Trial · NCT02638207
Study to Evaluate Safety and Efficacy of Three Different Dosages of NewGam in Patients With Chronic Inflammatory Demyelinating Poly (Radiculo) Neuropathy
NCT02638207, Phase 3, Completed, Octapharma; results first posted 2021-02-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Evaluate Safety and Efficacy of Three Different Dosages of NewGam in Patients With Chronic Inflammatory Demyelinating Poly (Radiculo) Neuropathy. Trials, record NCT02638207. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02638207
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate Safety and Efficacy of Three Different Dosages of NewGam in Patients With Chronic Inflammatory Demyelinating Poly (Radiculo) Neuropathy
- NCT number
- NCT02638207
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 142 participants, actual
- Lead sponsor
- Octapharma
- Conditions
- Chronic Inflammatory Demyelinating Poly(Radiculo)Neuropathy
- Interventions
- NewGam
- First posted
- 2015-12-23
- Last updated
- 2021-02-16
- Results first posted
- 2021-02-16
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Decrease in the Inflammatory Neuropathy Cause and Treatment (INCAT) Disability Score | at Week 24 | Efficacy - Proportion of responders in the 1.0 g/kg NewGam arm at Week 24 (Termination Visit) relative to baseline (Week 0). A responder being defined as a patient with a decrease of at least 1 point on the adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) disability score (a scale from 0 to 10, from healthy to unable to make any purposeful movements with arms and/or legs) |
| Secondary | Decrease in the Inflammatory Neuropathy Cause and Treatment (INCAT) Disability Score | at Week 24 | Proportion of responders in the 0.5 g/kg and 2.0 g/kg NewGam arms at Week 24 relative to baseline compared to the 1.0 g/kg arm, based on the adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) disability score |
| Secondary | Grip Strength Score | at Week 24 | Proportion of responders in the 0.5 g/kg and 2.0 g/kg NewGam arms at Week 24 relative to baseline at Week 0 compared to the 1.0 g/kg arm, based on the grip strength (Martin Vigorimeter) using the previously published minimum clinically important difference (MCID) cut-off of 8 kilopascal (kPa) |
| Secondary | Inflammatory Rasch-built Overall Disability Scale (I-RODS Score) | at Week 24 | Proportion of responders in the 0.5 g/kg and 2.0 g/kg NewGam arms at Week 24 relative to baseline at Week 0 compared to the 1.0 g/kg arm, based on the Inflammatory Rasch-built overall disability scale (I-RODS Score) using the MCID concept related to the varying standard errors (MCID-SE) as recently demonstrated |
| Secondary | Worsening in the Inflammatory Neuropathy Cause and Treatment (INCAT) Disability Score | Week 24 | Time to first confirmed worsening on the adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) disability scale by at least 1 point from the value at baseline (Week 0) |
| Secondary | Mean Change in Grip Strength | Up to 24 weeks | Mean change from baseline (Week 0) to Termination Visit in grip strength of both hands (assessed by Martin vigorimeter). The reported change was calculated from two time points as the value at the later time point minus the value at the earlier time point. |
| Secondary | Inflammatory Rasch-built Overall Disability Scale (I-RODS) | Up to 24 weeks | Mean change from baseline (Week 0) to Termination Visit in Inflammatory Rasch-built overall disability sum score (I-RODS using the concept of MCID-SE as recently reported) and number of improvers. The reported change was calculated from two time points as the value at the later time point minus the value at the earlier time point. A scale from 0 to 48, from "Not possible to perform" to "Possible without any difficulty". Higher values represent a better outcome. |
| Secondary | Motor Nerves | Up to 24 weeks | Mean change from baseline (Week 0) to Termination Visit in sum of the distal evoked amplitude of 4 right sided and 4 left sided motor nerves (peroneal, tibial, ulnar and median). The reported change was calculated from two time points as the value at the later time point minus the value at the earlier time point. |
| Secondary | Mean Change in Pain Intensity Numerical Rating Scale (PI-NRS Scale) | Up to 24 weeks | Mean change from baseline (Week 0) to Termination Visit in Pain Intensity Numeric Rating Scale (PI-NRS). The reported change was calculated from two time points as the value at the later time point minus the value at the earlier time point. The Pain Intensity Numeric Rating Scale (PI-NRS, a numeric scale where 0 = no pain and 10 = worst possible pain) is an 11-point scale for patient self-reporting of pain. A higher value represents a worse outcome. |
