Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of Moderate to Severe Inflammatory Bowel Disease, Including Ulcerative Colitis (UC) and Crohn's Disease (CD) (RISE-MX)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04873700
Recruitment Status : Recruiting
First Posted : May 5, 2021
Last Update Posted : December 14, 2021
Sponsor:
Information provided by (Responsible Party):
Takeda

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

The main aim of this study is to check the disease activity in people with moderate to severe ulcerative colitis and Crohn's disease.

Participants will complete questionnaires about their disease and quality of life on Day 1 clinic visit. They will do this during a standard scheduled appointment with their doctor. Some of this study will also involve collecting information about participants from their medical records.


Condition or disease
Inflammatory Bowel Diseases Colitis, Ulcerative Crohn Disease

Detailed Description:

This is a retrospective, cross-sectional, and non-interventional study of participants with moderate to severe IBD (UC or CD). The study will have a cross-sectional evaluation on Day 1 to provide the real-world data of disease activity, treatment patterns, burden of disease and quality of life in participants with moderate to severe UC or CD.

The study will involve an additional retrospective review of medical charts of participants of previous 3 years to describe the IBD treatments and use of other healthcare resources related with the management of UC or DC.

The study will enroll approximately 335 participants. All participants will be enrolled in one observational cohort.

This multi-center trial will be conducted in Mexico. The overall time for data collection in the study will be approximately 3 years before the start of the study (Day 1).

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 335 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Real-world Data of Moderate to Severe Inflammatory Bowel Disease (UC and CD) in Mexico: a Multicenter, Non-interventional Study to Evaluate Disease Control, Treatment Patterns, Burden of Disease and Patient Reported Outcomes
Actual Study Start Date : August 30, 2021
Estimated Primary Completion Date : March 4, 2022
Estimated Study Completion Date : March 4, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
All Participants
Participants diagnosed with moderate to severe UC or CD will be observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years prior to Day 1 to assess the IBD treatments and use of other healthcare resources related with the management of UC and CD.


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Percentage of Participants with Active CD at Day 1 [ Time Frame: Day 1 ]
    Percentage of participants with active CD observed, where active CD will be defined as Harvey Bradshaw index (HBI) greater than or equal to (>=) 8 or Crohn's disease active index (CDAI) >=220. CDAI assesses CD based on clinical signs and symptoms such as number of liquid stools, intensity of abdominal pain, general wellbeing, presence of comorbid conditions, use of antidiarrheal, physical examination and laboratory findings. Total score ranges from 0 to 600 points. Higher score indicates more severe disease. HBI score is used to measure disease activity of CD and consists of 5 clinical parameters: general well-being, abdominal pain, number of liquid stools per day, abdominal mass, and complications. Total score is sum of individual parameters. Score ranges from a minimum score of 0 to no pre-specified maximum score as it depends on number of liquid stools, where higher scores indicates more severe disease.

  2. Percentage of Participants with Active UC at Day 1 [ Time Frame: Day 1 ]
    Percentage of participants with active disease UC disease will be observed, where UC is defined as 9-point Partial Mayo Score (pMayo score) >=5. The Mayo score is composed of four categories (bleeding, stool frequency, physician assessment, and endoscopic appearance) rated from 0-3 that are summed into a total score ranging from 0-12. pMayo score consists of 3 sub scores: stool frequency, rectal bleeding, and physician global assessment of disease severity, each graded from 0 to 3. These scores are summed to give a total score range of 0 to 9; where higher scores indicating more severe disease. The pMayo score when compared with the full Mayo score and categorizes UC patients as being in remission (score of 0 to 2), having mild activity (pMayo of 3 or 4) or moderate to severe activity (pMayo of >=5).


Secondary Outcome Measures :
  1. Number of Participants With UC or CD Based on Clinical Presentation [ Time Frame: Day 1 ]
    Number of participants will be reported based on the clinical presentations (extent of inflammation and severity for UC participants, and location, behavior, perianal disease, achievement of ileal disease for CD participants).

  2. Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies [ Time Frame: From 3 years prior to Day 1 until Day 1 ]
    Number of participants will be reported based on the IBD therapies which include aminosalicylates, steroids, immunomodulators, immunossupressors, biologics, antibiotics, probiotics and surgeries.

  3. Duration of IBD Therapies [ Time Frame: From 3 years prior to Day 1 until Day 1 ]
    Time between the beginning of IBD therapy until the end of treatment or Day 1, whichever comes first. IBD therapies include aminosalicylates, steroids, immunomodulators, immunossupressors, biologics, antibiotics, probiotics and surgeries.

