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
Finalized
Finalized
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
Observational study model:
Cohort
Primary completion date:
2017-31-10
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)

No location data available.

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
Finalized
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
Participate in clinical trial
Access to clinical trial data by researchers
Visit website