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Ongoing Clinical Trials for Rheumatoid Arthritis

This article provides information about 55 ongoing clinical trials for rheumatoid arthritis, a chronic inflammatory condition that causes joint pain, swelling, and stiffness. These studies are testing various treatments including new medications, different dosing strategies, and combination therapies across multiple European countries.

Clinical trial locations

Evaluation of Two Prednisolone Treatment Strategies for Newly Diagnosed, Untreated Rheumatoid Arthritis Patients

This study in Sweden examines two different approaches to using prednisolone (a steroid medication) in patients newly diagnosed with rheumatoid arthritis who have not yet received treatment. The trial compares a faster reduction of low-dose prednisolone against a slower reduction, with both groups starting at the same dose.

Main inclusion criteria: Participants must be at least 18 years old and newly diagnosed with rheumatoid arthritis according to established criteria. They should not have received any prior treatment with disease-modifying anti-rheumatic drugs and must be suitable for prednisolone treatment without contraindications.

Main exclusion criteria: People with other serious health conditions, those who are pregnant or breastfeeding, current participants in other trials, those with allergies to study medications, and people with mental health conditions that could interfere with participation.

Trial focus: The research evaluates whether a faster reduction in prednisolone dosage is as effective as a slower reduction in managing symptoms. The study lasts up to 51 weeks and monitors disease activity through regular assessments including the DAS28 score, which measures inflammation and joint symptoms.

Investigational treatment: Prednisolone is a corticosteroid that reduces inflammation by calming the immune system’s response. In this study, it is administered in 5 mg and 2.5 mg tablets taken orally, with participants receiving either a faster or slower dose reduction strategy.

PET/CT Imaging Study for Patients with Giant Cell Arteritis or Rheumatoid Arthritis Using Zirconium (89Zr) Crefmirlimab Berdoxam

This imaging study in the Netherlands uses a special PET/CT scanning technique with a medication called 89Zr-Df-crefmirlimab to visualize inflammation in patients with either giant cell arteritis or active rheumatoid arthritis. The research aims to understand how well this imaging agent can show inflammation in arteries and joints.

Main inclusion criteria: For rheumatoid arthritis patients, requirements include being at least 30 years old, having a confirmed diagnosis, and showing active disease with arthritis in at least one joint. Patients must also need to start or change treatment and have stable medication doses for at least four weeks.

Main exclusion criteria: Those with other serious conditions, current participants in other trials, recent major surgery or planned surgery, pregnant or breastfeeding women, people with allergies to study medications, and those unable to comply with study procedures.

Trial focus: The study measures how much of the imaging medication is absorbed in different arteries or joints using standardized uptake values (SUVs). This information helps doctors understand the level of inflammation and could improve diagnosis and treatment options in the future.

Investigational treatment: 89Zr-Df-crefmirlimab is an imaging agent that helps visualize CD8 T cells (a type of immune cell) using PET/CT scans. It is given as an intravenous injection to highlight areas of inflammation in the body.

Study Comparing Methotrexate or Leflunomide with Targeted Therapy vs. Methotrexate or Leflunomide with Drug Combination for Rheumatoid Arthritis Patients

This French trial compares two treatment strategies for patients who have not responded well to either methotrexate or leflunomide. One approach combines these medications with targeted biological therapies, while the other adds sulfasalazine and hydroxychloroquine (a triple therapy combination).

Main inclusion criteria: Participants must have rheumatoid arthritis with a DAS28-CRP score greater than 3.2, indicating active disease, and have shown insufficient response to either methotrexate or leflunomide after at least three months of treatment. They must also have specific markers such as erosions on x-ray or positive tests for rheumatoid factor or anti-CCP antibodies.

Main exclusion criteria: People with conditions other than rheumatoid arthritis, those outside the age range, individuals unable to follow procedures, pregnant or breastfeeding women, and those with serious health conditions or allergies to study medications.

Trial focus: The study follows patients for 12 months to see which treatment strategy better achieves low disease activity. It monitors disease scores, joint counts, and overall health while tracking any serious side effects and medication levels in the blood.

