Trial · NCT02981979
Takayasu Arteritis Clinical Trial in China
NCT02981979, Not applicable, Completed, Jiang lindi
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Takayasu Arteritis Clinical Trial in China. Trials, record NCT02981979. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02981979
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Takayasu Arteritis Clinical Trial in China
- NCT number
- NCT02981979
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 116 participants, actual
- Lead sponsor
- Jiang lindi
- Conditions
- Takayasu Arteritis
- Interventions
- Leflunomide(LEF), Prednisone Acetate Tablets, Placebos
- First posted
- 2016-12-05
- Last updated
- 2025-04-24
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Achievement of clinical remission at week 24 | From the date of randomization until the end of induced remission therapy, assessed up to 24 weeks | Clinical remission is defined as follows: (i) have no systemic symptoms (e.g., fever, fatigue, weight loss); (ii) have no new onset of ischemic symptoms and signs; (iii) have a normal level of erythrocyte sedimentation rate (ESR). If not achieved, the investigator excluded other influencing factors (especially infection), re-measure the ESR after 1 week, and use the re-examined value in the analyses. Subject achieving clinical remission should meet all these criteria above. The clinical remission rate and its difference between LEF and placebo group with 95% confidence interval (CI) at week 24 was estimated by Newcombe-Wilson procedure. If the lower limit of the 95%CI of the difference \>10%, it is considered that the efficacy of LEF is significantly superior to placebo. |
| Secondary | Time to clinical remission | From the date of randomization until the date of first documented clinical remission, assessed up to 24 weeks | |
| Secondary | The mean prednisone dose at week 24 | At the end of induced remission therapy, assessed up to 24 weeks | |
| Secondary | Achievement of clinical remission at week 52 in those who switched from placebo to LEF from week 25 | From the time of switch from placebo to LEF treatment (week 25), assessed up to week 52 | |
| Secondary | Disease recurrence through week 25 to week 52 | From the beginning of week 25 to the end of follow up, assessed up to week 52 | Disease recurrence is defined as NIH score ≥2 or not meeting ≥2 criteria for clinical remission. NIH score: 1\) presence of systemic symptoms as fever, fatigue and weight loss (1'); 2）presence of ischemic symptoms or signs (1'); 3\) abnormal serum ESR levels (1'); 4\) progression or new site of vascular lesions on MRA or CTA compared to baseline(1'). |
| Secondary | Time to recurrence | from the beginning of achieving clinical remission to the date of the first documented disease recurrence, assessed up to 52 weeks | |
| Secondary | Imaging changes at the end of week 24 and week 52 compared to the baseline | From the date of randomization until the end of week 24 and week 52 | |
| Secondary | Safety-adverse events | From the date of randomization until the end of this trial, assessed up to 52 weeks | For safety analysis, the incidence and severity of AEs, adverse drug reactions and laboratory values in the LEF and placebo group would be estimated and compared using the χ2 test or Fisher's exact test. The association of an abnormal laboratory index and adverse event with the investigational drug would be evaluated. |
Source ClinicalTrials.gov
Outcomes0
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.
Papers2
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/NCT02981979
GET https://conductscience.org/api/trials/v1/NCT02981979/registered