Chronic Inflammatory Demyelinating PolyneuropathySCIGNCT02465359
Subcutaneous Immunoglobulin for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
A study testing Immune Globulin Subcutaneous (Human) in people with Chronic Inflammatory Demyelinating Polyneuropathy, run by University of South Florida at 1 site in United States.
Trial summary
The investigators are using self administered subcutaneous immunoglobulin (SCIG) in patients with CIDP who require Intravenous immunoglobulin (IVIG). Safety, efficacy, and patient satisfaction will be examined. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Inflammatory Demyelinating Polyneuropathy
- What is being tested?
- Immune Globulin Subcutaneous (Human)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to May 2021
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To qualify, a patient must have CIDP and persistence of significant symptoms (having 2 or more of the following):
- Weakness in any limb,
- Motor fatigue significant to interfere with activities of daily living (ADL) or work,
- Paresthesia of sufficient severity to require a medication,
- Sensory impairment,
- Walking impairment,
- AND requires IVIG to control symptoms.
Who cannot join
- Thrombocytopenia or other bleeding disorders,
- Anticoagulation therapy,
- Severe or anaphylactoid reactions to IVIG,
- Cancer,
- Pregnancy,
- Breast-feeding,
Show all 9Show fewer
- Renal insufficiency or failure,
- Congestive heart failure,
- Psychiatric illness.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study of Subcutaneous Immunoglobulin as Chronic Treatment for Patients With Chronic Inflammatory Demyelinating Polyneuropathy
The investigators are using self administered subcutaneous immunoglobulin (SCIG) in patients with CIDP who require Intravenous immunoglobulin (IVIG). Safety, efficacy, and patient satisfaction will be examined.
Read the detailed description
Chronic inflammatory demyelinating polyneuropathy (CIDP) is an autoimmune neurological disorder that causes limb weakness and numbness. Many patients require immunosuppressants and plasma exchange (PLEX) to control their symptoms. Intravenous immunoglobulin (IVIG) is also an effective treatment (Hughes et al, 2006 \& 2008; Hughes, 2009; Cocito et al, 2010), and the American Academy of Neurology (AAN) guideline recommended that it should be offered in the long-term treatment of CIDP (Patwa et al, 2012). While effective, IVIG causes systemic side effects in about 5% of patients. These side effects include rash, pruritus, myalgia, fever, chills, headache, low back pain, nausea, vomiting, changes in blood pressure or heart rate, renal failure, and aseptic meningitis (Berger, 2008). For many patients who are chronically treated with IVIG, venous access may be a problem over time. An alternative is the subcutaneous (SC) route, which has been in use since 1980 for primary immune deficiency disorders and is the treatment of choice for this condition in Scandinavia and England (Radinsky et al, 2003). As compared to intravenous (IV) route, SC route maintains higher trough levels of immunoglobulins, increases patient independence, reduces systemic side-effects, and is better tolerated in those who are pregnant or sensitized to Immunoglobulin A (IgA) (Radinsky et al, 2003). In a review of side effects associated with 33,168 SCIG infusions, no severe or anaphylactoid reactions occurred (Gardulf et al, 1995). Patients can self-administer medication, and hence, overall cost may be reduced. A retrospective study of 28 children with primary immunodeficiency in Canada showed that the mean difference in costs between IVIG and SCIG during the study period (1 year on IVIG and 1 year on SCIG) was $4,346 in favor of SCIG (Ducruet et al, 2011). A US$10,100 reduction in cost per year per patient associated with SCIG use was also reported by Gardulf et al (1995) in Sweden. Disadvantages of SCIG include more frequent infusions and local reactions at sites of infusion (transient swelling, soreness, redness, induration, local heat, and itching) in about 1% of patients.
- Being tested
- Immune Globulin Subcutaneous (Human)
- Medical subject headings
- Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immune Globulin Subcutaneous (Human)Drug
Also called Hizentra
Patients who have CIDP and are on IVIG will be allowed in the study to try subcutaneous immune Globulin (SCIG) as part of an open label study.
| Study group | Role | What they receive |
|---|---|---|
| Immune globulin subcutaneous (Human) | Experimental | lmmune Globulin Subcutaneous(Human) 20% Liquid (Hizentra) will be given weekly Receives: Drug: Immune Globulin Subcutaneous (Human) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Symptoms
This outcome measure, referred to as the relapse of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) symptoms, is a measure of how many participants experiences CIDP symptoms causing them to withdraw prematurely from the study. This is a count of participant withdrawals compared to the number of participants who completed the study.
