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

20 Participants Needed

Trial Summary

What is the purpose of this trial?

Current dosing practices for immunoglobulin G (IgG) may be inadequate in extreme body weight. The current study will evaluate the influence of body composition on intravenous and subcutaneous administration of immunoglobulin G in patients.

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.

What data supports the effectiveness of the drug for treating chronic inflammatory demyelinating polyneuropathy (CIDP)?

Research shows that both intravenous (IVIg) and subcutaneous immunoglobulin (SCIg) are effective in treating CIDP, with SCIg offering a more convenient and cost-effective option. Studies indicate that SCIg can stabilize the disease and improve quality of life for patients. ^{1 2 3 4 5}

Is IVIG and SCIG safe for humans?

Both intravenous immunoglobulin (IVIG) and subcutaneous immunoglobulin (SCIG) are generally safe for humans. SCIG is often preferred by some patients due to fewer systemic side effects compared to IVIG, and both methods are well tolerated in various conditions. ^{2 3 6 7 8}

How does the treatment of CIDP with IVIG and SCIG differ from other treatments?

The treatment for CIDP using intravenous immune globulin (IVIG) and subcutaneous immune globulin (SCIG) is unique because it offers different administration routes, with SCIG allowing for home-based self-infusion, which can improve quality of life and reduce treatment costs compared to hospital-based IVIG. SCIG is also associated with fewer systemic side effects, making it a potentially safer option for some patients. ^{1 3 4 9 10}

Research Team

Luigi Brunetti, PhD

Principal Investigator

Rutgers, The State University of New Jersey

Eligibility Criteria

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

I am over 18 and have been diagnosed with CIDP.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Denmark pubmed.ncbi.nlm.nih.gov

Quality of life in chronic inflammatory demyelinating polyneuropathy patients treated with subcutaneous immunoglobulin. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Subcutaneous immunoglobulin infusion: a new therapeutic option in chronic inflammatory demyelinating polyneuropathy. [2008]

3. England pubmed.ncbi.nlm.nih.gov

Subcutaneous immunoglobulin for maintenance treatment in chronic inflammatory demyelinating polyneuropathy (PATH): a randomised, double-blind, placebo-controlled, phase 3 trial. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Subcutaneous immunoglobulin as first-line therapy in treatment-naive patients with chronic inflammatory demyelinating polyneuropathy: randomized controlled trial study. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Immunomodulatory effects of intravenous and subcutaneous immunoglobulin in chronic inflammatory demyelinating polyneuropathy: An observational study. [2023]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Comparative study of subcutaneous versus intravenous IgG replacement therapy in pediatric patients with primary immunodeficiency diseases: a multicenter study in Argentina. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Impact of subcutaneous immunoglobulin on quality of life in patients with chronic inflammatory demyelinating polyneuropathy previously treated with intravenous immunoglobulin. [2021]

8. United States 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. [2017]

9. England pubmed.ncbi.nlm.nih.gov

Safety and efficacy of home-based subcutaneous immunoglobulin G in elderly patients with primary immunodeficiency diseases. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Choices in IgG replacement therapy for primary immune deficiency diseases: subcutaneous IgG vs. intravenous IgG and selecting an optimal dose. [2022]