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)

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03162796
• Date of registration: 19/05/2017
• Prospective Registration: Yes
• Primary sponsor: Janssen Research & Development, LLC
• Public title: 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) Discover-1
• Scientific 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
• Date of first enrolment: August 24, 2017
• Target sample size: 383
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03162796
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 3

Countries of recruitment

Australia, Canada, Czechia, Germany, Hungary, Korea, Republic of, Malaysia, Poland, Russian Federation, Spain, Taiwan, Ukraine, United States

Contacts

• Name: Janssen Research & Development, LLC Clinical Trial
• Affiliation: Janssen Research & Development, LLC

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Arthritis, Psoriatic

Intervention(s)

Drug: Placebo

Drug: Guselkumab

Primary Outcome(s)

Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 24 [Time Frame: Week 24]

Secondary Outcome(s)

ACR Component- C-reactive Protein (CRP) Through Week 24 [Time Frame: Weeks 4, 8, 12, 16, 20 and 24]

ACR Components- Patient's Assessment of Pain, Patient's Global Assessment of Disease Activity, Physician's Global Assessment of Disease Activity Through Week 24 [Time Frame: Weeks 4, 8, 12, 16, 20 and 24]

ACR Components- Swollen Joint Count and Tender Joint Count Through Week 24 [Time Frame: Weeks 4, 8, 12, 16, 20 and 24]

Change From Baseline in 36-Item Short Form Health Survey (SF-36) Mental Component Summary (MCS) Score at Week 24 [Time Frame: Baseline and Week 24]

Change From Baseline in Enthesitis Score (Based on LEI) at Week 24 Among the Participants With Enthesitis at Baseline [Time Frame: Baseline and Week 24]

Change From Baseline in Group of Research and Assessment of Psoriasis and Psoriatic Arthritis Composite (GRACE) Score at Weeks 16 and 24 [Time Frame: Baseline, Weeks 16 and 24]

ACR Component- Patient's Assessment of Physical Function as Assessed by HAQ-DI Scale Score at Weeks 4, 8, 12, 16, 20 and 24 [Time Frame: Weeks 4, 8, 12, 16, 20 and 24]

Change From Baseline in Group of Research and Assessment of Psoriasis and Psoriatic Arthritis Composite (GRACE) Score Index at Weeks 24 and 52 [Time Frame: Baseline, Weeks 24 and 52]

Change From Baseline in HAQ-DI Score at Weeks 24, 28, 36, 44 and 52 [Time Frame: Baseline, Weeks 24, 28, 36, 44 and 52]

Change From Baseline in Disease Activity Score (DAS28) (C-reactive Protein [CRP]) Score at Week 24 [Time Frame: Baseline and Week 24]

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 [Time Frame: Baseline, Weeks 16 and 24]

Percent Change From Baseline in ACR Components at Weeks 4, 8, 12, 16, 20 and 24 [Time Frame: Baseline, Weeks 4, 8, 12, 16, 20 and 24]

Change From Baseline in 36-Item Short Form Health Survey (SF-36) Mental Component Summary (MCS) at Weeks 8, 16 and 24 [Time Frame: Baseline, Weeks 8, 16 and 24]

Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score at Week 24 [Time Frame: Baseline and Week 24]

Change From Baseline in DAS28 (CRP) Score at Weeks 4, 8, 12, 16, 20 and 24 [Time Frame: Baseline, Weeks 4, 8, 12, 16, 20 and 24]

Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 8, 16, and 24 [Time Frame: Baseline, Weeks 8, 16 and 24]

Percentage of Participants Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score at Weeks 8, 16, and 24 [Time Frame: Weeks 8, 16, and 24]

Change From Baseline in Dactylitis Score at Weeks 4, 8, 16 and 24 Among the Participants With Dactylitis at Baseline [Time Frame: Baseline, Weeks 4, 8, 16 and 24]

Change From Baseline in BASDAI Score at Week 8, 16, and Week 24 Among Participants With Spondylitis and Peripheral Arthritis at Baseline [Time Frame: Baseline, Weeks 8, 16, and 24]

Percentage of Participants Who Achieved >=5 Point Improvement From Baseline in SF-36 MCS Score at Weeks 24, 36 and 52 [Time Frame: Weeks 24, 36 and 52]

Change From Baseline in FACIT-Fatigue Score at Week 24 by ACR 20 Response at Week 24 [Time Frame: Baseline and Week 24]

Change From Baseline in Dactylitis Scores at Week 24 Among the Participants With Dactylitis at Baseline [Time Frame: Baseline and Week 24]

Percentage of Participants Who Achieved a DAS28 (CRP) Remission at Weeks 24, 28, 36, 44 and 52 [Time Frame: Weeks 24, 28, 36, 44 and 52]

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 [Time Frame: Weeks 24, 28, 36, 44 and 52]

Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 24, 36 and 52 [Time Frame: Baseline, Weeks 24, 36 and 52]

