Study on the Effectiveness of Ixekizumab and Methotrexate for Treating Dactylitis in Patients with Psoriatic Arthritis

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What is this study about?

This clinical trial is focused on studying the effects of two treatments for , a condition that causes joint pain and swelling, often accompanied by skin psoriasis. The study will compare the effectiveness of two medications: , known by the brand name Taltz, and , known by the brand name Metother. Ixekizumab is a solution for injection that targets specific proteins in the body to reduce inflammation, while methotrexate is a chemical medication that also helps to control inflammation and is commonly used in various forms of arthritis.

The purpose of this study is to evaluate how well ixekizumab works compared to methotrexate in treating a specific symptom of psoriatic arthritis called dactylitis, which is the swelling of fingers or toes. Participants in the study will receive either ixekizumab or methotrexate as a monotherapy, meaning they will not be combined with other treatments. The study will use a scoring system called the DACTOS score to measure the response to treatment, along with ultrasound assessments to observe changes in the affected areas.

The study will take place over a period of time, with participants receiving their assigned treatment and undergoing regular assessments to monitor their progress. The goal is to determine which treatment is more effective in reducing the symptoms of dactylitis in people with psoriatic arthritis. This information will help improve treatment options for individuals living with this condition.

1 joining the trial

Upon joining the trial, you will be randomly assigned to one of two groups. One group will receive ixekizumab and the other will receive methotrexate. This is to compare the effectiveness of these treatments for psoriatic arthritis dactylitis.

2 initial assessment

An initial assessment will be conducted to evaluate your condition. This includes a physical examination to confirm the presence of active dactylitis, which is a swelling of the fingers or toes.

3 treatment administration

If you are in the ixekizumab group, you will receive an injection of 80 mg of the medication under the skin. If you are in the methotrexate group, you will receive an injection of 50 mg/ml of the medication under the skin. The frequency and duration of these treatments will be explained to you by the medical team.

4 ongoing assessments

Throughout the trial, regular assessments will be conducted to monitor your response to the treatment. These assessments may include physical examinations and ultrasound evaluations to measure the degree of response using the DACTOS score.

5 completion of the trial

At the end of the trial, a final assessment will be conducted to evaluate the overall effectiveness of the treatment you received. This will help determine the best treatment option for psoriatic arthritis dactylitis.

Who Can Join the Study?

Must be an adult (18 years or older).
Must meet the CASPAR criteria for psoriatic arthritis. This is a set of guidelines doctors use to diagnose psoriatic arthritis.
Must not have used csDMARDs or bDMARDs before. These are types of medications used to treat certain conditions.
Must have active dactylitis. This means having swelling of the fingers or toes, which will be checked by a doctor at the study center.

Who Cannot Join the Study?

Patients who are not diagnosed with psoriatic arthritis (PsA) cannot participate. Psoriatic arthritis is a type of arthritis that affects some people who have psoriasis, a condition that features red patches of skin topped with silvery scales.
Patients who are not within the specified age range for the study cannot participate. The study is open to adults.
Patients who are part of a vulnerable population, such as those who cannot give consent or are in a dependent relationship with the study staff, cannot participate.
Patients who are currently participating in another clinical trial cannot participate.
Patients who have any other medical condition that the study doctors think might interfere with the study cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Universita’ Degli Studi Di Palermo	Palermo	Italy

Other Sites

Site Name	City	Country
Asst Centro Specialistico Ortopedico Traumatologico Gaetano Pini Cto	Milan	Italy
Azienda Ospedaliera Ordine Mauriziano Di Torino	Turin	Italy
Universita’ Degli Studi Di Perugia	Perugia	Italy
Azienda Ospedaliera di Padova	Padua	Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I G M Lancisi G Salesi	Ancona	Italy
Universita’ Campus Bio-medico Di Roma	Rome	Italy
Fondazione Salvatore Maugeri Clinica Del Lavoro E Della Riabilitazione	Pavia	Italy
Ajogzal Sbqectspu Liwfof Rhvy 1	Rome	Italy

Trial status

Country	Status	Recruitment Start
Italy	Not yet recruiting	01.12.2025

Trial locations

Investigated drugs:

Methotrexate

Ixekizumab is a medication used to treat certain autoimmune conditions, such as psoriatic arthritis. It works by blocking a specific protein in the body that causes inflammation and other symptoms of the disease. In this clinical trial, ixekizumab is being tested to see how well it can reduce the symptoms of psoriatic arthritis, particularly in the fingers and toes, which is known as dactylitis.

Methotrexate is a medication that is commonly used to treat various autoimmune diseases, including psoriatic arthritis. It helps to reduce inflammation and slow down the disease process by affecting the immune system. In this trial, methotrexate is being used to compare its effectiveness against ixekizumab in treating dactylitis in patients with psoriatic arthritis.

Investigated diseases:

Psoriatic arthropathy

Psoriatic Arthritis – Psoriatic arthritis is a chronic inflammatory condition that affects the joints and areas where tendons and ligaments connect to bone. It often occurs in individuals with psoriasis, a skin condition characterized by red, scaly patches. The disease can cause joint pain, stiffness, and swelling, which may lead to reduced range of motion and joint damage over time. Symptoms can vary widely among individuals, with some experiencing mild discomfort and others facing severe joint issues. The progression of psoriatic arthritis can be unpredictable, with periods of increased symptoms, known as flares, and times of remission. Dactylitis, or swelling of the fingers and toes, is a common feature of this condition.

Trial ID:

2022-503119-40-00

Protocol code:

DACTOS

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effectiveness of Ixekizumab and Methotrexate for Treating Dactylitis in Patients with Psoriatic Arthritis

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?