Trial · NCT04650854
Outcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) | From Baseline (Day 1) to End of Study (up to 34 months) | Safety Set (SS): All study participants in the FAS who received at least one dose of IMP. Participants who switched doses were counted in both Rozanolixizumab (RLZ) doses. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With TEAEs Leading to Withdrawal of Investigational Medicinal Product (IMP) | From Baseline (Day 1) to End of Study (up to 34 months) | Safety Set (SS): All study participants in the FAS who received at least one dose of IMP. Participants who switched doses were counted in both RLZ doses. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline (Day 1) to Day 43 in Myasthenia Gravis-Activities of Daily Living (MG-ADL) Score Within One Treatment Cycle (Cycle 1, 2, and 3) | From Baseline (Day 1) to Day 43 of each cycle (Cycles 1, 2, and 3) | Safety Set (SS): All study participants in the FAS who received at least one dose of IMP. Number of Participants Analyzed included those participants who were evaluable for the assessment. Number Analyzed included those participants who were evaluable at specified timepoint. | score on a scale | MEAN |
| SECONDARY | Change From Baseline (Day 1) to Day 43 in Quantitative Myasthenia Gravis (QMG) Score Within One Treatment Cycle (Cycle 1, 2, and 3) | From Baseline (Day 1) to Day 43 of each cycle (Cycles 1, 2, and 3) | Safety Set (SS): All study participants in the FAS who received at least one dose of IMP. Number of Participants Analyzed included those participants who were evaluable for the assessment. Number Analyzed included those participants who were evaluable at specified timepoint. | score on a scale | MEAN |
| SECONDARY | Change From Baseline (Day 1) to Day 43 in Myasthenia Gravis-Composite (MG-C) Score Within One Treatment Cycle (Cycle 1, 2, and 3) | From Baseline (Day 1) to Day 43 of each cycle (Cycles 1, 2, and 3) | Safety Set (SS): All study participants in FAS who received at least 1 dose of IMP. Number of Participants Analyzed included participants who were evaluable for the assessment. Number Analyzed included participants who were evaluable at specified timepoint. | score on a scale | MEAN |
| SECONDARY | Change From Baseline (Day 1) to Day 43 in Myasthenia Gravis (MG) Symptoms Patient Reported Outcome (PRO) 'Muscle Weakness Fatigability' Score Within One Treatment Cycle (Cycle 1, 2, and 3) | From Baseline (Day 1) to Day 43 of each cycle (Cycles 1, 2, and 3) | Safety Set (SS): All study participants in FAS who received at least 1 dose of IMP. Number of Participants Analyzed: participants who were evaluable for the assessment. Number Analyzed: participants who were evaluable at specified timepoint. | score on a scale | MEAN |
| SECONDARY | Change From Baseline (Day 1) to Day 43 in MG Symptoms PRO 'Physical Fatigue' Score Within One Treatment Cycle (Cycle 1, 2, and 3) | From Baseline (Day 1) to Day 43 of each cycle (Cycles 1, 2, and 3) | Safety Set (SS): All study participants in FAS who received at least 1 dose of IMP. Number of Participants Analyzed: participants who were evaluable for the assessment. Number Analyzed: participants who were evaluable at specified timepoint. | score on a scale | MEAN |
| SECONDARY | Change From Baseline (Day 1) to Day 43 in MG Symptoms PRO 'Bulbar Muscle Weakness' Score Within One Treatment Cycle (Cycle 1, 2, and 3) | From Baseline (Day 1) to Day 43 of each cycle (Cycles 1, 2, and 3) | Safety Set (SS): All study participants in the FAS who received at least one dose of IMP. Number of Participants Analyzed: participants who were evaluable for the assessment. Number Analyzed included those participants who were evaluable at specified timepoint. | score on a scale | MEAN |
| SECONDARY | MG-ADL Responder Rate (>=2.0-point Improvement From Baseline [Day 1]) Within One Treatment Cycle (Cycle 1, 2, and 3 [Day 43]) | Day 43 of Cycle 1, 2, and 3 | Safety Set (SS): All study participants in the FAS who received at least one dose of IMP. Number of Participants Analyzed included those participants who were evaluable for the assessment. Number Analyzed: participants who were evaluable at specified timepoint. | percentage of participants | NUMBER |
| SECONDARY | Time to MG-ADL Response (>=2.0-point Improvement From Baseline [Day 1]) Within One Treatment Cycle (Cycle 1, 2, and 3) | From Baseline (Day 1) to Day 43 of each cycle (Cycles 1, 2, and 3) | Safety Set (SS): All study participants in the FAS who received at least one dose of IMP. Number Analyzed: participants who were evaluable at specified timepoint. | days | MEDIAN |
| SECONDARY | Time Between Consecutive Treatment Cycles | From end of the 6-week treatment cycle (Day 43) to the next 6-week treatment cycle (Day 1), assessed up to 2.5 years | Safety Set (SS): All study participants in FAS who received at least 1 dose of IMP. Number Analyzed: participants who were evaluable at specified timepoint. | days | MEDIAN |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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/NCT04650854/outcomes