Trial · NCT01545076
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) and Treatment With Subcutaneous Immunoglobulin (IgPro20)
NCT01545076, Phase 3, Completed, CSL Behring; results first posted 2018-07-05
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) and Treatment With Subcutaneous Immunoglobulin (IgPro20). Trials, record NCT01545076. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01545076
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) and Treatment With Subcutaneous Immunoglobulin (IgPro20)
- NCT number
- NCT01545076
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 208 participants, actual
- Lead sponsor
- CSL Behring
- Conditions
- Chronic Inflammatory Demyelinating Polyneuropathy, Polyradiculoneuropathy
- Interventions
- IgPro20 (low dose), Placebo, IgPro10, IgPro20 (high dose)
- First posted
- 2012-03-06
- Last updated
- 2018-07-05
- Results first posted
- 2018-07-05
Source ClinicalTrials.gov
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage (%) of Subjects With CIDP Relapse or Are Withdrawn for Any Other Reason During the Subcutaneous (SC) Treatment Period | Up to 25 weeks | Relapse is defined as an increase of at least 1 INCAT score point (except for the increase from 0 to 1 in the upper limb score). The INCAT score is a 10-point scale that covers the functionality of legs and arms, and has been successfully used to measure treatment effects in various CIDP studies. Scores for arm disability range from 0 ("No upper limb problems") to 5 ("Inability to use either arm for any purposeful movement"), and scores for leg disability range from 0 ("Walking not affected") to 5 ("Restricted to wheelchair, unable to stand and walk a few steps with help"). The INCAT (total) score is the sum of these 2 scores and ranges from 0 to 10. For the "adjusted" INCAT score, changes in the function of the upper limbs from 0 (normal) to 1 (minor symptoms) or from 1 to 0 were not recorded as deterioration or improvement because these changes are not considered clinically significant. |
| Secondary | Change in Inflammatory Neuropathy Cause and Treatment (INCAT) Scores During the SC Treatment Period | Baseline and up to 25 weeks | The INCAT score is a 10-point scale that covers the functionality of legs and arms, and has been successfully used to measure treatment effects in various CIDP studies. Scores for arm disability range from 0 ("No upper limb problems") to 5 ("Inability to use either arm for any purposeful movement"), and scores for leg disability range from 0 ("Walking not affected") to 5 ("Restricted to wheelchair, unable to stand and walk a few steps with help"). The INCAT (total) score is the sum of these 2 scores and ranges from 0 to 10. For the "adjusted" INCAT score, changes in the function of the upper limbs from 0 (normal) to 1 (minor symptoms) or from 1 to 0 were not recorded as deterioration or improvement because these changes are not considered clinically significant. |
| Secondary | Median Change From Baseline in the Mean Grip Strength Scores of the Dominant Hand During the SC Treatment Period | Baseline and up to 25 weeks | The hand-held Vigorimeter is a device that measures the strength of small muscles in the hand; ie, grip strength. Subjects squeezed a rubber bulb lying between the palm of the hand and the thumb and index fingers. The pressure was recorded via a rubber tube on a nanometer and expressed in kilopascal. At each assessment, the subjects squeezed 3 times with each hand. The mean grip strength median score of the dominant hand was determined. |
| Secondary | Change in the Medical Research Council (MRC) Sum Scores During the SC Treatment Period | Baseline and up to 25 weeks | An adapted version of the MRC sum score was used in the study. The MRC sum score is the sum of all 16 muscle scores, and ranges from 0 (paralysis) to 80 (normal strength). |
| Secondary | Change in Rasch-built Overall Disability Scale (R-ODS) Scores During the SC Treatment Period | Baseline and up to 25 weeks | The R-ODS centile score captures activity and social participation in subjects with CIDP. The R-ODS centile score ranges from 0 (most severe activity and social participation limitations) to 100 (no activity and social participation limitations). |
