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| ID | Type | Description | Link |
|---|---|---|---|
| 14/EM/0124 | Other Identifier | Research Ethics Committee |
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| Name | Class |
|---|---|
| Janssen Pharmaceutica N.V., Belgium | INDUSTRY |
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An investigator-initiated double-blind, parallel-group randomised controlled trial of Methotrexate versus GOLimumab and Methotrexate in very early PsA using clinical and whole body MRI outcomes.
Phase IIIb. Early Psoriatic Arthritis. Investigator initiated, double-blind, randomized, placebo-controlled, two-armed, parallel-group, single centre trial.
The Primary Objective is to assess whether the combination of golimumab with methotrexate and steroids is superior to standard care (MTX monotherapy plus steroids) in reducing clinical disease activity in patients with early, treatment naïve PsA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methotrexate | Active Comparator |
| |
| Golimumab & Methotrexate | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methotrexate | Drug | Methotrexate |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Psoriatic Arthritis Disease Activity Score (PASDAS) at 24 Weeks | The Psoriatic Arthritis Disease Activity Score ranges from 0-10; higher scores represent a worse outcome. | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Psoriatic Arthritis Disease Activity Score (PASDAS) at 12 Weeks. | The Psoriatic Arthritis Disease Activity Score ranges from 0-10; higher scores represent a worse outcome. | 12 weeks |
| Psoriatic Arthritis Disease Activity Score (PASDAS) at 36 Weeks. |
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Inclusion Criteria:
Male and female patients aged ≥18 years at the time of signing the Informed Consent Form.
Subjects with a diagnosis of psoriatic arthritis as per the Classification for Psoriatic Arthritis (CASPAR) criteria (Appendix 4) confirmed less than 24 months prior to screening.
Subjects with active PsA defined as the presence of at least 3/68 tender and at least 3/66 swollen joints or 2 swollen and 2 tender joints plus one affected entheseal site (Achilles tendon and/or plantar fascia) at baseline.
Are treatment naïve to DMARDs. Are capable of understanding and signing an informed consent form. Women of childbearing potential or men capable of fathering children must be using adequate birth control measures (eg, abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, surgical sterilization) during the study and for 6 months after receiving the last administration of study agent. Female subjects of childbearing potential must test negative for pregnancy. Female subjects must agree to not donate eggs (ova, oocytes) during the study and for 6 months after last dose of study agent. Male subjects must agree to not donate sperm while in the study and for 6 months after last dose of study agent.
Patients fulfilling the following TB criteria:
7.1. Have no history of latent or active TB prior to screening. An exception is made for subjects with a history of latent TB and documentation of having completed appropriate treatment for latent TB 3 years prior to the first administration of study agent. It is the responsibility of the investigator to verify the adequacy of previous antituberculous treatment and provide appropriate documentation.
7.2. Have no signs or symptoms suggestive of active TB upon medical history and/or physical examination.
7.3. Have had no close contact with a person with active TB or, if there has been such a contact, will be referred to a physician specializing in TB to undergo additional evaluation, and if warranted, receive appropriate treatment as if having latent TB prior to or simultaneously with the first administration of study agent.
7.4. Within 6 weeks prior to the administration of study agent, either have a negative QuantiFERON-TB Gold test result or have a newly identified positive QuantiFERON-TB Gold test result in which active TB has been ruled out and for which appropriate treatment for latent TB has been initiated either prior to or simultaneously with the first administration of study agent.
7.5. In the event of 2 indeterminate QuantiFERON-TB Gold in-tube tests results, the subjects will be treated as if having latent TB prior or simultaneously with the first administration of study agent.
7.6. Have a chest radiograph (posterior-anterior view), read by a qualified radiologist, whose diagnostic assessment is consistent with no evidence of current active TB or old inactive TB, and taken within 12 months of the study.
7.7. Have a screening laboratory test result as follows: 7.7.1. Hb≥8.5 g/dL or ≥5.3 mmol/L 7.7.2. White blood cell (WBC) count ≥3.5x103 cells/uL 7.7.3. Neutrophils ≥1.5 x103 cells/uL 7.7.4. Platelets ≥100x103 cells/uL 7.7.5. Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels not exceeding 1.5 times the upper limit of normal (UKN) for the central laboratory conducting the test.
7.7.6. Serum creatinine not exceeding 1.5 mg/dL
Exclusion Criteria:
Patients with significant concurrent medical diseases including uncompensated congestive heart failure, myocardial infarction within 52 weeks from screening, unstable angina pectoris, uncontrolled hypertension (BP>160/95), severe pulmonary disease, or history of human immunodeficiency virus (HIV) infection, immunodeficiency syndromes, central nervous system (CNS) demyelinating events suggestive of multiple sclerosis, renal or gastrointestinal conditions, which in the opinion of the investigator places the patient at an unacceptable risk for participation in the study or would make implementation of the protocol difficult.
Patients with cancer or a history of cancer (other than resected cutaneous basal cell carcinoma, and in situ cervical cancer) within 5 years of screening.
Patients with current crystal or infective arthritis. Patients with chronic infection of the upper respiratory tract (eg. Sinusitis), chest (eg. Bronchiectatic lung disease), urinary tract or skin (eg. Paronychia, chronic ulcers, open wounds) within 4 weeks of screening.
Patients who have a chest radiograph within 3 months prior to the first administration of study agent that shows an abnormality suggestive of a malignancy or current active infection, including TB, histoplasmosis or coccidioidomycosis.
Patients with any ongoing or active infection or any major episode of infection requiring hospitalization or treatment with IV antibiotics within the preceding 30 days of screening and/or orally administered antibiotics in the preceding 15 days of screening.
Patients with abnormal liver function including known liver cirrhosis, fibrosis, or known alcoholic steatohepatitis (NASH) at the time of screening or abnormal blood tests as shown by:
Aminotransferase (AST) / alanine aminotransferase (ALT) > 3x ULN, OR Bilirubin >51umol/L
Patients with known severe hypoproteinaemia at the time of screening, e.g. in nephrotic syndrome or impaired renal function, as shown by:
• Serum Creatinine > 133 mol/L
Patients with known significantly impaired bone marrow function as for example significant anaemia, leukopaenia, neutropaenia or thrombocytopaenia as shown by the following laboratory values at the time of screening:
White blood cells < 3000 x 106/L Platelets < 125 x 109/L Haemoglobin < 9.0 g/dL for males and < 8.5 g/dL for females Patients with a history of latent or active TB prior to screening will not be eligible. For exceptions refer to inclusion criteria.
Subjects must undergo screening for hepatitis B virus (HBV). At a minimum, this includes testing for HBsAg (surface antigen), anti-HBs (surface antibody), and anti-HBc total (core antibody total).
11.1. Subjects who test positive for surface antigen (HBsAg+) are not eligible for this study, regardless of the results of other hepatitis B tests.
11.2. Subjects who test negative for surface antibody (HBsAg-) and test positive for core antibody (anti-HBc+) and surface antibody (anti-HBs+) are eligible for this study.
