Chronic Inflammatory Demyelinating PolyneuropathyPhase 3NCT01545076
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) and Treatment With Subcutaneous Immunoglobulin (IgPro20)
A Phase 3 study testing IgPro20 (low dose), IgPro10 and IgPro20 (high dose) in people with Chronic Inflammatory Demyelinating Polyneuropathy and Polyradiculoneuropathy, run by CSL Behring at 91 sites in 16 countries.
Trial summary
This is a prospective, multicenter, randomized, double-blind, placebo-controlled, parallel-group 3-arm study to investigate 2 different doses of subcutaneous (SC) IgPro20 compared with placebo for maintenance treatment of patients with CIDP. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Inflammatory Demyelinating Polyneuropathy, Polyradiculoneuropathy
- What is being tested?
- IgPro20 (low dose), IgPro10 and IgPro20 (high dose)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 208 participants
- Where
- 91 sitesin 16 countries
- Study dates
- Mar 2012to Sep 2016
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Definite or probable CIDP according to the European Federation of Neurological Societies/Peripheral Nerve Society (EFNS/PNS) criteria 2010.
- An IVIG treatment during the last 8 weeks prior to enrollment.
- Age ≥18 years.
- Written informed consent for study participation obtained before undergoing any study-specific procedures.
Who cannot join
- Any polyneuropathy of other causes
- Any other disease (mainly neurological or chronic orthopedic) that has caused neurological symptoms or may interfere with treatment or outcome assessments
- Severe diseases and conditions that are likely to interfere with evaluation of the study product or satisfactory conduct of the study
- History of thrombotic episodes within the 2 years prior to enrolment
- Known allergic or other severe reactions to blood products including intolerability to previous IVIG
Trial locations and contacts
91 sites in 16 countries.
91 sites in 16 countries
United States22 sites
Site reference 8400181
Birmingham, Alabama, 35233
Site reference 8400077
Centennial, Colorado, 80112
Site reference 8400182
Charlotte, North Carolina, 28204
Site Reference 8400268
Charlottesville, Virginia, 22908
Site reference 8400162
Chicago, Illinois, 60611
Site Reference 8400247
Chicago, Illinois, 60611
Site reference 8400178
Columbus, Ohio, 43210
Site Reference 8400346
Durham, North Carolina, 27710
Site reference 8400164
Houston, Texas, 77030
Site Reference 8400215
Indianapolis, Indiana, 46202
Site reference 8400166
Kansas City, Kansas, 66160
Site reference 8400167
Los Angeles, California, 90033
Site reference 8400214
Miami, Florida, 33136
Site Reference 8400177
Nashville, Tennessee, 37232
Site Reference 8400347
New Brunswick, New Jersey, 08901
Site reference 8400169
New York, New York, 10021
Site reference 8400179
New York, New York, 10021
Site reference 8400217
Oklahoma City, Oklahoma, 73104
Site reference 8400173
Phoenix, Arizona, 85013
Site reference 8400172
Phoenix, Arizona, 85018
Site Reference 8400340
Seattle, Washington, 98195
Site Reference 8400352
Washington D.C., District of Columbia, 20037
Germany15 sites
Site reference 2760048
Berlin
Site reference 2760069
Berlin
Site reference 2760072
Berlin
Site reference 2760049
Bochum
Site reference 2760080
Cologne
Site reference 2760075
Düsseldorf
Site Reference 2760094
Essen, 45122
Site reference 2760052
Essen
Site reference 2760036
Göttingen
Site reference 2760053
Göttingen
Site reference 2760054
Hanover
Site Reference 2760113
Ibbenbueren, 49477
Site reference 2760055
Leipzig
Site reference 2760047
Potsdam
