Study on the Effectiveness and Safety of CT-P13 for Patients with Moderate to Severe Rheumatoid Arthritis

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What is this study about?

This clinical trial is focused on studying the effects of a medication called CT-P13 on patients with rheumatoid arthritis, a condition that causes pain and swelling in the joints. The study aims to evaluate how effective and safe CT-P13 is when given as a subcutaneous injection, which means it is injected under the skin. The trial will compare the effects of CT-P13 to a placebo, which is a substance with no active medication, to see if CT-P13 provides better relief from the symptoms of rheumatoid arthritis.

Participants in the study will receive either CT-P13 or a placebo over a period of time. The study will monitor the participants’ response to the treatment, specifically looking for a 20% improvement in their symptoms by the 12th week, as defined by the American College of Rheumatology (ACR). This improvement is known as the ACR20 response. The study will also involve other medications that are commonly used to manage rheumatoid arthritis, such as methotrexate, ibuprofen, paracetamol, hydroxychloroquine, hydrocortisone, and folic acid. These medications help reduce inflammation, relieve pain, and support overall health during the trial.

The trial is designed to last for several weeks, during which participants will be closely monitored by healthcare professionals. The goal is to determine if CT-P13 is more effective than the placebo in improving the symptoms of rheumatoid arthritis, providing valuable information for future treatment options. Participants will receive regular check-ups and assessments to ensure their safety and to track the progress of their condition throughout the study.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, diagnosis of rheumatoid arthritis, and active disease status.

Blood tests are performed to ensure adequate kidney and liver function, as well as to check blood cell counts.

2 baseline treatment

Patients must have been receiving methotrexate, a medication for rheumatoid arthritis, for at least 12 weeks prior to the study. The dosage should be stable between 10 to 25 mg per week for at least 4 weeks before starting the study.

3 study drug administration

The study involves the administration of a medication called CT-P13, which is given as a subcutaneous injection. This means it is injected under the skin.

A placebo, which is a substance with no active medication, may also be administered to maintain the study’s blindness. This ensures that neither the patient nor the researchers know who is receiving the actual medication.

4 additional medications

Other medications may be used during the study, including ibuprofen and paracetamol, which are taken orally to help manage pain.

Hydroxychloroquine and folic acid are also taken orally. Folic acid is often used to reduce side effects of methotrexate.

Hydrocortisone may be administered intravenously, which means it is given directly into a vein.

5 monitoring and follow-up

Patients are monitored regularly to assess the effectiveness of the treatment and to check for any side effects.

The primary goal is to see if there is a 20% improvement in symptoms by week 12, according to specific criteria for rheumatoid arthritis.

6 study duration

The study is expected to continue until August 2026, with recruitment starting in December 2024.

Who Can Join the Study?

The patient must be a male or female between the ages of 18 and 75.
The patient must have been diagnosed with rheumatoid arthritis (RA) at least 24 weeks before starting the study medication. This diagnosis should meet specific criteria set by medical organizations.
The patient must have active RA, which means having 6 or more swollen joints and 6 or more tender joints. Additionally, they must have certain levels of inflammation markers in their blood, like C-reactive protein (CRP) or erythrocyte sedimentation rate (ESR).
The patient must have been taking a medication called methotrexate (MTX) for at least 12 weeks and should be on a stable dose of 10 to 25 mg per week for at least 4 weeks before starting the study medication.
The patient must have normal kidney and liver function, as shown by specific blood test results. These include:
- Serum creatinine levels below a certain limit or a creatinine clearance level above 50 mL/min.
- Serum alanine aminotransferase (ALT) and serum aspartate aminotransferase (AST) levels below 2.5 times the upper limit of normal.
- Serum total bilirubin levels below 2 times the upper limit of normal.
The patient must have certain blood test results, including:
- Hemoglobin levels of at least 8.5 g/dL.
- White blood cell count of at least 3.5 x 10³ cells/µL.
- Neutrophil count of at least 1.5 x 10³ cells/µL.
- Platelet count of at least 100 x 10³ cells/µL.

Who Cannot Join the Study?

Patients who have any other serious health conditions that could interfere with the study.
Patients who are currently participating in another clinical trial.
Patients who have had a recent infection that required treatment with antibiotics.
Patients who have a history of allergic reactions to similar medications.
Patients who are pregnant or breastfeeding.
Patients who have a history of drug or alcohol abuse.
Patients who have received certain vaccines recently.
Patients who have a history of cancer, except for some types of skin cancer.
Patients who have a history of certain blood disorders.
Patients who have had a recent surgery or are planning to have surgery during the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Osteo-Medic s.c. Artur Racewicz, Jerzy Supronik	Bialystok	Poland
CENTRUM MEDYCZNE REUMA PARK	Warsaw	Poland
Futuremeds Sp. z o.o.	Wroclaw	Poland
NZOZ LECZNICA MAK-MED s.c.	Nadarzyn	Poland

Other Sites

Site Name	City	Country
Reumed Sp. z o.o.	Lublin	Poland
Etyka Osrodek Badan Klinicznych Tomasz Pesta S.K.A.	Olsztyn	Poland
Niepubliczny Zaklad Opieki Zdrowotnej Biogenes Sp. z o.o	Wroclaw	Poland
Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy	Bydgoszcz	Poland
Mawbsjkat Idvewcpnjo Cyjodzyy Swtakomd Sxr z oqoe	Warsaw	Poland
Swhenahyujp Pwawztodu Zpzism Otcxwx Zpzsxuziwn w Tjufvzyxqj Lqjqgvlym	Tomaszow Lubelski	Poland

Trial status

Country	Status	Recruitment Start
Poland	Not recruiting	02.12.2024

Trial locations

Investigated drugs:

CT-P13 is a medication used in this clinical trial to treat patients with moderately to severely active rheumatoid arthritis. It is administered through an injection under the skin. The goal of using CT-P13 in this study is to see if it can improve the symptoms of rheumatoid arthritis, such as reducing joint pain and swelling, by at least 20% after 12 weeks of treatment.

Investigated diseases:

Rheumatoid arthritis

Rheumatoid arthritis – Rheumatoid arthritis is a chronic inflammatory disorder that primarily affects the joints. It occurs when the immune system mistakenly attacks the body’s own tissues, leading to inflammation. Over time, this inflammation can cause damage to the cartilage and bones within the joints. The disease often begins with symptoms such as joint pain, swelling, and stiffness, particularly in the hands and feet. As it progresses, it can lead to joint deformities and loss of function. The condition can also affect other parts of the body, including the skin, eyes, and lungs.

Trial ID:

2024-510945-32-00

Protocol code:

CT-P13 3.11

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effectiveness and Safety of CT-P13 for Patients with Moderate to Severe Rheumatoid Arthritis

What is this study about?

Who Can Join the Study?

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