Disease × agent evidence record

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

Adalimumab 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 0 recruiting 13 publications Evidence tier A · Strong Score 74.0
Research Tracker › Pairs › Inflammatory Bowel Disease (Crohn's / UC) › Adalimumab
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

Adalimumab 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8 registered trials linking Adalimumab to Inflammatory Bowel Disease (Crohn's / UC): 7 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT02852694). The largest enrolment is 239 participants (NCT04131504). Registration activity spans 2007 to 2021. The literature layer holds 13 publications for this pair: 5 Cochrane reviews, 1 meta-analysis, 1 systematic review, 1 randomised controlled trial publication 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 score74.0 (trials 24.0, literature 30.0, tier 15, approved bonus 5.0)
Registered trials8 total: 0 recruiting, 0 active / not yet recruiting, 7 completed, 1 other
Linked publications13 (5 Cochrane reviews, 5 clinical trial publications, 1 meta-analysis, 1 systematic review, 1 randomised controlled trial publication)
Agent typeDrug (Small molecule)
Development stage (any indication)Approved
Mechanism / classNot recorded
Data sourcesDGIdb
Linked via biomarker / targetATG16L1
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
NCT02852694Reduce Risk for Crohn's Disease Patients
2017
completedPhase 4192
NCT01564823Adalimumab on Preventing Post-chirurgic Recurrence on Crohn´s Disease
2012
completedPhase 386
NCT02871635BI 695501 Versus Humira in Patients With Active Crohn's Disease: a Trial Comparing Efficacy, Endoscopic Improvement, Safety, and Immunogenicity
2016
completedPhase 3147
NCT00445939A Study of Adalimumab for the Induction of Clinical Remission in Japanese Subjects With Crohn's Disease
2007
completedPHASE2, PHASE390
NCT04131504Precision Crohn's Disease Management Utilizing Predictive Protein Panels (ENvISION)
2019
completedNot applicable239
NCT05720221Biologics in Management of Inflammatory Bowel Disease in Egyptian Patients
2021
completedNot applicable100
NCT05530122Prognosis in UC After First Biological
2009
completedNot applicable192
NCT02413047Evaluate if Response to Infliximab or Adalimumab May be Regained With an Immunomodulator
2015
terminatedNot applicable3

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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 ATG16L1. The tier describes how well the drug-disease link is documented, not how well the drug works.

Frequently asked questions

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

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

ClinicalTrials.gov lists 8 registered trials linking Adalimumab to Inflammatory Bowel Disease (Crohn's / UC): 7 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT02852694). The largest enrolment is 239 participants (NCT04131504). Registration activity spans 2007 to 2021.

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

Adalimumab 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 ATG16L1. The tier describes how well the drug-disease link is documented, not how well the drug works.

Cite this page

Open Source Medicine Foundation. Adalimumab 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/adalimumab.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.