Site reference 2760039
Würzburg
Japan12 sites
Site Reference 3920040
Aomori, 030-8553
Site Reference 3920042
Aomori, 030-8553
Site reference 3920038
Chiba
Site reference 3920061
Kanagawa
Site reference 3920045
Matsumoto
Site reference 3920058
Osaka
Site reference 3920037
Saitama
Site reference 3920034
Tokushima
Site Reference 3920065
Tokyo, 113-8431
Site Reference 3920062
Tokyo, 187-8551
Site reference 3920032
Tokyo
Site reference 3920035
Yamaguchi
Italy8 sites
Site reference 3800026
Chieti
Site reference 3800027
Florence
Site reference 3800028
Genova
Site reference 3800031
Milan
Site reference 3800035
Roma
Site reference 3800036
Roma
Site reference 3800030
Rozzano
Site reference 3800037
Torino
Canada5 sites
Site reference 1240006
Edmonton
Site Reference 1240051
Montreal, Quebec, H3A 2B4
Site reference 1240007
Québec
Site reference 1240009
Toronto
Site Reference 1240048
Vancouver, British Columbia, V5Z 1M9
Spain5 sites
Site reference 7240010
Barcelona
Site reference 7240011
Barcelona
Site reference 7240013
Madrid
Site reference 7240014
Madrid
Site reference 7240016
Seville
France4 sites
Site reference 2500024
Clermont-Ferrand
Site reference 2500013
Marseille
Site reference 2500022
Nice
Site reference 2500019
Pessac
Australia3 sites
Site reference 0360011
Fitzroy, Victoria
Site Reference 0360017
Herston, Queensland, 4029
Site reference 0360008
Southport
Czechia3 sites
Site reference 2030002
Hradec Králové
Site reference 2030009
Hradec Králové
Site reference 2030003
Prague
Netherlands3 sites
Site reference 5280001
Amsterdam
Site reference 5280005
Maastricht
Site reference 5280004
Utrecht
Poland3 sites
Site Reference 6160058
Gdansk, 80-803
Site Reference 6160060
Lodz, 90-324
Site Reference 6160055
Lublin, 20-954
Estonia2 sites
Site Reference 2330002
Tallinn, 10138
Site Reference 2330003
Tallinn, 10617
United Kingdom2 sites
Site reference 8260019
London
Site Reference 8260032
Manchester, M6 8HD
About this study
Official title: Randomized, Multicenter, Double-blind, Placebo-controlled, Parallel-group Phase III Study to Investigate the Efficacy, Safety, and Tolerability of 2 Different Doses of IgPro20 (Subcutaneous Immunoglobulin) for the Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) - the PATH Study
This is a prospective, multicenter, randomized, double-blind, placebo-controlled, parallel-group 3-arm study to investigate 2 different doses of subcutaneous (SC) IgPro20 compared with placebo for maintenance treatment of patients with CIDP.
Patients who received at lease 1 dose of intravenous immunoglobulin (IVIG) within 8 weeks before screening will be assessed during 4 separate study periods. Patients first undergo a Screening Period, followed by an IgG Dependency Test Period of up to 12 weeks to test for ongoing need of IgG. Those patients experiencing CIDP relapse during this test period will be administered a standardized IVIG regimen during an IVIG Re-stabilization Period. Patients with improved and maintained adjusted inflammatory neuropathy cause and treatment scale (INCAT) in the IVIG Re-stabilization Period will continue to the SC Treatment Period of the study. Patients entering the 24 week SC Treatment Period will be randomized to receive weekly infusions of 1 of 2 IgPro20 doses (0.2 or 0.4 g/kg body weight) or placebo.
The overall study duration is up to 52 weeks. Clinical outcomes will be assessed by the Inflammatory Neuropathy Cause and Treatment (INCAT) score, maximum grip strength, the Medical Research Council (MRC) sum score, the Rasch-built Overall Disability Scale (R-ODS), and electrophysiological evaluations.
- Being tested
- IgPro20 (low dose), Placebo, IgPro10, IgPro20 (high dose)
- Medical subject headings
- Polyradiculoneuropathy, Chronic Inflammatory Demyelinating, Polyradiculoneuropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IgPro20 (low dose)Biological
Also called Hizentra
20% liquid formulation (200 mg/mL) of human normal immunoglobulin for subcutaneous use administered weekly during the SC treatment period of the study according to the randomization:
0.2 g/kg body weight (low dose arm)
PlaceboBiological
2% human albumin administered by weekly SC infusions during the SC treatment period of the study.
IgPro10Biological
10% Immunoglobulin G (IgG) liquid formulation of human normal immunoglobulin (Privigen®) administered intravenously during Restabilization Period of the study and/or as Rescue Therapy during SC Treatment Period for subjects with a CIDP relapse.
IgPro20 (high dose)Biological
Also called Hizentra
20% liquid formulation (200 mg/mL) of human normal immunoglobulin for subcutaneous use administered weekly during the SC treatment period of the study according to the randomization:
0.4 g/kg body weight (high dose arm)
| Study group | Role | What they receive |
|---|---|---|
| IgPro20 low dose | Experimental | Not described Receives: Biological: IgPro20 (low dose); Biological: IgPro10 |
| IgPro20 high dose | Experimental | Not described Receives: Biological: IgPro10; Biological: IgPro20 (high dose) |
| Placebo | Placebo comparator | Not described Receives: Biological: Placebo; Biological: IgPro10 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage (%) of Subjects With CIDP Relapse or Are Withdrawn for Any Other Reason During the Subcutaneous (SC) Treatment Period
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.
Measured: Up to 25 weeks
Secondary outcomes (24)
Change in Inflammatory Neuropathy Cause and Treatment (INCAT) Scores During the SC Treatment Period
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.
Measured: Baseline and up to 25 weeks
Median Change From Baseline in the Mean Grip Strength Scores of the Dominant Hand During the SC Treatment Period
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.
Measured: Baseline and up to 25 weeks
Change in the Medical Research Council (MRC) Sum Scores During the SC Treatment Period
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).
Measured: Baseline and up to 25 weeks
Change in Rasch-built Overall Disability Scale (R-ODS) Scores During the SC Treatment Period
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).
Measured: Baseline and up to 25 weeks
Time to CIDP Relapse or Withdrawal Due to Any Other Reason During the SC Treatment Period
Measured: Up to 25 weeks
Number of Adverse Events Per IgPro20 Infusion During the SC Treatment Period
Measured: Up to 28 weeks
Number of Subjects With Adverse Events During the SC Treatment Period
Measured: Up to 28 weeks
Percentage of Subjects With Adverse Events During the SC Treatment Period
Measured: Up to 28 weeks
Time to Improvement During IgPro10 Re-stabilization Therapy
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.
Measured: Up to 13 weeks
Change in Mean Grip Strength During IgPro10 Re-stabilization Therapy
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.
Measured: Reference visit and up to 13 weeks
Change in MRC Sum Score During IgPro10 Re-stabilization Therapy
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).
Measured: Reference visit and up to 13 weeks
Change in R-ODS During IgPro10 Re-stabilization Therapy
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).
Measured: Reference visit and up to 13 weeks
Change in INCAT During IgPro10 Re-stabilization Therapy
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.
Measured: Reference visit and up to 13 weeks
Number of Adverse Events Per IgPro10 Infusion During Re-stabilization Therapy
Measured: Up to 13 weeks
Number of Subjects With Adverse Events During IgPro10 Re-stabilization Therapy
Measured: Up to 13 weeks
Percent of Subjects With Adverse Events During IgPro10 Re-stabilization Therapy
Measured: Up to 13 weeks
Time to Improvement After CIDP Relapse During IgPro10 Rescue Therapy
Improvement is defined as a decrease in INCAT score (except for the decrease from 1 to 0 in the upper limb score) back to or below the baseline 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.
Measured: Up to 13 weeks
Number of Adverse Events Per IgPro10 Infusion During Rescue Therapy
Measured: Up to 13 weeks
Number of Subjects With Adverse Events During IgPro10 Rescue Therapy
Measured: Up to 13 weeks
Percent of Subjects With Adverse Events During IgPro10 Rescue Therapy
Measured: Up to 13 weeks
Change in Mean Grip Strength During IgPro10 Rescue Therapy
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.
Measured: Before first rescue IgPro10 infusion and up to 13 weeks
Change in MRC Sum Score During IgPro10 Rescue Therapy
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).
Measured: Before first rescue IgPro10 infusion and up to 13 weeks
Change in R-ODS During IgPro10 Rescue Therapy
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).
Measured: Before first rescue IgPro10 infusion and up to 13 weeks
Change in INCAT During IgPro10 Rescue Therapy
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.
Measured: Before first rescue IgPro10 infusion and up to 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Inflammatory Demyelinating PolyneuropathyStudies of the same condition, open and under way.
- More trials run by CSL BehringThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- CSL Behring
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ICON Clinical Research
- Responsible party
- Sponsor
- Investigators
- Prof. Dr. Ivo N. van Schaik, Principal investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01545076
- Sponsor's protocol ID
- IgPro20_3003
- Status last verified
- Dec 2016
- First submitted
- 1 Mar 2012
- Last updated
- 5 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Bus SR, Wieske L, Keddie S, van Schaik IN, Eftimov F. Subcutaneous immunoglobulin for chronic inflammatory demyelinating polyradiculoneuropathy. Cochrane Database Syst Rev. 2026 Aug 11;8:CD014542. doi: 10.1002/14651858.CD014542.pub2.
PubMed 42578463van Schaik IN, Bril V, van Geloven N, Hartung HP, Lewis RA, Sobue G, Lawo JP, Praus M, Mielke O, Durn BL, Cornblath DR, Merkies ISJ; PATH study group. Subcutaneous immunoglobulin for maintenance treatment in chronic inflammatory demyelinating polyneuropathy (PATH): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Neurol. 2018 Jan;17(1):35-46. doi: 10.1016/S1474-4422(17)30378-2. Epub 2017 Nov 6.
PubMed 29122523van Schaik IN, van Geloven N, Bril V, Hartung HP, Lewis RA, Sobue G, Lawo JP, Mielke O, Cornblath DR, Merkies IS; PATH study group. Subcutaneous immunoglobulin for maintenance treatment in chronic inflammatory demyelinating polyneuropathy (The PATH Study): study protocol for a randomized controlled trial. Trials. 2016 Jul 25;17(1):345. doi: 10.1186/s13063-016-1466-2.
PubMed 27455854
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Multicenter, Double-blind, Placebo-controlled, Parallel-group Phase III Study to Investigate the Efficacy, Safety, and Tolerability of 2 Different Doses of IgPro20 (Subcutaneous Immunoglobulin) for the Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) - the PATH Study
- ClinicalTrials.gov ID
- NCT01545076
- Acronym / sponsor ID
- IgPro20_3003
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- CSL BehringIndustry (pharma, biotech, devices)
- Collaborators
- ICON Clinical Research
- Study start
- Mar 2012
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 6 Mar 2012 (estimated)
- Results
- Posted 5 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, multicenter, randomized, double-blind, placebo-controlled, parallel-group 3-arm study to investigate 2 different doses of subcutaneous (SC) IgPro20 compared with placebo for maintenance treatment of patients with CIDP.
Patients who received at lease 1 dose of intravenous immunoglobulin (IVIG) within 8 weeks before screening will be assessed during 4 separate study periods. Patients first undergo a Screening Period, followed by an IgG Dependency Test Period of up to 12 weeks to test for ongoing need of IgG. Those patients experiencing CIDP relapse during this test period will be administered a standardized IVIG regimen during an IVIG Re-stabilization Period. Patients with improved and maintained adjusted inflammatory neuropathy cause and treatment scale (INCAT) in the IVIG Re-stabilization Period will continue to the SC Treatment Period of the study. Patients entering the 24 week SC Treatment Period will be randomized to receive weekly infusions of 1 of 2 IgPro20 doses (0.2 or 0.4 g/kg body weight) or placebo.