11.3. Subjects who test positive only for surface antibody (anti-HBs+) are eligible for this study.
11.4. Subjects who test positive only for core antibody (anti-HBc+) must undergo further testing for hepatitis B deoxyribonucleic acid (HBV DNA test). If the HBV DNA test is positive, the subject is not eligible for this study. If the HBV DNA test is negative, the subject is eligible for this study. In the event the DNA test cannot be performed, the subject is not eligible for the study.
Primary or secondary immunodeficiency (history of or currently active) unless related to primary disease under investigation.
Pregnancy, lactation (nursing) or women of child-bearing potential (WCBP) unwilling to use an effective birth control measure (Appendix 1) whilst receiving treatment and after the last dose of protocol treatment as indicated in the relevant SmPC/IB.
Men whose partners are of child-bearing potential but who are unwilling to use an effective birth control measure whilst receiving treatment and after the last dose of protocol treatment as indicated in the relevant SmPC/IB.
Patients who have received any corticosteroids within 4 weeks prior to screening.
Patients with a history of confirmed blood dyscrasia. Patients with a history of mental illness that would interfere with their ability to comply with the study protocol.
Patients with a history of drug and/or alcohol abuse that would interfere with their ability to comply with the study protocol.
Patients with a history of any viral hepatitis within 1 year of screening Patients who have received or are expected to receive any live virus or bacterial vaccinations or treatments that include live organisms (eg. a therapeutic infectious agent such as BCG that is instilled into the bladder for the treatment of cancer) within 3 months prior to the first administration of study agent, during the trial, or within 6 months after the last administration of the study agent.
Patients who demonstrate Hypersensitivity to the active substance, or any of the excipients detailed in the SmPC.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Leeds Teaching Hospitals NHS Trust | Leeds | West Yorkshire | LS7 4SA | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42308540 | Derived | De Marco G, Maksymowych WP, Ostergaard M, Eshed I, Tan AL, Helliwell PS, McGonagle D, Hensor EMA, Marzo-Ortega H. Whole body-MRI identifies widespread, low intensity inflammation in peripheral joints, and axial involvement in a third of patients with early, treatment-naive, active psoriatic arthritis: Data from the GOLMePsA clinical trial. Rheumatology (Oxford). 2026 Jun 17:keag308. doi: 10.1093/rheumatology/keag308. Online ahead of print. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Methotrexate | Methotrexate: Methotrexate |
| FG001 | Golimumab & Methotrexate | Methotrexate: Methotrexate Golimumab: Simponi |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Methotrexate | Methotrexate: Methotrexate |
| BG001 | Golimumab & Methotrexate | Methotrexate: Methotrexate Golimumab: Simponi |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Psoriatic Arthritis Disease Activity Score (PASDAS) at 24 Weeks | The Psoriatic Arthritis Disease Activity Score ranges from 0-10; higher scores represent a worse outcome. | Full analysis set | Posted | Mean | Standard Deviation | score on a scale | 24 weeks |
|
52 Weeks
Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit.
AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Methotrexate | Methotrexate: Methotrexate | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Helena Marzo-Ortega | Leeds Teaching Hospital Trust | +44 (0) 113 392 4848 | H.Marzo-Ortega@leeds.ac.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 9, 2022 | Jun 10, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 17, 2023 | Jun 10, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D015535 | Arthritis, Psoriatic |
| ID | Term |
|---|---|
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
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| ID | Term |
|---|---|
| D008727 | Methotrexate |
| C529000 | golimumab |
| ID | Term |
|---|---|
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| Golimumab |
| Drug |
Simponi |
|
The Psoriatic Arthritis Disease Activity Score ranges from 0-10; higher scores represent a worse outcome.
| 36 weeks |
| Psoriatic Arthritis Disease Activity Score (PASDAS) at 52 Weeks. | The Psoriatic Arthritis Disease Activity Score ranges from 0-10; higher scores represent a worse outcome. | 52 weeks |
| Composite Psoriatic Disease Activity Index (CPDAI) at 12 Weeks. | The Composite Psoriatic Disease Activity Index ranges from 0-15; higher scores represent a worse outcome. | 12 weeks |
| Composite Psoriatic Disease Activity Index (CPDAI) at 24 Weeks. | The Composite Psoriatic Disease Activity Index ranges from 0-15; higher scores represent a worse outcome. | 24 weeks |
| Composite Psoriatic Disease Activity Index (CPDAI) at 36 Weeks. | The Composite Psoriatic Disease Activity Index ranges from 0-15; higher scores represent a worse outcome. | 36 weeks |
| Composite Psoriatic Disease Activity Index (CPDAI) at 52 Weeks. | The Composite Psoriatic Disease Activity Index ranges from 0-15; higher scores represent a worse outcome. | 52 weeks |
| Participant Disease Activity Visual Analogue Score at 24 Weeks. | The Participant Disease Activity Visual Analogue Score ranges from 0-100; higher scores represent a worse outcome. | 24 weeks |
| Participant Disease Activity Visual Analogue Score at 52 Weeks. | The Participant Disease Activity Visual Analogue Score ranges from 0-100; higher scores represent a worse outcome. | 52 weeks |
| 36-item Short Form Health Survey (SF-36) Physical Component Score at 24 Weeks. | The 36-item Short Form Health Survey (SF-36) Physical Component Score ranges from 0-100; higher scores represent a better outcome. | 24 weeks |
| 36-item Short Form Health Survey (SF-36) Physical Component Score at 52 Weeks. | The 36-item Short Form Health Survey (SF-36) Physical Component Score ranges from 0-100; higher scores represent a better outcome. | 52 weeks |
| 36-item Short Form Health Survey (SF-36) Mental Component Score at 24 Weeks. | The 36-item Short Form Health Survey (SF-36) Mental Component Score ranges from 0-100; higher scores represent a better outcome. | 24 weeks |
| 36-item Short Form Health Survey (SF-36) Mental Component Score at 52 Weeks. | The 36-item Short Form Health Survey (SF-36) Mental Component Score ranges from 0-100; higher scores represent a better outcome. | 52 weeks |
| Ultrasound Global OMERACT-EULAR System Score (GLOESS) at 12 Weeks. | In the joint set scanned in the Full Analysis Set, the Ultrasound Global OMERACT-EULAR System Score ranged from 0-72; higher scores represent a worse outcome. | 12 weeks |
| Ultrasound Global OMERACT-EULAR System Score (GLOESS) at 24 Weeks. | In the joint set scanned in the Full Analysis Set, the Ultrasound Global OMERACT-EULAR System Score ranged from 0-72; higher scores represent a worse outcome. | 24 weeks |
| Ultrasound Global OMERACT-EULAR System Score (GLOESS) at 36 Weeks. | In the joint set scanned in the Full Analysis Set, the Ultrasound Global OMERACT-EULAR System Score ranged from 0-72; higher scores represent a worse outcome. | 36 weeks |
