ETANERCEPT for Giant cell arteritis

Inclusion criteria

• {"criterion_text":"- Patient’s written informed consent to participate in the study"}
• {"criterion_text":"- Age ≥ 50 years."}
• {"criterion_text":"- Diagnosis of GCA according to 2022 American College of Rheumatology/EULAR classification criteria for GCA or, in the case of involvement of only extracranial arteries, patients with a diagnosis of GCA based on medium or large-sized arterities that occurred at the age of ≥ 50 years and was confirmed by imaging, i.e. ultrasound, CT, MRI, conventional angiography or PET-CT, at the time of screening or in the past."}
• {"criterion_text":"- New onset, refractory or relapsing GCA."}
• {"criterion_text":"- Active GCA, defined as the presence of symptoms or signs attributed to GCA and not related to prior damage and elevated inflammatory markers, i.e. ESR ≥ 30 mm/1 hour or CRP ≥ 10 mg/L attributed to active GCA at screening or within 8 weeks prior to screening."}
• {"criterion_text":"- Women of child-bearing potential and men who are sexually active with a woman of child-bearing potential must agree to the use of contraception with an adequate level of effectiveness during treatment with methotrexate/etanercept and for at least 6 months after its completion."}

Exclusion criteria

• {"criterion_text":"- Presence of ischemia of organ important for the patient’s survival (e.g. central nervous system, heart, lungs, kidneys, alimentary tract) in the course of GCA."}
• {"criterion_text":"- Moderate or severe heart failure (New York Heart Association class III or IV), unstable ischemic heart disease, a stroke or myocardial infarction within 6 months prior to screening, or other cardiovascular disease that, in the Investigator’s opinion, would expose the patient to an unacceptable risk in case of participation in the study."}
• {"criterion_text":"- Severe liver dysfunction"}
• {"criterion_text":"- Severe renal impairment"}
• {"criterion_text":"- Bone marrow hypoplasia"}
• {"criterion_text":"- Other severe disease (including, but not limited to, respiratory, nervous, endocrine, digestive, urinary tract disease) for which, in the Investigator’s opinion, participating in the study would expose patient to an unacceptable risk."}
• {"criterion_text":"- A malignancy within 5 years prior to screening, except for: a. A completely resected cervical carcinoma in situ with no signs of recurrence within 12 months prior to screening; b. A completely cured basal cell skin carcinoma with no signs of recurrence within 12 months prior to screening."}
• {"criterion_text":"- The following abnormalities in laboratory tests at screening: a.\tWBC < 3 G/L; b.\tNEU < 1 G/L; c.\tHGB < 9 g/dL; d.\tPLT < 100 G/L; e.\tALT > 2 x ULN; f.\tAST > 2 x ULN; g.\tTotal bilirubin >1,5 x ULN; h.\teGFR < 50ml/min/1,73 m2; i.\tpositive HBsAg; j.\tpositive anti-HBc (total); k.\tpositive anti-HCV; l.\tpositive anti-HIV; m.\tpositive or equivocal Quantiferon-TB Gold test."}
• {"criterion_text":"- Positive result of a pregnancy test performed in women of child-bearing potential at screening or Visit 1."}
• {"criterion_text":"- Previous use of the following treatment: a. Within 2 weeks prior to randomization: oral corticosteroids (CS) >60 mg/day prednisone or equivalent, parenteral CS; b. Within 12 weeks prior to randomization: methotrexate, leflunomide, sulfasalazine, chloroquine, hydroxychloroquine, azathioprine, cyclosporine A, mycophenolate mofetil, TNFα inhibitors, anakinra, abatacept, IL-17 blockers; c. Within 6 months prior to randomization: immunoglobulins, plasmapheresis, cyclophosphamide or other alkylating agents; d. Within 12 months prior to randomization: anti-CD20 antibodies; e. Oral or parenteral CS used chronically for reasons other than GCA."}
• {"criterion_text":"- Abuse or addiction to drugs, alcohol or psychoactive substances."}
• {"criterion_text":"- Presence or history of other chronic autoimmune rheumatic disease that could interfere with the evaluation of the results of the following study, including: systemic lupus erythematosus, rheumatoid arthritis, or other systemic connective tissue disease, other than GCA systemic vasculitis."}
• {"criterion_text":"- Live/attenuated vaccinations within 3 months prior to screening or planned administration of live vaccination during the study period."}
• {"criterion_text":"- Use of other investigational drugs within 12 weeks or 5 half-lives, whichever is longer, prior to screening."}
• {"criterion_text":"- Pregnancy or planned pregnancy during the study."}
• {"criterion_text":"- Breastfeeding or planned breastfeeding during the study."}
• {"criterion_text":"- Lack of patient cooperation"}
• {"criterion_text":"- Oral mucous ulcers."}
• {"criterion_text":"- Active stomach or duodenal ulcer."}
• {"criterion_text":"- Presence or history of demyelinating syndrome"}
• {"criterion_text":"- History of major organ transplant (kidneys, lungs, heart, liver)."}
• {"criterion_text":"- Major surgery within 3 months prior to screening or major surgery planned during the study period."}
• {"criterion_text":"- Hypersensitivity to methotrexate, etanercept or any other excipients of the methotrexate or etanercept."}
• {"criterion_text":"- Acute, recurrent or chronic infection (e.g. tuberculosis, HIV infection) for which, in the Investigator’s opinion, participating in the study would expose patient to an unacceptable risk."}

