NCT04876690: CONFLICT

A Study of the Quality of Life in Adults With Crohn's Disease With Complex Perianal Fistulas

Completed Results posted Last updated 5 August 2024

What this trial tests

trial in Crohn Disease in 15 participants. Completed in 27 May 2022.

Timeline

9 July 2021

Primary endpoint
27 May 2022

27 May 2022

Quick facts

Lead sponsor	Takeda
Status	Completed
Study type	OBSERVATIONAL
Enrollment	15
Start date	9 July 2021
Primary completion	27 May 2022
Estimated completion	27 May 2022
Sites	5 locations across Portugal

Conditions studied

• Crohn Disease — all drugs for Crohn Disease →
• Rectal Fistula — all drugs for Rectal Fistula →

Sponsor

Takeda — full company profile →

Who can join

18 and older, any sex, with Crohn Disease or Rectal Fistula. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Meta-Scores of the 12-Item Short Form Health Survey (SF-12) Questionnaire's Physical Component Score [PCS-12] Primary · At inclusion visit (Day 1)

SF-12 is 12-item self-report that assesses physical and mental health related general quality of life (QoL) whose results are expressed in terms of two meta-scores: the physical component summary (PCS) and the mental component summary (MCS), of which the PCS component is presented in this outcome measure. The PCS score has a range of 0 to 100. Higher scores indicate better physical functioning.

Group	Value	95% CI
CD Participants With CPF	45.36	± 7.58

Meta-Scores of the SF-12 Questionnaire's Mental Component Score [MCS-12]) Primary · At inclusion visit (Day 1)

SF-12 is 12-item self-report that assesses physical and mental health related general quality of life (QoL) whose results are expressed in terms of two meta-scores: the PCS and the MCS, of which the MCS component is presented in this outcome measure. The MCS score has a range of 0 to 100. Higher scores indicate better mental functioning.

Group	Value	95% CI
CD Participants With CPF	38.00	± 8.48

Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Score Secondary · At inclusion visit (Day 1)

The SIBDQ is an instrument used to assess QoL and is a disease-specific health-related quality of life questionnaire, that consists of 10 questions, each question is scored on a scale from 1 (poor quality of life) to 7 (good quality of life). The total score is reported and ranges from 10 to 70 with a higher score indicating a better health-related QoL.

Group	Value	95% CI
CD Participants With CPF	45.00	± 10.72

Sexual Quality of Life-Male (SQOL-M) Questionnaire Score for Male Participants Secondary · At inclusion visit (Day 1)

SQOL-M assessed the relationship between male sexual dysfunction and quality of life. It contains 11 items, each items are scored from 1 to 6 points (worst to best), completely agree = 1 to completely disagree = 6. The total score can range from 11 to 66 points. Higher scores indicate better male sexual quality of life.

Group	Value	95% CI
CD Participants With CPF	44.57	± 14.59

Sexual Quality of Life-Female (SQOL-F) Questionnaire Score for Female Participants Secondary · At inclusion visit (Day 1)

SQOL-F assessed the relationship between female sexual dysfunction and quality of life. It consists of 18 items, rated using a six-point scale (completely agree to completely disagree). The total score can range from 18 to 108 points. Higher scores indicate better female sexual quality of life.

Group	Value	95% CI
CD Participants With CPF	72.80	± 25.54

Fecal Incontinence as Assessed by Wexner Score Secondary · At inclusion visit (Day 1)

Fecal incontinence is measured by Wexner score. It consists of five questions to assess the degree of incontinence (solid, liquid, gas, wears pad, lifestyle alteration). The frequency of each type of incontinence is rated on a scale ranging from 0 (never) to 4 (always or to once a day) so that the sum of the frequencies add up to a total score that ranges from 0 to 20. Higher scores indicate worse fecal incontinence.

Group	Value	95% CI
CD Participants With CPF	7.43	± 5.50

Work Productivity and Activity Impairment (WPAI) as Assessed by WPAI Questionnaire Score Secondary · At inclusion visit (Day 1)

WPAI score was used to describe the indirect healthcare resources. It is self-administered 6-item questionnaire (scale of 0-10) which assesses the effect of disease on work productivity in the past 7 days obtained for absenteeism (work time missed), presenteeism (impairment at work / reduced on-the-job effectiveness), work productivity loss (overall work impairment / absenteeism plus presenteeism) and activity impairment / disability. Scores are presented as percentages (multiplying the scores by 100), Domain scores are expressed as a percentage, with a range of scores form 0-100%, with 0% rep

Absenteeism

Group	Value	95% CI
CD Participants With CPF	3.80	± 6.85

Presenteeism

Group	Value	95% CI
CD Participants With CPF	57.78	± 29.91

Work Productivity Loss

Group	Value	95% CI
CD Participants With CPF	58.89	± 30.28

Activity Impairment

Group	Value	95% CI
CD Participants With CPF	52.67	± 31.27

Number of Participants Characterized Based on Healthcare Resource Utilization (HCRU) Within Previous 3 Years Secondary · Up to 3 years prior to the inclusion visit at Day 1

Number of participants characterized based on HCRU associated with complex perianal fistulas (CPFs) management within the three years prior to the inclusion visit were collected. HCRU includes gastroenterology and other medical specialty appointments for the management of CPF; emergency room visits due to CPF; hospitalizations (greater than or equal to \[\>=\] 24 hours) due to CPF, and intensive care unit (ICU) admission. Only categories with at least one participant with event are reported.