| Ultrasound Entheseal Inflammatory Score at 12 Weeks. | The Ultrasound Entheseal Inflammatory Score ranged from 0-70; a higher score represents a worse outcome. | 12 weeks |
| Ultrasound Entheseal Inflammatory Score at 24 Weeks. | The Ultrasound Entheseal Inflammatory Score ranged from 0-70; a higher score represents a worse outcome. | 24 weeks |
| Ultrasound Entheseal Inflammatory Score at 36 Weeks. | The Ultrasound Entheseal Inflammatory Score ranged from 0-70; a higher score represents a worse outcome. | 36 weeks |
| Ultrasound Entheseal Chronicity Score at 12 Weeks. | The Ultrasound Entheseal Chronicity Score ranged from 0-50; a higher score represents a worse outcome. | 12 weeks |
| Ultrasound Entheseal Chronicity Score at 24 Weeks. | The Ultrasound Entheseal Chronicity Score ranged from 0-50; a higher score represents a worse outcome. | 24 weeks |
| Ultrasound Entheseal Chronicity Score at 36 Weeks. | The Ultrasound Entheseal Chronicity Score ranged from 0-50; a higher score represents a worse outcome. | 36 weeks |
| Leeds Enthesitis Index at 12 Weeks | The Leeds Enthesitis Index ranges from 0-6; a higher score represents a worse outcome. | 12 Weeks |
| Leeds Enthesitis Index at 24 Weeks | The Leeds Enthesitis Index ranges from 0-6; a higher score represents a worse outcome. | 24 Weeks |
| Leeds Enthesitis Index at 36 Weeks | The Leeds Enthesitis Index ranges from 0-6; a higher score represents a worse outcome. | 36 Weeks |
| Leeds Enthesitis Index at 52 Weeks | The Leeds Enthesitis Index ranges from 0-6; a higher score represents a worse outcome. | 52 Weeks |
| Leeds Dactylitis Index at 12 Weeks | The Leeds Dactylitis Index ranges from 0-~40; a higher score represents a worse outcome. | 12 Weeks |
| Leeds Dactylitis Index at 24 Weeks | The Leeds Dactylitis Index ranges from 0-~40; a higher score represents a worse outcome. | 24 Weeks |
| Leeds Dactylitis Index at 36 Weeks | The Leeds Dactylitis Index ranges from 0-~40; a higher score represents a worse outcome. | 36 Weeks |
| Leeds Dactylitis Index at 52 Weeks | The Leeds Dactylitis Index ranges from 0-~40; a higher score represents a worse outcome. | 52 Weeks |
| The Modified Nail Psoriasis Severity Index (mNAPSI) at 12 Weeks | The Modified Nail Psoriasis Severity Index ranges from 0-140; a higher score represents a worse outcome. | 12 Weeks |
| The Modified Nail Psoriasis Severity Index (mNAPSI) at 24 Weeks | The Modified Nail Psoriasis Severity Index ranges from 0-140; a higher score represents a worse outcome. | 24 Weeks |
| The Modified Nail Psoriasis Severity Index (mNAPSI) at 36 Weeks | The Modified Nail Psoriasis Severity Index ranges from 0-140; a higher score represents a worse outcome. | 36 Weeks |
| The Modified Nail Psoriasis Severity Index (mNAPSI) at 52 Weeks | The Modified Nail Psoriasis Severity Index ranges from 0-140; a higher score represents a worse outcome. | 52 Weeks |
| Psoriasis Area and Severity Index (PASI) Score at 12 Weeks | The Psoriasis Area and Severity Index ranges from 0-72; a higher score represents a worse outcome. | 12 Weeks |
| Psoriasis Area and Severity Index (PASI) Score at 24 Weeks | The Psoriasis Area and Severity Index ranges from 0-72; a higher score represents a worse outcome. | 24 Weeks |
| Psoriasis Area and Severity Index (PASI) Score at 36 Weeks | The Psoriasis Area and Severity Index ranges from 0-72; a higher score represents a worse outcome. | 36 Weeks |
| Psoriasis Area and Severity Index (PASI) Score at 52 Weeks | The Psoriasis Area and Severity Index ranges from 0-72; a higher score represents a worse outcome. | 52 Weeks |
| Dermatology Life Quality Index (DLQI) Score at 24 Weeks | The Dermatology Life Quality Index ranges from 0-30; a higher score represents a worse outcome. | 24 Weeks |
| Dermatology Life Quality Index (DLQI) Score at 52 Weeks | The Dermatology Life Quality Index ranges from 0-30; a higher score represents a worse outcome. | 52 Weeks |
| Minimal Disease Activity (MDA) at 12 Weeks | Minimal Disease Activity (coded 0=No, 1=Yes) is achieved when at least 5 of the 7 following criteria are met: Tender joint count (/68) ≤1 Swollen joint count (/66) ≤1 PASI ≤1 or BSA≤3 Patient pain VAS ≤15 Patient global disease activity VAS ≤20 HAQ ≤0.5 Enthesitis count ≤1. | 12 Weeks |
| Minimal Disease Activity (MDA) at 24 Weeks | Minimal Disease Activity (coded 0=No, 1=Yes) is achieved when at least 5 of the 7 following criteria are met: Tender joint count (/68) ≤1 Swollen joint count (/66) ≤1 PASI ≤1 or BSA≤3 Patient pain VAS ≤15 Patient global disease activity VAS ≤20 HAQ ≤0.5 Enthesitis count ≤1. | 24 Weeks |
| Minimal Disease Activity (MDA) at 36 Weeks | Minimal Disease Activity (coded 0=No, 1=Yes) is achieved when at least 5 of the 7 following criteria are met: Tender joint count (/68) ≤1 Swollen joint count (/66) ≤1 PASI ≤1 or BSA≤3 Patient pain VAS ≤15 Patient global disease activity VAS ≤20 HAQ ≤0.5 Enthesitis count ≤1. | 36 Weeks |
| Minimal Disease Activity (MDA) at 52 Weeks | Minimal Disease Activity (coded 0=No, 1=Yes) is achieved when at least 5 of the 7 following criteria are met: Tender joint count (/68) ≤1 Swollen joint count (/66) ≤1 PASI ≤1 or BSA≤3 Patient pain VAS ≤15 Patient global disease activity VAS ≤20 HAQ ≤0.5 Enthesitis count ≤1. | 52 Weeks |
| American College of Rheumatology 20 (ACR20) Response at 12 Weeks | American College of Rheumatology 20 Response (coded 0=No, 1=Yes) is achieved when there is:
| 12 Weeks |
| American College of Rheumatology 20 (ACR20) Response at 24 Weeks | American College of Rheumatology 20 Response (coded 0=No, 1=Yes) is achieved when there is:
| 24 Weeks |
| American College of Rheumatology 20 (ACR20) Response at 36 Weeks | American College of Rheumatology 20 Response (coded 0=No, 1=Yes) is achieved when there is:
| 36 Weeks |
| American College of Rheumatology 20 (ACR20) Response at 52 Weeks | American College of Rheumatology 20 Response (coded 0=No, 1=Yes) is achieved when there is:
| 52 Weeks |
| American College of Rheumatology 50 (ACR50) Response at 12 Weeks | American College of Rheumatology 50 Response (coded 0=No, 1=Yes) is achieved when there is:
| 12 Weeks |
| American College of Rheumatology 50 (ACR50) Response at 24 Weeks | American College of Rheumatology 50 Response (coded 0=No, 1=Yes) is achieved when there is:
| 24 Weeks |
| American College of Rheumatology 50 (ACR50) Response at 36 Weeks | American College of Rheumatology 50 Response (coded 0=No, 1=Yes) is achieved when there is:
| 36 Weeks |
| American College of Rheumatology 50 (ACR50) Response at 52 Weeks | American College of Rheumatology 50 Response (coded 0=No, 1=Yes) is achieved when there is:
| 52 Weeks |
| American College of Rheumatology 70 (ACR70) Response at 12 Weeks | American College of Rheumatology 70 Response (coded 0=No, 1=Yes) is achieved when there is:
| 12 Weeks |
| American College of Rheumatology 70 (ACR70) Response at 24 Weeks | American College of Rheumatology 70 Response (coded 0=No, 1=Yes) is achieved when there is:
| 24 Weeks |
| American College of Rheumatology 70 (ACR70) Response at 36 Weeks | American College of Rheumatology 70 Response (coded 0=No, 1=Yes) is achieved when there is:
| 36 Weeks |
| American College of Rheumatology 70 (ACR70) Response at 52 Weeks | American College of Rheumatology 70 Response (coded 0=No, 1=Yes) is achieved when there is:
| 52 Weeks |
