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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	21 February 2022
Main ID:	NCT03495973
Date of registration:	28/03/2018
Prospective Registration:	No
Primary sponsor:	Janssen-Cilag Ltd.
Public title:	Prospective Observational Study on Ustekinumab (Stelara) Assessing Efficacy and Healthcare Resource Utilization in Crohn's Disease PROSE
Scientific title:	Prospective Observational Study on Stelara Assessing Efficacy and Healthcare Resource Utilization in Crohn's Disease (PROSE)
Date of first enrolment:	October 25, 2017
Target sample size:	114
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT03495973
Study type:	Observational
Study design:
Phase:

Countries of recruitment
Sweden

Contacts

Name:	Janssen-Cilag Ltd. Clinical Trial
Address:
Telephone:
Email:
Affiliation:	Janssen-Cilag Ltd.

Key inclusion & exclusion 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

Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Crohn Disease

Intervention(s)

Drug: Ustekinumab

Primary Outcome(s)

Percentage of Participants with Clinical Remission at Week 104, Based on HBI [Time Frame: Week 104]

Percentage of Participants with Clinical Remission at Week 52, Based on HBI [Time Frame: Week 52]

Percentage of Participants with Clinical Remission at Week 16, Based on HBI [Time Frame: Week 16]

Percentage of Participants with Clinical Response at Week 16, Based on Harvey Bradshaw Index (HBI) [Time Frame: Week 16]

Secondary Outcome(s)

Healthcare Resource: Number of Imaging Procedures [Time Frame: Up to week 104]

Percentage of Participants in Every 12 weeks/8 weeks (q12 w/q8 w) maintenance groups at Week 16 [Time Frame: Week 16]

Percentage of Participants with Clinical Remission at Week 52 and 104 who are Remitters at 16 Weeks [Time Frame: Week 52 and 104]

Percentage of Participants with Clinical Remission at Week 52 and 104 who are Responders at 16 Weeks [Time Frame: Week 52 and 104]

Percentage of Participants with Clinical Response at Week 52 and 104, Based on HBI [Time Frame: Week 52 and 104]

Percentage of Participants with fCal Less Than (<)250 milligram per kilogram (mg/kg) [Time Frame: Week 16, 52 and 104]

Change from Baseline in EQ-5D-5L Visual Analog Scale (VAS) at Week 16, 52 and 104 [Time Frame: Baseline, Week 16, 52 and 104]

Healthcare Resource: Number of Participants Using Concomitant Treatment [Time Frame: Up to Week 104]

Number of Participants Requiring Antibiotics for any Infection Occurred During the Study [Time Frame: Up to Week 104]

Percentage of Participants with Corticosteroid Free Remission at Week 52 and 104 [Time Frame: Week 52 and 104]

Percentage of Participants with Dose Optimization [Time Frame: Year 1 and 2]

Healthcare Resource: Number of Laboratory Test [Time Frame: Up to Week 104]

Mean Change from Baseline in C-reactive Protein (CRP) Levels at Week 16, 52 and 104 [Time Frame: Baseline, Week 16, 52 and 104]

Mean Change from Baseline in Fecal Calprotectin (fCal) Levels at Week 16, 52 and 104 [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 [Time Frame: Baseline, Week 16, 52 and 104]

Healthcare Resource: Number of Dual Energy X-ray Absorptiometry (DEXA) Scans [Time Frame: Up to Week 104]

Healthcare Resource: Number of Surgical Procedures [Time Frame: Up to Week 104]

Participant's Time off Corticosteroids [Time Frame: Up to week 104]

Percentage of Participants on Initial q12 w Maintenance Dose Escalated from q12 w to q8 w in Year 1 and 2 [Time Frame: Year 1 and 2]

Percentage of Participants with fCal levels <250 mg/kg at Week 16, 52 and 104 [Time Frame: Week 16, 52 and 104]

Percentage of Participants with Normalization of Plasma-CRP (P-CRP) [Time Frame: Week 16, 52 and 104]

Change from Baseline in Short Health Scale (SHS) Score at Week 16, 52 and 104 [Time Frame: Baseline, Week 16, 52 and 104]

Percentage of Participants in Clinical Remission Overtime [Time Frame: Up to Week 104]

Healthcare Resource: Number of Days of Hospitalization [Time Frame: Up to Week 104]

Healthcare Resource: Number of Health Care Visits [Time Frame: Up to Week 104]

Average Maintenance Dose per Month [Time Frame: Week 52 and 104]

Change from Baseline in the Presence of Extra Intestinal Manifestations at Week 16, 52 and 104 [Time Frame: Baseline, Week 16, 52 and 104]

Healthcare Resource: Number of Participants with Endoscopies Performed [Time Frame: Up to Week 104]

Number of Participants with Malignancy [Time Frame: Up to Week 104]

Healthcare Resource: Number of Sick-Leaves [Time Frame: Up to Week 104]

Percentage of Participants with Clinical Remission at Week 104 who are Remitters at 52 Weeks [Time Frame: Week 104]

Secondary ID(s)

CNTO1275CRD4006

CR108430

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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