Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not yet recruiting

Add‑on Unsaturated Fatty Acids with TNF‑Alpha Inhibitor Drug Combination in Patients with Psoriatic Arthritis

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

Psoriatic arthritis is a joint disease that often occurs with skin psoriasis and can cause pain, swelling, and stiffness in the joints. Standard treatment may include medicines that block a protein called tumor necrosis factor, known as TNF-alpha inhibitor therapy. Examples of these medicines are adalimumab, certolizumab pegol, golimumab, infliximab, and etanercept. In this trial, participants also receive a dietary supplement containing polyunsaturated fatty acid ethyl esters that provides high levels of the omega‑3 fats EPA and DHA.

The purpose of the study is to see whether adding the omega‑3 supplement to the standard biologic therapy reduces pain and improves control of the disease compared with the biologic therapy alone. Participants are randomly assigned to receive either the biologic medicine by itself or the biologic plus the supplement for about six months. During this time, they attend regular clinic visits where they report their pain, answer questionnaires about daily activities, and have their joints examined by a doctor. No invasive procedures are required beyond routine blood draws.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment and randomization

    After providing informed consent, you are assigned by the study system to one of two groups: tnf-alpha inhibitor alone or polyunsaturated fatty acid ethyl esters plus a tnf-alpha inhibitor. the assignment is random and open-label, meaning you will know which treatment you receive.

  2. Step 2

    Baseline assessments

    Before starting any medication, a series of measurements are taken, including pain rating on a 0–10 scale, joint counts, skin and nail assessments, and quality‑of‑life questionnaires. blood samples are also collected for laboratory analysis.

  3. Step 3

    Start of study medication

    You receive a tnf-alpha inhibitor by subcutaneous injection (under the skin). the specific drug and dose are chosen from the following options:

    adalimumab 2.86 mg, certolizumab pegol 57.14 mg, golimumab 100 mg, infliximab 8.57 mg, or etanercept 7.14 mg. the injection schedule follows the standard regimen for the selected product and is administered by a health professional or trained self‑injector.

    If you are in the add‑on group, you also take polyunsaturated fatty acid ethyl esters orally at a dose of 1000 mg once daily. the preparation contains at least 85 % epa and dha, which are types of omega‑3 fatty acids. oral tablets are taken with water and may be taken with or without food.

  4. Step 4

    Month 3 follow‑up visit

    Three months after the first dose, you attend a clinic visit. the same set of assessments performed at baseline is repeated to evaluate changes in pain, joint swelling, skin involvement, and overall disease activity. blood is drawn again for laboratory tests. the study medication continues unchanged unless a safety issue is identified.

  5. Step 5

    Month 6 final visit

    Six months after starting treatment, a final assessment is performed. pain intensity, minimal disease activity status, and all secondary outcome measures are recorded. additional blood samples are collected to analyze biochemical markers. after this visit, the study medication is discontinued according to the protocol.

  6. Step 6

    Study completion

    Following the month 6 visit, you are no longer required to take the investigational products. you may continue any regular therapy for psoriatic arthritis as prescribed by your usual health‑care provider.

Who can join the trial?

8 criteria

  • You must be between 18 and 75 years old when you sign the consent form.
  • You need a confirmed diagnosis of psoriatic arthritis using the CASPAR classification criteria (a set of rules doctors use to identify this condition).
  • Your disease must be active, shown by a DAPSA score higher than 14 even though you are already on treatment. (DAPSA is a number that adds together joint pain, swelling, and other signs to show how active the arthritis is.)
  • You must be considered eligible to start a TNF-alpha inhibitor medication, based on your doctor’s judgment and current treatment guidelines. (TNF-alpha inhibitor drugs block a protein that causes inflammation.)
  • You must be planning to begin your first TNF-alpha inhibitor as your first biologic disease‑modifying anti‑rheumatic drug (biologic DMARD). (Biologic DMARD are advanced medicines that target specific parts of the immune system.)
  • You must not have used any biologic or targeted synthetic disease‑modifying anti‑rheumatic drugs (biologic DMARDs or targeted synthetic DMARDs) before for psoriatic arthritis. (Targeted synthetic DMARDs are newer oral medicines that block particular pathways in the immune system.)
  • If you are taking methotrexate, leflunomide, or sulfasalazine, the dose must have been stable for at least four weeks before the study starts and should stay the same during the trial, unless your doctor needs to change it for medical reasons. (These are common medicines used to control arthritis.)
  • You must be able and willing to follow the study rules, attend scheduled visits, complete questionnaires, allow an ultrasound assessment, give blood samples (blood sampling), and take part in other study procedures.