| Secondary | Worsening on the Inflammatory Rasch-built Overall Disability Scale (I-RODS Scale) | 24 weeks | Time to first confirmed worsening on the I-RODS scale. The reported change was calculated from two time points as the value at the later time point minus the value at the earlier time point. A scale from 0 to 48, from "Not possible to perform" to "Possible without any difficulty". Higher values represent a better outcome. Worsening is determined using the concept of MCID (minimum clinically important difference) using the individually obtained standard errors (MCID-SE). |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Decrease in the Inflammatory Neuropathy Cause and Treatment (INCAT) Disability Score | at Week 24 | Intention-to-treat Set (ITTS): The ITTS consist of all patients of the Safety Data Set for whom any data was collected post infusion of IMP. Three patients (one in the 0.5 g/kg group and two in the 2.0 g/kg group) were excluded from the ITTS as no data were collected post-infusion of IMP. Therefore n=139 for the ITTS. Every treated subject will be considered in the analysis according to his randomized treatment/dose assignment. | proportion of subjects | NUMBER |
| SECONDARY | Decrease in the Inflammatory Neuropathy Cause and Treatment (INCAT) Disability Score | at Week 24 | Intention-to-treat Set (ITTS): The ITTS consist of all patients of the Safety Data Set for whom any data was collected post infusion of IMP. Three patients (one in the 0.5 g/kg group and two in the 2.0 g/kg group) were excluded from the ITTS as no data were collected post-infusion of IMP. Therefore n=139 for the ITTS. Every treated subject will be considered in the analysis according to his randomized treatment/dose assignment. | Proportion of responders | NUMBER |
| SECONDARY | Grip Strength Score | at Week 24 | Intention-to-treat Set (ITTS): The ITTS consist of all patients of the Safety Data Set for whom any data was collected post infusion of IMP. Three patients (one in the 0.5 g/kg group and two in the 2.0 g/kg group) were excluded from the ITTS as no data were collected post-infusion of IMP. Therefore n=139 for the ITTS. Every treated subject will be considered in the analysis according to his randomized treatment/dose assignment. | Proportion of responders | NUMBER |
| SECONDARY | Inflammatory Rasch-built Overall Disability Scale (I-RODS Score) | at Week 24 | Intention-to-treat Set (ITTS): The ITTS consist of all patients of the Safety Data Set for whom any data was collected post infusion of IMP. Three patients (one in the 0.5 g/kg group and two in the 2.0 g/kg group) were excluded from the ITTS as no data were collected post-infusion of IMP. Therefore n=139 for the ITTS. Every treated subject will be considered in the analysis according to his randomized treatment/dose assignment. | Proportion of responders | NUMBER |
| SECONDARY | Worsening in the Inflammatory Neuropathy Cause and Treatment (INCAT) Disability Score | Week 24 | There was only 1 patient with worsening (in the 1.0 g/kg group), thus an analysis of the time to first worsening was not possible. | days | MEDIAN |
| SECONDARY | Mean Change in Grip Strength | Up to 24 weeks | Intention-to-treat Set (ITTS): The ITTS consist of all patients of the Safety Data Set for whom any data was collected post infusion of IMP. Three patients (one in the 0.5 g/kg group and two in the 2.0 g/kg group) were excluded from the ITTS as no data were collected post-infusion of IMP. Therefore n=139 for the ITTS. Every treated subject will be considered in the analysis according to his randomized treatment/dose assignment. | kPa | MEAN |
| SECONDARY | Inflammatory Rasch-built Overall Disability Scale (I-RODS) | Up to 24 weeks | Intention-to-treat Set (ITTS): The ITTS consist of all patients of the Safety Data Set for whom any data was collected post infusion of IMP. Three patients (one in the 0.5 g/kg group and two in the 2.0 g/kg group) were excluded from the ITTS as no data were collected post-infusion of IMP. Therefore n=139 for the ITTS. Every treated subject will be considered in the analysis according to his randomized treatment/dose assignment. | score on a scale | MEAN |
| SECONDARY | Motor Nerves | Up to 24 weeks | Intention-to-treat Set (ITTS): The ITTS consist of all patients of the Safety Data Set for whom any data was collected post infusion of IMP. Three patients (one in the 0.5 g/kg group and two in the 2.0 g/kg group) were excluded from the ITTS as no data were collected post-infusion of IMP. Therefore n=139 for the ITTS. Every treated subject will be considered in the analysis according to his randomized treatment/dose assignment. | mV | MEAN |
