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

NCT ID: NCT05363358

Last Updated: 2023-05-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 6086 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-05-27
• Study Completion Date: 2022-12-01

Brief Summary

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.

Conditions

Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baxalta Innovations GmbH, now part of Shire

INDUSTRY

Sponsor Role: collaborator

RTI Health Solutions

OTHER

Sponsor Role: collaborator

Takeda

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

Takeda

Locations

RTI Health Solutions

Durham, North Carolina, United States

Countries

United States

Related Links

https://clinicaltrials.takeda.com/study-detail/efe528d2b61341d9?idFilter=%5B%22TAK-771-4002%22%5D

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

Other Identifiers

EUPAS46101

Identifier Type: OTHER

Identifier Source: secondary_id

TAK-771-4002

Identifier Type: -

Identifier Source: org_study_id