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Sub-optimal Response to Anti-Tumor Necrosis Factor's in Inflammatory Bowel Disease in Emerging Markets

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03090139
Recruitment Status : Completed
First Posted : March 24, 2017
Last Update Posted : June 25, 2018
Information provided by (Responsible Party):

Brief Summary:
The purpose of this study is to establish the incidence of sub-optimal response to anti-TNF therapy in UC and CD participants.

Condition or disease Intervention/treatment
Colitis, Ulcerative Crohn Disease Inflammatory Bowel Diseases Drug: Anti-TNF Therapy

Detailed Description:

Participants with historical diagnosis of CD and UC who were naïve to anti-TNF therapy were observed in this retrospective study. The study will look to identify the local barriers in prescribing anti-TNF therapy, treatment patterns and indicators of sub-optimal response to anti-TNF therapy in UC and CD participants in real-world clinical practice in the EM countries, along with the associated incidence of sub-optimal response and impact on health care resource utilization (HCRU). The will enroll approximately 2000 participants.

The study consists of two periods, eligibility period followed by a data abstraction period. During the eligibility period participants who had initiated first anti-TNF therapy during 01 March 2010 up to 01 March 2015 will be recruited and observed. Participants will be followed up for a period of minimum 2 years (other than death) and a maximum of 5 years from the date of first treatment of anti-TNF therapy for CD and UC (Index date). During the data abstraction period participants who have eligible medical charts will be identified and all retrospective data will be collected.

This multi-center trial will be conducted in Argentina, China, Colombia, Mexico, Russia, Saudi Arabia, Singapore, South Korea, Taiwan and Turkey. The overall time to abstract data during the data extraction period from the web-based electronic data capture (EDC) system will be approximately 1 year from March 2017 to February 2018.

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Study Type : Observational
Actual Enrollment : 1731 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Indicators of Sub-Optimal Response to Anti-Tumor Necrosis Factor (TNF) Therapy in Patients With Crohn's Disease (CD) and Ulcerative Colitis (UC): A Retrospective Chart Review in the Emerging Market (EM) Region (EXPLORE)
Actual Study Start Date : March 28, 2017
Actual Primary Completion Date : June 13, 2018
Actual Study Completion Date : June 13, 2018

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
All Participants
All participants with diagnosis of UC and CD, who initiated treatment with anti-TNF therapy from 01 March 2010 up to 01 March 2015 will be observed. Retrospective data extraction will be done for eligible participants from March 2017 up to approximately February 2018.
Drug: Anti-TNF Therapy
Anti-TNF therapy.

Primary Outcome Measures :
  1. Incidence Rate of Sub-optimal Response in UC and CD Participants [ Time Frame: 5 years ]
    Incidence rate will be calculated as the number of events divided by the total person time at risk, for participants under anti-TNF therapy.

  2. Treatment Patterns in UC and CD Participants [ Time Frame: 5 years ]
  3. Number of Participants With Each Type of Anti-TNF Therapy [ Time Frame: 5 years ]
  4. Duration of Treatment [ Time Frame: 5 years ]
  5. Number of Participants With Response to Treatment [ Time Frame: 5 years ]
    Number of participants with response to treatment will be assessed.

  6. Treatment Pattern Results Stratified by Anti-TNF Response Group and by UC or CD Diagnosis [ Time Frame: 5 years ]
    Treatment patterns results were as per the Anti-TNF therapy response from UC and CD participants.

  7. Time-to-switch [ Time Frame: 5 years ]
    The time to switch at which the participant switched to another anti-TNF therapy will be evaluated.

  8. Time-to-first Indicator of Sub-optimal Therapy [ Time Frame: 5 years ]
    Time-to-first indicator of sub-optimal therapy was defined as the occurrence of dose escalation, therapy augmentation, therapy switch, therapy discontinuation, hospitalization, or surgery of participant, which ever occurred first.