Who cannot join the trial?

25 criteria

  • Having another inflammatory joint disease besides psoriatic arthritis, such as rheumatoid arthritis, axial spondyloarthritis, lupus, crystal arthritis, polymyalgia rheumatica, or other connective‑tissue diseases that could affect study results.
  • Having had major surgery in the past 8 weeks or planning to have major surgery during the 6‑month study period.
  • Having a current or past diagnosis of atrial fibrillation or atrial flutter (irregular heart rhythm).
  • Being allergic to the study drug, which contains polyunsaturated fatty acid ethyl esters, omega‑3‑acid ethyl esters, fish‑derived products, or any ingredient of the medication.
  • Having a bleeding disorder or a high risk of bleeding that the doctor believes makes participation unsafe.
  • Any medical reason that prevents starting a TNF‑alpha inhibitor therapy, according to the treating doctor, guidelines, or product information.
  • Planning to take any omega‑3 supplements or prescription omega‑3 medicines that are not part of the study.
  • Currently taking conventional synthetic DMARDs (disease‑modifying antirheumatic drugs) other than methotrexate, leflunomide, or sulfasalazine, unless those medicines are stopped before the first study visit.
  • Starting or changing the dose of methotrexate, leflunomide, or sulfasalazine within 4 weeks before the first study visit.
  • Using blood‑thinning medicines (anticoagulants) or antiplatelet drugs that the doctor thinks create an unacceptable bleeding risk with the study medication.
  • Having taken part in another interventional clinical trial within 30 days before screening, or currently being in another trial that could interfere with this study.
  • Having significant liver disease or abnormal liver test results that could place you at risk or affect study participation.
  • Testing positive for pregnancy at screening or baseline if you could become pregnant.
  • Any other findings that the doctor believes make you unsuitable for the trial.
  • Being unable or unwilling to use an adequate method of contraception during the study, when required.
  • Being unable to give informed consent (agreeing to join after understanding the study) or to follow the study procedures.
  • Any other medical condition that the doctor thinks would make participation inappropriate.
  • Being pregnant, breastfeeding, or unable/unwilling to follow the required pregnancy‑prevention measures (including for male participants who must follow reproductive safety rules).
  • Having taken systemic glucocorticoids (steroid medications that affect the whole body) within the 8 weeks before the first study visit.
  • Having taken NSAIDs (non‑steroidal anti‑inflammatory drugs such as ibuprofen) within the 2 weeks before the first study visit.
  • Having previously used any biologic DMARD (medicines made from living cells that target the immune system) or targeted synthetic DMARD for psoriatic arthritis.
  • Currently using omega‑3 supplements, prescription omega‑3 medicines, SPM‑containing supplements, or any other product intended to increase omega‑3/SPM levels within 4 weeks before the first study visit.
  • Having a severe non‑rheumatic (non‑joint) illness that could put you at high risk or interfere with study results.
  • Having had cancer or a lymphoproliferative disorder (a disease of the blood‑forming system) within the past 5 years, except for adequately treated non‑melanoma skin cancer or other cancers judged to have a very low chance of returning.
  • Having an active infection or a serious uncontrolled infection at screening or baseline.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not yet recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • Adalimumab

    is a medication that blocks a protein called tumor necrosis factor‑alpha (TNF‑α). By lowering the activity of this protein, it helps reduce inflammation and pain in joints and skin that are affected by psoriatic arthritis. In this study it is used as one of the standard treatments against which the new therapy is compared.