Investigational treatments: The study includes various medications: methotrexate and leflunomide (which slow disease progression), sulfasalazine and hydroxychloroquine (which reduce inflammation), and several targeted therapies including rituximab, tocilizumab, infliximab, and others that specifically target parts of the immune system.

Study Comparing Rituximab and KYV-101 for Patients with Active, ACPA-Positive, Treatment-Resistant Rheumatoid Arthritis

This German study compares rituximab (an established treatment) with KYV-101 (an experimental anti-CD19 CAR T cell therapy) in patients with particularly difficult-to-treat rheumatoid arthritis who are positive for anti-citrullinated protein antibodies (ACPA).

Main inclusion criteria: Patients must have definite rheumatoid arthritis with at least 6 tender and 6 swollen joints, a DAS28-CRP score above 3.2, and high levels of ACPA antibodies. They must also have failed treatment with 2-3 classes of biological or targeted drugs. Both men and women aged 18-65 can participate.

Main exclusion criteria: Those with serious health conditions, allergic reactions to similar medications, pregnancy or breastfeeding, active infections, history of cancer, severe organ problems, recent live vaccines, or inability to comply with study procedures.

Trial focus: The study primarily assesses safety by monitoring for specific side effects like Cytokine Release Syndrome and neurotoxicity. It also measures effectiveness by tracking how many patients achieve ACPA seroconversion (reduction in antibody levels), which indicates improvement in disease activity.

Investigational treatments: Rituximab reduces B-cells (a type of immune cell) to decrease inflammation. KYV-101 is an advanced cell therapy where a patient’s own T-cells are modified to better recognize and attack the B-cells causing inflammation.

Study of CIT-013 at Three Different Doses for Patients with Moderately Active Rheumatoid Arthritis

This multi-country study in Spain, Netherlands, Poland, Germany, and Belgium tests three different dose levels of CIT-013 (50 mg, 100 mg, and a placebo) in patients with moderately active rheumatoid arthritis who are taking conventional disease-modifying drugs.

Main inclusion criteria: Patients must have rheumatoid arthritis diagnosed at least 3 months prior, be 18 years or older, have moderate disease activity (DAS28-CRP of 3.2 or higher) with at least 3 swollen and 3 tender joints, and have been on stable methotrexate treatment for at least 3 months.

Main exclusion criteria: Those with severe rheumatoid arthritis, pregnant or breastfeeding women, active infections, recent tuberculosis, serious organ problems, recent cancer, heart conditions, and those taking certain interfering medications.

Trial focus: The study lasts 85 days and measures how well different doses of CIT-013 reduce disease activity. It tracks joint swelling and tenderness, disease activity scores, and patients’ ability to perform daily activities, as well as monitoring for side effects.

Investigational treatment: CIT-013 is an investigational medication being tested to reduce disease activity and inflammation in rheumatoid arthritis. A placebo is also used for comparison purposes.

Study of lutikizumab and ravagalimab in adults with moderate to severe rheumatoid arthritis

This German trial tests two medications, lutikizumab and ravagalimab, given as injections under the skin, in patients with moderate to severe rheumatoid arthritis who have tried other treatments without adequate improvement.

Main inclusion criteria: Participants must be adults with moderate to severe active rheumatoid arthritis who have been on biological or targeted medications for at least 3 months but still have symptoms, or had to stop due to side effects. They must be taking stable doses of methotrexate and cannot have used more than 2 different biological medications previously.

Main exclusion criteria: People aged below 18 or above 65, those with serious infections, allergic reactions to medications, active cancer, severe organ disease, pregnancy, certain blood disorders, and those unable to follow study procedures.

Trial focus: The study lasts 12 months and monitors how well the treatments control symptoms by measuring joint inflammation, disease activity scores, and improvements in daily activities. Both effectiveness and safety are evaluated through regular assessments.

Investigational treatments: While the trial is described as testing targeted therapies for rheumatoid arthritis, specific medication details are not provided in the source data.

