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Incidence of Hospitalizations for Serious Infections in Patients Receiving Biologic Anti-Inflammatories for Rheumatologic, Psoriatic, and Gastrointestinal Conditions: A Descriptive Analysis

NCT02922192 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 90360

Last updated 2023-07-27

No results posted yet for this study

Summary

Purpose:

With the existing biologic anti-inflammatory product patents expiring and the FDA approval of new biosimilar and innovator biologics, patients with rheumatologic (RA), psoriatic (PsO-PsA-AS), and gastrointestinal (GI) conditions will have additional therapeutic options. This observational study will describe the patient characteristics of new users of Tumor Necrosis Factor-α (TNF) antagonists, non-TNF- α antagonists, oral DMARD, and non-biologic agents. It will describe in the treatment cohorts outcomes of serious infections that require hospitalization. The BBCIC will use the findings from this descriptive analysis to design a comparative study evaluating the real-world effectiveness and safety of biosimilar and innovator anti-inflammatory biologics.

Conditions

Interventions

DRUG

TNF-α antagonists, non-TNFs, DMARD non-biologics

Exposure to TNF- α antagonists, non-TNF- α antagonists, oral DMARD, or non-biologic agents.

Sponsors & Collaborators

  • HealthCore, Inc.

    collaborator INDUSTRY

  • Aetna, Inc.

    collaborator INDUSTRY

  • University of Alabama; Rheumatologist and Healthcare Research

    collaborator UNKNOWN

  • AbbVie

    collaborator INDUSTRY

  • Amgen

    collaborator INDUSTRY

  • Boehringer Ingelheim

    collaborator INDUSTRY

  • Kaiser Permanente

    collaborator OTHER

  • Harvard Pilgrim Health Care

    collaborator OTHER

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • Momenta Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • Pfizer

    collaborator INDUSTRY

  • University of Pittsburgh

    collaborator OTHER

  • Biologics & Biosimilars Collective Intelligence Consortium

    lead OTHER

Principal Investigators

  • Kevin Haynes, PharmD, MSCE · Anthem HealthCore, Inc.

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-01
Primary Completion
2019-03-31
Completion
2020-06-01

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02922192 on ClinicalTrials.gov