Arthritis, Psoriatic
Conditions
Keywords
Psoriatic arthritis, Golimumab, Simponi
Brief summary
The purpose of this study is to evaluate the efficacy of intravenously (administration of a fluid into the vein) administered golimumab 2 milligram per kilogram (mg/kg) in participants with active psoriatic arthritis (a chronic inflammatory arthritis that is associated with psoriasis).
Detailed description
This is a Phase 3, multicenter (when more than one hospital or medical school team work on a medical research study), randomized (study drug assigned by chance), double-blind (neither the researchers nor the participants know what treatment the participant is receiving), placebo-controlled (an inactive substance; a pretend treatment \[with no drug in it\] that is compared in a clinical trial with a drug to test if the drug has a real effect) study of golimumab compared with placebo in participants with active psoriatic arthritis. The study will include 4 phases: Screening phase (up to 6 weeks), Double-blind placebo-controlled phase (Week 0 to Week 24), Active treatment phase (Week 24 to Week 52), and Safety follow-up phase (8 weeks from last study drug administration). Total duration of the study will be 60 weeks per participant. Eligible Participants will be randomly assigned to either Treatment Group 1: Placebo or Treatment Group 2: Golimumab. Participants randomized to Placebo Group, will receive intravenous infusions of placebo at Weeks 0, 4, 12 and 20. At Week 24, all participants receiving placebo will begin receiving intravenous infusions of golimumab (2 mg/kg) at Week 24, 28 and thereafter every 8 weeks up to Week 52. Participants randomized to Golimumab Group, will receive intravenous infusions of golimumab 2 mg/kg at Week 0, 4 and thereafter every 8 weeks up to Week 52. At Week 24, participants randomized to golimumab Group will receive a placebo infusion to maintain the blind. The efficacy will be assessed primarily by measuring percentage of participants who achieve a 20 percent improvement from baseline in the assessment used in active psoriatic arthritis at Week 14. Participants' safety will be monitored throughout the study.
Interventions
DRUGPlacebo
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.
DRUGGolimumab
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.
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have had psoriatic arthritis (PsA) for at least 6 months prior to the first administration of study agent * Have a diagnosis of active PSA as defined by 5 or more swollen joints and 5 or more tender joints at Screening and at Baseline and C-reactive protein \>=0.6 milligram per deciliter (mg/dL) at Screening * Have active plaque psoriasis or a documented history of plaque psoriasis * Have active PsA despite current or previous disease-modifying antirheumatic drugs (DMARD) and/or nonsteroidal anti-inflammatory drug (NSAID) therapy. DMARD therapy is defined as taking a DMARD for at least 3 months, or evidence of DMARD intolerance. NSAID therapy is defined as taking an NSAID for at least 4 weeks or evidence of NSAID intolerance
Exclusion criteria
* Have other inflammatory diseases that might confound the evaluations of benefit of Golimumab therapy, including but not limited to rheumatoid arthritis, ankylosing spondylitis, systemic lupus erythematosus, or Lyme disease * Are pregnant, nursing, or planning a pregnancy or fathering a child while enrolled in the study or within 4 months after receiving the last administration of study agent * Have used any biologic agents that are targeted for reducing tumor necrosis factors (TNF) alpha, including but not limited to Infliximab, Etanercept, Adalimumab, Golimumab, and Certolizumab Pegol * Have ever used cytotoxic drugs, including Chlorambucil, Cyclophosphamide, Nitrogen mustard, or other Alkylating agents
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 14 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Achieved an ACR 50 Response at Week 14 | 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). |
| Percentage of Participants Who Achieved Psoriatic Area and Severity Index (PASI) 75 Response at Week 14 | 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. |
