Recruiting

NCT Number: NCT06603337

Sequencing in Inflammatory Bowel Diseases (IBD) Therapy: "the Latium Net".

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.

Recruiting

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Key information

Conditions

IBD (Inflammatory Bowel Disease) Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC CEMAD

Roma, 00168, Italy

Location status: Recruiting

Location contact

Franco Scaldaferri

CONTACT

[email protected]

+390630156876

Franco Scaldaferri

PRINCIPAL_INVESTIGATOR

About this study

Multicenter, ambispectic observational study with drug

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

Primary outcomes

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).

Study contacts

Contact information is provided by the study sponsor or research team.

Francesca Profeta, SC

CONTACT

[email protected]

+390630156876

Franco Scaldaferri, PI

CONTACT

[email protected]

+390630156876

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

Sequencing in Inflammatory Bowel Diseases (IBD) Therapy: "the Latium Net". A Key Multicenter Study

Acronym: STRIKE

Important dates

Study start: 2024
Primary completion: 2026
Study completion: 2028
First posted: Sep 19, 2024
Registry last updated: Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Recruiting