Trial · NCT04524273
Registered outcomes36
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 36
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline at Week 26 in Myasthenia Gravis Activities of Daily Living (MG-ADL) Score in the Overall Study Population | Baseline and Week 26 | MG-ADL score is an 8-item questionnaire that focuses on relevant symptoms and functional performance of activities of daily living over the previous 7 days. The MG-ADL score assesses disability secondary to ocular (2 items), bulbar (3 items), respiratory (1 item) and gross motor or limb (2 items) impairment related to effects from MG. Each response is graded 0 (normal) to 3 (most severe). The range of total MG-ADL scores is 0-24. A higher score represents more severe disease Outcome measure is reported for the overall population. |
| Secondary | Change From Baseline in Quantitative Myasthenia Gravis (QMG) Score at Week 26 in the Overall Study Population | Baseline and Week 26 | The QMG score is a validated outcome comprised of 13 items: ocular (2 items), facial (1 item), bulbar (2 items), gross motor (6 items), axial (1 item), and respiratory (1 item). Each item has a possible score of between 0 and 3 points. The total score range is 0-39 points, with higher score indicating more severe disease. Outcome measure is reported for the overall population. |
| Secondary | Change From Baseline at Week 26 in MG-ADL Score in Anti-AChR-Ab+ and Anti-MuSK-Ab+ Populations | Baseline and Week 26 | MG-ADL score is an 8-item questionnaire that focuses on relevant symptoms and functional performance of activities of daily living over the previous 7 days. The MG-ADL score assesses disability secondary to ocular (2 items), bulbar (3 items), respiratory (1 item) and gross motor or limb (2 items) impairment related to effects from MG. Each response is graded 0 (normal) to 3 (most severe). The range of total MG-ADL scores is 0-24. A higher score represents more severe disease. Outcome measure is reported for the Anti-AChR-Ab+ and Anti-MuSK-Ab+ populations. |
| Secondary | Change From Baseline in QMG Score at Week 26 in Anti-AChR-Ab+ and Anti-MuSK-Ab+ Populations | Baseline and Week 26 | The QMG score is a validated outcome comprised of 13 items: ocular (2 items), facial (1 item), bulbar (2 items), gross motor (6 items), axial (1 item), and respiratory (1 item). Each item has a possible score of between 0 and 3 points. The total score range is 0-39 points, with higher score indicating more severe disease. Outcome measure is reported for the Anti-AChR-Ab+ and Anti-MuSK-Ab+ populations. |
| Secondary | Percentage of Participants With Both ≥ 3-point Improvement in MG-ADL Score at Week 26 and no Use of Rescue Therapy Between Day 28 and Week 26 in the Overall Study Population | Up to Week 26 | MG-ADL score is an 8-item questionnaire that focuses on relevant symptoms and functional performance of activities of daily living over the previous 7 days. The MG-ADL score assesses disability secondary to ocular (2 items), bulbar (3 items), respiratory (1 item) and gross motor or limb (2 items) impairment related to effects from MG. Each response is graded 0 (normal) to 3 (most severe). The range of total MG-ADL scores is 0-24. A higher score represents more severe disease. The protocol-allowed rescue therapy options included intravenous immunoglobulin (IVIg) and therapeutic plasma exchange (PLEX). Outcome measure is reported for the overall population. |
| Secondary | Percentage of Participants With Both ≥ 3-point Improvement in MG-ADL Score at Week 26 and no Use of Rescue Therapy Between Day 28 and Week 26 in Anti-AChR-Ab+ and Anti-MuSK-Ab+ Populations | Up to Week 26 | MG-ADL score is an 8-item questionnaire that focuses on relevant symptoms and functional performance of activities of daily living over the previous 7 days. The MG-ADL score assesses disability secondary to ocular (2 items), bulbar (3 items), respiratory (1 item) and gross motor or limb (2 items) impairment related to effects from MG. Each response is graded 0 (normal) to 3 (most severe). The range of total MG-ADL scores is 0-24. A higher score represents more severe disease. The protocol-allowed rescue therapy options included IVIg and PLEX. Outcome measure is reported in Anti-AChR-Ab+ and Anti-MuSK-Ab+ populations. |
