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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-000242-30 | EudraCT Number | ||
| CNTO148PSA3001 | Other Identifier | Janssen Research & Development, LLC |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group 1: Placebo | Placebo Comparator | 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. |
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| Treatment Group 2: Golimumab | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Glendale | Arizona | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35313978 | Derived | 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. | |
| 32143685 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo (Week 0-24) | Participants received intravenous infusions of placebo at Weeks 0, 4, 12 and 20. |
| FG001 | Placebo Then Golimumab 2 mg/kg (Week 24-60) | Participants who received placebo up to Week 20 were then crossed over at Week 24 to receive intravenous infusions of golimumab 2 milligram per kilogram (mg/kg) at Week 24, 28 and every 8 weeks thereafter up to Week 52. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Up to Week 24 |
|
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| Golimumab | Drug | 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. |
|
| Baseline and Week 14 |
| 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). | Week 14 |
| 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. | Week 14 |
| 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. | Baseline and Week 24 |
| 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). | Baseline and Week 14 |
| 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. | Baseline and Week 14 |
| 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. | Baseline and Week 14 |
| 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). | Week 24 |
| 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). | Week 14 |
| 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. | Baseline and Week 14 |
| Mesa |
| Arizona |
| United States |
| Huntington Beach | California | United States |
| Lakewood | California | United States |
| Granger | Indiana | United States |
| Indianapolis | Indiana | United States |
| Monroe | Louisiana | United States |
| Tupelo | Mississippi | United States |
| St Louis | Missouri | United States |
| Orchard Park | New York | United States |
| Salisbury | North Carolina | United States |
| Duncansville | Pennsylvania | United States |
| Austin | Texas | United States |
| Daw Park | Australia |
| Maroochydore | Australia |
| Grodno | Belarus |
| Homyel | Belarus |
| Minsk | Belarus |
| Vitebsk | Belarus |
| St. John's | Newfoundland and Labrador | Canada |
| Waterloo | Ontario | Canada |
| Burlington | Canada |
| Bad Doberan | Germany |
| Berlin | Germany |
| Cologne | Germany |
| Erfurt | Germany |
| Hamburg | Germany |
| Ratingen | Germany |
| Zerbst | Germany |
| Balatonfüred | Hungary |
| Budapest | Hungary |
| Debrecen | Hungary |
| Hévíz | Hungary |
| Kistarcsa | Hungary |
| Nyíregyháza | Hungary |
| Szombathely | Hungary |
| Alytus | Lithuania |
| Kaunas | Lithuania |
| Klaipėda | Lithuania |
| Šiauliai | Lithuania |
| Vilnius | Lithuania |
| Bydgoszcz | Poland |
| Bytom | Poland |
| Częstochowa | Poland |
| Krakow | Poland |
| Lublin | Poland |
| Nadarzyn | Poland |
| Nowa Sól | Poland |
| Poznan | Poland |
| Warsaw | Poland |
| Wroclaw | Poland |
| Bucharest | Romania |
| Constanța | Romania |
| Iași | Romania |
| Ploieşti | Romania |
| Kemerovo | Russia |
| Korolyov | Russia |
| Krasnoyarsk | Russia |
| Kursk | Russia |
| Moscow | Russia |
| Novosibirsk | Russia |
| Orenburg | Russia |
| Petrozavodsk | Russia |
| Ryazan | Russia |
| Saint Petersburg | Russia |
| Saratov | Russia |
| Tomsk | Russia |
| Tver' | Russia |
| Ulyanovsk | Russia |
| Vladimir | Russia |
| Yaroslavl | Russia |
| Córdoba | Spain |
| Getafe | Spain |
| Seville | Spain |
| Chernihiv | Ukraine |
| Dnipropetrovsk | Ukraine |
| Kharkiv | Ukraine |
| Khmelnitsky | Ukraine |
| Kryvyi Rih | Ukraine |
| Kyiv | Ukraine |
| Lviv | Ukraine |
| Odesa | Ukraine |
| Poltava | Ukraine |
| Sumy | Ukraine |
| Ternopil | Ukraine |
| Uzhhorod | Ukraine |
| Vinnytsia | Ukraine |
| Zaporizhzhia | Ukraine |
| 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. |
| 30980514 | Derived | 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. |
| 30770519 | Derived | 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. |
| 28805045 | Derived | 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. |
| FG002 | Golimumab 2 mg/kg (Week 0-60) | Participants were randomized to receive intravenous infusions of golimumab 2 mg/kg at Weeks 0, 4 and every 8 weeks thereafter up to Week 52. At Week 24, participants received a placebo intravenous infusion to maintain the blind. |
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
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| Week 24-Week 60 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo (Week 0-24) | Participants received intravenous infusions of placebo at Weeks 0, 4, 12 and 20. |
| BG001 | Golimumab 2 mg/kg | Participants were randomized to receive intravenous infusions of golimumab 2 mg/kg at Weeks 0, 4 and every 8 weeks thereafter up to Week 52. At Week 24, participants received a placebo intravenous infusion to maintain the blind. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | 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). | The full analysis set (FAS) included all participants who were randomized. | Posted | Number | Percentage of Participants | Week 14 |
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| Secondary | 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. | The full analysis set (FAS) included all participants who were randomized. Here "N" (number of participants analyzed) signifies the number of participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Week 14 |
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| Secondary | 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). | The full analysis set (FAS) included all participants who were randomized. | Posted | Number | Percentage of Participants | Week 14 |
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| Secondary | 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. | The analysis set included randomized participants with greater than or equal to (>=) 3 percent (%) body surface area (BSA) Psoriasis Skin Involvement at Baseline. | Posted | Number | Percentage of participants | Week 14 |
