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Immunomodulator

IVIG vs SCIG for CIDP

Phase 1
Recruiting
Led By Luigi Brunetti, PhD
Research Sponsored by Rutgers, The State University of New Jersey
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients aged >18 years with a current diagnosis of CIDP (based on European Federation of Neurological sciences / Peripheral Nerve Society CIDP diagnostic criteria)
1:1 conversion of IVIG to SCIG (weekly dose conversion) must fall within 0.2-to-0.4 mg/kg dose for SCIG.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up just before drug administration, immediately after drug administration, approximately days 7 and 14 post drug administration
Awards & highlights

Study Summary

This trial will look at how body weight affects the effectiveness of IgG when given through IV or injection.

Who is the study for?
This trial is for adults over 18 with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP). They must meet specific diagnostic criteria and have a dosage conversion rate that fits the study's range. People with active cancer, immune or autoimmune diseases, diabetes, myasthenia gravis, or significant liver or kidney issues cannot participate.Check my eligibility
What is being tested?
The study compares two ways of giving immunoglobulin G (IgG) to CIDP patients: through the veins (IVIG) and under the skin (SCIG). It aims to see how body composition affects these methods in people with different body weights.See study design
What are the potential side effects?
Possible side effects include reactions at the injection site like redness and swelling, headaches, fever, nausea, fatigue. Rarely there can be more serious reactions such as blood clots or kidney problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am over 18 and have been diagnosed with CIDP.
Select...
My weekly dose for SCIG is between 0.2 and 0.4 mg/kg.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and just before administration of next immune globulin dose.
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and just before administration of next immune globulin dose. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Assessment of drug half-life
Immunoglobulins
Immunoglobulins
Secondary outcome measures
Fatigue
Assessment of grip strength
Assessment of muscle function
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Subcutaneous immune globulin GExperimental Treatment1 Intervention
The dosage will be converted from the subject's current intravenous immune globulin G dosage 1:1 (gm per gm).
Group II: Intravenous immune globulin GExperimental Treatment1 Intervention
Subjects will receive there current intravenous immune globulin dose.

Find a Location

Who is running the clinical trial?

Rutgers, The State University of New JerseyLead Sponsor
426 Previous Clinical Trials
64,175 Total Patients Enrolled
Luigi Brunetti, PhDPrincipal InvestigatorRutgers, The State University of New Jersey
1 Previous Clinical Trials
300 Total Patients Enrolled

Media Library

Intravenous immune globulin G (Immunomodulator) Clinical Trial Eligibility Overview. Trial Name: NCT05584631 — Phase 1
Primary Immunodeficiency Research Study Groups: Intravenous immune globulin G, Subcutaneous immune globulin G
Primary Immunodeficiency Clinical Trial 2023: Intravenous immune globulin G Highlights & Side Effects. Trial Name: NCT05584631 — Phase 1
Intravenous immune globulin G (Immunomodulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05584631 — Phase 1
Primary Immunodeficiency Patient Testimony for trial: Trial Name: NCT05584631 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What aims is this medical trial trying to achieve?

"The principal metric quantifying success of this clinical trial, measured over the course of 4 weeks, is the serum concentration of immunoglobulin G after intravenous infusion. Additionally, participants' fatigue intensity will be assessed via Rasch-built Fatigue Severity Scale (R-FSS), muscle strength and function through Medical Research Council's score system, and finally grip strength with a handheld Martin Vigorimeter."

Answered by AI

Has the FDA authorized the use of Intravenous immune globulin G?

"Due to limited safety and efficacy data, Intravenous immune globulin G achieved a score of 1."

Answered by AI

How many participants are currently involved in this research?

"Affirmative. According to the information hosted on clinicaltrials.gov, this medical trial is actively seeking applicants and was first posted on October 18th 2022. 20 participants are required from 1 centre with no recent updates since October 13th of the same year."

Answered by AI

Is this experiment open to enrollment?

"Affirmative. The details on clinicaltrials.gov demonstrate that this investigation is actively recruiting participants, having first been posted to the website on October 18th 2022 and lastly updated on 13th of the same month. 20 people are needed at a single centre for enrolment in this study."

Answered by AI

Am I eligible to become involved in this medical experiment?

"This medical research is looking for 20 individuals, aged 18 to 65, that have been diagnosed with chronic inflammatory demyelinating polyradiculoneuropathy. Furthermore, it's necessary for potential participants to meet the following criteria: according to European Federation of Neurological sciences/Peripheral Nerve Society CIDP diagnostic standards they must be over 18 and their weekly dose conversion rate (1:1 IVIG converted into SCIG) must fall within 0.2-to-0.4 mg/kg."

Answered by AI

Is this trial restricted to any particular age group?

"Candidates aged between 18 and 65 are eligible to participate in this study. There is a separate set of trials for those below the age of consent (4) as well as additional ones targeting an elderly population (34)."

Answered by AI

Who else is applying?

What state do they live in?
New Jersey
Texas
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
1
2
What site did they apply to?
Rutgers, The State University of New Jersey Clinical Research Center

Why did patients apply to this trial?

I am hoping this trial will help with my condition.
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

How long does the screening take?
PatientReceived 1 prior treatment

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. Rutgers, The State University of New Jersey Clinical Research Center: < 48 hours
Average response time
  • < 2 Days
~5 spots leftby Oct 2024