Psoriatic Arthritis
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGMethotrexate
Methotrexate
DRUGGolimumab
Simponi
Sponsors
Janssen Pharmaceutica N.V., Belgium
The Leeds Teaching Hospitals NHS Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
1. Received previous treatment with any DMARDs. 2. Received previous treatment with golimumab or other tumour necrosis factor inhibitor (TNFi) or other biologic drugs. 3. Any chronic inflammatory arthritis diagnosed before 16 years old. Exclusions for general safety 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Psoriatic Arthritis Disease Activity Score (PASDAS) at 24 Weeks | 24 weeks | The Psoriatic Arthritis Disease Activity Score ranges from 0-10; higher scores represent a worse outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Psoriatic Arthritis Disease Activity Score (PASDAS) at 36 Weeks. | 36 weeks | The Psoriatic Arthritis Disease Activity Score ranges from 0-10; higher scores represent a worse outcome. |
| Psoriatic Arthritis Disease Activity Score (PASDAS) at 52 Weeks. | 52 weeks | The Psoriatic Arthritis Disease Activity Score ranges from 0-10; higher scores represent a worse outcome. |
| Composite Psoriatic Disease Activity Index (CPDAI) at 12 Weeks. | 12 weeks | The Composite Psoriatic Disease Activity Index ranges from 0-15; higher scores represent a worse outcome. |
| Composite Psoriatic Disease Activity Index (CPDAI) at 24 Weeks. | 24 weeks | The Composite Psoriatic Disease Activity Index ranges from 0-15; higher scores represent a worse outcome. |
| Composite Psoriatic Disease Activity Index (CPDAI) at 36 Weeks. | 36 weeks | The Composite Psoriatic Disease Activity Index ranges from 0-15; higher scores represent a worse outcome. |
| Composite Psoriatic Disease Activity Index (CPDAI) at 52 Weeks. | 52 weeks | The Composite Psoriatic Disease Activity Index ranges from 0-15; higher scores represent a worse outcome. |
| Participant Disease Activity Visual Analogue Score at 24 Weeks. | 24 weeks | The Participant Disease Activity Visual Analogue Score ranges from 0-100; higher scores represent a worse outcome. |
| Participant Disease Activity Visual Analogue Score at 52 Weeks. | 52 weeks | The Participant Disease Activity Visual Analogue Score ranges from 0-100; higher scores represent a worse outcome. |
| 36-item Short Form Health Survey (SF-36) Physical Component Score at 24 Weeks. | 24 weeks | The 36-item Short Form Health Survey (SF-36) Physical Component Score ranges from 0-100; higher scores represent a better outcome. |
| 36-item Short Form Health Survey (SF-36) Physical Component Score at 52 Weeks. | 52 weeks | The 36-item Short Form Health Survey (SF-36) Physical Component Score ranges from 0-100; higher scores represent a better outcome. |
| 36-item Short Form Health Survey (SF-36) Mental Component Score at 24 Weeks. | 24 weeks | The 36-item Short Form Health Survey (SF-36) Mental Component Score ranges from 0-100; higher scores represent a better outcome. |
| 36-item Short Form Health Survey (SF-36) Mental Component Score at 52 Weeks. | 52 weeks | The 36-item Short Form Health Survey (SF-36) Mental Component Score ranges from 0-100; higher scores represent a better outcome. |
| Ultrasound Global OMERACT-EULAR System Score (GLOESS) at 12 Weeks. | 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. |
| Ultrasound Global OMERACT-EULAR System Score (GLOESS) at 24 Weeks. | 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. |
| Ultrasound Global OMERACT-EULAR System Score (GLOESS) at 36 Weeks. | 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. |
| Ultrasound Entheseal Inflammatory Score at 12 Weeks. | 12 weeks | The Ultrasound Entheseal Inflammatory Score ranged from 0-70; a higher score represents a worse outcome. |
| Ultrasound Entheseal Inflammatory Score at 24 Weeks. | 24 weeks | The Ultrasound Entheseal Inflammatory Score ranged from 0-70; a higher score represents a worse outcome. |
| Ultrasound Entheseal Inflammatory Score at 36 Weeks. | 36 weeks | The Ultrasound Entheseal Inflammatory Score ranged from 0-70; a higher score represents a worse outcome. |
| Ultrasound Entheseal Chronicity Score at 12 Weeks. | 12 weeks | The Ultrasound Entheseal Chronicity Score ranged from 0-50; a higher score represents a worse outcome. |
| Ultrasound Entheseal Chronicity Score at 24 Weeks. | 24 weeks | The Ultrasound Entheseal Chronicity Score ranged from 0-50; a higher score represents a worse outcome. |
| Ultrasound Entheseal Chronicity Score at 36 Weeks. | 36 weeks | The Ultrasound Entheseal Chronicity Score ranged from 0-50; a higher score represents a worse outcome. |
| Leeds Enthesitis Index at 12 Weeks | 12 Weeks | The Leeds Enthesitis Index ranges from 0-6; a higher score represents a worse outcome. |
| Leeds Enthesitis Index at 24 Weeks | 24 Weeks | The Leeds Enthesitis Index ranges from 0-6; a higher score represents a worse outcome. |
| Leeds Enthesitis Index at 36 Weeks | 36 Weeks | The Leeds Enthesitis Index ranges from 0-6; a higher score represents a worse outcome. |
| Leeds Enthesitis Index at 52 Weeks | 52 Weeks | The Leeds Enthesitis Index ranges from 0-6; a higher score represents a worse outcome. |
| Leeds Dactylitis Index at 12 Weeks | 12 Weeks | The Leeds Dactylitis Index ranges from 0-\ 40; a higher score represents a worse outcome. |
| Leeds Dactylitis Index at 24 Weeks | 24 Weeks | The Leeds Dactylitis Index ranges from 0-\ 40; a higher score represents a worse outcome. |
| Leeds Dactylitis Index at 36 Weeks | 36 Weeks | The Leeds Dactylitis Index ranges from 0-\ 40; a higher score represents a worse outcome. |
| Leeds Dactylitis Index at 52 Weeks | 52 Weeks | The Leeds Dactylitis Index ranges from 0-\ 40; a higher score represents a worse outcome. |
| The Modified Nail Psoriasis Severity Index (mNAPSI) at 12 Weeks | 12 Weeks | The Modified Nail Psoriasis Severity Index ranges from 0-140; a higher score represents a worse outcome. |
| The Modified Nail Psoriasis Severity Index (mNAPSI) at 24 Weeks | 24 Weeks | The Modified Nail Psoriasis Severity Index ranges from 0-140; a higher score represents a worse outcome. |
| The Modified Nail Psoriasis Severity Index (mNAPSI) at 36 Weeks | 36 Weeks | The Modified Nail Psoriasis Severity Index ranges from 0-140; a higher score represents a worse outcome. |
| The Modified Nail Psoriasis Severity Index (mNAPSI) at 52 Weeks | 52 Weeks | The Modified Nail Psoriasis Severity Index ranges from 0-140; a higher score represents a worse outcome. |
| Psoriasis Area and Severity Index (PASI) Score at 12 Weeks | 12 Weeks | The Psoriasis Area and Severity Index ranges from 0-72; a higher score represents a worse outcome. |
| Psoriasis Area and Severity Index (PASI) Score at 24 Weeks | 24 Weeks | The Psoriasis Area and Severity Index ranges from 0-72; a higher score represents a worse outcome. |
| Psoriasis Area and Severity Index (PASI) Score at 36 Weeks | 36 Weeks | The Psoriasis Area and Severity Index ranges from 0-72; a higher score represents a worse outcome. |
| Psoriasis Area and Severity Index (PASI) Score at 52 Weeks | 52 Weeks | The Psoriasis Area and Severity Index ranges from 0-72; a higher score represents a worse outcome. |
| Dermatology Life Quality Index (DLQI) Score at 24 Weeks | 24 Weeks | The Dermatology Life Quality Index ranges from 0-30; a higher score represents a worse outcome. |
| Dermatology Life Quality Index (DLQI) Score at 52 Weeks | 52 Weeks | The Dermatology Life Quality Index ranges from 0-30; a higher score represents a worse outcome. |
