Trial · NCT04035668
Outcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) Total Score at Week 24 | Baseline, Week 24 | Participants in the Full Analysis Set (FAS) with a valid assessment for the outcome measure. FAS included all participants who were randomized in the study. | score on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in ESSDAI Total Score Over Time | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16 and Week 20 | Participants in the Full Analysis Set (FAS) with a valid assessment for the outcome measure. FAS included all participants who were randomized in the study. | score on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) Total Score Over Time | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20 and Week 24 | Participants in the Full Analysis Set (FAS) with a valid assessment for the outcome measure. FAS included all participants who were randomized in the study. | score on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F) Total Score Over Time | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20 and Week 24 | Participants in the Full Analysis Set (FAS) with a valid assessment for the outcome measure. FAS included all participants who were randomized in the study. | score on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in EuroQual 5 Dimensions (EQ-5D) VAS Score Over Time | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20 and Week 24 | Participants in the Full Analysis Set (FAS) with a valid assessment for the outcome measure. FAS included all participants who were randomized in the study. | score on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Physician Global Assessment Scale (PhGA) Score Over Time | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20 and Week 24 | Participants in the Full Analysis Set (FAS) with a valid assessment for the outcome measure. FAS included all participants who were randomized in the study. | score on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs | From first dose of study treatment up 30 days after last dose (Week 29) | Safety Analysis Set defined as participants who received at least one dose of the study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Maximum Observed Blood Concentration (Cmax) of Remibrutinib at Week 4 | pre-dose, 0.5, 1, 2, 3 and 4 hours post-dose at Week 4 | Participants in the PK Analysis Set (PKS) with a valid value for the outcome measure. PKS is defined as participants with at least one available valid PK concentration measurement, who received any study drug, and with no protocol deviations that impact PK data. | ng/mL | MEAN |
| SECONDARY | Maximum Observed Blood Concentration (Cmax) of Remibrutinib at Week 24 | pre-dose, 0.5, 1, 2, 3 and 4 hours post-dose at Week 24 | Participants in the PK Analysis Set (PKS) with a valid value for the outcome measure. PKS is defined as participants with at least one available valid PK concentration measurement, who received any study drug, and with no protocol deviations that impact PK data. | ng/mL | MEAN |
| SECONDARY | Time to Reach Maximum Observed Blood Concentration (Tmax) of Remibrutinib at Week 4 | pre-dose, 0.5, 1, 2, 3 and 4 hours post-dose at Week 4 | Participants in the PK Analysis Set (PKS) with a valid value for the outcome measure. PKS is defined as participants with at least one available valid PK concentration measurement, who received any study drug, and with no protocol deviations that impact PK data. | hours | MEDIAN |
| SECONDARY | Time to Reach Maximum Observed Blood Concentration (Tmax) of Remibrutinib at Week 24 | pre-dose, 0.5, 1, 2, 3 and 4 hours post-dose at Week 24 | Participants in the PK Analysis Set (PKS) with a valid value for the outcome measure. PKS is defined as participants with at least one available valid PK concentration measurement, who received any study drug, and with no protocol deviations that impact PK data. | hours | MEDIAN |
| SECONDARY | Area Under the Blood Concentration-time Curve Within a Dosing Interval (Tau) at Steady-state (AUCtau) of Remibrutinib at Week 4 | pre-dose, 0.5, 1, 2, 3 and 4 hours post-dose at Week 4 | Participants in the PK Analysis Set (PKS) with a valid value for the outcome measure. PKS is defined as participants with at least one available valid PK concentration measurement, who received any study drug, and with no protocol deviations that impact PK data. | h*ng/mL | MEAN |
| SECONDARY | Area Under the Blood Concentration-time Curve Within a Dosing Interval (Tau) at Steady-state (AUCtau) of Remibrutinib at Week 24 | pre-dose, 0.5, 1, 2, 3 and 4 hours post-dose at Week 24 | Participants in the PK Analysis Set (PKS) with a valid value for the outcome measure. PKS is defined as participants with at least one available valid PK concentration measurement, who received any study drug, and with no protocol deviations that impact PK data. | h*ng/mL | MEAN |
| SECONDARY | Area Under the Blood Concentration-time Curve From Time Zero to 4 Hours Post-dose (AUC0-4h) of Remibrutinib at Week 4 | pre-dose, 0.5, 1, 2, 3 and 4 hours post-dose at Week 4 | Participants in the PK Analysis Set (PKS) with a valid value for the outcome measure. PKS is defined as participants with at least one available valid PK concentration measurement, who received any study drug, and with no protocol deviations that impact PK data. | h*ng/mL | MEAN |
| SECONDARY | Area Under the Blood Concentration-time Curve From Time Zero to 4 Hours Post-dose (AUC0-4h) of Remibrutinib at Week 24 | pre-dose, 0.5, 1, 2, 3 and 4 hours post-dose at Week 24 | Participants in the PK Analysis Set (PKS) with a valid value for the outcome measure. PKS is defined as participants with at least one available valid PK concentration measurement, who received any study drug, and with no protocol deviations that impact PK data. | h*ng/mL | MEAN |
| SECONDARY | Elimination Half-life (T1/2) of Remibrutinib at Week 4 | pre-dose, 0.5, 1, 2, 3 and 4 hours post-dose at Week 4 | Participants in the PK Analysis Set (PKS) with a valid value for the outcome measure. PKS is defined as participants with at least one available valid PK concentration measurement, who received any study drug, and with no protocol deviations that impact PK data. | hours | MEAN |
| SECONDARY | Elimination Half-life (T1/2) of Remibrutinib at Week 24 | pre-dose, 0.5, 1, 2, 3 and 4 hours post-dose at Week 24 | Participants in the PK Analysis Set (PKS) with a valid value for the outcome measure. PKS is defined as participants with at least one available valid PK concentration measurement, who received any study drug, and with no protocol deviations that impact PK data. | hours | 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.
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GET https://conductscience.org/api/trials/v1/NCT04035668/outcomes