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Efficacy of Golimumab in Combination With Methotrexate (MTX) Versus MTX Monotherapy, in Improving Dactylitis, in MTX naïve Psoriatic Arthritis Patients | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Efficacy of Golimumab in Combination With Methotrexate (MTX) Versus MTX Monotherapy, in Improving Dactylitis, in MTX naïve Psoriatic Arthritis Patients

A Multicentre, Randomized, Double-blind, Parallel-group Study To Compare The Efficacy Of Golimumab In Combination With Methotrexate (MTX) Versus MTX Monotherapy, In Improving Dactylitis And Enthesitis, In MTX Naïve Psoriatic Arthritis Patients.

NCT02065713•Instituto de Medicina Molecular João Lobo Antunes

View on ClinicalTrials.gov

Summary

Dactylitis is a poor prognostic factor in psoriatic arthritis (PsA) patients. The efficacy of synthetic or biologic disease modifying anti-rheumatic drugs (DMARDs) on dactylitis has not been previously studied in randomized controlled trials as a primary endpoint. In this investigator initiated clinical trial the investigators aim to test the hypothesis that the combination therapy of golimumab and methotrexate (MTX) will result in a significant improvement of dactylitis in comparison with MTX monotherapy, in MTX naïve psoriatic arthritis patients, at week 24. Similarly the efficacy on enthesitis, peripheral and axial involvement, skin and nail psoriasis, inflammation and damage of the feet and hands assessed by magnetic resonance imaging (MRI), composite indexes of disease activity, remission, function and quality of life will be determined. This is a national multicentre, interventional, double-blinded, placebo-controlled, parallel design trial. 136 patients with active dactylitis, refractory to at least two systemic non-steroidal anti-inflammatory drugs (NSAIDs), at optimal dosage, for 3 months will be included and centrally randomized to golimumab in combination with MTX versus MTX monotherapy, in a 1:1 ratio. The study duration will be 24 weeks. The investigators expect the results from this trial will contribute to a better definition of the treatment algorithm of PsA patients with dactylitis.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Each subject must be/have…..
•Able and willing to give written informed consent and comply with the requirements of the study protocol.
•Age ≥ 18 years old, at baseline. A subject may be of both gender and any race/ethnicity.
•PsA diagnosis according to Classification of Psoriatic Arthritis (CASPAR) criteria, established at least 3 months prior to screening.
•Active psoriatic arthritis, at the time of entry into the study, defined by:
•≥1 tender dactylitis, refractory to at least two systemic NSAIDs, at optimal dosage, for 3 months and at least one other site of active inflammation (peripheral joints, enthesis, spine, skin or nails).
•Naïve to MTX therapy.
•Patients can have been previously treated with synthetic DMARDs (except MTX) or corticosteroids but must have withdrawn according to the following schedules:
•* All synthetic DMARDs and oral corticosteroids withdrawn at least two weeks prior to screening or 5 half lives according, to what is longer, except for leflunomide.
•* leflunomide ≥ 12 weeks or ≥ 2 weeks after standard cholestyramine or activated charcoal washout.
+5 more criteria

Exclusion Criteria

•The subject has ….
•Known or suspected allergy to trial product or related products.
•Body weight \> 100 Kg.
•Current chronic inflammatory autoimmune disease other than PsA that might confound the evaluations of safety and toxicity such as, but not limited to, ankylosing spondylitis, rheumatoid arthritis, tophaceous gout, reactive arthritis, pseudogout, arthropathy of inflammatory bowel disease, systemic erythematosus lupus, mixed connective tissue disease, scleroderma or variants, and polymyositis
•Active current infection or history of recurrent or chronic bacterial, viral, fungal, mycobacterial or other infections, including but not limited to tuberculosis and atypical mycobacterial disease, hepatitis B and C, HIV and herpes zoster.
•History of severe systemic bacterial, viral or fungal infections within the past 12 months prior to screening.
•Past or current malignancy with the exception of:
•* Adequately treated and cured basal cell carcinoma of the skin occurring more than 12 months prior to screening.
•* Other cancer with a complete response duration of \> 5 years or any period of time longer than that, respectively for those malignancies which are considered as resolved after passing this duration of response.
•Any clinically significant medical condition or situation, other than the condition being studied that, in the opinion of the investigator, would interfere with the trial evaluations or patients safety and optimal participation in the trial such as, but not limited to:
+12 more criteria

Locations (1)

Centro Académico de Medicina de Lisboa

Lisbon, Portugal

Key Dates

Start Date

August 1, 2014

Primary Completion Date

June 1, 2017

Completion Date

June 1, 2017

Last Updated

November 13, 2020

Enrollment

ACTUAL participants

Conditions

Psoriatic Arthritis

Interventions

Golimumab

DRUG

Methotrexate

DRUG

Placebo

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

NCT06100744

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 13, 2020Data 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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Efficacy of Golimumab in Combination With Methotrexate (MTX) Versus MTX Monotherapy, in Improving Dactylitis, in MTX naïve Psoriatic Arthritis Patients

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

Rheumatology Patient Registry and Biorepository

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