Study on Abatacept for Predicting Treatment Response in Patients with Early Rheumatoid Arthritis

This study across Spain, Italy, Netherlands, Portugal, and Belgium investigates whether specific biomarkers (CD80/CD86) can predict how well patients with early rheumatoid arthritis will respond to abatacept treatment over 16 weeks.

Main inclusion criteria: Participants must be 18 or older, have rheumatoid arthritis symptoms for less than 12 months, not have taken disease-modifying drugs previously, have moderate to severe disease activity (DAS28 greater than 3.2), and have at least one swollen joint suitable for tissue sampling.

Main exclusion criteria: Those from vulnerable populations, people who cannot attend visits or follow procedures, and those unable to provide informed consent.

Trial focus: The study evaluates whether molecular markers in joint tissue can predict treatment response. It measures disease activity at 16 weeks using the Clinical Disease Activity Index (CDAI) and also tracks improvements in quality of life and other health measures.

Investigational treatment: Abatacept is administered through subcutaneous injection (under the skin) in 125 mg doses. It works by interfering with immune system activity, specifically T-cell activation, to reduce inflammation and joint damage.

Study on Abatacept for Rheumatoid Arthritis in Patients Responding to Initial TNF Inhibitor Treatment

This French trial compares switching to abatacept versus continuing TNF inhibitor treatment in patients who have responded well initially but still have active disease. The study lasts 36 weeks to see which strategy better maintains remission.

Main inclusion criteria: Patients must be 18 or older, have rheumatoid arthritis positive for ACPA antibodies, be taking methotrexate or leflunomide for at least 3 months, and have a DAS28-CRP score greater than 3.2 while on these medications. They must also have increased inflammation markers in recent months and have medical reasons to start TNF inhibitor therapy.

Main exclusion criteria: Those with serious interfering health conditions, pregnant or breastfeeding women, recent infections requiring antibiotics, allergies to study medications, recent use of experimental drugs, drug or alcohol abuse, recent cancer, certain blood disorders, or recent live vaccines.

Trial focus: The study measures how many patients maintain remission (defined as DAS28-CRP less than 2.6) over 36 weeks and tracks disease flare-ups, safety, and medication levels in the blood throughout the treatment period.

Investigational treatments: Abatacept reduces inflammation by interfering with T-cell activation, while TNF inhibitors block tumor necrosis factor protein that causes inflammation. Both aim to reduce symptoms and prevent joint damage.

Study on Adjusting Adalimumab Dosage for Patients with Rheumatoid Arthritis in Remission

This French study explores personalizing adalimumab treatment by adjusting doses based on blood concentration levels in patients who have been in remission for at least six months.

Main inclusion criteria: Patients must be over 18, have rheumatoid arthritis diagnosed according to 2010 criteria, have been in remission (DAS28 less than 2.6) for at least 6 months, and have been receiving adalimumab 40 mg every other week for at least 6 months while on stable methotrexate.

Main exclusion criteria: Those not in remission for 6 months, not on both methotrexate and adalimumab treatment, and those from vulnerable populations.

Trial focus: The study aims to find the minimal necessary concentration of adalimumab to maintain remission. It monitors disease flare-ups (defined as DAS28 increases), tracks antibody levels against adalimumab, and records any infections throughout the study period until mid-2026.

Investigational treatments: Adalimumab is a TNF-blocking medication given by injection that reduces inflammation and slows disease progression. MTX (methotrexate) is used alongside as a supporting medication to manage symptoms and prevent joint damage.

Study on Baricitinib and Anti-TNF Drug Combination for Patients with Rheumatoid Arthritis

This French trial compares combination therapy (baricitinib plus anti-TNF drugs adalimumab or etanercept) versus baricitinib alone in patients whose rheumatoid arthritis has not responded adequately to previous treatments. The study lasts 24 weeks with monitoring up to 52 weeks.

