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:

• People aged 18 to 65 years old (any gender).
• People whose blood tests show a protein called CD19 is present on their B cells (a type of immune cell), confirmed by a specific lab test.
• People whose bone marrow, liver, kidneys, blood clotting, and heart are functioning at a level that meets the trial's minimum requirements, as determined by blood tests and medical assessment.
• People who are able to use an approved form of contraception or abstain from sex during the treatment period and for at least 6 months afterwards (applies to people who could become pregnant or whose partner could become pregnant).
• People who are not currently pregnant, not planning to become pregnant, and not breastfeeding — with a negative pregnancy blood test taken within 7 days before joining.
• People who are willing to take part voluntarily, sign a consent form, follow the study requirements, and attend follow-up appointments.

People must also have one of the following specific conditions:

• Lupus (Systemic Lupus Erythematosus): People diagnosed with lupus according to 2019 international classification standards, whose disease remains active at a certain measured level, and whose condition has not responded to standard treatments for more than 6 months, or has flared up again after a period of improvement. Standard treatments include steroids, cyclophosphamide, and at least one other medication from a specified list (confirm with trial site).
• Sjögren's Syndrome: People diagnosed with primary Sjögren's syndrome according to recognised international criteria, with an active disease score of 6 or above, a positive anti-SSA/Ro antibody blood test, and whose condition has not responded to standard treatments for more than 6 months or has returned after a period of improvement.
• Systemic Sclerosis (Scleroderma): People diagnosed with systemic sclerosis according to 2013 international criteria, with a positive related antibody, who have either widespread skin hardening or active lung inflammation shown on a specific type of scan, and whose condition has not responded to standard treatments or is getting significantly worse (confirm with trial site for specific progression measurements).
• Inflammatory Myopathy (Muscle Inflammation): People diagnosed with an inflammatory muscle disease (including dermatomyositis, polymyositis, antisynthetase syndrome, or necrotising myopathy) according to 2017 international criteria, with a positive myositis antibody, whose muscle strength or other disease measures fall below certain levels, or who have active lung involvement — and whose condition has not responded to standard treatments or is getting worse.
• ANCA-Associated Vasculitis (Blood Vessel Inflammation): People diagnosed with a type of blood vessel inflammation (including microscopic polyangiitis, granulomatosis with polyangiitis, or eosinophilic granulomatosis with polyangiitis) according to 2022 international criteria, with a positive related antibody, a disease activity score of 15 or above out of 63, and whose condition has not responded to standard treatments for more than 6 months or has returned after improvement.
• Antiphospholipid Syndrome: People diagnosed with primary antiphospholipid syndrome according to 2006 international criteria, with consistently positive antiphospholipid antibodies confirmed on at least two occasions, and whose condition has either continued despite standard anticoagulation treatment, or who have a severe form called catastrophic antiphospholipid syndrome involving three or more organs (confirm with trial site for full criteria).

Who may not be able to join:

• People with severe drug allergies or a history of serious allergic reactions.
• People who have an active infection (fungal, bacterial, viral, or other) that is not under control or requires treatment.
• People with certain disorders of the brain or central nervous system that are not caused by the autoimmune condition being treated (confirm with trial site).
• People with significant heart problems affecting heart function.
• People born with a condition that means their immune system cannot produce immunoglobulins (antibodies).
• People who have had a cancer diagnosis within the past five years.
• People with end-stage kidney failure.
• People who test positive for hepatitis B (with detectable virus in the blood), hepatitis C (with detectable virus in the blood), HIV, or syphilis.
• People with a significant mental illness or severe problems with thinking, memory, or understanding.
• People who have taken part in another clinical trial within the 3 months before joining.
• People who have recently used certain immunosuppressant medications or biological therapies within a specified period before joining (confirm with trial site for exact timeframes).
• People who are pregnant or planning to become pregnant.
• People who the trial investigators determine are not suitable for other reasons.

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