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Trial · NCT06587867

Seronegative Myasthenia Gravis - Efgartigimod IV

NCT06587867, Phase 3, Unknown, University Health Network, Toronto

3 sourcestrials-2026-11-12-0.4.0

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ConductScience Library. Seronegative Myasthenia Gravis - Efgartigimod IV. Trials, record NCT06587867. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06587867

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Seronegative Myasthenia Gravis - Efgartigimod IV
NCT number
NCT06587867
Status
Unknown
Phases
Phase 3
Enrollment
30 participants, estimated
Lead sponsor
University Health Network, Toronto
Conditions
Efgartigimod, Generalized Myasthenia Gravis
Interventions
efgartigimod
First posted
2024-09-19
Last updated
2024-09-19

Source ClinicalTrials.gov

Registered outcomes7

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryTotal Myasthenia Gravis Impairment Index (MGII) scorethrough study completion for 42 weeks
Myasthenia Gravis Impairment Index (MGII) is a composite score based on a patient self-reported multidomain questionnaire as well as physician-documented clinical measures. MGII has 22 patient-reported and 6 physician-assessed items with a final composite score of 84, with higher score signifying greater disability.
SecondaryMG-ADL (Myasthenia Gravis-Activities of Daily Living)through study completion for 42 weeks
The MG-ADL is an 8-item patient-reported scale to assess MG symptoms and their effects on daily activities. The MG-ADL total score range is 0-24, with higher scores indicative of greater disease severity.
SecondaryQMG (Quantitative Myasthenia Gravis) scorethrough study completion for 42 weeks
The QMG scale quantifies disease severity based on impairments of body functions and structures as defined by the International Classification of Disability and Health. The QMG scale consists of 13 items that measure endurance or fatigability, and accounts for fluctuations in disease state. The QMG total score range is 0-39, with higher scores indicative of greater disease severity.
SecondaryMG-QOL (Myasthenia Gravis Quality of Life)through study completion for 42 weeks
MG-QOL revised consists of 15 items/ question. These include mobility (9 items), symptoms (3 items), and contentment and emotional well-being (3 items). Items are scored in a Likert scale from 0 to 4 and the total sum score ranges from 0 to 60, where higher scores indicate worse HRQoL.
SecondaryPASS (Patient Acceptable Symptom State) responsethrough study completion for 42 weeks
The PASS response is based on a dichotomous 'Yes' or 'No' response, asking whether a patient is satisfied overall with their current status and thus measures holistic satisfaction with their MG state. The PASS response of "Yes" has been shown to correlate with a favourable MGII and the simple single question (SSQ, percentage of normal).
SecondarySingle Simple Question (SSQ)through study completion for 42 weeksThe SSQ is a question that asks what percentage of normal that the patient feels with respect to their MG. A SSQ threshold ≥72.5% out of normal at 100% predicts an acceptable MG state.
SecondaryMyasthenia Gravis Foundation of America (MGFA)through study completion for 42 weeks
The MGFA classes are pure ocular (class I), mild generalized (class II), moderate generalized (class III), severe generalized (class IV), and intubation/myasthenic crisis (class V). Within the generalized categories II, III, and IV, patients are subclassified as class A if their symptoms are predominantly generalized or class B if their symptoms are predominantly bulbar. The MGFA also has a system to classify patients based on postintervention outcomes and includes remission, defined as 1 year or longer without signs or symptoms and without any symptomatic (pyridostigmine) treatment, and which can be divided in complete (no pharmacologic treatment at all) or pharmacologic remission. Minimal manifestation status is defined as minimal signs or symptoms (no specific timeframe was defined) and pyridostigmine use may be accepted.

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMIDListed as
41180124DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Source

Release
trials-2026-11-12-0.4.0
Release manifest SHA-256
0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
Registry capture
2026-11-12
Results copy, AACT
2026-03-23
NIH clinical studies file
2026-11-13

Source ClinicalTrials.gov

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 trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT06587867

GET https://conductscience.org/api/trials/v1/NCT06587867/registered