| Minimal Disease Activity (MDA) at 12 Weeks | 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. |
| Minimal Disease Activity (MDA) at 24 Weeks | 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. |
| Minimal Disease Activity (MDA) at 36 Weeks | 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. |
| Minimal Disease Activity (MDA) at 52 Weeks | 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. |
| American College of Rheumatology 20 (ACR20) Response at 12 Weeks | 12 Weeks | American College of Rheumatology 20 Response (coded 0=No, 1=Yes) is achieved when there is: * 20% improvement in both TJC (68 joints count) and SJC (66 joints count) and * 20% improvement in at least 3 of the following 5 ACR Core set criteria: 1. Patient's Assessment of Pain Visual Analogue Scale (VAS) 2. Patient's Global Assessment of Disease Activity VAS 3. Physician's Global Assessment of Disease Activity VAS 4. Patient's Assessment of Physical Function as measured by the HAQ-DI 5. Acute phase reactant as measured by CRP |
| American College of Rheumatology 20 (ACR20) Response at 24 Weeks | 24 Weeks | American College of Rheumatology 20 Response (coded 0=No, 1=Yes) is achieved when there is: * 20% improvement in both TJC (68 joints count) and SJC (66 joints count) and * 20% improvement in at least 3 of the following 5 ACR Core set criteria: 1. Patient's Assessment of Pain Visual Analogue Scale (VAS) 2. Patient's Global Assessment of Disease Activity VAS 3. Physician's Global Assessment of Disease Activity VAS 4. Patient's Assessment of Physical Function as measured by the HAQ-DI 5. Acute phase reactant as measured by CRP |
| American College of Rheumatology 20 (ACR20) Response at 36 Weeks | 36 Weeks | American College of Rheumatology 20 Response (coded 0=No, 1=Yes) is achieved when there is: * 20% improvement in both TJC (68 joints count) and SJC (66 joints count) and * 20% improvement in at least 3 of the following 5 ACR Core set criteria: 1. Patient's Assessment of Pain Visual Analogue Scale (VAS) 2. Patient's Global Assessment of Disease Activity VAS 3. Physician's Global Assessment of Disease Activity VAS 4. Patient's Assessment of Physical Function as measured by the HAQ-DI 5. Acute phase reactant as measured by CRP |
| American College of Rheumatology 20 (ACR20) Response at 52 Weeks | 52 Weeks | American College of Rheumatology 20 Response (coded 0=No, 1=Yes) is achieved when there is: * 20% improvement in both TJC (68 joints count) and SJC (66 joints count) and * 20% improvement in at least 3 of the following 5 ACR Core set criteria: 1. Patient's Assessment of Pain Visual Analogue Scale (VAS) 2. Patient's Global Assessment of Disease Activity VAS 3. Physician's Global Assessment of Disease Activity VAS 4. Patient's Assessment of Physical Function as measured by the HAQ-DI 5. Acute phase reactant as measured by CRP |
| American College of Rheumatology 50 (ACR50) Response at 12 Weeks | 12 Weeks | American College of Rheumatology 50 Response (coded 0=No, 1=Yes) is achieved when there is: * 50% improvement in both TJC (68 joints count) and SJC (66 joints count) and * 50% improvement in at least 3 of the following 5 ACR Core set criteria: 1. Patient's Assessment of Pain Visual Analogue Scale (VAS) 2. Patient's Global Assessment of Disease Activity VAS 3. Physician's Global Assessment of Disease Activity VAS 4. Patient's Assessment of Physical Function as measured by the HAQ-DI 5. Acute phase reactant as measured by CRP |
| American College of Rheumatology 50 (ACR50) Response at 24 Weeks | 24 Weeks | American College of Rheumatology 50 Response (coded 0=No, 1=Yes) is achieved when there is: * 50% improvement in both TJC (68 joints count) and SJC (66 joints count) and * 50% improvement in at least 3 of the following 5 ACR Core set criteria: 1. Patient's Assessment of Pain Visual Analogue Scale (VAS) 2. Patient's Global Assessment of Disease Activity VAS 3. Physician's Global Assessment of Disease Activity VAS 4. Patient's Assessment of Physical Function as measured by the HAQ-DI 5. Acute phase reactant as measured by CRP |
| American College of Rheumatology 50 (ACR50) Response at 36 Weeks | 36 Weeks | American College of Rheumatology 50 Response (coded 0=No, 1=Yes) is achieved when there is: * 50% improvement in both TJC (68 joints count) and SJC (66 joints count) and * 50% improvement in at least 3 of the following 5 ACR Core set criteria: 1. Patient's Assessment of Pain Visual Analogue Scale (VAS) 2. Patient's Global Assessment of Disease Activity VAS 3. Physician's Global Assessment of Disease Activity VAS 4. Patient's Assessment of Physical Function as measured by the HAQ-DI 5. Acute phase reactant as measured by CRP |
| American College of Rheumatology 50 (ACR50) Response at 52 Weeks | 52 Weeks | American College of Rheumatology 50 Response (coded 0=No, 1=Yes) is achieved when there is: * 50% improvement in both TJC (68 joints count) and SJC (66 joints count) and * 50% improvement in at least 3 of the following 5 ACR Core set criteria: 1. Patient's Assessment of Pain Visual Analogue Scale (VAS) 2. Patient's Global Assessment of Disease Activity VAS 3. Physician's Global Assessment of Disease Activity VAS 4. Patient's Assessment of Physical Function as measured by the HAQ-DI 5. Acute phase reactant as measured by CRP |
| American College of Rheumatology 70 (ACR70) Response at 12 Weeks | 12 Weeks | American College of Rheumatology 70 Response (coded 0=No, 1=Yes) is achieved when there is: * 70% improvement in both TJC (68 joints count) and SJC (66 joints count) and * 70% improvement in at least 3 of the following 5 ACR Core set criteria: 1. Patient's Assessment of Pain Visual Analogue Scale (VAS) 2. Patient's Global Assessment of Disease Activity VAS 3. Physician's Global Assessment of Disease Activity VAS 4. Patient's Assessment of Physical Function as measured by the HAQ-DI 5. Acute phase reactant as measured by CRP |
| American College of Rheumatology 70 (ACR70) Response at 24 Weeks | 24 Weeks | American College of Rheumatology 70 Response (coded 0=No, 1=Yes) is achieved when there is: * 70% improvement in both TJC (68 joints count) and SJC (66 joints count) and * 70% improvement in at least 3 of the following 5 ACR Core set criteria: 1. Patient's Assessment of Pain Visual Analogue Scale (VAS) 2. Patient's Global Assessment of Disease Activity VAS 3. Physician's Global Assessment of Disease Activity VAS 4. Patient's Assessment of Physical Function as measured by the HAQ-DI 5. Acute phase reactant as measured by CRP |
| American College of Rheumatology 70 (ACR70) Response at 36 Weeks | 36 Weeks | American College of Rheumatology 70 Response (coded 0=No, 1=Yes) is achieved when there is: * 70% improvement in both TJC (68 joints count) and SJC (66 joints count) and * 70% improvement in at least 3 of the following 5 ACR Core set criteria: 1. Patient's Assessment of Pain Visual Analogue Scale (VAS) 2. Patient's Global Assessment of Disease Activity VAS 3. Physician's Global Assessment of Disease Activity VAS 4. Patient's Assessment of Physical Function as measured by the HAQ-DI 5. Acute phase reactant as measured by CRP |
| American College of Rheumatology 70 (ACR70) Response at 52 Weeks | 52 Weeks | American College of Rheumatology 70 Response (coded 0=No, 1=Yes) is achieved when there is: * 70% improvement in both TJC (68 joints count) and SJC (66 joints count) and * 70% improvement in at least 3 of the following 5 ACR Core set criteria: 1. Patient's Assessment of Pain Visual Analogue Scale (VAS) 2. Patient's Global Assessment of Disease Activity VAS 3. Physician's Global Assessment of Disease Activity VAS 4. Patient's Assessment of Physical Function as measured by the HAQ-DI 5. Acute phase reactant as measured by CRP |
