The main purpose of this study is to assess ustekinumab's ability to induce clinical response and remission ("effectiveness") at Week 16 and remission at Week 52 and Week 104 in participants with Crohn's disease (CD). Response and remission will be assessed using clinical parameters. Retention rate at week 52 and 104 will also be studied.
Study Type
OBSERVATIONAL
Enrollment
114
Participants that are initiated on treatment with ustekinumab and are registered in Swibreg will be recruited into the cohort. All aspects of treatment and clinical management of participants will be in accordance with local clinical practice and applicable local regulations, and at the discretion of the participating physician.
Universitetssjukhuset Orebro
Örebro, Sweden
Percentage of Participants with Clinical Response at Week 16, Based on Harvey Bradshaw Index (HBI)
Clinical response for Crohn's disease (CD) is assessed by Harvey Bradshaw Index (HBI) and is defined as decrease of 3 points in baseline HBI score. HBI 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 per day and number of complications, where higher scores indicates more severe disease and, score is presented as: less than (\<)5 (remission), 5-7 (mild disease), 8-16 (moderate disease), and greater than (\>)16 (severe disease).
Time frame: Week 16
Percentage of Participants with Clinical Remission at Week 16, Based on HBI
Clinical remission for CD is assessed by HBI and is defined as HBI less than (\<)5. HBI 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 per day and number of complications, where higher scores indicates more severe disease and, score indicates: less than (\<)5 (remission), 5-7 (mild disease), 8-16 (moderate disease), and greater than (\>)16 (severe disease).
Time frame: Week 16
Percentage of Participants with Clinical Remission at Week 52, Based on HBI
Clinical remission for CD is assessed by HBI and is defined as HBI \<5. HBI 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 per day and number of complications, where higher scores indicates more severe disease and, score is presented as: less than (\<)5 (remission), 5-7 (mild disease), 8-16 (moderate disease), and greater than (\>)16 (severe disease).
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Time frame: Week 52
Percentage of Participants with Clinical Remission at Week 104, Based on HBI
Clinical remission for CD is assessed by HBI and is defined as HBI \<5. HBI 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 per day and number of complications, where higher scores indicates more severe disease and, score is presented as: less than (\<)5 (remission), 5-7 (mild disease), 8-16 (moderate disease), and greater than (\>)16 (severe disease).
Time frame: Week 104
Percentage of Participants with Clinical Response at Week 52 and 104, Based on HBI
Clinical response for CD is assessed by HBI and is defined as decrease of 3 points in baseline HBI score. HBI 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 per day and number of complications, where higher scores indicates more severe disease and, score is presented as: less than (\<)5 (remission), 5-7 (mild disease), 8-16 (moderate disease), and greater than (\>)16 (severe disease).
Time frame: Week 52 and 104
Percentage of Participants with Clinical Remission at Week 52 and 104 who are Remitters at 16 Weeks
Clinical remission for CD is assessed by HBI and is defined as HBI \<5. HBI 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 per day and number of complications, where higher scores indicates more severe disease and, score is presented as: less than (\<)5 (remission), 5-7 (mild disease), 8-16 (moderate disease), and greater than (\>)16 (severe disease).
Time frame: Week 52 and 104
Percentage of Participants with Clinical Remission at Week 104 who are Remitters at 52 Weeks
Clinical remission for CD is assessed by HBI and is defined as HBI \<5. HBI 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 per day and number of complications, where higher scores indicates more severe disease and, score is presented as: less than (\<)5 (remission), 5-7 (mild disease), 8-16 (moderate disease), and greater than (\>)16 (severe disease).
Time frame: Week 104
Percentage of Participants with Clinical Remission at Week 52 and 104 who are Responders at 16 Weeks
Clinical remission for CD is assessed by HBI and is defined as HBI \<5. Responders are defined as the participants with decrease of 3 points in baseline HBI score. HBI 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 per day and number of complications, where higher scores indicates more severe disease.
Time frame: Week 52 and 104
Percentage of Participants in Clinical Remission Overtime
Clinical remission for CD is assessed by HBI and is defined as HBI \<5. HBI 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 per day and number of complications, where higher scores indicates more severe disease.
Time frame: Up to Week 104
Percentage of Participants with Corticosteroid Free Remission at Week 52 and 104
Participants on corticosteroids at baseline will be analyzed according to the percentage of participants in remission at week 52 and 104 without corticosteroids to assess corticosteroids free remission.
Time frame: Week 52 and 104
Participant's Time off Corticosteroids
Duration for which participants were off from corticosteroids will be determined.
Time frame: Up to week 104
Percentage of Participants in Every 12 weeks/8 weeks (q12 w/q8 w) maintenance groups at Week 16
Percentage of participants in q12 w/q8 w maintenance groups will be determined at Week 16.
Time frame: Week 16
Percentage of Participants on Initial q12 w Maintenance Dose Escalated from q12 w to q8 w in Year 1 and 2
Percentage of participants on initial q12 maintenance dose escalated from q12 w to q8 w in Year 1 and 2 will be determined.
Time frame: Year 1 and 2
Percentage of Participants with Dose Optimization
Percentage of participants with dose optimized to other dose than 90 milligram (mg) q8 w/q12 w in maintenance in Year 1 and 2 will be determined.