Primary endpoints

• {"endpoint_text":"- Percentage of sustained steroid-free GCA remission at week 52 from randomization, defined as lack of symptoms and signs attributable to GCA and not related to prior damage and normalization of inflammatory markers (i.e. ESR < 30 mm/1 hour and CRP < 10 mg/L) with adherence to the protocol-defined prednisone taper regimen.","definition_or_measurement_approach":"Sustained steroid-free remission at week 52 defined by: lack of symptoms and signs attributable to GCA (not related to prior damage) AND normalization of inflammatory markers (ESR < 30 mm/1 hour and CRP < 10 mg/L) with adherence to protocol-defined prednisone taper regimen."}

Secondary endpoints

• {"endpoint_text":"- Mortality rate in the course of GCA at 52 and 104 week from randomization.","definition_or_measurement_approach":"All-cause mortality related to course of GCA measured at weeks 52 and 104 post-randomization."}
• {"endpoint_text":"- Percentage of severe ischemic complications of GCA at 52 and 104 week, defined as: a.\tstroke, b.\tmyocardial infarction, c.\tcomplete or partial vision loss, d.\tlimb ischemia, e.\tischemia of organs important for the patient's survival (i.e. lungs, kidneys, alimentary tract).","definition_or_measurement_approach":"Severe ischemic complications defined as occurrence of stroke, myocardial infarction, complete or partial vision loss, limb ischemia, or ischemia of organs important for survival; assessed at weeks 52 and 104."}
• {"endpoint_text":"- Percentage of sustained steroid-free GCA remission at week 104 from randomization, defined as lack of symptoms and signs attributable to GCA and not related to prior damage and normalization of inflammatory markers (ESR < 30 mm/1 hour and CRP < 10 mg/L) with adherence to the protocol-defined prednisone taper regimen.","definition_or_measurement_approach":"Same definition as primary endpoint applied at week 104."}
• {"endpoint_text":"- Percentage of GCA remission at 24, 52, 78 and 104 week from randomization, defined as lack of symptoms and signs attributable to GCA and not related to prior damage and normalization of inflammatory markers (i.e. ESR < 30 mm/1 hour and CRP < 10 mg/L).","definition_or_measurement_approach":"Remission defined by absence of attributable symptoms/signs and normalization of ESR (<30 mm/1h) and CRP (<10 mg/L) assessed at specified weeks."}
• {"endpoint_text":"- Percentage of GCA remission (defined as lack of symptoms and signs attributable to GCA and not related to prior damage and normalization of inflammatory markers, i.e. ESR < 30 mm/1 hour and CRP < 10 mg/L) with concomitant achievement of prednisone dose ≤ 5mg/day at 26, 52, 78 and 104 week from randomization.","definition_or_measurement_approach":"Remission plus prednisone dose ≤5 mg/day at specified weeks."}
• {"endpoint_text":"- Percentage of GCA remission (defined as lack of symptoms and signs attributable to GCA and not related to prior damage and normalization of inflammatory markers, i.e. ESR < 30 mm/1 hour and CRP < 10 mg/L) with concomitant achievement of prednisone dose ≤ 7,5mg/day at 26, 52, 78 and 104 week from randomization.","definition_or_measurement_approach":"Remission plus prednisone dose ≤7.5 mg/day at specified weeks."}
• {"endpoint_text":"- Cumulative dose of prednisone at 26, 52, 78 and 104 week from randomization.","definition_or_measurement_approach":"Total cumulative prednisone dose received by participant measured at specified weeks."}
• {"endpoint_text":"- Time to GCA relapse (after achieving remission).","definition_or_measurement_approach":"Time from remission to relapse; relapse criteria per study definitions."}
• {"endpoint_text":"- Major GCA relapse within 26, 52, 78 and 104 weeks from randomization.","definition_or_measurement_approach":"Occurrence of major relapse events assessed at specified weeks."}
• {"endpoint_text":"- Minor GCA relapse within 26, 52, 78 and 104 weeks from randomization.","definition_or_measurement_approach":"Occurrence of minor relapse events assessed at specified weeks."}
• {"endpoint_text":"- Change in quality of life measured by SF-36 v.2 questionnaire at 26, 52, 78 and 104 week (compared to the randomization visit).","definition_or_measurement_approach":"Change from baseline in SF-36 v2 scores at specified weeks."}
• {"endpoint_text":"- Occurrence of serious adverse events within 26, 52, 78 and 104 weeks from randomization.","definition_or_measurement_approach":"Recording of SAEs occurring within the specified follow-up windows."}
• {"endpoint_text":"- Occurrence of non-serious adverse events within 26, 52, 78 and 104 weeks from randomization.","definition_or_measurement_approach":"Recording of non-serious AEs occurring within the specified follow-up windows."}

Poland

Earliest CTIS Part Ii Submission Date

30-04-2024

Latest Decision Or Authorization Date

24-02-2026

Processing Time Days

665

Number Of Sites

6

Number Of Participants

88

Primary sponsor

Full Name

Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Poland

Third parties

• {"country":"","full_name":"Agencja Badań Medycznych","duties_or_roles":"Source of monetary support","organisation_type":""}