GOLimumab and Methotrexate Versus Methotrexate in Very Early PsA (GOLMePsA)

An Investigator-initiated Double-blind, Parallel-group Randomised Controlled Trial of GOLimumab and Methotrexate Versus Methotrexate in Very Early PsA Using Clinical and Whole Body MRI Outcomes: the GOLMePsA Study.

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.

Study Overview

• Status: Completed
• Conditions: Psoriatic Arthritis
• Intervention / Treatment: Drug: Methotrexate; Drug: Golimumab

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.

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Phase 3

Contacts and Locations

Study Locations

• United Kingdom
  • West Yorkshire
    • Leeds, West Yorkshire, United Kingdom, LS7 4SA
      • The Leeds Teaching Hospitals Nhs Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Methotrexate	Drug: Methotrexate; Methotrexate
Experimental: Golimumab & Methotrexate	Drug: Methotrexate; Methotrexate; Drug: Golimumab; Simponi

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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: 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:Patient's Assessment of Pain Visual Analogue Scale (VAS)Patient's Global Assessment of Disease Activity VASPhysician's Global Assessment of Disease Activity VASPatient's Assessment of Physical Function as measured by the HAQ-DIAcute phase reactant as measured by CRP	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: 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:Patient's Assessment of Pain Visual Analogue Scale (VAS)Patient's Global Assessment of Disease Activity VASPhysician's Global Assessment of Disease Activity VASPatient's Assessment of Physical Function as measured by the HAQ-DIAcute phase reactant as measured by CRP	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: 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:Patient's Assessment of Pain Visual Analogue Scale (VAS)Patient's Global Assessment of Disease Activity VASPhysician's Global Assessment of Disease Activity VASPatient's Assessment of Physical Function as measured by the HAQ-DIAcute phase reactant as measured by CRP	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: 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:Patient's Assessment of Pain Visual Analogue Scale (VAS)Patient's Global Assessment of Disease Activity VASPhysician's Global Assessment of Disease Activity VASPatient's Assessment of Physical Function as measured by the HAQ-DIAcute phase reactant as measured by CRP	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: 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:Patient's Assessment of Pain Visual Analogue Scale (VAS)Patient's Global Assessment of Disease Activity VASPhysician's Global Assessment of Disease Activity VASPatient's Assessment of Physical Function as measured by the HAQ-DIAcute phase reactant as measured by CRP	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: 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:Patient's Assessment of Pain Visual Analogue Scale (VAS)Patient's Global Assessment of Disease Activity VASPhysician's Global Assessment of Disease Activity VASPatient's Assessment of Physical Function as measured by the HAQ-DIAcute phase reactant as measured by CRP	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: 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:Patient's Assessment of Pain Visual Analogue Scale (VAS)Patient's Global Assessment of Disease Activity VASPhysician's Global Assessment of Disease Activity VASPatient's Assessment of Physical Function as measured by the HAQ-DIAcute phase reactant as measured by CRP	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: 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:Patient's Assessment of Pain Visual Analogue Scale (VAS)Patient's Global Assessment of Disease Activity VASPhysician's Global Assessment of Disease Activity VASPatient's Assessment of Physical Function as measured by the HAQ-DIAcute phase reactant as measured by CRP	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: 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:Patient's Assessment of Pain Visual Analogue Scale (VAS)Patient's Global Assessment of Disease Activity VASPhysician's Global Assessment of Disease Activity VASPatient's Assessment of Physical Function as measured by the HAQ-DIAcute phase reactant as measured by CRP	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: 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:Patient's Assessment of Pain Visual Analogue Scale (VAS)Patient's Global Assessment of Disease Activity VASPhysician's Global Assessment of Disease Activity VASPatient's Assessment of Physical Function as measured by the HAQ-DIAcute phase reactant as measured by CRP	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: 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:Patient's Assessment of Pain Visual Analogue Scale (VAS)Patient's Global Assessment of Disease Activity VASPhysician's Global Assessment of Disease Activity VASPatient's Assessment of Physical Function as measured by the HAQ-DIAcute phase reactant as measured by CRP	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: 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:Patient's Assessment of Pain Visual Analogue Scale (VAS)Patient's Global Assessment of Disease Activity VASPhysician's Global Assessment of Disease Activity VASPatient's Assessment of Physical Function as measured by the HAQ-DIAcute phase reactant as measured by CRP	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: At least 30% reduction in tender joint grade (total of 68 joints graded 0-3); At least 30% reduction in swollen joint grade (total of 66 joints graded 0-3); At least a 1 point reduction in physician's assessment of articular disease (1-5 Likert scale); At least a 1 point reduction in patient's assessment of articular disease (1-5 Likert scale)	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: At least 30% reduction in tender joint grade (total of 68 joints graded 0-3); At least 30% reduction in swollen joint grade (total of 66 joints graded 0-3); At least a 1 point reduction in physician's assessment of articular disease (1-5 Likert scale); At least a 1 point reduction in patient's assessment of articular disease (1-5 Likert scale)	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: At least 30% reduction in tender joint grade (total of 68 joints graded 0-3); At least 30% reduction in swollen joint grade (total of 66 joints graded 0-3); At least a 1 point reduction in physician's assessment of articular disease (1-5 Likert scale); At least a 1 point reduction in patient's assessment of articular disease (1-5 Likert scale)	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: At least 30% reduction in tender joint grade (total of 68 joints graded 0-3); At least 30% reduction in swollen joint grade (total of 66 joints graded 0-3); At least a 1 point reduction in physician's assessment of articular disease (1-5 Likert scale); At least a 1 point reduction in patient's assessment of articular disease (1-5 Likert scale)	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

Collaborators and Investigators

• Sponsor: The Leeds Teaching Hospitals NHS Trust
• Collaborators: Janssen Pharmaceutica N.V., Belgium

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2015
• Primary Completion (Actual): July 1, 2023
• Study Completion (Actual): July 1, 2023

Study Registration Dates

• First Submitted: September 26, 2019
• First Submitted That Met QC Criteria: September 27, 2019
• First Posted (Actual): September 30, 2019

Study Record Updates

• Last Update Posted (Estimated): December 2, 2025
• Last Update Submitted That Met QC Criteria: November 14, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Spinal Diseases; Spondylarthropathies; Skin Diseases, Papulosquamous; Skin Diseases; Spondylarthritis; Spondylitis; Psoriasis; Skin and Connective Tissue Diseases; Arthritis, Psoriatic; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pterins; Pteridines; Aminopterin; Methotrexate; golimumab
• Other Study ID Numbers: RR13/10782; 14/EM/0124 (Other Identifier: Research Ethics Committee)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No