Rheumatoid ArthritisNCT02922192
Incidence of Hospitalizations for Serious Infections in Patients Receiving Biologic Anti-Inflammatories for Rheumatologic, Psoriatic, and Gastrointestinal Conditions: A Descriptive Analysis
An observational study of Rheumatoid Arthritis and Inflammatory Bowel Disease, run by Biologics & Biosimilars Collective Intelligence Consortium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis, Inflammatory Bowel Disease, Psoriasis
- What is being tested?
- TNF-α antagonists, non-TNFs, DMARD non-biologics
- Type of treatment
- Pill or oral medicine
- How many people
- 90,360 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2012to 1 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- 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
About this study
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.
Read the 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.
- Conditions
- Rheumatoid Arthritis, Inflammatory Bowel Disease, Psoriasis, Psoriatic Arthritis, Ankylosing Spondylitis
- Being tested
- TNF-α antagonists, non-TNFs, DMARD non-biologics
- Keywords
- Anti-inflammatory, Biologics, Biologic and Biosimilars Collective Intelligence Consortium, BBCIC
- Medical subject headings
- Arthritis, Rheumatoid, Inflammatory Bowel Diseases, Psoriasis, Arthritis, Psoriatic, Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TNF-α antagonists, non-TNFs, DMARD non-biologicsDrug
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| Rheumatoid arthritis (RA) | With exposure to TNF-α antagonists, non-TNFs, DMARD non-biologics Receives: Drug: TNF-α antagonists, non-TNFs, DMARD non-biologics | |
| Inflammatory bowel disease (IBD) | With exposure to TNF-α antagonists, non-TNFs, DMARD non-biologics Receives: Drug: TNF-α antagonists, 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 Receives: Drug: TNF-α antagonists, non-TNFs, DMARD non-biologics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of hospitalization for serious infections
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).
Measured: Anticipated completion January 2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2016 (estimated)
- Study start1 Jan 2012
- Primary completion31 Mar 2019
- Study completion1 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 90,360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biologics & Biosimilars Collective Intelligence Consortium
- Sponsor type
- University, hospital or other
- 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 LLC, Momenta Pharmaceuticals, Inc., Pfizer, University of Pittsburgh
- Responsible party
- Sponsor
- Investigators
- Kevin Haynes, PharmD, MSCE, Principal investigator, Anthem HealthCore, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02922192
- Sponsor's protocol ID
- BBCIC-Anti-inflammatory
- Status last verified
- Jul 2023
- First submitted
- 28 Sep 2016
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: BBCIC Charter requires transparency and publication
Publications
Mendelsohn AB, Nam YH, Marshall J, McDermott CL, Kochar B, Kappelman MD, Brown JS, Lockhart CM. Utilization patterns and characteristics of users of biologic anti-inflammatory agents in a large, US commercially insured population. Pharmacol Res Perspect. 2021 Feb;9(1):e00708. doi: 10.1002/prp2.708.
PubMed 33372729
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Hospitalizations for Serious Infections in Patients Receiving Biologic Anti-Inflammatories for Rheumatologic, Psoriatic, and Gastrointestinal Conditions: A Descriptive Analysis
- ClinicalTrials.gov ID
- NCT02922192
- Acronym / sponsor ID
- BBCIC-Anti-inflammatory
- Conditions
- Rheumatoid Arthritis, Inflammatory Bowel Disease, Psoriasis, Psoriatic Arthritis, Ankylosing Spondylitis
- Keywords
- Anti-inflammatory, Biologics, Biologic and Biosimilars Collective Intelligence Consortium, BBCIC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90,360 participants (actual)
- Lead sponsor
- Biologics & Biosimilars Collective Intelligence ConsortiumUniversity, hospital or other
- 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 LLC, Momenta Pharmaceuticals, Inc., Pfizer, University of Pittsburgh
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 4 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Rheumatoid arthritis (RA) | – | Drug: TNF-α antagonists, non-TNFs, DMARD non-biologicsWith exposure to TNF-α antagonists, non-TNFs, DMARD non-biologics |
| Inflammatory bowel disease (IBD) | – | Drug: TNF-α antagonists, non-TNFs, DMARD non-biologicsWith exposure to TNF-α antagonists, non-TNFs, DMARD non-biologics |
| Psoriatic conditions | – | Drug: TNF-α antagonists, non-TNFs, DMARD non-biologicsPatients with a psoriasis, psoriatic arthritis, ankylosing spondylitis with exposure to TNF-α antagonists, non-TNFs, DMARD non-biologics |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- During baseline 365 days, any patient with
- During baseline 183 days, any patient with hospitalization for any infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TNF-α antagonists, non-TNFs, DMARD non-biologicsAlso: 18 drug names in TNF, non-TNFs, DMARD non-biologicsExposure to TNF- α antagonists, non-TNF- α antagonists, oral DMARD, or non-biologic agents. | Drug | Inflammatory bowel disease (IBD), Psoriatic conditions, Rheumatoid arthritis (RA) |
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Results publication: PubMed 33372729Mendelsohn AB, Nam YH, Marshall J, McDermott CL, Kochar B, Kappelman MD, Brown JS, Lockhart CM. Utilization patterns and characteristics of users of biologic anti-inflammatory agents in a large, US commercially insured population. Pharmacol Res Perspect. 2021 Feb;9(1):e00708. doi: 10.1002/prp2.708.
- The Biologics and Biosimilars Collective Intelligence Consortium (BBCIC) was established in 2015 to address anticipated needs for post-marketed evidence generation for novel biologics, their corresponding biosimilars and other related products.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. BBCIC Charter requires transparency and publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin Haynes, PharmD, MSCE principal investigator
Anthem HealthCore, Inc.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis and Inflammatory Bowel Disease, run by Biologics & Biosimilars Collective Intelligence Consortium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of hospitalization for serious infections (time frame: Anticipated completion January 2017). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02922192, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.