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A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy of Methotrexate as Remission Maintenance Therapy after Remission-Induction Therapy with Tocilizumab and Glucocorticoids in Subjects with Giant Cell Arteritis (MTXinGCA)
EU CTIS ID: 2022-501058-12-00
What this study is testing
To assess efficacy of metex® on sustained remission of 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
- 1. Subjects male or female, aged ≥18 years
- 2. Written informed consent of the capable subject for voluntary participation in the study.
- 3. Diagnosis of GCA as confirmed by the investigator fulfilment (also in retro-spect) of the proposed extended 1990 classification criteria for GCA.
- 4. Previous treatment with glucocorticoids and tocilizumab for new or relapsing GCA
- 5. GCA patients who have been treated with tocilizumab and in whom discontinuation of tocilizumab therapy has been decided by the treating rheumatologist, within standard treatment at the department of rheumatology are eligible.
- 6. Total tocilizumab therapy should have been at least 6 months before inclusion.
You likely can't join if
- 1. Severe renal (glomerular filtration rate <30/min) failure
- 2. Conditions other than GCA requiring continuous or intermittent treatment with oral or parenteral Glucocorticoids (GCs) unless the last exposure to GCs was >1 months before screening
- 3. Other inflammatory rheumatic diseases (e.g. rheumatoid arthritis)
- 4. Current treatment with any other conventional, biologic or targeted synthet-ic DMARD except tocilizumab
- 5. Elevation of transaminases above three times the norm
- 6. Simultaneous participation in another clinical trial, or participation in a clinical trial taking an investigational product, up to 30 days prior to participation in this clinical trial.
See the full eligibility criteria
- 1. Subjects male or female, aged ≥18 years
- 2. Written informed consent of the capable subject for voluntary participation in the study.
- 3. Diagnosis of GCA as confirmed by the investigator fulfilment (also in retro-spect) of the proposed extended 1990 classification criteria for GCA.
- 4. Previous treatment with glucocorticoids and tocilizumab for new or relapsing GCA
- 5. GCA patients who have been treated with tocilizumab and in whom discontinuation of tocilizumab therapy has been decided by the treating rheumatologist, within standard treatment at the department of rheumatology are eligible.
- 6. Total tocilizumab therapy should have been at least 6 months before inclusion.
- 7. Patients should be in stable remission (defined as the absence of signs or symptoms of GCA and normal CRP <1mg/dl), off glucocorticoids for at least 1 months at screening.
- 8. Willing and able to inject methotrexate or placebo subcutaneously at randomization
- 9. Male and female subjects agreeing to conduct efficient contraception (unless they have no childbearing potential)
- 1. Severe renal (glomerular filtration rate <30/min) failure
- 2. Conditions other than GCA requiring continuous or intermittent treatment with oral or parenteral Glucocorticoids (GCs) unless the last exposure to GCs was >1 months before screening
- 3. Other inflammatory rheumatic diseases (e.g. rheumatoid arthritis)
- 4. Current treatment with any other conventional, biologic or targeted synthet-ic DMARD except tocilizumab
- 5. Elevation of transaminases above three times the norm
- 6. Simultaneous participation in another clinical trial, or participation in a clinical trial taking an investigational product, up to 30 days prior to participation in this clinical trial.
- 7. Pregnant or breast feeding women
- 8. Contraindications for therapy with metex®, as indicated in the summary of product characteristics
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, 18-64 years, 65+ 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.