  4. Percentage of Participants With UC or CD Based on Biologic-experience [ Time Frame: From 3 years prior to Day 1 until Day 1 ]
    Percentage of participants who have experienced any biologic therapy (examples, infliximab, adalimumab, golimumab, ustekinumab, certolizumab) once or more than once according to medical history until the day 1.

  5. Percentage of Participants With UC or CD who Have not Responded Previously to Biologic Therapies [ Time Frame: From 3 years prior to Day 1 until Day 1 ]
  6. Percentage of Participants With UC or CD Based on Reasons for Non-response to Previous Biologic Therapies [ Time Frame: From 3 years prior to Day 1 until Day 1 ]
  7. Number of Participants With UC or CD Introduced With IBD Treatment at Day 1 [ Time Frame: Day 1 ]
  8. Number of Participants With HBI >=8 or CDAI >=220 Points Versus HBI <8 or CDAI <220 Points Categorized Based on Socio-demographic, Clinical and Treatment-related Variables in CD Participants [ Time Frame: Day 1 ]
    CDAI assesses clinical signs and symptoms: number of liquid stools, intensity of abdominal pain, general wellbeing, presence of comorbid conditions, use of antidiarrheal, physical examination and laboratory findings. Total score ranges from 0-600 points. Higher score indicates more severe disease. HBI score measures disease activity of CD based on 5 clinical parameters: general well-being, abdominal pain, number of liquid stools/day, abdominal mass, and complications. Total score is sum of individual parameters. Score ranges from a minimum score of 0 to no pre-specified maximum score as it depends on number of liquid stools, where higher scores indicates more severe disease. Socio-demographic variables will include age, sex, professional status, educational level, participant income. Clinical variables will include duration and age at diagnosis, steroid dependence or refractoriness, family history, medical history and comorbidities, criteria used for diagnosis, calprotectin and EIM.

  9. Number of Participants With pMayo Score >=5 Versus pMayo Score <5 Categorized Based on Socio-demographic, Clinical and Treatment-related Variables in UC Participants [ Time Frame: Day 1 ]
    Mayo score is composed of 4 categories (bleeding, stool frequency, physician assessment, and endoscopic appearance) rated from 0-3 that are summed into a total score ranging from 0-12. pMayo score consists of 3 sub scores: stool frequency, rectal bleeding, and physician global assessment of disease severity, each graded from 0 to 3. These scores are summed to give a total score range of 0 to 9; where higher scores indicating more severe disease. The pMayo score when compared with the full Mayo score and categorizes UC patients as being in remission (score of 0-2), having mild activity (pMayo of 3-4) or moderate to severe activity (pMayo >=5). Socio-demographic variables will include age, sex, professional status, educational level, participant income. Clinical variables will include duration and age at diagnosis, steroid dependence or refractoriness, family history, medical history and comorbidities, criteria used for diagnosis, calprotectin and extraintestinal manifestations (EIM).

  10. Mean Score of Components of 36-item Short Form health Survey (SF-36) of UC or CD Participants [ Time Frame: Day 1 ]
    SF-36 is a general quality of life (QoL)-questionnaire, which evaluates 8 health dimensions: physical functioning, bodily pain, role physical (limitations due to physical problems), role emotional (limitations due to personal or emotional problems), mental health, social functioning, vitality, and general health perceptions. Based on these 8 dimensions, two weighted scores are generated: the physical component summary (PCS) score and the mental component summary (MCS) score. Scores range between 0 and 100, with higher scores indicating a better quality of life. Mean score of each components (physical component and mental component) will be reported.

  11. Mean Total Score of Inflammatory Bowel Disease Questionnaire (IBDQ) of UC or CD Participants [ Time Frame: Day 1 ]
    IBDQ is a disease-specific questionnaire with 32 items that measures four dimensions: bowel function, emotional status, systemic symptoms, and social function. Within dimensions, each question presents seven possible answers/points. Each domain score is the sum of 8 responses each ranging from 1 to 7, where 1 indicates worst function and 7 the best. The sub-score ranges from 8 to 56 and thus the total score ranges from 32 to 224, where higher score indicates better quality of life.

  12. Mean Total Percentage of Work Impairment Assessed by Work Productivity and Activity Impairment questionnaire (WPAI) in UC or CD Participants [ Time Frame: The last 7 days prior to Day 1 ]
    WPAI assesses the impact of IBD on work productivity and daily activities during the previous 7 days. The WPAI includes 6 questions: 1 (if currently employed); 2 (hours missed due to disease); 3 (hours missed other reasons); 4 (hours actually worked); 5 (degree disease affected productivity while working); 6 (degree disease affected regular activities). WPAI generates four component scores: percentage of work time missed (absenteeism); percentage of impairment while working (presentisms); percentage of overall work impairment (absenteeism and presentisms combined); and percentage of activity impairment. Scores for WPAI range from 0% to 100%, where 0 % indicates no impairment and 100% is total loss of work productivity/activity. Employed participants will be evaluated for this outcome measure. Mean total percentage of work impairment (absenteeism and presentisms) will be reported in terms of hours.

