Disease × agent evidence record

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

Methotrexate 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 18 publications Evidence tier A · Strong Score 71.5
Research Tracker › Pairs › Inflammatory Bowel Disease (Crohn's / UC) › Methotrexate
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

Methotrexate 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trials linking Methotrexate to Inflammatory Bowel Disease (Crohn's / UC): 5 have completed; 3 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT02177071). The largest enrolment is 355 participants (NCT03760003). Registration activity spans 2010 to 2020. The literature layer holds 18 publications for this pair: 5 Cochrane reviews, 5 meta-analyses, 2 systematic reviews, 1 randomised controlled trial publication and 5 clinical trial publications. Publication years run from 2019 to 2025. 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 score71.5 (trials 21.5, literature 30.0, tier 15, approved bonus 5.0)
Registered trials8 total: 0 recruiting, 0 active / not yet recruiting, 5 completed, 3 other
Linked publications18 (5 Cochrane reviews, 5 meta-analyses, 5 clinical trial publications, 2 systematic reviews, 1 randomised controlled trial publication)
Agent typeDrug (Small molecule)
Development stage (any indication)Approved
Mechanism / classNot recorded
Data sourcesDGIdb
Linked via biomarker / targetALOX5
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
NCT02852694Reduce Risk for Crohn's Disease Patients
2017
completedPhase 4192
NCT01802593Comparison of 2 Immunomodulator Withdrawal Schemes for Infliximab Monotherapy in Active Pediatric Crohn's Disease After Thiopurine Failure
2013
terminatedPhase 420
NCT03760003Dose-Ranging Phase 2b Study of ABX464 in Moderate to Severe Ulcerative Colitis
2019
completedPhase 2355
NCT01860963Anal Dysplasia in Patients With Inflammatory Bowel Disease and Healthy Controls
2010
completedNot applicable310
NCT03553472Identifying Young Inflammatory Bowel Disease Patients at Risk for Herpes Zoster
2018
completedNot applicable97
NCT02413047Evaluate if Response to Infliximab or Adalimumab May be Regained With an Immunomodulator
2015
terminatedNot applicable3
NCT05386290A Multicentered Prospective Cohort Study of Chinese IBD Patients
2020
status unknownNot applicable200

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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 ALOX5. The tier describes how well the drug-disease link is documented, not how well the drug works.

Frequently asked questions

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

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

ClinicalTrials.gov lists 8 registered trials linking Methotrexate to Inflammatory Bowel Disease (Crohn's / UC): 5 have completed; 3 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT02177071). The largest enrolment is 355 participants (NCT03760003). Registration activity spans 2010 to 2020.

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

Methotrexate 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 ALOX5. The tier describes how well the drug-disease link is documented, not how well the drug works.

Cite this page

Open Source Medicine Foundation. Methotrexate 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/methotrexate.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.