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Study on Tildrakizumab for Patients with Active Psoriatic Arthritis Who Have Not Used Anti-TNF Therapy

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What is this study about?

This clinical trial is focused on studying Psoriatic Arthritis, a condition that causes joint pain and swelling in people who have psoriasis, a skin disease. The study is testing a treatment called Tildrakizumab, which is given as an injection under the skin. The trial will compare the effects of Tildrakizumab to a placebo to see how well it works and how safe it is for people who have not previously been treated with anti-TNF medications, which are drugs that reduce inflammation by blocking a protein called tumor necrosis factor.

The purpose of the study is to evaluate the effectiveness and safety of Tildrakizumab in people with active Psoriatic Arthritis. Participants in the study will receive either Tildrakizumab or a placebo and will be monitored over a period of 24 weeks. During this time, researchers will assess how many participants experience a 20% improvement in their symptoms, as well as monitor any side effects.

This study aims to provide valuable information about the potential benefits and risks of using Tildrakizumab for treating Psoriatic Arthritis. By participating, individuals will contribute to research that could lead to better treatment options for this condition in the future.

1 initial treatment phase

The study begins with the administration of the investigational medication, tildrakizumab, or a placebo. This is done through a subcutaneous injection, which means the medication is injected under the skin.

The medication is provided in a pre-filled syringe, containing either Ilumetri 100 mg or a placebo solution. The exact dosage and frequency of administration will be determined by the study protocol.

2 ongoing treatment and monitoring

Participants will continue to receive the assigned treatment over a period of 24 weeks. During this time, regular monitoring will occur to assess the effectiveness and safety of the treatment.

Participants may be required to maintain stable doses of any concurrent medications, such as methotrexate, leflunomide, or oral corticosteroids, unless adjustments are needed due to side effects.

3 evaluation of treatment response

At the end of the 24-week period, the primary goal is to evaluate the proportion of participants who achieve a 20% improvement in symptoms, as measured by the American College of Rheumatology response criteria, known as ACR20.

Secondary evaluations will include assessments of more significant improvements, such as ACR50 and ACR70, as well as changes in physical function and skin condition.

4 completion of study participation

Upon completion of the study, participants will undergo a final assessment to determine the overall impact of the treatment on their condition.

The study is expected to conclude by August 2025, with all data collected and analyzed to understand the efficacy and safety of tildrakizumab for treating psoriatic arthritis.

Who Can Join the Study?

  • The person must have given written permission to participate in the study.
  • If taking methotrexate (a medication for arthritis) or leflunomide (another arthritis medication), the person must have been on a stable dose for at least 3 months and continue the same dose for the first 24 weeks of the study. They cannot take both medications at the same time.
  • If taking oral corticosteroids (a type of medication that reduces inflammation), the person must be on a stable dose not exceeding the equivalent of 10 mg of prednisone per day for at least 4 weeks before starting the study and continue the same dose for the first 24 weeks.
  • The person must have a negative test for tuberculosis (TB) within 4 weeks before starting the study. If the test is positive or unclear, additional checks are needed to ensure no active TB is present.
  • The person must be 18 years or older at the time of the study screening.
  • The person must have been diagnosed with active Psoriatic Arthritis (PsA) for at least 6 months and have active symptoms at the time of screening and the start of the study.
  • The person must have at least 3 tender and 3 swollen joints at screening and the start of the study. Dactylitis (swelling of a finger or toe) counts as one joint for eligibility.
  • The person must test negative for rheumatoid factor (RF) and anti-cyclic citrullinated peptide antibodies (anti-CCP Ab), which are markers often found in other types of arthritis.
  • The person must have active plaque psoriasis (PsO), with at least one psoriatic plaque of 2 cm or more in diameter at screening or a history of plaque psoriasis.
  • The person must not have previously used anti-tumor necrosis factor (anti-TNF) agents for treating Psoriasis or Psoriatic Arthritis.
  • If taking non-steroidal anti-inflammatory drugs (NSAIDs) or low-strength painkillers like tramadol, meperidine, or codeine, the person must be on a stable dose for at least 4 weeks before starting the study and continue the same dose for the first 24 weeks, unless a change is needed due to side effects.
  • If receiving non-drug therapies like physical therapy, massage, diet, exercise, skin moisturizers, or joint taping, these must be stable for the 4 weeks before starting the study and continue through the study period.

Who Cannot Join the Study?

  • Patients who have previously been treated with medications known as anti-Tumour Necrosis Factor (TNF) therapies. These are drugs used to reduce inflammation in certain conditions.
  • Patients who do not have active psoriatic arthritis, which is a type of arthritis that affects some people with the skin condition psoriasis.
  • Patients who are not within the specified age range for the study.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Osteo-Medic s.c. Artur Racewicz, Jerzy Supronik Bialystok Poland

Other Sites

Site Name City Country Status
Revmatologicky Ustav Prague Czechia
Reumed Sp. z o.o. Lublin Poland
Hospital Quironsalud Sagrado Corazon Sevilla Spain
Clinicmed Daniluk Nowak Sp. k. Bialystok Poland
Rheumatologische Schwerpunktpraxis Berlin Germany
Ai Centrum Medyczne Sp. z o.o. Poznan Poland
Rheuma Medicus Sp. z o.o. Warsaw Poland
St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr Herne Germany
PV-Medical s.r.o. Zlin Czechia
MUDR. Zuzana URBANOVA Prague Czechia
Rllbdwsycduz scwemu Brno-Sever Czechia
Fmqivgtfo Pblv Lu Ikyqjkxlnclbd Bfkzqwoss Dai Hgghdtje Uftcysqvapdeh Lf Pyq Madrid Spain
Hoigtmcj Ucmnmbgzrpyvh de A Cfjjie A Coruna Galicia Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Czechia Czechia
Not recruiting
22.12.2020
Germany Germany
Not recruiting
22.12.2020
Poland Poland
Not recruiting
22.12.2020
Spain Spain
Not recruiting
22.12.2020

Trial locations

Investigated drugs:

Tildrakizumab is a medication being studied for its effectiveness and safety in treating individuals with active psoriatic arthritis who have not previously received anti-TNF therapy. It is designed to help reduce inflammation and improve symptoms by targeting specific pathways in the immune system. The goal of the trial is to see if patients experience a significant improvement in their condition, specifically a 20% reduction in symptoms, after 24 weeks of treatment.

Psoriatic Arthritis – Psoriatic arthritis is a chronic inflammatory condition that affects both the skin and joints. It is associated with psoriasis, a skin disease characterized by red, scaly patches. The disease can cause joint pain, stiffness, and swelling, which may worsen over time. It often affects the fingers and toes, leading to a sausage-like appearance known as dactylitis. The progression of psoriatic arthritis can vary, with periods of increased symptoms followed by times of remission. Over time, it can lead to joint damage and reduced physical function if not managed properly.

Trial ID:
2024-512142-42-00
Protocol code:
TILD-19-19
Trial Phase:
Therapeutic confirmatory (Phase III)

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