| Secondary | Percentage of Participants With Both ≥ 3-point Improvement in MG-ADL Score at Week 52 and no Use of Rescue Therapy Between Day 28 and Week 52 in Anti-AChR-Ab+ Population | Up to Week 52 | MG-ADL score is an 8-item questionnaire that focuses on relevant symptoms and functional performance of activities of daily living over the previous 7 days. The MG-ADL score assesses disability secondary to ocular (2 items), bulbar (3 items), respiratory (1 item) and gross motor or limb (2 items) impairment related to effects from MG. Each response is graded 0 (normal) to 3 (most severe). The range of total MG-ADL scores is 0-24. A higher score represents more severe disease. The protocol-allowed rescue therapy options included IVIg and PLEX. Outcome measure is reported for the Anti-AChR-Ab+ population. |
| Secondary | Percentage of Participants With no Use of Rescue Therapy Between Day 28 and Week 52 in Anti-AChR-Ab+ Population | Up to Week 52 | The protocol-allowed rescue therapy options included corticosteroids, IVIg and PLEX. Outcome measure is reported for the Anti-AChR-Ab+ population. |
| Secondary | Change From Baseline in MG-ADL Score at Week 52 in the Anti-AChR-Ab+ Population | Baseline and Week 52 | MG-ADL score is an 8-item questionnaire that focuses on relevant symptoms and functional performance of activities of daily living over the previous 7 days. The MG-ADL score assesses disability secondary to ocular (2 items), bulbar (3 items), respiratory (1 item) and gross motor or limb (2 items) impairment related to effects from MG. Each response is graded 0 (normal) to 3 (most severe). The range of total MG-ADL scores is 0-24. A higher score represents more severe disease. Outcome measure is reported for the Anti-AChR-Ab+ population. |
| Secondary | Change From Baseline in QMG Score at Week 52 in the Anti-AChR-Ab+ Population | Baseline and Week 52 | The QMG score is a validated outcome comprised of 13 items: ocular (2 items), facial (1 item), bulbar (2 items), gross motor (6 items), axial (1 item), and respiratory (1 item). Each item has a possible score of between 0 and 3 points. The total score range is 0-39 points, with higher score indicating more severe disease. Outcome measure is reported for the Anti-AChR-Ab+ population. |
| Secondary | Change From Baseline in Myasthenia Gravis Composite (MGC) Score at Week 26 in the Overall Study Population | Baseline and Week 26 | The MGC score consists of test items from MG-ADL score and the QMG score, with weighted response options. Scores range from 0-50, with higher scores indicating worse disease manifestations. Outcome measure is reported for the overall population. |
| Secondary | Change From Baseline in MGC Score at Week 26 in Anti-AChR-Ab+ and Anti-MuSK-Ab+ Populations | Baseline and Week 26 | The MGC score consists of test items from MG-ADL score and the QMG score, with weighted response options. Scores range from 0-50, with higher scores indicating worse disease manifestations. Outcome measure is reported for the Anti-AChR-Ab+ and Anti-MuSK-Ab+ populations. |
| Secondary | Change From Baseline in MGC Score at Week 52 in Anti-AChR-Ab+ Population | Baseline and Week 52 | The MGC score consists of test items from MG-ADL score and the QMG score, with weighted response options. Scores range from 0-50, with higher scores indicating worse disease manifestations. Outcome measure is reported for the Anti-AChR-Ab+ population. |
| Secondary | Change From Baseline in Myasthenia Gravis Quality of Life-15, Revised (MGQOL-15r) Score at Week 26 in the Overall Study Population | Baseline and Week 26 | MGQOL-15r score is a validated, patient-scored instrument, which measures the impact of MG on health-related quality of life (HRQoL). The 15 items in the questionnaire evaluate mobility (9 items), symptoms (3 items), general contentment (1 item), and emotional well-being (2 items) domains. Each item is rated on a 3-point scale ranging from 0 ("not at all") to 2 ("very much") based on their experience "over the past few weeks." Items scores are summed to generate a total score ranging from 0-45, with higher score indicating worse HRQoL. Outcome measure is reported for the overall population. |
