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Active, Not Recruiting

NCT Number: NCT07177209

Describing Treatment Patterns and Creating an Updated Treatment Flow in an Ulcerative Colitis Population

Describing Treatment Patterns and Creating an Updated Treatment Flow in an Ulcerative Colitis Population

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pfizer

Tadworth, KT207NS, United Kingdom

About this study

Exploring the long-term outcomes of uncontrolled inflammation, and how does early switching to advanced treatments affect disease outcomes and inflammation control in patients with poorly controlled ulcerative colitis.

Who can participate

Healthy volunteers accepted: No

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

Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:

  • Patient enrolled in IBD registry from 2009
  • >18 years at time of diagnosis.
  • Diagnosis of Ulcerative Colitis.
  • Patient data entered during the study period.
  • Minimum duration of data post UC diagnosis (Cohort A: 6 months, Cohort B-D 6 months)

Treatment and study plan

Non-Interventional Study

Drug

As provided in real world practice

Other names: etrasimod, ozanimod, upadicitinib, filgotinib, tofacitinib, vedolizumab, guselkumab, ustekinumab, risankizumab, adalimumab, infliximab, golimumab

Primary outcomes

  1. Proportion of patients that achieve early control of inflammation on conventional therapeutics within 6-24 months of UC diagnosis.

    Time frame: 6-24 months from UC diagnosis.

    Proportion of patients that achieve early control of inflammation on conventional therapeutics within 6-24 months of UC diagnosis in the Lothian inflammatory bowel disease registry (LIBDR).

  2. Difference in proportion of patients with inadequate control of inflammation (defined as two or more episodes of raised CRP or faecal calprotectin) treated with conventional therapeutics versus treatment escalation 24 months post UC diagnosis.

    Time frame: 24 months

    Explore the differences in long term outcomes for patients with uncontrolled inflammation, treated with prolonged conventional therapeutics versus treatment escalation up to 24 months for patients with inadequate control of inflammation in the Lothian inflammatory bowel disease registry (LIBDR).

Secondary outcomes

  1. Characterise patient demography at the time of diagnosis and associated co-morbidities and extra-intestinal manifestations of interest.

    Time frame: Baseline demography.

    Characterise patient demography at the time of UC diagnosis and associated co-morbidities and extra-intestinal manifestations of interest in the Lothian inflammatory bowel disease registry (LIBDR).

  2. Map treatment use from conventional therapies to advanced therapies from time of UC diagnosis.

    Time frame: Study period is up to 1st August 2025 (2008 - 2025).

    Map treatment use from from conventional therapies to advanced therapies from time of UC diagnosis in the Lothian inflammatory bowel disease registry (LIBDR).

  3. Change from Baseline in Faecal Calprotectin (Fcal).

    Time frame: Study period is up to 1st August 2025 (2008 - 2025).

    Generate Faecal Calprotectin (Fcal) profile and longitudinal inflammatory response models for patients on conventional therapy in the Lothian inflammatory bowel disease registry (LIBDR).

  4. Change from Baseline in C-Reactive Protein (CRP).

    Time frame: Study period is up to 1st August 2025 (2008 - 2025).

    Generate C-Reactive Protein (CRP) profile and longitudinal inflammatory response models for patients on conventional therapy in the Lothian inflammatory bowel disease registry (LIBDR).

  5. Proportion of patients with colectomies from baseline.

    Time frame: Study period is up to 1st August 2025 (2008 - 2025).

    Assess colectomy rates of patients in the Lothian inflammatory bowel disease registry (LIBDR) with a relevant UC diagnosis.

  6. Proportion of patients with hospitalisations from baseline.

    Time frame: Study period is up to 1st August 2025 (2008 - 2025).

    Assess hospitalisation rates in the Lothian inflammatory bowel disease registry (LIBDR) with a relevant UC diagnosis.

  7. Proportion of patients with advanced therapy (AT) requirements with relevant UC diagnosis.

    Time frame: Study period is up to 1st August 2025 (2008 - 2025).

    Assess advanced therapy (AT) requirements in the Lothian inflammatory bowel disease registry (LIBDR).

  8. Correlate duration of uncontrolled inflammation within first 6-24 months of treatment to long term outcomes as provided in real world evidence practice.

    Time frame: Study period is up to 1st August 2025 (2008 - 2025).

    Duration of uncontrolled inflammation in the Lothian inflammatory bowel disease registry (LIBDR).

  9. Describe the effects of conventional treatment to AT's (etrasimod and tofacitinib) by change from baseline in steroid utilisation.

    Time frame: Study period is up to 1st August 2025 (2008 - 2025).

    Effects of conventional treatment to advanced therapies (AT's) in steroid utilisation in the Lothian inflammatory bowel disease registry (LIBDR).

  10. Change from baseline in control of inflammation (CRP or faecal calprotectin) in patients that are moved from conventional treatments to advanced treatments with a UC diagnosis.

    Time frame: From baseline, study period is up to 1st August 2025 (2008 - 2025).

    Describe the effects of changing from conventional treatment to advanced treatments (etrasimod and tofacitinib) in control of inflammation (CRP or faecal calprotectin) in the Lothian inflammatory bowel disease registry (LIBDR).

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

DESCRIBING PRESCRIPTION PATTERNS IN AN ULCERATIVE COLITIS POPULATION AND GENERATING AN UPDATED ULCERATIVE COLITIS TREATMENT PARADIGM

Acronym: EFFECT-1LAT

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Sep 16, 2025
Registry last updated
May 14, 2026

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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