Trial · NCT03772587
Outcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability | Up to Day 113 | The safety population included all participants who received any amount of nipocalimab or placebo. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) | Up to Day 113 | The safety population included all participants who received any amount of nipocalimab or placebo. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Treatment-emergent Adverse Events of Special Interest (AESI) | Up to Day 113 | The safety population included all participants who received any amount of nipocalimab or placebo. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Change From Baseline to Day 57 in the Myasthenia Gravis - Activities of Daily Living (MG-ADL) Total Score | Baseline to Day 57 | Intent-to-Treat (ITT) population included all randomized participants. Here 'N' (number of participants analyzed) included all participants who were evaluated for this outcome measure (OM). | score on a scale | MEAN |
| SECONDARY | Change From Baseline in Total MG-ADL Score as a Function of Total Serum Immunoglobulin G (IgG) at Day 57 | Baseline and Day 57 | All participants over all arms with both an MG-ADL score and an IgG result at both baseline and Day 57 are included in the analysis. Participants are combined over all groups because the analysis correlates MG-ADL change with IgG change and arm was not included as a factor in the pre-specified analysis. Therefore, results by arm are not available. | score on a scale per 10% IgG reduction | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Total MG-ADL Score as a Response to Percent Change in Total Serum IgG, for Participants Positive for Anti-acetylcholine Receptor (Anti-AChR) Antibodies, at Day 57 | Baseline and Day 57 | All anti-AChR positive participants over all arms with both an MG-ADL score and an IgG result at both baseline and Day 57 are included in the analysis. Participants are combined over all groups because the analysis correlates MG-ADL change with IgG change and arm was not included as a factor in the pre-specified analysis. Therefore, results by arm are not available. | score on a scale per 10% IgG reduction | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Total Quantitative Myasthenia Gravis (QMG) Score as a Function of Total Serum IgG at Day 57 | Baseline and Day 57 | All participants over all arms with both an QMG score and an IgG result at both baseline and Day 57 are included in the analysis. Participants are combined over all groups because the analysis correlates QMG change with IgG change and arm was not included as a factor in the pre-specified analysis. Therefore, results by arm are not available. | score on a scale per 10% IgG reduction | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Total QMG Score as a Response to Percent Change in Total Serum IgG, for Participants Positive for Anti-acetylcholine Receptor (Anti-AChR) Antibodies, at Day 57 | Baseline and Day 57 | All anti-AChR positive participants over all arms with both an QMG score and an IgG result at both baseline and Day 57 are included in the analysis. Participants are combined over all groups because the analysis correlates QMG change with IgG change and arm was not included as a factor in the pre-specified analysis. Therefore, results by arm are not available. | score on a scale per 10% IgG reduction | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With a 2-, 3-, 4-, 5-, 6-, 7-, or Greater Than or Equal to (>=) 8-point Improvement in Total MG-ADL Score at Day 57 | Day 57 | Population analyzed included ITT participants for whom data was available at Day 57. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Total QMG Score at Day 57 | Baseline and Day 57 | ITT population included all randomized participants. Here 'N' (number of participants analyzed) included all participants who were evaluated for this OM. | score on a scale | MEAN |
| SECONDARY | Number of Participants With a 3-, 4-, 5-, 6-, 7-, or >= 8-point Improvement in Total QMG Score at Day 57 | Day 57 | Population analyzed included ITT participants for whom data was available at Day 57. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Total Revised Myasthenia Gravis Quality of Life - 15 (MG-QoL-15r) Scale Score at Day 57 | Baseline and Day 57 | ITT population included all randomized participants. Here 'N' (number of participants analyzed) included all participants who were evaluated for this OM. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in Total Serum IgG at Day 57 | Baseline and Day 57 | ITT population included all randomized participants. Here 'N' (number of participants analyzed) included all participants who were evaluated for this OM. | gram/liter (g/L) | MEAN |
| SECONDARY | Change From Baseline in Total MG-ADL Score at Day 85 and Day 113 | Baseline, Day 85 and Day 113 | ITT population included all randomized participants. Here 'N' (number of participants analyzed) included all participants who were evaluated for this OM and 'n' (number analyzed) included the number of participants evaluated for specific timepoints. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in Total QMG Score at Day 85 and Day 113 | Baseline, Day 85 and Day 113 | ITT population included all randomized participants. Here 'N' (number of participants analyzed) included all participants who were evaluated for this OM and 'n' (number analyzed) included the number of participants evaluated for specific timepoints. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in Total MG-QoL15r Score at Day 85 and Day 113 | Baseline, Day 85 and Day 113 | ITT population included all randomized participants. Here 'N' (number of participants analyzed) included all participants who were evaluated for this OM and 'n' (number analyzed) included the number of participants evaluated for specific timepoints. | score on a scale | MEAN |
| SECONDARY | Number of Participants With Shift From Baseline in Myasthenia Gravis Foundation of America (MGFA) Classification at Day 57 | Baseline and Day 57 | ITT population included all randomized participants. Here 'N' (number of participants analyzed) included all participants who were evaluated for this OM. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Shift From Baseline in MGFA Classification to Day 113 | Baseline to Day 113 | ITT population included all randomized participants. Here 'N' (number of participants analyzed) included all participants who were evaluated for this OM. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Total Serum IgG at Day 85 and Day 113 | Baseline, Day 85 and Day 113 | ITT population included all randomized participants. Here 'N' (number of participants analyzed) included all participants who were evaluated for this OM and 'n' (number analyzed) included the number of participants evaluated for specific timepoints. | g/L | MEAN |
| SECONDARY | Serum Concentrations of Nipocalimab | Baseline (Pre Infusion and Post Infusion), Day 15 (Pre Infusion), Day 29 (Pre Infusion), Day 43 (Pre Infusion), Day 57 (Pre Infusion and Post Infusion) and Day 85 | The safety population included all participants who received any amount of nipocalimab or placebo. Here 'n' (number analyzed) included the number of participants evaluated for specific timepoints. | micrograms/milliliter (mcg/mL) | MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
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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