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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02181673




Registration number
NCT02181673
Ethics application status
Date submitted
2/07/2014
Date registered
4/07/2014
Date last updated
21/12/2017

Titles & IDs
Public title
A Study of Golimumab in Participants With Active Psoriatic Arthritis
Scientific title
A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, an Anti-TNFa Monoclonal Antibody, Administered Intravenously, in Subjects With Active Psoriatic Arthritis
Secondary ID [1] 0 0
2014-000242-30
Secondary ID [2] 0 0
CR103796
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Arthritis, Psoriatic 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - Golimumab

Placebo comparator: Treatment Group 1: Placebo - Participants 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.

Experimental: Treatment Group 2: Golimumab - Participants 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.


Treatment: Drugs: Placebo
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.

Treatment: Drugs: Golimumab
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 14
Timepoint [1] 0 0
Week 14
Secondary outcome [1] 0 0
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 14
Timepoint [1] 0 0
Baseline and Week 14
Secondary outcome [2] 0 0
Percentage of Participants Who Achieved an ACR 50 Response at Week 14
Timepoint [2] 0 0
Week 14
Secondary outcome [3] 0 0
Percentage of Participants Who Achieved Psoriatic Area and Severity Index (PASI) 75 Response at Week 14
Timepoint [3] 0 0
Week 14
Secondary outcome [4] 0 0
Change From Baseline in Total Modified Van Der Heijde-Sharp (vdH-S) Score at Week 24
Timepoint [4] 0 0
Baseline and Week 24
Secondary outcome [5] 0 0
Change From Baseline in Leeds Enthesitis Index (LEI) at Week 14 in Participants With Enthesitis at Baseline
Timepoint [5] 0 0
Baseline and Week 14
Secondary outcome [6] 0 0
Change From Baseline in Dactylitis Scores at Week 14 in Participants With Dactylitis at Baseline
Timepoint [6] 0 0
Baseline and Week 14
Secondary outcome [7] 0 0
Change From Baseline in Short Form-36 Health Survey (SF-36) Physical Component Summary (PCS) at Week 14
Timepoint [7] 0 0
Baseline and Week 14
Secondary outcome [8] 0 0
Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 50 Response at Week 24
Timepoint [8] 0 0
Week 24
Secondary outcome [9] 0 0
Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 70 Response at Week 14
Timepoint [9] 0 0
Week 14
Secondary outcome [10] 0 0
Change From Baseline in Short Form-36 Health Survey (SF)-36 Mental Component Summary (MCS) at Week 14
Timepoint [10] 0 0
Baseline and Week 14

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/09/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
22/03/2017
Sample size
Target
Accrual to date
Final
480
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Daw Park
Recruitment hospital [2] 0 0
- Maroochydore
Recruitment postcode(s) [1] 0 0
- Daw Park
Recruitment postcode(s) [2] 0 0
- Maroochydore
Recruitment outside Australia
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United States of America
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Arizona
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United States of America
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California
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Indiana
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United States of America
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Louisiana
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Mississippi
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Missouri
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New York
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North Carolina
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Pennsylvania
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Texas
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Belarus
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Gomel
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Belarus
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Grodno
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Belarus
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Minsk
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Belarus
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Vitebsk
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Canada
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Newfoundland and Labrador
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Canada
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Ontario
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Canada
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Burlington
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Germany
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Bad Doberan
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Berlin
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Germany
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Erfurt
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Germany
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Hamburg
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Germany
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Köln
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Germany
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Ratingen
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Germany
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Zerbst
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Hungary
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Balatonfured
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Hungary
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Budapest
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Hungary
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Debrecen
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Hungary
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Heviz
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Hungary
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Kistarcsa
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Hungary
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Nyiregyhaza
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Hungary
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Szombathely
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Lithuania
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Alytus
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Lithuania
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Kaunas
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Lithuania
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Klaipeda
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Lithuania
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Siauliai
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Lithuania
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Vilnius
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Poland
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Bydgoszcz
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Bytom
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Lublin
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Nowa Sól
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Poznan
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Warszawa
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Poland
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Wroclaw
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Romania
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Bucuresti
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Romania
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Constanta
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Romania
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Iasi
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Romania
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Ploiesti
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Russian Federation
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Kemerovo
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Russian Federation
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Korolev
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Krasnoyarsk
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Russian Federation
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Kursk
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Russian Federation
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Moscow
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Russian Federation
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Novosibirsk
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Russian Federation
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Orenburg
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Russian Federation
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Petrozavodsk
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Russian Federation
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Ryazan
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Russian Federation
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Saint Petersburg
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Russian Federation
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Saint-Petersburg
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Russian Federation
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Saratov
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Russian Federation
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Tomsk
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Russian Federation
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Tver
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Russian Federation
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Ulyanovsk
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Russian Federation
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Vladimir
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Russian Federation
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Yaroslavl
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Spain
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Cordoba
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Spain
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Getafe
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Spain
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Sevilla
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Ukraine
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Chernihiv
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Ukraine
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Dnipropetrovsk
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Ukraine
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Kharkiv
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Khmelnitsky
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Kryvyi Rih
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Kyiv
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Lviv
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Ukraine
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Odessa
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Ukraine
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Poltava
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Ukraine
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Sumy
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Ukraine
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Ternopil
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Ukraine
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Uzhhorod
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Ukraine
State/province [83] 0 0
Vinnytsia
Country [84] 0 0
Ukraine
State/province [84] 0 0
Zaporizhzhia

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Janssen Research & Development, LLC
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/study/NCT02181673
Trial related presentations / publications
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.
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.
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.
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.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02181673