| Psoriatic Arthritis Response Criteria (PsARC) Response at 12 Weeks | Psoriatic Arthritis Response Criteria Response (coded 0=No, 1=Yes) is defined by improvement from baseline assessment in 2 of 4 criteria, 1 of which must be a joint count; there must not be worsening in any of the 4 criteria:
| 12 Weeks |
| Psoriatic Arthritis Response Criteria (PsARC) Response at 24 Weeks | Psoriatic Arthritis Response Criteria Response (coded 0=No, 1=Yes) is defined by improvement from baseline assessment in 2 of 4 criteria, 1 of which must be a joint count; there must not be worsening in any of the 4 criteria:
| 24 Weeks |
| Psoriatic Arthritis Response Criteria (PsARC) Response at 36 Weeks | Psoriatic Arthritis Response Criteria Response (coded 0=No, 1=Yes) is defined by improvement from baseline assessment in 2 of 4 criteria, 1 of which must be a joint count; there must not be worsening in any of the 4 criteria:
| 36 Weeks |
| Psoriatic Arthritis Response Criteria (PsARC) Response at 52 Weeks | Psoriatic Arthritis Response Criteria Response (coded 0=No, 1=Yes) is defined by improvement from baseline assessment in 2 of 4 criteria, 1 of which must be a joint count; there must not be worsening in any of the 4 criteria:
| 52 Weeks |
| Psoriatic Arthritis Skin Index (PASI) Response at 12 Weeks | Psoriatic Arthritis Skin Index (PASI) Response (coded 0=No, 1=Yes) is defined as an improvement of at least 75% in the PASI compared to baseline. | 12 Weeks |
| Psoriatic Arthritis Skin Index (PASI) Response at 24 Weeks | Psoriatic Arthritis Skin Index (PASI) Response (coded 0=No, 1=Yes) is defined as an improvement of at least 75% in the PASI compared to baseline. | 24 Weeks |
| Psoriatic Arthritis Skin Index (PASI) Response at 36 Weeks | Psoriatic Arthritis Skin Index (PASI) Response (coded 0=No, 1=Yes) is defined as an improvement of at least 75% in the PASI compared to baseline. | 36 Weeks |
| Psoriatic Arthritis Skin Index (PASI) Response at 52 Weeks | Psoriatic Arthritis Skin Index (PASI) Response (coded 0=No, 1=Yes) is defined as an improvement of at least 75% in the PASI compared to baseline. | 52 Weeks |
| Ultrasound Imaging Remission at 12 Weeks | Ultrasound Imaging Remission (coded 0=No, 1=Yes) is achieved when all joints and entheses score grey scale<=1 & power Doppler=0. | 12 Weeks |
| Ultrasound Imaging Remission at 24 Weeks | Ultrasound Imaging Remission (coded 0=No, 1=Yes) is achieved when all joints and entheses score grey scale<=1 & power Doppler=0. | 24 Weeks |
| Ultrasound Imaging Remission at 36 Weeks | Ultrasound Imaging Remission (coded 0=No, 1=Yes) is achieved when all joints and entheses score grey scale<=1 & power Doppler=0. | 36 Weeks |
| Additional Steroid Received Before 24 Weeks | Participants were eligible for additional steroid at weeks 8 and 12 if they had not achieved a PsARC response; this variable was coded 0=No, 1=Yes. | 12 Weeks |
| Non-compliance |
|
| Unable to attend final visit |
|
| Missed study medication |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| PASDAS | The Psoriatic Arthritis Disease Activity Score (PASDAS) is a composite outcome based on the physician global VAS, participant global VAS, SF-36 physical component score, 66 swollen joint count, 68 tender joint count, Leeds enthesitis index, tender dactylitis count and C-reactive protein. The PASDAS ranges from 0-10, with higher values indicating higher disease activity. | Mean | Standard Deviation | units on a scale |
|
| Leeds Enthesitis Index | The Leeds Enthesitis Index is a count of the number of tender entheses out of a possible 6 (lateral epicondyle, left and right, medial femoral condyle, left and right, Achilles tendon insertion, left and right). A higher score indicates a wider extent of enthesitis. | Mean | Standard Deviation | score on a scale |
|
| Leeds Dactylitis Index | The Leeds Dactylitis Index measures dactylitis severity. The ratio of the circumference of the affected digit to the circumference of the digit on the opposite side is measured. Each dactylitic digit is defined by a minimum increase of 10% in circumference over the contra-lateral digit. The calculated ratio is then multiplied by a tenderness score of 0 (non-tender), 1 (tender), 2 (tender and wince) or 3 (tender and withdraw). Tenderness is assessed in the area between the joints. The results of each digit are then added to produce a total score. Range 0-~40, higher score means worse dactylitis | Mean | Standard Deviation | units on a scale |
|
| Psoriatic Arthritis Skin Index Score | The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation, erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no Pso to 72 for the most severe disease. | Median | Inter-Quartile Range | units on a scale |
|
| Modified Nail Psoriasis Severity Index (mNAPSI) | Each fingernail is scored for the presence and the severity of pitting, onycholysis, oil-drop dyschromia and nail plate crumbling (score 0-3) and the presence or absence of splinter haemorrhages, leuconychia, red spots in the lunula and nail bed hyperkeratosis (score 1 for each if present). The scale ranges from 0 to 140, higher scores indicate worse nail psoriasis. | Mean | Standard Deviation | units on a scale |
|
| Composite Psoriatic Disease Activity Index (CPDAI) | Domains include peripheral arthritis (assessed by 68 tender joints count, 66 swollen joints count, and the Health Assessment Questionnaire), skin as assessed by the PASI and the DLQI, enthesitis as assessed by the number of sites with enthesitis and the HAQ, dactylitis as assessed by the number of digits affected, and spinal disease as assessed by the BASDAI and ASQoL. Scores range from 0 to 15. Higher scores indicate higher disease activity. | Mean | Standard Deviation | units on a scale |
|
| Ultrasound Global OMERACT-EULAR System Score (GLOESS) | Joints are scored 0-3 for grey scale and power Doppler; a combined score takes a value of 0 if grey scale=0, if grey scale is >0 then the combined score is the maximum of the grey scale and power Doppler scores. Scores for individual joints are then summated to give a total global score. For the set of joints scanned in all participants, this ranges from 0-72; for the subset in whom a wider set of joints were scanned, this ranges from 0 to 144. Higher scores indicate worse synovial hypertrophy and vascularisation. | Mean | Standard Deviation | units on a scale |
|
| Ultrasound Entheseal Inflammatory Score | Grey scale changes in the entheses related to inflammation (entheseal hypoechogenicity and thickening) are added to power Doppler scores. The score ranges from 0-70, higher scores indicate worse entheseal inflammation. | Mean | Standard Deviation | units on a scale |
|
| Ultrasound Entheseal Chronicity Score | Grey scale changes related to chronic findings (calcifications, erosion and enthesophytes) are summated. The score ranges from 0-50; higher scores indicate a greater extent of chronic entheseal pathology. | Mean | Standard Deviation | units on a scale |
|
| Participant Disease Activity Visual Analogue Scale | Participants are asked to assess their current level of joint pain by marking a vertical line on a 100 mm horizontal VAS where 0 represents no joint pain ("excellent") and 100 represents worst imaginable joint pain ("poor"). | Mean | Standard Deviation | units on a scale |
|