| Change From Baseline in Total Modified Van Der Heijde-Sharp (vdH-S) Score at Week 24 | Baseline and 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. |
| Change From Baseline in Leeds Enthesitis Index (LEI) at Week 14 in Participants With Enthesitis at Baseline | Baseline and Week 14 | 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). |
| Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 14 | Baseline and 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. |
| Change From Baseline in Short Form-36 Health Survey (SF-36) Physical Component Summary (PCS) at Week 14 | Baseline and 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. |
| Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 50 Response at Week 24 | 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). |
| Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 70 Response at Week 14 | 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). |
| Change From Baseline in Short Form-36 Health Survey (SF)-36 Mental Component Summary (MCS) at Week 14 | Baseline and 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. |
| Change From Baseline in Dactylitis Scores at Week 14 in Participants With Dactylitis at Baseline | Baseline and Week 14 | 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. |
Countries
Australia, Belarus, Canada, Germany, Hungary, Lithuania, Poland, Romania, Russia, Spain, Ukraine, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo (Week 0-24) Participants received intravenous infusions of placebo at Weeks 0, 4, 12 and 20. | 239 |
| 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. | 241 |
| Total | 480 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Up to Week 24 | Adverse Event | 2 | 0 | 3 |
| Up to Week 24 | Death | 1 | 0 | 0 |
| Up to Week 24 | Lack of Efficacy | 1 | 0 | 0 |
| Up to Week 24 | Lost to Follow-up | 1 | 0 | 0 |
| Up to Week 24 | Other | 2 | 0 | 3 |
| Up to Week 24 | Physician Decision | 0 | 0 | 3 |
| Up to Week 24 | Randomized not Treated | 0 | 0 | 1 |
| Up to Week 24 | Withdrawal by Subject | 10 | 0 | 1 |
| Week 24-Week 60 | Adverse Event | 0 | 4 | 10 |
| Week 24-Week 60 | Lack of Efficacy | 0 | 0 | 1 |
| Week 24-Week 60 | Lost to Follow-up | 0 | 0 | 1 |
| Week 24-Week 60 | Other | 0 | 2 | 1 |
| Week 24-Week 60 | Physician Decision | 0 | 0 | 1 |
| Week 24-Week 60 | Pregnancy | 0 | 0 | 1 |
| Week 24-Week 60 | Withdrawal by Subject | 0 | 2 | 2 |
Baseline characteristics
| Characteristic | Placebo (Week 0-24) | Golimumab 2 mg/kg | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 2 Participants | 0 Participants | 2 Participants |
| Age, Categorical >=65 years | 21 Participants | 13 Participants | 34 Participants |
| Age, Categorical Between 18 and 65 years | 216 Participants | 228 Participants | 444 Participants |
| Age, Continuous | 46.7 years STANDARD_DEVIATION 12.53 | 45.7 years STANDARD_DEVIATION 11.25 | 46.2 years STANDARD_DEVIATION 11.9 |
| Region of Enrollment Belarus | 14 Participants | 8 Participants | 22 Participants |
| Region of Enrollment Canada | 1 Participants | 0 Participants | 1 Participants |
| Region of Enrollment Germany | 3 Participants | 1 Participants | 4 Participants |
| Region of Enrollment Hungary | 13 Participants | 9 Participants | 22 Participants |
| Region of Enrollment Lithuania | 13 Participants | 17 Participants | 30 Participants |
| Region of Enrollment Poland | 43 Participants | 34 Participants | 77 Participants |
| Region of Enrollment Romania | 3 Participants | 1 Participants | 4 Participants |
| Region of Enrollment Russian Federation | 79 Participants | 74 Participants | 153 Participants |
| Region of Enrollment Spain | 1 Participants | 2 Participants | 3 Participants |
| Region of Enrollment Ukraine | 61 Participants | 86 Participants | 147 Participants |
| Region of Enrollment United States | 8 Participants | 9 Participants | 17 Participants |
| Sex: Female, Male Female | 118 Participants | 113 Participants | 231 Participants |
| Sex: Female, Male Male | 121 Participants | 128 Participants | 249 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 19 / 239 | 25 / 220 | 40 / 240 |
| serious Total, serious adverse events | 8 / 239 | 5 / 220 | 19 / 240 |
Outcome results
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).