Time frame: Year 1 and 2
Average Maintenance Dose per Month
Average maintenance dose (in mg) taken per month will be determined.
Time frame: Week 52 and 104
Mean Change from Baseline in Fecal Calprotectin (fCal) Levels at Week 16, 52 and 104
Mean change from baseline in fCal (inflammatory biomarker) levels will be determined.
Time frame: Baseline, Week 16, 52 and 104
Mean Change from Baseline in C-reactive Protein (CRP) Levels at Week 16, 52 and 104
Mean change from baseline in C-reactive protein (CRP) (inflammatory biomarker) levels will be determined.
Time frame: Baseline, Week 16, 52 and 104
Percentage of Participants with fCal Less Than (<)250 milligram per kilogram (mg/kg)
Percentage of participants with fCal \<250 mg/kg will be determined.
Time frame: Week 16, 52 and 104
Percentage of Participants with fCal levels <250 mg/kg at Week 16, 52 and 104
Percentage of participants with fCal levels \<250 mg/kg at Week 16, 52 and 104 will be determined in total and amongst participants with fCal levels greater than (\>)250 mg/kg at baseline.
Time frame: Week 16, 52 and 104
Percentage of Participants with Normalization of Plasma-CRP (P-CRP)
Percentage of participants with normalization of P-CRP in in participants with abnormal P-CRP at baseline will be reported. Normalization of P-CRP is defined as the high-sensitive (Hs)-CRP level \<3 milligram per Liter (mg/L) or CRP below threshold of abnormal CRP concentration.
Time frame: Week 16, 52 and 104
Change from Baseline in Short Health Scale (SHS) Score at Week 16, 52 and 104
Quality of life will be assessed by SHS score. SHS is a health related quality of life (HRQoL) questionnaire in which the participants rate the disease impact on 4 important aspects of subjective health (symptoms, function, worry, and general well-being). Responses are scored on 100-mm visual analogue scales and presented as individual scores for each of the four questions. The scores are then added for a total score. Total score ranges from 0 (low disease activity) to 100 (high disease activity).
Time frame: Baseline, Week 16, 52 and 104
Change from Baseline in EuroQoL 5-Dimension 5-Level Health Status (EQ-5D-5L) Questionnaire at Week 16, 52 and 104
Quality of life will be assessed by EQ-5D-5L score. The EQ-5D-5L descriptive system comprises following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each of 5 dimension is divided into 5 levels of perceived problems (Level 1: no problem, Level 2: slight problems, Level 3: moderate problems, Level 4: severe problems, and Level 5: extreme problems). The participant selects an answer for each of 5 dimensions considering response that best matches his or her health "today". The descriptive system can be represented as a health state.
Time frame: Baseline, Week 16, 52 and 104
Change from Baseline in EQ-5D-5L Visual Analog Scale (VAS) at Week 16, 52 and 104
The EQ-VAS self-rating scale records respondent's own assessment of his or her overall health status at time of completion, on a scale of 0 (worst imaginable health) to 100 (best imaginable health).
Time frame: Baseline, Week 16, 52 and 104
Change from Baseline in the Presence of Extra Intestinal Manifestations at Week 16, 52 and 104
Change in the presence of extra intestinal manifestations, that is arthralgia, peripheral arthritis, anchylosing spondylitis, uveitis, erythema nodosum, pyoderma gangrenosum, primary sclerosing cholangitis, psoriatic arthritis and psoriasis will be determined.
Time frame: Baseline, Week 16, 52 and 104
Healthcare Resource: Number of Imaging Procedures
Number of imaging procedures completed as a part of healthcare resources used in participants will be reported.
Time frame: Up to week 104
Healthcare Resource: Number of Laboratory Test
Number of Laboratory tests completed as a part of healthcare resources used in participants will be reported.
Time frame: Up to Week 104
Healthcare Resource: Number of Surgical Procedures
Number of surgical procedures completed as a part of healthcare resources used in participants will be reported.
Time frame: Up to Week 104
Healthcare Resource: Number of Dual Energy X-ray Absorptiometry (DEXA) Scans
Number of DEXA scans performed as a part of healthcare resources used will be reported.
Time frame: Up to Week 104
Healthcare Resource: Number of Participants with Endoscopies Performed
Number of participants with endoscopies performed as a part of healthcare resources used will be reported.
Time frame: Up to Week 104
Healthcare Resource: Number of Days of Hospitalization
Number of days of hospitalization (defined as number of days from the day of admission to discharge) as a part of healthcare resources used will be reported.
Time frame: Up to Week 104
Healthcare Resource: Number of Sick-Leaves
Number of sick-leaves taken by participants as a part of healthcare resources used will be reported.
Time frame: Up to Week 104
Healthcare Resource: Number of Participants Using Concomitant Treatment
Number of participants using concomitant treatment as a part of healthcare resources used will be reported.
Time frame: Up to Week 104
Healthcare Resource: Number of Health Care Visits
Number of health care visits to nurses, dieticians and doctors as a part of healthcare resources used will be reported.
Time frame: Up to Week 104
Number of Participants with Malignancy
Number of participants with malignancy developed during the study will be reported.
Time frame: Up to Week 104
Number of Participants Requiring Antibiotics for any Infection Occurred During the Study
Number of participants requiring antibiotics for any infection occurred during the study will be reported.
Time frame: Up to Week 104