| Dermatology Life Quality Index (DLQI) | The DLQI is a simple, patient administered, 10 question, validated, quality of life questionnaire that covers 6 domains including symptoms and feelings, daily activities, leisure, work and school, personal relationships and treatment. Response categories include "not at all", "a lot" and "very much" with corresponding scores of 1, 2 and 3 respectively and unanswered ("not relevant") responses scored as "0". Totals range from 0 to 30 (less to more impairment) and a 5-point change from baseline is considered clinically relevant. | Median | Inter-Quartile Range | units on a scale |
|
| 36-Item Short Form Health Survey (SF-36) Physical Component Summary | The SF-36 physical component summary scale ranges from 0-100, with scores above 50 indicating better than average physical health. | Mean | Standard Deviation | units on a scale |
|
| 36-Item Short Form Health Survey (SF-36) Mental Component Summary | The SF-36 mental component summary scale ranges from 0-100, with scores above 50 indicating better than average mental health. | Mean | Standard Deviation | units on a scale |
|
| Units |
|---|
| Counts |
|---|
| Participants |
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| Secondary | Psoriatic Arthritis Disease Activity Score (PASDAS) at 12 Weeks. | The Psoriatic Arthritis Disease Activity Score ranges from 0-10; higher scores represent a worse outcome. | Full analysis set | Posted | Mean | Standard Deviation | score on a scale | 12 weeks |
|
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|
| Secondary | Psoriatic Arthritis Disease Activity Score (PASDAS) at 36 Weeks. | The Psoriatic Arthritis Disease Activity Score ranges from 0-10; higher scores represent a worse outcome. | Full analysis set | Posted | Mean | Standard Deviation | score on a scale | 36 weeks |
|
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|
| Secondary | Psoriatic Arthritis Disease Activity Score (PASDAS) at 52 Weeks. | The Psoriatic Arthritis Disease Activity Score ranges from 0-10; higher scores represent a worse outcome. | Full analysis set | Posted | Mean | Standard Deviation | score on a scale | 52 weeks |
|
|
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| Secondary | Composite Psoriatic Disease Activity Index (CPDAI) at 12 Weeks. | The Composite Psoriatic Disease Activity Index ranges from 0-15; higher scores represent a worse outcome. | Full analysis set | Posted | Mean | Standard Deviation | score on a scale | 12 weeks |
|
|
|
|
| Secondary | Composite Psoriatic Disease Activity Index (CPDAI) at 24 Weeks. | The Composite Psoriatic Disease Activity Index ranges from 0-15; higher scores represent a worse outcome. | Full analysis set | Posted | Mean | Standard Deviation | score on a scale | 24 weeks |
|
|
|
|
| Secondary | Composite Psoriatic Disease Activity Index (CPDAI) at 36 Weeks. | The Composite Psoriatic Disease Activity Index ranges from 0-15; higher scores represent a worse outcome. | Full analysis set | Posted | Mean | Standard Deviation | score on a scale | 36 weeks |
|
|
|
|
| Secondary | Composite Psoriatic Disease Activity Index (CPDAI) at 52 Weeks. | The Composite Psoriatic Disease Activity Index ranges from 0-15; higher scores represent a worse outcome. | Full analysis set | Posted | Mean | Standard Deviation | score on a scale | 52 weeks |
|
|
|
|
| Secondary | Participant Disease Activity Visual Analogue Score at 24 Weeks. | The Participant Disease Activity Visual Analogue Score ranges from 0-100; higher scores represent a worse outcome. | Full analysis set | Posted | Mean | Standard Deviation | score on a scale | 24 weeks |
|
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| Secondary | Participant Disease Activity Visual Analogue Score at 52 Weeks. | The Participant Disease Activity Visual Analogue Score ranges from 0-100; higher scores represent a worse outcome. | Full analysis set | Posted | Mean | Standard Deviation | score on a scale | 52 weeks |
|
|
|
|
| Secondary | 36-item Short Form Health Survey (SF-36) Physical Component Score at 24 Weeks. | The 36-item Short Form Health Survey (SF-36) Physical Component Score ranges from 0-100; higher scores represent a better outcome. | Full analysis set | Posted | Mean | Standard Deviation | score on a scale | 24 weeks |
|
|
|
|
| Secondary | 36-item Short Form Health Survey (SF-36) Physical Component Score at 52 Weeks. | The 36-item Short Form Health Survey (SF-36) Physical Component Score ranges from 0-100; higher scores represent a better outcome. | Full analysis set | Posted | Mean | Standard Deviation | score on a scale | 52 weeks |
|
|
|
|
| Secondary | 36-item Short Form Health Survey (SF-36) Mental Component Score at 24 Weeks. | The 36-item Short Form Health Survey (SF-36) Mental Component Score ranges from 0-100; higher scores represent a better outcome. | Full analysis set | Posted | Mean | Standard Deviation | score on a scale | 24 weeks |
|
|
|
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| Secondary | 36-item Short Form Health Survey (SF-36) Mental Component Score at 52 Weeks. | The 36-item Short Form Health Survey (SF-36) Mental Component Score ranges from 0-100; higher scores represent a better outcome. | Full analysis set | Posted | Mean | Standard Deviation | score on a scale | 52 weeks |
|
|
|
|
| Secondary | Ultrasound Global OMERACT-EULAR System Score (GLOESS) at 12 Weeks. | In the joint set scanned in the Full Analysis Set, the Ultrasound Global OMERACT-EULAR System Score ranged from 0-72; higher scores represent a worse outcome. | Full analysis set | Posted | Mean | Standard Deviation | score on a scale | 12 weeks |
|
|
|
|
| Secondary | Ultrasound Global OMERACT-EULAR System Score (GLOESS) at 24 Weeks. | In the joint set scanned in the Full Analysis Set, the Ultrasound Global OMERACT-EULAR System Score ranged from 0-72; higher scores represent a worse outcome. | Full analysis set | Posted | Mean | Standard Deviation | score on a scale | 24 weeks |
|
|
|
|
| Secondary | Ultrasound Global OMERACT-EULAR System Score (GLOESS) at 36 Weeks. | In the joint set scanned in the Full Analysis Set, the Ultrasound Global OMERACT-EULAR System Score ranged from 0-72; higher scores represent a worse outcome. | Full analysis set | Posted | Mean | Standard Deviation | score on a scale | 36 weeks |
|
|
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|
| Secondary | Ultrasound Entheseal Inflammatory Score at 12 Weeks. | The Ultrasound Entheseal Inflammatory Score ranged from 0-70; a higher score represents a worse outcome. | Full analysis set | Posted | Mean | Standard Deviation | score on a scale | 12 weeks |
|
|
|
|
| Secondary | Ultrasound Entheseal Inflammatory Score at 24 Weeks. | The Ultrasound Entheseal Inflammatory Score ranged from 0-70; a higher score represents a worse outcome. | Full analysis set | Posted | Mean | Standard Deviation | score on a scale | 24 weeks |
|
|
|
|
| Secondary | Ultrasound Entheseal Inflammatory Score at 36 Weeks. | The Ultrasound Entheseal Inflammatory Score ranged from 0-70; a higher score represents a worse outcome. | Full analysis set | Posted | Mean | Standard Deviation | score on a scale | 36 weeks |
|
|
|
|
| Secondary | Ultrasound Entheseal Chronicity Score at 12 Weeks. | The Ultrasound Entheseal Chronicity Score ranged from 0-50; a higher score represents a worse outcome. | Full analysis set | Posted | Mean | Standard Deviation | score on a scale | 12 weeks |
|
|
|
|
