Sub-optimal Response to Anti-Tumor Necrosis Factor's in Inflammatory Bowel Disease in Emerging Markets
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|ClinicalTrials.gov Identifier: NCT03090139|
Recruitment Status : Completed
First Posted : March 24, 2017
Last Update Posted : June 25, 2018
|Condition or disease||Intervention/treatment|
|Colitis, Ulcerative Crohn Disease Inflammatory Bowel Diseases||Drug: Anti-TNF Therapy|
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.
|Study Type :||Observational|
|Actual Enrollment :||1731 participants|
|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|
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
- 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.
- Treatment Patterns in UC and CD Participants [ Time Frame: 5 years ]
- Number of Participants With Each Type of Anti-TNF Therapy [ Time Frame: 5 years ]
- Duration of Treatment [ Time Frame: 5 years ]
- Number of Participants With Response to Treatment [ Time Frame: 5 years ]Number of participants with response to treatment will be assessed.
- 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.
- Time-to-switch [ Time Frame: 5 years ]The time to switch at which the participant switched to another anti-TNF therapy will be evaluated.
- 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.
- 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.
- 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.
- 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.
- Number of Participants with Co-morbidities [ Time Frame: Baseline ]
- 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.
- 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).
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT03090139
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|Study Director:||Medical Director||Takeda|