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

NCT ID: NCT02822235

Last Updated: 2020-02-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 407 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-10-11
• Study Completion Date: 2018-02-19

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.

Conditions

Inflammatory Bowel Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No Intervention

Intervention Type: OTHER

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.

No Intervention

Intervention Type: OTHER

Interventions

No Intervention

Intervention Type: OTHER

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;

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Takeda

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Abner Augusto Lobão Neto Clinical Science

Role: STUDY_DIRECTOR

Takeda

Locations

Salvador, Estado de Bahia, Brazil

Goiânia, Goiás, Brazil

Belo Horizonte, Minas Gerais, Brazil

Juiz de Fora, Minas Gerais, Brazil

Curitiba, Paraná, Brazil

Teresina, Piauí, Brazil

Porto Alegre, Rio Grande do Sul, Brazil

Botucatu, São Paulo, Brazil

Ribeirão Preto, São Paulo, Brazil

Santo André, São Paulo, Brazil

São José do Rio Preto, São Paulo, Brazil

Rio de Janeiro, , Brazil

São Paulo, , Brazil

Countries

Brazil

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

U1111-1178-66445

Identifier Type: REGISTRY

Identifier Source: secondary_id

Vedolizumab-4008

Identifier Type: -

Identifier Source: org_study_id