| Secondary | Ultrasound Entheseal Chronicity Score at 24 Weeks. | The Ultrasound Entheseal Chronicity Score ranged from 0-50; a higher score represents a worse outcome. | Full analysis set | Posted | Mean | Standard Deviation | score on a scale | 24 weeks |
|
|
|
|
| Secondary | Ultrasound Entheseal Chronicity Score at 36 Weeks. | The Ultrasound Entheseal Chronicity Score ranged from 0-50; a higher score represents a worse outcome. | Full analysis set | Posted | Mean | Standard Deviation | score on a scale | 36 weeks |
|
|
|
|
| Secondary | Leeds Enthesitis Index at 12 Weeks | The Leeds Enthesitis Index ranges from 0-6; a higher score represents a worse outcome. | Full Analysis Set | Posted | Mean | Standard Deviation | score on a scale | 12 Weeks |
|
|
|
|
| Secondary | Leeds Enthesitis Index at 24 Weeks | The Leeds Enthesitis Index ranges from 0-6; a higher score represents a worse outcome. | Full Analysis Set | Posted | Mean | Standard Deviation | score on a scale | 24 Weeks |
|
|
|
|
| Secondary | Leeds Enthesitis Index at 36 Weeks | The Leeds Enthesitis Index ranges from 0-6; a higher score represents a worse outcome. | Full Analysis Set | Posted | Mean | Standard Deviation | score on a scale | 36 Weeks |
|
|
|
|
| Secondary | Leeds Enthesitis Index at 52 Weeks | The Leeds Enthesitis Index ranges from 0-6; a higher score represents a worse outcome. | Full Analysis Set | Posted | Mean | Standard Deviation | score on a scale | 52 Weeks |
|
|
|
|
| Secondary | Leeds Dactylitis Index at 12 Weeks | The Leeds Dactylitis Index ranges from 0-~40; a higher score represents a worse outcome. | Full Analysis Set | Posted | Mean | Standard Deviation | units on a scale | 12 Weeks |
|
|
|
|
| Secondary | Leeds Dactylitis Index at 24 Weeks | The Leeds Dactylitis Index ranges from 0-~40; a higher score represents a worse outcome. | Full Analysis Set | Posted | Mean | Standard Deviation | units on a scale | 24 Weeks |
|
|
|
|
| Secondary | Leeds Dactylitis Index at 36 Weeks | The Leeds Dactylitis Index ranges from 0-~40; a higher score represents a worse outcome. | Full Analysis Set | Posted | Mean | Standard Deviation | units on a scale | 36 Weeks |
|
|
|
|
| Secondary | Leeds Dactylitis Index at 52 Weeks | The Leeds Dactylitis Index ranges from 0-~40; a higher score represents a worse outcome. | Full Analysis Set | Posted | Mean | Standard Deviation | units on a scale | 52 Weeks |
|
|
|
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| Secondary | The Modified Nail Psoriasis Severity Index (mNAPSI) at 12 Weeks | The Modified Nail Psoriasis Severity Index ranges from 0-140; a higher score represents a worse outcome. | Full Analysis Set | Posted | Mean | Standard Deviation | units on a scale | 12 Weeks |
|
|
|
|
| Secondary | The Modified Nail Psoriasis Severity Index (mNAPSI) at 24 Weeks | The Modified Nail Psoriasis Severity Index ranges from 0-140; a higher score represents a worse outcome. | Full Analysis Set | Posted | Mean | Standard Deviation | units on a scale | 24 Weeks |
|
|
|
|
| Secondary | The Modified Nail Psoriasis Severity Index (mNAPSI) at 36 Weeks | The Modified Nail Psoriasis Severity Index ranges from 0-140; a higher score represents a worse outcome. | Full Analysis Set | Posted | Mean | Standard Deviation | units on a scale | 36 Weeks |
|
|
|
|
| Secondary | The Modified Nail Psoriasis Severity Index (mNAPSI) at 52 Weeks | The Modified Nail Psoriasis Severity Index ranges from 0-140; a higher score represents a worse outcome. | Full Analysis Set | Posted | Mean | Standard Deviation | units on a scale | 52 Weeks |
|
|
|
|
| Secondary | Psoriasis Area and Severity Index (PASI) Score at 12 Weeks | The Psoriasis Area and Severity Index ranges from 0-72; a higher score represents a worse outcome. | Full Analysis Set | Posted | Median | Inter-Quartile Range | score on a scale | 12 Weeks |
|
|
|
|
| Secondary | Psoriasis Area and Severity Index (PASI) Score at 24 Weeks | The Psoriasis Area and Severity Index ranges from 0-72; a higher score represents a worse outcome. | Full Analysis Set | Posted | Median | Inter-Quartile Range | score on a scale | 24 Weeks |
|
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| Secondary | Psoriasis Area and Severity Index (PASI) Score at 36 Weeks | The Psoriasis Area and Severity Index ranges from 0-72; a higher score represents a worse outcome. | Full Analysis Set | Posted | Median | Inter-Quartile Range | score on a scale | 36 Weeks |
|
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| Secondary | Psoriasis Area and Severity Index (PASI) Score at 52 Weeks | The Psoriasis Area and Severity Index ranges from 0-72; a higher score represents a worse outcome. | Full Analysis Set | Posted | Median | Inter-Quartile Range | score on a scale | 52 Weeks |
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| Secondary | Dermatology Life Quality Index (DLQI) Score at 24 Weeks | The Dermatology Life Quality Index ranges from 0-30; a higher score represents a worse outcome. | Full Analysis Set | Posted | Median | Inter-Quartile Range | score on a scale | 24 Weeks |
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| Secondary | Dermatology Life Quality Index (DLQI) Score at 52 Weeks | The Dermatology Life Quality Index ranges from 0-30; a higher score represents a worse outcome. | Full Analysis Set | Posted | Median | Inter-Quartile Range | score on a scale | 52 Weeks |
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| Secondary | Minimal Disease Activity (MDA) at 12 Weeks | Minimal Disease Activity (coded 0=No, 1=Yes) is achieved when at least 5 of the 7 following criteria are met: Tender joint count (/68) ≤1 Swollen joint count (/66) ≤1 PASI ≤1 or BSA≤3 Patient pain VAS ≤15 Patient global disease activity VAS ≤20 HAQ ≤0.5 Enthesitis count ≤1. | Posted | Count of Participants | Participants | No | 12 Weeks |
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| Secondary | Minimal Disease Activity (MDA) at 24 Weeks | Minimal Disease Activity (coded 0=No, 1=Yes) is achieved when at least 5 of the 7 following criteria are met: Tender joint count (/68) ≤1 Swollen joint count (/66) ≤1 PASI ≤1 or BSA≤3 Patient pain VAS ≤15 Patient global disease activity VAS ≤20 HAQ ≤0.5 Enthesitis count ≤1. | Posted | Count of Participants | Participants | No | 24 Weeks |
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| Secondary | Minimal Disease Activity (MDA) at 36 Weeks | Minimal Disease Activity (coded 0=No, 1=Yes) is achieved when at least 5 of the 7 following criteria are met: Tender joint count (/68) ≤1 Swollen joint count (/66) ≤1 PASI ≤1 or BSA≤3 Patient pain VAS ≤15 Patient global disease activity VAS ≤20 HAQ ≤0.5 Enthesitis count ≤1. | Posted | Count of Participants | Participants | No | 36 Weeks |
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| Secondary | Minimal Disease Activity (MDA) at 52 Weeks | Minimal Disease Activity (coded 0=No, 1=Yes) is achieved when at least 5 of the 7 following criteria are met: Tender joint count (/68) ≤1 Swollen joint count (/66) ≤1 PASI ≤1 or BSA≤3 Patient pain VAS ≤15 Patient global disease activity VAS ≤20 HAQ ≤0.5 Enthesitis count ≤1. | Posted | Count of Participants | Participants | No | 52 Weeks |
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| Secondary | American College of Rheumatology 20 (ACR20) Response at 12 Weeks | American College of Rheumatology 20 Response (coded 0=No, 1=Yes) is achieved when there is:
| Full Analysis Set | Posted | Count of Participants | Participants | No | 12 Weeks |
