GOLimumab and Methotrexate Versus Methotrexate in Very Early PsA
NCT ID: NCT04108468
Last Updated: 2025-12-02
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Total Enrollment
84 participants
Study Classification
INTERVENTIONAL
Study Start Date
2015-10-27
Study Completion Date
2023-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Initial Treatment With Golimumab in Early PsA
NCT01871649
Psoriatic Arthritis
COMPLETED
PHASE3
Efficacy of Golimumab in Combination With Methotrexate (MTX) Versus MTX Monotherapy, in Improving Dactylitis, in MTX naïve Psoriatic Arthritis Patients
NCT02065713
Psoriatic Arthritis
COMPLETED
PHASE3
A Study of Golimumab in Participants With Active Psoriatic Arthritis
NCT02181673
Arthritis, Psoriatic
COMPLETED
PHASE3
A Study of Guselkumab and Golimumab Combination Therapy in Participants With Active Psoriatic Arthritis
NCT05071664
Arthritis, Psoriatic
COMPLETED
PHASE2
Filgotinib Alone and in Combination With Methotrexate (MTX) in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Are Naive to MTX Therapy
NCT02886728
Rheumatoid Arthritis
COMPLETED
PHASE3
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Psoriatic Arthritis
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
DOUBLE
Participants
Investigators
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Methotrexate
Group Type
ACTIVE_COMPARATOR
Methotrexate
Intervention Type
DRUG
Methotrexate
Golimumab & Methotrexate
Group Type
EXPERIMENTAL
Methotrexate
Intervention Type
DRUG
Methotrexate
Golimumab
Intervention Type
DRUG
Simponi
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Methotrexate
Methotrexate
Intervention Type
DRUG
Golimumab
Simponi
Intervention Type
DRUG
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
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
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.
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
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.
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:
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:
Minimum Eligible Age
18 Years
Maximum Eligible Age
100 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Janssen Pharmaceutica N.V., Belgium
INDUSTRY
Sponsor Role
collaborator
The Leeds Teaching Hospitals NHS Trust
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Responsibility Role
SPONSOR
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The Leeds Teaching Hospitals NHS Trust
Leeds, West Yorkshire, United Kingdom
Site Status
Countries
Review the countries where the study has at least one active or historical site.
United Kingdom
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
14/EM/0124
Identifier Type: OTHER
Identifier Source: secondary_id
RR13/10782
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
A Study of Golimumab in Participants With Active Ankylosing Spondylitis
NCT02186873
COMPLETED
PHASE3
Exploration of TNF-alpha Blockade With Golimumab in the Induction of Clinical Remission in Patients With Early Peripheral Spondyloarthritis (SpA) According to ASAS-criteria
NCT01426815
COMPLETED
PHASE3
Thermography in Assessing Treatment Response to Golimumab in Psoriatic Arthritis
NCT02841176
TERMINATED
NA
Golimumab Versus Pamidronate for the Treatment of Axial Spondyloarthropathy: a 48-week Trial
NCT01718951
COMPLETED
PHASE4
A Study of the Safety and Efficacy of Golimumab in Patients With Active Psoriatic Arthritis
NCT00265096
COMPLETED
PHASE3
Study to Evaluate the Efficacy and Safety of Filgotinib in Participants With Active Psoriatic Arthritis Who Are Naive to Biologic DMARD Therapy
NCT04115748
TERMINATED
PHASE3
An Efficacy and Safety Study of Golimumab in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy
NCT00264550
COMPLETED
PHASE3
Combined Treatment of Methotrexate + Glucocorticoids Versus Glucocorticoids Alone in Patients With PM and DM
NCT00651040
COMPLETED
PHASE3
Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate
NCT02889796
COMPLETED
PHASE3
Novel MRI ANd Biomarkers in GOlimumab-treated Patients With Axial Spondyloarthritis
NCT02011386
COMPLETED
An Effectiveness and Safety Study of Intravenous Golimumab in Patients With Active Rheumatoid Arthritis Despite Treatment With Methotrexate Therapy
NCT00973479
COMPLETED
PHASE3
Effect of Golimumab in Participants With Active Axial Spondyloarthritis (P07642, MK-8259-006)
NCT01453725
COMPLETED
PHASE3
Multicenter Randomized Prospective Trial Comparing Methotrexate Alone or in Combination With Adalimumab in Early Arthritis
NCT00291915
UNKNOWN
PHASE4
A Study of Guselkumab in Participants With Active Psoriatic Arthritis
NCT04882098
ACTIVE_NOT_RECRUITING
PHASE3
A Study to Evaluate the Efficacy and Safety of MLTA3698A in Combination With a Disease-Modifying Anti-Rheumatic Drug (DMARD) Compared With Adalimumab in Combination With a DMARD in Patients With Active Rheumatoid Arthritis
NCT01225393
COMPLETED
PHASE2
A Study of the Safety and Efficacy of Golimumab (CNTO 148) in Subjects With Active Rheumatoid Arthritis Previously Treated With Biologic Anti-TNFa Agent(s)
NCT00299546
COMPLETED
PHASE3
A Study of Golimumab in the Treatment of Indian Participants With Active Spondyloarthropathy of Ankylosing Spondylitis or Psoriatic Arthritis
NCT03733925
COMPLETED
PHASE4
A Safety and Efficacy Study of Golimumab (CNTO 148) in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy
NCT00727987
COMPLETED
PHASE3
Study of the Safety and Efficacy of Golimumab in Chinese Patients With Ankylosing Spondylitis
NCT01248793
COMPLETED
PHASE3
BG9924 in Combination With Methotrexate for Participants With Active Rheumatoid Arthritis
NCT00458861
TERMINATED
PHASE2
An Open-label, Long-term Extension Study With Filgotinib in Active Psoriatic Arthritis.
NCT03320876
TERMINATED
PHASE2
A Trial Investigating the Mechanism of Action of NNC0109-0012 (Anti-IL-20 mAb) Through Synovial Biopsies in Subjects With Rheumatoid Arthritis and an Inadequate Response to Methotrexate
NCT02097264
WITHDRAWN
PHASE2