The overall study duration is up to 52 weeks. Clinical outcomes will be assessed by the Inflammatory Neuropathy Cause and Treatment (INCAT) score, maximum grip strength, the Medical Research Council (MRC) sum score, the Rasch-built Overall Disability Scale (R-ODS), and electrophysiological evaluations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IgPro20 low dose | Experimental | Biological: IgPro20 (low dose), Biological: IgPro10 |
| IgPro20 high dose | Experimental | Biological: IgPro10, Biological: IgPro20 (high dose) |
| Placebo | Placebo comparator | Biological: Placebo, Biological: IgPro10 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Definite or probable CIDP according to the European Federation of Neurological Societies/Peripheral Nerve Society (EFNS/PNS) criteria 2010.
- An IVIG treatment during the last 8 weeks prior to enrollment.
- Age ≥18 years.
- Written informed consent for study participation obtained before undergoing any study-specific procedures.
Key exclusion criteria (5 listed)
- Any polyneuropathy of other causes
- Any other disease (mainly neurological or chronic orthopedic) that has caused neurological symptoms or may interfere with treatment or outcome assessments
- Severe diseases and conditions that are likely to interfere with evaluation of the study product or satisfactory conduct of the study
- History of thrombotic episodes within the 2 years prior to enrolment
- Known allergic or other severe reactions to blood products including intolerability to previous IVIG
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IgPro20 (low dose)Also: Hizentra20% liquid formulation (200 mg/mL) of human normal immunoglobulin for subcutaneous use administered weekly during the SC treatment period of the study according to the randomization: 0.2 g/kg body weight (low dose arm) | Biological | IgPro20 low dose |
| Placebo2% human albumin administered by weekly SC infusions during the SC treatment period of the study. | Biological | Placebo |
| IgPro1010% Immunoglobulin G (IgG) liquid formulation of human normal immunoglobulin (Privigen®) administered intravenously during Restabilization Period of the study and/or as Rescue Therapy during SC Treatment Period for subjects with a CIDP relapse. | Biological | IgPro20 high dose, IgPro20 low dose, Placebo |
| IgPro20 (high dose)Also: Hizentra20% liquid formulation (200 mg/mL) of human normal immunoglobulin for subcutaneous use administered weekly during the SC treatment period of the study according to the randomization: 0.4 g/kg body weight (high dose arm) | Biological | IgPro20 high dose |
Primary outcome
Percentage (%) of Subjects With CIDP Relapse or Are Withdrawn for Any Other Reason During the Subcutaneous (SC) Treatment Period
Time frame: 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.