| Psoriatic Arthritis Response Criteria (PsARC) Response at 12 Weeks | 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: 1. At least 30% reduction in tender joint grade (total of 68 joints graded 0-3) 2. At least 30% reduction in swollen joint grade (total of 66 joints graded 0-3) 3. At least a 1 point reduction in physician's assessment of articular disease (1-5 Likert scale) 4. At least a 1 point reduction in patient's assessment of articular disease (1-5 Likert scale) |
| Psoriatic Arthritis Response Criteria (PsARC) Response at 24 Weeks | 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: 1. At least 30% reduction in tender joint grade (total of 68 joints graded 0-3) 2. At least 30% reduction in swollen joint grade (total of 66 joints graded 0-3) 3. At least a 1 point reduction in physician's assessment of articular disease (1-5 Likert scale) 4. At least a 1 point reduction in patient's assessment of articular disease (1-5 Likert scale) |
| Psoriatic Arthritis Response Criteria (PsARC) Response at 36 Weeks | 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: 1. At least 30% reduction in tender joint grade (total of 68 joints graded 0-3) 2. At least 30% reduction in swollen joint grade (total of 66 joints graded 0-3) 3. At least a 1 point reduction in physician's assessment of articular disease (1-5 Likert scale) 4. At least a 1 point reduction in patient's assessment of articular disease (1-5 Likert scale) |
| Psoriatic Arthritis Response Criteria (PsARC) Response at 52 Weeks | 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: 1. At least 30% reduction in tender joint grade (total of 68 joints graded 0-3) 2. At least 30% reduction in swollen joint grade (total of 66 joints graded 0-3) 3. At least a 1 point reduction in physician's assessment of articular disease (1-5 Likert scale) 4. At least a 1 point reduction in patient's assessment of articular disease (1-5 Likert scale) |
| Psoriatic Arthritis Disease Activity Score (PASDAS) at 12 Weeks. | 12 weeks | The Psoriatic Arthritis Disease Activity Score ranges from 0-10; higher scores represent a worse outcome. |
| Psoriatic Arthritis Skin Index (PASI) Response at 24 Weeks | 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. |
| Psoriatic Arthritis Skin Index (PASI) Response at 36 Weeks | 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. |
| Psoriatic Arthritis Skin Index (PASI) Response at 52 Weeks | 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. |
| Ultrasound Imaging Remission at 12 Weeks | 12 Weeks | Ultrasound Imaging Remission (coded 0=No, 1=Yes) is achieved when all joints and entheses score grey scale\<=1 & power Doppler=0. |
| Ultrasound Imaging Remission at 24 Weeks | 24 Weeks | Ultrasound Imaging Remission (coded 0=No, 1=Yes) is achieved when all joints and entheses score grey scale\<=1 & power Doppler=0. |
| Ultrasound Imaging Remission at 36 Weeks | 36 Weeks | Ultrasound Imaging Remission (coded 0=No, 1=Yes) is achieved when all joints and entheses score grey scale\<=1 & power Doppler=0. |
| Additional Steroid Received Before 24 Weeks | 12 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. |
| Psoriatic Arthritis Skin Index (PASI) Response at 12 Weeks | 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. |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Methotrexate Methotrexate: Methotrexate | 41 |
| Golimumab & Methotrexate Methotrexate: Methotrexate
Golimumab: Simponi | 43 |
| Total | 84 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Missed study medication | 0 | 1 |
| Overall Study | Non-compliance | 1 | 1 |
| Overall Study | Physician Decision | 0 | 1 |
| Overall Study | Unable to attend final visit | 2 | 0 |
Baseline characteristics
| Characteristic | Golimumab & Methotrexate | Total | Methotrexate |
|---|---|---|---|
| 36-Item Short Form Health Survey (SF-36) Mental Component Summary | 46.7 units on a scale STANDARD_DEVIATION 10.7 | 46.7 units on a scale STANDARD_DEVIATION 11.5 | 46.6 units on a scale STANDARD_DEVIATION 12.5 |
| 36-Item Short Form Health Survey (SF-36) Physical Component Summary | 32.5 units on a scale STANDARD_DEVIATION 10 | 34.9 units on a scale STANDARD_DEVIATION 10.2 | 37.5 units on a scale STANDARD_DEVIATION 9.9 |
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 5 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 40 Participants | 79 Participants | 39 Participants |
| Age, Continuous | 42.1 years STANDARD_DEVIATION 12.5 | 42.5 years STANDARD_DEVIATION 12.4 | 42.9 years STANDARD_DEVIATION 12.5 |
| Composite Psoriatic Disease Activity Index (CPDAI) | 7.0 units on a scale STANDARD_DEVIATION 2.6 | 6.7 units on a scale STANDARD_DEVIATION 2.6 | 6.4 units on a scale STANDARD_DEVIATION 2.7 |
| Dermatology Life Quality Index (DLQI) | 5.0 units on a scale | 3.5 units on a scale | 3.0 units on a scale |
| Leeds Dactylitis Index | 38.04 units on a scale STANDARD_DEVIATION 50.85 | 32.45 units on a scale STANDARD_DEVIATION 42.32 | 26.60 units on a scale STANDARD_DEVIATION 30.56 |
| Leeds Enthesitis Index | 1.37 score on a scale STANDARD_DEVIATION 1.47 | 1.44 score on a scale STANDARD_DEVIATION 1.62 | 1.51 score on a scale STANDARD_DEVIATION 1.76 |
| Modified Nail Psoriasis Severity Index (mNAPSI) | 11.36 units on a scale STANDARD_DEVIATION 18.15 | 9.35 units on a scale STANDARD_DEVIATION 15.23 | 7.25 units on a scale STANDARD_DEVIATION 11.26 |
| Participant Disease Activity Visual Analogue Scale | 59.1 units on a scale STANDARD_DEVIATION 21.4 | 55.7 units on a scale STANDARD_DEVIATION 23.5 | 52.1 units on a scale STANDARD_DEVIATION 25.2 |
| PASDAS | 5.9 units on a scale STANDARD_DEVIATION 1.3 | 5.7 units on a scale STANDARD_DEVIATION 1.2 | 5.6 units on a scale STANDARD_DEVIATION 1.1 |
| Psoriatic Arthritis Skin Index Score | 3.4 units on a scale | 2.7 units on a scale | 2.6 units on a scale |
| Race/Ethnicity, Customized Asian | 3 Participants | 5 Participants | 2 Participants |
| Race/Ethnicity, Customized Not stated | 10 Participants | 16 Participants | 6 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 2 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 29 Participants | 61 Participants | 32 Participants |
| Region of Enrollment United Kingdom | 43 participants | 84 participants | 41 participants |
| Sex: Female, Male Female | 19 Participants | 38 Participants | 19 Participants |
| Sex: Female, Male Male | 24 Participants | 46 Participants | 22 Participants |
| Ultrasound Entheseal Chronicity Score | 3.5 units on a scale STANDARD_DEVIATION 3 | 3.2 units on a scale STANDARD_DEVIATION 3 | 3.0 units on a scale STANDARD_DEVIATION 3.1 |
| Ultrasound Entheseal Inflammatory Score | 5.4 units on a scale STANDARD_DEVIATION 3.9 | 4.8 units on a scale STANDARD_DEVIATION 3.8 | 4.2 units on a scale STANDARD_DEVIATION 3.7 |
| Ultrasound Global OMERACT-EULAR System Score (GLOESS) | 24.8 units on a scale STANDARD_DEVIATION 13 | 23.2 units on a scale STANDARD_DEVIATION 12.2 | 21.6 units on a scale STANDARD_DEVIATION 11.2 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 41 | 0 / 43 |
| other Total, other adverse events | 38 / 41 | 41 / 43 |
| serious Total, serious adverse events | 0 / 41 | 0 / 43 |
Outcome results
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.
