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Anti-tumor Necrosis Factor in Patients With Ulcerative Colitis in Clinical Remission: to Continue or Not? (BIOSTOP)

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ClinicalTrials.gov Identifier: NCT03011268
Recruitment Status : Recruiting
First Posted : January 5, 2017
Last Update Posted : September 9, 2020
Sponsor:
Collaborators:
Oslo University Hospital
University of Oslo
Information provided by (Responsible Party):
Helse Møre og Romsdal HF

Brief Summary:
The primary objective is to assess if discontinuation of anti- tumor necrosis factor alpha (TNF) treatment in ulcerative colitis patients in sustained clinical remission, with the option to restart treatment in the case of relapse, is non-inferior to continued anti-TNF treatment. Secondary objectives are to assess the efficacy and safety of restarting anti-TNF treatment after a relapse

Condition or disease Intervention/treatment Phase
Colitis,Ulcerative Other: Discontinuation of anti-TNF treatment Other: Continuation of anti-TNF treatment Not Applicable

Detailed Description:

The BIOSTOP study is a prospective, open randomized, multicenter, parallel-group study to compare clinical outcome of discontinuing (interventional group) compared to continuing (control group) biologic treatment with anti-TNF in ulcerative colitis patients in clinical remission.

Adult male and female patients with an established diagnosis of ulcerative colitis treated for minimum one year with anti-TNF maintenance therapy and being in clinical remission during the last 3 months are potential study patients. Eligible patients who have given their informed written consent will be randomized 1:1 to either discontinue anti-TNF treatment or to continue anti-TNF treatment for another two years.

Patients in the control group who are still in clinical and endoscopic remission after two years on continued anti-TNF treatment, will then be switched to discontinue anti-TNF treatment.

End of study/follow-up is after 4 years. In order to identify the primary endpoint (occurrence of disease relapse), each study center will have a phone number for patients to call in case of symptoms suspect of increased disease activity. If a patient is experiencing a potential disease flare (6-point Mayo score > 1) and/or 2 consecutive calprotectin tests are positive (> 200 mg/kg), an unscheduled visit including recto sigmoidoscopy will be performed without delay to document disease status.

150 participants enrolled, September 2020 Covid 19 - randomization period extended until 31.12.2020

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Continuing or Discontinuing Anti-tumor Necrosis Factor Treatment in Patients With Ulcerative Colitis in Clinical Remission: a Prospective Open Randomized Parallel-group Study
Actual Study Start Date : June 9, 2017
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Anti TNF discontinuation
Discontinuation of anti-TNF treatment (Infliximab, Adalimumab, Golimumab)
Other: Discontinuation of anti-TNF treatment
Discontinuation of treatment with Infliximab, Adalimumab, and Golimumab in order to record time to relapse occurrences
Other Name: Remicade, Remsima, Inflectra, Humira, Simponi

Active Comparator: Anti TNF continuation
Continuation of anti-TNF treatment (Infliximab, Adalimumab, Golimumab)
Other: Continuation of anti-TNF treatment
Continuation of treatment with Infliximab, Adalimumab, and Golimumab for 2 years after randomization, then discontinue
Other Name: Remicade, Remsima, Inflectra, Humira, Simponi




Primary Outcome Measures :
  1. Proportion of patients in sustained clinical remission [ Time Frame: 2 years ]
    Remission confirmed endoscopically by mucosal healing defined as Mayo Endoscopic Subscore (MES) score 0 or 1 after 2 years of randomized treatment


Secondary Outcome Measures :
  1. Proportion of patients in sustained clinical remission [ Time Frame: 4 years ]
    Remission confirmed endoscopically by mucosal healing defined as Mayo Endoscopic Subscore (MES) score 0 or 1 after 4 years of randomized treatment

  2. Time from randomization to relapse [ Time Frame: 2 years ]
    Relapse time

  3. Time from randomization to relapse [ Time Frame: 4 years ]
    Relapse time

  4. Proportion of patients who are no longer in remission, but who do not need to restart anti-tumor necrosis factor (TNF) therapy [ Time Frame: 2 years ]
    Remission, but no need to restart anti-tnf therapy

  5. Proportion of patients who are no longer in remission, but who do not need to restart anti-tumor necrosis factor (TNF) therapy [ Time Frame: 4 years ]
    Remission, but no need to restart anti-tnf therapy

  6. Proportion of relapse patients achieving remission after anti-TNF restart [ Time Frame: 2 years ]
    Remission after relapse

  7. Proportion of relapse patients achieving remission after anti-TNF restart [ Time Frame: 4 years ]
    Remission after relapse

  8. Adverse events and serious adverse events frequency and severity [ Time Frame: 2 years ]
    Adverse events

  9. Adverse events and serious adverse events frequency and severity [ Time Frame: 4 years ]
    Adverse events



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • confirmed diagnosis of ulcerative colitis
  • treated for minimum 1 year with first-line anti-tumor necrosis factor (TNF) treatment
  • in sustained clinical remission during the last 3 months
  • capable of understanding and signing an informed consent form

Exclusion Criteria:

  • Discontinuation of systemic 5-Aminosalicylic 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
  • Participation in any other studies
  • pregnancy
  • breastfeeding

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): NCT03011268


Contacts
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Contact: Dag Arne L Hoff, md, phd + 4770105000 Dag.Arne.Lihaug.Hoff@helse-mr.no
Contact: Ingrid P Berset, md +4770105000 Ingrid.Prytz.Berset@helse-mr.no

Locations
Show Show 19 study locations
Sponsors and Collaborators
Helse Møre og Romsdal HF
Oslo University Hospital
University of Oslo
Investigators
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Study Director: Dag Arne L Hoff, md, phd Helse Møre og Romsdal Hospital Trust
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Responsible Party: Helse Møre og Romsdal HF
ClinicalTrials.gov Identifier: NCT03011268    
Other Study ID Numbers: HMR2016-0.6
2016-001409-18 ( EudraCT Number )
First Posted: January 5, 2017    Key Record Dates
Last Update Posted: September 9, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: At this time there is no such plan for IPD sharing. It might be an issue regarding material stored in the study Biobank - that will be elucidated at a later stage.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Helse Møre og Romsdal HF:
Tumor Necrosis Factor-alpha/antagonists & inhibitors
Infliximab
Adalimumab
Golimumab
Recurrence
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Necrosis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Adalimumab
Infliximab
Antibodies, Monoclonal
Anti-Inflammatory Agents
Antirheumatic Agents
Dermatologic Agents
Gastrointestinal Agents
Immunologic Factors
Physiological Effects of Drugs