Inflammatory DiseasePROTECT-IMIDNCT05696106
Risk of Incident IMID in Patients Treated With Biologics and Immunosuppressive Drugs for a Single IMID
An observational study of Inflammatory Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Individuals with immune-mediated inflammatory diseases (IMIDs) are at increased risk of developing other IMIDs, possibly through shared pathogenic inflammatory pathways, and up to 25% of patients with IMIDs have at least one other IMID. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Disease
- How many people
- 750,000 participants
- Where
- 1 siteFrance
- Study dates
- 2 Apr 2023to 15 Jan 2024
- 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: All the individual subtypes of second IMIDs included in the primary outcome definition, for which incidence during follow-up will be sufficient.
Who may be able to join
- Aged 18 years or older at index date (≥ 18 years)
- Identified with a first IMID diagnosis prior to index date, among IBD (Crohn's disease and ulcerative colitis), inflammatory rheumatic diseases (rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis), or inflammatory skin diseases (psoriasis).
Who cannot join
- Patients with a diagnosis of more than one of the IMIDs of interest at index date.
- Patients exposed to biologics or immunosuppressive drugs of interest in 2006 or 2007.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Risk of Incident Immune-mediated Inflammatory Diseases (IMID) in Patients Treated With Biologics and Immunosuppressive Drugs for a Single IMID
Individuals with immune-mediated inflammatory diseases (IMIDs) are at increased risk of developing other IMIDs, possibly through shared pathogenic inflammatory pathways, and up to 25% of patients with IMIDs have at least one other IMID. Additionally, a concomitant diagnosis of a second IMID is associated with a higher burden of disease, which usually requires therapeutic escalation. Thus, this risk should be taken into account in the benefit-risk balance of IMIDs-related treatment. While the risk of other major adverse events, such as serious infection, cancer, and cardiovascular events, have been assessed in patients exposed to immunosuppressive drugs and biologics, the impact of these drugs on the risk of incident IMIDs remains largely unknown.
The main aim of this study is to assess the risk of an incident second IMID in patients starting biologics including anti-TNF and immunosuppressive drugs including small molecules for a first IMID (either inflammatory bowel disease, inflammatory rheumatic diseases, or cutaneous psoriasis).
Read the detailed description
This is a retrospective cohort study including all patients identified with a first IMID between 2008 and 2020 based on the French administrative healthcare databases (Système National des Données de Santé). Index date will be the date of initiation of the first treatment of interest within the observation period.
Primary objective
- To assess the risk of an incident second IMID in patients starting biologics including anti-TNF and immunosuppressive drugs including small molecules for a first IMID (either IBD, inflammatory rheumatic diseases, or cutaneous psoriasis)
Secondary objectives
- To describe the subtype of incident second IMIDs in patients starting biologics and immunosuppressive drugs for a first IMID and the related burden of disease.
- To assess the risk of an incident second IMID in patients starting biologics and immunosuppressive drugs for a first IMID, according to each drug class:
- Conventional immunosuppressive drug including immunomodulators (thiopurines) and csDMARDs (methotrexate)
- Anti-TNF (infliximab, adalimumab, golimumab, certolizumab, etanercept)
- Biologics targeting the IL-12/IL-23 pathways (ustekinumab, risankizumab, guselkumab)
- Biologics targeting the IL-6 pathways (tocilizumab, sarilumab)
- Biologics targeting the IL-17 pathways (secukinumab, ixékizumab, brodalumab)
- Biologics targeting cell adhesion, anti-integrins (vedolizumab)
- JAK inhibitors (tofacitinib, baricitinib, upadacitinib)
- To assess the risk of an incident second IMID in patients with a first incident IMID (after January 1st, 2008) and starting biologics and immunosuppressive drugs for this IMID.
