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Initial Treatment With Golimumab in Early PsA | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Initial Treatment With Golimumab in Early PsA

A Randomized, Double-blind, Placebo-controlled Trial of Golimumab+Methotrexate Versus Methotrexate Alone in Methotrexate-naïve Patients With Psoriatic Arthritis

NCT01871649•Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

View on ClinicalTrials.gov

Summary

The investigators will perform a 22-week randomized, double-blind, placebo-controlled trial of golimumab + methotrexate (MTX) versus methotrexate alone in methotrexate-naïve patients with Psoriatic Arthritis (PsA). Afterwards, a 28 week open label phase with methotrexate alone is started. Golimumab will be discontinued. Hypotheses: First, the investigators hypothesize that initiation of a combination therapy with golimumab + MTX will be safe and superior to MTX alone in MTX-naïve PsA patients, as assessed by the percentage of patients achieving Disease Activity Score (the investigators hypothesize that more patients with the early combination treatment will respond (according to Disease Activity Score (DAS), American college of Rheumatology (ACR), or Psoriatic Arthritis Response Criteria (PsARC) responses) and achieve a state of Low Disease Activity (LDA) or Minimal Disease Activity (MDA) than patients on MTX alone. Third, the investigators hypothesize that a significant proportion of the patients will continue to benefit from this early aggressive treatment initiation even after stopping golimumab treatment.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Prior to any study procedure, voluntary written informed consent must be obtained, after the nature and purpose of this study were explained
•Patients should be between 18 and 70 years of age at time of consent
•Patients must have a diagnosis of PsA according to the Classification for psoriatic Arthritis (CASPAR) classification criteria (see Appendix 1).
•The patient must have an active disease as defined by 3 swollen and 3 tender joints.
•The use of a stable dose of concomitant nonsteroidal antiinflammatory drug (NSAIDs) and/or corticosteroids is allowed. The dose of corticosteroids should not exceed a prednisone equivalent of 10 mg/day and must be stable for at least 4 weeks prior to baseline. The dose of concomitant NSAIDs and corticosteroids should be kept stable during the whole study period.
•Patients are considered to be in generally good health based upon the result of a medical history, physical examination, laboratory profile, chest X-ray and electrocardiography (ECG).

Exclusion Criteria

•Patient has a concomitant rheumatic condition other than PsA
•Positivity for rheumatoid factor (RF) or anti-cyclic citrullinated peptide (anti CCP) antibodies (ACPA)
•Current or previous use of methotrexate
•Current use of other Disease Modifying Antirheumatic drug (DMARDs) (sulphasalazine or leflunomide).
•Prior use of other DMARDs (sulphasalazine or leflunomide) within 3 months before baseline.
•Current or previous use of biologicals, including Tumor Necrosis Factor (TNF) blocking therapy
•Patient has active tuberculosis. A purified protein derivative (PPD) skin test and chest X-ray at screening should be negative (in case of latent tuberculosis, a patient may enter the study if prophylaxis with isoniazide is begun prior to administration of study medication). If a patient has an adequately treated tuberculosis in the past, he/she may enter the trial.
•Patient has received an intra-articular injection with corticosteroids within 4 weeks prior to baseline.
•Patient has a malignancy (other than basal cell carcinoma of the skin) in the past 5 years
•Patients has a recent history of (or persistent) infection requiring hospitalization or antibiotic treatment within 4 weeks of baseline Patient has a significant history of cardiac, pulmonary, renal (glomerular filtration rate \<40ml/min), hepatic (liver cirrhosis), hematological, neurological, metabolic or any other disease that may affect his/her participation in this study. This should be decided by the opinion of the investigator.
+5 more criteria

Locations (2)

Reade

Amsterdam, North Holland, Netherlands

Academic Medical Center/University of Amsterdam

Amsterdam, North Holland, Netherlands

Key Dates

Start Date

August 1, 2013

Primary Completion Date

November 1, 2018

Completion Date

November 1, 2018

Last Updated

November 26, 2018

Enrollment

ACTUAL participants

Conditions

Psoriatic Arthritis

Interventions

golimumab

DRUG

methotrexate

DRUG

A Study of Picankibart in Patients With Active Psoriatic Arthritis

NCT07295509

Psoriatic Arthritis

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RECRUITINGPHASE3

A Study to Assess Adverse Events, Change in Disease Activity, and How the Drug Moves Through the Body in Children With Juvenile Psoriatic Arthritis (jPsA) Receiving Subcutaneously Injected Risankizumab or Adalimumab

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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: November 26, 2018Data 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.

View ClinicalTrials.gov Terms and Conditions

Initial Treatment With Golimumab in Early PsA

Inclusion Criteria

Exclusion Criteria

A Study of Picankibart in Patients With Active Psoriatic Arthritis

A Study to Assess Adverse Events, Change in Disease Activity, and How the Drug Moves Through the Body in Children With Juvenile Psoriatic Arthritis (jPsA) Receiving Subcutaneously Injected Risankizumab or Adalimumab

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