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Stavanger IBD Study - Cross Sectional (SUSI-CS)

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ClinicalTrials.gov Identifier: NCT02134054
Recruitment Status : Active, not recruiting
First Posted : May 8, 2014
Last Update Posted : February 5, 2020
Sponsor:
Collaborator:
Oslo University Hospital
Information provided by (Responsible Party):
Helse Stavanger HF

Brief Summary:

In this cross sectional and longitudinal study, patients with inflammatory bowel disease on biological treatment with infliximab or adalimumab will be included.

After inclusion, the dosage of their existing biological therapy will be adjusted following regular trough-level and antibody-level monitoring, according to a treatment algorithm.

Disease activity markers, fatigue and QoL will be assessed during the study. The hypothesis is that therapeutic drug monitoring may improve clinical disease outcome after one year of follow-up.


Condition or disease
Inflammatory Bowel Disease

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Study Type : Observational
Actual Enrollment : 210 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Stavanger University Hospital IBD Study - a Cross Sectional Longitudinal Study on Patients Treated With Biologics
Study Start Date : April 2014
Actual Primary Completion Date : November 2015
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Group/Cohort
Biologic
Patients on treatment with biologics (infliximab or adalimumab)



Primary Outcome Measures :
  1. Clinical remission rate [ Time Frame: One Year ]
    Harvey Bradshaw Index <5 Partial Mayo score <=2


Secondary Outcome Measures :
  1. Symptom scoring [ Time Frame: One Year ]
    Harvey Bradshaw Index, Partial Mayo Score. Change after therapeutic drug monitoring.

  2. Inflammatory markers [ Time Frame: One year ]
    C reactive protein, Fecal Calprotectin. Change after therapeutic drug monitoring.

  3. Fatigue scoring [ Time Frame: One Year ]
    Assessed by Fatigue severity scale and Visual analogue scale. Change after therapeutic drug monitoring.


Other Outcome Measures:
  1. Healthcare resource utilization [ Time Frame: One year ]

    Registration of

    • Outpatient visits
    • Hospital admissions (days)
    • Sick leave (days)
    • Visits at general practitioner due to IBD activity
    • Endoscopy due to IBD activity


Biospecimen Retention:   Samples Without DNA
Standard blood sampling Serum sampling - trough/antibodies of biological agent


Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with inflammatory bowel disease established (minimum 3 doses) on treatment with infliximab or adalimumab
Criteria

Inclusion Criteria:

  • Patients diagnosed with inflammatory bowel disease on treatment with infliximab or adalimumab of any duration (at least 3 doses)

Exclusion Criteria:

  • Inability to consent
  • Inability to adhere to treatment protocol.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02134054


Locations
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Norway
Stavanger University Hospital
Stavanger, Norway, 4068
Sponsors and Collaborators
Helse Stavanger HF
Oslo University Hospital
Investigators
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Principal Investigator: Tore B Grimstad, MD, PhD Stavanger University Hospital, Department of Medicine
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Helse Stavanger HF
ClinicalTrials.gov Identifier: NCT02134054    
Other Study ID Numbers: SUSI-CS_1
First Posted: May 8, 2014    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Helse Stavanger HF:
Therapeutic drug monitoring
Biological treatment
IBD
Additional relevant MeSH terms:
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Inflammatory Bowel Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis