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INTOReTAK - Multicentre, randomized, prospective trial evaluating the efficacy and safety of Infliximab to tocilizumab in refractory or relapsing Takayasu arteritis
EU CTIS ID: 2024-512229-10-00
What this study is testing
To obtain, by arm, ≥ 70% of patients at 6 months post-treatment with prednisone (or the prednisolone) ≤ 0.1mg/kg per day and inactive disease during the last 3 months.
- 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
- Diagnosis of Takayasu arteritis (see protocol)
- For subjects with reproductive potential, a willingness to use contraceptive measures adequate to prevent the subject or the subject’s partner from becoming pregnant during the study.
- Active disease according to the international criteria of the National Institute of Health (NIH) (appendix 2) - see protocol
- Refractory/relapsing disease or symptomatic severe arterial involvement
- For Refractory/relapsing disease, patients with one immunosuppressive agent (methotrexate, azathioprine, mercaptopurine or mycophenolate mofetil, leflunomide, ciclosporine, hydroxychloroquine) with no change in dosage within the last 30 days unless allergy/intolerance or contraindication to immunosuppressive agents.
- Age of 15 years or older
You likely can't join if
- Active tuberculosis or latent tuberculosis infection currently treated less than 3 weeks
- Hepatic dysfunction as shown by aspartate transaminase (AST) or alanine transaminase (ALT) levels >5‐fold the upper limit of normal
- Heart failure ≥ stage III / IV NYHA,
- History of any malignant neoplasm except adequately treated basal or squamous cell carcinoma of the skin, or solid tumors treated with curative therapy and disease free for at least 5 years.
- History of multiple sclerosis and/or demyelinating disorder
- History of severe allergic or anaphylactic reactions to infliximab, any chimeric murine monoclonal antibody, tocilizumab, and their respective excipients or prednisone (or the prednisolone).
See the full eligibility criteria
Who can join
- Diagnosis of Takayasu arteritis (see protocol)
- For subjects with reproductive potential, a willingness to use contraceptive measures adequate to prevent the subject or the subject’s partner from becoming pregnant during the study.
- Active disease according to the international criteria of the National Institute of Health (NIH) (appendix 2) - see protocol
- Refractory/relapsing disease or symptomatic severe arterial involvement
- For Refractory/relapsing disease, patients with one immunosuppressive agent (methotrexate, azathioprine, mercaptopurine or mycophenolate mofetil, leflunomide, ciclosporine, hydroxychloroquine) with no change in dosage within the last 30 days unless allergy/intolerance or contraindication to immunosuppressive agents.
- Age of 15 years or older
- Weight 40 – 120 kg
- For symptomatic severe arterial involvement, patients with one immunosuppressive agent (methotrexate, azathioprine, mercaptopurine or mycophenolate mofetil, leflunomide, ciclosporine, hydroxychloroquine) unless allergy/intolerance or contraindication to immunosuppressive agents.
- Medical follow-up in a university or general hospital in France
- Social insurance
- Willing and able to provide written informed consent
- Chest X-ray results (postero-anterior and lateral) or chest CT within 12 weeks prior to the inclusion & randomization visit with no evidence of active tuberculosis, active infection, or malignancy
- Tuberculosis assessment meeting one of the following conditions (see protocol)
- Negative human immunodeficiency virus (HIV) serology, negative hepatitis C RNA, and hepatitis B surface antigen within 3 months.
- Willing and able to comply with treatment and follow-up procedures required by the study protocol
- For female subjects of child-bearing age, a negative serum pregnancy test and no pregnancy plans within 12 months.
What rules you out
- Active tuberculosis or latent tuberculosis infection currently treated less than 3 weeks
- Hepatic dysfunction as shown by aspartate transaminase (AST) or alanine transaminase (ALT) levels >5‐fold the upper limit of normal
- Heart failure ≥ stage III / IV NYHA,
- History of any malignant neoplasm except adequately treated basal or squamous cell carcinoma of the skin, or solid tumors treated with curative therapy and disease free for at least 5 years.
- History of multiple sclerosis and/or demyelinating disorder
- History of severe allergic or anaphylactic reactions to infliximab, any chimeric murine monoclonal antibody, tocilizumab, and their respective excipients or prednisone (or the prednisolone).
- History of immediate hypersensitivity reaction to iodinated and gadolinium-based contrast media
- Cytopenia: Hemoglobin < 8.5 g/dL, absolute neutrophil < 1.5 G/L, Platelet count < 80 G/L
- Any live (attenuated) vaccine fewer than 4 weeks before enrolment. Recombinant or killed virus vaccines fewer than 2 weeks before the inclusion & randomization visit.
- Use of the following systemic treatments during the specified periods: a.Treatment with biologic therapy (infliximab, adalimumab, certolizumab pegol, golimumab, anakinra, tocilizumab, etanercept, abatacept, ixekizumab, secukinumab, ustekinumab, alemtuzumab) within 3 months prior to the inclusion & randomization visit b. Past treatment with rituximab within the past months, or past treatment with rituximab more than months ago where the B lymphocytes count has not returned to normal at time of the inclusion & randomization visit c. Treatment with any systemic alkylating agents within 3 months prior to the inclusion & randomization visit (e.g., cyclophosphamide, chlorambucil)
- Indication to initiate infliximab or tocilizumab for another active disease than Takayasu arteritis
- Evidence of active infection (includes chronic infection)
- Lack of affiliation to a social security benefit plan (as a beneficiary or assignee)
- Presence of any of the following on-ongoing and on-treatment disease processes: o Microscopic polyangiitis o Granulomatosis with polyangiitis o Eosinophilic granulomatosis with polyangiitis o Polyarteritis nodosa o Cogan’s syndrome o Behcet’s disease o Kawasaki’s disease o Atypical mycobacterial infections o Deep fungal infections o Lymphoma, lymphomatoid granulomatosis, or other type of malignancy tha mimics vasculitis o Cryoglobulinemic vasculitis o Systemic lupus erythematosus o Rheumatoid arthritis o Mixed connective tissue disease or any overlap autoimmune syndrome o Known constitutive immunodeficiency
- Infection requiring treatment with antibiotics within 2 weeks prior to the inclusion & randomization visit
- Infection with positive human immunodeficiency virus (HIV) serology, positive hepatitis C RNA, or a positive hepatitis B surface antigen.
- Pregnancy or lactation
- Inability to comply with study guidelines
- Inability to provide informed consent
- Alcohol or drug abuse, that, in the investigator’s opinion, could prevent a subject from fulfilling the study requirements or that would increase the risk of study procedures
- Severe renal insufficiency (creatinine clairance <30mL/min/1,73m2)
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, 0-17 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.