Main inclusion criteria: Patients aged 18-65 with rheumatoid arthritis according to specific criteria, having active disease (DAS28-ESR greater than 3.2) despite adequate treatment with at least one traditional disease-modifying drug, and taking prednisone 10 mg daily or less.

Main exclusion criteria: Those with serious interfering health conditions, pregnant or breastfeeding women, recent infections, allergies to medications, current participation in other trials, recent treatments, certain blood disorders, history of cancer, heart or lung problems, and inability to comply with procedures.

Trial focus: The primary goal is to measure how many patients achieve ACR50 response (50% improvement in symptoms) at week 24. The study also tracks disease activity scores, patient-reported outcomes, and monitors for side effects throughout the treatment period.

Investigational treatments: Baricitinib is a JAK inhibitor taken as a daily 4 mg tablet that reduces inflammation. Adalimumab (40 mg every two weeks) and etanercept (50 mg weekly) are anti-TNF injections that block inflammation-causing proteins.

Summary

The 55 ongoing clinical trials for rheumatoid arthritis show significant research activity across Europe, with France, Germany, Spain, Italy, and the Netherlands hosting the most studies. These trials represent a diverse range of treatment approaches including:

  • Dose optimization studies: Several trials examine whether medication doses can be reduced while maintaining disease control, potentially minimizing side effects and costs.
  • Combination therapies: Multiple studies test whether combining different medications provides better results than single treatments.
  • Biosimilars: Several trials evaluate whether biosimilar medications work as well as their reference products.
  • Personalized medicine: Some studies use biomarkers or blood levels to tailor treatment approaches to individual patients.
  • Novel therapies: Advanced treatments like CAR T-cell therapy and new monoclonal antibodies are being tested for difficult-to-treat cases.
  • Early intervention: Many trials focus specifically on newly diagnosed patients to determine optimal first-line treatments.

Notable patterns include concentration on JAK inhibitors (filgotinib, baricitinib, tofacitinib, upadacitinib), anti-TNF agents (adalimumab, etanercept, infliximab), and other targeted biologics (abatacept, tocilizumab, rituximab). The Eastern European countries (Poland, Romania, Bulgaria, Czech Republic, Hungary) are particularly active in hosting biosimilar and comparative effectiveness trials, while Western European countries focus more on novel therapies and dose optimization strategies.

These studies collectively aim to improve treatment options by finding more effective combinations, identifying which patients will respond best to specific treatments, reducing medication burden where possible, and developing new therapeutic approaches for patients who don’t respond to standard treatments.

Ongoing Clinical Trials on Rheumatoid arthritis

  • Study of Tocilizumab Subcutaneous Injection to Evaluate Bone Healing in Adult Patients with Rheumatoid Arthritis

    Not recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    France

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

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Poland

  • Study on Spironolactone for Treating Active Rheumatoid Arthritis in Patients

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    France Germany

  • Study on the Effects of Ianalumab in Adults with Rheumatoid Arthritis, Systemic Lupus Erythematosus, or Sjögren’s Disease

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Czechia Germany Hungary Italy The Netherlands Poland +1

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

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Bulgaria Czechia Denmark Poland Romania

  • Study Comparing Abatacept and Adalimumab for Adults with Early Rheumatoid Arthritis Not Responding to Methotrexate

    Not recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Czechia France Germany Italy Poland Spain

  • Study on Methotrexate and Glucocorticoid Combination for Early Rheumatoid Arthritis, with Optional Etanercept for Non-Responders

    Not recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium

  • Study on Rosnilimab for Patients with Moderate to Severe Rheumatoid Arthritis

    Not recruiting

    1
    Investigated diseases:
    Investigated drugs:
    Belgium Estonia France Germany Hungary Italy +3

  • Study on the Effectiveness and Safety of Abatacept Biosimilar (DRL_AB) and Methotrexate for Patients with Moderate to Severe Rheumatoid Arthritis

    Not recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Bulgaria Czechia Estonia Hungary Latvia Lithuania +2

  • Study on the Effects of Baricitinib in Early-Stage Rheumatoid Arthritis

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Germany

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