A Study of Golimumab in Participants With Active Psoriatic Arthritis
A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, an Anti-TNFα Monoclonal Antibody, Administered Intravenously, in Subjects With Active Psoriatic Arthritis
3 other identifiers
interventional
480
12 countries
88
Brief Summary
The purpose of this study is to evaluate the efficacy of intravenously (administration of a fluid into the vein) administered golimumab 2 milligram per kilogram (mg/kg) in participants with active psoriatic arthritis (a chronic inflammatory arthritis that is associated with psoriasis).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Sep 2014
Typical duration for phase_3
88 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 2, 2014
CompletedFirst Posted
Study publicly available on registry
July 4, 2014
CompletedStudy Start
First participant enrolled
September 8, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 5, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 22, 2017
CompletedResults Posted
Study results publicly available
December 21, 2017
CompletedDecember 21, 2017
December 1, 2017
1.7 years
July 2, 2014
November 10, 2017
December 20, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 14
The ACR 20 response is defined as greater than or equal to (\>=) 20 percent (%) improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints) and \>=20% improvement from baseline in at least 3 of the following 5 assessments: Patient's assessment of pain (on a 0 to 10 centimeter \[cm\] scale), Patient's Global Assessment of Disease Activity (on a 0 to 10 cm scale), Physician's Global Assessment of Disease Activity (on a 0 to 10 cm scale), Patient's assessment of physical function as measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI) and measurement of a blood test called C-reactive protein (CRP).
Week 14
Secondary Outcomes (10)
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 14
Baseline and Week 14
Percentage of Participants Who Achieved an ACR 50 Response at Week 14
Week 14
Percentage of Participants Who Achieved Psoriatic Area and Severity Index (PASI) 75 Response at Week 14
Week 14
Change From Baseline in Total Modified Van Der Heijde-Sharp (vdH-S) Score at Week 24
Baseline and Week 24
Change From Baseline in Leeds Enthesitis Index (LEI) at Week 14 in Participants With Enthesitis at Baseline
Baseline and Week 14
- +5 more secondary outcomes
Study Arms (2)
Treatment Group 1: Placebo
PLACEBO COMPARATORParticipants will receive intravenous infusions of placebo at Weeks 0, 4, 12 and 20. At Week 24, all participants receiving placebo will begin receiving intravenous infusions of golimumab 2 milligram per kilogram (mg/kg) at Week 24, 28 and thereafter every 8 weeks up to Week 52.
Treatment Group 2: Golimumab
EXPERIMENTALParticipants will receive intravenous infusions of golimumab 2 mg/kg at Weeks 0, 4 and thereafter every 8 weeks up to Week 52. At Week 24, participants will receive a placebo infusion to maintain the blind.
Interventions
Participants will receive intravenous infusions of placebo at Weeks 0, 4, 12 and 20 in treatment Group 1 and intravenous infusions of placebo at Week 24 to maintain the blind in treatment Group 2.
Participants will receive intravenous infusions of golimumab 2mg/kg at Weeks 0, 4 and thereafter every 8 weeks up to Week 52 in treatment Group 2 and intravenous infusions of golimumab (2mg/kg) at Weeks 24, 28 and thereafter every 8 weeks up to Week 52 in treatment Group 1.
Eligibility Criteria
You may qualify if:
- Have had psoriatic arthritis (PsA) for at least 6 months prior to the first administration of study agent
- Have a diagnosis of active PSA as defined by 5 or more swollen joints and 5 or more tender joints at Screening and at Baseline and C-reactive protein \>=0.6 milligram per deciliter (mg/dL) at Screening
- Have active plaque psoriasis or a documented history of plaque psoriasis
- Have active PsA despite current or previous disease-modifying antirheumatic drugs (DMARD) and/or nonsteroidal anti-inflammatory drug (NSAID) therapy. DMARD therapy is defined as taking a DMARD for at least 3 months, or evidence of DMARD intolerance. NSAID therapy is defined as taking an NSAID for at least 4 weeks or evidence of NSAID intolerance
You may not qualify if:
- Have other inflammatory diseases that might confound the evaluations of benefit of Golimumab therapy, including but not limited to rheumatoid arthritis, ankylosing spondylitis, systemic lupus erythematosus, or Lyme disease
- Are pregnant, nursing, or planning a pregnancy or fathering a child while enrolled in the study or within 4 months after receiving the last administration of study agent
- Have used any biologic agents that are targeted for reducing tumor necrosis factors (TNF) alpha, including but not limited to Infliximab, Etanercept, Adalimumab, Golimumab, and Certolizumab Pegol
- Have ever used cytotoxic drugs, including Chlorambucil, Cyclophosphamide, Nitrogen mustard, or other Alkylating agents
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (88)
Unknown Facility
Glendale, Arizona, United States
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Mesa, Arizona, United States
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Huntington Beach, California, United States
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Lakewood, California, United States
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Granger, Indiana, United States
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Indianapolis, Indiana, United States
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Monroe, Louisiana, United States
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Tupelo, Mississippi, United States
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St Louis, Missouri, United States
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Orchard Park, New York, United States
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Salisbury, North Carolina, United States
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Duncansville, Pennsylvania, United States
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Austin, Texas, United States
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Daw Park, Australia
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Maroochydore, Australia
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Grodno, Belarus
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Homyel, Belarus
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Minsk, Belarus
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Vitebsk, Belarus
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St. John's, Newfoundland and Labrador, Canada
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Waterloo, Ontario, Canada
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Burlington, Canada