  • Certolizumab pegol

    is another TNF‑α blocker. It works by attaching to TNF‑α and preventing it from causing inflammation. This drug is given by injection under the skin and is commonly used to control the symptoms of psoriatic arthritis. It serves as a comparator in the trial.

  • Golimumab

    is a TNF‑α inhibitor that is also administered by subcutaneous injection. It reduces the inflammatory response that leads to joint damage and skin lesions in psoriatic arthritis patients. In the trial it is one of the reference treatments.

  • Infliximab

    is a medication that binds to TNF‑α and stops it from triggering inflammation. It is given by infusion or injection and helps improve joint pain and skin symptoms in people with psoriatic arthritis. It is included as a comparator in the study.

  • Etanercept

    is a biologic drug that works as a “decoy” receptor for TNF‑α, soaking up the protein so it cannot cause inflammation. Given by injection under the skin, it helps lessen joint swelling and skin plaques in psoriatic arthritis. It is used as another comparator in the trial.

  • Polyunsaturated fatty acid ethyl esters

    (a mixture rich in EPA and DHA) are taken orally as a nutritional supplement. These fatty acids have anti‑inflammatory properties and may help lower pain and improve disease control when added to standard TNF‑α inhibitor therapy. In this study they are the test treatment being evaluated for added benefit.

What is already known about the treatment

  • Adalimumab

    This medicine is given by a small injection under the skin. It is an approved drug that has been studied in many clinical papers for treating inflammatory diseases. It is mainly used for conditions like psoriatic arthritis and rheumatoid arthritis. It works by attaching to a protein called TNF‑alpha, stopping it from causing inflammation, and it belongs to the class of anti‑TNF monoclonal antibodies.

  • Certolizumab pegol

    This drug is also taken as a subcutaneous injection. It is an approved therapy that appears in many research studies for autoimmune disorders. It is used to treat psoriatic arthritis and similar joint diseases. It binds to TNF‑alpha and blocks its activity, and it is classified as a pegylated anti‑TNF biologic.

  • Golimumab

    Golimumab is administered by injection under the skin. It is a licensed medication with extensive clinical literature for inflammatory joint conditions. It is prescribed for psoriatic arthritis, ulcerative colitis and other autoimmune diseases. It works by linking to TNF‑alpha and preventing it from triggering inflammation, and it is a monoclonal antibody anti‑TNF agent.

  • Infliximab

    Infliximab is usually given by an injection into a vein, but it can also be used subcutaneously. It is an approved biologic that has been widely studied for many immune‑mediated illnesses. It is used for psoriatic arthritis, Crohn’s disease and similar conditions. It attaches to TNF‑alpha, neutralizing its effect, and it belongs to the class of chimeric anti‑TNF monoclonal antibodies.

  • Etanercept

    Etanercept is taken as a subcutaneous injection. It is an established drug with a large body of research supporting its use. It is indicated for psoriatic arthritis, rheumatoid arthritis and other inflammatory disorders. It acts as a decoy receptor that catches TNF‑alpha before it can cause inflammation, and it is classified as a TNF‑receptor fusion protein.

  • Polyunsaturated fatty acid ethyl esters

    This product is taken as an oral capsule or liquid. It is a dietary supplement that has been examined in many nutrition and medical studies. It is used to provide omega‑3 fatty acids, especially EPA and DHA, which may help reduce joint pain and inflammation. It supplies the body with fatty acids that can lower inflammatory signals, and it is classified as a polyunsaturated fatty acid supplement.

Investigated diseases

Psoriatic arthritis - Psoriatic arthritis is a chronic inflammatory disease that affects both the joints and the skin. It often starts with pain, swelling, and stiffness in the fingers and toes and can spread to larger joints over time. As the condition progresses, joint damage may increase and the spine can become involved, leading to reduced mobility.
Trial detailsLast updated 8 Oct 2026
Age18+ yearsPhasePhase IITrial ID2026-526768-20-00Protocol codeResolve-PSAEstimated enrolment50 patientsSponsorFondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata Fon

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.