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|
| Secondary | American College of Rheumatology 20 (ACR20) Response at 24 Weeks | American College of Rheumatology 20 Response (coded 0=No, 1=Yes) is achieved when there is:
| Full Analysis Set | Posted | Count of Participants | Participants | No | 24 Weeks |
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|
|
| Secondary | American College of Rheumatology 20 (ACR20) Response at 36 Weeks | American College of Rheumatology 20 Response (coded 0=No, 1=Yes) is achieved when there is:
| Full Analysis Set | Posted | Count of Participants | Participants | No | 36 Weeks |
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|
|
| Secondary | American College of Rheumatology 20 (ACR20) Response at 52 Weeks | American College of Rheumatology 20 Response (coded 0=No, 1=Yes) is achieved when there is:
| Full Analysis Set | Posted | Count of Participants | Participants | No | 52 Weeks |
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|
|
| Secondary | American College of Rheumatology 50 (ACR50) Response at 12 Weeks | American College of Rheumatology 50 Response (coded 0=No, 1=Yes) is achieved when there is:
| Full Analysis Set | Posted | Count of Participants | Participants | No | 12 Weeks |
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|
|
| Secondary | American College of Rheumatology 50 (ACR50) Response at 24 Weeks | American College of Rheumatology 50 Response (coded 0=No, 1=Yes) is achieved when there is:
| Full Analysis Set | Posted | Count of Participants | Participants | No | 24 Weeks |
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|
|
| Secondary | American College of Rheumatology 50 (ACR50) Response at 36 Weeks | American College of Rheumatology 50 Response (coded 0=No, 1=Yes) is achieved when there is:
| Full Analysis Set | Posted | Count of Participants | Participants | No | 36 Weeks |
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|
|
| Secondary | American College of Rheumatology 50 (ACR50) Response at 52 Weeks | American College of Rheumatology 50 Response (coded 0=No, 1=Yes) is achieved when there is:
| Full Analysis Set | Posted | Count of Participants | Participants | No | 52 Weeks |
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|
| Secondary | American College of Rheumatology 70 (ACR70) Response at 12 Weeks | American College of Rheumatology 70 Response (coded 0=No, 1=Yes) is achieved when there is:
| Full Analysis Set | Posted | Count of Participants | Participants | No | 12 Weeks |
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|
| Secondary | American College of Rheumatology 70 (ACR70) Response at 24 Weeks | American College of Rheumatology 70 Response (coded 0=No, 1=Yes) is achieved when there is:
| Full Analysis Set | Posted | Count of Participants | Participants | No | 24 Weeks |
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|
|
| Secondary | American College of Rheumatology 70 (ACR70) Response at 36 Weeks | American College of Rheumatology 70 Response (coded 0=No, 1=Yes) is achieved when there is:
| Full Analysis Set | Posted | Count of Participants | Participants | No | 36 Weeks |
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|
| Secondary | American College of Rheumatology 70 (ACR70) Response at 52 Weeks | American College of Rheumatology 70 Response (coded 0=No, 1=Yes) is achieved when there is:
| Full Analysis Set | Posted | Count of Participants | Participants | No | 52 Weeks |
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| Secondary | Psoriatic Arthritis Response Criteria (PsARC) Response at 12 Weeks | Psoriatic Arthritis Response Criteria Response (coded 0=No, 1=Yes) is defined by improvement from baseline assessment in 2 of 4 criteria, 1 of which must be a joint count; there must not be worsening in any of the 4 criteria:
| Full Analysis Set | Posted | Count of Participants | Participants | No | 12 Weeks |
|
|
|
|
| Secondary | Psoriatic Arthritis Response Criteria (PsARC) Response at 24 Weeks | Psoriatic Arthritis Response Criteria Response (coded 0=No, 1=Yes) is defined by improvement from baseline assessment in 2 of 4 criteria, 1 of which must be a joint count; there must not be worsening in any of the 4 criteria:
| Full Analysis Set | Posted | Count of Participants | Participants | No | 24 Weeks |
|
|
|
|
| Secondary | Psoriatic Arthritis Response Criteria (PsARC) Response at 36 Weeks | Psoriatic Arthritis Response Criteria Response (coded 0=No, 1=Yes) is defined by improvement from baseline assessment in 2 of 4 criteria, 1 of which must be a joint count; there must not be worsening in any of the 4 criteria:
| Full Analysis Set | Posted | Count of Participants | Participants | No | 36 Weeks |
|
|
|
|
| Secondary | Psoriatic Arthritis Response Criteria (PsARC) Response at 52 Weeks | Psoriatic Arthritis Response Criteria Response (coded 0=No, 1=Yes) is defined by improvement from baseline assessment in 2 of 4 criteria, 1 of which must be a joint count; there must not be worsening in any of the 4 criteria:
| Full Analysis Set | Posted | Count of Participants | Participants | No | 52 Weeks |
|
|
|
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| Secondary | Psoriatic Arthritis Skin Index (PASI) Response at 12 Weeks | Psoriatic Arthritis Skin Index (PASI) Response (coded 0=No, 1=Yes) is defined as an improvement of at least 75% in the PASI compared to baseline. | Full Analysis Set (restricted to those with >=3% body surface area affected by psoriasis at baseline) | Posted | Count of Participants | Participants | No | 12 Weeks |
|
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|
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| Secondary | Psoriatic Arthritis Skin Index (PASI) Response at 24 Weeks | Psoriatic Arthritis Skin Index (PASI) Response (coded 0=No, 1=Yes) is defined as an improvement of at least 75% in the PASI compared to baseline. | Full Analysis Set (restricted to those with >=3% body surface area affected by psoriasis at baseline) | Posted | Count of Participants | Participants | No | 24 Weeks |
|
|
|
|
| Secondary | Psoriatic Arthritis Skin Index (PASI) Response at 36 Weeks | Psoriatic Arthritis Skin Index (PASI) Response (coded 0=No, 1=Yes) is defined as an improvement of at least 75% in the PASI compared to baseline. | Full Analysis Set (restricted to those with >=3% body surface area affected by psoriasis at baseline) | Posted | Count of Participants | Participants | No | 36 Weeks |
|
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|
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| Secondary | Psoriatic Arthritis Skin Index (PASI) Response at 52 Weeks | Psoriatic Arthritis Skin Index (PASI) Response (coded 0=No, 1=Yes) is defined as an improvement of at least 75% in the PASI compared to baseline. | Full Analysis Set (restricted to those with >=3% body surface area affected by psoriasis at baseline) | Posted | Count of Participants | Participants | No | 52 Weeks |
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| Secondary | Ultrasound Imaging Remission at 12 Weeks | Ultrasound Imaging Remission (coded 0=No, 1=Yes) is achieved when all joints and entheses score grey scale<=1 & power Doppler=0. | Full Analysis Set | Posted | Count of Participants | Participants | No | 12 Weeks |
|
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|
|
