Trial · NCT02465359
Subcutaneous Immunoglobulin for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
NCT02465359, Not applicable, Completed, University of South Florida; results first posted 2024-10-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Subcutaneous Immunoglobulin for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). Trials, record NCT02465359. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02465359
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Subcutaneous Immunoglobulin for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
- NCT number
- NCT02465359
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 15 participants, actual
- Lead sponsor
- University of South Florida
- Conditions
- Chronic Inflammatory Demyelinating Polyneuropathy
- Interventions
- Immune Globulin Subcutaneous (Human)
- First posted
- 2015-06-08
- Last updated
- 2024-10-08
- Results first posted
- 2024-10-08
- Limitations and caveats
Small, open-label trial; lacks immunoglobulin G (IgG)-dependency test; predictors of poor QOL were not substratified during analysis of the primary and secondary endpoints; lack of baseline IVIg observation period.
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Relapse of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Symptoms | 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. |
| Secondary | Mean Change in Short Form 36 (SF-36) Domain: Physical Functioning Between Week 24 and Screening | 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 physical functioning is shown, listed as the mean change from screening to 24 weeks. |
| Secondary | Mean Change in Inflammatory Rasch-built Overall Disability Scale (I-RODS) From Screening to Week 24 | 24 weeks | 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 1. = performed with difficulty 2. = 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. |
| Secondary | Mean Change in Chronic Acquired Polyneuropathy Patient-Reported Index (CAP-PRI) Between Week 24 and Screening | 24 weeks | 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. |
| Secondary | Treatment Satisfaction Questionnaire for Medication (TSQM) | 24 weeks | 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. |
| Secondary | Mean Change in Short Form 36 Domain: Role Limitations-physical Between Screening and Week 24 | 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 "role limitations-physical" is shown, listed as the mean change between screening to 24 weeks. |
| Secondary | Mean Change in Short Form 36 Domain: Role Limitations - Emotional (Between Week 24 and Screening) | 24 weeks | 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. |
| Secondary | Mean Change in Short Form 36 Domain: Energy/Fatigue Between Screening and Week 24 | 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 "energy/fatigue" is shown, listed as the mean change between screening and 24 weeks. |
| Secondary | Mean Change in Short Form 36 Domain: Emotional Well-being Between Screening and 24 Weeks | 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. |
| Secondary | Mean Change in Short Form 36 Domain: Social Functioning Between Screening and Week 24 | 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 "social functioning" is shown, listed as the mean change between screening and 24 weeks. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Relapse of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Symptoms | 24 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Mean Change in Short Form 36 (SF-36) Domain: Physical Functioning Between Week 24 and Screening | 24 weeks | score on a scale | MEAN | |
| SECONDARY | Mean Change in Inflammatory Rasch-built Overall Disability Scale (I-RODS) From Screening to Week 24 | 24 weeks | units on a scale | MEAN | |
| SECONDARY | Mean Change in Chronic Acquired Polyneuropathy Patient-Reported Index (CAP-PRI) Between Week 24 and Screening | 24 weeks | units on a scale | MEAN | |
| SECONDARY | Treatment Satisfaction Questionnaire for Medication (TSQM) | 24 weeks | units on a scale | MEAN | |
| SECONDARY | Mean Change in Short Form 36 Domain: Role Limitations-physical Between Screening and Week 24 | 24 weeks | score on a scale | MEAN | |
| SECONDARY | Mean Change in Short Form 36 Domain: Role Limitations - Emotional (Between Week 24 and Screening) | 24 weeks | score on a scale | MEAN | |