Time frame: 24 weeks
Population: Full analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Methotrexate | Psoriatic Arthritis Disease Activity Score (PASDAS) at 24 Weeks | 3.09 score on a scale | Standard Deviation 1.32 |
| Golimumab & Methotrexate | Psoriatic Arthritis Disease Activity Score (PASDAS) at 24 Weeks | 2.70 score on a scale | Standard Deviation 1.38 |
p-value: 0.06495% CI: [-1.12, 0.03]Regression, Linear
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.
Time frame: 24 weeks
Population: Full analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Methotrexate | 36-item Short Form Health Survey (SF-36) Mental Component Score at 24 Weeks. | 52.11 score on a scale | Standard Deviation 9.34 |
| Golimumab & Methotrexate | 36-item Short Form Health Survey (SF-36) Mental Component Score at 24 Weeks. | 51.27 score on a scale | Standard Deviation 8.84 |
p-value: 0.6295% CI: [-4.23, 2.54]Regression, Linear
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.
Time frame: 52 weeks
Population: Full analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Methotrexate | 36-item Short Form Health Survey (SF-36) Mental Component Score at 52 Weeks. | 52.44 score on a scale | Standard Deviation 10.03 |
| Golimumab & Methotrexate | 36-item Short Form Health Survey (SF-36) Mental Component Score at 52 Weeks. | 51.65 score on a scale | Standard Deviation 9.75 |
p-value: 0.44995% CI: [-5.02, 2.24]Regression, Linear
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.
Time frame: 24 weeks
Population: Full analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Methotrexate | 36-item Short Form Health Survey (SF-36) Physical Component Score at 24 Weeks. | 45.62 score on a scale | Standard Deviation 9.45 |
| Golimumab & Methotrexate | 36-item Short Form Health Survey (SF-36) Physical Component Score at 24 Weeks. | 46.10 score on a scale | Standard Deviation 9.32 |
p-value: 0.26895% CI: [-1.76, 6.25]Regression, Linear
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.
Time frame: 52 weeks
Population: Full analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Methotrexate | 36-item Short Form Health Survey (SF-36) Physical Component Score at 52 Weeks. | 44.44 score on a scale | Standard Deviation 10.25 |
| Golimumab & Methotrexate | 36-item Short Form Health Survey (SF-36) Physical Component Score at 52 Weeks. | 42.80 score on a scale | Standard Deviation 10.38 |
p-value: 0.60595% CI: [-3.42, 5.83]Regression, Linear
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.
Time frame: 12 Weeks
Population: Full Analysis Set
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Methotrexate | Additional Steroid Received Before 24 Weeks | 20 Participants |
| Golimumab & Methotrexate | Additional Steroid Received Before 24 Weeks | 9 Participants |
p-value: 0.00995% CI: [0.11, 0.72]Regression, Logistic
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: * 20% improvement in both TJC (68 joints count) and SJC (66 joints count) and * 20% improvement in at least 3 of the following 5 ACR Core set criteria: 1. Patient's Assessment of Pain Visual Analogue Scale (VAS) 2. Patient's Global Assessment of Disease Activity VAS 3. Physician's Global Assessment of Disease Activity VAS 4. Patient's Assessment of Physical Function as measured by the HAQ-DI 5. Acute phase reactant as measured by CRP
Time frame: 12 Weeks
Population: Full Analysis Set
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Methotrexate | American College of Rheumatology 20 (ACR20) Response at 12 Weeks | 23 Participants |
| Golimumab & Methotrexate | American College of Rheumatology 20 (ACR20) Response at 12 Weeks | 28 Participants |
p-value: 0.51695% CI: [0.55, 3.27]Regression, Logistic
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: * 20% improvement in both TJC (68 joints count) and SJC (66 joints count) and * 20% improvement in at least 3 of the following 5 ACR Core set criteria: 1. Patient's Assessment of Pain Visual Analogue Scale (VAS) 2. Patient's Global Assessment of Disease Activity VAS 3. Physician's Global Assessment of Disease Activity VAS 4. Patient's Assessment of Physical Function as measured by the HAQ-DI 5. Acute phase reactant as measured by CRP
Time frame: 24 Weeks
Population: Full Analysis Set
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Methotrexate | American College of Rheumatology 20 (ACR20) Response at 24 Weeks | 27 Participants |
| Golimumab & Methotrexate | American College of Rheumatology 20 (ACR20) Response at 24 Weeks | 28 Participants |
p-value: 0.93995% CI: [0.39, 2.38]Regression, Logistic
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: * 20% improvement in both TJC (68 joints count) and SJC (66 joints count) and * 20% improvement in at least 3 of the following 5 ACR Core set criteria: 1. Patient's Assessment of Pain Visual Analogue Scale (VAS) 2. Patient's Global Assessment of Disease Activity VAS 3. Physician's Global Assessment of Disease Activity VAS 4. Patient's Assessment of Physical Function as measured by the HAQ-DI 5. Acute phase reactant as measured by CRP
Time frame: 36 Weeks
Population: Full Analysis Set
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Methotrexate | American College of Rheumatology 20 (ACR20) Response at 36 Weeks | 24 Participants |
| Golimumab & Methotrexate | American College of Rheumatology 20 (ACR20) Response at 36 Weeks | 27 Participants |
p-value: 0.70195% CI: [0.48, 2.94]Regression, Logistic
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: * 20% improvement in both TJC (68 joints count) and SJC (66 joints count) and * 20% improvement in at least 3 of the following 5 ACR Core set criteria: 1. Patient's Assessment of Pain Visual Analogue Scale (VAS) 2. Patient's Global Assessment of Disease Activity VAS 3. Physician's Global Assessment of Disease Activity VAS 4. Patient's Assessment of Physical Function as measured by the HAQ-DI 5. Acute phase reactant as measured by CRP
Time frame: 52 Weeks
Population: Full Analysis Set
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Methotrexate | American College of Rheumatology 20 (ACR20) Response at 52 Weeks | 28 Participants |
| Golimumab & Methotrexate | American College of Rheumatology 20 (ACR20) Response at 52 Weeks | 23 Participants |
p-value: 0.12495% CI: [0.19, 1.22]Regression, Logistic
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: * 50% improvement in both TJC (68 joints count) and SJC (66 joints count) and * 50% improvement in at least 3 of the following 5 ACR Core set criteria: 1. Patient's Assessment of Pain Visual Analogue Scale (VAS) 2. Patient's Global Assessment of Disease Activity VAS 3. Physician's Global Assessment of Disease Activity VAS 4. Patient's Assessment of Physical Function as measured by the HAQ-DI 5. Acute phase reactant as measured by CRP
Time frame: 12 Weeks
Population: Full Analysis Set
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Methotrexate | American College of Rheumatology 50 (ACR50) Response at 12 Weeks | 12 Participants |
| Golimumab & Methotrexate | American College of Rheumatology 50 (ACR50) Response at 12 Weeks | 20 Participants |
p-value: 0.16195% CI: [0.78, 4.63]Regression, Logistic
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: * 50% improvement in both TJC (68 joints count) and SJC (66 joints count) and * 50% improvement in at least 3 of the following 5 ACR Core set criteria: 1. Patient's Assessment of Pain Visual Analogue Scale (VAS) 2. Patient's Global Assessment of Disease Activity VAS 3. Physician's Global Assessment of Disease Activity VAS 4. Patient's Assessment of Physical Function as measured by the HAQ-DI 5. Acute phase reactant as measured by CRP
Time frame: 24 Weeks
Population: Full Analysis Set
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Methotrexate | American College of Rheumatology 50 (ACR50) Response at 24 Weeks | 15 Participants |
