Trial · NCT02807103
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The percentage of patients who obtained a BVAS=0 and prednisone dose ≤7.5 mg/day at day 180. | 180 days | |
| Secondary | Number of adverse events | 180 days | expressed as adverse events according to the CTCAE toxicity grading system per patient-year for the following adverse events combined: death (all causes), grade 2 or higher leukopenia or thrombocytopenia, grade 3 or higher infections, hemorrhagic cystitis, malignancies, venous thromboembolic events, hospitalization resulting either from the disease or from a complication due to the study treatment, infusion reactions (within 24 hours of infusion) that result in the cessation of further infusions |
| Secondary | Number of adverse events | 360 days | expressed as adverse events according to the CTCAE toxicity grading system per patient-year for the following adverse events combined: death (all causes), grade 2 or higher leukopenia or thrombocytopenia, grade 3 or higher infections, hemorrhagic cystitis, malignancies, venous thromboembolic events, hospitalization resulting either from the disease or from a complication due to the study treatment, infusion reactions (within 24 hours of infusion) that result in the cessation of further infusions |
| Secondary | Area under the curve for corticosteroids | 180 days | To measure the corticosteroid dose and to compare the corticosteroid sparing effect of rituximab versus conventional therapy |
| Secondary | Area under the curve for corticosteroids | 360 days | To measure the corticosteroid dose and to compare the corticosteroid sparing effect of rituximab versus conventional therapy |
| Secondary | Number of sequelae assessed by the Vasculitis Damage Index | 180 days | |
| Secondary | Number of sequelae assessed by the Vasculitis Damage Index | day 180 and day 360 | |
| Secondary | ANCA titers and CD19+cells | day 180 and day 360 | |
| Secondary | Health Assessment Questionnaire (HAQ) score | 180 days | to evaluate functional disability |
| Secondary | Health Assessment Questionnaire (HAQ) score | 360 days | to evaluate functional disability |
| Secondary | Short Form-36 score | 180 days | to evaluate quality of life |
| Secondary | Short Form-36 score | 360 days | to evaluate quality of life |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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
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GET https://conductscience.org/api/trials/v1/NCT02807103/registered