Clinical trial NCT02822235: Non-interventional Study of Moderate to Severe Inflammatory Bowel Disease in Brazil
Official title: Real-world Data of Moderate to Severe Inflammatory Bowel Disease in Brazil: a Non-interventional, Multicenter Study to Evaluate Disease Control, Treatment Patterns, Burden of Disease and Quality of Life (RISE BR)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammatory Bowel Disease
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2016-07-04
Enrollment: 407
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult participants diagnosed with moderate to severe Crohn's Disease (CD) or Ulcerative Colitis (UC) were observed.

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.

Detailed description: This is a non-interventional study to determine the rate of control of disease activity in moderate to severe inflammatory bowel disease (IBD) participants, with two parts: cross-sectional evaluation (Day 1) with retrospective data collection and a prospective 12-month evaluation for patients with active IBD at cross-sectional evaluation (Day 1).

The study enrolled 407 patients. This multicenter trial was conducted in Brazil. Retrospective data of previous IBD treatments (drug, dose, treatment duration, drug changes), and use of other health resources related with the management of IBD for previous three years will be collected. Prospective data was collected for a period of 12 months in participants with active disease. UC participants, with no or light disease activity at Day 1 did not continue to 12-month follow up. CD participants, with no or light disease activity at Day 1 but with colonoscopy or calprotectin levels (i.e, calprotectin \>200 ug/g) in the previous year suggestive of inadequate control of activity progressed to 12-month follow up.

Eligibility criteria: Inclusion Criteria:

1. Male or female.
2. 18 years or older (at the time of diagnosis of moderate to severe UC or CD).
3. Diagnosis of moderate to severe CD or UC for at least 6 months prior to Day 1 appointment according the clinical or endoscopic \\ criteria.
4. 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:
5. 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).
6. 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.

Exclusion Criteria:

1. Indeterminate or not classified colitis.
2. 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:
3. Presenting mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
4. Hospitalized participants at Day 1.
5. 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:

1. Withdrawal of consent: participants who for any reason withdraw the free and informed consent;
2. Lost to follow-up (no return of the participant on the expected date of visit - drop-out from the protocol);
3. Death;
4. Study termination;
5. Any situation that places the participant within one of the exclusion criteria.

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.

Primary outcomes:
measure: Percentage of Participants With Active Crohn's Disease (CD) at Day 1
timeFrame: Day 1
measure: Number of Participants With Active Ulcerative Colitis (UC) at Day 1
timeFrame: Day 1
Secondary outcomes:
measure: 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
timeFrame: Day 1
measure: Number of Participants With Moderate to Severe CD or UC Stratified by Clinical Variables
timeFrame: Day 1
measure: Percentage of Participants With Moderate to Severe CD or UC Who Used Various Types of Therapies for IBD in Previous 3 Years
timeFrame: Within the previous 3 years including Day 1
measure: Percentage of Participants With Moderate to Severe CD or UC Treated With Biologic Therapy Within 3 Previous Years
timeFrame: Within the previous 3 years including Day 1
measure: Percentage of Participants With Moderate to Severe CD or UC Who Have Not Responded Previously to Biologic Therapies
timeFrame: Day 1
measure: Percentage of Participants With Moderate to Severe CD or UC Who Were Ongoing IBD Treatment at Day 1
timeFrame: Day 1
measure: Number of Participants With Moderate to Severe Activity of CD or With Light or no Activity Stratified by Socio-demographic Variables
timeFrame: Day 1
measure: Number of Participants With Moderate to Severe Activity of CD or With Light or no Activity Stratified by Clinical Variables
timeFrame: Day 1
measure: Percentage of Participants With Treatment Beginning or Ongoing at Day 1 by Moderate to Severe Activity of CD or With Light or no Activity Stratified by Treatment Variables
timeFrame: Day 1
measure: Number of Participants With Moderate to Severe Activity of UC or With Light or no Activity Stratified by Socio-demographic Variables
timeFrame: Day 1
measure: Number of Participants With Moderate to Severe Activity of UC or With Light or no Activity Stratified by Clinical Variables
timeFrame: Day 1
measure: Percentage of Participants With Treatment Beginning or Ongoing at Day 1 by Moderate to Severe Activity of UC or With Light or no Activity Stratified by Treatment Variables
timeFrame: Day 1
measure: Harvey Bradshaw Index (HBI) Total Score in Participants Who Had Moderate to Severe Active CD at Day 1 and Month 12
timeFrame: Day 1 and Month 12
measure: Crohn´s Disease Activity Index (CDAI) Total Score in Participants Who Had Moderate to Severe Active CD at Day 1 and Month 12
timeFrame: Day 1 and Month 12
measure: Partial Mayo Score in Participants Who Had Moderate to Severe Active UC at Day 1 and Month 12
timeFrame: Day 1 and Month 12
measure: Percentage of Participants With Moderate to Severe Active CD or UC Who Changed IBD Treatment at Month 12, by Reason
timeFrame: Month 12
measure: Quality of Life as Assessed by European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Day 1
timeFrame: Day 1
measure: Quality of Life as Assessed by 36-Item Short Form Health Survey (SF-36) Component Score at Day 1
timeFrame: Day 1
measure: Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Day 1
timeFrame: Day 1
measure: Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score at Day 1
timeFrame: Day 1
measure: Mean of Percentage of Total Work Impairment Due to CD as Assessed by Work Productivity and Activity Impairment (WPAI) Questionnaire at Day 1
timeFrame: Day 1
measure: Mean of Percentage of Work Time Missed Due to CD as Assessed by WPAI at Day 1
timeFrame: Day 1
measure: Mean of Percentage of Impairment While Working Due to CD as Assessed by WPAI at Day 1
timeFrame: Day 1
measure: Mean of Percentage of Total Activity Impairment Due to CD as Assessed by WPAI
timeFrame: Day 1
measure: Percentage of Participants Who Used Healthcare Resources
timeFrame: Day 1
Other outcomes:
Locations:
city: Salvador
country: Brazil
state: Bahia
city: Goiania
country: Brazil
state: Goias
city: Belo Horizonte
country: Brazil
state: Minas Gerais
city: Juiz de Fora
country: Brazil
state: Minas Gerais
city: Curitiba
country: Brazil
state: Parana
city: Teresina
country: Brazil
state: Piaui
city: Porto Alegre
country: Brazil
state: Rio Grande Do Sul
city: Botucatu
country: Brazil
state: Sao Paulo
city: Ribeirao Preto
country: Brazil
state: Sao Paulo
city: Santo Andre
country: Brazil
state: Sao Paulo
city: Sao Jose do Rio Preto
country: Brazil
state: Sao Paulo
city: Rio de Janeiro
country: Brazil
city: Sao Paulo
country: Brazil
Study officials:
affiliation: Takeda
name: Abner Augusto Lobão Neto Clinical Science
role: STUDY_DIRECTOR
References: