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 @ 3:04 AM
Ignite Modification Date:
2025-12-25 @ 3:04 AM
NCT ID:
NCT02531633
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of GCA defined by the following Revised GCA Diagnosis Criteria:
Age \>=50 years. History of ESR \>=50 millimeter/hour (mm/hour) or CRP \>=2.45 milligram/deciliter(mg/dL).
Presence of at least one of the following: Unequivocal cranial symptoms of GCA; Unequivocal symptoms of polymyalgia rheumatic (PMR).
Presence of at least one of the following: Temporal artery biopsy revealing features of GCA; Evidence of large-vessel vasculitis by angiography or cross-sectional imaging.
* Active GCA within 6 weeks of Randomization (Baseline) where active disease is defined by an ESR \>=30 mm/hr or CRP \>=1 mg/dL AND the presence of at least one of the following:
Unequivocal cranial symptoms of GCA; Unequivocal symptoms of PMR; Other features judged by the clinician investigator to be consistent with GCA or PMR flares.
* At screening, receiving or able to receive prednisone 20-60 mg/day for the treatment of active GCA.
* Clinically stable GCA disease at baseline such that the subject is able to safely participate in the blinded prednisone taper regimen in the opinion of the investigator.
* Practicing acceptable methods of birth control if a female of child-bearing potential.
* No evidence of active or latent infection with Mycobacterium tuberculosis (TB).
Exclusion Criteria:
* Are pregnant or breastfeeding.
* Recent (within the past 12 weeks) or planned major surgery that would impact on study procedures or assessments.
* Organ transplantation recipients (except corneas within 3 months prior to baseline visit).
* Had prior treatment with any of the following:
Systemic immunosuppressives) within 4 weeks of baseline; Biologic agents targeted at reducing tumor necrosis factor-alpha (TNF-alpha) within 2-8 weeks of baseline, depending on the agent; Any prior use of tocilizumab or other anti-IL-6 agents; B-cell depleting agents (eg, rituximab) within 12 months prior to baseline or longer if B cell counts have not returned to normal range or baseline levels; Cytotoxic drugs such as cyclophosphamide, chlorambucil, nitrogen mustard, or other alkylating agents within 4 weeks of baseline; Abatacept within 8 weeks of baseline; Tofacitinib within 4 weeks of baseline; Methotrexate use within 2 weeks of baseline.
Methylprednisolone \> 100 mg/day intravenous (IV) (or equivalent) within 8 weeks of baseline.
* History of severe allergic reactions to monoclonal antibodies, human proteins, or excipients.
* Evidence of serious concomitant disease, which in the opinion of the investigator makes them unsuitable for participation in the study.
* Major ischemic event, unrelated to GCA, within 12 weeks of screening.
* Marked baseline prolongation of corrected QT (QTc) interval \>= 450 milliseconds (msec) (QTc by Bazett's formula \[QTcB \]or QTc by Fridericia's formula \[QTcF\] ), history of Torsade de Pointes, family history of long QT syndrome, history of second or third degree heart block.
* Current liver disease that could interfere with the trial
* History of or current active diverticulitis, inflammatory bowel disease, or other symptomatic gastrointestinal tract condition that might predispose to bowel perforation.
* History of known demyelinating diseases such as multiple sclerosis or optic neuritis.
* Active infections, or history of recurrent infections or have required management of acute or chronic infections, as follows:
Currently on any suppressive therapy for a chronic infection, history or suspicion of chronic infection, hospitalization for treatment of infection within 60 days of the baseline visit, or use of parenteral (IV) or intra-muscular \[IM\]) antimicrobials within 60 days of baseline or oral antimicrobials within 30 days of baseline
* Primary or secondary immunodeficiency or any other autoimmune disease.
* Human immunodeficiency virus (HIV) infection, hepatitis C or hepatitis B infection
* Live virus or bacterial vaccination within 3 months before the first administration of study drug
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT02531633
Study Brief:
Protocol Section:
NCT02531633