Trial · NCT03288324
Outcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Oral Clearance (CL/F) (Cohort 1 Only) | Day 5 | Tofacitinib PK was collected from in total of 8 patients, PK parameters were generated for N=7 patients. The PK data for one patient was not used when generating the PK parameters and descriptive summaries due to a dosing event error. | (L/hr) | GEOMETRIC_MEAN |
| SECONDARY | Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Activity Score | weeks 4, 8 and 24 compared to baseline. | score on a scale | MEAN | |
| SECONDARY | AUCt (Cohort 1 Only) | Day 5 | (ng.hr/mL) | GEOMETRIC_MEAN | |
| SECONDARY | Cmax (Cohort 1 Only) | Day 5 | Tofacitinib PK was collected from in total of 8 patients, PK parameters were generated for N=7 patients. The PK data for one patient was not used when generating the PK parameters and descriptive summaries due to a dosing event error. | (ng/mL) | GEOMETRIC_MEAN |
| SECONDARY | Tmax (Cohort 1 Only) | Day 5 | Tofacitinib PK was collected from in total of 8 patients, PK parameters were generated for N=7 patients. The PK data for one patient was not used when generating the PK parameters and descriptive summaries due to a dosing event error. | hr | MEDIAN |
| SECONDARY | Vz/F (Cohort 1 Only) | Day 5 | Tofacitinib PK was collected from in total of 8 patients, PK parameters were generated for N=7 patients. The PK data for one patient was not used when generating the PK parameters and descriptive summaries due to a dosing event error. | L | GEOMETRIC_MEAN |
| SECONDARY | Half-life of Tofacitinib (Cohort 1 Only) | Day 5 | Tofacitinib PK was collected from in total of 8 patients, PK parameters were generated for N=7 patients. The PK data for one patient was not used when generating the PK parameters and descriptive summaries due to a dosing event error. | hr | MEAN |
| SECONDARY | Safety of Tofacitinib: Total Number of Adverse Events is Reported (Cohorts 1 and 2) | 76 weeks | total adverse events | NUMBER | |
| OTHER_PRE_SPECIFIED | Steroid Dose Comparison at 72 Weeks | 72 weeks | Patients who completed 72 wks of study period | mg | MEAN |
| OTHER_PRE_SPECIFIED | Change in SLE Disease Activity Index (SLEDAI) Score | 72 weeks | score on a scale | MEAN | |
| OTHER_PRE_SPECIFIED | Change in SKINDEX Score | Baseline, week 24 and week 72 | score on a scale | MEAN | |
| OTHER_PRE_SPECIFIED | Change in Patients Global Assessment Score | Baseline, week 24 and week 76 | score on a scale | MEAN |
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
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT03288324/outcomes