IVIG vs SCIG for CIDP

Overseen By Luigi Brunetti, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Rutgers, The State University of New Jersey

Must be taking: Immunoglobulin G

Disqualifiers: Liver impairment, Renal dysfunction, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two methods of administering immunoglobulin G (IgG), a treatment for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), which affects the nerves. Researchers aim to determine how body weight and composition might influence the effectiveness of intravenous (IV) and subcutaneous (under the skin) forms of IgG. Individuals diagnosed with CIDP and currently receiving IV IgG may be suitable candidates for this study. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to contribute to groundbreaking research.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that both intravenous (IV) and subcutaneous (under the skin) immune globulin G treatments are safe for people with CIDP (Chronic Inflammatory Demyelinating Polyneuropathy).

For IV immune globulin G, studies have found that doses up to 2.0 g/kg are safe and generally well-tolerated, even when administered quickly. Patients typically handle the treatment well, with few serious side effects.

Subcutaneous immune globulin G also has a strong safety record. Reviews indicate it is well-tolerated, meaning most people do not experience severe side effects. Real-world studies confirm these findings, supporting its safety.

Both treatments manage CIDP and have been studied for safety in similar conditions. While each method has its own considerations, evidence supports their general safety for use. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) because they offer different delivery methods compared to the standard intravenous immune globulin (IVIG) therapy. While IVIG is administered through an IV drip, the subcutaneous immune globulin (SCIG) provides a more flexible option, allowing patients to self-administer the treatment at home. This shift from hospital-based infusions to home-based care can significantly improve convenience and quality of life for patients. Additionally, SCIG maintains the same active ingredient as IVIG, ensuring that patients receive the same therapeutic benefits with potentially fewer hospital visits.

What evidence suggests that this trial's treatments could be effective for CIDP?

Research has shown that both IVIG (intravenous immune globulin G) and SCIG (subcutaneous immune globulin G) effectively treat CIDP, a condition affecting the nerves. In this trial, participants will receive either IVIG or SCIG. Studies indicate that IVIG helps about 70% of patients maintain their symptoms without worsening through regular treatments. SCIG is also effective and safe, offering the convenience of self-administration. Strong evidence supports the reliability of both treatments in managing CIDP symptoms over time. ^{2 3 6 7 8}

Who Is on the Research Team?

Luigi Brunetti, PhD

Principal Investigator

Rutgers, The State University of New Jersey

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My weekly dose for SCIG is between 0.2 and 0.4 mg/kg.

Exclusion Criteria

I am not receiving IVIG for conditions other than CIDP.

I have a weakened immune system.

My liver and kidney functions are within normal ranges.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intravenous or subcutaneous immune globulin G based on their current dosage

4 weeks

Visits just before drug administration, immediately after, and on days 2, 4, 7, and 14

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Intravenous immune globulin G
• Subcutaneous immune globulin G

Trial Overview 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.

How Is the Trial Designed?

Group I: Subcutaneous immune globulin G Experimental Treatment 1 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 G Experimental Treatment 1 Intervention

Subjects will receive there current intravenous immune globulin dose.

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials

471

Recruited

81,700+

Published Research Related to This Trial

Switching from intravenous immunoglobulin (IVIG) to subcutaneous immunoglobulin (SCIG) in patients with chronic inflammatory demyelinating polyneuropathy (CIDP) or multifocal motor neuropathy (MMN) resulted in a slight increase in hemoglobin levels, indicating improved blood health.

The study showed that SCIG led to a reduction in hemolytic activity, as evidenced by improved haptoglobin, reticulocyte counts, and bilirubin levels, suggesting that SCIG may be a safer alternative to IVIG with less risk of hemolysis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improvement of hemoglobin levels after a switch from intravenous to subcutaneous administration of immunoglobulin in chronic inflammatory demyelinating polyneuropathy and multifocal motor neuropathy. Markvardsen, LH., Christiansen, I., Jakobsen, J.[2017]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10310601/

Intravenous Immunoglobulin Treatment Patterns and ... The aim of this study was to describe real-world treatment patterns and outcomes of patients with CIDP in the Define initiating IVIG treatment.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT00220740

NCT00220740 | Immune Globulin Intravenous (IGIV) For ... The intent of this study is to demonstrate the efficacy and safety of Immune Globulin Intravenous (Human), 10% Caprylate/Chromatography Purified (IGIV-C) in ...

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1111%2Fene.70110

The Results of ADVANCE‐CIDP IVIG Trial: Intravenous ... Open-label ADVANCE-CIDP IVIG included adult patients with confirmed CIDP relapse (≥ 1-point increase in adjusted Inflammatory Neuropathy Cause ...

4. jnnp.bmj.com jnnp.bmj.com/content/88/10/832

a multicentre, open-label, 52-week phase III trial Maintenance treatment with 1.0 g/kg intravenous Ig every 3 weeks is an efficacious therapy for patients with CIDP, and approximately 70% of them had a ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0022510X19304290

Immunoglobulin administration for the treatment of CIDP Based on these trials there is high quality evidence that IVIG is safe and effective for CIDP induction and maintenance treatment [14]. The most informative ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10442284/

Safety and Tolerability of Intravenous Immunoglobulin in ... Infusions of 10% IVIg at doses up to 2.0 g/kg with high infusion rates were safe and well tolerated in patients with CIDP.

7. jamanetwork.com jamanetwork.com/journals/jamaneurology/fullarticle/801187

Safety and Tolerability of Immune Globulin Intravenous in ... Safety and Tolerability of Immune Globulin Intravenous in Chronic Inflammatory Demyelinating Polyradiculoneuropathy. Peter D. Donofrio, MD; Vera Bril, MD; ...

8. link.springer.com link.springer.com/article/10.1007/s40264-023-01326-z

Results of the ProCID Study | Drug Safety Infusions of 10% IVIg at doses up to 2.0 g/kg with high infusion rates were safe and well tolerated in patients with CIDP.