An Exploratory Phase II, Randomized, Open-Label, Proof-of-Concept Trial Evaluating Add-on Polyunsaturated Fatty Acid Ethyl Esters on Pain and Minimal Disease Activity in Psoriatic Arthritis Patients Starting TNF-alpha Inhibitors

Trial details

Who runs it

Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata Fon

Trial code

EU 2026-526768-20-00

Record updated

2026. október 6.

Original description

CO-PRIMARY OBJECTIVE 1 (PO1): To evaluate whether add-on polyunsaturated fatty acid ethyl esters, 1000 mg, with an EPA and DHA content not lower than 85%, combined with TNF-alpha inhibitor therapy, reduces pain intensity compared with TNF-alpha inhibitor therapy alone in patients with PsA. CO-PRIMARY OBJECTIVE 2 (PO2): To explore whether add-on polyunsaturated fatty acid ethyl esters, 1000 mg, with an EPA and DHA content not lower than 85% improves disease activity control compared with TNF-alpha inhibitor therapy alone.Read full original descriptionShow less

CO-PRIMARY OBJECTIVE 1 (PO1): To evaluate whether add-on polyunsaturated fatty acid ethyl esters, 1000 mg, with an EPA and DHA content not lower than 85%, combined with TNF-alpha inhibitor therapy, reduces pain intensity compared with TNF-alpha inhibitor therapy alone in patients with PsA. CO-PRIMARY OBJECTIVE 2 (PO2): To explore whether add-on polyunsaturated fatty acid ethyl esters, 1000 mg, with an EPA and DHA content not lower than 85% improves disease activity control compared with TNF-alpha inhibitor therapy alone.

Inclusion: Participant must be 18 to 75 years of age inclusive at the time of signing the informed consent; Diagnosis of psoriatic arthritis according to CASPAR classification criteria; Active PsA defined as DAPSA >14 despite ongoing treatment; Eligible to initiate TNF-alpha inhibitor therapy according to clinical practice, the treating rheumatologist’s judgement, applicable national/international recommendations, and the current Summary of Product Characteristics of the selected medicinal product; Planned initiation of a first TNF-alpha inhibitor as the first biologic DMARD; No prior exposure to biologic (b)DMARDs or targeted synthetic (ts)DMARDs for PsA (namely, b/tsDMARD naive patients); If receiving methotrexate, leflunomide or sulfasalazine, the dose must be stable for at least 4 weeks before baseline and expected to remain stable during the trial, unless a change is clinically indicated; Ability and willingness to comply with the protocol requirements, scheduled visits, clinical assessments, questionnaires, ultrasound assessment, blood sampling, and study procedures.

Exclusion: Major surgery within the previous 8 weeks, or planned major surgery during the 6-month treatment period; Current or previous documented atrial fibrillation or atrial flutter; Any contraindication to initiation of TNF-alpha inhibitor therapy according to the treating rheumatologist’s judgement, national/international recommendations, or the applicable product information; Current treatment with conventional synthetic DMARDs other than methotrexate, leflunomide or sulfasalazine, unless discontinued before baseline according to investigator judgement and local practice; Initiation or dose change of methotrexate, leflunomide or sulfasalazine within 4 weeks before baseline; Participation in another interventional clinical trial within 30 days before screening or current participation in another interventional trial that may interfere with the objectives, procedures or safety assessment of this study; -Positive pregnancy test at Screening or Baseline before randomization in a woman of childbearing potential. - Pregnancy or breastfeeding. -Inability or unwillingness of a woman of childbearing potential to use an adequate method of pregnancy prevention, as defined in Section 5.4.2, during treatment with the investigational medicinal product. - For male participants, inability or unwillingness to comply with the reproductive requirements specified in Section 5.4.2. - Inability or unwillingness to comply with any additional reproductive-risk precautions required by the current Summary of Product Characteristics of a concomitant or background medicinal product, where applicable; Treatment with systemic glucocorticoids within the previous 8 weeks before baseline; Treatment with NSAIDs within the previous 2 weeks before baseline; Prior exposure to any biologic DMARD or targeted synthetic DMARD for PsA; Current treatment with omega-3 supplements, prescription omega-3 medicinal products, SPM-containing supplements, or other non-study products specifically intended to increase omega-3/SPM exposure within 4 weeks before baseline; Inflammatory musculoskeletal disease other than PsA, including but not limited to rheumatoid arthritis, axial spondyloarthritis not attributable to PsA, systemic lupus erythematosus, crystal arthritis as the main cause of symptoms, polymyalgia rheumatica, or other connective tissue disease considered by the investigator to interfere with trial assessments; Known hypersensitivity to polyunsaturated fatty acid ethyl esters, omega-3-acid ethyl esters, fish-derived products, or any component of the investigational medicinal product; Clinically relevant bleeding disorder or high bleeding risk that, in the investigator’s judgement, makes participation unsafe; Current anticoagulant or antiplatelet therapy that, in the investigator’s judgement, creates an unacceptable bleeding risk in the context of the investigational intervention; Clinically significant liver disease or liver test abnormality that, in the investigator’s judgement, may place the participant at unacceptable risk or interfere with trial participation; Any other condition that, in the investigator’s judgement, would make participation in the trial inappropriate; Malignancy or lymphoproliferative disorder within the past 5 years, except adequately treated non-melanoma skin cancer or other malignancies considered by the investigator to have negligible recurrence risk, if acceptable according to local clinical practice and regulatory requirements; Active infection or clinically significant uncontrolled infection at screening or baseline; Planned use of non-study omega-3 supplements or prescription omega-3 medicinal products during the trial; Positive pregnancy test at screening or baseline in participants of childbearing potential; Screening or baseline findings that, in the investigator’s judgement, indicate that the participant is not suitable for trial participation; Inability or unwillingness to use an adequate method of contraception during the study, where applicable or indicated; Inability to provide informed consent or to comply with protocol procedures; Severe non-rheumatic comorbidity that, in the investigator’s judgement, may place the participant at unacceptable risk or interfere with study participation or interpretation of study outcomes.

EU CTIS 2026-526768-20-00