  13. Mean Work Time Missed Assessed by WPAI in UC or CD Participants [ Time Frame: The last 7 days prior to Day 1 ]
    WPAI assesses the impact of IBD on work productivity and daily activities during the previous 7 days. The WPAI includes 6 questions: 1 (if currently employed); 2 (hours missed due to disease); 3 (hours missed other reasons); 4 (hours actually worked); 5 (degree disease affected productivity while working); 6 (degree disease affected regular activities). WPAI generates four component scores: percentage of work time missed (absenteeism); percentage of impairment while working (presentisms); percentage of overall work impairment (absenteeism and presentisms combined); and percentage of activity impairment. Scores for WPAI range from 0% to 100%, where 0 % indicates no impairment and 100% is total loss of work productivity/activity. Employed participants will be evaluated for this outcome measure. Mean work time missed (absenteeism) will be reported.

  14. Mean Impairment While Working Assessed by WPAI in UC or CD Participants [ Time Frame: The last 7 days prior to Day 1 ]
    WPAI assesses the impact of IBD on work productivity and daily activities during the previous 7 days. The WPAI includes 6 questions: 1 (if currently employed); 2 (hours missed due to disease); 3 (hours missed other reasons); 4 (hours actually worked); 5 (degree disease affected productivity while working); 6 (degree disease affected regular activities). WPAI generates four component scores: percentage of work time missed (absenteeism); percentage of impairment while working (presentisms); percentage of overall work impairment (absenteeism and presentisms combined); and percentage of activity impairment. Scores for WPAI range from 0% to 100%, where 0 % indicates no impairment and 100% is total loss of work productivity/activity. Employed participants will be evaluated for this outcome measure. Mean impairment while working (presentisms) will be reported.

  15. Mean Total Activity Impairment Assessed by WPAI in UC or CD Participants [ Time Frame: The last 7 days prior to Day 1 ]
    WPAI assesses the impact of IBD on work productivity and daily activities during the previous 7 days. The WPAI includes 6 questions: 1 (if currently employed); 2 (hours missed due to disease); 3 (hours missed other reasons); 4 (hours actually worked); 5 (degree disease affected productivity while working); 6 (degree disease affected regular activities). WPAI generates four component scores: percentage of work time missed (absenteeism); percentage of impairment while working (presentisms); percentage of overall work impairment (absenteeism and presentisms combined); and percentage of activity impairment. Unemployed participants will only answer to questions related to employment status and regular activities impairment. Scores for WPAI range from 0% to 100%, where 0 % indicates no impairment and 100% is total loss of work productivity/activity. Mean total activity impairment will be reported.

  16. Percentage of Participants With UC or CD Who Quit Their Job due to IBD and Unable to Return to Work [ Time Frame: Day 1 ]
  17. Percentage of Participants With UC or CD Categorized Based on Healthcare Resources [ Time Frame: From 3 years prior to Day 1 until Day 1 ]
    Healthcare resources includes use of surgeries, hospitalizations, medical appointments, imaging and laboratory testing.

  18. Number of Participants With UC or CD Based on Direct Medical Cost [ Time Frame: From 3 years prior to Day 1 until Day 1 ]
    Direct costs will be obtained by multiplying resource use with relevant unit costs, consisting of 2 components: (1) Health care costs: Consumer price index (CPI)-adjusted IBD (UC or CD)- related health care costs computed as total costs, medical costs, UC and CD drug costs, and other costs (sum of surgeries, hospitalization, medical appointments; imaging and laboratory testing costs). (2) Treatment pattern costs: calculated as total UC or CD-related health care costs, stratified by the defined treatment patterns.

  19. Number of Participants With UC or CD Based on Indirect Cost [ Time Frame: From 3 years prior to Day 1 until Day 1 ]
    The indirect costs will be reported as the cost of productivity loss by absenteeism and presentisms per participant. Human capital method will be used to calculate indirect costs as exactly the cost of the salary paid to the employee (participant) proportionally to the hours of absence/ work impairment based on the average incomes and the absence/impaired work hours reported during the study. This outcome measure will be evaluated only for participants with employment (active workers).