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| Secondary | 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. | FAS for structural damage endpoints (FAS-SD) defined as participants in the FAS who were treated and had a non-missing baseline total modified vdH-S score for the analysis. | Posted | Mean | Standard Error | units on a scale | Baseline and Week 24 |
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| Secondary | 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). | Population included all randomized participants with Enthesitis at Baseline. Here "N" (number of participants analyzed) signifies the number of participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Week 14 |
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| Secondary | 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. | Population included all Randomized participants With Dactylitis (Score >0) at Baseline. Here "N" (number of participants analyzed) signifies the number of participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Week 14 |
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| Secondary | 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. | The full analysis set (FAS) included all participants who were randomized. Here "N" (number of participants analyzed) signifies the number of participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Week 14 |
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| Secondary | 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). | The full analysis set (FAS) included all participants who were randomized. | Posted | Number | Percentage of participants | Week 24 |
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| Secondary | 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). | The full analysis set (FAS) included all participants who were randomized. | Posted | Number | Percentage of participants | Week 14 |
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| Secondary | 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. | The full analysis set (FAS) included all participants who were randomized. Here "N" (number of participants analyzed) signifies the number of participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Week 14 |
|
Up to 60 Weeks
Safety Population included all participants who received at least 1 dose of study agent.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo (Week 0-24) | Participants received intravenous infusions of placebo at Weeks 0, 4, 12 and 20. | 8 | 239 | 19 | 239 | ||
| EG001 | Placebo Then Golimumab 2 mg/kg (Week 24-60) | Participants who received placebo up to Week 20 were then crossed over at Week 24 to receive intravenous infusions of golimumab 2 milligram per kilogram (mg/kg) at Week 24, 28 and every 8 weeks thereafter up to Week 52. | 5 | 220 | 25 | 220 | ||
| EG002 | Golimumab 2 mg/kg (Week 0-60) | Participants were randomized to receive intravenous infusions of golimumab 2 mg/kg at Weeks 0, 4 and every 8 weeks thereafter up to Week 52. At Week 24, participants received a placebo intravenous infusion to maintain the blind. | 19 | 240 | 40 | 240 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure acute | Cardiac disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Oedematous pancreatitis | Gastrointestinal disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Drug-induced liver injury | Hepatobiliary disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Hepatitis acute | Hepatobiliary disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Hepatitis chronic active | Hepatobiliary disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Empyema | Infections and infestations | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Infected dermal cyst | Infections and infestations | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Periodontitis | Infections and infestations | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Pulmonary tuberculosis | Infections and infestations | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Epidural haemorrhage | Injury, poisoning and procedural complications | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Facial bones fracture | Injury, poisoning and procedural complications | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Skull fracture | Injury, poisoning and procedural complications | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Gene mutation identification test positive | Investigations | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Laboratory test abnormal | Investigations | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Meningioma benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Non-small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Oesophageal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Pleomorphic adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Cerebral haematoma | Nervous system disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Neuritis | Nervous system disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Calculus urinary | Renal and urinary disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Pustular psoriasis | Skin and subcutaneous tissue disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA Version 19.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA Version 19.1 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA Version 19.1 | Non-systematic Assessment |
|
A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Director Clinical Development | Janssen Research & Development, LLC | ClinicalTrialDisclosure@its.jnj.com |
| ID | Term |
|---|---|
| D015535 | Arthritis, Psoriatic |
| ID | Term |
|---|---|
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C529000 | golimumab |
Not provided
Not provided
Not provided
| Withdrawal by Subject |
|
| Pregnancy |
|
| Lack of Efficacy |
|
| Lost to Follow-up |
|
| Physician Decision |
|
| >=65 years |
|
| Male |
|
| Canada |
|
| Germany |
|
| Hungary |
|
| Lithuania |
|
| Poland |
|
| Romania |
|
| Russian Federation |
|
| Spain |
|
| Ukraine |
|
| United States |
|
| Units | Counts |
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| Counts |
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| Participants |
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| Participants |
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| Units |
|---|
| Counts |
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| Participants |
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| Participants |
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| Participants |
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