Predicting Relapse of Ulcerative Colitis With Gastrointestinal Ultrasound

NCT03501758 | Unknown

• 1 other identifier: 2017/1769
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

Rationale: Ulcerative colitis (UC) is remitting disease with a variable course. Predicting disease relapse after remission is important for the adjustment of medical treatment. Ileocolonoscopy is the best tool for doing this, but due to its invasiveness should be replaced by a method better accepted by the patient. Gastrointestinal ultrasound (GIUS) could be such a method.The PRELAPSE study will include UC patients who have been on maintenance anti-TNF therapy for at one year or more and in clinical remission for the 3 past months at least in two centres, Haukeland University Hospital and Ålesund Hospital. The infrastructure for recruiting these patients has already been established in the BIOSTOP study (Protocol ID no: HMR2016-0.6 and EudraCT (European Clinical Trials Database) no: 2016-001409-18). Objective: To study if GIUS or individual US parameters can predict endoscopic relapse at follow up examinations in a group of patients with ulcerative colitis in sustained clinical and endoscopic remission Study design: Prospective, longitudinal, explorative, observational multi-centric study for diagnostic accuracy Study population: Adult patients with histo-pathologically confirmed diagnosis of UC between 18 and 80 years of age that have entered the BIOSTOP trial (Trial number: EudraCT: 2016-001409-18) will be considered for inclusion in the proposed study. Intervention: All patients will be subjected to trans-abdominal gastrointestinal ultrasound and ileocolonoscopy. Blood and faeces samples will be collected at one time point for measuring relevant inflammatory markers. Main study parameter: Ultrasound measurements of the intestine of patients with ulcerative colitis Nature and extent of the burden and risks associated with participation, benefit and group relatedness: All patients will be examined repeatedly with gastrointestinal ultrasound (GIUS) and at certain time points with ileocolonoscopy or sigmoidoscopy. As all these procedures already are scheduled as a part of the BIOSTOP study the only extra burden for the patients will be the ultrasound examination. GIUS is a safe procedure that uses high frequency sound waves for the visualization of internal organs. The implementation of GIUS for the assessment of disease activity in UC patients might result in a reduced need for ileocolonoscopy, thereby reducing costs and the burden for patients. Compared to invasive endoscopic procedures GIUS can be performed without preparation, which is an advantage for the patients as treatment decisions can be made without delay. GIUS is also cheaper than ileocolonoscopy, causes little discomfort and has few or no complications.

Conditions

Ulcerative Colitis in Remission; Ultrasound; Relapse/Recurrence

Keywords

ulcerative colitis; ultrasound; remission; relapse

Outcome Measures

Primary Outcomes (1)

• Endoscopic relapse

  Endscopic relapse defined as a MAYO endoscopic subscore ≥2

  Follow up period (24 months)

Secondary Outcomes (3)

• Clinical relapse

  Follow up period (24 months)

• Interobserver variation

  Follow up period (24 months)

• Interobserver variation

  Follow up period (24 months)

Other Outcomes (2)

• Strict endoscopic relapse

  Follow up period (24 months)

• Histological relapse

  Follow up period (24 months)

Study Arms (2)

Remission with treatment

Patients randomized to continue medical treatment with biologics

Diagnostic Test: Ultrasound; Diagnostic Test: Analysis of prouroguanyline and uroguanyline in full blood

Remission without treatment

Patients randomized to stop medical treatment with biologics

Diagnostic Test: Ultrasound; Diagnostic Test: Analysis of prouroguanyline and uroguanyline in full blood

Interventions

Ultrasound DIAGNOSTIC_TEST

Transabdominal ultrasound of the bowel for categorisation of disease activity

Remission with treatment; Remission without treatment

Analysis of prouroguanyline and uroguanyline in full blood DIAGNOSTIC_TEST

Withdrawal of full blood at each study visit, Storage in biobank. Analysis of prouroguanyline and proguanyline.

Remission with treatment; Remission without treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult male and female patients with an established diagnosis of ulcerative colitis treated for minimum 1 year with anti-TNF maintenance therapy and in clinical remission during the last 3 months. Patients will be included from two hospitals in Norway (Haukeland University Hospital in Bergen and Ålesund Hospital in Ålesund.).

You may qualify if:

• A confirmed diagnosis of ulcerative colitis
• Six-point Mayo score ≤ 1
• Two consecutive faecal calprotectin tests \<200 mg/kilogram
• Male or non-pregnant, non-nursing female
• Patients treated for minimum 1 year with first-line anti-tumor necrosis factor (TNF) treatment in sustained clinical remission during the last 3 months
• Subject capable of understanding and signing an informed consent form

You may not qualify if:

• Discontinuation of systemic 5-acetylsalicylic acid (ASA) or immunomodulatory therapy or other medication that could affect disease activity during the last 3 months prior to randomization
• Any treatment of systemic corticosteroids due to disease exacerbation during the last 3 months (i.e. patients being in steroid free clinical remission.
• Patients on anti-TNF monotherapy with intolerance to both 5-ASA and immunomodulatory therapy
• Change in the anti-TNF treatment during the last 3 months due to disease related factors, not including dose/frequency adjustments due to drug concentration measurements
• Use of any second-line anti-TNF medication irrespective of reason for stopping first-line anti-TNF
• Previous failed attempts of anti-TNF discontinuation of more than 4 months' duration, with the exception of discontinuation due to pregnancy
• Detection of anti-TNF antibodies in moderate-high titers prior to randomization
• Psychiatric or mental disorders, alcohol abuse or other substance abuse, language barriers or other factors which makes adherence to the study protocol impossible
• Pregnancy
• Breastfeeding
• Participation in any other investigational medicinal Product (IMP) studies

Sponsors & Collaborators

• Haukeland University Hospital: lead
• Alesund Hospital: collaborator

Study Sites (2)

Department of Medicine, Haukeland University Hospital

Bergen, Hordaland, 5021, Norway

RECRUITING

Ålesund Hospital

Ålesund, Møre og Romsdal, Norway

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

3 ml EDTA full blood

MeSH Terms

Conditions

Recurrence; Colitis, Ulcerative

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Kim Nylund, PhD

  Dep. of Medicine, Haukeland University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kim Nylund, PhD

CONTACT

004755975000; kim.nylund@helse-bergen.no

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2018
• First Posted: April 18, 2018
• Study Start: January 17, 2017
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: September 18, 2019

Record last verified: 2019-09

Locations

NO (2)