Last updated: 07/31/2020 02:50:05

Ulcerative Colitis and Crohn’s Disease: Resource Utilization and costs after initiation of biologics

GSK study ID
207449
See study documents
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Ulcerative Colitis and Crohn’s Disease: Resource Utilization and costs after initiation of biologics
Trial description: Crohn’s disease (CD) and Ulcerative colitis (UC) are the two main forms of Inflammatory Bowel Disease (IBD), a chronic, inflammatory condition of the digestive system. There are limited real world data on healthcare resource utilization and costs for subjects on specific biologic therapies for IBD. This retrospective study aims to address these gaps. The study will use data from a US administrative claims database which will be assessed using the Instant Health Data (IHD) tool. The study will include subjects with at least one diagnosis of UC or CD and those who are on therapy for at least 1 year.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Number of subjects for healthcare resource utilization (Intention to treat (ITT) analyses)

Timeframe: Baseline (12 months prior) and 12 months after the initial dose

Evaluation of Mean counts and median counts per subject (ITT analyses)

Timeframe: Baseline (12 months prior to) and 12 months after the initial dose

Evaluation of annual mean expenditure per subject: (ITT analyses)

Timeframe: Baseline (12 months prior to) and 12 months after the initial dose

Number of subjects for healthcare resource utilization (As-treated analyses)

Timeframe: Baseline (12 months prior to) and 12 months after the initial dose

Evaluation of Mean counts and median counts per subject (as-treated analyses)

Timeframe: Baseline (12 months prior to) and 12 months after the initial dose

Evaluation of annual mean expenditure per subject (as-treated analyses)

Timeframe: Baseline (12 months prior to) and 24 months after the initial dose

Secondary outcomes:

Number of subjects for healthcare resource utilization: (ITT analyses)

Timeframe: Baseline (12 months prior to) and up to 24 months after the initial dose

Evaluation of Mean counts and median counts per subject: (ITT analyses)

Timeframe: Baseline (12 months prior to) and up to 24 months after the initial dose

Evaluation of annual mean expenditure per subject: (ITT analyses)

Timeframe: Baseline (12 months prior to) and up to 24 months after the initial dose

Number of subjects for healthcare resource utilization (As-treated analyses)

Timeframe: Baseline (12 months prior to) and up to 24 months after the initial dose

Evaluation of Mean counts and median counts per subject (as-treated analyses)

Timeframe: Baseline (12 months prior to) and up to 24 months after the initial dose

Evaluation of annual mean expenditure per subject (as-treated analyses)

Timeframe: Baseline (12 months prior to) and up to 24 months after the initial dose

Interventions:
  • Drug: Biologic therapy
    • Enrollment:
    0
    Primary completion date:
    2017-31-10
    Observational study model:
    Cohort
    Time perspective:
    Retrospective
    Clinical publications:
    S. Perera, S. Yang, M. Stott-Miller. J. Brady.Analysis of Healthcare Resource Utilization and Costs after the Initiation of Biologic Treatment in Patients with Ulcerative Colitis and Crohn’s Disease.J Health Econ Outcomes Res.2018;6(1):96-112
    Medical condition
    Inflammatory Bowel Diseases
    Product
    GSK2982772
    Collaborators
    Not applicable
    Study date(s)
    November 2016 to October 2017
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    none
    • Separately for UC and CD, subjects that meet all of the following criteria will be extracted from the Commercial and Medicare databases:
    • Initiation of a biologic between January 1, 2010 and December 31, 2014. Date of initiation will be set as the index date.
    • Administration of a biologic during the Baseline period.
    • Diagnosis of cancer at any time during the study period.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Separately for UC and CD, subjects that meet all of the following criteria will be extracted from the Commercial and Medicare databases:
    • Initiation of a biologic between January 1, 2010 and December 31, 2014. Date of initiation will be set as the index date.
    • At least 12 months of continuous enrolment with medical and pharmacy benefits prior to the index date (Baseline period).
    • At least 12 months of continuous enrolment with medical and pharmacy benefits after the index date.
    • At least one diagnosis of UC or CD during the Baseline period or on index date.
    • Subjects who have claims for both CD and UC during the Baseline period will be identified, and disease assignment will be made based on the majority of the most recent 3 claims with a UC or CD diagnosis code in the Baseline period or on index.
    • At least 18 years of age as of the index date.
    Exclusion criteria:
    • Administration of a biologic during the Baseline period.
    • Diagnosis of cancer at any time during the study period.

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Protocol
    Available language(s): English
    Download document(s)
    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    2017-31-10
    Actual study completion date
    2017-31-10

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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