| Golimumab & Methotrexate | American College of Rheumatology 50 (ACR50) Response at 24 Weeks | 21 Participants |
p-value: 0.25195% CI: [0.7, 4.02]Regression, Logistic
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: * 50% improvement in both TJC (68 joints count) and SJC (66 joints count) and * 50% improvement in at least 3 of the following 5 ACR Core set criteria: 1. Patient's Assessment of Pain Visual Analogue Scale (VAS) 2. Patient's Global Assessment of Disease Activity VAS 3. Physician's Global Assessment of Disease Activity VAS 4. Patient's Assessment of Physical Function as measured by the HAQ-DI 5. Acute phase reactant as measured by CRP
Time frame: 36 Weeks
Population: Full Analysis Set
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Methotrexate | American College of Rheumatology 50 (ACR50) Response at 36 Weeks | 16 Participants |
| Golimumab & Methotrexate | American College of Rheumatology 50 (ACR50) Response at 36 Weeks | 21 Participants |
p-value: 0.36395% CI: [0.63, 3.6]Regression, Logistic
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: * 50% improvement in both TJC (68 joints count) and SJC (66 joints count) and * 50% improvement in at least 3 of the following 5 ACR Core set criteria: 1. Patient's Assessment of Pain Visual Analogue Scale (VAS) 2. Patient's Global Assessment of Disease Activity VAS 3. Physician's Global Assessment of Disease Activity VAS 4. Patient's Assessment of Physical Function as measured by the HAQ-DI 5. Acute phase reactant as measured by CRP
Time frame: 52 Weeks
Population: Full Analysis Set
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Methotrexate | American College of Rheumatology 50 (ACR50) Response at 52 Weeks | 15 Participants |
| Golimumab & Methotrexate | American College of Rheumatology 50 (ACR50) Response at 52 Weeks | 16 Participants |
p-value: 0.99195% CI: [0.4, 2.46]Regression, Logistic
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: * 70% improvement in both TJC (68 joints count) and SJC (66 joints count) and * 70% improvement in at least 3 of the following 5 ACR Core set criteria: 1. Patient's Assessment of Pain Visual Analogue Scale (VAS) 2. Patient's Global Assessment of Disease Activity VAS 3. Physician's Global Assessment of Disease Activity VAS 4. Patient's Assessment of Physical Function as measured by the HAQ-DI 5. Acute phase reactant as measured by CRP
Time frame: 12 Weeks
Population: Full Analysis Set
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Methotrexate | American College of Rheumatology 70 (ACR70) Response at 12 Weeks | 6 Participants |
| Golimumab & Methotrexate | American College of Rheumatology 70 (ACR70) Response at 12 Weeks | 15 Participants |
p-value: 0.03795% CI: [1.07, 9.1]Regression, Logistic
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: * 70% improvement in both TJC (68 joints count) and SJC (66 joints count) and * 70% improvement in at least 3 of the following 5 ACR Core set criteria: 1. Patient's Assessment of Pain Visual Analogue Scale (VAS) 2. Patient's Global Assessment of Disease Activity VAS 3. Physician's Global Assessment of Disease Activity VAS 4. Patient's Assessment of Physical Function as measured by the HAQ-DI 5. Acute phase reactant as measured by CRP
Time frame: 24 Weeks
Population: Full Analysis Set
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Methotrexate | American College of Rheumatology 70 (ACR70) Response at 24 Weeks | 10 Participants |
| Golimumab & Methotrexate | American College of Rheumatology 70 (ACR70) Response at 24 Weeks | 19 Participants |
p-value: 0.05695% CI: [0.98, 6.4]Regression, Logistic
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: * 70% improvement in both TJC (68 joints count) and SJC (66 joints count) and * 70% improvement in at least 3 of the following 5 ACR Core set criteria: 1. Patient's Assessment of Pain Visual Analogue Scale (VAS) 2. Patient's Global Assessment of Disease Activity VAS 3. Physician's Global Assessment of Disease Activity VAS 4. Patient's Assessment of Physical Function as measured by the HAQ-DI 5. Acute phase reactant as measured by CRP
Time frame: 36 Weeks
Population: Full Analysis Set
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Methotrexate | American College of Rheumatology 70 (ACR70) Response at 36 Weeks | 9 Participants |
| Golimumab & Methotrexate | American College of Rheumatology 70 (ACR70) Response at 36 Weeks | 14 Participants |
p-value: 0.27795% CI: [0.65, 4.57]Regression, Logistic
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: * 70% improvement in both TJC (68 joints count) and SJC (66 joints count) and * 70% improvement in at least 3 of the following 5 ACR Core set criteria: 1. Patient's Assessment of Pain Visual Analogue Scale (VAS) 2. Patient's Global Assessment of Disease Activity VAS 3. Physician's Global Assessment of Disease Activity VAS 4. Patient's Assessment of Physical Function as measured by the HAQ-DI 5. Acute phase reactant as measured by CRP
Time frame: 52 Weeks
Population: Full Analysis Set
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Methotrexate | American College of Rheumatology 70 (ACR70) Response at 52 Weeks | 8 Participants |
| Golimumab & Methotrexate | American College of Rheumatology 70 (ACR70) Response at 52 Weeks | 11 Participants |
p-value: 0.54895% CI: [0.48, 3.92]Regression, Logistic
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.
Time frame: 12 weeks
Population: Full analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Methotrexate | Composite Psoriatic Disease Activity Index (CPDAI) at 12 Weeks. | 4.10 score on a scale | Standard Deviation 2.76 |
| Golimumab & Methotrexate | Composite Psoriatic Disease Activity Index (CPDAI) at 12 Weeks. | 3.49 score on a scale | Standard Deviation 2.41 |
p-value: 0.04195% CI: [-1.88, -0.04]Regression, Linear
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.
Time frame: 24 weeks
Population: Full analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Methotrexate | Composite Psoriatic Disease Activity Index (CPDAI) at 24 Weeks. | 3.24 score on a scale | Standard Deviation 2.58 |
| Golimumab & Methotrexate | Composite Psoriatic Disease Activity Index (CPDAI) at 24 Weeks. | 3.12 score on a scale | Standard Deviation 2.45 |
p-value: 0.37595% CI: [-1.41, 0.54]Regression, Linear
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.
Time frame: 36 weeks
Population: Full analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Methotrexate | Composite Psoriatic Disease Activity Index (CPDAI) at 36 Weeks. | 2.97 score on a scale | Standard Deviation 2.69 |
| Golimumab & Methotrexate | Composite Psoriatic Disease Activity Index (CPDAI) at 36 Weeks. | 3.17 score on a scale | Standard Deviation 2.8 |
p-value: 0.39295% CI: [-1.46, 0.58]Regression, Linear
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.
Time frame: 52 weeks
Population: Full analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Methotrexate | Composite Psoriatic Disease Activity Index (CPDAI) at 52 Weeks. | 3.03 score on a scale | Standard Deviation 2.71 |
| Golimumab & Methotrexate | Composite Psoriatic Disease Activity Index (CPDAI) at 52 Weeks. | 3.49 score on a scale | Standard Deviation 2.75 |
p-value: 0.54195% CI: [-1.34, 0.71]Regression, Linear
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.
Time frame: 24 Weeks
Population: Full Analysis Set
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Methotrexate | Dermatology Life Quality Index (DLQI) Score at 24 Weeks | 1.00 score on a scale |
| Golimumab & Methotrexate | Dermatology Life Quality Index (DLQI) Score at 24 Weeks | 1.00 score on a scale |
p-value: 0.28195% CI: [-1.42, 0.42]Quantile (median) regression
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.