Change From Baseline in HAQ-DI Score at Weeks 4, 8, 12, 16, 20 and 24 [Time Frame: Baseline, Week 4, 8, 12, 16, 20 and 24]

Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) at Weeks 8, 16 and 24 [Time Frame: Baseline, Weeks 8, 16 and 24]

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 [Time Frame: Weeks 8, 16 and 24]

Change From Baseline in SF-36 Physical Component Summary (PCS) Score at Weeks 24, 36 and 52 [Time Frame: Baseline, Weeks 24, 36 and 52]

Change From Baseline in DAS28 (CRP) Score at Weeks 24, 28, 36, 44 and 52 [Time Frame: Baseline, Weeks 24, 28, 36, 44 and 52]

Percentage of Participants Who Achieved ACR 70 Response at Weeks 24, 28, 36, 44 and 52 [Time Frame: Weeks 24, 28, 36, 44 and 52]

Change From Baseline in the Psoriatic Arthritis Disease Activity (PASDAS) Score at Weeks 8, 16 and 24 [Time Frame: Baseline, Weeks 8, 16 and 24]

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 [Time Frame: Baseline, Weeks 24 and 52]

Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Scores at Weeks 24, 36 and 52 [Time Frame: Baseline, Weeks 24, 36 and 52]

Percentage of Participants Who Achieve an American College of Rheumatology (ACR) 70 Response at Week 24 [Time Frame: Week 24]

Change From Baseline in the Disease Activity Index for Psoriatic Arthritis (DAPSA) Score at Weeks 24, 28, 36, 44 and 52 [Time Frame: Baseline, Weeks 24, 28, 36, 44 and 52]

Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 16 [Time Frame: Week 16]

Percentage of Participants Who Achieved a DAS28 (CRP) Remission by Visit Over Time Through Week 24 [Time Frame: Week 4, 8, 12, 16, 20 and 24]

Percentage of Participants Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score at Weeks 24, 36 and 52 [Time Frame: Weeks 24, 36 and 52]

Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 50 Response at Week 16 [Time Frame: Week 16]

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 [Time Frame: Weeks 24 and 52]

Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24 [Time Frame: Baseline and Week 24]

Percentage of Participants Who Maintained an ACR 20 Response at Week 52 Among Participants Who Achieved an ACR 20 Response at Week 24 [Time Frame: Week 52]

Percentage of Participants Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score at Week 24 by ACR 20 Response at Week 24 [Time Frame: Week 24]

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 [Time Frame: Weeks 24 and 52]

Percentage of Participants Who Achieved a DAS28 (CRP) Response by Visit Over Time Through Week 24 [Time Frame: Weeks 4, 8, 12, 16, 20 and 24]

Percentage of Participants Who Achieved >=5 Point Improvement From Baseline in SF-36 PCS Score at Weeks 24, 36 and 52 [Time Frame: Weeks 24, 36 and 52]

Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 MCS Score by Visit Over Time Through Week 24 [Time Frame: Weeks 8, 16 and 24]

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 [Time Frame: Weeks 24 and 52]

Percentage of Participants Who Achieved ACR 50 Response by Visit Over Time Through Week 24 [Time Frame: Weeks 4, 8, 12, 16, 20 and 24]

Percentage of Participants Who Maintained an ACR 50 Response at Week 52 Among Participants Who Achieved an ACR 50 Response at Week 24 [Time Frame: Week 52]

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 [Time Frame: Weeks 16 and 24]

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 [Time Frame: Weeks 16 and 24]

Percentage of Participants With Resolution of Dactylitis by Visit Over Time Through Week 24 Among the Participants With Dactylitis at Baseline [Time Frame: Weeks 4, 8, 16 and 24]

Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 [Time Frame: Baseline, Week 8, 16 and 24]

Percentage of Participants With Resolution of Enthesitis at Week 24 Among the Participants With Enthesitis at Baseline [Time Frame: Week 24]

Percentage of Participants Who Achieved >=5 Point Improvement From Baseline in SF-36 PCS Score Through Week 24 [Time Frame: Weeks 8, 16 and 24]

Percentage of Participants Who Achieved ACR 20 Response by Visit Over Time Through Week 24 [Time Frame: Weeks 4, 8, 12, 16, 20 and 24]

Percentage of Participants With Very Low Disease Activity (VLDA) by Visit Over Time Through Week 24 [Time Frame: Weeks 16 and 24]

Percentage of Participants Who Achieved ACR 70 Response by Visit Over Time Through Week 24 [Time Frame: Weeks 4, 8, 12, 16, 20 and 24]

Percentage of Participants Who Achieved an Improvement of >=3 Points From Baseline in PROMIS-29 Domain Scores at Weeks 8, 16, and 24 [Time Frame: Weeks 8, 16, and 24]

Percentage of Participants Who Achieved an Improvement of >=5 Points From Baseline in PROMIS-29 Domain Scores at Weeks 8, 16, and 24 [Time Frame: Weeks 8, 16, and 24]