| SECONDARY | Mean Change in Short Form 36 Domain: Energy/Fatigue Between Screening and Week 24 | 24 weeks | score on a scale | MEAN | |
| SECONDARY | Mean Change in Short Form 36 Domain: Emotional Well-being Between Screening and 24 Weeks | 24 weeks | score on a scale | MEAN | |
| SECONDARY | Mean Change in Short Form 36 Domain: Social Functioning Between Screening and Week 24 | 24 weeks | score on a scale | MEAN |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group15
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Relapse of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Symptoms | Immune Globulin Subcutaneous (Human) | withdrew prematurely | 3 | Participants | |
| Relapse of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Symptoms | Immune Globulin Subcutaneous (Human) | completed study | 12 | Participants | |
| Mean Change in Short Form 36 (SF-36) Domain: Physical Functioning Between Week 24 and Screening | Immune Globulin Subcutaneous (Human) | 0 | 95% Confidence Interval -0.12 to 0.12 | score on a scale | |
| Mean Change in Inflammatory Rasch-built Overall Disability Scale (I-RODS) From Screening to Week 24 | Immune Globulin Subcutaneous (Human) | -1.5 | 95% Confidence Interval -4.6 to 1.6 | units on a scale | |
| Mean Change in Chronic Acquired Polyneuropathy Patient-Reported Index (CAP-PRI) Between Week 24 and Screening | Immune Globulin Subcutaneous (Human) | -4.3 | 95% Confidence Interval -7.7 to -0.9 | units on a scale | |
| Treatment Satisfaction Questionnaire for Medication (TSQM) | Immune Globulin Subcutaneous (Human) | 10.3 | 95% Confidence Interval 4.3 to 16.2 | units on a scale | |
| Mean Change in Short Form 36 Domain: Role Limitations-physical Between Screening and Week 24 | Immune Globulin Subcutaneous (Human) | 0.24 | 95% Confidence Interval 0.03 to 0.46 | score on a scale | |
| Mean Change in Short Form 36 Domain: Role Limitations - Emotional (Between Week 24 and Screening) | Immune Globulin Subcutaneous (Human) | -0.01 | 95% Confidence Interval -0.27 to 0.24 | score on a scale | |
| Mean Change in Short Form 36 Domain: Energy/Fatigue Between Screening and Week 24 | Immune Globulin Subcutaneous (Human) | 0.09 | 95% Confidence Interval 0.00 to 0.18 | score on a scale | |
| Mean Change in Short Form 36 Domain: Emotional Well-being Between Screening and 24 Weeks | Immune Globulin Subcutaneous (Human) | 0.03 | 95% Confidence Interval -0.04 to 0.09 | score on a scale |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Immune Globulin Subcutaneous (Human) | 15 | |
| Overall Study | COMPLETED | Immune Globulin Subcutaneous (Human) | 12 | |
| Overall Study | NOT COMPLETED | Immune Globulin Subcutaneous (Human) | 3 |
Source ClinicalTrials.gov
Adverse events32
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 | Pain at infusion site | General disorders | Immune Globulin Subcutaneous (Human) | 13 | 15 | |
| other | Transient swelling at site of infusion | General disorders | Immune Globulin Subcutaneous (Human) | 12 | 15 | |
| other | Redness at site of infusion | General disorders | Immune Globulin Subcutaneous (Human) | 11 | 15 | |
| other | Induration at site of infusion | General disorders | Immune Globulin Subcutaneous (Human) | 7 | 15 | |
| other | Itching at site of infusion | General disorders | Immune Globulin Subcutaneous (Human) | 7 | 15 | |
| other | Numbness | General disorders | Immune Globulin Subcutaneous (Human) | 5 | 15 | |
| other | Bruising at site of infusion | General disorders | Immune Globulin Subcutaneous (Human) | 5 | 15 | |
| other | Increased Exhaustion | General disorders | Immune Globulin Subcutaneous (Human) | 4 | 15 | |
| other | Hedache/Migrane | Nervous system disorders | Immune Globulin Subcutaneous (Human) | 4 | 15 | |
| other | Local heat at site of infusion | Skin and subcutaneous tissue disorders | Immune Globulin Subcutaneous (Human) | 3 | 15 |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Immune Globulin Subcutaneous (Human) | 0 | 15 |
| Total, other adverse events | Immune Globulin Subcutaneous (Human) | 13 | 15 |
| Total, serious adverse events | Immune Globulin Subcutaneous (Human) | 0 | 15 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT02465359
GET https://conductscience.org/api/trials/v1/NCT02465359/events?page=2