Non-interventional Study of Moderate to Severe Inflammatory Bowel Disease in Brazil

NCT02822235 | Completed Results

• 2 other identifiers: Vedolizumab-4008U1111-1178-66445
• Study Type: observational
• Target: 407
• Locations: 1 country
• Sites: 13

Brief Summary

The purpose of this study is to gather information regarding the population with moderate to severe inflammatory bowel disease (IBD), the burden of the disease, and understand their treatment patterns, particularly on the use of available biologic therapies.

Conditions

Inflammatory Bowel Disease

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants With Active Crohn's Disease (CD) at Day 1

  Participants with Harvey Bradshaw Index (HBI) score of ≥8 or Crohn´s Disease Activity Index (CDAI) ≥220 points at Day 1 were classified as participants with active disease. HBI scale assessed five dimensions (general well-being, abdominal pain, number of liquid stools per day, abdominal mass, and complications). These dimensions were scored from the previous day. The total score ranges from 0 to 25. The CDAI evaluated the severity of signs and symptoms of CD. Collected data included information on the number of liquid stools, intensity of abdominal pain, general well-being, presence of comorbid conditions, use of medications for diarrhea, physical examination, and laboratory findings (abdominal mass, hematocrit, body weight), yielding 8 items that were combined with data from a 7-day diary to obtain the total CDAI score which ranges from 0 to approximately 600 points, where higher score indicates higher disease activity.

  Day 1

• Number of Participants With Active Ulcerative Colitis (UC) at Day 1

  Participants with ≥5 points in Partial Mayo Score were classified as active UC disease. The mayo score without endoscopy measured severity of ulcerative colitis. Three sub-scores for stool frequency, rectal bleeding, and physician's global assessment were each graded from 0 to 3 with higher scores indicating more severe disease. Individual sub-scores were then summed to provide the total score ranging from 0 (normal or inactive disease) to 9 (severe disease).

  Day 1

Secondary Outcomes (25)

• Number of Participants With Moderate to Severe CD or UC Stratified by Age, Gender, Professional Status, Family History, Educational Level and Income at Day 1

  Day 1

• Number of Participants With Moderate to Severe CD or UC Stratified by Clinical Variables

  Day 1

• Percentage of Participants With Moderate to Severe CD or UC Who Used Various Types of Therapies for IBD in Previous 3 Years

  Within the previous 3 years including Day 1

• Percentage of Participants With Moderate to Severe CD or UC Treated With Biologic Therapy Within 3 Previous Years

  Within the previous 3 years including Day 1

• Percentage of Participants With Moderate to Severe CD or UC Who Have Not Responded Previously to Biologic Therapies

  Day 1

Study Arms (2)

Crohn's Disease

Participants with diagnosis of moderate to severe Crohn's disease (CD) for at least 6 months prior to Day 1 were observed to collect the retrospective data including previous inflammatory bowel disease (IBD) treatments (drug dose, treatment duration, drug changes), and use of other health resources related with the management of IBD for previous three years at Day 1. Participants with active IBD and CD at Day 1 were followed up for 12 months in prospective phase.

Other: No Intervention

Ulcerative Colitis

Participants diagnosed with diagnosis of moderate to severe ulcerative colitis (UC) for at least 6 months prior to Day 1 were observed to collect the retrospective data including previous inflammatory bowel disease (IBD) treatments (drug dose, treatment duration, drug changes), and use of other health resources related with the management of IBD for previous three years at Day 1. Participants with active IBD and UC at Day 1 were followed up for 12 months in prospective phase.

Other: No Intervention

Interventions

No Intervention OTHER

Crohn's Disease; Ulcerative Colitis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult participants diagnosed with moderate to severe Crohn's Disease (CD) or Ulcerative Colitis (UC) were observed.

You may qualify if:

• Male or female.
• years or older (at the time of diagnosis of moderate to severe UC or CD).
• Diagnosis of moderate to severe CD or UC for at least 6 months prior to Day 1 appointment according the clinical or endoscopic \\ criteria.
• Has provided the written informed consent. For the prospective period, eligible participants should present at least one of the following criteria that will only be applied at Day 1:
• For CD participants:
• Harvey Bradshaw Index (HBI) ≥8 or
• Crohn's Disease Activity Index (CDAI) ≥220 or Considering that for CD participants, the disease activity may not be clearly documented only with clinical data, some objective criteria may be considered as entry criteria for the 12-month prospective period:
• Colonoscopy in the previous year suggestive of inadequate control of activity or,
• Calprotectin levels in the previous year suggestive of inadequate control of activity (i.e, calprotectin \>200 µg/g).
• For UC: partial Mayo Score ≥5.
• Note: Participants with colostomy and prospective period: Although clinical scales defined above are impacted by colostomy these participants will not be excluded from the protocol to ensure the assessment of different clinical presentations of the IBD. In addition, participants with colostomy must follow the same criteria as above to be eligible to the prospective phase.

You may not qualify if:

• Indeterminate or not classified colitis.
• Current or previous participation in interventional clinical trial (within the last 3 years). In addition, for the 12-month prospective period, participants will be excluded if:
• Presenting mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
• Hospitalized participants at Day 1.
• Current off label treatment with Vedolizumab.
• Study Discontinuation Criteria It will be considered a premature termination the situation in which the participant discontinues the participation, i.e. they are withdrawn from the study before completing the 12 months of follow up period (365 days ± 14 days from Day 1), due to any of the reasons listed below:
• Withdrawal of consent: participants who for any reason withdraw the free and informed consent;
• Lost to follow-up (no return of the participant on the expected date of visit - drop-out from the protocol);
• Death;
• Study termination;
• Note: Participants who are eligible for the prospective period, it means, with active disease at Day 1 but who during the 12 months period presents disease remission and/or no activity disease condition, are allowed to continue the participation in the study.

Sponsors & Collaborators

• Takeda: lead

Study Sites (13)

Unknown Facility

Salvador, Estado de Bahia, Brazil

Location

Unknown Facility

Goiânia, Goiás, Brazil

Location

Unknown Facility

Belo Horizonte, Minas Gerais, Brazil

Location

Unknown Facility

Juiz de Fora, Minas Gerais, Brazil

Location

Unknown Facility

Curitiba, Paraná, Brazil

Location

Unknown Facility

Teresina, Piauí, Brazil

Location

Unknown Facility

Porto Alegre, Rio Grande do Sul, Brazil

Location

Unknown Facility

Botucatu, São Paulo, Brazil

Location

Unknown Facility

Ribeirão Preto, São Paulo, Brazil

Location

Unknown Facility

Santo André, São Paulo, Brazil

Location

Unknown Facility

São José do Rio Preto, São Paulo, Brazil

Location

Unknown Facility

Rio de Janeiro, Brazil

Location

Unknown Facility

São Paulo, Brazil

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Limitations and Caveats

Missing data on paticipants medical records in retrospective analysis and missing information in medical activity scores of participants in prospective analysis resulted in improper collection of data for IBD participants.

Results Point of Contact

• Title: Medical Director
• Organization: Takeda

trialdisclosures@takeda.com

+1-877-825-3327

Study Officials

• Abner Augusto Lobão Neto Clinical Science

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2016
• First Posted: July 4, 2016
• Study Start: October 11, 2016
• Primary Completion: February 5, 2018
• Study Completion: February 19, 2018
• Last Updated: February 25, 2020
• Results First Posted: February 25, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will share

Locations

BR (13)