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Layout table for eligibility information
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
Adult participants diagnosed with moderate to severe UC or CD will be enrolled.
Criteria

Inclusion Criteria:

  1. Diagnosed with moderate to severe CD or UC established for at least 6 months prior to Day 1 appointment, based on clinical, endoscopic or image criteria.
  2. Participants aged 18 years or older (at the time of diagnosis of moderate to severe UC or CD).

Exclusion Criteria:

  1. Has indeterminate or not classified colitis.
  2. Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ClinicalTrials.gov identifier (NCT number): NCT04873700


Contacts
Layout table for location contacts
Contact: Takeda Contact +1-877-825-3327 medinfoUS@takeda.com

Locations
Layout table for location information
Mexico
Unidad de Enfermedades Reumaticas y Cronico dgenerativas Recruiting
Torreon, Coahuila, Mexico, 27000
Contact: Site Contact    (871) 184 6505    gastrolaguna@yahoo.com.mx   
Principal Investigator: Francisco Alfonso Solis Galindo         
Centro De Investigacion Clinica De Alta Especialidad "Cicae" Recruiting
Torreon, Coahuila, Mexico, 27010
Contact: Site Contact    (871) 714 47 35    karlasuhei@gmail.com   
Principal Investigator: Karla Suhei Torres Castillo         
Hospital Medica Sur Tlalpan Recruiting
Ciudad de Mexico, Distrito Federal, Mexico, 14050
Contact: Site Contact    55 37 08 58 09    kazuofurusho@hotmail.com   
Principal Investigator: Jesus Kazuo Yamamoto Furusho         
Instituto Nacional de Ciencias Medicas Y Nutricion Salvador Zubiran Not yet recruiting
Ciudad de Mexico, Distrito Federal, Mexico, 14080
Contact: Site Contact    55 37 08 58 09    kazuofurusho@hotmail.com   
Principal Investigator: Jesus Kazuo Yamamoto Furusho         
Endoamer S.C. Recruiting
Guadalajara, Jalisco, Mexico, 44600
Contact: Site Contact    52 33 3345 5800    rs_jaramillo@hotmail.com   
Principal Investigator: Christian Jaramillo Buendia         
CIMESAP Sociedad de Responsabilidad Limitada de Capital Variable Recruiting
Zapopan, Jalisco, Mexico, 45138
Contact: Site Contact    52 33 3321 6743    marivibielsa@yahoo.com.mx   
Principal Investigator: Maria Bielsa Fernandez         
Fundacion Santos y de la Garza Evia Recruiting
Monterrey, Nuevo Leon, Mexico, 64710
Contact: Site Contact    88880000 ext 3766    fbosques58@hotmail.com   
Principal Investigator: Francisco Javier Bosques Padilla         
Oncare Oncology Recruiting
San Pedro Garza Garcia, Nuevo Leon, Mexico, 66220
Contact: Site Contact    811 544 1903    drgenarovazquez@gmail.com   
Principal Investigator: Genaro Vazquez Elizondo         
Hospital Zambrano Hellion TecSalud Recruiting
San Pedro Garza Garcia, Nuevo Leon, Mexico, 66278
Contact: Site Contact    81 88880000 ext 3764    manuelmartinezgastro@gmail.com   
Principal Investigator: Manuel Alejandro Martinez Vazquez         
Centro de Investigacion Clinica de Oaxaca Recruiting
Oaxaca de Juarez, Oaxaca, Mexico, 68020
Contact: Site Contact    951 199 97 59    jsantiago@ciclooax.com   
Principal Investigator: Jose Ernesto Santiago Martinez         
Torre Medica Sanatorio Toluca Recruiting
Toluca, Mexico, 50120
Contact: Site Contact    52 55 5403 6905    moetrmc@gmail.com   
Principal Investigator: Rosa Miranda Cordero         
Arke SMO S.A. De C.V Recruiting
Veracruz, Mexico, 91910
Contact: Site Contact    229 931 4102    r.cervantes@arke.com.mx   
Principal Investigator: Reyes Javier Cervantes Ortiz         
Sponsors and Collaborators
Takeda
Investigators
Layout table for investigator information
Study Director: Study Director Takeda
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT04873700    
Other Study ID Numbers: IBD-5010
U1111-1262-1609 ( Registry Identifier: WHO )
First Posted: May 5, 2021    Key Record Dates
Last Update Posted: December 14, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
URL: https://vivli.org/ourmember/takeda/

Layout table for additional information
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:
Layout table for MeSH terms
Crohn Disease
Colitis
Intestinal Diseases
Inflammatory Bowel Diseases
Colitis, Ulcerative
Ulcer
 Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Pathologic Processes