| Secondary | Time to CIDP Relapse or Withdrawal Due to Any Other Reason During the SC Treatment Period | Up to 25 weeks | |
| Secondary | Number of Adverse Events Per IgPro20 Infusion During the SC Treatment Period | Up to 28 weeks | |
| Secondary | Number of Subjects With Adverse Events During the SC Treatment Period | Up to 28 weeks | |
| Secondary | Percentage of Subjects With Adverse Events During the SC Treatment Period | Up to 28 weeks | |
| Secondary | Time to Improvement During IgPro10 Re-stabilization Therapy | Up to 13 weeks | Improvement is defined as an INCAT score decrease by 1 point (except for the decrease from 1 to 0 in the upper limb score), R-ODS improvement by at least 4 points, Mean Grip strength improvement by at least 8 kPa in one hand, or MRC Sum score \>=3. |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 registered outcomesOutcomes25
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage (%) of Subjects With CIDP Relapse or Are Withdrawn for Any Other Reason During the Subcutaneous (SC) Treatment Period | Up to 25 weeks | Intention-to-treat Set (ITTS): The ITTS consists of all randomized subjects who received at least 1 dose of IgPro20 / placebo and satisfied inclusion criterion #1 (diagnosis of CIDP). | percentage of subjects | NUMBER |
| SECONDARY | Change in Inflammatory Neuropathy Cause and Treatment (INCAT) Scores During the SC Treatment Period | Baseline and up to 25 weeks | ITTS. Not all subjects from the ITTS were available for data collection for this outcome measure. | units on a scale | MEDIAN |
| SECONDARY | Median Change From Baseline in the Mean Grip Strength Scores of the Dominant Hand During the SC Treatment Period | Baseline and up to 25 weeks | ITTS. Not all subjects from the ITTS were available for data collection for this outcome measure.. | Kilopascal (kPa) | MEDIAN |
| SECONDARY | Change in the Medical Research Council (MRC) Sum Scores During the SC Treatment Period | Baseline and up to 25 weeks | ITTS. Not all subjects from the ITTS were available for data collection for this outcome measure. | units on a scale | MEDIAN |
| SECONDARY | Change in Rasch-built Overall Disability Scale (R-ODS) Scores During the SC Treatment Period | Baseline and up to 25 weeks | ITTS. Not all subjects from the ITTS were available for data collection for this outcome measure. | units on a scale | MEDIAN |
| SECONDARY | Time to CIDP Relapse or Withdrawal Due to Any Other Reason During the SC Treatment Period | Up to 25 weeks | ITTS | Days | MEDIAN |
| SECONDARY | Number of Adverse Events Per IgPro20 Infusion During the SC Treatment Period | Up to 28 weeks | Safety Data Set (SDS): The SDS consists of all randomized subjects who received at least 1 dose of IgPro20 or placebo. | Adverse events/Infusion | NUMBER |
| SECONDARY | Number of Subjects With Adverse Events During the SC Treatment Period | Up to 28 weeks | SDS | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Subjects With Adverse Events During the SC Treatment Period | Up to 28 weeks | SDS | percentage of subjects | NUMBER |
| SECONDARY | Time to Improvement During IgPro10 Re-stabilization Therapy | Up to 13 weeks | Pre-randomization Safety Data Set (PSDS): The PSDS was based on all subjects enrolled into the study who received at least 1 dose of IgPro10 (in the re-stabilization period) before randomization into the subcutaneous period. One subject withdrew from the re-stabilization period prior to receiving IgPro10, therefore n=207 for the PSDS. | Days | MEDIAN |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 outcomesResults by group43
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage (%) of Subjects With CIDP Relapse or Are Withdrawn for Any Other Reason During the Subcutaneous (SC) Treatment Period | IgPro20 (0.4) | 32.8 | percentage of subjects | ||
| Percentage (%) of Subjects With CIDP Relapse or Are Withdrawn for Any Other Reason During the Subcutaneous (SC) Treatment Period | IgPro20 (0.2) | 38.6 | percentage of subjects | ||
