Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Number of Participants With Change From Baseline in QoLAF-Q Scores at Month 12 After Treatment Initiation for CPF |
QoLAF-Q evaluates quality of life (QoL) among participants with both simple and complex anal fistula (AF). It is composed of a total of 14 items with a Likert scale from 1 to 5 points. Its score range is the following: zero impact=14 points; limited impact=15 to 28 points; moderate impact=29 to 42 points; high impact=43 to 56 points; and very high impact=57 to 70 points. |
Baseline and Month 12 |
|
| Secondary |
Number of Participants With Change From Baseline in QoLAF-Q Scores at Month 6 After Treatment Initiation for CPF |
QoLAF-Q evaluates QoL among participants with both simple and complex AF. It is composed of a total of 14 items with a Likert scale from 1 to 5 points. Its score range is the following: zero impact=14 points; limited impact=15 to 28 points; moderate impact=29 to 42 points; high impact=43 to 56 points; and very high impact=57 to 70 points. |
Baseline and Month 6 |
|
| Secondary |
Percentage of Participants With Clinically Significant Change From Baseline in QoLAF-Q Score at Months 6 and 12 After Treatment for CPF |
QoLAF-Q evaluates QoL among participants with both simple and complex AF. It is composed of a total of 14 items with a Likert scale from 1 to 5 points. Its score range is the following: zero impact=14 points; limited impact=15 to 28 points; moderate impact=29 to 42 points; high impact=43 to 56 points; and very high impact=57 to 70 points. |
Baseline, Months 6 and 12 |
|
| Secondary |
Change From Baseline in EuroQoL-Five Dimensions, Five Levels (EQ-5D-5L) Scores at Months 6 and 12 After Treatment for CPF |
The EQ-5D- is a generic, self-reported measure of utility that consists of a five-item descriptive system and a visual analogue scale (EQ VAS). The descriptive system has two versions, namely the 3L and 5L, both involving five health dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). In the EQ-5D-5L that will be used, participants may choose from the following five response levels: no problems=1; slight problems=2; moderate problems=3; severe problems=4; and unable to/extreme problems=5. Higher values indicate worst health. |
Baseline, Months 6 and 12 |
|
| Secondary |
Change From Baseline in Faecal Incontinence Quality of Life Scale (FIQOL) Scores at Months 6 and 12 After Treatment for CPF |
FIQOL comprises of 29 items that cover four dimensions of perceived health: lifestyle (10 items), behavior (9 items), depression/ self-perception (7 items), and embarrassment (3 items). Each item has a range of 1 to 4, with 1 being the lowest value for the state of quality of life. |
Baseline, Months 6 and 12 |
|
| Secondary |
Change From Baseline in Perceived Stress Scale (PSS) Scores at Months 6 and 12 After Treatment for CPF |
The PSS assesses participant's perceived nonspecific stress in a given situation or a daily life situation. The overall score of the scale is measured on a 14-item scale (from 0 to 4 points). Each item is scored 0 (never) to 4 (very often). Total score is obtained by inverting the scores on items 4, 5, 6, 7, 9, 10 y 13 (as follows: 0=4, 1=3, 2=2, 3=1 y 4=0) and summing up the scores of the 14 items. Higher total scores indicate higher perceived stress. |
Baseline, Months 6 and 12 |
|
| Secondary |
Change From Baseline in International Index of Erectile Function (IIEF) Scores at Months 6 and 12 After Treatment for CPF |
The IIEF is a multi-dimensional, self-administered questionnaire to assess erectile dysfunction. A score of 0 to 5 is awarded to each of the 15 questions that examine the 4 main domains of male sexual function: Erectile Function (EF), Orgasmic Function (OF), Sexual Desire (SD) and Intercourse Satisfaction (IS). EF has five categories: 1-10(Severe Erectile Dysfunction), 11-16(Moderate dysfunction), 17-21(Mild to moderate dysfunction), 22-25(Mild dysfunction), 26-30 (No dysfunction). OF: sum of Questions (Q) 9 and Q10, each rated 0 (no sexual stimulation) to 5 (almost always/always). OF domain score range: 0 to 10; lower scores denoted lower OF. SD: sum of Q11 and Q12, each rated 1 (almost never or low/no sexual desire) to 5 (almost always or very high sexual desire). SD domain score range: 2 to 10;lower scores denoted lower SD. IS: sum of Q6, Q7, and Q8, each rated 0 (low/no satisfaction) to 5 (high satisfaction). IS domain score range: 0 to 15; lower scores denoted lower satisfaction. |
Baseline, Months 6 and 12 |
|
| Secondary |
Change From Baseline in Female Sexual Function Index (FSFI) Scores at Months 6 and 12 After Treatment for CPF |
The FSFI is a 19-item multidimensional self-report questionnaire for the assessment of female sexual function. It has five domains of sexual function, including: desire and subjective arousal, lubrication, orgasm, satisfaction, and pain/discomfort. FSFI is scored on a scale ranging from 1.2 to 6.0 (desire), 0 to 6.0 (arousal, lubrication, orgasm, and pain/discomfort) or 0.8 to 6.0 (satisfaction), with higher scores indicating better performance. The total score, falling in a possible range from 2.0 to 36.0, is obtained by adding the six domain scores together. |
Baseline, Months 6 and 12 |
|
| Secondary |
Number of Participants Based on Type of Treatment, Dose, Dose Frequency and Date of Initiation |
|
Baseline |
|
| Secondary |
Number of Participants Based on Biological Data |
Biological data includes blood count, electrolytes, C-reactive protein (CRP), and fecal calprotectin. |
Baseline, Months 6 and 12 |
|
| Secondary |
Number of Participants With Comorbidities Based on Charlson Comorbidity Index |
The Charlson Comorbidity Index is a 19-item measure assessing comorbid conditions. The total possible score on the Charlson Comorbidity Index ranges from 0 to 37. If a condition is not present, the score for that condition is zero. The higher scores indicate greater comorbidity. |
Baseline |
|
| Secondary |
Number of Participants With Comedications for Treatment of CD and Fistula |
|
Baseline |
|
| Secondary |
Number of Participants With Target CPF |
|
Baseline |
|
| Secondary |
Number of Participants With the Presence of new CPF at Months 6 and 12 |
|
Months 6 and 12 |
|
| Secondary |
Montreal Classification Assessed at Baseline |
Montreal Classification includes age at diagnosis, disease location and disease behavior. Disease behavior was classified according to the following: B1 = non-stricturing, non-penetrating; B2 = structuring; B3 = penetrating; P = perianal disease modifier. The change in Montreal Classification is presented in three categories: no change, deterioration, and improvement. Deterioration defined as an increase in behavior index between 1 and 3, or development of perianal disease. |
Baseline |
|
| Secondary |
Number of Participants With Clinical characteristics Based on Harvey Bradshaw Index (HBI) |
HBI score is used to measure the disease activity of CD. It consists of clinical parameters: general well-being (0-4, where higher score means lower well being), 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. |
Baseline, Months 6 and 12 |
|
| Secondary |
Number of Participants With Clinical Characteristics Based on Perianal Crohn´s Disease Activity Index (PDAI) or Fistula Drainage Assessment (FDA) |
The PDAI is a scoring system to evaluate the severity of perianal lesion associated with CD. It includes the following 5 items: (a) Discharge; (b) Pain; (c) Restriction of sexual activity; (d) Type of perianal disease; and (e) Degree of induration. Each item is graded on a 5-point scale ranging from no symptoms (score of 0) to severe symptoms (score of 4) and total range of score is from 0 to 20. Higher score means more severe disease. |
Baseline, Months 6 and 12 |
|
| Secondary |
Number of Occurrences of Treatment Switching or Dose Change |
|
Months 6 and 12 |
|
| Secondary |
Relation Between Participants QoLAF-Q Score and Clinical Variables |
A parametric test will be used to measure the degree of association between the QolAF score and clinical variable. QoLAF-Q evaluates QoL among participants with both simple and complex AF. It is composed of a total of 14 items with a Likert scale from 1 to 5 points. Its score range is the following: zero impact=14 points; limited impact=15 to 28 points; moderate impact=29 to 42 points; high impact=43 to 56 points; and very high impact=57 to 70 points. |
Baseline |
|
| Secondary |
Number of Participants Based on Methods Used to Evaluate the Response to Different Treatments for CPF in Routine Clinical Practice |
|
Months 6 and 12 |
|
| Secondary |
Number of Participants Based on Effectiveness of Different Treatment Options for CPF Grouped According to Therapeutic Class |
The effectiveness of different treatment options for CPF grouped according to therapeutic class (medical treatment, surgery or both) will be defined as the absence of draining despite gentle finger compression. |
Months 6 and 12 |
|
| Secondary |
Health Care Resources Utilization (HCRU) |
HCRU includes emergency department and Intensive Care Units (ICU) visits; hospitalization (greater than or equal to (>=) 24 hours or related complications; number, type and reason for gastroenterology specialist or other specialty referral outpatient visits for management of complex perianal fistulas; surgeries or related complications; number of Magnetic Resonance Imaging (MRI) of the pelvis or transperineal, endoscopic ultrasound (EUS), and other non-surgical procedures performed to guide therapy, number of blood tests performed. |
Baseline, Months 6 and 12 |
|
| Secondary |
Correlation Between the Change in CD Participant's Scores in the QoLAF-Q, the EQ-5D-5L and Rapid Assessment Faecal Incontinence Score (RAFIS) |
Correlations between the scores obtained in the QoLAF-Q scale and the scores obtained in the RAFIS and EQ-5D-5L will be studied using Pearson correlation coefficients. QoLAF-Q evaluates QoL among participants with both simple and complex AF. It consists of a total of 14 items with a Likert scale from 1-5 points. Its score ranges:zero impact=14 points;limited impact=15 to 28 points; moderate impact=29 to 42 points;high impact=43 to 56 points;and very high impact=57 to 70 points. The EQ-5D- is a generic, self-reported measure of utility that consists of a 5-item descriptive system and EQ VAS. The descriptive system has 2 versions: 3L and 5L,both involving 5 health dimensions (mobility,self-care,usual activities, pain/discomfort and anxiety/depression). In the EQ-5D-5L that will be used, participants may choose from the following 5 response levels:no problems=1; slight problems=2;moderate problems=3; severe problems=4;and unable to/extreme problems=5.Higher values indicate worst health. |
Baseline, Months 6 and 12 |
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