Measured: 24 weeks
Secondary outcomes (13)
Mean Change in Short Form 36 (SF-36) Domain: Physical Functioning Between Week 24 and Screening
The short form 36 (SF-36) is a health status profile designed to measure health status and outcomes of patients. Per the paper from Burholt and Nash (2011) scoring and domains are as follows:" The SF-36 is a 36 item scale, which measures eight domains of health status: physical functioning (10 items); physical role limitations (four items); bodily pain (two items); general health perceptions (five items); energy/vitality (four items); social functioning (two items); emotional role limitations (three items) and mental health (five items). A scoring algorithm is used to convert the raw scores into the eight dimensions listed above. The scores are transformed to range from zero where the respondent has the worst possible health to 100 where the respondent is in the best possible health." For this particular outcome measure, only the domain pertaining to physical functioning is shown, listed as the mean change from screening to 24 weeks.
Measured: 24 weeks
Mean Change in Inflammatory Rasch-built Overall Disability Scale (I-RODS) From Screening to Week 24
The Inflammatory Rasch-built Overall Disability Scale (I-RODS) is an instrument answered by the patient to assess overall disability through assessing activity and social participation limitations in patients with inflammatory neuropathies. It is a 24-item scale, with each item representing a common, daily activity. The patient assigns a score between 0 and 2 to each item as follows:
0 = impossible to perform
- = performed with difficulty
- = easily performed
The total raw score on the I-RODS (0-48 max) is transformed to a final score (0-100), with a lower score indicating worse outcomes. Here the outcome measure is the mean change between screening and week 24, as calculated from transformed total I-RODS score. A negative change between week 24 and screening, or a reduction in I-RODS score, indicates a worsening of the patient's perceived daily functioning, as measured by the I-RODS.
Measured: 24 weeks
Mean Change in Chronic Acquired Polyneuropathy Patient-Reported Index (CAP-PRI) Between Week 24 and Screening
The Chronic Acquired Polyneuropathy Patient-Reported Index (CAP-PRI) is used to evaluate quality of life in patients with polyneuropathy. The scale consists of 15 items, resulting in a single-score with 4 life domains (physical, social, pain and emotional well-being). Each item assessed is scored 0-2 (0= not at all, 1 = a little bit, 2 = a lot). Max score possible is 30 with a higher score indicating worse outcomes.
This outcome measure was evaluated at screening and week 24 by determining the mean change between these two time points. A negative score would indicate an improvement as perceived by the participant.
Measured: 24 weeks
Treatment Satisfaction Questionnaire for Medication (TSQM)
The Treatment Satisfaction Questionnaire for Medication (TSQM) is used to assess the patient's treatment satisfaction with intravenous immune globulin (IVIg) compared to the use of subcutaneous immune globulin (SCIg). There are 14 items and the TSQM addresses four domains: effectiveness, side effects, convenience, and global satisfaction. Questions are scored from one (least satisfied) to five or seven (most satisfied), with the exception of item 4 relating to side effects (scored yes/no, 1 or 0, respectively). Item scores are summed to give four domain scores, which are in turn transformed to a scale of 0-100. Higher scores indicate higher treatment satisfaction.
Measured: 24 weeks
Mean Change in Short Form 36 Domain: Role Limitations-physical Between Screening and Week 24
The short form 36 (SF-36) is a health status profile designed to measure health status and outcomes of patients. Per the paper from Burholt and Nash (2011) scoring and domains are as follows:" The SF-36 is a 36 item scale, which measures eight domains of health status: physical functioning (10 items); physical role limitations (four items); bodily pain (two items); general health perceptions (five items); energy/vitality (four items); social functioning (two items); emotional role limitations (three items) and mental health (five items). A scoring algorithm is used to convert the raw scores into the eight dimensions listed above. The scores are transformed to range from zero where the respondent has the worst possible health to 100 where the respondent is in the best possible health." For this particular outcome measure, only the domain pertaining to "role limitations-physical" is shown, listed as the mean change between screening to 24 weeks.