| Secondary | Ultrasound Imaging Remission at 24 Weeks | Ultrasound Imaging Remission (coded 0=No, 1=Yes) is achieved when all joints and entheses score grey scale<=1 & power Doppler=0. | Full Analysis Set | Posted | Count of Participants | Participants | No | 24 Weeks |
|
|
|
|
| Secondary | Ultrasound Imaging Remission at 36 Weeks | Ultrasound Imaging Remission (coded 0=No, 1=Yes) is achieved when all joints and entheses score grey scale<=1 & power Doppler=0. | Full Analysis Set | Posted | Count of Participants | Participants | No | 36 Weeks |
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| Secondary | Additional Steroid Received Before 24 Weeks | Participants were eligible for additional steroid at weeks 8 and 12 if they had not achieved a PsARC response; this variable was coded 0=No, 1=Yes. | Full Analysis Set | Posted | Count of Participants | Participants | No | 12 Weeks |
|
|
|
|
| 41 |
| 0 |
| 41 |
| 38 |
| 41 |
| EG001 | Golimumab & Methotrexate | Methotrexate: Methotrexate Golimumab: Simponi | 0 | 43 | 0 | 43 | 41 | 43 |
| Leukocytosis | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Blurred vision | Eye disorders | CTCAE (4.0) | Systematic Assessment |
|
| Cataract | Eye disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dry eye | Eye disorders | CTCAE (4.0) | Systematic Assessment |
|
| Flashing lights | Eye disorders | CTCAE (4.0) | Systematic Assessment |
|
| Glaucoma | Eye disorders | CTCAE (4.0) | Systematic Assessment |
|
| Vitreous hemorrage | Eye disorders | CTCAE (4.0) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Bloating | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dental caries | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Lower gastrointestinal hemorrhage | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Mucositis oral | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Other: Broken tooth | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Other: Fatty infiltration of pancreas | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Other: Loose stools | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Other: Mouth ulcers | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Stomach pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Flu like symptoms | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Other: Fatty liver | Hepatobiliary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Other: Hepatic steatosis | Hepatobiliary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Other: Liver fibrosis | Hepatobiliary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Other: Steatohepatitis | Hepatobiliary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Allergic reaction | Immune system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Abdominal Infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Bladder infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Enterocolitis infectious | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Herpes simplex reactivation | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Laryngitis | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Lung infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Mucosal infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Nail infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Other: Genital thrush | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Otitis externa | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Papulopustular rash | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Shingles | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Skin infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Soft tissue infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Upper respiratory infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Vaginal infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Bruising | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
| Burn | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
| Fracture | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
| Other: Skin injury | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
| Other: Spider bite | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
| Other: Twisted right knee | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
| Other: Vaccine complication | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
| Wrist fracture | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Aspartate Aminotransferase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Creatinine increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Other: HBA1C elevated | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Other: Macrocytosis | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Other: Vitamin D insufficiency | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Platelet count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Weight gain | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Weight loss | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| White blood cell decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Glucose intolerance | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Muscle cramp | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Other: Mass right forearm | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Other: Muscle spasm | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Other: Raynaud's phenomenon | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Other: Trigger finger | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Other: Restless legs syndrome | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Paresthesia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Somnolence | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Depression | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Libido decreased | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Other: Mood swings | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Urinary frequency | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dyspareunia | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
|
| Erectile Dysfunction | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
|
| Irregular menstruation | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
|
| Menorrhagia | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
|
| Other: Erythematous lesion at the tip of penis, balanitis (dermatologist confirmed) | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
|
| Other: High secretion from the breast | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
|
| Uterine haemorrhage | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pharyngeal mucositis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Postnasal drip | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Sneezing | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Sore throat | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dyshidrotic eczema | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Other: Contact dermatitis | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Flushing | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hematoma | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Other: Varicose veins | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
Not provided
Not provided
Not provided
| 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 |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |