Disease × agent evidence record

Infliximab for Inflammatory Bowel Disease (Crohn's / UC): evidence, trials and status

Infliximab has both completed registered trials and synthesis-level publications linked to Inflammatory Bowel Disease (Crohn's / UC). That is the strongest profile in this database, but the summaries here do not extract effect sizes, so read the linked reviews for direction and magnitude of benefit.

8 registered trials 1 recruiting 15 publications Evidence tier A · Strong Score 75.0
Research Tracker › Pairs › Inflammatory Bowel Disease (Crohn's / UC) › Infliximab
Research map, not treatment advice. This page aggregates registry and literature records. It does not evaluate efficacy, dosing or safety for any individual. Discuss any treatment decision with a qualified clinician.

Summary

Infliximab has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Inflammatory Bowel Disease (Crohn's / UC) would be drug repurposing rather than first-in-human development. This does not mean it is approved for Inflammatory Bowel Disease (Crohn's / UC). ClinicalTrials.gov lists 8 registered trials linking Infliximab to Inflammatory Bowel Disease (Crohn's / UC): 1 is currently recruiting; 6 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT02177071). The largest enrolment is 1109 participants (NCT04344249). Registration activity spans 2006 to 2023. The literature layer holds 15 publications for this pair: 5 Cochrane reviews, 2 meta-analyses, 1 systematic review, 2 randomised controlled trial publications and 5 clinical trial publications. Publication years run from 2025 to 2026. Because at least one synthesis-level source exists (systematic review, meta-analysis or Cochrane review), this pair has been assessed beyond single studies, although the synthesis may concern a different indication.

The RepurpOS disease-intelligence file for Inflammatory Bowel Disease ranks 200 candidate therapeutics from Open Targets, ChEMBL, DGIdb and PubMed; only a minority carry direct clinical evidence, and this page covers one of those. Spontaneous remission context recorded for the condition: Disease course unchanged in ~85% of patients at 10 years on standard care; ~23% (CD) and ~12% (UC) relapse within 12 months of thiopurine withdrawal in sustained remission.

Open in Repurposing ExplorerInflammatory Bowel Disease (Crohn's / UC) hubInflammatory Bowel Disease (Crohn's / UC) biomarkers & interventions

Evidence table

Evidence tierA · Strong
Evidence score75.0 (trials 25.0, literature 30.0, tier 15, approved bonus 5.0)
Registered trials8 total: 1 recruiting, 0 active / not yet recruiting, 6 completed, 1 other
Linked publications15 (5 Cochrane reviews, 5 clinical trial publications, 2 meta-analyses, 2 randomised controlled trial publications, 1 systematic review)
Agent typeDrug (Small molecule)
Development stage (any indication)Approved
Mechanism / classNot recorded
Data sourcesDGIdb
Linked via biomarker / targetADAM17
How the evidence score is calculated
  • Each registered trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5). The trial component is capped at 30.
  • Each literature item scores by design (Cochrane review 5, meta-analysis 4, systematic review 3, RCT 3, clinical trial publication 2, curated reference 1.5, other PubMed record 1). The literature component is capped at 30.
  • The existing evidence tier adds 15 (A / Strong), 10 (B / Moderate), 5 (C / Preliminary) or 0 (D / Anecdotal).
  • Agents approved for any indication (max clinical phase 4) add 5, because an approved agent has an established safety profile that lowers the barrier to repurposing trials.
  • The score ranks what has been studied, not what works. It does not read effect sizes or directions of effect.

Registered clinical trials

NCT IDTitleStatusPhaseEnrolment
NCT02177071A proSpective Randomized Controlled Trial comParing infliximAb-antimetabolites Combination Therapy to Anti-metabolites monotheRapy and Infliximab monothErapy in Crohn's Disease Patients in Sustained Steroid-free Remission on Combination Therapy
2015
completedPhase 4211
NCT06051253TDM-based Infliximab Treatment for Active Perianal Fistulizing Crohn's Disease
2023
recruitingPhase 486
NCT00308581Certolizumab in Crohn's Disease Patients With Loss of Response or Intolerance to Infliximab
2006
completedPhase 3539
NCT04344249Cohort of Patients With Inflammatory Bowel Disease During COVID-19 Pandemic
2020
completedNot applicable1,109
NCT04131504Precision Crohn's Disease Management Utilizing Predictive Protein Panels (ENvISION)
2019
completedNot applicable239
NCT00586599Levels of the Stat4 Alpha and Stat4 Beta Isoforms in PBMCs From Patients With Crohn's Disease and Ulcerative Colitis
2007
completedNot applicable51
NCT05530122Prognosis in UC After First Biological
2009
completedNot applicable192
NCT04761952N-3 Polyunsaturated Fatty Acids Prevent Postoperative Recurrence of Crohn's Disease
2021
status unknownNot applicable236

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Published literature

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Mechanism and notes

No mechanism of action is recorded for this pair in the source databases.

OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in DGIdb, in this case via the biomarker or target ADAM17. The tier describes how well the drug-disease link is documented, not how well the drug works.

Frequently asked questions

Is Infliximab approved for Inflammatory Bowel Disease (Crohn's / UC)?

Infliximab has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Inflammatory Bowel Disease (Crohn's / UC) would be drug repurposing rather than first-in-human development. This does not mean it is approved for Inflammatory Bowel Disease (Crohn's / UC). Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.

Is Infliximab in clinical trials for Inflammatory Bowel Disease (Crohn's / UC)?

ClinicalTrials.gov lists 8 registered trials linking Infliximab to Inflammatory Bowel Disease (Crohn's / UC): 1 is currently recruiting; 6 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT02177071). The largest enrolment is 1109 participants (NCT04344249). Registration activity spans 2006 to 2023.

What does the evidence show for Infliximab in Inflammatory Bowel Disease (Crohn's / UC)?

Infliximab has both completed registered trials and synthesis-level publications linked to Inflammatory Bowel Disease (Crohn's / UC). That is the strongest profile in this database, but the summaries here do not extract effect sizes, so read the linked reviews for direction and magnitude of benefit. OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in DGIdb, in this case via the biomarker or target ADAM17. The tier describes how well the drug-disease link is documented, not how well the drug works.

Cite this page

Open Source Medicine Foundation. Infliximab for Inflammatory Bowel Disease (Crohn's / UC): evidence, trials and status. OSMF Research Tracker. Updated 2026-07-05. https://research.opensourcemed.info/pairs/inflammatory-bowel-disease/infliximab.html

Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-05. Page built 2026-10-07.

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This is a research map, not treatment advice. Evidence tiers and scores summarise what has been studied, not whether a treatment works or is safe for you.