Trial · NCT03893136
The Registry Study of Takayasu Arteritis in East China
NCT03893136, Unknown, Shanghai Zhongshan Hospital
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. The Registry Study of Takayasu Arteritis in East China. Trials, record NCT03893136. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03893136
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Registry Study of Takayasu Arteritis in East China
- NCT number
- NCT03893136
- Status
- Unknown
- Enrollment
- 1,000 participants, estimated
- Lead sponsor
- Shanghai Zhongshan Hospital
- Conditions
- Takayasu Arteritis, Mechanisms, Defense, Pregnancy Related, Treatment Refusal, Outcome
- Interventions
- Tocilizumab, Leflunomide
- First posted
- 2019-03-28
- Last updated
- 2021-08-10
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The change of manifestations of systemic symptom - fever | Through study completion, an average of 2 months. | The change of manifestations of systemic symptoms could effectively reflect the disease status of patients. The systemic symptoms associated with Takayasu arteritis mainly consist of fever, fatigue and chest congestion. Fever is examined by thermometer with the axillary's temperature, and the T\>37.5 degree is considered to be fever. After investigators excluding the fever caused by infection through CT or laboratory examinations, the occurrence of fever usually indicates the disease activity. |
| Primary | The change of manifestations of systemic symptom - fatigue | Through study completion, an average of 2 months. | The occurrence of fatigue indicates that the disease might be in the active phase. Self reported fatigue is obtained through inquiry, recorded by investigators and classified as "WITH" and "WITHOUT". |
| Primary | The change of manifestations of systemic symptoms - chest congestion | Through study completion, an average of 2 months. | The occurrence of chest congestion indicates that the heart and pulmonary might be involved and the disease might be in the active phase. Self reported chest congestion is obtained through inquiry, recorded by investigators and classified as "WITH" and "WITHOUT". |
| Primary | The change of the emerging signs or symptoms of ischemia | Through study completion, an average of 2 months. | Multiple emerging signs or symptoms could sensitively reflect the extent of ischemia of artery or organs. Self-reported emerging signs or symptoms of ischemia including vascular pain, dizziness, headache, amaurosis, vision loss, blurred vision, palpitations, chest pain, abdominal pain, claudication and other symptom through inquiry are recorded by investigators and classified as "WITH" and "WITHOUT". Participants with emerging signs or symptoms of ischemia usually face aggravating TA disease. |
| Primary | The change of the signs or symptoms of ischemia | Through study completion, an average of 2 months. | The vascular bruits and pulse strength are evaluated and scored from 0 to 2 (0=without bruits and pulse; 1=bruits and decreased pulse; 2= normal) by a special well-trained investigator. If the score decreases, the ischemia is exacerbated and classified as "WITH". |
| Primary | The change of the blood pressure | Through study completion, an average of 2 months. | The blood pressure change is measured with sphygmomanometer by the investigators. The measure is performed three times in each visit, and the mean systolic blood pressure (SBP) and mean diastolic blood pressure (DBP) are recorded. If the pressure fluctuates over 20mmHg, the stenosis of artery may exacerbate and the disease might be in the active phase. |
| Primary | The change of laboratory tests. | Through study completion, an average of 2 months. | The laboratory inflammatory markers such as erythrocyte sedimentation rate (ESR) are concise and efficient methods to monitor the change of disease status, and are examined by clinical laboratory in Zhongshan Hospital of Fudan University. Investigators record and summarize the results and evaluate the change of ESR under different treatment options. |
| Primary | The change of IL-6 in plasma | Through study completion, an average of 2 months. | IL-6 plays an important role in the progression of Takayasu arteritis. The level of plasma IL-6 is detected by clinical laboratory in Zhongshan Hospital of Fudan University. Investigators record and summarize the results and evaluate the change of IL-6 under different interventions, and analyze the relationship between IL-6 and disease status. |
| Primary | The change of vascular imaging. | Through study completion, an average of 2 months. | MRA and contrast-enhanced carotid ultrasound imaging are important methods to evaluate TA vascular inflammation and structural change. In the initial interview and every 3 times of follow-up, the imaging examination are carried out and the images are stored at the hospital. Two radiologists perform the independent reading and evaluation. Vascular imaging is employed to monitor the improvement of the vascular wall inflammation and vascular structures (including vessel wall thickness and vascular stenosis) during treatment. For patients with stent or other metallic foreign things in the body, PET-CT and CT are also used to examine the shape and lumen of the vessels. |
| Primary | The change of quality of life(QOF): SF-36 questionnaire | Through study completion, an average of 2 months. | The change of Quality of Life (QOF) with the SF-36 questionnaire Self reported the change of quality of life. Patients complete the SF-36 quality of life assessment questionnaire. Investigators provide the guidance and training on how to complete the questionnaire but must not interfere with the patients' own choice. Investigators evaluate the change of overall quality of life of patients and score the change from 0 to 2 (0= alleviated, 1=similar, 2= worsen). |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers16
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03893136
GET https://conductscience.org/api/trials/v1/NCT03893136/registered