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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
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Indiana
Country [4] 0 0
United States of America
State/province [4] 0 0
Louisiana
Country [5] 0 0
United States of America
State/province [5] 0 0
Mississippi
Country [6] 0 0
United States of America
State/province [6] 0 0
Missouri
Country [7] 0 0
United States of America
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New York
Country [8] 0 0
United States of America
State/province [8] 0 0
North Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Pennsylvania
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
Belarus
State/province [11] 0 0
Gomel
Country [12] 0 0
Belarus
State/province [12] 0 0
Grodno
Country [13] 0 0
Belarus
State/province [13] 0 0
Minsk
Country [14] 0 0
Belarus
State/province [14] 0 0
Vitebsk
Country [15] 0 0
Canada
State/province [15] 0 0
Newfoundland and Labrador
Country [16] 0 0
Canada
State/province [16] 0 0
Ontario
Country [17] 0 0
Canada
State/province [17] 0 0
Burlington
Country [18] 0 0
Germany
State/province [18] 0 0
Bad Doberan
Country [19] 0 0
Germany
State/province [19] 0 0
Berlin
Country [20] 0 0
Germany
State/province [20] 0 0
Erfurt
Country [21] 0 0
Germany
State/province [21] 0 0
Hamburg
Country [22] 0 0
Germany
State/province [22] 0 0
Köln
Country [23] 0 0
Germany
State/province [23] 0 0
Ratingen
Country [24] 0 0
Germany
State/province [24] 0 0
Zerbst
Country [25] 0 0
Hungary
State/province [25] 0 0
Balatonfured
Country [26] 0 0
Hungary
State/province [26] 0 0
Budapest
Country [27] 0 0
Hungary
State/province [27] 0 0
Debrecen
Country [28] 0 0
Hungary
State/province [28] 0 0
Heviz
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Hungary
State/province [29] 0 0
Kistarcsa
Country [30] 0 0
Hungary
State/province [30] 0 0
Nyiregyhaza
Country [31] 0 0
Hungary
State/province [31] 0 0
Szombathely
Country [32] 0 0
Lithuania
State/province [32] 0 0
Alytus
Country [33] 0 0
Lithuania
State/province [33] 0 0
Kaunas
Country [34] 0 0
Lithuania
State/province [34] 0 0
Klaipeda
Country [35] 0 0
Lithuania
State/province [35] 0 0
Siauliai
Country [36] 0 0
Lithuania
State/province [36] 0 0
Vilnius
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Poland
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Bydgoszcz
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Poland
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Bytom
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Czestochowa
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Poland
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Krakow
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Lublin
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Poland
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Nadarzyn
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Poland
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Nowa Sól
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Poland
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Poznan
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Poland
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Warszawa
Country [46] 0 0
Poland
State/province [46] 0 0
Wroclaw
Country [47] 0 0
Romania
State/province [47] 0 0
Bucuresti
Country [48] 0 0
Romania
State/province [48] 0 0
Constanta
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Romania
State/province [49] 0 0
Iasi
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Romania
State/province [50] 0 0
Ploiesti
Country [51] 0 0
Russian Federation
State/province [51] 0 0
Kemerovo
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Russian Federation
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Korolev
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Russian Federation
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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
State/province [57] 0 0
Orenburg
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Russian Federation
State/province [58] 0 0
Petrozavodsk
Country [59] 0 0
Russian Federation
State/province [59] 0 0
Ryazan
Country [60] 0 0
Russian Federation
State/province [60] 0 0
Saint Petersburg
Country [61] 0 0
Russian Federation
State/province [61] 0 0
Saint-Petersburg
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Russian Federation
State/province [62] 0 0
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
Country [66] 0 0
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
State/province [71] 0 0
Chernihiv
Country [72] 0 0
Ukraine
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Dnipropetrovsk
Country [73] 0 0
Ukraine
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Kharkiv
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Ukraine
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Khmelnitsky
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Ukraine
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Kryvyi Rih
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Ukraine
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Kyiv
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Ukraine
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Lviv
Country [78] 0 0
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
Country [82] 0 0
Ukraine
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Uzhhorod
Country [83] 0 0
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
Trial website
Trial related presentations / publications
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT02181673