Time frame: 52 Weeks
Population: Full Analysis Set
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Methotrexate | Dermatology Life Quality Index (DLQI) Score at 52 Weeks | 1.00 score on a scale |
| Golimumab & Methotrexate | Dermatology Life Quality Index (DLQI) Score at 52 Weeks | 1.00 score on a scale |
p-value: 0.98595% CI: [-1.44, 1.47]Quantile (median) regression
Secondary
Leeds Dactylitis Index at 12 Weeks
The Leeds Dactylitis Index ranges from 0-\ 40; a higher score represents a worse outcome.
Time frame: 12 Weeks
Population: Full Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Methotrexate | Leeds Dactylitis Index at 12 Weeks | 11.46 units on a scale | Standard Deviation 19.88 |
| Golimumab & Methotrexate | Leeds Dactylitis Index at 12 Weeks | 2.22 units on a scale | Standard Deviation 7.92 |
p-value: 0.08395% CI: [0.02, 1.26]Negative binomial regression
Secondary
Leeds Dactylitis Index at 24 Weeks
The Leeds Dactylitis Index ranges from 0-\ 40; a higher score represents a worse outcome.
Time frame: 24 Weeks
Population: Full Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Methotrexate | Leeds Dactylitis Index at 24 Weeks | 5.04 units on a scale | Standard Deviation 17.1 |
| Golimumab & Methotrexate | Leeds Dactylitis Index at 24 Weeks | 0.48 units on a scale | Standard Deviation 2.52 |
p-value: 0.43295% CI: [0.01, 7.64]Negative binomial regression
Secondary
Leeds Dactylitis Index at 36 Weeks
The Leeds Dactylitis Index ranges from 0-\ 40; a higher score represents a worse outcome.
Time frame: 36 Weeks
Population: Full Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Methotrexate | Leeds Dactylitis Index at 36 Weeks | 4.38 units on a scale | Standard Deviation 11.31 |
| Golimumab & Methotrexate | Leeds Dactylitis Index at 36 Weeks | 3.36 units on a scale | Standard Deviation 15.15 |
p-value: 0.07195% CI: [0.01, 1.21]Negative binomial regression
Secondary
Leeds Dactylitis Index at 52 Weeks
The Leeds Dactylitis Index ranges from 0-\ 40; a higher score represents a worse outcome.
Time frame: 52 Weeks
Population: Full Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Methotrexate | Leeds Dactylitis Index at 52 Weeks | 6.58 units on a scale | Standard Deviation 14.89 |
| Golimumab & Methotrexate | Leeds Dactylitis Index at 52 Weeks | 3.45 units on a scale | Standard Deviation 14.76 |
p-value: 0.03795% CI: [0, 0.84]Negative binomial regression
Secondary
Leeds Enthesitis Index at 12 Weeks
The Leeds Enthesitis Index ranges from 0-6; a higher score represents a worse outcome.
Time frame: 12 Weeks
Population: Full Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Methotrexate | Leeds Enthesitis Index at 12 Weeks | 0.95 score on a scale | Standard Deviation 1.76 |
| Golimumab & Methotrexate | Leeds Enthesitis Index at 12 Weeks | 0.74 score on a scale | Standard Deviation 1.35 |
p-value: 0.97195% CI: [0.48, 2.14]Negative binomial regression
Secondary
Leeds Enthesitis Index at 24 Weeks
The Leeds Enthesitis Index ranges from 0-6; a higher score represents a worse outcome.
Time frame: 24 Weeks
Population: Full Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Methotrexate | Leeds Enthesitis Index at 24 Weeks | 0.61 score on a scale | Standard Deviation 1.34 |
| Golimumab & Methotrexate | Leeds Enthesitis Index at 24 Weeks | 0.53 score on a scale | Standard Deviation 0.98 |
p-value: 0.81795% CI: [0.49, 2.46]Negative binomial regression
Secondary
Leeds Enthesitis Index at 36 Weeks
The Leeds Enthesitis Index ranges from 0-6; a higher score represents a worse outcome.
Time frame: 36 Weeks
Population: Full Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Methotrexate | Leeds Enthesitis Index at 36 Weeks | 0.65 score on a scale | Standard Deviation 1.37 |
| Golimumab & Methotrexate | Leeds Enthesitis Index at 36 Weeks | 0.74 score on a scale | Standard Deviation 1.43 |
p-value: 0.44195% CI: [0.63, 2.93]Negative binomial regression
Secondary
Leeds Enthesitis Index at 52 Weeks
The Leeds Enthesitis Index ranges from 0-6; a higher score represents a worse outcome.
Time frame: 52 Weeks
Population: Full Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Methotrexate | Leeds Enthesitis Index at 52 Weeks | 0.43 score on a scale | Standard Deviation 1.09 |
| Golimumab & Methotrexate | Leeds Enthesitis Index at 52 Weeks | 0.50 score on a scale | Standard Deviation 0.97 |
p-value: 0.56395% CI: [0.55, 3.03]Negative binomial regression
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.
Time frame: 12 Weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Methotrexate | Minimal Disease Activity (MDA) at 12 Weeks | 18 Participants |
| Golimumab & Methotrexate | Minimal Disease Activity (MDA) at 12 Weeks | 20 Participants |
p-value: 0.86995% CI: [0.45, 2.6]Regression, Logistic
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.
Time frame: 24 Weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Methotrexate | Minimal Disease Activity (MDA) at 24 Weeks | 24 Participants |
| Golimumab & Methotrexate | Minimal Disease Activity (MDA) at 24 Weeks | 24 Participants |
p-value: 0.80295% CI: [0.38, 2.13]Regression, Logistic
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.
Time frame: 36 Weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Methotrexate | Minimal Disease Activity (MDA) at 36 Weeks | 22 Participants |
| Golimumab & Methotrexate | Minimal Disease Activity (MDA) at 36 Weeks | 25 Participants |
p-value: 0.76795% CI: [0.48, 2.72]Regression, Logistic
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.
Time frame: 52 Weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Methotrexate | Minimal Disease Activity (MDA) at 52 Weeks | 20 Participants |
| Golimumab & Methotrexate | Minimal Disease Activity (MDA) at 52 Weeks | 17 Participants |
p-value: 0.31595% CI: [0.26, 1.55]Regression, Logistic
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.
Time frame: 24 weeks
Population: Full analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Methotrexate | Participant Disease Activity Visual Analogue Score at 24 Weeks. | 27.56 score on a scale | Standard Deviation 23.54 |
| Golimumab & Methotrexate | Participant Disease Activity Visual Analogue Score at 24 Weeks. | 27.72 score on a scale | Standard Deviation 23.42 |
p-value: 0.63395% CI: [-12.14, 7.43]Regression, Linear
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.
Time frame: 52 weeks
Population: Full analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Methotrexate | Participant Disease Activity Visual Analogue Score at 52 Weeks. | 32.73 score on a scale | Standard Deviation 25.62 |
| Golimumab & Methotrexate | Participant Disease Activity Visual Analogue Score at 52 Weeks. | 36.57 score on a scale | Standard Deviation 26.06 |
p-value: 0.82695% CI: [-9.95, 12.43]Regression, Linear
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.
Time frame: 12 Weeks
Population: Full Analysis Set
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Methotrexate | Psoriasis Area and Severity Index (PASI) Score at 12 Weeks | 1.00 score on a scale |
| Golimumab & Methotrexate | Psoriasis Area and Severity Index (PASI) Score at 12 Weeks | 0.20 score on a scale |
p-value: 0.51295% CI: [-1.53, 0.77]Quantile (median) regression
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.
Time frame: 24 Weeks
Population: Full Analysis Set
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Methotrexate | Psoriasis Area and Severity Index (PASI) Score at 24 Weeks | 0.60 score on a scale |
| Golimumab & Methotrexate | Psoriasis Area and Severity Index (PASI) Score at 24 Weeks | 0.00 score on a scale |
p-value: 0.3295% CI: [-1.33, 0.44]Quantile (median) regression
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.
