Clinical trial NCT02181673: A Study of Golimumab in Participants With Active Psoriatic Arthritis
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, an Anti-TNFα Monoclonal Antibody, Administered Intravenously, in Subjects With Active Psoriatic Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Arthritis, Psoriatic
Keywords: Psoriatic arthritis
Golimumab
Simponi
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2014-07-04
Enrollment: 480
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 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).

Detailed description: This is a Phase 3, multicenter (when more than one hospital or medical school team work on a medical research study), randomized (study drug assigned by chance), double-blind (neither the researchers nor the participants know what treatment the participant is receiving), placebo-controlled (an inactive substance; a pretend treatment \[with no drug in it\] that is compared in a clinical trial with a drug to test if the drug has a real effect) study of golimumab compared with placebo in participants with active psoriatic arthritis. The study will include 4 phases: Screening phase (up to 6 weeks), Double-blind placebo-controlled phase (Week 0 to Week 24), Active treatment phase (Week 24 to Week 52), and Safety follow-up phase (8 weeks from last study drug administration). Total duration of the study will be 60 weeks per participant. Eligible Participants will be randomly assigned to either Treatment Group 1: Placebo or Treatment Group 2: Golimumab. Participants randomized to Placebo Group, 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 mg/kg) at Week 24, 28 and thereafter every 8 weeks up to Week 52. Participants randomized to Golimumab Group, will receive intravenous infusions of golimumab 2 mg/kg at Week 0, 4 and thereafter every 8 weeks up to Week 52. At Week 24, participants randomized to golimumab Group will receive a placebo infusion to maintain the blind. The efficacy will be assessed primarily by measuring percentage of participants who achieve a 20 percent improvement from baseline in the assessment used in active psoriatic arthritis at Week 14. Participants' safety will be monitored throughout the study.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 14
timeFrame: Week 14
Secondary outcomes:
measure: Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 14
timeFrame: Baseline and Week 14
measure: Percentage of Participants Who Achieved an ACR 50 Response at Week 14
timeFrame: Week 14
measure: Percentage of Participants Who Achieved Psoriatic Area and Severity Index (PASI) 75 Response at Week 14
timeFrame: Week 14
measure: Change From Baseline in Total Modified Van Der Heijde-Sharp (vdH-S) Score at Week 24
timeFrame: Baseline and Week 24
measure: Change From Baseline in Leeds Enthesitis Index (LEI) at Week 14 in Participants With Enthesitis at Baseline
timeFrame: Baseline and Week 14
measure: Change From Baseline in Dactylitis Scores at Week 14 in Participants With Dactylitis at Baseline
timeFrame: Baseline and Week 14
measure: Change From Baseline in Short Form-36 Health Survey (SF-36) Physical Component Summary (PCS) at Week 14
timeFrame: Baseline and Week 14
measure: Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 50 Response at Week 24
timeFrame: Week 24
measure: Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 70 Response at Week 14
timeFrame: Week 14
measure: Change From Baseline in Short Form-36 Health Survey (SF)-36 Mental Component Summary (MCS) at Week 14
timeFrame: Baseline and Week 14
Other outcomes:
Locations:
city: Glendale
country: United States
state: Arizona
city: Mesa
country: United States
state: Arizona
city: Huntington Beach
country: United States
state: California
city: Lakewood
country: United States
state: California
city: Granger
country: United States
state: Indiana
city: Indianapolis
country: United States
state: Indiana
city: Monroe
country: United States
state: Louisiana
city: Tupelo
country: United States
state: Mississippi
city: Saint Louis
country: United States
state: Missouri
city: Orchard Park
country: United States
state: New York
city: Salisbury
country: United States
state: North Carolina
city: Duncansville
country: United States
state: Pennsylvania
city: Austin
country: United States
state: Texas
city: Daw Park
country: Australia
city: Maroochydore
country: Australia
city: Gomel
country: Belarus
city: Grodno
country: Belarus
city: Minsk
country: Belarus
city: Vitebsk
country: Belarus
city: Saint-John'S
country: Canada
state: Newfoundland and Labrador
city: Waterloo
country: Canada
state: Ontario
city: Burlington
country: Canada
city: Bad Doberan
country: Germany
city: Berlin
country: Germany
city: Erfurt
country: Germany
city: Hamburg
country: Germany
city: Köln
country: Germany
city: Ratingen
country: Germany
city: Zerbst
country: Germany
city: Balatonfured
country: Hungary
city: Budapest
country: Hungary
city: Debrecen
country: Hungary
city: Heviz
country: Hungary
city: Kistarcsa
country: Hungary
city: Nyiregyhaza
country: Hungary
city: Szombathely
country: Hungary
city: Alytus
country: Lithuania
city: Kaunas
country: Lithuania
city: Klaipeda
country: Lithuania
city: Siauliai
country: Lithuania
city: Vilnius
country: Lithuania
city: Bydgoszcz
country: Poland
city: Bytom
country: Poland
city: Czestochowa
country: Poland
city: Krakow
country: Poland
city: Lublin
country: Poland
city: Nadarzyn
country: Poland
city: Nowa Sól
country: Poland
city: Poznan
country: Poland
city: Warszawa
country: Poland
city: Wroclaw
country: Poland
city: Bucuresti
country: Romania
city: Constanta
country: Romania
city: Iasi
country: Romania
city: Ploiesti
country: Romania
city: Kemerovo
country: Russian Federation
city: Korolev
country: Russian Federation
city: Krasnoyarsk
country: Russian Federation
city: Kursk
country: Russian Federation
city: Moscow
country: Russian Federation
city: Novosibirsk
country: Russian Federation
city: Orenburg
country: Russian Federation
city: Petrozavodsk
country: Russian Federation
city: Ryazan
country: Russian Federation
city: Saint Petersburg
country: Russian Federation
city: Saint-Petersburg
country: Russian Federation
city: Saratov
country: Russian Federation
city: Tomsk
country: Russian Federation
city: Tver
country: Russian Federation
city: Ulyanovsk
country: Russian Federation
city: Vladimir
country: Russian Federation
city: Yaroslavl
country: Russian Federation
city: Cordoba
country: Spain
city: Getafe
country: Spain
city: Sevilla
country: Spain
city: Chernihiv
country: Ukraine
city: Dnipropetrovsk
country: Ukraine
city: Kharkiv
country: Ukraine
city: Khmelnitsky
country: Ukraine
city: Kryvyi Rih
country: Ukraine
city: Kyiv
country: Ukraine
city: Lviv
country: Ukraine
city: Odessa
country: Ukraine
city: Poltava
country: Ukraine
city: Sumy
country: Ukraine
city: Ternopil
country: Ukraine
city: Uzhhorod
country: Ukraine
city: Vinnytsia
country: Ukraine
city: Zaporizhzhia
country: Ukraine
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Mease 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.
citation: Husni 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.
citation: Kavanaugh 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.
citation: Kavanaugh 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.