Study on Tildrakizumab for Patients with Active Psoriatic Arthritis Who Have Previously 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 purpose of the study is to evaluate how effective and safe Tildrakizumab is for people who have previously been treated with anti-TNF medications, which are drugs that help reduce inflammation in the body.

Participants in the study will receive either Tildrakizumab or a placebo, which looks like the treatment but does not contain the active medicine. The study will last for 24 weeks, during which time participants will receive regular injections and have their health monitored by the study team. The main goal is to see if participants experience a 20% improvement in their symptoms by the end of the study period.

Throughout the study, the safety and tolerability of Tildrakizumab will be closely observed to ensure that it is safe for use in treating Psoriatic Arthritis. Participants will have regular check-ups to monitor their progress and any potential side effects. This study aims to provide valuable information on the effectiveness of Tildrakizumab for individuals with this condition.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and current medications.

A negative tuberculosis (TB) test is required within four weeks before starting the study medication. If TB is detected, appropriate treatment must be completed before participation.

2 baseline evaluation

A baseline evaluation is performed to document the current state of psoriatic arthritis. This includes checking for at least three tender and three swollen joints.

The presence of active psoriatic arthritis is confirmed, and any existing psoriatic plaques are noted.

3 medication administration

The study involves the administration of tildrakizumab or a placebo. Tildrakizumab is given as a subcutaneous injection.

The dosage is 100 mg, administered through a pre-filled syringe. The frequency and duration of administration are determined by the study protocol.

4 ongoing treatment

Participants receiving methotrexate or leflunomide must maintain a stable dose for the first 24 weeks of the study. Methotrexate should not exceed 25 mg per week, and leflunomide should not exceed 20 mg per day.

For those on oral corticosteroids, the dose should not exceed the equivalent of 10 mg of prednisone per day and must remain stable for the first 24 weeks.

5 monitoring and evaluation

Participants are monitored regularly to assess the efficacy and safety of the treatment. This includes evaluating the reduction in symptoms and any side effects.

The primary goal is to achieve a 20% reduction in symptoms by week 24, as measured by specific criteria.

6 study completion

The study is expected to conclude by December 23, 2025. Participants will undergo a final evaluation to document the outcomes of the treatment.

The results will contribute to understanding the effectiveness and safety of tildrakizumab for treating psoriatic arthritis.

Who Can Join the Study?

The patient must have given written permission to participate in the study.
If the patient is taking methotrexate (MTX) or leflunomide, they must have been on this treatment for at least 3 months, with a stable dose for at least 8 weeks before starting the study medication. The dose should not exceed 25 mg of MTX per week or 20 mg of leflunomide per day. The patient should not be taking both medications at the same time.
If the patient is taking oral corticosteroids, they must be on a stable dose (not more than the equivalent of 10 mg of prednisone per day) for at least 4 weeks before starting the study medication.
The patient must have a negative test for tuberculosis (TB) within 4 weeks before starting the study medication. If the test is positive or unclear, the patient can still participate if they have no history or symptoms of active TB, a clear chest X-ray, and have followed treatment guidelines for latent TB if needed.
The patient must be 18 years or older at the time of the study screening.
The patient must have been diagnosed with active Psoriatic Arthritis (PsA) for at least 6 months and have active PsA confirmed at the screening and start of the study.
The patient must have at least 3 tender and 3 swollen joints at the screening and start of the study.
The patient 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 patient must have active plaque psoriasis (PsO), with at least one psoriatic plaque of 2 cm or larger, or a history of plaque PsO.
The patient must have previously used anti-tumor necrosis factor (anti-TNF) agents for treating PsO or PsA.
If the patient is taking non-steroidal anti-inflammatory drugs (NSAIDs) or low potency opioids like tramadol, meperidine, or codeine, they must be on a stable dose for at least 4 weeks before starting the study medication.
If the patient is receiving non-drug therapies like physical therapy, massage, diet, exercise, or joint taping, these must be stable for the 4 weeks before starting the study medication and continue to be stable through the study period.

Who Cannot Join the Study?

