Phase 3 Vasculitis Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You have been newly diagnosed with, or are experiencing a relapse of, a condition called granulomatosis with polyangiitis (GPA), confirmed using recognised medical guidelines
• You are 18 years old or older
• You currently have active symptoms caused by GPA
• Your GPA has not responded well enough to standard treatments, meaning you have previously tried steroids (such as prednisone) combined with either cyclophosphamide or rituximab (or both)
• Your disease either kept getting worse, improved by less than half, or remained active enough that you still need a daily steroid dose of at least 7.5 mg of prednisone (or equivalent) after at least 12 weeks of treatment
• You have been on a stable daily steroid dose of at least 7.5 mg of prednisone (or equivalent) for the 4 weeks before joining the trial
• If you are already taking certain arthritis or immune-suppressing medications (called cDMARDs), your dose has been stable for at least 4 weeks before joining
• You are able to understand what the study involves, agree to take part in writing, and are willing and able to follow the study procedures and attend required visits
• You are covered by a social security or health insurance scheme (confirm with trial site)

Who may not be able to join:

• You have had an allergic reaction or sensitivity to monoclonal antibody medicines, or specifically to rituximab, abatacept, tocilizumab, or any of their ingredients
• You have previously been treated with rituximab combined with certain immune-suppressing drugs (cDMARDs), with tofacitinib, or with tocilizumab
• You have a medical reason why you cannot take rituximab with a cDMARD, tofacitinib, or tocilizumab — for example, you currently have an active infection, you have had cancer in the last 5 years (except certain cured skin cancers), or you are pregnant or breastfeeding
• Your GPA is very severe and affecting your kidneys seriously (very high creatinine levels) or causing severe bleeding in your lungs, requiring a treatment called plasma exchange
• Your GPA is currently in remission (not active)
• Your symptoms are caused by long-term, inactive GPA rather than currently active disease
• You have severe heart failure (classified as the most serious level, known as "Class IV") (confirm with trial site)
• You currently have an active infection or a long-term ongoing infection, including HIV, hepatitis B, or hepatitis C
• You have active cancer or have had cancer in the last 5 years, with exceptions for certain low-risk prostate cancer controlled by hormonal treatment and a specific type of cured skin cancer
• You are pregnant or breastfeeding; women who could become pregnant must have a negative pregnancy test before starting and must use highly effective contraception throughout the study and for a set period after their last treatment (the length of time depends on which study drug is used — confirm details with trial site)
• You have other serious uncontrolled health conditions, such as drug or alcohol problems or severe mental health conditions, that could affect your ability to take part
• You have taken part in another clinical drug trial within the past 3 months
• There are concerns that you may not be able to follow the treatment plan as required
• Your recent blood test results show certain abnormal values, specifically: liver enzyme levels more than 5 times the normal limit, a platelet count below 100,000/mm³, or a white blood cell count below 2,000/mm³

Important: Always verify eligibility with the trial site directly before applying.