Clinical trial NCT03495973: Prospective Observational Study on Ustekinumab (Stelara) Assessing Efficacy and Healthcare Resource Utilization in Crohn's Disease
Official title: Prospective Observational Study on Stelara Assessing Efficacy and Healthcare Resource Utilization in Crohn's Disease (PROSE)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Crohn Disease
Lead sponsor: Janssen-Cilag Ltd.
Sponsor class: INDUSTRY
First posted: 2018-04-12
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with a confirmed Crohn's disease (CD) aged over 18 years treated with ustekinumab.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Participant has a diagnosis of CD confirmed by investigator
* Participants with active CD who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic therapy or have medical contraindications to such therapies
* The participant must sign informed consent before enrollment in the study. The consent form permits extraction of data from SWIBREG at baseline and during participation of the study and linkages to the Patient Registry (Patientregistret), SCB's registry USA for occupational details (Longitudinell integrationsdatabas for sjukforsakrings- och arbetsmarknadsstudi er), the Social Insurance registry on long-term sick leave (Forsakringskassans register gallande sjukskrivningar) and the Prescription registry (Lakemedelsregistret)
* The participant must have been initiated on treatment with ustekinumab within the last 2 weeks (that is including those who already discontinued) or started on ustekinumab treatment less than (\<) 3 months ago if treatment start was documented in SWIBREG within 2 weeks of onset and has a record of Harvey Bradshaw Index (HBI) when starting ustekinumab

Exclusion Criteria:

* The participant is enrolled in a clinical trial (randomized or non-randomized) in which the treatment of CD is dictated by a study protocol. If the participant is participating in another observational study (non-interventional), the participant may be included in this observational study
* Received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 60 days before the start of the study or the first data collection time point
* Participants who started ustekinumab despite contraindications for use
* Participants with planned stop of treatment with ustekinumab within 24 months from onset of treatment, that is bridging to other treatment or pregnancy planned

Primary outcomes:
measure: Percentage of Participants with Clinical Response at Week 16, Based on Harvey Bradshaw Index (HBI)
timeFrame: Week 16
measure: Percentage of Participants with Clinical Remission at Week 16, Based on HBI
timeFrame: Week 16
measure: Percentage of Participants with Clinical Remission at Week 52, Based on HBI
timeFrame: Week 52
measure: Percentage of Participants with Clinical Remission at Week 104, Based on HBI
timeFrame: Week 104
Secondary outcomes:
measure: Percentage of Participants with Clinical Response at Week 52 and 104, Based on HBI
timeFrame: Week 52 and 104
measure: Percentage of Participants with Clinical Remission at Week 52 and 104 who are Remitters at 16 Weeks
timeFrame: Week 52 and 104
measure: Percentage of Participants with Clinical Remission at Week 104 who are Remitters at 52 Weeks
timeFrame: Week 104
measure: Percentage of Participants with Clinical Remission at Week 52 and 104 who are Responders at 16 Weeks
timeFrame: Week 52 and 104
measure: Percentage of Participants in Clinical Remission Overtime
timeFrame: Up to Week 104
measure: Percentage of Participants with Corticosteroid Free Remission at Week 52 and 104
timeFrame: Week 52 and 104
measure: Participant's Time off Corticosteroids
timeFrame: Up to week 104
measure: Percentage of Participants in Every 12 weeks/8 weeks (q12 w/q8 w) maintenance groups at Week 16
timeFrame: Week 16
measure: Percentage of Participants on Initial q12 w Maintenance Dose Escalated from q12 w to q8 w in Year 1 and 2
timeFrame: Year 1 and 2
measure: Percentage of Participants with Dose Optimization
timeFrame: Year 1 and 2
measure: Average Maintenance Dose per Month
timeFrame: Week 52 and 104
measure: Mean Change from Baseline in Fecal Calprotectin (fCal) Levels at Week 16, 52 and 104
timeFrame: Baseline, Week 16, 52 and 104
measure: Mean Change from Baseline in C-reactive Protein (CRP) Levels at Week 16, 52 and 104
timeFrame: Baseline, Week 16, 52 and 104
measure: Percentage of Participants with fCal Less Than (<)250 milligram per kilogram (mg/kg)
timeFrame: Week 16, 52 and 104
measure: Percentage of Participants with fCal levels <250 mg/kg at Week 16, 52 and 104
timeFrame: Week 16, 52 and 104
measure: Percentage of Participants with Normalization of Plasma-CRP (P-CRP)
timeFrame: Week 16, 52 and 104
measure: Change from Baseline in Short Health Scale (SHS) Score at Week 16, 52 and 104
timeFrame: Baseline, Week 16, 52 and 104
measure: Change from Baseline in EuroQoL 5-Dimension 5-Level Health Status (EQ-5D-5L) Questionnaire at Week 16, 52 and 104
timeFrame: Baseline, Week 16, 52 and 104
measure: Change from Baseline in EQ-5D-5L Visual Analog Scale (VAS) at Week 16, 52 and 104
timeFrame: Baseline, Week 16, 52 and 104
measure: Change from Baseline in the Presence of Extra Intestinal Manifestations at Week 16, 52 and 104
timeFrame: Baseline, Week 16, 52 and 104
measure: Healthcare Resource: Number of Imaging Procedures
timeFrame: Up to week 104
measure: Healthcare Resource: Number of Laboratory Test
timeFrame: Up to Week 104
measure: Healthcare Resource: Number of Surgical Procedures
timeFrame: Up to Week 104
measure: Healthcare Resource: Number of Dual Energy X-ray Absorptiometry (DEXA) Scans
timeFrame: Up to Week 104
measure: Healthcare Resource: Number of Participants with Endoscopies Performed
timeFrame: Up to Week 104
measure: Healthcare Resource: Number of Days of Hospitalization
timeFrame: Up to Week 104
measure: Healthcare Resource: Number of Sick-Leaves
timeFrame: Up to Week 104
measure: Healthcare Resource: Number of Participants Using Concomitant Treatment
timeFrame: Up to Week 104
measure: Healthcare Resource: Number of Health Care Visits
timeFrame: Up to Week 104
measure: Number of Participants with Malignancy
timeFrame: Up to Week 104
measure: Number of Participants Requiring Antibiotics for any Infection Occurred During the Study
timeFrame: Up to Week 104
Other outcomes:
Locations:
city: Örebro
country: Sweden
facility: Universitetssjukhuset Orebro
Study officials:
affiliation: Janssen-Cilag Ltd.
name: Janssen-Cilag Ltd. Clinical Trial
role: STUDY_DIRECTOR
References: