Psoriatic ArthritisPhase 3GOLMePsANCT04108468
GOLimumab and Methotrexate Versus Methotrexate in Very Early PsA
A Phase 3 study testing Methotrexate and Golimumab in people with Psoriatic Arthritis, run by The Leeds Teaching Hospitals NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Psoriatic Arthritis
- What is being tested?
- Methotrexate and Golimumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 27 Oct 2015to Jul 2023
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- Received previous treatment with any DMARDs.
- Received previous treatment with golimumab or other tumour necrosis factor inhibitor (TNFi) or other biologic drugs.
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Leeds Teaching Hospitals NHS Trust
Leeds, West Yorkshire, LS7 4SA
About this study
Official title: 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.
Read the 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.
- Conditions
- Psoriatic Arthritis
- Being tested
- Methotrexate, Golimumab
- Medical subject headings
- Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethotrexateDrug
Methotrexate
GolimumabDrug
Simponi
| Study group | Role | What they receive |
|---|---|---|
| Methotrexate | Active comparator | Not described Receives: Drug: Methotrexate |
| Golimumab & Methotrexate | Experimental | Not described Receives: Drug: Methotrexate; Drug: Golimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 weeks
Secondary outcomes (68)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 36 weeks
Leeds Enthesitis Index at 12 Weeks
The Leeds Enthesitis Index ranges from 0-6; a higher score represents a worse outcome.
Measured: 12 Weeks
Leeds Enthesitis Index at 24 Weeks
The Leeds Enthesitis Index ranges from 0-6; a higher score represents a worse outcome.
Measured: 24 Weeks
Leeds Enthesitis Index at 36 Weeks
The Leeds Enthesitis Index ranges from 0-6; a higher score represents a worse outcome.
Measured: 36 Weeks
Leeds Enthesitis Index at 52 Weeks
The Leeds Enthesitis Index ranges from 0-6; a higher score represents a worse outcome.
Measured: 52 Weeks
Leeds Dactylitis Index at 12 Weeks
The Leeds Dactylitis Index ranges from 0-~40; a higher score represents a worse outcome.
Measured: 12 Weeks
Leeds Dactylitis Index at 24 Weeks
The Leeds Dactylitis Index ranges from 0-~40; a higher score represents a worse outcome.
Measured: 24 Weeks
Leeds Dactylitis Index at 36 Weeks
The Leeds Dactylitis Index ranges from 0-~40; a higher score represents a worse outcome.
Measured: 36 Weeks
Leeds Dactylitis Index at 52 Weeks
The Leeds Dactylitis Index ranges from 0-~40; a higher score represents a worse outcome.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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 VAS
- Physician's Global Assessment of Disease Activity VAS
- Patient's Assessment of Physical Function as measured by the HAQ-DI
- Acute phase reactant as measured by CRP
Measured: 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 VAS
- Physician's Global Assessment of Disease Activity VAS
- Patient's Assessment of Physical Function as measured by the HAQ-DI
- Acute phase reactant as measured by CRP
Measured: 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 VAS
- Physician's Global Assessment of Disease Activity VAS
- Patient's Assessment of Physical Function as measured by the HAQ-DI
- Acute phase reactant as measured by CRP
Measured: 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 VAS
- Physician's Global Assessment of Disease Activity VAS
- Patient's Assessment of Physical Function as measured by the HAQ-DI
- Acute phase reactant as measured by CRP
Measured: 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 VAS
- Physician's Global Assessment of Disease Activity VAS
- Patient's Assessment of Physical Function as measured by the HAQ-DI
- Acute phase reactant as measured by CRP
Measured: 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 VAS
- Physician's Global Assessment of Disease Activity VAS
- Patient's Assessment of Physical Function as measured by the HAQ-DI
- Acute phase reactant as measured by CRP
Measured: 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 VAS
- Physician's Global Assessment of Disease Activity VAS
- Patient's Assessment of Physical Function as measured by the HAQ-DI
- Acute phase reactant as measured by CRP
