A Safety Study of GAMMAGARD LIQUID (GGL) in Participants With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

Evaluating the Safety of GAMMAGARD LIQUID for the Treatment of Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy

The main aim of this study is to evaluate the rates of adverse events of special interest (AESIs) (thrombotic events, acute kidney injury [AKI], and hemolytic events) among participants with CIDP initiating GGL compared with rates among participants with CIDP initiating comparator intravenous immunoglobulin (IVIG) products.

No study medicines will be provided to participants in this study.

Study Overview

• Status: Completed
• Conditions: Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

• Study Type: Observational
• Enrollment (Actual): 6086

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 12194
      • RTI Health Solutions

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants with CIDP on treatment with GGL and other IVIG products will be observed in this retrospective study.

Description

Inclusion Criteria:

• Have a minimum of 6 months of continuous enrollment in the study database with medical and pharmacy coverage before the index date. Gaps in continuous enrollment less than or equal to (<=) 31 days are permitted.
• Fulfill the Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) diagnosis algorithm on or before the index date using all available baseline data for each participant.
• Additionally, to be eligible for the Ig-naive (new-to-class) cohort, participants will be required to meet the following inclusion criterion:
• Be free of any previous recorded use of any Ig product at any point before IVIG initiation.
• To be eligible for the Ig-experienced (new-to-drug) cohort, participants will be required to meet the following inclusion criterion:
• Have any previous recorded use of an Ig product at any point before the index date.

Exclusion Criteria:

• Having claims for greater than or equal to (>=) 2 different IVIG products on the index date.

• Recorded diagnosis of any of the following conditions where Ig products are used for treatment on or before the index date

  1. Primary immunodeficiency disease (PID).
  2. Evidence of secondary immunodeficiency (SID), including hematological malignancy (e.g., diagnosis of multiple myeloma or chronic lymphocytic leukemia) or treatment with rituximab.
  3. Idiopathic thrombocytopenic purpura (ITP).
  4. Dermatomyositis or polymyositis.
  5. Systemic sclerosis/scleroderma.
  6. Myasthenia gravis.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Ig-naive (New-to-class) Cohort; Participants who initiate GGL or one of the comparator IVIG products who have no record of previous use of any Ig product (Ig naive) for at least 6 months before study initiation will be include in this cohort.
Ig-experienced (New-to-drug) Cohort; Participants who initiate either GGL or a comparator IVIG product with no record of previous use of that specific IVIG product but with previous use of any other Ig product (Ig experienced) in all available study data will be included in this cohort.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Thrombotic Events (TEs)	Thrombotic events will be reported as adverse events of special interest (AESI) and will include: acute ischemic stroke, acute myocardial infarction (AMI), and acute venous thromboembolism (VTE) events including (deep vein thrombosis (DVT), cerebral venous thrombosis (CVT), pulmonary embolism (PE).	Throughout observational period, from 01 January 2008 to 31 December 2019 (Up to 12 years)
Number of Participants With Acute kidney injury (AKI)	AKI will be reported as AESI and will include acute renal failure.	Throughout observational period, from 01 January 2008 to 31 December 2019 (Up to 12 years)
Number of Participants With Hemolytic Events (HEs)	HEs will be reported as AESI and will include nonautoimmune hemolytic anemia, acquired hemolytic anemia, ABO incompatibility reaction, or hemolytic transfusion reaction.	Throughout observational period, from 01 January 2008 to 31 December 2019 (Up to 12 years)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Anaphylaxis	Anaphylaxis will be reported as adverse event (AE) and will include anaphylactic reaction or anaphylactic shock.	Throughout observational period, from 01 January 2008 to 31 December 2019 (Up to 12 years)
Number of Participants With Transfusion-related Acute Lung Injury (TRALI)	Number of participants with TRALI will be reported.	Throughout observational period, from 01 January 2008 to 31 December 2019 (Up to 12 years)
Number of Participants With Transfusion-associated Circulatory Overload (TACO)	Number of participants with TACO will be reported.	Throughout observational period, from 01 January 2008 to 31 December 2019 (Up to 12 years)

Collaborators and Investigators

• Sponsor: Takeda
• Collaborators: RTI Health Solutions; Baxalta Innovations GmbH, now part of Shire

Publications and helpful links

Helpful Links

• To obtain more information on the study, click here/on this link

Study record dates

Study Major Dates

• Study Start (Actual): May 27, 2022
• Primary Completion (Actual): December 1, 2022
• Study Completion (Actual): December 1, 2022

Study Registration Dates

• First Submitted: May 2, 2022
• First Submitted That Met QC Criteria: May 2, 2022
• First Posted (Actual): May 5, 2022

Study Record Updates

• Last Update Posted (Actual): May 1, 2023
• Last Update Submitted That Met QC Criteria: April 28, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Immune System Diseases; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Polyneuropathies; Polyradiculoneuropathy; Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
• Other Study ID Numbers: TAK-771-4002; EUPAS46101 (Other Identifier: EUPAS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: De-identified individual participant data from this particular study will not be shared as the data are subject to contractual (or consent) provisions that prohibit transfer to third parties.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No