Trial · NCT03943589
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Guillain Barré Syndrome Disability Score (GBS DS) - Time to Improve by at Least 1 Grade | Baseline to Day 360 | Efficacy is assessed as proportion of subjects with improvement of one (1) or more grades in disability outcome on the 6-point GBS DS over time. The 6-point Guillain Barré Syndrome disability score (GBS DS) is a widely accepted and easily obtainable scoring system used to assess disability status of GBS subjects. The DS score is as follows: 0=Healthy, 1=Minor symptoms and capable of running (subjects must be asked to run), 2=Able to walk independently 10 meters or more but unable to run, 3=Able to walk more than 10 meters across an open space with help, 4=Bedridden or chair bound, 5=Needing mechanical ventilation, 6=Dead |
| Primary | Guillain Barré Syndrome Disability Score (GBS DS) - Time to Improve by at Least 2 Grades | Baseline to Day 360 | Efficacy is assessed as proportion of subjects with improvement of one (1) or more grades in disability outcome on the 6-point GBS DS over time. The 6-point Guillain Barré Syndrome disability score (GBS DS) is a widely accepted and easily obtainable scoring system used to assess disability status of GBS subjects. The DS score is as follows: 0=Healthy, 1=Minor symptoms and capable of running (subjects must be asked to run), 2=Able to walk independently 10 meters or more but unable to run, 3=Able to walk more than 10 meters across an open space with help, 4=Bedridden or chair bound, 5=Needing mechanical ventilation, 6=Dead |
| Primary | Guillain Barré Syndrome Disability Score (GBS DS) - Ability to Walk Unaided | Baseline to Day 360 | Efficacy is assessed as proportion of subjects able to walk unaided (i.e. GBS DS=2) over time |
| Primary | Proportion of Patients Who Are Able to Run Over Time (GBS DS≤1) | Baseline to Day 360 | Efficacy is assessed as proportion of patients able to run (i.e. Guillain Barré Syndrome disability score \[GBS DS\] ≤1) over time |
| Primary | Mean MRC Sum Score Over Time | Baseline until Day 180 | Efficacy is assessed as Medical Research Council (MRC) sum score over time. The MRC sum score is widely used to assess the motor impairment in subjects with peripheral neuropathies. It is a sum score of power in 6 muscle groups on each side (abduction of arm, flexion of forearm, extension of the wrist, hip flexion, and extension of knee and dorsal flexion of the foot). The sum of these scores ranges from 0 (total paralysis) to 60 (normal power). It provides valuable information about the muscle strength. Change in MRC sum score helps in identification of GBS patients with treatment related fluctuation or exacerbation. The individual MRC grades are defined as follows: 0=No visible contraction,1=Visible contraction without movement of the limb, 2=Movement of the limb but not against gravity, 3=Movement against gravity (almost full range), 4=Movement against gravity and resistance, 5=Normal |
| Primary | Change From Baseline in MRC Sum Score Over Time | Baseline until Day 180 | Efficacy is assessed as change in Medical Research Council (MRC) sum score. The MRC sum score is widely used to assess the motor impairment in subjects with peripheral neuropathies. It is a sum score of power in 6 muscle groups on each side (abduction of arm, flexion of forearm, extension of the wrist, hip flexion, and extension of knee and dorsal flexion of the foot). The sum of these scores ranges from 0 (total paralysis) to 60 (normal power). It provides valuable information about the muscle strength. Change in MRC sum score helps in identification of GBS patients with treatment related fluctuation or exacerbation. The individual MRC grades are defined as follows: 0=No visible contraction,1=Visible contraction without movement of the limb, 2=Movement of the limb but not against gravity, 3=Movement against gravity (almost full range), 4=Movement against gravity and resistance, 5=Normal |