Secondary Outcome Measures :
  1. Number of Participants With CD Achieving Clinical Response Based on Harvey Bradshaw Index (HBI) [ Time Frame: Baseline up to 5 years ]
    Clinical response is defined as a decrease in HBI score of greater than or equal to (>=) 3 points from baseline. HBI score is used to measure the disease activity of CD. It consists of clinical parameters: abdominal pain (0-3, higher score means more severe pain), number of liquid stools per day, abdominal mass (0-3, where higher score means presence of swelling in the abdomen), and complications (score 1 per item). Total score is the sum of individual parameters. The score ranges from a minimum score of 0 to no pre-specified maximum score as it depends on the number of liquid stools, where higher scores indicating more severe disease.

  2. Number of Participants With UC Achieving Clinical Response Based on Mayo Scores [ Time Frame: Baseline up to 5 years ]
    Clinical response is defined as a decrease in the partial Mayo Score of at least 2 points and >=25% from baseline, with an accompanying decrease in rectal bleeding subscore of >=1 point from baseline or absolute rectal bleeding subscore of less than or equal to (<=) 1 point. Mayo score is an instrument designed to measure disease activity of UC. It consists of 3 subscores: stool frequency, rectal bleeding, and physician global assessment of disease severity, each graded from 0 to 3 with higher scores indicating more severe disease. These scores are summed to give a total score range of 0 to 9; where higher scores indicating more severe disease.

  3. Number of Participants with Inflammatory Bowel Disease (IBD) Related Surgeries and Hospitalisation [ Time Frame: 2 years prior to index anti-TNF therapy ]
    IBD-related surgeries and hospitalisation will be conducted in the two years prior to index anti-TNF therapy in UC or CD participants.

  4. Number of Participants with Co-morbidities [ Time Frame: Baseline ]
  5. Number of Participants with Predictors of Sub-optimal Therapy in UC or CD Participants [ Time Frame: Baseline up to 5 years ]
    The predictors of sub-optimal response will be assessed through multivariate analysis using logistic regression or other appropriate statistical methods. Multivariate analyses may be conducted to derive predictors of sub-optimal response to anti-TNF therapy globally and individually.

  6. Health Care Resources Utilisation (HCRU) [ Time Frame: Baseline up to 7 years ]
    HCRU will be calculated for physician clinic visits, emergency department visits, IBD-related surgeries, invasive procedures, imaging, and in-participant admissions related to UC or CD, or related complications as available in the medical record and captured in the electronic case report form (eCRF).

  7. Physician Survey Questionnaire [ Time Frame: Baseline ]
    The physician survey questionnaire will include questions on local accessibility to infusion centres, potential restrictions of prescription, potential local difficulties for drug access (example, reimbursement process, economic burden), and other reasons for participants compliant with the local label to not receive anti-TNF therapy.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population will consist of participants with a diagnosis of CD or UC who were naive to anti-TNF therapy and received their first dose of anti-TNF treatment for CD or UC during the eligibility period at private and public sites that routinely treat IBD participants and prescribe anti-TNF therapy from the targeted countries of interest.

Inclusion Criteria:

  1. Who are 18 years or older at Index Date and diagnosed with UC or CD.
  2. Who were naive to anti-TNF therapy and received their first dose of any anti-TNF therapy (index date) for UC or CD within the Eligibility Period from 01 March 2010 through 01 March 2015.

Exclusion Criteria:

  1. Diagnosed with indeterminate/unspecified type of IBD.
  2. Were part of an IBD-related clinical trial during the observational period should be excluded (that is, index date up to the date of chart abstraction).
  3. Who received an anti-TNF therapy for any non-UC or non-CD conditions (example, rheumatoid arthritis, ankylosing spondylitis, psoriasis, or cancer).
  4. Who received an anti-TNF/biologic therapy at any point that was administered outside of the labelled dosing regimen (example, episodic use of anti-TNF therapy).
  5. With UC who had a total colectomy prior to their first anti-TNF therapy.
  6. Charts not available.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03090139

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Sponsors and Collaborators
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Study Director: Medical Director Takeda

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Responsible Party: Takeda Identifier: NCT03090139     History of Changes
Other Study ID Numbers: IBD-5001
First Posted: March 24, 2017    Key Record Dates
Last Update Posted: June 25, 2018
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Takeda:
Drug therapy
Additional relevant MeSH terms:
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Crohn Disease
Intestinal Diseases
Inflammatory Bowel Diseases
Colitis, Ulcerative
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Pathologic Processes