Phase 2 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 are willing and able to sign a consent form and follow the study's requirements
• You have been diagnosed with Giant Cell Arteritis (GCA), a condition affecting the blood vessels, confirmed by at least one symptom (such as new headaches, scalp or jaw pain, vision loss, or shoulder/hip stiffness in the mornings) AND at least one medical test result confirming the diagnosis (such as a biopsy, ultrasound, MRI, CT scan, or PET scan)
• You have been receiving Tocilizumab (also called Actemra, or an approved similar drug) by injection or IV infusion for at least 12 months before joining the trial, without missing more than one dose in the 2 months beforehand
• Your GCA has been in remission (no active symptoms and normal inflammation blood test results) for at least 12 months before joining the trial
• You have not taken any steroid medications (such as prednisone) by mouth, injection, or IV for at least 3 months before joining the trial

Who may not be able to join:

• You have another autoimmune or long-term condition that requires ongoing steroid or immune-suppressing treatment (note: inhaled or skin-applied treatments are generally acceptable)
• You were hospitalised in the 8 weeks before joining the trial
• You have suspected or confirmed problems with your adrenal glands not producing enough hormones
• You have taken part in another clinical drug trial within the past 12 months
• You have taken certain other biologic immune-suppressing medications within the past 12 months, or certain non-biologic immune-suppressing medications within the past 3 months (confirm specific medications with trial site)
• You received a live or weakened-virus vaccine within 4 weeks before joining the trial
• You have had a severe allergic or anaphylactic reaction to Tocilizumab or to steroids such as prednisone
• You have serious, uncontrolled conditions affecting your heart, lungs, kidneys, liver, nervous system, mental health, bones, eyes, or digestive system
• You have evidence of a current or past hepatitis B or C infection (some exceptions may apply after specialist review — confirm with trial site)
• You tested positive for tuberculosis (TB) on a blood test, unless you have been on appropriate TB preventive treatment for at least 30 days before starting the study (confirm with trial site)
• You currently have an active infection of any kind (minor nail fungal infections or surface skin infections treated with creams may be acceptable)
• You are pregnant, breastfeeding, or planning to become pregnant during the study
• You have needed antibiotic treatment through an IV in the past 4 weeks, or antibiotic tablets in the past 2 weeks
• You are currently being treated for cancer (preventive hormonal therapy, such as for prostate or breast cancer, may be acceptable — confirm with trial site)
• You have a history of alcohol, drug, or chemical misuse in the past 12 months
• You have had repeated or long-lasting infections in the past 12 months (some minor infections may be acceptable — confirm with trial site)
• You have had a serious or unusual infection in the past 12 months, unless cleared by a specialist
• Certain blood test results from screening fall outside acceptable ranges, including abnormal liver function, low platelet count, low red blood cell levels, or low white blood cell levels (confirm specific values with trial site)
• The study doctor believes there are other medical reasons that could put you at risk or affect the study results

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