Ulcerative ColitisREAD-UCNCT04156672
Real World Study Of The Clinical Profile And Treatment Outcomes Of Advanced Therapies For Ulcerative Colitis In Portugal
An observational study of Ulcerative Colitis, run by Pfizer.
Trial summary
This study aims to characterize the Portuguese population of patients with moderate-to-severe UC receiving advanced therapies, by describing clinical and sociodemographic characteristics, and remission outcomes . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 6 Oct 2020to 30 Apr 2021
- 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: Patients followed at Portuguese gastroenterology services, presenting moderate-to-severe Ulcerative Colitis and receiving advanced therapies (i.e., anti-TNF or anti-integrin or JAK inhibitors drugs) for at least 16 weeks.
Who may be able to join
- Aged at least 18 years old
- Diagnosed with Ulcerative Colitis, confirmed by a gastroenterologist
- Treated with anti-TNF or anti-integrin or JAK inhibitors drugs for at least 16 weeks
- Followed at one of the participating centers when initiating and during the current treatment
- Signed informed consent
Who cannot join
- Treated with anti-TNF or anti-integrin or JAK inhibitors drugs at induction phase
- Enrolled in randomized clinical trials or other experimental studies in the last 12 months prior to initiation of advanced therapy
About this study
Official title: REal-world Study of the Clinical Profile and Treatment Outcomes of Advanced Therapies for Ulcerative Colitis in Portugal-READ UC
This study aims to characterize the Portuguese population of patients with moderate-to-severe UC receiving advanced therapies, by describing clinical and sociodemographic characteristics, and remission outcomes . The clinical, biochemical, endoscopic, and histological outcomes will also be described, as well as frequency of selected EIM, comorbidities and the uptake of preventive care measures and hospitalizations .
- Conditions
- Ulcerative Colitis
- Medical subject headings
- Colitis, Ulcerative
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants achieving remission at study appointment, defined as both symptomatic and faecal biomarker remission
- percentage of participants with both a Mayo stool frequency subscore of 0 or 1 and Mayo rectal bleeding subscore of 0 , and a Faecal Calprotectin concentrations < to the cut-off concentration of 150-200 μg/g
Measured: at baseline
Demographics and clinical characteristics of Ulcerative Colitis participants
- percentage of gender distribution, age distribution, smoking status distribution, height and weight distribution, BMI distribution
- percentage of Ulcerative Colitis extend and severity (Montreal criteria) distribution, percentage of prior acute severe Ulcerative Colitis, percentage of clinical relapses
Measured: till baseline
Secondary outcomes (12)
Proportion of participants achieving remission at study appointment, defined as both symptomatic and faecal biomarker remission, by previous treatment line and by treatment duration
Measured: at baseline
Proportion of Ulcerative Colitis participants with symptomatic remission
Measured: at baseline
Duration of symptomatic remission
Measured: since initiation symptomatic remission till baseline
Proportion of participants with faecal biomarker <150-200 μg/g and >150-200 μg/g
Measured: at baseline
Proportion of participants with steroid use
Measured: at baseline
Total time without steroids since initiation of current advanced therapy
Measured: since initiation current advanced therapy till baseline
Proportion of participants in steroid-free remission
Measured: at baseline
Time spent in hospital, including all Inflammatory Bowel Disease-related admissions requiring an overnight stay
Measured: since initiation current advanced therapy till baseline
Frequency and incidence of hospitalizations and emergency visits
Measured: since initiation current adavnced therapy till baseline
Frequency of registered preventive care measures
Measured: in the 12 months prior initiation current advanced therapy till baseline
Proportion of Ulcerative Colitis participants with history or current evidence of Extra Intestinal Manifestations
Measured: till baseline
Proportion of Ulcerative Colitis participants with history or current evidence of comorbidities
Measured: till baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2019
- Study start6 Oct 2020 (estimated)
- Primary completion30 Apr 2021 (estimated)
- Study completion30 Apr 2021 (estimated)
Why it stopped: Study was cancelled due to reclassification of study design. No subjects enrolled in the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by PfizerThe 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
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04156672
- Sponsor's protocol ID
- A3921353
- Other IDs
- READ UC
- Acronym
- READ-UC
- Status last verified
- Jan 2021
- First submitted
- 24 Oct 2019
- Last updated
- 27 Jan 2021
- Results posted
- No
- Individual data sharing
- No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REal-world Study of the Clinical Profile and Treatment Outcomes of Advanced Therapies for Ulcerative Colitis in Portugal-READ UC
- ClinicalTrials.gov ID
- NCT04156672
- Acronym / sponsor ID
- READ-UC / A3921353
- Conditions
- Ulcerative Colitis
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study was cancelled due to reclassification of study design. No subjects enrolled in the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 6 Oct 2020 (estimated)
- Primary completion
- 30 Apr 2021 (estimated)
- Study completion
- 30 Apr 2021 (estimated)
- First posted
- 7 Nov 2019 (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.