| Percentage (%) of Subjects With CIDP Relapse or Are Withdrawn for Any Other Reason During the Subcutaneous (SC) Treatment Period | Placebo | 63.2 | percentage of subjects | ||
| Change in Inflammatory Neuropathy Cause and Treatment (INCAT) Scores During the SC Treatment Period | IgPro20 (0.4) | 0 | Full Range -2 to 3 | units on a scale | |
| Change in Inflammatory Neuropathy Cause and Treatment (INCAT) Scores During the SC Treatment Period | IgPro20 (0.2) | 0 | Full Range -2 to 5 | units on a scale | |
| Change in Inflammatory Neuropathy Cause and Treatment (INCAT) Scores During the SC Treatment Period | Placebo | 1 | Full Range -1 to 4 | units on a scale | |
| Median Change From Baseline in the Mean Grip Strength Scores of the Dominant Hand During the SC Treatment Period | IgPro20 (0.4) | -2.7 | Full Range -80 to 55 | Kilopascal (kPa) | |
| Median Change From Baseline in the Mean Grip Strength Scores of the Dominant Hand During the SC Treatment Period | IgPro20 (0.2) | -0.6 | Full Range -80 to 55 | Kilopascal (kPa) | |
| Median Change From Baseline in the Mean Grip Strength Scores of the Dominant Hand During the SC Treatment Period | Placebo | -6.6 | Full Range -51 to 22 | Kilopascal (kPa) | |
| Change in the Medical Research Council (MRC) Sum Scores During the SC Treatment Period | IgPro20 (0.4) | 0 | Full Range -12 to 7 | units on a scale |
1 to 10 of 43Source ClinicalTrials.gov
See all 43 results by groupParticipant flow45
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| IgPro10 Restabilization Period | STARTED | IgPro10 Re-stabilization | 208 | |
| IgPro10 Restabilization Period | STARTED | IgPro20 (0.4) | 0 | |
| IgPro10 Restabilization Period | STARTED | IgPro20 (0.2) | 0 | |
| IgPro10 Restabilization Period | STARTED | Placebo | 0 | |
| IgPro10 Restabilization Period | STARTED | IgPro10 Rescue | 0 | |
| IgPro10 Restabilization Period | COMPLETED | IgPro10 Re-stabilization | 172 | |
| IgPro10 Restabilization Period | COMPLETED | IgPro20 (0.4) | 0 | |
| IgPro10 Restabilization Period | COMPLETED | IgPro20 (0.2) | 0 | |
| IgPro10 Restabilization Period | COMPLETED | Placebo | 0 | |
| IgPro10 Restabilization Period | COMPLETED | IgPro10 Rescue | 0 |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 participant flowAdverse events195
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 | Fall | Injury, poisoning and procedural complications | IgPro10 Restabilization | 5 | 207 | 5 |
| other | Fall | Injury, poisoning and procedural complications | IgPro20 (0.4) | 1 | 58 | 1 |
| other | Fall | Injury, poisoning and procedural complications | IgPro20 (0.2) | 3 | 57 | 8 |
| other | Fall | Injury, poisoning and procedural complications | Placebo | 0 | 57 | 0 |
| other | Fall | Injury, poisoning and procedural complications | IgPro10 Rescue | 0 | 60 | 0 |
| other | Headache | Nervous system disorders | IgPro10 Restabilization | 34 | 207 | 53 |
| other | Headache | Nervous system disorders | IgPro20 (0.4) | 4 | 58 | 4 |
| other | Headache | Nervous system disorders | IgPro20 (0.2) | 4 | 57 | 5 |
| other | Headache | Nervous system disorders | Placebo | 2 | 57 | 2 |
| other | Headache | Nervous system disorders | IgPro10 Rescue | 4 | 60 | 6 |
1 to 10 of 195Source ClinicalTrials.gov
See all 195 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | IgPro10 Restabilization | 0 | 207 |
| Total, all-cause mortality | IgPro20 (0.4) | 0 | 58 |
| Total, all-cause mortality | IgPro20 (0.2) | 0 | 57 |
| Total, all-cause mortality | Placebo | 0 | 57 |
| Total, all-cause mortality | IgPro10 Rescue | 0 | 60 |
| Total, other adverse events | IgPro10 Restabilization | 50 | 207 |
| Total, other adverse events | IgPro20 (0.4) | 20 | 58 |
| Total, other adverse events | IgPro20 (0.2) | 22 | 57 |
| Total, other adverse events | Placebo | 15 | 57 |
| Total, other adverse events | IgPro10 Rescue | 7 | 60 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 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.
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/NCT01545076
GET https://conductscience.org/api/trials/v1/NCT01545076/registered?page=2