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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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 - 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).
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 - The Health Assessment Questionnaire-Disability Index (HAQ-DI) is a 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping and activities of daily living). Responses in each functional area are scored from 0 to 3 (0=no difficulty and 3=inability to perform a task in that area). Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.
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 - The ACR 50 response is defined as: greater than or equal to (>=) 50 percent (%) improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints) and >=50% improvement from baseline in at least 3 of the following 5 assessments: Patient's assessment of pain (on a 0 to 10 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).
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 - The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 75 response represents participants who achieved at least a 75 percent improvement from baseline in the PASI score.
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 - The modified vdH-S score is a radiographic evaluation of hand and feet erosions and joint space narrowing (JSN) for 20 joints per hand and 6 joints per foot with a total score ranging from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score and positive score changes indicate more radiographic damage and radiographic progression, respectively.
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 - Enthesitis will be assessed using the Leeds Enthesitis Index (LEI). The LEI was developed to assess enthesitis in participants with PsA, and evaluates the presence (score of 1) or absence of pain (score of 0) by applying local pressure to Lateral elbow epicondyle, left and right, Medial femoral condyle, left and right, and Achilles tendon insertion, left and right. LEI scores ranging from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness).
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 - Dactylitis is characterized by swelling of the entire finger or toe. The severity of dactylitis is scored on a scale of 0-3, where 0=tenderness and 3=extreme tenderness in each digit of the hands and feet. The range of total dactylitis scores for a participant is 0-60. Higher score indicates greater degree of tenderness.
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 - The SF-36 is a survey of participant health. It consists of 8 individual domains, which are weighted sums of the questions in their section. The 8 domains are: vitality (VT), physical functioning (PF), bodily pain (BP), general health (GH), Role-Physical (RP), Role-Emotional (RE), social functioning (SF) and mental health (MH). Each of these 8 scales (domains) is scored from 0 to 100 with higher scores indicating better health. Based on the scale scores, the summary physical component score (PCS) is derived. Scales contributing most to the scoring of the SF-36 PCS include the PF, RP, BP and GH. Other domains not noted contribute to the scoring but to a lesser degree. The scoring is derived based on an algorithm that has been developed in a software provided by the developer. The summary PCS score is also scaled from 0 to 100 with higher scores indicating better health.
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 - The ACR 50 response is defined as greater than or equal to (>=) 50 percent (%) improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints) and >=50% 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).
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 - The ACR 70 response is defined as greater than or equal to (>=) 70 percent (%) improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints) and >=70% 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).
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 - The SF-36 is a survey of participant health. It consists of 8 individual domains, which are weighted sums of the questions in their section. The 8 domains are: vitality (VT), physical functioning (PF), bodily pain (BP), general health (GH), Role-Physical (RP), Role-Emotional (RE), social functioning (SF) and mental health (MH). Each of these 8 scales (domains) is scored from 0 to 100 with higher scores indicating better health. Based on the scale scores, the summary mental component score (MCS) is derived. Scales contributing most to the scoring of the SF-36 MCS include the VT, SF, RE and MH. Other domains not noted contribute to the scoring but to a lesser degree. The scoring is derived based on an algorithm that has been developed in a software provided by the developer. The summary MCS score is also scaled from 0 to 100 with higher scores indicating better health.
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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
State/province [7] 0 0
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
Country [29] 0 0
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
Country [37] 0 0
Poland
State/province [37] 0 0
Bydgoszcz
Country [38] 0 0
Poland
State/province [38] 0 0
Bytom
Country [39] 0 0
Poland
State/province [39] 0 0
Czestochowa
Country [40] 0 0
Poland
State/province [40] 0 0
Krakow
Country [41] 0 0
Poland
State/province [41] 0 0
Lublin
Country [42] 0 0
Poland
State/province [42] 0 0
Nadarzyn
Country [43] 0 0
Poland
State/province [43] 0 0
Nowa Sól
Country [44] 0 0
Poland
State/province [44] 0 0
Poznan
Country [45] 0 0
Poland
State/province [45] 0 0
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
Country [49] 0 0
Romania
State/province [49] 0 0
Iasi
Country [50] 0 0
Romania
State/province [50] 0 0
Ploiesti
Country [51] 0 0
Russian Federation
State/province [51] 0 0
Kemerovo
Country [52] 0 0
Russian Federation
State/province [52] 0 0
Korolev
Country [53] 0 0
Russian Federation
State/province [53] 0 0
Krasnoyarsk
Country [54] 0 0
Russian Federation
State/province [54] 0 0
Kursk
Country [55] 0 0
Russian Federation
State/province [55] 0 0
Moscow
Country [56] 0 0
Russian Federation
State/province [56] 0 0
Novosibirsk
Country [57] 0 0
Russian Federation
State/province [57] 0 0
Orenburg
Country [58] 0 0
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
Country [62] 0 0
Russian Federation
State/province [62] 0 0
Saratov
Country [63] 0 0
Russian Federation
State/province [63] 0 0
Tomsk
Country [64] 0 0
Russian Federation
State/province [64] 0 0
Tver
Country [65] 0 0
Russian Federation
State/province [65] 0 0
Ulyanovsk
Country [66] 0 0
Russian Federation
State/province [66] 0 0
Vladimir
Country [67] 0 0
Russian Federation
State/province [67] 0 0
Yaroslavl
Country [68] 0 0
Spain
State/province [68] 0 0
Cordoba
Country [69] 0 0
Spain
State/province [69] 0 0
Getafe
Country [70] 0 0
Spain
State/province [70] 0 0
Sevilla
Country [71] 0 0
Ukraine
State/province [71] 0 0
Chernihiv
Country [72] 0 0
Ukraine
State/province [72] 0 0
Dnipropetrovsk
Country [73] 0 0
Ukraine
State/province [73] 0 0
Kharkiv
Country [74] 0 0
Ukraine
State/province [74] 0 0
Khmelnitsky
Country [75] 0 0
Ukraine
State/province [75] 0 0
Kryvyi Rih
Country [76] 0 0
Ukraine
State/province [76] 0 0
Kyiv
Country [77] 0 0
Ukraine
State/province [77] 0 0
Lviv
Country [78] 0 0
Ukraine
State/province [78] 0 0
Odessa
Country [79] 0 0
Ukraine
State/province [79] 0 0
Poltava
Country [80] 0 0
Ukraine
State/province [80] 0 0
Sumy
Country [81] 0 0
Ukraine
State/province [81] 0 0
Ternopil
Country [82] 0 0
Ukraine
State/province [82] 0 0
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
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/show/NCT02181673
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

Summary results
Other publications