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

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What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name City Country Status
Haga Hospital Hague The Netherlands
Amphia Hospital Breda The Netherlands
Albert Schweitzer Ziekenhuis Dordrecht The Netherlands
Medisch Spectrum Twente Enschede The Netherlands
Universitair Medisch Centrum Utrecht Utrecht The Netherlands
Maasstad Ziekenhuis Stichting Rotterdam The Netherlands
Sint Franciscus Vlietland Groep Stichting Rotterdam The Netherlands
Lcnds Uzjgvppekckq Mcyicpa Cvcnofq (xzwnw Leiden The Netherlands
Armxkzfp Do Rftsdu Zwiezcyien Byhf Goes The Netherlands
Iqoylujobl Ztlgopcvej Capelle Aan Den Ijssel The Netherlands
Ehisrch Udjnshxrmeen Mwtetlt Cjwctkl Rffywpxir (bzvqvaj Mxd Rotterdam The Netherlands

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
The Netherlands The Netherlands
Not recruiting
09.04.2021

Trial locations

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.

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 ID:
2024-511530-12-01
Protocol code:
PRIMERA001
Trial Phase:
Therapeutic confirmatory (Phase III)

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