Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2025-12-25 @ 3:38 AM
NCT ID:
NCT03725202
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of giant cell arteritis (GCA) according to the following criteria:
* History of erythrocyte sedimentation rate (ESR) \>= 50 mm/hour or high sensitivity C-reactive protein (hsCRP)/CRP \>=1.0 mg/dL
* Presence of at least one of the following: Unequivocal cranial symptoms of GCA or Unequivocal symptoms of polymyalgia rheumatica (PMR)
* Presence of at least one of the following: temporal artery biopsy revealing features of GCA or evidence of large vessel vasculitis by angiography or cross-sectional imaging such as ultrasound, magnetic resonance imaging (MRI), computed tomography (CT) or positron emission tomography (PET).
* Active GCA, either new onset or relapsing, within 8 weeks of Baseline.
* Participants must have received treatment with \>=40 mg prednisone (or equivalent) at any time prior to Baseline and be receiving prednisone (or equivalent) \>= 20 mg once daily (QD) at Baseline.
* Participants must have GCA that, in the opinion of the investigator, is clinically stable to allow the participant to safely initiate the protocol-defined corticosteroid (CS) taper regimen.
* Females must either be postmenopausal or permanently surgically sterile or, practicing at least 1 specified method of birth control through the study.
Exclusion Criteria:
* Prior exposure to any Janus Kinase (JAK) inhibitor.
* Treatment with an interleukin-6 (IL-6) inhibitor within 4 weeks of study start, or prior treatment with an IL-6 inhibitor and experienced a disease flare during treatment.
* Use of any of the following systemic immunosuppressant treatments within the specified timeframe prior to study start:
* Anakinra within 1 week of study start.
* Methotrexate, hydroxychloroquine, cyclosporine, azathioprine, or mycophenolate within 4 weeks of study start.
* Oral corticosteroid (CS) for conditions other than GCA within 4 week of study start, or intravenous CS within 4 weeks of study start.
* Greater than or equal to 8 weeks for leflunomide if no elimination procedure was followed, or adhere to an elimination procedure.
* Cell-depleting agents or alkylating agents including cyclophosphamide within 6 months of study start.
* Current or past history of infection including herpes zoster or herpes simplex, human immunodeficiency virus (HIV), active Tuberculosis, active or chronic recurring infection, active hepatitis B or C.
* Female who is pregnant, breastfeeding, or considering pregnancy during the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT03725202
Study Brief:
Protocol Section:
NCT03725202