Measured: 24 weeks
Mean Change in Short Form 36 Domain: Role Limitations - Emotional (Between Week 24 and Screening)
The short form 36 (SF-36) measure health status of patients. Per Burholt and Nash (2011) scoring and domains are as follows:" The SF-36 is a 36 item scale, which measures eight domains of health status: physical functioning (10 items); physical role limitations (four items); bodily pain (two items); general health perceptions (five items); energy/vitality (four items); social functioning (two items); emotional role limitations (three items) and mental health (five items). A scoring algorithm is used to convert the raw scores into the eight dimensions listed above. The scores are transformed to range from zero where the respondent has the worst possible health to 100 where the respondent is in the best possible health." For this particular outcome measure, only the domain pertaining to "role limitations-emotional" is shown, listed as the mean change from screening to 24 weeks.
A negative value for this measure indicates a worsening of role limitations related to emotional health.
Measured: 24 weeks
Mean Change in Short Form 36 Domain: Energy/Fatigue Between Screening and Week 24
The short form 36 (SF-36) is a health status profile designed to measure health status and outcomes of patients. Per the paper from Burholt and Nash (2011) scoring and domains are as follows:" The SF-36 is a 36 item scale, which measures eight domains of health status: physical functioning (10 items); physical role limitations (four items); bodily pain (two items); general health perceptions (five items); energy/vitality (four items); social functioning (two items); emotional role limitations (three items) and mental health (five items). A scoring algorithm is used to convert the raw scores into the eight dimensions listed above. The scores are transformed to range from zero where the respondent has the worst possible health to 100 where the respondent is in the best possible health." For this particular outcome measure, only the domain pertaining to "energy/fatigue" is shown, listed as the mean change between screening and 24 weeks.
Measured: 24 weeks
Mean Change in Short Form 36 Domain: Emotional Well-being Between Screening and 24 Weeks
The short form 36 (SF-36) is a health status profile designed to measure health status and outcomes of patients. Per the paper from Burholt and Nash (2011) scoring and domains are as follows:" The SF-36 is a 36 item scale, which measures eight domains of health status: physical functioning (10 items); physical role limitations (four items); bodily pain (two items); general health perceptions (five items); energy/vitality (four items); social functioning (two items); emotional role limitations (three items) and mental health (five items). A scoring algorithm is used to convert the raw scores into the eight dimensions listed above. The scores are transformed to range from zero where the respondent has the worst possible health to 100 where the respondent is in the best possible health." For this particular outcome measure, only the domain pertaining to "emotional well-being" is shown, listed as the mean change between screening and 24 weeks.
Measured: 24 weeks
Mean Change in Short Form 36 Domain: Social Functioning Between Screening and Week 24
The short form 36 (SF-36) is a health status profile designed to measure health status and outcomes of patients. Per the paper from Burholt and Nash (2011) scoring and domains are as follows:" The SF-36 is a 36 item scale, which measures eight domains of health status: physical functioning (10 items); physical role limitations (four items); bodily pain (two items); general health perceptions (five items); energy/vitality (four items); social functioning (two items); emotional role limitations (three items) and mental health (five items). A scoring algorithm is used to convert the raw scores into the eight dimensions listed above. The scores are transformed to range from zero where the respondent has the worst possible health to 100 where the respondent is in the best possible health." For this particular outcome measure, only the domain pertaining to "social functioning" is shown, listed as the mean change between screening and 24 weeks.
Measured: 24 weeks
Mean Change in Short Form 36 Domain: Pain Between Screening and 24 Weeks
The short form 36 (SF-36) is a health status profile designed to measure health status and outcomes of patients. Per the paper from Burholt and Nash (2011) scoring and domains are as follows:" The SF-36 is a 36 item scale, which measures eight domains of health status: physical functioning (10 items); physical role limitations (four items); bodily pain (two items); general health perceptions (five items); energy/vitality (four items); social functioning (two items); emotional role limitations (three items) and mental health (five items). A scoring algorithm is used to convert the raw scores into the eight dimensions listed above. The scores are transformed to range from zero where the respondent has the worst possible health to 100 where the respondent is in the best possible health." For this particular outcome measure, only the domain pertaining to "pain" is shown, listed as the mean change between screening and 24 weeks.
