N/A
Completed N=15
Subcutaneous Immunoglobulin for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Source: ClinicalTrials.gov NCT02465359 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcomePrimary: Relapse of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Symptoms — 3; 12 Participants
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.
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 | — |
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. Informational only — not medical advice.