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Bad Doberan, Germany
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Berlin, Germany
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Cologne, Germany
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Erfurt, Germany
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Hamburg, Germany
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Ratingen, Germany
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Zerbst, Germany
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Balatonfüred, Hungary
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Budapest, Hungary
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Debrecen, Hungary
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Hévíz, Hungary
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Kistarcsa, Hungary
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Nyíregyháza, Hungary
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Szombathely, Hungary
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Alytus, Lithuania
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Kaunas, Lithuania
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Klaipėda, Lithuania
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Šiauliai, Lithuania
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Vilnius, Lithuania
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Bydgoszcz, Poland
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Bytom, Poland
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Częstochowa, Poland
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Krakow, Poland
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Lublin, Poland
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Nadarzyn, Poland
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Nowa Sól, Poland
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Poznan, Poland
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Warsaw, Poland
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Wroclaw, Poland
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Bucharest, Romania
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Constanța, Romania
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Iași, Romania
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Ploieşti, Romania
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Kemerovo, Russia
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Korolyov, Russia
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Krasnoyarsk, Russia
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Kursk, Russia
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Moscow, Russia
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Novosibirsk, Russia
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Orenburg, Russia
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Petrozavodsk, Russia
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Ryazan, Russia
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Saint Petersburg, Russia
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Saratov, Russia
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Tomsk, Russia
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Tver', Russia
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Ulyanovsk, Russia
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Vladimir, Russia
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Yaroslavl, Russia
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Córdoba, Spain
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Getafe, Spain
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Seville, Spain
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Chernihiv, Ukraine
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Dnipropetrovsk, Ukraine
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Kharkiv, Ukraine
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Khmelnitsky, Ukraine
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Kryvyi Rih, Ukraine
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Kyiv, Ukraine
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Lviv, Ukraine
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Odesa, Ukraine
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Poltava, Ukraine
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Sumy, Ukraine
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Ternopil, Ukraine
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Uzhhorod, Ukraine
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Vinnytsia, Ukraine
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Zaporizhzhia, Ukraine
Related Publications (5)
Husni ME, Deodhar A, Schwartzman S, Chakravarty SD, Hsia EC, Leu JH, Zhou Y, Lo KH, Kavanaugh A. Pooled safety results across phase 3 randomized trials of intravenous golimumab in rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. Arthritis Res Ther. 2022 Mar 21;24(1):73. doi: 10.1186/s13075-022-02753-6.
PMID: 35313978DERIVEDMease P, Husni ME, Kafka S, Chakravarty SD, Harrison DD, Lo KH, Xu S, Hsia EC, Kavanaugh A. Inhibition of radiographic progression across levels of composite index-defined disease activity in patients with active psoriatic arthritis treated with intravenous golimumab: results from a phase-3, double-blind, placebo-controlled trial. Arthritis Res Ther. 2020 Mar 6;22(1):43. doi: 10.1186/s13075-020-2126-1.
PMID: 32143685DERIVEDHusni ME, Kavanaugh A, Murphy F, Rekalov D, Harrison DD, Kim L, Lo KH, Leu JH, Hsia EC. Efficacy and Safety of Intravenous Golimumab Through One Year in Patients With Active Psoriatic Arthritis. Arthritis Care Res (Hoboken). 2020 Jun;72(6):806-813. doi: 10.1002/acr.23905. Epub 2020 May 15.
PMID: 30980514DERIVEDKavanaugh A, Husni ME, Harrison DD, Kim L, Lo KH, Noonan L, Hsia EC. Radiographic Progression Inhibition with Intravenous Golimumab in Psoriatic Arthritis: Week 24 Results of a Phase III, Randomized, Double-blind, Placebo-controlled Trial. J Rheumatol. 2019 Jun;46(6):595-602. doi: 10.3899/jrheum.180681. Epub 2019 Feb 15.
PMID: 30770519DERIVEDKavanaugh A, Husni ME, Harrison DD, Kim L, Lo KH, Leu JH, Hsia EC. Safety and Efficacy of Intravenous Golimumab in Patients With Active Psoriatic Arthritis: Results Through Week Twenty-Four of the GO-VIBRANT Study. Arthritis Rheumatol. 2017 Nov;69(11):2151-2161. doi: 10.1002/art.40226.
PMID: 28805045DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Director Clinical Development
- Organization
- Janssen Research & Development, LLC
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 2, 2014
First Posted
July 4, 2014
Study Start
September 8, 2014
Primary Completion
May 5, 2016
Study Completion
March 22, 2017
Last Updated
December 21, 2017
Results First Posted
December 21, 2017
Record last verified: 2017-12