Measured: 24 weeks
Mean Change in Short Form 36 Domain "General Health" Between Screening and Week 24
The short form 36 (SF-36) is a health status profile designed to measure health status and outcomes of patients. Per the paper from Burholt and Nash (2011) scoring and domains are as follows:" The SF-36 is a 36 item scale, which measures eight domains of health status: physical functioning (10 items); physical role limitations (four items); bodily pain (two items); general health perceptions (five items); energy/vitality (four items); social functioning (two items); emotional role limitations (three items) and mental health (five items). A scoring algorithm is used to convert the raw scores into the eight dimensions listed above. The scores are transformed to range from zero where the respondent has the worst possible health to 100 where the respondent is in the best possible health." For this particular outcome measure, only the domain pertaining to "general health" is shown, listed as the mean change between screening and 24 weeks.
Measured: 24 weeks
Mean Change in Limb Motor Strength Testing (LMST) Over 24 Weeks
LMST is a discrete variable that tests muscle strength in upper and lower limbs. It is a sum of the strength of 16 muscle groups tested at a given time point. LMST is measured and reported in pounds (lbs). For this outcome measure, the mean change, in pounds, between screening and week 24 LMST is reported.
Measured: 24 weeks
Mean Change in Timed 25-foot Walk (T25-FW) Between Screening and Week 24
The T25-FW is a quantitative mobility and leg function performance test based on a timed 25-foot walk. A lower time indicates greater mobility and leg performance, thus suggesting better outcomes. Time is measured in seconds. This outcome is the mean change between timed 25 foot walk times between screening and week 24.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2015 (estimated)
- Study startSep 2014
- Primary completionMar 2018
- Study completionMay 2021
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.
- Other trials for Chronic Inflammatory Demyelinating PolyneuropathyStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Collaborators
- CSL Behring
- Responsible party
- Sponsor
- Investigators
- Tuan Vu, MD, Principal investigator, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02465359
- Sponsor's protocol ID
- Pro00016957
- Acronym
- SCIG
- Status last verified
- Sep 2024
- First submitted
- 12 Dec 2014
- Last updated
- 8 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Subcutaneous Immunoglobulin as Chronic Treatment for Patients With Chronic Inflammatory Demyelinating Polyneuropathy
- ClinicalTrials.gov ID
- NCT02465359
- Acronym / sponsor ID
- SCIG / Pro00016957
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Collaborators
- CSL Behring
- Study start
- Sep 2014
- Primary completion
- Mar 2018 (actual)
- Study completion
- May 2021 (actual)
- First posted
- 8 Jun 2015 (estimated)
- Results
- Posted 8 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators are using self administered subcutaneous immunoglobulin (SCIG) in patients with CIDP who require Intravenous immunoglobulin (IVIG). Safety, efficacy, and patient satisfaction will be examined.
