BridgeMD
A randomized trial comparing efficacy and safety of etanercept and methotrexate in giant cell arteritis (EFFECTA)
EU CTIS ID: 2023-506623-29-01
What this study is testing
To compare the effectiveness of treatment with etanercept (ETN) versus methotrexate (MTX) in the induction of sustained steroid-free remission in patients with giant cell arteritis (GCA).
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 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.
- 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.
You likely can't join if
- 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.
- 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.
See the full eligibility criteria
Who can join
- 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 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.
- 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.
What rules you out
- 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.
- 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.
- 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.
- 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.
- 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.