Time frame: 36 Weeks
Population: Full Analysis Set
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Methotrexate | Psoriasis Area and Severity Index (PASI) Score at 36 Weeks | 0.70 score on a scale |
| Golimumab & Methotrexate | Psoriasis Area and Severity Index (PASI) Score at 36 Weeks | 0.00 score on a scale |
p-value: 0.2295% CI: [-1.22, 0.28]Quantile (median) regression
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.
Time frame: 52 Weeks
Population: Full Analysis Set
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Methotrexate | Psoriasis Area and Severity Index (PASI) Score at 52 Weeks | 0.40 score on a scale |
| Golimumab & Methotrexate | Psoriasis Area and Severity Index (PASI) Score at 52 Weeks | 0.55 score on a scale |
p-value: 0.91295% CI: [-0.85, 0.95]Quantile (median) regression
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.
Time frame: 12 weeks
Population: Full analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Methotrexate | Psoriatic Arthritis Disease Activity Score (PASDAS) at 12 Weeks. | 3.70 score on a scale | Standard Deviation 1.62 |
| Golimumab & Methotrexate | Psoriatic Arthritis Disease Activity Score (PASDAS) at 12 Weeks. | 3.01 score on a scale | Standard Deviation 1.31 |
p-value: 0.00795% CI: [-1.48, -0.24]Regression, Linear
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.
Time frame: 36 weeks
Population: Full analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Methotrexate | Psoriatic Arthritis Disease Activity Score (PASDAS) at 36 Weeks. | 3.30 score on a scale | Standard Deviation 1.7 |
| Golimumab & Methotrexate | Psoriatic Arthritis Disease Activity Score (PASDAS) at 36 Weeks. | 2.93 score on a scale | Standard Deviation 3.42 |
p-value: 0.09695% CI: [-1.26, 0.11]Regression, Linear
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.
Time frame: 52 weeks
Population: Full analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Methotrexate | Psoriatic Arthritis Disease Activity Score (PASDAS) at 52 Weeks. | 3.36 score on a scale | Standard Deviation 1.39 |
| Golimumab & Methotrexate | Psoriatic Arthritis Disease Activity Score (PASDAS) at 52 Weeks. | 3.42 score on a scale | Standard Deviation 1.55 |
p-value: 0.84495% CI: [-0.72, 0.59]Regression, Linear
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: 1. At least 30% reduction in tender joint grade (total of 68 joints graded 0-3) 2. At least 30% reduction in swollen joint grade (total of 66 joints graded 0-3) 3. At least a 1 point reduction in physician's assessment of articular disease (1-5 Likert scale) 4. At least a 1 point reduction in patient's assessment of articular disease (1-5 Likert scale)
Time frame: 12 Weeks
Population: Full Analysis Set
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Methotrexate | Psoriatic Arthritis Response Criteria (PsARC) Response at 12 Weeks | 26 Participants |
| Golimumab & Methotrexate | Psoriatic Arthritis Response Criteria (PsARC) Response at 12 Weeks | 37 Participants |
p-value: 0.01895% CI: [1.25, 10.97]Regression, Logistic
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: 1. At least 30% reduction in tender joint grade (total of 68 joints graded 0-3) 2. At least 30% reduction in swollen joint grade (total of 66 joints graded 0-3) 3. At least a 1 point reduction in physician's assessment of articular disease (1-5 Likert scale) 4. At least a 1 point reduction in patient's assessment of articular disease (1-5 Likert scale)
Time frame: 24 Weeks
Population: Full Analysis Set
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Methotrexate | Psoriatic Arthritis Response Criteria (PsARC) Response at 24 Weeks | 36 Participants |
| Golimumab & Methotrexate | Psoriatic Arthritis Response Criteria (PsARC) Response at 24 Weeks | 38 Participants |
p-value: 0.92695% CI: [0.28, 4.02]Regression, Logistic
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: 1. At least 30% reduction in tender joint grade (total of 68 joints graded 0-3) 2. At least 30% reduction in swollen joint grade (total of 66 joints graded 0-3) 3. At least a 1 point reduction in physician's assessment of articular disease (1-5 Likert scale) 4. At least a 1 point reduction in patient's assessment of articular disease (1-5 Likert scale)
Time frame: 36 Weeks
Population: Full Analysis Set
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Methotrexate | Psoriatic Arthritis Response Criteria (PsARC) Response at 36 Weeks | 33 Participants |
| Golimumab & Methotrexate | Psoriatic Arthritis Response Criteria (PsARC) Response at 36 Weeks | 38 Participants |
p-value: 0.38595% CI: [0.5, 5.94]Regression, Logistic
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: 1. At least 30% reduction in tender joint grade (total of 68 joints graded 0-3) 2. At least 30% reduction in swollen joint grade (total of 66 joints graded 0-3) 3. At least a 1 point reduction in physician's assessment of articular disease (1-5 Likert scale) 4. At least a 1 point reduction in patient's assessment of articular disease (1-5 Likert scale)
Time frame: 52 Weeks
Population: Full Analysis Set
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Methotrexate | Psoriatic Arthritis Response Criteria (PsARC) Response at 52 Weeks | 27 Participants |
| Golimumab & Methotrexate | Psoriatic Arthritis Response Criteria (PsARC) Response at 52 Weeks | 28 Participants |
p-value: 0.68495% CI: [0.32, 2.12]Regression, Logistic
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.
Time frame: 12 Weeks
Population: Full Analysis Set (restricted to those with \>=3% body surface area affected by psoriasis at baseline)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Methotrexate | Psoriatic Arthritis Skin Index (PASI) Response at 12 Weeks | 0 Participants |
| Golimumab & Methotrexate | Psoriatic Arthritis Skin Index (PASI) Response at 12 Weeks | 7 Participants |
p-value: 0.06395% CI: [0.86, 326.19]Regression, Logistic
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.
Time frame: 24 Weeks
Population: Full Analysis Set (restricted to those with \>=3% body surface area affected by psoriasis at baseline)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Methotrexate | Psoriatic Arthritis Skin Index (PASI) Response at 24 Weeks | 3 Participants |
| Golimumab & Methotrexate | Psoriatic Arthritis Skin Index (PASI) Response at 24 Weeks | 11 Participants |
p-value: 0.04195% CI: [1.09, 72.42]Regression, Logistic
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.
Time frame: 36 Weeks
Population: Full Analysis Set (restricted to those with \>=3% body surface area affected by psoriasis at baseline)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Methotrexate | Psoriatic Arthritis Skin Index (PASI) Response at 36 Weeks | 2 Participants |
| Golimumab & Methotrexate | Psoriatic Arthritis Skin Index (PASI) Response at 36 Weeks | 9 Participants |
p-value: 0.06995% CI: [0.86, 52.14]Regression, Logistic
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.
Time frame: 52 Weeks
Population: Full Analysis Set (restricted to those with \>=3% body surface area affected by psoriasis at baseline)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Methotrexate | Psoriatic Arthritis Skin Index (PASI) Response at 52 Weeks | 2 Participants |
| Golimumab & Methotrexate | Psoriatic Arthritis Skin Index (PASI) Response at 52 Weeks | 6 Participants |
p-value: 0.39795% CI: [0.33, 16.66]Regression, Logistic
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.
Time frame: 12 Weeks
Population: Full Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Methotrexate | The Modified Nail Psoriasis Severity Index (mNAPSI) at 12 Weeks | 4.78 units on a scale | Standard Deviation 8.73 |
| Golimumab & Methotrexate | The Modified Nail Psoriasis Severity Index (mNAPSI) at 12 Weeks | 6.37 units on a scale | Standard Deviation 10.66 |
p-value: 0.29695% CI: [0.32, 1.41]Negative binomial regression
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.
Time frame: 24 Weeks
Population: Full Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Methotrexate | The Modified Nail Psoriasis Severity Index (mNAPSI) at 24 Weeks | 4.02 units on a scale | Standard Deviation 6.41 |
| Golimumab & Methotrexate | The Modified Nail Psoriasis Severity Index (mNAPSI) at 24 Weeks | 3.12 units on a scale | Standard Deviation 6.88 |
p-value: 0.08195% CI: [0.23, 1.09]Negative binomial regression
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.
Time frame: 36 Weeks
Population: Full Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Methotrexate | The Modified Nail Psoriasis Severity Index (mNAPSI) at 36 Weeks | 4.47 units on a scale | Standard Deviation 7.73 |
| Golimumab & Methotrexate | The Modified Nail Psoriasis Severity Index (mNAPSI) at 36 Weeks | 5.50 units on a scale | Standard Deviation 11.16 |
p-value: 0.45895% CI: [0.36, 1.59]Negative binomial regression
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.
Time frame: 52 Weeks
Population: Full Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Methotrexate | The Modified Nail Psoriasis Severity Index (mNAPSI) at 52 Weeks | 3.91 units on a scale | Standard Deviation 7.32 |
| Golimumab & Methotrexate | The Modified Nail Psoriasis Severity Index (mNAPSI) at 52 Weeks | 7.72 units on a scale | Standard Deviation 12.27 |
p-value: 0.79895% CI: [0.46, 2.72]Negative binomial regression
Secondary
Ultrasound Entheseal Chronicity Score at 12 Weeks.
The Ultrasound Entheseal Chronicity Score ranged from 0-50; a higher score represents a worse outcome.
Time frame: 12 weeks
Population: Full analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Methotrexate | Ultrasound Entheseal Chronicity Score at 12 Weeks. | 3.17 score on a scale | Standard Deviation 2.38 |
| Golimumab & Methotrexate | Ultrasound Entheseal Chronicity Score at 12 Weeks. | 2.50 score on a scale | Standard Deviation 2.79 |
p-value: 0.05895% CI: [-1.93, 0.03]Regression, Linear
Secondary
Ultrasound Entheseal Chronicity Score at 24 Weeks.
The Ultrasound Entheseal Chronicity Score ranged from 0-50; a higher score represents a worse outcome.
Time frame: 24 weeks
Population: Full analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Methotrexate | Ultrasound Entheseal Chronicity Score at 24 Weeks. | 2.85 score on a scale | Standard Deviation 2.31 |
| Golimumab & Methotrexate | Ultrasound Entheseal Chronicity Score at 24 Weeks. | 2.63 score on a scale | Standard Deviation 2.21 |
p-value: 0.21395% CI: [-1.54, 0.35]Regression, Linear
Secondary
Ultrasound Entheseal Chronicity Score at 36 Weeks.
The Ultrasound Entheseal Chronicity Score ranged from 0-50; a higher score represents a worse outcome.
Time frame: 36 weeks
Population: Full analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Methotrexate | Ultrasound Entheseal Chronicity Score at 36 Weeks. | 2.79 score on a scale | Standard Deviation 2.64 |
| Golimumab & Methotrexate | Ultrasound Entheseal Chronicity Score at 36 Weeks. | 2.97 score on a scale | Standard Deviation 2.66 |
p-value: 0.60695% CI: [-0.88, 1.5]Regression, Linear
Secondary
Ultrasound Entheseal Inflammatory Score at 12 Weeks.
The Ultrasound Entheseal Inflammatory Score ranged from 0-70; a higher score represents a worse outcome.
Time frame: 12 weeks
Population: Full analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Methotrexate | Ultrasound Entheseal Inflammatory Score at 12 Weeks. | 4.86 score on a scale | Standard Deviation 4.8 |
| Golimumab & Methotrexate | Ultrasound Entheseal Inflammatory Score at 12 Weeks. | 4.68 score on a scale | Standard Deviation 4.28 |
p-value: 0.37295% CI: [-2.45, 0.93]Regression, Linear
Secondary
Ultrasound Entheseal Inflammatory Score at 24 Weeks.
The Ultrasound Entheseal Inflammatory Score ranged from 0-70; a higher score represents a worse outcome.
Time frame: 24 weeks
Population: Full analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Methotrexate | Ultrasound Entheseal Inflammatory Score at 24 Weeks. | 4.89 score on a scale | Standard Deviation 4.49 |
| Golimumab & Methotrexate | Ultrasound Entheseal Inflammatory Score at 24 Weeks. | 4.90 score on a scale | Standard Deviation 3.92 |
p-value: 0.78195% CI: [-2.05, 1.55]Regression, Linear
Secondary
Ultrasound Entheseal Inflammatory Score at 36 Weeks.
The Ultrasound Entheseal Inflammatory Score ranged from 0-70; a higher score represents a worse outcome.
Time frame: 36 weeks
Population: Full analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Methotrexate | Ultrasound Entheseal Inflammatory Score at 36 Weeks. | 6.17 score on a scale | Standard Deviation 6.49 |
| Golimumab & Methotrexate | Ultrasound Entheseal Inflammatory Score at 36 Weeks. | 4.14 score on a scale | Standard Deviation 3.45 |
p-value: 0.03795% CI: [-4.39, -0.14]Regression, Linear
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.
Time frame: 12 weeks
Population: Full analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Methotrexate | Ultrasound Global OMERACT-EULAR System Score (GLOESS) at 12 Weeks. | 18.74 score on a scale | Standard Deviation 10.12 |
| Golimumab & Methotrexate | Ultrasound Global OMERACT-EULAR System Score (GLOESS) at 12 Weeks. | 23.07 score on a scale | Standard Deviation 11.74 |
p-value: 0.36495% CI: [-2.04, 5.48]Regression, Linear
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.
Time frame: 24 weeks
Population: Full analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Methotrexate | Ultrasound Global OMERACT-EULAR System Score (GLOESS) at 24 Weeks. | 20.63 score on a scale | Standard Deviation 10.06 |
| Golimumab & Methotrexate | Ultrasound Global OMERACT-EULAR System Score (GLOESS) at 24 Weeks. | 22.44 score on a scale | Standard Deviation 10.26 |
p-value: 0.80695% CI: [-3.6, 4.61]Regression, Linear
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.
Time frame: 36 weeks
Population: Full analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Methotrexate | Ultrasound Global OMERACT-EULAR System Score (GLOESS) at 36 Weeks. | 22.46 score on a scale | Standard Deviation 9.83 |
| Golimumab & Methotrexate | Ultrasound Global OMERACT-EULAR System Score (GLOESS) at 36 Weeks. | 24.20 score on a scale | Standard Deviation 7.96 |
p-value: 0.58895% CI: [-2.79, 4.89]Regression, Linear
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.
Time frame: 12 Weeks
Population: Full Analysis Set
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Methotrexate | Ultrasound Imaging Remission at 12 Weeks | 4 Participants |
| Golimumab & Methotrexate | Ultrasound Imaging Remission at 12 Weeks | 1 Participants |
p-value: 0.30995% CI: [0.04, 2.83]Regression, Logistic
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.
Time frame: 24 Weeks
Population: Full Analysis Set
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Methotrexate | Ultrasound Imaging Remission at 24 Weeks | 3 Participants |
| Golimumab & Methotrexate | Ultrasound Imaging Remission at 24 Weeks | 3 Participants |
p-value: 0.87195% CI: [0.17, 4.6]Regression, Logistic
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.
Time frame: 36 Weeks
Population: Full Analysis Set
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Methotrexate | Ultrasound Imaging Remission at 36 Weeks | 2 Participants |
| Golimumab & Methotrexate | Ultrasound Imaging Remission at 36 Weeks | 1 Participants |
p-value: 0.55595% CI: [0.04, 5.52]Regression, Logistic