24 secondary outcomes
Change in Inflammatory Neuropathy Cause and Treatment (INCAT) Scores During the SC Treatment Period
Time frame: Baseline and up to 25 weeks
Median Change From Baseline in the Mean Grip Strength Scores of the Dominant Hand During the SC Treatment Period
Time frame: Baseline and up to 25 weeks
Change in the Medical Research Council (MRC) Sum Scores During the SC Treatment Period
Time frame: Baseline and up to 25 weeks
Change in Rasch-built Overall Disability Scale (R-ODS) Scores During the SC Treatment Period
Time frame: Baseline and up to 25 weeks
Time to CIDP Relapse or Withdrawal Due to Any Other Reason During the SC Treatment Period
Time frame: Up to 25 weeks
Number of Adverse Events Per IgPro20 Infusion During the SC Treatment Period
Time frame: Up to 28 weeks
Number of Subjects With Adverse Events During the SC Treatment Period
Time frame: Up to 28 weeks
Percentage of Subjects With Adverse Events During the SC Treatment Period
Time frame: Up to 28 weeks
Time to Improvement During IgPro10 Re-stabilization Therapy
Time frame: Up to 13 weeks
Change in Mean Grip Strength During IgPro10 Re-stabilization Therapy
Time frame: Reference visit and up to 13 weeks
Change in MRC Sum Score During IgPro10 Re-stabilization Therapy
Time frame: Reference visit and up to 13 weeks
Change in R-ODS During IgPro10 Re-stabilization Therapy
Time frame: Reference visit and up to 13 weeks
Change in INCAT During IgPro10 Re-stabilization Therapy
Time frame: Reference visit and up to 13 weeks
Number of Adverse Events Per IgPro10 Infusion During Re-stabilization Therapy
Time frame: Up to 13 weeks
Number of Subjects With Adverse Events During IgPro10 Re-stabilization Therapy
Time frame: Up to 13 weeks
Percent of Subjects With Adverse Events During IgPro10 Re-stabilization Therapy
Time frame: Up to 13 weeks
Time to Improvement After CIDP Relapse During IgPro10 Rescue Therapy
Time frame: Up to 13 weeks
Number of Adverse Events Per IgPro10 Infusion During Rescue Therapy
Time frame: Up to 13 weeks
Number of Subjects With Adverse Events During IgPro10 Rescue Therapy
Time frame: Up to 13 weeks
Percent of Subjects With Adverse Events During IgPro10 Rescue Therapy
Time frame: Up to 13 weeks
Change in Mean Grip Strength During IgPro10 Rescue Therapy
Time frame: Before first rescue IgPro10 infusion and up to 13 weeks
Change in MRC Sum Score During IgPro10 Rescue Therapy
Time frame: Before first rescue IgPro10 infusion and up to 13 weeks
Change in R-ODS During IgPro10 Rescue Therapy
Time frame: Before first rescue IgPro10 infusion and up to 13 weeks
Change in INCAT During IgPro10 Rescue Therapy
Time frame: Before first rescue IgPro10 infusion and up to 13 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42578463Bus SR, Wieske L, Keddie S, van Schaik IN, Eftimov F. Subcutaneous immunoglobulin for chronic inflammatory demyelinating polyradiculoneuropathy. Cochrane Database Syst Rev. 2026 Aug 11;8:CD014542. doi: 10.1002/14651858.CD014542.pub2.
- Derived from this study: PubMed 29122523van Schaik IN, Bril V, van Geloven N, Hartung HP, Lewis RA, Sobue G, Lawo JP, Praus M, Mielke O, Durn BL, Cornblath DR, Merkies ISJ; PATH study group. Subcutaneous immunoglobulin for maintenance treatment in chronic inflammatory demyelinating polyneuropathy (PATH): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Neurol. 2018 Jan;17(1):35-46. doi: 10.1016/S1474-4422(17)30378-2. Epub 2017 Nov 6.
- Derived from this study: PubMed 27455854van Schaik IN, van Geloven N, Bril V, Hartung HP, Lewis RA, Sobue G, Lawo JP, Mielke O, Cornblath DR, Merkies IS; PATH study group. Subcutaneous immunoglobulin for maintenance treatment in chronic inflammatory demyelinating polyneuropathy (The PATH Study): study protocol for a randomized controlled trial. Trials. 2016 Jul 25;17(1):345. doi: 10.1186/s13063-016-1466-2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prof. Dr. Ivo N. van Schaik principal investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
91 sites in 16 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing IgPro20 (low dose), IgPro10 and IgPro20 (high dose) in people with Chronic Inflammatory Demyelinating Polyneuropathy and Polyradiculoneuropathy, run by CSL Behring at 91 sites in 16 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 91 sites in United States, Germany, Japan, Italy, Canada and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage (%) of Subjects With CIDP Relapse or Are Withdrawn for Any Other Reason During the Subcutaneous (SC) Treatment Period (time frame: Up to 25 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01545076, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2018.