| Primary | Mean R-ODS Over Time | Baseline to Day 360 | The patients have rated their ability to perform different common activities using the Rasch-built overall disability score (R-ODS) questionnaire. R-ODS is a linearly weighted disease specific scale, which captures activities and social participation limitation in patients with immune-mediated neuropathies, including GBS. The questionnaire comprises 24 items ranging from ability to read a book or newspaper (as the easiest item to accomplish) to ability to run (most difficult item to accomplish). The response options for each item are: 0=Not possible, 1=Possible with effort, 2=Easy to perform. The obtained raw summed score is subsequently translated to a centile metric ranging from 0 (most severe disability) to 100 (no disability at all). |
| Primary | Change From Baseline in R-ODS Over Time | Baseline to Day 360 | The patients have rated their ability to perform different common activities using the Rasch-built overall disability score (R-ODS) questionnaire. R-ODS is a linearly weighted disease specific scale, which captures activities and social participation limitation in patients with immune-mediated neuropathies, including GBS. The questionnaire comprises 24 items ranging from ability to read a book or newspaper (as the easiest item to accomplish) to ability to run (most difficult item to accomplish). The response options for each item are: 0=Not possible, 1=Possible with effort, 2=Easy to perform. The obtained raw summed score is subsequently translated to a centile metric ranging from 0 (most severe disability) to 100 (no disability at all). |
| Primary | Days in Hospital | Baseline to Day 360 | The number of days the patients were admitted to hospital |
| Primary | Time in an ICU | Baseline until Day 360 | Efficacy is assessed as time in an intensive care unit (ICU) |
| Primary | Need for Mechanical Ventilation | Baseline until Day 180 | |
| Primary | Patient's Health State Over Time as Assessed by EQ VAS | Day 8, Day 15, Day 29, Day 57, Day 92, Day 180, and Day 360 | Quality of Life will be assessed using the EurQol group's EurQol - 5 dimension (EQ-5D) Health questionnaire. The EQ-5D consists of 2 parts: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ VAS records the patient's self-rated health on a vertical scale, where score 100 is 'The best health you can imagine' and score 0 is the 'The worst health you can imagine'. |
| Secondary | PK Profile of Imlifidase: Cmax | Within 2 hours before imlifidase dose until Day 15 | Cmax=Maximum observed plasma concentration of imlifidase following dosing |
| Secondary | PK Profile of Imlifidase: Tmax | Within 2 hours before imlifidase dose until Day 15 | Tmax=Time point for maximum observed plasma concentration of imlifidase following dosing |
| Secondary | PK Profile of Imlifidase: AUC | Within 2 hours before imlifidase dose until Day 15 | AUC=Area under the imlifidase plasma concentration versus time curve |
| Secondary | PK Profile of Imlifidase: t1/2 | Within 2 hours before imlifidase dose until Day 15 | t1/2=Terminal half-life of imlifidase |
| Secondary | PK Profile of Imlifidase: CL | Within 2 hours before imlifidase dose until Day 15 | CL=Clearance of imlifidase |
| Secondary | PK Profile of Imlifidase: V | Within 2 hours before imlifidase dose until Day 15 | V=Volume of distribution |
| Secondary | Pharmacodynamics - IgG Level in Serum Over Time | Within 2 hours before imlifidase dose until Day 15 | The pharmacodynamic (PD) effect of imlifidase is assessed as the elimination of IgG. IgG is cleaved by imlifidase in two steps, the first cut generates single-cleaved IgG (scIgG), and the second cut generates one F(ab')2 fragment and one Fc fragment. The IgG concentration measured in serum using the MSD technology is the sum of intact IgG and scIgG and a decrease in the measured IgG concentration therefore represents complete cleavage of the IgG molecule to Fc and F(ab')2 fragments. For the first 16 patients included in the trial a more frequent PD sampling schedule was conducted. After amending the protocol a less frequent PD sampling schedule was applied. |
| Secondary | Immunogenicity - Anti-imlifidase Antibodies (ADA) Over Time | Within 2 hours before imlifidase dose until Day 180 | Anti-imlifidase IgG antibodies (ADA) in serum. |
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.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT03943589/registered