| SECONDARY | Mean Change in Pain Intensity Numerical Rating Scale (PI-NRS Scale) | Up to 24 weeks | Intention-to-treat Set (ITTS): The ITTS consist of all patients of the Safety Data Set for whom any data was collected post infusion of IMP. Three patients (one in the 0.5 g/kg group and two in the 2.0 g/kg group) were excluded from the ITTS as no data were collected post-infusion of IMP. Therefore n=139 for the ITTS. Every treated subject will be considered in the analysis according to his randomized treatment/dose assignment. | score on a scale | MEAN |
| SECONDARY | Worsening on the Inflammatory Rasch-built Overall Disability Scale (I-RODS Scale) | 24 weeks | There was 1 patient with worsening in the 0.5 g/kg group and 2 in the 1.0 g/kg group; an analysis of the time to first worsening was not possible | days | MEDIAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group37
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Decrease in the Inflammatory Neuropathy Cause and Treatment (INCAT) Disability Score | 1.0 g/kg NewGam | .7971 | proportion of subjects | ||
| Decrease in the Inflammatory Neuropathy Cause and Treatment (INCAT) Disability Score | 0.5 g/kg NewGam | .6471 | Proportion of responders | ||
| Decrease in the Inflammatory Neuropathy Cause and Treatment (INCAT) Disability Score | 1.0 g/kg NewGam | .7971 | Proportion of responders | ||
| Decrease in the Inflammatory Neuropathy Cause and Treatment (INCAT) Disability Score | 2.0 g/kg NewGam | .9167 | Proportion of responders | ||
| Grip Strength Score | 0.5 g/kg NewGam | .5588 | Proportion of responders | ||
| Grip Strength Score | 1.0 g/kg NewGam | .6522 | Proportion of responders | ||
| Grip Strength Score | 2.0 g/kg NewGam | .8333 | Proportion of responders | ||
| Inflammatory Rasch-built Overall Disability Scale (I-RODS Score) | 0.5 g/kg NewGam | .3824 | Proportion of responders | ||
| Inflammatory Rasch-built Overall Disability Scale (I-RODS Score) | 1.0 g/kg NewGam | .5507 | Proportion of responders | ||
| Inflammatory Rasch-built Overall Disability Scale (I-RODS Score) | 2.0 g/kg NewGam | .7222 | Proportion of responders |
1 to 10 of 37Source ClinicalTrials.gov
See all 37 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 0.5 g/kg NewGam | 35 | |
| Overall Study | STARTED | 1.0 g/kg NewGam | 69 | |
| Overall Study | STARTED | 2.0 g/kg NewGam | 38 | |
| Overall Study | COMPLETED | 0.5 g/kg NewGam | 28 | |
| Overall Study | COMPLETED | 1.0 g/kg NewGam | 61 | |
| Overall Study | COMPLETED | 2.0 g/kg NewGam | 34 | |
| Overall Study | NOT COMPLETED | 0.5 g/kg NewGam | 7 | |
| Overall Study | NOT COMPLETED | 1.0 g/kg NewGam | 8 | |
| Overall Study | NOT COMPLETED | 2.0 g/kg NewGam | 4 |
Source ClinicalTrials.gov
Adverse events412
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Pyrexia | General disorders | NGAM 0.5 g/kg | 3 | 35 | 4 |
| other | Pyrexia | General disorders | NGAM 1.0 g/kg | 6 | 69 | 6 |
| other | Pyrexia | General disorders | NGAM 2.0 g/kg | 2 | 38 | 3 |
| other | Pyrexia | General disorders | Total | 11 | 142 | 13 |
| other | Chills | General disorders | NGAM 0.5 g/kg | 3 | 35 | 4 |
| other | Chills | General disorders | NGAM 1.0 g/kg | 3 | 69 | 3 |
| other | Chills | General disorders | NGAM 2.0 g/kg | 1 | 38 | 1 |
| other | Chills | General disorders | Total | 7 | 142 | 8 |
| other | Influenza like illness | General disorders | NGAM 0.5 g/kg | 0 | 35 | 0 |
| other | Influenza like illness | General disorders | NGAM 1.0 g/kg | 3 | 69 | 3 |
1 to 10 of 412Source ClinicalTrials.gov
See all 412 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | NGAM 0.5 g/kg | 0 | 35 |
| Total, all-cause mortality | NGAM 1.0 g/kg | 1 | 69 |
| Total, all-cause mortality | NGAM 2.0 g/kg | 1 | 38 |
| Total, all-cause mortality | Total | 2 | 142 |
| Total, other adverse events | NGAM 0.5 g/kg | 20 | 35 |
| Total, other adverse events | NGAM 1.0 g/kg | 45 | 69 |
| Total, other adverse events | NGAM 2.0 g/kg | 24 | 38 |
| Total, other adverse events | Total | 88 | 142 |
| Total, serious adverse events | NGAM 0.5 g/kg | 1 | 35 |
| Total, serious adverse events | NGAM 1.0 g/kg | 4 | 69 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers3
The papers the trial lists on ClinicalTrials.gov.
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.
Data dates
The day each source was copied for this release.
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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Read this trial from software.
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