Clinical trial · Interventional
Anti-tumor Necrosis Factor in Patients With Ulcerative Colitis in Clinical Remission: to Continue or Not?
Continuing or Discontinuing Anti-tumor Necrosis Factor Treatment in Patients With Ulcerative Colitis in Clinical Remission: a Prospective Open Randomized Parallel-group Study
NCT03011268CI-TRIAL-00090388BIOSTOPcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colitis,Ulcerative | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Continuation of anti-TNF treatment | Other | — | UNRESOLVED |
| Discontinuation of anti-TNF treatment | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Anti TNF discontinuation
- description
- Discontinuation of anti-TNF treatment (Infliximab, Adalimumab, Golimumab)
- interventionNames
- Other: Discontinuation of anti-TNF treatment
- type
- ACTIVE_COMPARATOR
- label
- Anti TNF continuation
- description
- Continuation of anti-TNF treatment (Infliximab, Adalimumab, Golimumab)
- interventionNames
- Other: Continuation of anti-TNF treatment
Primary outcomes (1)
- measure
- Proportion of patients in sustained clinical remission
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDBerset IP, Lerang F, Moum B, Jahnsen J, Grimstad T, Kristensen V, Wiig H, Aabrekk T, Ness-Jenssen E, Eskeland S, Melsom E, Von Volkmann H, Huppertz-Hauss G, Torp R, Hovlid O, Buset M, Riise G, Horvei G, Finjord T, Jelsness-Jorgensen LP, Olsen IC, Jahnsen FL, Myklebust TA, Molsaeter K, Hoff DAL, Lundin KEA. Anti-TNF withdrawal or long-term treatment in ulcerative colitis (BIOSTOP): a multicentre open label, randomized controlled trial. J Crohns Colitis. 2026 Aug 5;20(8):jjag110. doi: 10.1093/ecco-jcc/jjag110. PMID 42557857