This study aims to characterize the Portuguese population of patients with moderate-to-severe UC receiving advanced therapies, by describing clinical and sociodemographic characteristics, and remission outcomes . The clinical, biochemical, endoscopic, and histological outcomes will also be described, as well as frequency of selected EIM, comorbidities and the uptake of preventive care measures and hospitalizations .
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients followed at Portuguese gastroenterology services, presenting moderate-to-severe Ulcerative Colitis and receiving advanced therapies (i.e., anti-TNF or anti-integrin or JAK inhibitors drugs) for at least 16 weeks.
Key inclusion criteria (5 listed)
- Aged at least 18 years old
- Diagnosed with Ulcerative Colitis, confirmed by a gastroenterologist
- Treated with anti-TNF or anti-integrin or JAK inhibitors drugs for at least 16 weeks
- Followed at one of the participating centers when initiating and during the current treatment
- Signed informed consent
Key exclusion criteria (2 listed)
- Treated with anti-TNF or anti-integrin or JAK inhibitors drugs at induction phase
- Enrolled in randomized clinical trials or other experimental studies in the last 12 months prior to initiation of advanced therapy
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
Proportion of participants achieving remission at study appointment, defined as both symptomatic and faecal biomarker remission
Time frame: at baseline
- percentage of participants with both a Mayo stool frequency subscore of 0 or 1 and Mayo rectal bleeding subscore of 0 , and a Faecal Calprotectin concentrations < to the cut-off concentration of 150-200 μg/g
Demographics and clinical characteristics of Ulcerative Colitis participants
Time frame: till baseline
* percentage of gender distribution, age distribution, smoking status distribution, height and weight distribution, BMI distribution * percentage of Ulcerative Colitis extend and severity (Montreal criteria) distribution, percentage of prior acute severe Ulcerative Colitis, percentage of clinical relapses
12 secondary outcomes
Proportion of participants achieving remission at study appointment, defined as both symptomatic and faecal biomarker remission, by previous treatment line and by treatment duration
Time frame: at baseline
Proportion of Ulcerative Colitis participants with symptomatic remission
Time frame: at baseline
Duration of symptomatic remission
Time frame: since initiation symptomatic remission till baseline
Proportion of participants with faecal biomarker <150-200 μg/g and >150-200 μg/g
Time frame: at baseline
Proportion of participants with steroid use
Time frame: at baseline
Total time without steroids since initiation of current advanced therapy
Time frame: since initiation current advanced therapy till baseline
Proportion of participants in steroid-free remission
Time frame: at baseline
Time spent in hospital, including all Inflammatory Bowel Disease-related admissions requiring an overnight stay
Time frame: since initiation current advanced therapy till baseline
Frequency and incidence of hospitalizations and emergency visits
Time frame: since initiation current adavnced therapy till baseline
Frequency of registered preventive care measures
Time frame: in the 12 months prior initiation current advanced therapy till baseline
Proportion of Ulcerative Colitis participants with history or current evidence of Extra Intestinal Manifestations
Time frame: till baseline
Proportion of Ulcerative Colitis participants with history or current evidence of comorbidities
Time frame: till baseline
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2021.
- Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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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.
Pfizer CT.gov Call Center study director
Pfizer
Questions about this trial
What is this clinical trial studying?
An observational study of Ulcerative Colitis, run by Pfizer.
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 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: withdrawn, as of the sponsor's last update on 27 Jan 2021. 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 was withdrawn before enrolling participants, so there are no results.
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?
Proportion of participants achieving remission at study appointment, defined as both symptomatic and faecal biomarker remission (time frame: at baseline). The study lists 2 primary outcomes in all. 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 27 Jan 2021.