- To assess the risk of an incident second IMID in patients starting biologics and immunosuppressive drugs for a first IMID:
- By type of first IMID
- By type of second IMID
- Conditions
- Inflammatory Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients initiating a biologic or immunosuppressive drug | Patients initiating a biologic or immunosuppressive drug including small molecules for a first IMID (either IBD, inflammatory rheumatic diseases, or cutaneous psoriasis) * Conventional immunosuppressive drug including immunomodulators (thiopurines) and csDMARDs (methotrexate) * Anti-TNF (infliximab, adalimumab, golimumab, certolizumab, etanercept) * Biologics targeting the IL-12/IL-23 pathways (ustekinumab, risankizumab, guselkumab) * Biologics targeting the IL-6 pathways (tocilizumab, sarilumab) * Biologics targeting the IL-17 pathways (secukinumab, ixékizumab, brodalumab) * Biologics targeting cell adhesion, anti-integrins (vedolizumab) * JAK inhibitors (tofacitinib, baricitinib, upadacitinib) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of incident second IMID
The primary outcome will be defined as the first occurrence of incident IMIDs after cohort entry, including: (Crohn's disease and ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis, systemic lupus erythematosus, drug-induced lupus, sarcoidosis, vasculitis, crohn's disease and ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis, systemic lupus erythematosus, drug-induced lupus, sarcoidosis, vasculitis). Identification algorithms used for inclusion criteria will be similarly used to assess outcomes. We performed a feasibility analysis by assessing the identification method of IBD diagnosis in patients previously diagnosed with either rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, or psoriasis. This analysis was based on a cohort of patients diagnosed with IBD between 1st January, 2008 and December 31st, 2018
Measured: between 1st January, 2008 and December 31st, 2018
Secondary outcomes (1)
All the individual subtypes of second IMIDs included in the primary outcome definition
All the individual subtypes of second IMIDs included in the primary outcome definition, for which incidence during follow-up will be sufficient.
Burden of disease will be based on healthcare resource utilization, notably hospitalizations, emergency department visits, outpatient visits, and drug deliveries.
Measured: between 1st January, 2008 and December 31st, 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2023
- Study start2 Apr 2023
- Primary completion15 Dec 2023 (estimated)
- Study completion15 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory DiseaseStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Other
- Enrolment
- 750,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05696106
- Sponsor's protocol ID
- PHRC-21-0113
- Acronym
- PROTECT-IMID
- Status last verified
- Apr 2023
- First submitted
- 3 Jan 2023
- Last updated
- 24 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk of Incident Immune-mediated Inflammatory Diseases (IMID) in Patients Treated With Biologics and Immunosuppressive Drugs for a Single IMID
- ClinicalTrials.gov ID
- NCT05696106
- Acronym / sponsor ID
- PROTECT-IMID / PHRC-21-0113
- Conditions
- Inflammatory Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 750,000 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 2 Apr 2023 (actual)
- Primary completion
- 15 Dec 2023 (estimated)
- Study completion
- 15 Jan 2024 (estimated)
- First posted
- 25 Jan 2023 (actual)
- 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.
Individuals with immune-mediated inflammatory diseases (IMIDs) are at increased risk of developing other IMIDs, possibly through shared pathogenic inflammatory pathways, and up to 25% of patients with IMIDs have at least one other IMID. Additionally, a concomitant diagnosis of a second IMID is associated with a higher burden of disease, which usually requires therapeutic escalation. Thus, this risk should be taken into account in the benefit-risk balance of IMIDs-related treatment. While the risk of other major adverse events, such as serious infection, cancer, and cardiovascular events, have been assessed in patients exposed to immunosuppressive drugs and biologics, the impact of these drugs on the risk of incident IMIDs remains largely unknown.
The main aim of this study is to assess the risk of an incident second IMID in patients starting biologics including anti-TNF and immunosuppressive drugs including small molecules for a first IMID (either inflammatory bowel disease, inflammatory rheumatic diseases, or cutaneous psoriasis).
Detailed description
This is a retrospective cohort study including all patients identified with a first IMID between 2008 and 2020 based on the French administrative healthcare databases (Système National des Données de Santé). Index date will be the date of initiation of the first treatment of interest within the observation period.
