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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

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ClinicalTrials.gov Identifier: NCT02922192
Recruitment Status : Unknown
Verified September 2016 by Biologics & Biosimilars Collective Intelligence Consortium.
Recruitment status was:  Active, not recruiting
First Posted : October 4, 2016
Last Update Posted : October 7, 2016
Sponsor:
Collaborators:
HealthCore, Inc.
Aetna, Inc.
University of Alabama; Rheumatologist and Healthcare Research
AbbVie
Amgen
Boehringer Ingelheim
Kaiser Permanente
Harvard Pilgrim Health Care
Merck Sharp & Dohme Corp.
Momenta Pharmaceuticals, Inc.
Pfizer
University of Pittsburgh
Information provided by (Responsible Party):
Biologics & Biosimilars Collective Intelligence Consortium

Brief 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.


Condition or disease Intervention/treatment
Rheumatoid Arthritis Inflammatory Bowel Disease Psoriasis Psoriatic Arthritis Ankylosing Spondylitis Drug: TNF-α antagonists, non-TNFs, DMARD non-biologics

Detailed 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.

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Study Type : Observational
Estimated Enrollment : 100000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Incidence of Hospitalizations for Serious Infections in Patients Receiving Biologic Anti-Inflammatories for Rheumatologic, Psoriatic, and Gastrointestinal Conditions: A Descriptive Analysis
Study Start Date : January 2006
Actual Primary Completion Date : September 2015
Estimated Study Completion Date : January 2017


Group/Cohort Intervention/treatment
Rheumatoid arthritis (RA)
With exposure to TNF-α antagonists, non-TNFs, DMARD non-biologics
Drug: TNF-α antagonists, non-TNFs, DMARD non-biologics
Exposure to TNF- α antagonists, non-TNF- α antagonists, oral DMARD, or non-biologic agents.
Other Name: 18 drug names in TNF, non-TNFs, DMARD non-biologics

Inflammatory bowel disease (IBD)
With exposure to TNF-α antagonists, non-TNFs, DMARD non-biologics
Drug: TNF-α antagonists, non-TNFs, DMARD non-biologics
Exposure to TNF- α antagonists, non-TNF- α antagonists, oral DMARD, or non-biologic agents.
Other Name: 18 drug names in TNF, non-TNFs, DMARD non-biologics

Psoriatic conditions
Patients with a psoriasis, psoriatic arthritis, ankylosing spondylitis with exposure to TNF-α antagonists, non-TNFs, DMARD non-biologics
Drug: TNF-α antagonists, non-TNFs, DMARD non-biologics
Exposure to TNF- α antagonists, non-TNF- α antagonists, oral DMARD, or non-biologic agents.
Other Name: 18 drug names in TNF, non-TNFs, DMARD non-biologics




Primary Outcome Measures :
  1. Incidence of hospitalization for serious infections [ Time Frame: Anticipated completion January 2017 ]
    Primary: Incidence of hospitalization for serious infections (i.e., infections of the respiratory tract, skin and soft tissue, genito-urinary tract, gastrointestinal tract, central nervous system, septicemia/sepsis).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Study subjects are selected according to inclusion criteria from a source population within the Sentinel Common Data Mode v5.0.1 (SCDM). The SCDM includes over 100 million individuals with 358 million person-years of observation time who are covered by Aetna, Anthem, Group Health Cooperative, Harvard Pilgrim Health Care, and HealthPartners. The time period assessed will be 1/1/2006 - 9/30/2015.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02922192


Sponsors and Collaborators
Biologics & Biosimilars Collective Intelligence Consortium
HealthCore, Inc.
Aetna, Inc.
University of Alabama; Rheumatologist and Healthcare Research
AbbVie
Amgen
Boehringer Ingelheim
Kaiser Permanente
Harvard Pilgrim Health Care
Merck Sharp & Dohme Corp.
Momenta Pharmaceuticals, Inc.
Pfizer
University of Pittsburgh
Investigators
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Principal Investigator: Kevin Haynes, PharmD, MSCE Anthem HealthCore, Inc.

Additional Information:
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Responsible Party: Biologics & Biosimilars Collective Intelligence Consortium
ClinicalTrials.gov Identifier: NCT02922192    
Other Study ID Numbers: BBCIC-Anti-inflammatory
First Posted: October 4, 2016    Key Record Dates
Last Update Posted: October 7, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: BBCIC Charter requires transparency and publication
Keywords provided by Biologics & Biosimilars Collective Intelligence Consortium:
Anti-inflammatory
Biologics
Biologic and Biosimilars Collective Intelligence Consortium
BBCIC
Additional relevant MeSH terms:
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Spondylitis
Arthritis
Arthritis, Psoriatic
Spondylitis, Ankylosing
Inflammatory Bowel Diseases
Psoriasis
Infection
Joint Diseases
Musculoskeletal Diseases
Skin Diseases, Papulosquamous
Skin Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Bone Diseases, Infectious
Bone Diseases
Spinal Diseases
Spondylarthropathies
Spondylarthritis
Ankylosis
Antirheumatic Agents
Anti-Inflammatory Agents