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GOLimumab and Methotrexate Versus Methotrexate in Very Early PsA | Clinical Trials | Clareo Health

COMPLETEDPHASE3

GOLimumab and Methotrexate Versus Methotrexate in Very Early PsA

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.

NCT04108468•The Leeds Teaching Hospitals NHS Trust

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 100 years

Sex

ALL

Healthy Volunteers

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.
+4 more criteria

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
+13 more criteria

Locations (1)

The Leeds Teaching Hospitals NHS Trust

Leeds, West Yorkshire, United Kingdom

Key Dates

Start Date

October 27, 2015

Primary Completion Date

July 1, 2023

Completion Date

July 1, 2023

Last Updated

December 2, 2025

Enrollment

ACTUAL participants

Conditions

Psoriatic Arthritis

Interventions

Methotrexate

DRUG

Golimumab

DRUG

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RECRUITINGPHASE3

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Juvenile Psoriatic Arthritis

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RECRUITING

Rheumatology Patient Registry and Biorepository

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 2, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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GOLimumab and Methotrexate Versus Methotrexate in Very Early PsA

Inclusion Criteria

Exclusion Criteria

A Study of Picankibart in Patients With Active Psoriatic Arthritis

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