A study to evaluate nipocalimab and certolizumab combination therapy in participants with active rheumatoid arthritis
Rheumatoid arthritis is a condition where the body's immune system mistakenly attacks its own joints, causing ongoing pain, stiffness, and swelling. While many treatments exist, they do not work well for everyone. This Phase II clinical trial looks at whether combining an experimental medicine called nipocalimab with an established medicine called certolizumab works better than certolizumab alone. Certolizumab reduces joint inflammation, while nipocalimab lowers certain proteins in the blood that are linked to immune system attacks. Participants are randomly placed into one of two groups. One group receives both medicines, while the other receives certolizumab alongside a dummy treatment (placebo). The study lasts around nine months and includes regular health checks, blood tests, and medical monitoring. The trial is open to adults aged 18 to 75 who still have active arthritis symptoms despite trying previous advanced therapies.
במבט חטוף
על מה המחקר הזה?
Rheumatoid arthritis is a long-term condition that causes inflammation in the joints. In a healthy body, the immune system defends against illnesses like colds and infections. In rheumatoid arthritis, however, the immune system becomes confused and attacks the lining of the joints instead. This can lead to persistent swelling, joint pain, tiredness, and difficulty carrying out everyday tasks.
This clinical trial is testing a new way to treat the condition by using two medicines at the same time. The first drug, certolizumab, is already used to treat arthritis by blocking a specific protein that causes inflammation. The second drug, nipocalimab, is an experimental treatment that works differently by lowering certain antibodies that drive autoimmune attacks. Researchers hope that tackling the disease from two different angles will provide better relief for people with persistent symptoms.
This research is particularly important for individuals whose arthritis has not responded well to standard biological therapies. If the combination proves to be safe and effective, it could offer a valuable new option for people struggling to find relief from severe joint symptoms.
נקודות עיקריות
- A Phase II clinical trial testing a two-drug combination for active rheumatoid arthritis.
- Aimed at adults whose joint symptoms have not improved on other advanced treatments.
- Participants receive either both medicines or one medicine plus a dummy treatment.
- The study lasts approximately nine months and involves regular clinic appointments.
- Taking part is voluntary, all study care is free, and travel costs can be reimbursed.
מי עשוי להיות זכאי?
This trial is for adults aged 18 to 75 who have had a confirmed diagnosis of rheumatoid arthritis for at least three months. To qualify, you must have active arthritis, meaning you currently have significant joint inflammation with at least six swollen joints and six tender joints.
You will also need specific blood test results that show active disease. These include having positive markers commonly found in rheumatoid arthritis (such as rheumatoid factor or ACPA) and raised levels of C-reactive protein (CRP), which shows that inflammation is present in the body.
Finally, the study is specifically looking for people who have already tried advanced arthritis medicines—such as biological drugs or anti-TNF therapies—without enough success. This means the previous medicine either did not control your joint pain and swelling well enough, or caused side effects that meant you had to stop taking it.
האם מחקר זה יכול להתאים לך?
ענה על השאלות המהירות הללו כדי לבדוק אם אתה עשוי להיות זכאי. זהו מדריך בלבד — צוות המחקר מקבל את ההחלטה הסופית.
- Are you aged between 18 and 75?
- Have you been diagnosed with rheumatoid arthritis for at least three months?
- Do you currently have at least six swollen joints and six tender joints?
- Have you previously tried advanced biological medicines that did not work well or caused side effects?
- Are you able to travel to regular hospital visits over a nine-month period?
מה כרוך בהשתתפות?
Taking part in the trial lasts around nine months (up to 36 weeks) and is split into three main parts:
1. Screening (up to 6 weeks): The study team will run health checks, blood tests, and urine tests to make sure the trial is safe and suitable for you. 2. Treatment period (up to 22 weeks): You will be randomly assigned to one of two groups. One group receives nipocalimab and certolizumab. The other group receives certolizumab and a dummy medicine (placebo). Neither you nor your doctor will know which group you are in. You will visit the clinic regularly for your doses and health checks. 3. Follow-up period (up to 8 weeks): After your last dose, the team will monitor your recovery and check for any delayed side effects.
All study drugs and medical tests are provided free of charge, and reasonable travel and parking expenses will be reimbursed.
סיכונים ותועלות פוטנציאליים
מיקומים (3)
- Kings College HospitalמשוערLondon, England
- Western General Hospitalעיר בלבדLothian, Scotland
- Medway Maritime HospitalמשוערGillingham, England
שאלות נפוצות
האם אני בהחלט אקבל את התרופה החדשה?
Not necessarily. A computer randomly decides whether you receive the combination of both drugs or certolizumab with a dummy treatment (placebo). Both groups receive active arthritis treatment.
האם אני צריך לשלם כדי להשתתף?
No. The trial medicines, clinic visits, and tests are completely free, and you can be reimbursed for reasonable travel and parking expenses.
Can I leave the trial if I change my mind?
Yes. You have the right to withdraw from the study at any point, for any reason, without it affecting your standard medical care or relationship with your doctors.
What happens if I get an infection during the study?
Because these medicines affect your immune defences, you must tell the study team immediately if you feel unwell or notice signs of an infection, so they can treat you promptly.
Will my own GP or rheumatologist know I am in the study?
Yes. With your permission, the study team will keep your regular healthcare providers updated about your involvement and your health.
כיצד לגלות עוד
- Medical Information and Product Information Enquiry
תמיד התייעץ עם רופא המשפחה או המומחה שלך לפני שתחליט להשתתף במחקר.
דיון
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