Measured: 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 VAS
- Physician's Global Assessment of Disease Activity VAS
- Patient's Assessment of Physical Function as measured by the HAQ-DI
- Acute phase reactant as measured by CRP
Measured: 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 VAS
- Physician's Global Assessment of Disease Activity VAS
- Patient's Assessment of Physical Function as measured by the HAQ-DI
- Acute phase reactant as measured by CRP
Measured: 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 VAS
- Physician's Global Assessment of Disease Activity VAS
- Patient's Assessment of Physical Function as measured by the HAQ-DI
- Acute phase reactant as measured by CRP
Measured: 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 VAS
- Physician's Global Assessment of Disease Activity VAS
- Patient's Assessment of Physical Function as measured by the HAQ-DI
- Acute phase reactant as measured by CRP
Measured: 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 VAS
- Physician's Global Assessment of Disease Activity VAS
- Patient's Assessment of Physical Function as measured by the HAQ-DI
- Acute phase reactant as measured by CRP
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2019
- Study start27 Oct 2015
- Primary completionJul 2023
- Study completionJul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Psoriatic ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Leeds Teaching Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen Pharmaceutica N.V., Belgium
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04108468
- Sponsor's protocol ID
- RR13/10782
- Other IDs
- 14/EM/0124
- Acronym
- GOLMePsA
- Status last verified
- Nov 2025
- First submitted
- 26 Sep 2019
- Last updated
- 2 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
De Marco G, Maksymowych WP, Ostergaard M, Eshed I, Tan AL, Helliwell PS, McGonagle D, Hensor EMA, Marzo-Ortega H. Whole body-MRI identifies widespread, low intensity inflammation in peripheral joints, and axial involvement in a third of patients with early, treatment-naive, active PsA: data from the GOLMePsA clinical trial. Rheumatology (Oxford). 2026 Jun 30;65(7):keag308. doi: 10.1093/rheumatology/keag308.
PubMed 42308540
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT04108468
- Acronym / sponsor ID
- GOLMePsA / RR13/10782
- Conditions
- Psoriatic Arthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- The Leeds Teaching Hospitals NHS TrustUniversity, hospital or other
- Collaborators
- Janssen Pharmaceutica N.V., Belgium
- Study start
- 27 Oct 2015 (actual)
- Primary completion
- Jul 2023 (actual)
- Study completion
- Jul 2023 (actual)
- First posted
- 30 Sep 2019 (actual)
- Results
- Posted 2 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methotrexate | Active comparator | Drug: Methotrexate |
| Golimumab & Methotrexate | Experimental | Drug: Methotrexate, Drug: Golimumab |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
- 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.
Key exclusion criteria (27 listed)
- Received previous treatment with any DMARDs.
- Received previous treatment with golimumab or other tumour necrosis factor inhibitor (TNFi) or other biologic drugs.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MethotrexateMethotrexate | Drug | Golimumab & Methotrexate, Methotrexate |
| GolimumabSimponi | Drug | Golimumab & Methotrexate |
Primary outcome
Psoriatic Arthritis Disease Activity Score (PASDAS) at 24 Weeks
Time frame: 24 weeks
The Psoriatic Arthritis Disease Activity Score ranges from 0-10; higher scores represent a worse outcome.
68 secondary outcomes
Psoriatic Arthritis Disease Activity Score (PASDAS) at 12 Weeks.
Time frame: 12 weeks
Psoriatic Arthritis Disease Activity Score (PASDAS) at 36 Weeks.
Time frame: 36 weeks
Psoriatic Arthritis Disease Activity Score (PASDAS) at 52 Weeks.
Time frame: 52 weeks
Composite Psoriatic Disease Activity Index (CPDAI) at 12 Weeks.
Time frame: 12 weeks
Composite Psoriatic Disease Activity Index (CPDAI) at 24 Weeks.
Time frame: 24 weeks
Composite Psoriatic Disease Activity Index (CPDAI) at 36 Weeks.
Time frame: 36 weeks
Composite Psoriatic Disease Activity Index (CPDAI) at 52 Weeks.
Time frame: 52 weeks
Participant Disease Activity Visual Analogue Score at 24 Weeks.
