Trial · NCT03288324
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 | Oral Clearance (CL/F) (Cohort 1 Only) | Day 5 | Apparent total clearance of the drug from plasma after oral administration |
| Secondary | Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Activity Score | weeks 4, 8 and 24 compared to baseline. | Proportion of subjects who achieve a skin response per the validated CLASI The Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) activity score consists of two scores. The first summarizes the activity of the disease while the second is a measure of the damage done by the disease. The Activity Score range is 0-70 with the maximum score (70) indicating the worst outcome. The Damage Score range is 0-80 with the maximum score (80) indicating the worst outcome. |
| Secondary | AUCt (Cohort 1 Only) | Day 5 | Area under the plasma concentration-time curve linear scale Median Concentration (ng/mL) per nominal time 0-8 hours. |
| Secondary | Cmax (Cohort 1 Only) | Day 5 | Maximum (or peak) plasma concentration of Tofacitinib |
| Secondary | Tmax (Cohort 1 Only) | Day 5 | Time to reach maximum (peak) plasma concentration following administration of Tofacitinib |
| Secondary | Vz/F (Cohort 1 Only) | Day 5 | Apparent volume of distribution during terminal phase after non-intravenous administration |
| Secondary | Half-life of Tofacitinib (Cohort 1 Only) | Day 5 | half-life of Tofacitinib |
| Secondary | Safety of Tofacitinib: Total Number of Adverse Events is Reported (Cohorts 1 and 2) | 76 weeks | Rate and severity of adverse events and lab abnormalities experienced by participants in both cohorts of the research study. |
| Other | Steroid Dose Comparison at 72 Weeks | 72 weeks | Assess steroid sparing properties of Tofacitinib by comparing doses to baseline and rate of steroid discontinuation |
| Other | Change in SLE Disease Activity Index (SLEDAI) Score | 72 weeks | Measure Tofacitinib impact on disease activity The SLEDAI (version 2k) was completed and its MC domain (range:0-6) and extra-MC (range: 0-99) scores calculated. SLEDAI summary scores can be interpreted as following: 1-5 mild disease activity, 6-10 moderate disease activity, and 11 and more severe disease activity27, range: 0-105), with higher scores indicating higher activity |
| Other | Change in SKINDEX Score | Baseline, week 24 and week 72 | The Skindex-29 is a validated quality-of-life instrument designed to assess the impact of skin disease on patients. Each of the 29 items is rated on a 5-point Likert scale, from 1 ("Never") to 5 ("All the time"), with higher values indicating greater impairment of quality of life. Responses are averaged within domains or across all items, and the resulting mean scores are transformed to a 0-100. On this scale, 0 represents the lowest possible impact and 100 represents the highest possible impact. |
| Other | Change in Patients Global Assessment Score | Baseline, week 24 and week 76 | Quality-of-life measure for patients The Global Assessment is a rating scale used to capture the patient's overall perception of disease activity. Patients rate their condition on a 0-10 scale, where 0 indicates no disease activity and 10 represents the maximum level of disease activity. Higher scores therefore reflect worse overall disease impact. |
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.
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GET https://conductscience.org/api/trials/v1/NCT03288324/registered