Primary objective
- To assess the risk of an incident second IMID in patients starting biologics including anti-TNF and immunosuppressive drugs including small molecules for a first IMID (either IBD, inflammatory rheumatic diseases, or cutaneous psoriasis)
Secondary objectives
- To describe the subtype of incident second IMIDs in patients starting biologics and immunosuppressive drugs for a first IMID and the related burden of disease.
- To assess the risk of an incident second IMID in patients starting biologics and immunosuppressive drugs for a first IMID, according to each drug class:
- Conventional immunosuppressive drug including immunomodulators (thiopurines) and csDMARDs (methotrexate)
- Anti-TNF (infliximab, adalimumab, golimumab, certolizumab, etanercept)
- Biologics targeting the IL-12/IL-23 pathways (ustekinumab, risankizumab, guselkumab)
- Biologics targeting the IL-6 pathways (tocilizumab, sarilumab)
- Biologics targeting the IL-17 pathways (secukinumab, ixékizumab, brodalumab)
- Biologics targeting cell adhesion, anti-integrins (vedolizumab)
- JAK inhibitors (tofacitinib, baricitinib, upadacitinib)
- To assess the risk of an incident second IMID in patients with a first incident IMID (after January 1st, 2008) and starting biologics and immunosuppressive drugs for this IMID.
- To assess the risk of an incident second IMID in patients starting biologics and immunosuppressive drugs for a first IMID:
- By type of first IMID
- By type of second IMID
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients initiating a biologic or immunosuppressive drug | – | –Patients initiating a biologic or immunosuppressive drug including small molecules for a first IMID (either IBD, inflammatory rheumatic diseases, or cutaneous psoriasis) * Conventional immunosuppressive drug including immunomodulators (thiopurines) and csDMARDs (methotrexate) * Anti-TNF (infliximab, adalimumab, golimumab, certolizumab, etanercept) * Biologics targeting the IL-12/IL-23 pathways (ustekinumab, risankizumab, guselkumab) * Biologics targeting the IL-6 pathways (tocilizumab, sarilumab) * Biologics targeting the IL-17 pathways (secukinumab, ixékizumab, brodalumab) * Biologics targeting cell adhesion, anti-integrins (vedolizumab) * JAK inhibitors (tofacitinib, baricitinib, upadacitinib) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All the individual subtypes of second IMIDs included in the primary outcome definition, for which incidence during follow-up will be sufficient.
Key inclusion criteria (2 listed)
- Aged 18 years or older at index date (≥ 18 years)
- Identified with a first IMID diagnosis prior to index date, among IBD (Crohn's disease and ulcerative colitis), inflammatory rheumatic diseases (rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis), or inflammatory skin diseases (psoriasis).
Key exclusion criteria (2 listed)
- Patients with a diagnosis of more than one of the IMIDs of interest at index date.
- Patients exposed to biologics or immunosuppressive drugs of interest in 2006 or 2007.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Occurrence of incident second IMID
Time frame: between 1st January, 2008 and December 31st, 2018
The primary outcome will be defined as the first occurrence of incident IMIDs after cohort entry, including: (Crohn's disease and ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis, systemic lupus erythematosus, drug-induced lupus, sarcoidosis, vasculitis, crohn's disease and ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis, systemic lupus erythematosus, drug-induced lupus, sarcoidosis, vasculitis). Identification algorithms used for inclusion criteria will be similarly used to assess outcomes. We performed a feasibility analysis by assessing the identification method of IBD diagnosis in patients previously diagnosed with either rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, or psoriasis. This analysis was based on a cohort of patients diagnosed with IBD between 1st January, 2008 and December 31st, 2018
1 secondary outcome
All the individual subtypes of second IMIDs included in the primary outcome definition
Time frame: between 1st January, 2008 and December 31st, 2018
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 24 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
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?
Occurrence of incident second IMID (time frame: between 1st January, 2008 and December 31st, 2018). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Apr 2023.