Not recruiting

Study on the Effects of AP1189 and Methotrexate for Patients with Early Rheumatoid Arthritis and Active Inflammation

Verified siteRegistered drugNo placebo

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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 new treatment for Rheumatoid Arthritis, a condition that causes pain and swelling in the joints. The study will test a medication called AP1189, which is taken as a tablet, in combination with another medication called Methotrexate, also in tablet form. Participants in the study will be those who have recently been diagnosed with rheumatoid arthritis and have not yet been treated with any Disease-Modifying Anti-Rheumatic Drugs (DMARDs).

The purpose of the study is to evaluate how effective and safe the combination of AP1189 and Methotrexate is over a 12-week period. Participants will be randomly assigned to receive either the combination of these medications or a placebo, which looks like the medication but does not contain any active ingredients. The study will compare the effects of the combination treatment to those of Methotrexate alone. The doses of AP1189 being tested are 40 mg, 70 mg, and 100 mg, and the treatment will be taken orally.

Throughout the study, participants will have regular check-ups to monitor their condition and any changes in their symptoms. The study aims to see if the combination of AP1189 and Methotrexate can reduce the activity of the disease and improve the participants' quality of life. The trial is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo, to ensure unbiased results.

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
Joining the study
Upon joining the study, informed consent is required. This involves understanding the trial's purpose and agreeing to participate.
Eligibility is confirmed based on specific criteria, such as age, diagnosis of rheumatoid arthritis, and absence of prior treatment with certain medications.
Step 2
Baseline assessment
A baseline assessment is conducted to evaluate the current state of rheumatoid arthritis. This includes measuring joint tenderness and swelling, and assessing overall disease activity.
Blood tests are performed to check levels of specific proteins and antibodies related to inflammation and rheumatoid arthritis.
Step 3
Treatment initiation
Treatment begins with the administration of methotrexate and AP1189 or a placebo. Methotrexate is taken orally in tablet form.
AP1189 is administered in doses of 40, 70, or 100 mg, also in tablet form, taken orally. The exact dosage is determined randomly.
Step 4
Treatment period
The treatment period lasts for 12 weeks. During this time, the combination of methotrexate and AP1189 or placebo is continued.
Regular monitoring is conducted to assess the response to treatment and any side effects. This includes periodic visits to the study site for evaluations.
Step 5
End of treatment assessment
At the end of the 12-week treatment period, a comprehensive assessment is performed to evaluate changes in disease activity.
This includes measuring joint tenderness and swelling, as well as overall health assessments.
Step 6
Follow-up
After completing the treatment, follow-up visits are scheduled to monitor long-term effects and gather additional data on the treatment's efficacy and safety.
Participants are encouraged to report any ongoing symptoms or side effects during these visits.

Who can join the trial?

12 criteria

You must sign and date a form to show you agree to participate before any trial-specific procedures begin.
You should be willing and able to attend all study visits, follow the treatment plan, and complete all study procedures.
If you are a female who can have children, you must have a negative pregnancy test at the start and again before the trial begins.
If you are sexually active and can have children, you and your partner must use a very effective birth control method during the study and for 90 days after the last dose of the study drug. This includes options like hormonal contraceptives, an intrauterine device, vasectomy, bilateral tubal occlusion, or choosing not to have sex.
You must be at least 18 years old.
You need to have a confirmed diagnosis of **Rheumatoid Arthritis** based on specific criteria from 2010.
Your **Rheumatoid Arthritis** should have been diagnosed no more than 6 months ago, and you should have had symptoms for no more than 18 months. Symptoms include joint pain, swelling, and tenderness.
You should not have taken any **Disease-Modifying Anti-Rheumatic Drugs (DMARDs)** before. This includes conventional, biological, or targeted synthetic DMARDs.
You must have at least 6 tender and 6 swollen joints at the start and during the initial screening.
You should have "high" disease activity, shown by a **Disease Activity Score 28 (DAS28)** with a **C-Reactive Protein (CRP)** score greater than 5.1, and a **Clinical Disease Activity Index (CDAI)** score greater than 22 at the start and during screening.
Your blood test should show a **high sensitive C-Reactive Protein (hsCRP)** level of at least 3 mg/L during screening.
You should test positive for **rheumatoid factor (RF)** or **anti-cyclic citrullinated peptide antibodies (anti-CCP)**. If you do not have these, your **hsCRP** level should be at least 6 mg/L during screening.