Patients who have not experienced treatment with anti-TNF medications. Anti-TNF medications are drugs used to reduce inflammation in conditions like arthritis.
Patients who do not have active psoriatic arthritis. Active means that the symptoms of the disease are currently present and noticeable.
Patients who are part of a vulnerable population. This refers to groups of people who might be at higher risk of harm or exploitation, such as children or those with certain disabilities.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
IRCCS Humanitas Research Hospital	Rozzano	Italy
Osteo-Medic s.c. Artur Racewicz, Jerzy Supronik	Bialystok	Poland
NZOZ LECZNICA MAK-MED s.c.	Nadarzyn	Poland
Innomedica OÜ	Tallin	Estonia

Other Sites

Site Name	City	Country
Revmatologicky Ustav	Prague	Czechia
Reumed Sp. z o.o.	Lublin	Poland
Hospital Quironsalud Sagrado Corazon	Sevilla	Spain
Clinicmed Daniluk Nowak Sp. k.	Bialystok	Poland
Solumed Sp. z o.o. sp.k.	Poznan	Poland
Centrum Medyczne Oporow	Wroclaw	Poland
Centrum Medyczne All-Med Badania Kliniczne	Cracow	Poland
Rheuma Medicus Sp. z o.o.	Warsaw	Poland
Ai Centrum Medyczne Sp. z o.o.	Poznan	Poland
Etyka Osrodek Badan Klinicznych Tomasz Pesta S.K.A.	Olsztyn	Poland
Rheumatologische Schwerpunktpraxis	Berlin	Germany
Medman s.r.o.	Martin	Slovakia
Kliiniliste Uuringute Keskus OÜ	Tartu	Estonia
Universita’ Degli Studi Di Verona	Verona	Italy
Universidade De Santiago De Compostela	Santiago De Compostela	Spain
Hospital Universitario Virgen De Valme	Sevilla	Spain
Pratia S.A.	Skorzewo	Poland
St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr	Herne	Germany
Reum.hapi s.r.o.	Nove Mesto Nad Vahom	Slovakia
MediTrials OÜ	Tartu	Estonia
PV-Medical s.r.o.	Zlin	Czechia
North Estonia Medical Centre Foundation	Tallin	Estonia
MUDR. Zuzana URBANOVA	Prague	Czechia
Rxleacrpvgis soqvjl	Brno-Sever	Czechia
Miggvlbhm Itqvhumwbj Colkygzn Shkwzthe Sgg z ovrj	Warsaw	Poland
Psqb Tbziy Hngrispo Ueqjhfarwqod	Sabadell	Spain
Fkplrvfzq Ppvx Lq Idjxjifghzrvk Bkvbfcgvl Djn Hlbekyxj Ujgdmchtobjxp Lp Pxj	Madrid	Spain
Hystynty Uuqrtlfkccwhs dv A Cphlcr	A Coruna Galicia	Spain

Trial status

Country	Status	Recruitment Start
Czechia	Not recruiting	22.12.2020
Estonia	Not recruiting	22.12.2020
Germany	Not recruiting	22.12.2020
Italy	Not recruiting	22.12.2020
Poland	Not recruiting	22.12.2020
Slovakia	Not recruiting	22.12.2020
Spain	Not recruiting	22.12.2020

Trial locations

Investigated drugs:

Tildrakizumab

Tildrakizumab is a medication being studied for its effectiveness and safety in treating people with active psoriatic arthritis who have previously been treated with anti-TNF medications. The goal of the study is to see if this medication can help reduce the symptoms of psoriatic arthritis, such as joint pain and swelling, by at least 20% after 24 weeks of treatment. The study also aims to ensure that the medication is safe and well-tolerated by the participants.

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. The progression of the disease can vary, with periods of increased symptoms followed by times of remission. It can also lead to changes in the nails, such as pitting or separation from the nail bed.

Trial ID:

2023-507415-35-00

Protocol code:

TILD-19-07

NCT ID:

NCT04314544

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Tildrakizumab for Patients with Active Psoriatic Arthritis Who Have Previously Used Anti-TNF Therapy

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