A Phase 4 interventional study of Prednisone and Methotrexate in Takayasu Arteritis, sponsored by Shanghai Zhongshan Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-10-17.
Sponsored by Shanghai Zhongshan Hospital · Phase 4, Interventional, and Treatment
This study aimed to compare the efficacy and safety of a precision treatment regimen based on clinical-molecular phenotypes with a conventional treatment regimen in the treatment of patients with active Takayasu's arteritis based on a randomized, controlled, open-label, multicenter study.
78 studies on the registry are indexed under Takayasu Arteritis; 32 are open to participants now.
This study's planned enrollment of 124 is above the median of 50 across 37 interventional studies indexed under Takayasu Arteritis.
Browse Takayasu Arteritis studies →Shanghai Zhongshan Hospital is the lead sponsor of 652 studies on the registry; 291 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
8)For patients with no obvious active tuberculosis lesions but elevated T-spot, it is recommended that infectious specialists evaluate them, and preventive anti-tuberculosis therapy should be performed first if necessary. After T-spot declines, researchers will assess the relevant risks before deciding whether they are suitable to participate in this study, and continue preventive anti-tuberculosis therapy for a total of 9 months.
9)For patients with , if the viral replication was detected, it is recommended to take anti-viral treatment for 2-4 weeks, and researchers will evaluate whether they are suitable to participate in this study when no DNA replication is detected.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients will be given treatment based on their clinical-molecular phenotype according to a predesigned scheme: 1. Patients in constitutional type will be given treatments with GCs combined with TCZ and MTX. 2. Patients in vascular inflammation type without IL-6 and TNF-α elevation will be given treatments with GCs combined with TOF. 3. Patients in vascular inflammation type with IL-6 elevation will be given treatments with GCs combined with TCZ and MTX. 4. Patients in vascular inflammation type with TNF-α elevation will be given treatments with GCs combined with ADA and MTX.
Drug: Prednisone · Drug: Methotrexate · Drug: Tocilizumab · Drug: Tofacitinib · Drug: Adalimumab
Patients will be given traditional treatment based on their clinical-molecular phenotype according to a predesigned scheme.
Drug: Prednisone · Drug: Methotrexate
This drug will be used in both arms. Patients' initial daily prednisone dose will be calculated according to their weights (0.6mg \* weight(kg), maximum 50mg/day), and then tapered gradually during the study course.
Also known as: Glucocorticoids
This drug will be used in the traditional arm. A dose of 15mg per week will be used.
Also known as: MTX
This drug will be used in the precise treatment arm. For patients in constitutional type a dose (8mg/kg weight) will be used every 2 weeks (iv drip) for 12 weeks, then a dose (8mg/kg weight) will be used every 4 weeks (iv drip). For patients in vascular inflammation type, a dose (8mg/kg weight) will be used every 4 weeks (iv drip).
Also known as: TCZ
This drug will be used in the precise treatment arm. A sustained release tablet will be used (11mg per day).
Also known as: TOF
This drug will be used in the precise treatment arm. A dose of 40mg (ih) will used every 2 weeks.
Also known as: ADA
Effectiveness rate
Effectiveness is defined if patients meet the following three in criteria ①-④ and criteria ⑤. * No systemic symptoms such as fever, malaise, or wasting; * No new onset of vascular symptoms and signs; * Normal blood sedimentation (in case of abnormality, it is necessary to exclude non-disease active factors and to review and evaluate with the review value); ④ Imaging: no progression of primary vascular lesions or new vascular lesions; ⑤ Glucocorticoids are reduced to 7.5mg/day and maintained for at least 4 weeks.
Time frame: 6 months
Effectiveness rate
* No systemic symptoms such as fever, malaise, or wasting; * No new onset of vascular symptoms and signs; * Normal blood sedimentation (in case of abnormality, it is necessary to exclude non-disease active factors and to review and evaluate with the review value); ④ Imaging: no progression of primary vascular lesions or new vascular lesions; ⑤ Glucocorticoids are reduced to 5mg/day and maintained for at least 4 weeks.
Time frame: 12 months
Relapse rate
The relapse is defined as disease re-activation after remission. Disease activity is assessed according to NIH criteria. NIH≥2 is considered active status. NIH criteria includes: * Systemic symptoms, such as fever, skeletal and muscular symptoms; * Blood sedimentation (erythrocyte sedimentation rate, ESR) \>20mm/H; ③ Characteristics of vascular ischaemia or inflammation: e.g. intermittent claudication, diminished or absent pulse, vascular murmur, vascular pain blood pressure asymmetry; ④Abnormalities of angiography.
Time frame: 12 months
Time to the first relapse
The first time to develop relapse during 12 months' treatment.
Time frame: 12 months
Adverse events
The occurrence of adverse events and the corresponding rate.
Time frame: 12 months
Vascular imaging changes
New vascular lesions, vascular thickness changes, vascular stenosis changes and vascular dilation changes upon MRA or CTA.
Time frame: 12 months
Cytokine changes
Changes of different cytokine profiles, including interleukin levels, chemotactic protein levels, fibrotic marker levels. The spepcific parameters include PTX3, IL6, IFN-g,TNFa, IL8, IL10, IL17, YKL40, CCL22, IL16, CCL2, CCL5, VEGF-A, PDGF-AB, FGF2, MMP1,MMP2, MMP3, MMP9,Leptin, PCSK5, FABP3, GPNMB.
Time frame: 12 months
Improvement of Visual Analog Score for pain
Visual Analog Score for pain score ranges from 0 to 10, higher scores indicate a worse outcome.
Time frame: 12 months
Improvement of 36-Item Short Form Survey
The 36-Item Short Form Survey score ranges from 0 to 800, higher scores indicate a better outcome.
Time frame: 12 months
Improvement of Functional Assessment of Chronic Illness Therapy - Fatigue
The Functional Assessment of Chronic Illness Therapy - Fatigue score ranges from 0 to 52, higher socres indicate a worse outcome.
Time frame: 12 months
Plan to share: No — No appliable
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Started Jun 2024 (actual). Primary completion is estimated for Jun 2026, 24 months after the start.
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Studies of the drugs tested here: Tocilizumab · Tofacitinib · Adalimumab