Trial reportGastroenterology2018
Methotrexate Is Not Superior to Placebo in Maintaining Steroid-Free Response or Remission in Ulcerative Colitis.
Trial report in Gastroenterology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01393405 (Randomized, Double Blind, Prospective Trial Investigating the Efficacy of Methotrexate in Induction and Maintenance of Steroid Free Remission in Ulcerative Colitis), which is not on this map. Cited by 35 papers, 5 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Randomized, Double Blind, Prospective Trial Investigating the Efficacy of Methotrexate in Induction and Maintenance of Steroid Free Remission in Ulcerative Colitis (MEthotrexate Response In Treatment of UC - MERIT-UC)
Who cites it
35 citing papers in PubMed, 5 syntheses or guidelines pooled it, 89 citations in OpenAlex.
- Second United Arab Emirates consensus guidance on the diagnosis and management of inflammatory bowel disease.World journal of gastroenterology · 2025Pooled it
- Management of paediatric ulcerative colitis, part 1: Ambulatory care-An updated evidence-based consensus guideline from the European Society of Paediatric Gastroenterology, Hepatology and Nutrition and the European Crohn's and Colitis Organisation.Journal of pediatric gastroenterology and nutrition · 2025Guideline
- Fecal microbiota transplantation for patients with ulcerative colitis: a systematic review and meta-analysis of randomized control trials.Techniques in coloproctology · 2025Pooled it
- Risk of postoperative infectious complications from medical therapies in inflammatory bowel disease.The Cochrane database of systematic reviews · 2020Pooled it
- AGA Clinical Practice Guidelines on the Management of Moderate to Severe Ulcerative Colitis.Gastroenterology · 2020Guideline
- Emerging mechanistic trends and clinical efficacy for methotrexate: Applications to inflammatory bowel disease.Pharmacological reviews · 2026Review
- The roles and heterogeneity of CD8International journal of molecular medicine · 2026Review
- Practical Considerations for the Treatment of Patients with Psoriatic Arthritis and Comorbid Inflammatory Bowel Disease.Rheumatic diseases clinics of North America · 2025Review
- Oral creatine-modified selenium-based hyaluronic acid nanogel mediated mitochondrial energy recovery to drive the treatment of inflammatory bowel disease.Journal of nanobiotechnology · 2024Article
- An interactive dose optimizer based on population pharmacokinetic study to guide dosing of methotrexate in Chinese patients with osteosarcoma.Cancer chemotherapy and pharmacology · 2024Article
- A Future Avenue of Treatment Ulcerative Colitis Targeting Macrophage Polarization: A Phytochemical Application.Crohn's & colitis 360 · 2024Article
- Choosing Therapies in Ulcerative Colitis.Journal of the Canadian Association of Gastroenterology · 2024Article
- Oral Versus Subcutaneous Methotrexate in Immune-Mediated Inflammatory Disorders: an Update of the Current Literature.Current rheumatology reports · 2023Review
- Spondyloarthritis with inflammatory bowel disease: the latest on biologic and targeted therapies.Nature reviews. Rheumatology · 2023Review
- The Role of Low-Dose Oral Methotrexate in Increasing Anti-TNF Drug Levels and Reducing Immunogenicity in IBD.Journal of clinical medicine · 2023Review
- Management of Concomitant Inflammatory Bowel Disease or Uveitis in Patients with Psoriatic Arthritis: An Updated Review Informing the 2021 GRAPPA Treatment Recommendations.The Journal of rheumatology · 2023Review
- Effectiveness and tolerability of methotrexate monotherapy in Crohn's disease patients: a multicenter observational study.Therapeutic advances in gastroenterology · 2023Article
- Favourable Tolerability and Drug Survival of Tioguanine Versus Methotrexate After Failure of Conventional Thiopurines in Crohn's Disease.Journal of Crohn's & colitis · 2022Article
- Spondyloarthropathy in Inflammatory Bowel Disease: From Pathophysiology to Pharmacological Targets.Drugs · 2022Article
- Live or let die: Translational insights and clinical perspectives of gasdermin B-dependent intestinal epithelial cell fate.Clinical and translational medicine · 2022Article
Corrections and comments
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Authors and funding
28 authors at 19 institutions in 1 country.
Funding
Abstract
BACKGROUND &
aimsParenteral methotrexate induces clinical remission but not endoscopic improvement of mucosal inflammation in patients with ulcerative colitis (UC). We performed a randomized, placebo-controlled trial to assess the efficacy of parenteral methotrexate in maintaining steroid-free response or remission in patients with UC after induction therapy with methotrexate and steroids.
methodsWe performed a 48-week trial, from February 2012 through May 2016, of 179 patients with active UC (Mayo score of 6-12 with endoscopy subscore ≥ 2) despite previous conventional or biological therapy. The study comprised a 16-week open label methotrexate induction period followed by a 32-week double-blind, placebo-controlled maintenance period. Patients were given subcutaneous methotrexate (25 mg/wk) and a 12-week steroid taper. At week 16, steroid-free responders were randomly assigned to groups that either continued methotrexate (25 mg/wk, n = 44) or were given placebo (n = 40) until week 48. We compared the efficacy of treatment by analyzing the proportion of patients who remained relapse free and were in remission at week 48 without use of steroids or other medications to control disease activity.
resultsNinety-one patients (51%) achieved response at week 16, and 84 patients were included in the maintenance period study. During this period, 60% of patients in the placebo group (24/40) and 66% in the methotrexate group (29/44) had a relapse of UC (P = .75). At week 48, 30% of patients in the placebo group (12/40) and 27% of patients in the methotrexate group (12/44) were in steroid-free clinical remission without need for additional therapies (P = .86). No new safety signals for methotrexate were detected.
conclusionsParenteral methotrexate (25 mg/wk) was not superior to placebo in preventing relapses of UC in patients who achieved steroid-free response during induction therapy. ClinicalTrials.gov, Number: NCT01393405.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.