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 [Time Frame: Week 4, 8, 12, 16, 20 and 24]

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 [Time Frame: Weeks 16 and 24]

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 [Time Frame: Weeks 24 and 52]

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 [Time Frame: Weeks 16 and 24]

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 [Time Frame: Baseline, Weeks 4, 8, 12, 16, 20 and 24]

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 [Time Frame: Weeks 24 and 52]

Percentage of Participants Who Achieved Resolution of Enthesitis at Weeks 4, 8, 16, and 24 Among the Participants With Enthesitis at Baseline [Time Frame: Weeks 4, 8, 16, and 24]

Percentage of Participants Who Achieved a DAS28 (CRP) Response at Weeks 24, 28, 36, 44 and 52 [Time Frame: Weeks 24, 28, 36, 44 and 52]

Percentage of Participants Who Achieved ACR 50 Response at Weeks 24, 28, 36, 44 and 52 [Time Frame: Weeks 24, 28, 36, 44 and 52]

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 [Time Frame: Week 52]

Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 50 Response at Week 24 [Time Frame: Week 24]

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 [Time Frame: Weeks 24 and 52]

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 [Time Frame: Weeks 16 and 24]

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 [Time Frame: Weeks 8, 16 and 24]

Percentage of Participants With Resolution of Dactylitis at Week 24 Among the Participants With Dactylitis at Baseline [Time Frame: Week 24]

Percentage of Participants With Resolution of Dactylitis at Weeks 24, 36, 44 and 52 Among Participants With Dactylitis at Baseline [Time Frame: Weeks 24, 36, 44 and 52]

Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) at Weeks 24, 28, 36, 44 and 52 [Time Frame: Weeks 24, 28, 36, 44 and 52]

Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) by Visit Over Time Through Week 24 [Time Frame: Weeks 4, 8, 12, 16, 20 and 24]

Percentage of Participants Who Achieved ACR 20 Response at Weeks 24, 28, 36, 44 and 52 [Time Frame: Weeks 24, 28, 36, 44 and 52]

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 [Time Frame: Weeks 24 and 52]

Percentage of Participants Who Achieved Minimal Disease Activity (MDA) at Weeks 16 and 24 [Time Frame: Weeks 16 and Week 24]

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 [Time Frame: Weeks 16 and 24]

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 [Time Frame: Week 24]

Change From Baseline in Dactylitis Score at Weeks 24, 36, 44 and 52 Among the Participants With Dactylitis at Baseline [Time Frame: Baseline, Weeks 24, 36, 44 and 52]

Change From Baseline in Enthesitis Score (Based on LEI) at Weeks 24, 36, 44 and 52 Among the Participants With Enthesitis at Baseline [Time Frame: Baseline, Weeks 24, 36, 44 and 52]

Change From Baseline in Enthesitis Score (Based on SPARCC) at Weeks 24, 36, 44 and 52 Among the Participants With Enthesitis at Baseline [Time Frame: Baseline, Weeks 24, 36, 44 and 52]

Change From Baseline in Enthesitis Score at Weeks 4, 8, 16 and 24 Among the Participants With Enthesitis at Baseline [Time Frame: Baseline, Weeks 4, 8, 16 and 24]

Change From Baseline in Norm Based Scores of SF-36 Scales at Week 24, 36 and 52 [Time Frame: Baseline, Weeks 24, 36 and 52]

Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Scores at Weeks 8, 16 and 24 [Time Frame: Baseline, Weeks 8, 16 and 24]

Change From Baseline in Psoriatic Arthritis Disease Activity (PASDAS) Score at Weeks 24 and 52 [Time Frame: Baseline, Weeks 24 and 52]

Change From Baseline in SF-36 Mental Component Summary (MCS) Score at Weeks 24, 36 and 52 [Time Frame: Baseline, Weeks 24, 36 and 52]

Change From Baseline in the Disease Activity Index for Psoriatic Arthritis (DAPSA) Score at Weeks 4, 8, 12, 16, 20 and 24 [Time Frame: Baseline, Weeks 4, 8, 12, 16, 20 and 24]

Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 [Time Frame: Baseline, Weeks 24, 28, 36, 44 and 52]

Percentage of Participants Who Achieved Minimal Disease Activity (MDA) at Weeks 24 and 52 [Time Frame: Weeks 24 and 52]

Percentage of Participants Who Maintained an ACR 70 Response at Week 52 Among Participants Who Achieved an ACR 70 Response at Week 24 [Time Frame: Week 52]

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 [Time Frame: Weeks 16 and 24]

Percentage of Participants With Resolution of Enthesitis at Weeks 24, 36, 44 and 52 Among the Participants With Enthesitis at Baseline [Time Frame: Weeks 24, 36, 44 and 52]

Secondary ID(s)

CNTO1959PSA3001

2016-001163-37

CR108218

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 14/10/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03162796