Not recruiting

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

Fast replyRegistered drugNo placebo

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 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.
Step 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.
Step 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.
Step 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.
Step 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.
Step 6
Study duration
The study is expected to continue until August 2026, with recruitment starting in December 2024.

Who can join the trial?

11 criteria

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.
check
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.
- check
  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 trial?

10 criteria

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.

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Responsive
Futuremeds Sp. z o.o.
Wroclaw, Poland

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

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.

What is already known about the treatment

CT-P13 – This medication is administered subcutaneously, meaning it is injected under the skin. It is currently being studied in a Phase 3 clinical trial to assess its effectiveness and safety for treating moderately to severely active rheumatoid arthritis. The main therapeutic indication for CT-P13 is rheumatoid arthritis, a condition characterized by inflammation and pain in the joints. At the molecular level, CT-P13 works by targeting and inhibiting specific proteins involved in the inflammatory process, thereby reducing inflammation and alleviating symptoms. It is classified pharmacologically as a monoclonal antibody, which is a type of biologic drug designed to interact with specific targets in the body.

Investigated diseases

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.