N/A
N=15
Subcutaneous Immunoglobulin for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Chronic Inflammatory Demyelinating Polyneuropathy
Bottom Line
View on ClinicalTrials.gov: NCT02465359 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcome: Primary: Relapse of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Symptoms — 3; 12 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Immune Globulin Subcutaneous (Human) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of South Florida
- Primary completion
- Mar 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Relapse of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Symptoms |
3; 12 | — |
| SECONDARY Mean Change in Short Form 36 (SF-36) Domain: Physical Functioning Between Week 24 and Screening |
— | — |
| SECONDARY Mean Change in Inflammatory Rasch-built Overall Disability Scale (I-RODS) From Screening to Week 24 |
-1.5 | — |
| SECONDARY Mean Change in Chronic Acquired Polyneuropathy Patient-Reported Index (CAP-PRI) Between Week 24 and Screening |
-4.3 | — |
| SECONDARY Treatment Satisfaction Questionnaire for Medication (TSQM) |
10.3 | — |
| SECONDARY Mean Change in Short Form 36 Domain: Role Limitations-physical Between Screening and Week 24 |
0.24 | — |
| SECONDARY Mean Change in Short Form 36 Domain: Role Limitations - Emotional (Between Week 24 and Screening) |
-0.01 | — |
| SECONDARY Mean Change in Short Form 36 Domain: Energy/Fatigue Between Screening and Week 24 |
0.09 | — |
| SECONDARY Mean Change in Short Form 36 Domain: Emotional Well-being Between Screening and 24 Weeks |
0.03 | — |
| SECONDARY Mean Change in Short Form 36 Domain: Social Functioning Between Screening and Week 24 |
0.06 | — |
| SECONDARY Mean Change in Short Form 36 Domain: Pain Between Screening and 24 Weeks |
0.08 | — |
| SECONDARY Mean Change in Short Form 36 Domain "General Health" Between Screening and Week 24 |
0.01 | — |
| SECONDARY Mean Change in Limb Motor Strength Testing (LMST) Over 24 Weeks |
5.6 | — |
| SECONDARY Mean Change in Timed 25-foot Walk (T25-FW) Between Screening and Week 24 |
-1.0 | — |
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.
Eligibility Criteria
Inclusion Criteria
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.
Exclusion Criteria
- Thrombocytopenia or other bleeding disorders,
- Anticoagulation therapy,
- Severe or anaphylactoid reactions to IVIG,
- Cancer,
- Pregnancy,
- Breast-feeding,
- Renal insufficiency or failure,
- Congestive heart failure,
- Psychiatric illness.
Data sourced from ClinicalTrials.gov (NCT02465359). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.