Phase 3 Polymyalgia Rheumatica 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 who have been diagnosed with giant cell arteritis (GCA) — either for the first time or as a returning condition — and who meet at least 3 out of 5 specific diagnostic criteria (including at least one involving a temporal artery exam or biopsy/imaging result)
• People whose GCA has shown signs of being active within the past 8 weeks
• People who are willing and able to follow all treatment and follow-up appointments required by the study
• People of childbearing potential (both male and female) who are willing to use an effective form of contraception throughout the study, such as abstinence, surgical sterilisation, barrier methods, or hormonal contraception
• People who are willing and able to sign a written consent form agreeing to take part

Who may not be able to join:

• People who had a serious infection requiring hospital care or intravenous antibiotics in the 60 days before joining, or any infection requiring antibiotic or antiviral tablets in the 30 days before joining
• People with a history of ongoing or frequently returning bacterial infections (such as recurring kidney infections, bone infections, or chronic lung disease involving infected airways)
• People with a history of shingles occurring more than once, shingles that spread beyond one area of the body, widespread cold sore virus (herpes simplex) infections, or shingles affecting the eye — unless those symptoms cleared up more than 60 days before the screening visit
• People with a history of serious fungal infections that spread through the body (such as histoplasmosis, blastomycosis, or coccidioidomycosis)
• People with a history of a primary immune system deficiency (a condition where the immune system does not work properly from birth or early life)
• People with current or past tuberculosis (TB) that was not properly treated, or people with a positive TB screening test indicating latent (inactive) TB — unless certain conditions are met, such as no signs of active TB on chest X-ray and current or completed treatment for latent TB (confirm with trial site)
• People who are pregnant or currently breastfeeding
• People who are unable to follow the study guidelines
• People with certain low blood count results, including low platelets, low white blood cells, low neutrophils, or low red blood cell levels (confirm specific thresholds with trial site)
• People with significantly reduced kidney function, defined by a specific measure of kidney filtration rate (confirm with trial site)
• People with liver enzyme levels (AST or ALT) more than three times the upper limit of normal
• People with another serious, worsening, or uncontrolled illness that the study doctor believes would make participation unsafe or not possible
• People with a current cancer diagnosis, or a cancer diagnosis within the past 5 years — with the exception of certain treated skin cancers (non-spreading squamous or basal cell skin cancer) or treated cervical cancer in situ
• People who have taken part in another clinical trial involving an experimental medicine or device within the 30 days before joining
• People who received a live vaccine within 3 months before joining the trial
• People currently taking certain non-biological immune-suppressing medications (such as azathioprine, mycophenolate, leflunomide, hydroxychloroquine, cyclosporin, tacrolimus, or similar drugs) — these would need to be stopped before joining
• People who have recently taken certain other immune-suppressing or biologic medications, including specific ones within defined time windows before joining (confirm which medications and timeframes apply with trial site)
• People who will need to take steroid tablets or infusions during the trial for any condition other than GCA
• People with a known allergy or sensitivity to the study drug (abatacept) or any of its ingredients
• People who have certain other autoimmune or inflammatory conditions, including Takayasu arteritis, granulomatosis with polyangiitis, microscopic polyangiitis, eosinophilic granulomatosis with polyangiitis, polyarteritis nodosa, Cogan's syndrome, Behçet's disease, sarcoidosis, certain types of lymphoma or cancers that resemble vasculitis, cryoglobulinaemic vasculitis, lupus, rheumatoid arthritis, mixed connective tissue disease, or any overlapping autoimmune condition

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