, Hsia EC, Xu XL, Sheng S, Agarwal P, Zhou B, Ritchlin CT, Rahman P, Mease PJ. Resolution of enthesitis by guselkumab and relationships to disease burden: 1-year results of two phase 3 psoriatic arthritis studies. Rheumatology (Oxford). 2021 Nov 3;60(11):5337-5350. doi: 10.1093/rheumatology/keab285.
citation: Deodhar A, Helliwell PS, Boehncke WH, Kollmeier AP, Hsia EC, Subramanian RA, Xu XL, Sheng S, Agarwal P, Zhou B, Zhuang Y, Ritchlin CT; DISCOVER-1 Study Group. Guselkumab in patients with active psoriatic arthritis who were biologic-naive or had previously received TNFalpha inhibitor treatment (DISCOVER-1): a double-blind, randomised, placebo-controlled phase 3 trial. Lancet. 2020 Apr 4;395(10230):1115-1125. doi: 10.1016/S0140-6736(20)30265-8. Epub 2020 Mar 13.