Clinical trial NCT05363358: A Safety Study of GAMMAGARD LIQUID (GGL) in Participants With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
Official title: Evaluating the Safety of GAMMAGARD LIQUID for the Treatment of Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
Lead sponsor: Takeda
Sponsor class: INDUSTRY
Collaborators: name: Baxalta Innovations GmbH, now part of Shire
name: RTI Health Solutions
First posted: 2022-05-05
Enrollment: 6086
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.


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.

Primary outcomes:
measure: Number of Participants With Thrombotic Events (TEs)
timeFrame: Throughout observational period, from 01 January 2008 to 31 December 2019 (Up to 12 years)
measure: Number of Participants With Acute kidney injury (AKI)
timeFrame: Throughout observational period, from 01 January 2008 to 31 December 2019 (Up to 12 years)
measure: Number of Participants With Hemolytic Events (HEs)
timeFrame: Throughout observational period, from 01 January 2008 to 31 December 2019 (Up to 12 years)
Secondary outcomes:
measure: Number of Participants With Anaphylaxis
timeFrame: Throughout observational period, from 01 January 2008 to 31 December 2019 (Up to 12 years)
measure: Number of Participants With Transfusion-related Acute Lung Injury (TRALI)
timeFrame: Throughout observational period, from 01 January 2008 to 31 December 2019 (Up to 12 years)
measure: Number of Participants With Transfusion-associated Circulatory Overload (TACO)
timeFrame: Throughout observational period, from 01 January 2008 to 31 December 2019 (Up to 12 years)
Other outcomes:
Locations:
city: Durham
country: United States
facility: RTI Health Solutions
state: North Carolina
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: