A randomized trial comparing efficacy and safety of etanercept and methotrexate in giant cell arteritis (EFFECTA)

Phase 1

• Conditions: Giant cell arteritis; MedDRA version: 20.0Level: LLTClassification code: 10018250Term: Giant cell arteritis Class: 10047065; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: CTIS2023-506623-29-01
• Lead Sponsor: Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-05
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 212

Inclusion Criteria

Patient’s written informed consent to participate in the study, Age = 50 years., Diagnosis of GCA according to 2022 American College of Rheumatology/EULAR classification criteria for GCA at the time of screening or in the past., New onset, refractory or relapsing GCA., 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., 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

Presence of major organ ischemia (e.g. central nervous system, heart, lungs, kidneys, alimentary tract) in the course of GCA., 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., Severe liver dysfunction, Severe renal impairment, Bone marrow hypoplasia, 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., 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., 16.The following abnormalities in laboratory tests at screening: a.WBC < 3 G/L; b.NEU < 1 G/L; c.HGB < 9 g/dL; d.PLT < 100 G/L; e.ALT > 2 x ULN; f.AST > 2 x ULN; g.Total bilirubin >1,5 x ULN; h.eGFR < 50ml/min/1,73 m2; i.positive HBsAg; j.positive anti-HBc (total); k.positive anti-HCV; l.positive anti-HIV; m.positive or equivocal Quantiferon-TB Gold test., Positive result of a pregnancy test performed in women of child-bearing potential at screening or Visit 1., 18.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, TNFa 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., Abuse or addiction to drugs, alcohol or psychoactive substances., 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., Live/attenuated vaccinations within 3 months prior to screening or planned administration of live vaccination during the study period., Use of other investigational drugs within 12 weeks or 5 half-lives, whichever is longer, prior to screening., Pregnancy or planned pregnancy during the study., Breastfeeding or planned breastfeeding during the study., Lack of patient cooperation, Oral mucous ulcers., Active stomach or duodenal ulcer., Presence or history of demyelinating syndrome, History of major organ transplant (kidneys, lungs, heart, liver)., Major surgery within 3 months prior to screening or major surgery planned during the study period., Hypersensitivity to methotrexate, etanercept or any other excipients of the methotrexate or etanercept., 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified