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:

General requirements (all conditions):

• Adults between 18 and 65 years old, of any gender
• Blood cell counts within acceptable ranges — enough red blood cells, white blood cells, and infection-fighting cells (neutrophils), without having received certain blood-boosting medications in the 2 weeks before testing
• Liver test results within acceptable ranges
• Blood clotting test results within acceptable ranges
• Stable heart function with no major circulation problems
• Women who could become pregnant must have a negative pregnancy test and agree to use reliable contraception throughout the trial
• Willing to take part voluntarily, sign a consent form, and attend follow-up visits as required

People with Lupus (SLE) may also need to meet:

• A confirmed diagnosis of SLE based on established classification criteria
• A history of disease that has not responded to, or has returned after, standard treatment — meaning at least three medications have been tried, including high-dose steroids plus at least two other immune-suppressing or biologic drugs, used for more than 6 months

People with Systemic Sclerosis (SSc) may also need to meet:

• A confirmed SSc diagnosis according to 2013 international classification criteria
• Disease that began within the last 60 months, counting from the first symptom other than Raynaud's phenomenon (cold-triggered colour changes in fingers)
• A skin involvement score of 10 or higher on a standard scale, or active lung scarring shown on specialised scans with lung function below certain thresholds
• Either: disease that has not responded to, or has returned after, standard treatment (steroids plus cyclophosphamide and at least one other immune-suppressing or biologic drug for more than 6 months); or disease that has clearly worsened in the past 6 months, shown by a 25% or more increase in skin score, or a significant decline in lung function measurements

People with Inflammatory Muscle Disease (IIM) may also need to meet:

• A confirmed diagnosis of dermatomyositis, polymyositis, antisynthetase antibody syndrome, or immune-mediated necrotising myositis, based on 2017 international criteria
• Muscle weakness or disease activity measured above certain thresholds on standardised assessment tools, or active lung scarring shown on specialised scans
• A positive blood test for myositis-specific antibodies
• Either: disease that has not responded to, or has returned after, standard treatment (high-dose steroids plus cyclophosphamide and at least one other immune-suppressing or biologic drug for more than 6 months); or rapidly worsening lung inflammation

People with ANCA-associated vasculitis may also need to meet:

• A confirmed diagnosis of microscopic polyangiitis (MPA) or granulomatosis with polyangiitis (GPA) based on 2022 international criteria
• A positive blood test for PR3-ANCA or MPO-ANCA antibodies (either now or in the past)
• A disease activity score of 15 or higher on a standard vasculitis scale, with evidence of active blood vessel inflammation or kidney involvement
• Kidney function above a minimum threshold (eGFR of at least 15 mL/min/1.73m²)
• Disease that has not responded to standard treatment for more than 6 months, or disease that has returned after a period of remission

People with Sjögren's Syndrome may also need to meet:

• A confirmed diagnosis based on 2002 or 2016 international classification criteria
• A positive blood test for anti-SSA/Ro-60 antibodies
• A disease activity score of 5 or higher on the standard Sjögren's disease activity index
• Disease that has not responded to standard treatment for more than 6 months, or disease that has returned after remission

People with Antiphospholipid Syndrome (APS) may also need to meet:

• A confirmed diagnosis of primary APS based on the 2006 Sydney criteria
• At least two positive blood tests for specific antiphospholipid antibodies, taken more than 12 weeks apart, at medium to high levels
• Either: recurrent blood clots despite standard blood-thinning treatment; or a severe form called catastrophic APS, involving at least three organs within one week, confirmed by imaging and blood tests

Who may not be able to join:

General exclusion criteria (all conditions):

• People who also have another connective tissue disease
• People with severe involvement of the heart (such as angina, heart attack, heart failure, or significant irregular heartbeat), kidneys (very low kidney function), liver (liver test results above certain limits), lungs (lung function below certain thresholds), or blood counts below minimum levels
• People with signs of active or chronic hepatitis B or hepatitis C infection on blood tests
• People with active tuberculosis or latent (hidden) tuberculosis
• People who test positive for HIV or have a known history of HIV infection
• People with any serious active infection (bacterial, viral, or fungal), including those who needed hospital admission or intravenous antibiotics in the 4 weeks before screening, or oral antibiotics in the 2 weeks before screening; or people being treated for ongoing infections such as certain fungal, viral, or bacterial conditions
• People with a primary or secondary immune deficiency condition
• People with certain very low levels of immune proteins (IgA below 10 mg/dL or IgG below 400 mg/dL)
• People who have taken part in another clinical drug trial within the 3 months before screening
• People with a history of cancer diagnosed within the past 5 years, except for certain treated skin cancers or treated cervical changes
• People who are pregnant, breastfeeding, planning a pregnancy in the near future, or unwilling to use reliable contraception throughout the trial
• People with a known allergy to human or animal proteins or monoclonal antibody treatments
• People who received a live or live-attenuated vaccine within 4 weeks before being enrolled in the trial
• People who are unlikely to be able to follow the trial requirements or complete the study, such as those with certain psychiatric conditions or a history of alcohol or substance misuse
• Anyone the trial investigators consider unsuitable for other reasons

Additional exclusion criteria for Systemic Sclerosis:

• People with a localised (skin-only) form of SSc rather than systemic disease
• People whose SSc symptoms began more than 5 years ago (from the first non-Raynaud's symptom)
• People whose SSc-like condition is linked to environmental exposures such as certain chemicals
• People with any history of a scleroderma kidney crisis
• People with intermediate or high-risk pulmonary hypertension (high blood pressure in the lung arteries)
• People with active widening of blood vessels in the stomach lining (confirm with trial site)

Additional exclusion criteria for Inflammatory Muscle Disease:

• People whose muscle condition was caused by a medication
• People with inclusion body myositis (a specific type of muscle disease)
• People whose muscle disease is linked to a cancer diagnosis within the past 2 years

Additional exclusion criteria for ANCA-associated vasculitis:

• People with active bleeding in the lungs requiring a breathing machine, expected to continue beyond the screening period
• People who need dialysis or plasma exchange during the screening period
• People who have previously had a kidney transplant

Additional exclusion criteria for Sjögren's Syndrome:

• People who also have liver cirrhosis
• People who also have aplastic anaemia, myelodysplastic syndrome, or other bone marrow disorders
• People whose low platelet count is caused by a medication
• People with thrombotic thrombocytopenic purpura or related small blood vessel conditions

Additional exclusion criteria for Antiphospholipid Syndrome:

• People whose APS is related only to pregnancy complications
• People whose APS occurs alongside another connective tissue disease
• People whose APS involves the nervous system

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