Detailed description
Chronic inflammatory demyelinating polyneuropathy (CIDP) is an autoimmune neurological disorder that causes limb weakness and numbness. Many patients require immunosuppressants and plasma exchange (PLEX) to control their symptoms. Intravenous immunoglobulin (IVIG) is also an effective treatment (Hughes et al, 2006 \& 2008; Hughes, 2009; Cocito et al, 2010), and the American Academy of Neurology (AAN) guideline recommended that it should be offered in the long-term treatment of CIDP (Patwa et al, 2012). While effective, IVIG causes systemic side effects in about 5% of patients. These side effects include rash, pruritus, myalgia, fever, chills, headache, low back pain, nausea, vomiting, changes in blood pressure or heart rate, renal failure, and aseptic meningitis (Berger, 2008). For many patients who are chronically treated with IVIG, venous access may be a problem over time. An alternative is the subcutaneous (SC) route, which has been in use since 1980 for primary immune deficiency disorders and is the treatment of choice for this condition in Scandinavia and England (Radinsky et al, 2003). As compared to intravenous (IV) route, SC route maintains higher trough levels of immunoglobulins, increases patient independence, reduces systemic side-effects, and is better tolerated in those who are pregnant or sensitized to Immunoglobulin A (IgA) (Radinsky et al, 2003). In a review of side effects associated with 33,168 SCIG infusions, no severe or anaphylactoid reactions occurred (Gardulf et al, 1995). Patients can self-administer medication, and hence, overall cost may be reduced. A retrospective study of 28 children with primary immunodeficiency in Canada showed that the mean difference in costs between IVIG and SCIG during the study period (1 year on IVIG and 1 year on SCIG) was $4,346 in favor of SCIG (Ducruet et al, 2011). A US$10,100 reduction in cost per year per patient associated with SCIG use was also reported by Gardulf et al (1995) in Sweden. Disadvantages of SCIG include more frequent infusions and local reactions at sites of infusion (transient swelling, soreness, redness, induration, local heat, and itching) in about 1% of patients.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Immune globulin subcutaneous (Human) | Experimental | Drug: Immune Globulin Subcutaneous (Human)lmmune Globulin Subcutaneous(Human) 20% Liquid (Hizentra) will be given weekly |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- To qualify, a patient must have CIDP and persistence of significant symptoms (having 2 or more of the following):
- Weakness in any limb,
- Motor fatigue significant to interfere with activities of daily living (ADL) or work,
- Paresthesia of sufficient severity to require a medication,
- Sensory impairment,
Key exclusion criteria (9 listed)
- Thrombocytopenia or other bleeding disorders,
- Anticoagulation therapy,
- Severe or anaphylactoid reactions to IVIG,
- Cancer,
- Pregnancy,
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 |
|---|---|---|
| Immune Globulin Subcutaneous (Human)Also: HizentraPatients who have CIDP and are on IVIG will be allowed in the study to try subcutaneous immune Globulin (SCIG) as part of an open label study. | Drug | Immune globulin subcutaneous (Human) |
Primary outcome
Relapse of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Symptoms
Time frame: 24 weeks
This outcome measure, referred to as the relapse of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) symptoms, is a measure of how many participants experiences CIDP symptoms causing them to withdraw prematurely from the study. This is a count of participant withdrawals compared to the number of participants who completed the study.
13 secondary outcomes
Mean Change in Short Form 36 (SF-36) Domain: Physical Functioning Between Week 24 and Screening
Time frame: 24 weeks
Mean Change in Inflammatory Rasch-built Overall Disability Scale (I-RODS) From Screening to Week 24
Time frame: 24 weeks
Mean Change in Chronic Acquired Polyneuropathy Patient-Reported Index (CAP-PRI) Between Week 24 and Screening
Time frame: 24 weeks
Treatment Satisfaction Questionnaire for Medication (TSQM)
Time frame: 24 weeks
Mean Change in Short Form 36 Domain: Role Limitations-physical Between Screening and Week 24
Time frame: 24 weeks
Mean Change in Short Form 36 Domain: Role Limitations - Emotional (Between Week 24 and Screening)
Time frame: 24 weeks
Mean Change in Short Form 36 Domain: Energy/Fatigue Between Screening and Week 24
Time frame: 24 weeks
Mean Change in Short Form 36 Domain: Emotional Well-being Between Screening and 24 Weeks
Time frame: 24 weeks
Mean Change in Short Form 36 Domain: Social Functioning Between Screening and Week 24
Time frame: 24 weeks
Mean Change in Short Form 36 Domain: Pain Between Screening and 24 Weeks
Time frame: 24 weeks
Mean Change in Short Form 36 Domain "General Health" Between Screening and Week 24
Time frame: 24 weeks
Mean Change in Limb Motor Strength Testing (LMST) Over 24 Weeks
Time frame: 24 weeks
Mean Change in Timed 25-foot Walk (T25-FW) Between Screening and Week 24
Time frame: 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
Tuan Vu, MD principal investigator
University of South Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immune Globulin Subcutaneous (Human) in people with Chronic Inflammatory Demyelinating Polyneuropathy, run by University of South Florida at 1 site in United States.
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 7 inclusion and 9 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 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Oct 2024). 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?
Relapse of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Symptoms (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Oct 2024.