Who cannot join the trial?

9 criteria

Patients who have been diagnosed with **Rheumatoid Arthritis** for a long time and have already been treated with other **Disease-Modifying Anti-Rheumatic Drugs (DMARDs)**. These are medications used to slow down the progression of arthritis.
Patients who are not within the specified age range for the study.
Patients who are not able to take oral medications, which means medicines that are swallowed.
Patients who have other serious health conditions that might interfere with the study.
Patients who are pregnant or breastfeeding, as the study may not be safe for them.
Patients who are participating in another clinical trial at the same time.
Patients who have a history of allergic reactions to the study medications.
Patients who have a history of substance abuse, which means using drugs or alcohol in a harmful way.
Patients who are unable to follow the study procedures or instructions.

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Verified sites

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

Verified
Dc-Med Michal Kowalski sp.k.
Swidnica, Poland
Verified
Diagnostic-consultative center “Aleksandrovska” EOOD
Sofia, Bulgaria
Verified
M2m Med. Sp. z o.o.
Chorzow, Poland
Not recruiting

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Investigated drugs

AP1189
is an experimental medication being tested for its effectiveness in treating early rheumatoid arthritis. It is taken orally and is being studied to see how well it works in combination with another medication, methotrexate, over a 12-week period. The goal is to see if AP1189 can help reduce inflammation and improve symptoms in patients who have not previously been treated with other disease-modifying anti-rheumatic drugs.
Methotrexate
is a well-established medication used to treat rheumatoid arthritis. It helps to reduce inflammation and slow the progression of the disease. In this trial, methotrexate is used as a standard treatment to compare the effects of adding AP1189 to the treatment plan. Methotrexate is taken orally and is a common first-line treatment for patients with rheumatoid arthritis.

What is already known about the treatment

AP1189
This medication is administered orally and is currently being studied in clinical trials for its effectiveness in treating rheumatoid arthritis. It is in the phase II stage of clinical research, where its safety and efficacy are being evaluated. The main therapeutic indication for AP1189 is rheumatoid arthritis, particularly in patients who have not previously been treated with disease-modifying anti-rheumatic drugs (DMARDs). At the molecular level, AP1189 works by modulating specific pathways involved in inflammation, aiming to reduce the symptoms of rheumatoid arthritis. It is classified pharmacologically as an anti-inflammatory agent.
Methotrexate
Methotrexate is administered orally and is a well-established medication in the treatment of rheumatoid arthritis. It is widely recognized in medical literature as a first-line treatment for this condition. The primary therapeutic indication for methotrexate is rheumatoid arthritis, where it helps to control inflammation and slow disease progression. Methotrexate works by inhibiting the metabolism of folic acid, which is necessary for the synthesis of DNA and RNA, thereby reducing the proliferation of inflammatory cells. It is classified as a disease-modifying anti-rheumatic drug (DMARD).

Investigated diseases

Rheumatoid Arthritis – Rheumatoid arthritis is a chronic inflammatory disorder that primarily affects the joints. It typically causes pain, swelling, and stiffness in the joints, often starting in the small joints of the hands and feet. Over time, the inflammation can lead to joint damage and deformities. The disease may also affect other parts of the body, including the skin, eyes, lungs, and blood vessels. Symptoms often worsen after periods of rest, particularly in the morning. The progression of rheumatoid arthritis can vary, with some people experiencing periods of remission and others having persistent symptoms.