Time frame: 24 weeks
Participant Disease Activity Visual Analogue Score at 52 Weeks.
Time frame: 52 weeks
36-item Short Form Health Survey (SF-36) Physical Component Score at 24 Weeks.
Time frame: 24 weeks
36-item Short Form Health Survey (SF-36) Physical Component Score at 52 Weeks.
Time frame: 52 weeks
36-item Short Form Health Survey (SF-36) Mental Component Score at 24 Weeks.
Time frame: 24 weeks
36-item Short Form Health Survey (SF-36) Mental Component Score at 52 Weeks.
Time frame: 52 weeks
Ultrasound Global OMERACT-EULAR System Score (GLOESS) at 12 Weeks.
Time frame: 12 weeks
Ultrasound Global OMERACT-EULAR System Score (GLOESS) at 24 Weeks.
Time frame: 24 weeks
Ultrasound Global OMERACT-EULAR System Score (GLOESS) at 36 Weeks.
Time frame: 36 weeks
Ultrasound Entheseal Inflammatory Score at 12 Weeks.
Time frame: 12 weeks
Ultrasound Entheseal Inflammatory Score at 24 Weeks.
Time frame: 24 weeks
Ultrasound Entheseal Inflammatory Score at 36 Weeks.
Time frame: 36 weeks
Ultrasound Entheseal Chronicity Score at 12 Weeks.
Time frame: 12 weeks
Ultrasound Entheseal Chronicity Score at 24 Weeks.
Time frame: 24 weeks
Ultrasound Entheseal Chronicity Score at 36 Weeks.
Time frame: 36 weeks
Leeds Enthesitis Index at 12 Weeks
Time frame: 12 Weeks
Leeds Enthesitis Index at 24 Weeks
Time frame: 24 Weeks
Leeds Enthesitis Index at 36 Weeks
Time frame: 36 Weeks
Leeds Enthesitis Index at 52 Weeks
Time frame: 52 Weeks
Leeds Dactylitis Index at 12 Weeks
Time frame: 12 Weeks
Leeds Dactylitis Index at 24 Weeks
Time frame: 24 Weeks
Leeds Dactylitis Index at 36 Weeks
Time frame: 36 Weeks
Leeds Dactylitis Index at 52 Weeks
Time frame: 52 Weeks
The Modified Nail Psoriasis Severity Index (mNAPSI) at 12 Weeks
Time frame: 12 Weeks
The Modified Nail Psoriasis Severity Index (mNAPSI) at 24 Weeks
Time frame: 24 Weeks
The Modified Nail Psoriasis Severity Index (mNAPSI) at 36 Weeks
Time frame: 36 Weeks
The Modified Nail Psoriasis Severity Index (mNAPSI) at 52 Weeks
Time frame: 52 Weeks
Psoriasis Area and Severity Index (PASI) Score at 12 Weeks
Time frame: 12 Weeks
Psoriasis Area and Severity Index (PASI) Score at 24 Weeks
Time frame: 24 Weeks
Psoriasis Area and Severity Index (PASI) Score at 36 Weeks
Time frame: 36 Weeks
Psoriasis Area and Severity Index (PASI) Score at 52 Weeks
Time frame: 52 Weeks
Dermatology Life Quality Index (DLQI) Score at 24 Weeks
Time frame: 24 Weeks
Dermatology Life Quality Index (DLQI) Score at 52 Weeks
Time frame: 52 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42308540De Marco G, Maksymowych WP, Ostergaard M, Eshed I, Tan AL, Helliwell PS, McGonagle D, Hensor EMA, Marzo-Ortega H. Whole body-MRI identifies widespread, low intensity inflammation in peripheral joints, and axial involvement in a third of patients with early, treatment-naive, active PsA: data from the GOLMePsA clinical trial. Rheumatology (Oxford). 2026 Jun 30;65(7):keag308. doi: 10.1093/rheumatology/keag308.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Methotrexate and Golimumab in people with Psoriatic Arthritis, run by The Leeds Teaching Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psoriatic Arthritis Disease Activity Score (PASDAS) at 24 Weeks (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04108468, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.