Recruiting

Study Comparing Conventional Therapy and Biologic Treatments for Early Rheumatoid Arthritis Using Hydroxychloroquine, Abatacept, and Azathioprine in Responsive Patients

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 Rheumatoid Arthritis, a condition that causes pain and swelling in the joints. The study aims to compare the effectiveness of different treatments for this disease. The treatments being tested include both conventional and biologic therapies. Conventional therapies involve medications like Hydroxychloroquine, Azathioprine, Sulfasalazine, Methotrexate, Leflunomide, and Betamethasone. Biologic therapies include medications such as Certolizumab Pegol, Tocilizumab, and Abatacept. These treatments are administered in various forms, including oral tablets, subcutaneous injections (injections under the skin), and infusions (a method of delivering medication directly into the bloodstream).

The purpose of the study is to assess how well patients achieve remission, which means a reduction or disappearance of symptoms, with these treatments. The study will also explore two different strategies for reducing the dosage of medication in patients who respond well to the initial treatment. Participants will be randomly assigned to receive either conventional therapy or one of the biologic treatments. The study will monitor the participants over a period to see how their condition improves and whether they can maintain remission with reduced medication.

Throughout the study, participants will receive regular assessments to track their progress. These assessments will help determine the effectiveness of the treatments and the best approach for managing Rheumatoid Arthritis. The study is designed to provide valuable information on how different treatments can help patients achieve and maintain remission, ultimately improving their quality of life.

The research process

The trial runs in 7 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 a review of medical history, a physical examination, and laboratory tests.
A chest X-ray and an electrocardiogram (ECG) are performed to ensure good general health.
Step 2
Treatment allocation
Participants are randomly assigned to receive either active conventional therapy or one of three biologic treatments.
The specific treatment plan is determined based on the study's randomization process.
Step 3
Medication administration
Medications are administered according to the assigned treatment group. This may include oral medications such as hydroxychloroquine, azathioprine, or sulfasalazine, or injections such as abatacept or certolizumab pegol.
The frequency and dosage depend on the specific medication and treatment plan.
Step 4
Monitoring and follow-up
Regular follow-up visits are scheduled to monitor health and response to treatment. This includes assessments of joint swelling and tenderness, as well as blood tests to measure inflammation levels.
Adjustments to the treatment plan may be made based on these assessments.
Step 5
Evaluation of remission
At week 24, the primary outcome is evaluated to determine if remission has been achieved. This is assessed using the Clinical Disease Activity Index (CDAI).
If remission is achieved, the study may proceed to a de-escalation phase where medication doses are gradually reduced.
Step 6
De-escalation phase
For participants who respond to treatment, a de-escalation strategy is implemented. This involves reducing the dosage of medications over a specified period.
The goal is to maintain remission with the lowest effective dose.
Step 7
Final assessment
The study concludes with a final assessment to evaluate the long-term effects of the treatment and the success of the de-escalation strategy.
Participants are monitored for any changes in their condition and overall health.

Who can join the trial?

11 criteria

The person must be at least 18 years old.
The person must be able and willing to sign a form agreeing to participate and follow the study rules.
The person must be able and willing to give themselves injections under the skin, or have someone qualified to do it for them.
The person must have a diagnosis of Rheumatoid Arthritis (RA) according to specific criteria set in 2010.
The person must have had arthritis symptoms for less than 24 months.
The person must have a DAS28 (CRP) score greater than 3.2. This is a measure of RA activity based on joint swelling and tenderness.
The person must have at least 2 swollen joints and at least 2 tender joints.
The person must meet one of the following: be RF positive (Rheumatoid Factor), ACPA positive (Anti-Citrullinated Protein Antibody), or have a CRP (C-reactive protein) level of 10 mg/L or higher.
If the person is a woman who can have children, she must use a reliable method of birth control during the study and for 150 days after it ends. Options include an intrauterine device (IUD), contraceptives like pills or patches, or having a partner who has had a vasectomy.
Women who can have children must have a negative pregnancy test before starting the study.
The person must be in good general health, as determined by the study doctor, based on medical history, lab tests, physical exam, chest X-ray, and heart test (ECG) done before the study starts.

Who cannot join the trial?

4 criteria

Patients who have a different condition than Rheumatoid Arthritis cannot participate.
Patients who are not within the specified age range cannot participate. The age range is typically defined by the study, so it's important to check if you fit within it.
Patients who are part of a vulnerable population, which means groups that might need special protection, cannot participate.
Patients who do not respond to the first-line therapy, which is the initial treatment given for a condition, cannot participate in the de-escalation strategies part of 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

Aalborg University Hospital
Verified
Aalborg, Denmark
Aarhus University Hospital
Verified
Aarhus, Denmark
Universitetssykehuset Nord-Norge HF
Responsive
Tromsø, Norway

Trial locations

Where you can join this trial

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

RecruitingNot yet 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

Methotrexate
is a medication used as part of active conventional therapy for treating early rheumatoid arthritis. It helps reduce inflammation and slow down the progression of the disease by affecting the immune system.
Adalimumab
is a biologic therapy used to treat rheumatoid arthritis. It works by blocking a specific protein in the body that causes inflammation, helping to reduce symptoms and prevent joint damage.
Etanercept
is another biologic treatment option for rheumatoid arthritis. It acts by interfering with the inflammatory process in the body, which can help alleviate pain and swelling in the joints.
Tocilizumab
is a biologic medication used in the treatment of rheumatoid arthritis. It targets and blocks a specific receptor involved in the inflammatory process, helping to control symptoms and improve joint function.

What is already known about the treatment

Adalimumab
This medication is administered via subcutaneous injection and is currently well-established in medical literature as a treatment for rheumatoid arthritis. It is primarily used to reduce inflammation and slow the progression of joint damage in patients with this condition. Adalimumab works by blocking a specific protein in the body called tumor necrosis factor (TNF), which plays a key role in causing inflammation. It is classified as a biologic disease-modifying antirheumatic drug (DMARD).
Etanercept
Administered through subcutaneous injection, this medication is widely recognized in the medical community for treating rheumatoid arthritis. It helps alleviate symptoms by inhibiting the activity of tumor necrosis factor (TNF), a substance in the body that leads to inflammation and joint damage. Etanercept is categorized as a biologic disease-modifying antirheumatic drug (DMARD).
Tocilizumab
This medication is given either by intravenous infusion or subcutaneous injection and is well-documented in medical literature for its use in managing rheumatoid arthritis. It targets and blocks the interleukin-6 (IL-6) receptor, a protein involved in the inflammatory process, thereby reducing inflammation and preventing joint damage. Tocilizumab is classified as a biologic disease-modifying antirheumatic 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, it 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. It progresses through periods of flares and remissions, where symptoms can worsen or improve. The exact cause is unknown, but it involves the immune system attacking the body's own tissues.