Overview

This trial is active, not recruiting.

Conditions rheumatoid arthritis, inflammatory bowel disease, psoriasis, psoriatic arthritis, ankylosing spondylitis
Treatment tnf-α antagonists, non-tnfs, dmard non-biologics
Sponsor Biologics & Biosimilars Collective Intelligence Consortium
Collaborator HealthCore, Inc.
Start date January 2006
End date September 2015
Trial size 100000 participants
Trial identifier NCT02922192, BBCIC-Anti-inflammatory

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective retrospective
Arm
With exposure to TNF-α antagonists, non-TNFs, DMARD non-biologics
tnf-α antagonists, non-tnfs, dmard non-biologics 18 drug names in TNF, non-TNFs, DMARD non-biologics
Exposure to TNF- α antagonists, non-TNF- α antagonists, oral DMARD, or non-biologic agents.
With exposure to TNF-α antagonists, non-TNFs, DMARD non-biologics
tnf-α antagonists, non-tnfs, dmard non-biologics 18 drug names in TNF, non-TNFs, DMARD non-biologics
Exposure to TNF- α antagonists, non-TNF- α antagonists, oral DMARD, or non-biologic agents.
Patients with a psoriasis, psoriatic arthritis, ankylosing spondylitis with exposure to TNF-α antagonists, non-TNFs, DMARD non-biologics
tnf-α antagonists, non-tnfs, dmard non-biologics 18 drug names in TNF, non-TNFs, DMARD non-biologics
Exposure to TNF- α antagonists, non-TNF- α antagonists, oral DMARD, or non-biologic agents.

Primary Outcomes

Measure
Incidence of hospitalization for serious infections
time frame: Anticipated completion January 2017

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Individuals with baseline period of 365 days with continuous medical and pharmacy coverage preceding the first prescription fill - new and users of the following exposures - TNF -α antagonists (including adalimumab, certolizumab, etanercept [not included for IBD], golimumab, infliximab, and natalizumab [IBD only]) - Non-TNF-alpha antagonist biologics in RA only (abatacept, rituximab, and tocilizumab) - Non-biologic medications (after any use of methotrexate in the previous year includes RA: hydroxychloroquine, leflunomide, or sulfasalazine; IBD: 6- mercaptopurine or azathioprine; PsO-PsA-AS: methotrexate, leflunomide, or sulfasalazine). Exclusion Criteria: - During baseline 365 days, any patient with - Active cancer or a history of non-melanoma cancer* - Any immunocompromising conditions (organ transplantation, HIV, and advanced kidney/liver disease)* - *if occur during the follow-up period, patients also will be censored. - During baseline 183 days, any patient with hospitalization for any infection

Additional Information

Official title Incidence of Hospitalizations for Serious Infections in Patients Receiving Biologic Anti-Inflammatories for Rheumatologic, Psoriatic, and Gastrointestinal Conditions: A Descriptive Analysis
Principal investigator Kevin Haynes, PharmD, MSCE
Description Additional information: To most effectively interpret results from this descriptive analysis it is important to consider that this protocol was not designed to support a hypothesis. This information is being provided to the public in the interest of transparency and for demonstrating the BBCIC's Distributed Research Network's (DRN) ability to define exposures, outcomes, covariates and confounders. When published, the report will caution that the protocol does not support any ability to compare safety or effectiveness but instead is to be used only to explore the feasibility of future, more detailed comparative analyses and to better understand the capabilities of the BBCIC project. Further, the report will caution that information from this protocol should not affect use of the medical products described in any way and the fact that the BBCIC is performing this descriptive analysis in no way suggests there is a safety or effectiveness issue with any of the products described.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Biologics & Biosimilars Collective Intelligence Consortium.