Any Medical Specialty Appointments for the Management of CPF

Group	Value	95% CI
CD Participants With CPF	15

Emergency Room Visits due to CPF

Group	Value	95% CI
CD Participants With CPF	3

Hospitalizations (>= 24 Hours) due to CPF

Group	Value	95% CI
CD Participants With CPF	5

Number of Participants Categorized Based on Sociodemographic and Anthropometric Characteristics Secondary · At inclusion visit (Day 1)

Sociodemographic and anthropometric variables included age (in years), sex (male or female), and body mass index (BMI).

Age: 22 to 64 Years

Group	Value	95% CI
CD Participants With CPF	15

Sex: Female

Group	Value	95% CI
CD Participants With CPF	8

Sex: Male

Group	Value	95% CI
CD Participants With CPF	7

BMI: Underweight

Group	Value	95% CI
CD Participants With CPF	0

BMI: Normal range

Group	Value	95% CI
CD Participants With CPF	9

BMI: Overweight

Group	Value	95% CI
CD Participants With CPF	4

BMI: Obese

Group	Value	95% CI
CD Participants With CPF	2

Number of Participants With Moderate to Severe Crohn's Disease (CD) Stratified by Clinical Characteristics Secondary · At inclusion visit (Day 1)

The Montreal classification index for CD is used to classify the extent of the disease activity. It consists of two parameters: location and behavior of the disease activity. There are four different disease locations presented: Location 1 (L1) is ileum, Location 2 (L2) is colonic disease, Location 3 (L3) is ileocolon and Location 4 (L4) is isolated upper gastrointestinal (GI) tract disease. The first three categories (L1-L3) is combined with L4 where disease sites coexisted. There are 4 different categories for the behavior of the disease activity: Behavior 1 (B1) is non stenosing or non pene

Disease Location 1: Terminal Ileum

Group	Value	95% CI
CD Participants With CPF	4

Disease Location 1 + 4: Terminal Ileum + Upper Gastrointestinal

Group	Value	95% CI
CD Participants With CPF	1

Disease Location 2: Colon

Group	Value	95% CI
CD Participants With CPF	3

Disease Location 3: Ileocolon

Group	Value	95% CI
CD Participants With CPF	5

Disease Location 3 + 4: Ileocolon + Upper Gastrointestinal

Group	Value	95% CI
CD Participants With CPF	2

Disease Behavior, Perianal Disease B1p: Nonstricturing, Nonpenetrating + Perianal

Group	Value	95% CI
CD Participants With CPF	8

Disease Behavior, Perianal Disease B2p: Stricturing + Perianal

Group	Value	95% CI
CD Participants With CPF	5

Disease Behavior, Perianal Disease B3p: Penetrating + Perianal

Group	Value	95% CI
CD Participants With CPF	2

Number of Participants Characterized Based on Pharmacological Treatments and Surgeries for CPF Secondary · Up to 3 years prior to the inclusion visit at Day 1

For each pharmacological treatment (antibiotics, monoclonal antibodies, immunosuppressants, and others), participants were divided into three categories (current users, past users, and non-users) considering the three years prior to the inclusion visit. Surgical treatment in the last three years for the management of CPF was also recorded. A participant may be included in more than one category.

Current Users: Antibiotics

Group	Value	95% CI
CD Participants With CPF	2

Current Users: Monoclonal Antibodies

Group	Value	95% CI
CD Participants With CPF	13

Current Users: Immunosuppressants

Group	Value	95% CI
CD Participants With CPF	7

Past Users: Antibiotics

Group	Value	95% CI
CD Participants With CPF	10

Past Users: Monoclonal Antibodies

Group	Value	95% CI
CD Participants With CPF	2

Past Users: Immunosuppressants

Group	Value	95% CI
CD Participants With CPF	2

Non-users: Antibiotics

Group	Value	95% CI
CD Participants With CPF	5

Non-users: Monoclonal Antibodies

Group	Value	95% CI
CD Participants With CPF	2

Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables Secondary · At inclusion visit (Day 1)

The following qualitative variables were considered for the bivariate analysis: sex, smoking status, employment status, extraintestinal manifestations of Crohn's disease, Montreal classification for CD disease (age at onset, disease location, and disease behavior), fistula type and position, CD disease activity, treatment-naïve, surgery-naïve, type of surgery, and presence of seton, perianal abscess and anorectal stricture. PCS-12 scores were transformed to a 0 to 100, with higher scores indicating better quality of life.

PCS-12: Sex- Male

Group	Value	95% CI
CD Participants With CPF	48.63	± 8.16

PCS-12: Sex- Female

Group	Value	95% CI
CD Participants With CPF	42.50	± 6.15

PCS-12: Employment Status- Employed

Group	Value	95% CI
CD Participants With CPF	44.01	± 7.33

PCS-12: Employment Status- Unemployed

Group	Value	95% CI
CD Participants With CPF	48.22	± 12.30

PCS-12: Employment Status- Retired

Group	Value	95% CI
CD Participants With CPF	48.18	± 3.49

PCS-12: Employment Status- Student

Group	Value	95% CI
CD Participants With CPF	43.25	± NA

PCS-12: Smoking Status- Never

Group	Value	95% CI
CD Participants With CPF	47.90	± 7.66

Sponsor's own description

The main aim of the study is to assess the quality of life of people with Crohn's disease after treatment for complex perianal fistulas (CPF) in a standard clinic setting.

Study doctors will review the participants' medical records in the last 3 years. Participants will also be asked to visit the clinic once to complete 1 questionnaire on their quality of life.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.