| Secondary | Change From Baseline in MGQOL-15r Score at Week 26 in Anti-AChR-Ab+ and Anti-MuSK-Ab+ Populations | Baseline and Week 26 | MGQOL-15r score is a validated, patient-scored instrument, which measures the impact of MG on health-related quality of life (HRQoL). The 15 items in the questionnaire evaluate mobility (9 items), symptoms (3 items), general contentment (1 item), and emotional well-being (2 items) domains. Each item is rated on a 3-point scale ranging from 0 ("not at all") to 2 ("very much") based on their experience "over the past few weeks." Items scores are summed to generate a total score ranging from 0-45, with higher score indicating worse HRQoL. Outcome measure is reported in Anti-AChR-Ab+ and Anti-MuSK-Ab+ populations. |
| Secondary | Change From Baseline in MGQOL-15r Score at Week 52 in Anti-AChR-Ab+ Population | Baseline and Week 52 | MGQOL-15r score is a validated, patient-scored instrument, which measures the impact of MG on health-related quality of life (HRQoL). The 15 items in the questionnaire evaluate mobility (9 items), symptoms (3 items), general contentment (1 item), and emotional well-being (2 items) domains. Each item is rated on a 3-point scale ranging from 0 ("not at all") to 2 ("very much") based on their experience "over the past few weeks." Items scores are summed to generate a total score ranging from 0-45, with higher score indicating worse HRQoL. Outcome Measure is reported for the Anti-AChR-Ab+ population. |
| Secondary | Percentage of Participants With Patient Global Impression of Change (PGIC) Scores at Week 26 in the Overall Study Population | Week 26 | The self-report measure PGIC reflects a participant's belief about the efficacy of treatment. PGIC is a 7 point scale depicting a participant's rating of overall improvement. Participant rate their change as "very much improved", "much improved", "minimally improved", "no change", "minimally worse", "much worse", or "very much worse", Outcome measure is reported for the overall population. |
| Secondary | Percentage of Participants With PGIC Scores at Week 26 in Anti-AChR-Ab+ and Anti-MuSK-Ab+ Populations | Week 26 | The self-report measure PGIC reflects a participant's belief about the efficacy of treatment. PGIC is a 7 point scale depicting a participant's rating of overall improvement. Participants rate their change as "very much improved", "much improved", "minimally improved", "no change", "minimally worse", "much worse", or "very much worse". Outcome measure is reported for the Anti-AChR-Ab+ and Anti-MuSK-Ab+ populations. |
| Secondary | Percentage of Participants With PGIC Scores at Week 52 in Anti-AChR-Ab+ Population | Week 52 | The self-report measure PGIC score reflects a participant's belief about the efficacy of treatment. PGIC is a 7 point scale depicting a participant's rating of overall improvement. participants rate their change as "very much improved", "much improved", "minimally improved", "no change", "minimally worse", "much worse", or "very much worse". Outcome measure is reported for the Anti-AChR-Ab+ population. |
| Secondary | Percentage of Participants Experiencing Exacerbation by Week 26 in the Overall Study Population | Up to Week 26 | An exacerbation was defined as one of the following: * Use of protocol defined rescue therapy, or * Myasthenic crisis, defined as worsening of myasthenic weakness requiring intubation or non-invasive ventilation to avoid intubation, except when these measures are employed during routine postoperative management, or * Significant symptomatic worsening to a score of 3 or a 2-point worsening from baseline on any one of the individual MG-ADL items other than double vision or eyelid droop. Outcome measure is reported for the overall population. |
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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