Study on Long-Term Safety and Efficacy of Tildrakizumab for Adults with Psoriatic Arthritis

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What is this study about?

This clinical trial is focused on studying the long-term safety and effectiveness of a medication called tildrakizumab in patients with Psoriatic Arthritis. 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. The medication being tested, tildrakizumab, is given as an injection under the skin using a pre-filled syringe. It is designed to help reduce inflammation and improve symptoms in people with this condition.

The purpose of the study is to evaluate how safe and well-tolerated tildrakizumab is over a long period, as well as how effective it is in treating Psoriatic Arthritis. Participants in the study will receive regular injections of tildrakizumab and will be monitored by healthcare professionals to assess their response to the treatment. The study will also track any side effects or adverse events that may occur during the treatment period.

Throughout the study, participants will have regular check-ups and assessments to monitor their health and the progress of their condition. These assessments will help determine how well the medication is working and ensure the safety of the participants. The study aims to provide valuable information about the long-term use of tildrakizumab in managing Psoriatic Arthritis.

1 joining the study

Upon joining the study, you will be asked to provide written consent. This means you agree to participate and understand the study requirements.

You will need to confirm that you can follow the study rules, attend scheduled treatments, and complete necessary assessments.

2 initial assessment

An initial assessment will be conducted to ensure you meet all criteria from the previous study and have not developed any conditions that would prevent participation.

This assessment will include a review of your medical history and current health status.

3 treatment administration

You will receive the medication tildrakizumab, which is provided as a solution for injection in a pre-filled syringe.

The medication is administered subcutaneously, meaning it is injected under the skin.

4 ongoing treatment

The treatment will continue over a long-term period, with regular injections as specified by the study protocol.

You will be monitored for any side effects or adverse reactions throughout the study.

5 regular assessments

You will undergo regular assessments to evaluate the safety and effectiveness of the treatment.

These assessments will include checking for any adverse events and measuring your response to the treatment using specific criteria.

6 completion of study

The study is expected to continue until December 2028, at which point your participation will conclude.

Final assessments will be conducted to gather data on the long-term effects of the treatment.

Who Can Join the Study?

The study is for adults with Psoriatic Arthritis (PsA), a type of arthritis that affects some people with the skin condition psoriasis.
You must be able to understand what the study involves.
You need to sign a form to show you agree to take part in the study. This form is called an informed consent form.
You must agree to follow the study rules, attend scheduled treatments, and complete all required tests and procedures.
You should have participated in a previous related study, completed its treatment period, and not have any reasons that would have required you to stop that study early.
Both men and women can participate in this study.
The study includes people who might need extra protection or care, known as a vulnerable population.

Who Cannot Join the Study?

Patients who do not have Psoriatic Arthritis cannot participate.
Patients who are not adults cannot participate.
Patients who are not able to understand or follow the study procedures cannot participate.
Patients who have any other medical condition that might interfere with the study cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have participated in another clinical trial recently may not be eligible.
Patients who have a history of allergic reactions to similar medications cannot participate.
Patients who are taking certain medications that 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
Osteo-Medic s.c. Artur Racewicz, Jerzy Supronik	Bialystok	Poland
NZOZ LECZNICA MAK-MED s.c.	Nadarzyn	Poland

Other Sites

Site Name	City	Country
Hospital Universitario Virgen De Valme	Sevilla	Spain
Reum.hapi s.r.o.	Nove Mesto Nad Vahom	Slovakia
Centrum Medyczne Oporow	Wroclaw	Poland
Etyka Osrodek Badan Klinicznych Tomasz Pesta S.K.A.	Olsztyn	Poland
St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr	Herne	Germany
Revmatologicky Ustav	Prague	Czechia
Kliiniliste Uuringute Keskus OÜ	Tartu	Estonia
Universita’ Degli Studi Di Verona	Verona	Italy
Universidade De Santiago De Compostela	Santiago De Compostela	Spain
Medman s.r.o.	Martin	Slovakia
Reumed Sp. z o.o.	Lublin	Poland
Ai Centrum Medyczne Sp. z o.o.	Poznan	Poland
Hospital Quironsalud Sagrado Corazon	Sevilla	Spain
Clinicmed Daniluk Nowak Sp. k.	Bialystok	Poland
Rheumatologische Schwerpunktpraxis	Berlin	Germany
PV-Medical s.r.o.	Zlin	Czechia
Centrum Medyczne All-Med Badania Kliniczne	Cracow	Poland
Rheuma Medicus Sp. z o.o.	Warsaw	Poland
Innomedica OÜ	Nomme Linnaosa	Estonia
MUDR. Zuzana URBANOVA	Prague	Czechia
Mlemslpbv Itksiqggup Cxwcsgqn Sdvehjhi Sha z okhy	Warsaw	Poland
Mkvzskdbxe Oc	Tartu	Estonia
Ftzzdnspx Pxrz Lu Iydfxqrrdjyhd Bapzxritw Dgz Hodwodsi Utnnayryurrtt Lu Plt	Madrid	Spain
Rulvfyywuvcj smqzfs	Brno-Sever	Czechia
Hheyfsim Udwzptaozdckb dl A Cvyhiq	A Coruna Galicia	Spain

Trial status

Country	Status	Recruitment Start
Czechia	Not recruiting	30.03.2023
Estonia	Not recruiting	30.03.2023
Germany	Not recruiting	30.03.2023
Italy	Not recruiting	30.03.2023
Poland	Not recruiting	30.03.2023
Slovakia	Not recruiting	30.03.2023
Spain	Not recruiting	30.03.2023

Trial locations

Investigated drugs:

Tildrakizumab

Tildrakizumab is a medication used in this clinical trial to help people with psoriatic arthritis, a condition that causes joint pain and skin problems. This medication works by targeting a specific part of the immune system that is involved in causing inflammation and symptoms of psoriatic arthritis. The goal of using Tildrakizumab in this study is to see how safe it is for long-term use and how well it can help reduce the symptoms of psoriatic arthritis over time. Participants in the trial will receive this medication to see if it can improve their condition and make them feel better.

Psoriatic Arthritis – Psoriatic Arthritis is a chronic inflammatory condition that affects both the skin and joints. It is characterized by joint pain, stiffness, and swelling, which can lead to joint damage over time. The disease often progresses with periods of flare-ups and remissions, where symptoms can worsen or improve. Skin symptoms typically include red, scaly patches known as psoriasis, which can appear on various parts of the body. As the disease progresses, it can affect multiple joints, including those in the fingers, toes, and spine. The severity and progression of symptoms can vary widely among individuals.

Trial ID:

2022-501480-41-00

Protocol code:

TILD-21-01

NCT ID:

NCT04991116

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Long-Term Safety and Efficacy of Tildrakizumab for Adults with Psoriatic Arthritis

What is this study about?

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