IBD (Inflammatory Bowel Disease)STRIKENCT06603337
Sequencing in Inflammatory Bowel Diseases (IBD) Therapy: "the Latium Net".
An observational study of IBD (Inflammatory Bowel Disease), run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
Patients with IBD, both UC and CD, who fulfil the inclusion and exclusion criteria will be included consecutively: Retrospective cohort Patients treated with IBD from January 2015 to June 2024 will be included. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- IBD (Inflammatory Bowel Disease)
- How many people
- 2,700 participants
- Where
- 1 siteItaly
- Study dates
- 18 Sep 2024to 1 Oct 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with IBD, both UC and CD, who meet the inclusion and exclusion criteria
Who may be able to join
- Age 18 to 70 years
- Patients with a previous diagnosis of CD or UC at least 3 months before baseline.
- Patients who have already failed at least one advanced (biological or small molecule) therapy for IBD and who have experienced failure to at least one mechanism of action (failure is defined as primary failure, secondary failure, or intolerance).
- Patients who have already started a new advanced therapy for IBD based on clinical practice indication (primary loss of response, secondary loss of response, intolerance to the previous drug) since at least 1 week and up to 8 weeks after starting it.
- Written informed consent certifying the willingness of the subject to participate to the study.
Who cannot join
- Age < 18 years.
- Patients with diagnosis of indeterminate colitis.
- Patients naive to advanced (biological or small molecule) therapy for IBD.
- Refusal to sign written informed consent certifying the willingness of the subject to participate to the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC CEMAD
Roma, 00168
Franco Scaldaferri, +390630156876, franco.scaldaferri@policlinicogemelli.it
Franco Scaldaferri
About this study
Official title: Sequencing in Inflammatory Bowel Diseases (IBD) Therapy: "the Latium Net". A Key Multicenter Study
Patients with IBD, both UC and CD, who fulfil the inclusion and exclusion criteria will be included consecutively:
- Retrospective cohort Patients treated with IBD from January 2015 to June 2024 will be included.
- Prospective cohort Consecutive patients with IBD who are starting, from clinical practice, new biological/small molecule therapies, failure (already exposed) to a mechanism of action (for anti TNF-alpha, more than one molecule is allowed), and who belong to the Lazio Regional Health System.
Read more
Eligible subjects will be identified among patients belonging to the IBD Unit of the Digestive Diseases Centre (CEMAD) of the Foundation and to all the other IBD Units of all the centres specified in Annex 1. Based on the number of patients referred to the clinics, we estimate 112 patients per month, the time for recruitment is 24 months.
Potential study participants will receive oral and written information about the study. Patients who agree to participate in the study will be asked to sign a written informed consent according to GCP.
Read the detailed description
Multicenter, ambispectic observational study with drug
- Conditions
- IBD (Inflammatory Bowel Disease)
- Medical subject headings
- Inflammatory Bowel Diseases
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 |
|---|---|---|
| Retrospective cohort | Patients treated with IBD from January 2015 to June 2024 will be included | |
| Prospective cohort | Consecutive patients with IBD who are starting, from clinical practice, new biologic/small molecule therapies, "failure" (already exposed) to a mechanism of action (for anti TNF-alpha, multiple molecules are allowed), and who belong to the Lazio Regional Health System will be enrolled. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Steroid-free deep remission of IBD
To evaluate the percentage of patients achieving the steroid-free deep remission of UC and CD after 12 months of different II line therapy (second sequential biological/advanced therapy).
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start18 Sep 2024
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IBD (Inflammatory Bowel Disease)Studies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe 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
- 2,700 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Franco Scaldaferri, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06603337
- Sponsor's protocol ID
- STRIKE - 6837
- Acronym
- STRIKE
- Status last verified
- Sep 2024
- First submitted
- 16 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sequencing in Inflammatory Bowel Diseases (IBD) Therapy: "the Latium Net". A Key Multicenter Study
- ClinicalTrials.gov ID
- NCT06603337
- Acronym / sponsor ID
- STRIKE / STRIKE - 6837
- Conditions
- IBD (Inflammatory Bowel Disease)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,700 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 18 Sep 2024 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 19 Sep 2024 (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.
Patients with IBD, both UC and CD, who fulfil the inclusion and exclusion criteria will be included consecutively:
- Retrospective cohort Patients treated with IBD from January 2015 to June 2024 will be included.
- Prospective cohort Consecutive patients with IBD who are starting, from clinical practice, new biological/small molecule therapies, failure (already exposed) to a mechanism of action (for anti TNF-alpha, more than one molecule is allowed), and who belong to the Lazio Regional Health System.
Eligible subjects will be identified among patients belonging to the IBD Unit of the Digestive Diseases Centre (CEMAD) of the Foundation and to all the other IBD Units of all the centres specified in Annex 1. Based on the number of patients referred to the clinics, we estimate 112 patients per month, the time for recruitment is 24 months.
Potential study participants will receive oral and written information about the study. Patients who agree to participate in the study will be asked to sign a written informed consent according to GCP.
Detailed description
Multicenter, ambispectic observational study with drug
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective cohort | – | –Patients treated with IBD from January 2015 to June 2024 will be included |
| Prospective cohort | – | –Consecutive patients with IBD who are starting, from clinical practice, new biologic/small molecule therapies, "failure" (already exposed) to a mechanism of action (for anti TNF-alpha, multiple molecules are allowed), and who belong to the Lazio Regional Health System will be enrolled. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with IBD, both UC and CD, who meet the inclusion and exclusion criteria
Key inclusion criteria (5 listed)
- Age 18 to 70 years
- Patients with a previous diagnosis of CD or UC at least 3 months before baseline.
- Patients who have already failed at least one advanced (biological or small molecule) therapy for IBD and who have experienced failure to at least one mechanism of action (failure is defined as primary failure, secondary failure, or intolerance).
- Patients who have already started a new advanced therapy for IBD based on clinical practice indication (primary loss of response, secondary loss of response, intolerance to the previous drug) since at least 1 week and up to 8 weeks after starting it.
- Written informed consent certifying the willingness of the subject to participate to the study.
Key exclusion criteria (4 listed)
- Age < 18 years.
- Patients with diagnosis of indeterminate colitis.
- Patients naive to advanced (biological or small molecule) therapy for IBD.
- Refusal to sign written informed consent certifying the willingness of the subject to participate to the study.
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
Steroid-free deep remission of IBD
Time frame: 24 months
To evaluate the percentage of patients achieving the steroid-free deep remission of UC and CD after 12 months of different II line therapy (second sequential biological/advanced therapy).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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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.
Franco Scaldaferri principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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 IBD (Inflammatory Bowel Disease), run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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 4 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: looking for participants now, as of the sponsor's last update on 19 Sep 2024. 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Franco Scaldaferri, PI (+390630156876, franco.scaldaferri@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Steroid-free deep remission of IBD (time frame: 24 months). 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 19 Sep 2024; AzTrials last refreshed its copy on 6 Nov 2026.