Time frame: Week 14
Population: The full analysis set (FAS) included all participants who were randomized.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 14 | 21.8 Percentage of Participants |
| Golimumab | Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 14 | 75.1 Percentage of Participants |
p-value: <0.00195% CI: [45.8, 60.9]Cochran-Mantel-Haenszel
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.
Time frame: Baseline and Week 14
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Dactylitis Scores at Week 14 in Participants With Dactylitis at Baseline | -2.8 units on a scale | Standard Deviation 7.03 |
| Golimumab | Change From Baseline in Dactylitis Scores at Week 14 in Participants With Dactylitis at Baseline | -7.8 units on a scale | Standard Deviation 8.57 |
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.
Time frame: Baseline and Week 14
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 14 | -0.12 units on a scale | Standard Deviation 0.466 |
| Golimumab | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 14 | -0.60 units on a scale | Standard Deviation 0.53 |
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).
Time frame: Baseline and Week 14
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Leeds Enthesitis Index (LEI) at Week 14 in Participants With Enthesitis at Baseline | -0.8 units on a scale | Standard Deviation 1.98 |
| Golimumab | Change From Baseline in Leeds Enthesitis Index (LEI) at Week 14 in Participants With Enthesitis at Baseline | -1.8 units on a scale | Standard Deviation 1.75 |
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.
Time frame: Baseline and Week 14
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Short Form-36 Health Survey (SF)-36 Mental Component Summary (MCS) at Week 14 | 0.97 units on a scale | Standard Deviation 7.644 |
| Golimumab | Change From Baseline in Short Form-36 Health Survey (SF)-36 Mental Component Summary (MCS) at Week 14 | 5.33 units on a scale | Standard Deviation 9.948 |
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.
Time frame: Baseline and Week 14
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Short Form-36 Health Survey (SF-36) Physical Component Summary (PCS) at Week 14 | 2.69 units on a scale | Standard Deviation 5.92 |
| Golimumab | Change From Baseline in Short Form-36 Health Survey (SF-36) Physical Component Summary (PCS) at Week 14 | 8.65 units on a scale | Standard Deviation 7.602 |
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.
Time frame: Baseline and Week 24
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Total Modified Van Der Heijde-Sharp (vdH-S) Score at Week 24 | 1.95 units on a scale | Standard Error 0.264 |
| Golimumab | Change From Baseline in Total Modified Van Der Heijde-Sharp (vdH-S) Score at Week 24 | -0.36 units on a scale | Standard Error 0.144 |
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).
Time frame: Week 14
Population: The full analysis set (FAS) included all participants who were randomized.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Who Achieved an ACR 50 Response at Week 14 | 6.3 Percentage of Participants |
| Golimumab | Percentage of Participants Who Achieved an ACR 50 Response at Week 14 | 43.6 Percentage of Participants |
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).
Time frame: Week 24
Population: The full analysis set (FAS) included all participants who were randomized.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 50 Response at Week 24 | 6.3 Percentage of participants |
| Golimumab | Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 50 Response at Week 24 | 53.5 Percentage of participants |
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).
Time frame: Week 14
Population: The full analysis set (FAS) included all participants who were randomized.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 70 Response at Week 14 | 2.1 Percentage of participants |
| Golimumab | Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 70 Response at Week 14 | 24.5 Percentage of participants |
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.
Time frame: Week 14
Population: The analysis set included randomized participants with greater than or equal to (\>=) 3 percent (%) body surface area (BSA) Psoriasis Skin Involvement at Baseline.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Who Achieved Psoriatic Area and Severity Index (PASI) 75 Response at Week 14 | 13.6 Percentage of participants |
| Golimumab | Percentage of Participants Who Achieved Psoriatic Area and Severity Index (PASI) 75 Response at Week 14 | 59.2 Percentage of participants |