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Study on Rheumatoid Arthritis: Evaluating Methotrexate, Golimumab, and Hydroxychloroquine Sulfate for Patients with Autoantibodies and Response to Glucocorticoids

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 focuses on studying the effectiveness of different treatments for rheumatoid arthritis, a condition that causes pain and swelling in the joints. The study will compare a personalized treatment approach with usual care. The personalized approach considers the presence of specific proteins in the blood, known as autoantibodies, and how quickly patients respond to certain medications like glucocorticoids and JAK inhibitors. The goal is to determine if the personalized approach can help patients achieve low disease activity more quickly without using more expensive medications.

The trial will involve several medications, including Methotrexate, Simponi (containing golimumab), Hydroxychloroquine sulfate, Cimzia (containing certolizumab pegol), Depo-Medrol (containing methylprednisolone acetate), Leflunomide, Enbrel (containing etanercept), Humira (containing adalimumab), Sulfasalazine, Jyseleca (containing filgotinib), Kenacort-A (containing triamcinolone acetonide), and Remicade (containing infliximab). Some patients may receive a placebo, which is a substance with no active medication, to compare the effects of the actual treatments.

Participants in the study will be randomly assigned to either the personalized treatment group or the usual care group. The study will last for several months, during which patients will receive their assigned treatments and have their disease activity monitored regularly. The effectiveness of the treatments will be assessed by measuring how well the disease is controlled and the overall cost-effectiveness of the treatment approaches. The study aims to provide insights into whether a personalized approach can improve outcomes for patients with rheumatoid arthritis.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

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

    Blood tests may be performed to check for specific markers related to rheumatoid arthritis.

  2. Step 2

    Treatment allocation

    Participants are randomly assigned to either the usual care group or the tailor-made treatment group.

    The tailor-made approach considers the presence of autoantibodies and response to specific medications.

  3. Step 3

    Medication administration

    Participants may receive one or more of the following medications based on their group assignment and individual needs:

    Methotrexate: 2.5 mg film-coated tablets, taken orally.

    Simponi: 50 mg solution for injection, administered subcutaneously.

    Hydroxychloroquine sulfate: 200 mg film-coated tablets, taken orally.

    Cimzia: 200 mg solution for injection, administered subcutaneously.

    Depo-Medrol: 80 mg/2 ml suspension for injection, administered intramuscularly.

    Leflunomide: 20 mg film-coated tablets, taken orally.

    Enbrel: 50 mg solution for injection, administered subcutaneously.

    Humira: 40 mg solution for injection, administered subcutaneously.

    Sulfasalazine: 500 mg tablets, taken orally.

    Jyseleca: 200 mg film-coated tablets, taken orally.

    Kenacort-A: 40 mg/ml suspension for injection, administered intramuscularly.

    Remicade: 100 mg powder for concentrate for solution for infusion, administered intravenously.

  4. Step 4

    Monitoring and follow-up

    Regular follow-up visits are scheduled to monitor disease activity and treatment response.

    Disease activity is measured using the Disease Activity Score (DAS) and other assessments such as the Routine Assessment of Patient Index Data 3 (RAPID3).

    Additional evaluations may include assessments of morning stiffness, general health, fatigue, pain, functional ability, quality of life, and patient satisfaction.

  5. Step 5

    Final assessment

    At the end of the trial period, a final assessment is conducted to evaluate the overall effectiveness of the treatment.

    The primary outcomes include the proportion of patients using specific medications and changes in disease activity over time.

Who can join the trial?

5 criteria

  • The patient must have **rheumatoid arthritis** diagnosed according to the 2010 criteria. **Rheumatoid arthritis** is a condition that causes pain and swelling in the joints.
  • The patient must be newly diagnosed and not have taken any **DMARDs** before. **DMARDs** are medications used to slow down the progression of rheumatoid arthritis.
  • The patient must be **18 years old or older**.
  • Both **men and women** can participate in the study.
  • The study does not include vulnerable populations, meaning it is not designed for people who might need special protection or care.

Who cannot join the trial?

4 criteria

  • Patients who do not have rheumatoid arthritis as defined by the 2010 criteria cannot participate. Rheumatoid arthritis is a condition that causes pain and swelling in the joints.
  • Patients who are not within the specified age range cannot participate. The age range includes adults and older adults.
  • Both male and female patients are eligible, so gender is not an exclusion criterion.
  • Patients who are part of a vulnerable population are not excluded, meaning they can participate if they meet other criteria.
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Investigated drugs

  • bDMARDs

    These are biological disease-modifying antirheumatic drugs used to treat rheumatoid arthritis. They work by targeting specific parts of the immune system to reduce inflammation and slow down the progression of the disease.

  • tsDMARDs

    These are targeted synthetic disease-modifying antirheumatic drugs. They are designed to specifically target certain pathways in the immune system to help control inflammation and manage symptoms of rheumatoid arthritis.

What is already known about the treatment

Adalimumab – This medication is administered via subcutaneous injection and is currently well-established in medical literature for the treatment of rheumatoid arthritis. It is primarily indicated for reducing inflammation and slowing the progression of joint damage in patients with rheumatoid arthritis. At the molecular level, Adalimumab works by blocking tumor necrosis factor-alpha (TNF-alpha), a substance in the body that causes inflammation in the joints. It is classified as a biologic disease-modifying antirheumatic drug (bDMARD).

Investigated diseases

Rheumatoid Arthritis – Rheumatoid arthritis is a chronic inflammatory disorder that primarily affects the joints. It typically causes pain, swelling, and stiffness, particularly in the hands, wrists, and knees. Over time, the inflammation can lead to joint damage and deformities. The disease often progresses in a symmetrical pattern, meaning if one knee or hand is affected, the other one is likely to be affected as well. It can also cause systemic symptoms such as fatigue and fever. The exact cause is unknown, but it is believed to involve a combination of genetic and environmental factors.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-511530-12-01Protocol codePRIMERA001Estimated enrolment300 patientsSponsorErasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

sourced from the EU Clinical Trials Register and site verification

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