Trial reportJournal of Crohn's & colitis2018
Efficacy of Adalimumab for Treatment of Perianal Fistula in Children with Moderately to Severely Active Crohn's Disease: Results from IMAgINE 1 and IMAgINE 2.
Trial report in Journal of Crohn's & colitis, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 21 papers, 4 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.
A Multi-Center, Double-Blind Study to Evaluate the Safety, Efficacy and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects With Moderate to Severe Crohn's Disease
A Multi-center, Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Efficacy and the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects With Crohn's Disease Who Have Demonstrated a Clinical Response in the M06-806 Study
Who cites it
21 citing papers in PubMed, 4 syntheses or guidelines pooled it, 34 citations in OpenAlex.
- Perianal fistulizing Crohn's disease: Clinical practice update from Colitis and Crohn's Foundation (India).Indian journal of gastroenterology : official journal of the Indian Society of Gastroenterology · 2026Guideline
- Tumor necrosis factor-alpha antagonists for treatment of pediatric Crohn's disease.The Cochrane database of systematic reviews · 2025Pooled it
- Adalimumab for induction of remission in Crohn's disease.The Cochrane database of systematic reviews · 2019Pooled it
- Strategies to Optimize Anti-tumor Necrosis Factor Therapy for Perianal Fistulizing Crohn's Disease: A Systematic Review.Digestive diseases and sciences · 2019Pooled it
- Characteristics and long-term outcomes of children with perianal Crohn's disease.Intestinal research · 2026Article
- Biologics in the management of pediatric inflammatory bowel disease: When and what to choose.World journal of clinical pediatrics · 2025Review
- Infliximab serum concentrations and disease activity in perianal fistulizing Crohn's disease: a cross-sectional study.Techniques in coloproctology · 2024Article
- The Future of Advanced Therapies for Pediatric Crohn's Disease.Paediatric drugs · 2023Article
- Treatment escalation and de-escalation decisions in Crohn's disease: Delphi consensus recommendations from Japan, 2021.Journal of gastroenterology · 2023Review
- The Optimal Management of Fistulizing Crohn's Disease: Evidence beyond Randomized Clinical Trials.Journal of clinical medicine · 2022Review
- Therapeutic Drug Monitoring in Perianal Fistulizing Crohn's Disease.Journal of clinical medicine · 2022Review
- Adalimumab in Pediatric Inflammatory Bowel Disease.Frontiers in pediatrics · 2022Review
- Therapeutic Drug Monitoring of Biologics in IBD: Essentials for the Surgical Patient.Journal of clinical medicine · 2021Review
- Approach to medical therapy in perianal Crohn's disease.World journal of gastroenterology · 2021Review
- Correlation of serum levels of anti-tumor necrosis factor agents with perianal fistula healing in Crohn's disease: a narrative review.Intestinal research · 2021Article
- Various Forms of Tuberculosis in Patients with Inflammatory Bowel Diseases Treated with Biological Agents.International journal of inflammation · 2021Review
- Positioning Biologic Therapies in the Management of Pediatric Inflammatory Bowel Disease.Gastroenterology & hepatology · 2020Article
- The Treatment of Pediatric Inflammatory Bowel Disease with Biologic Therapies.Current gastroenterology reports · 2020Review
- Potential Utility of Therapeutic Drug Monitoring of Adalimumab in Predicting Short-Term Mucosal Healing and Histologic Remission in Pediatric Crohn's Disease Patients.Journal of Korean medical science · 2020Article
- A Review on the Use of Anti-TNF in Children and Adolescents with Inflammatory Bowel Disease.International journal of molecular sciences · 2019Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors at 8 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND AND
aimsAdalimumab has been shown to be more effective than placebo in healing fistulae in adults with moderately to severely active Crohn's disease. The efficacy and safety of adalimumab in healing fistulae in children/adolescents with Crohn's disease from the 52-week IMAgINE 1 clinical trial, and its open-label extension IMAgINE 2, are reported.
methodsChildren/adolescents with perianal fistulae at baseline of IMAgINE 1 were assessed for fistula closure and improvement during IMAgINE 1 [Weeks 0-52] and from Week 0 of IMAgINE 2 [Week 52 of IMAgINE 1] through to Week 240 of IMAgINE 2 using non-responder imputation.
resultsA total of 36 children/adolescents had fistulae at baseline of IMAgINE 1 and were included in the analysis. Fistula closure and improvement were observed in 44.4% and 52.8%, respectively, at Week 12. Rates of closure and improvement were maintained throughout the analysis period to Week 292. No new safety signals were identified.
conclusionsIn children/adolescents with moderately to severely active, fistulizing Crohn's disease, adalimumab induced perianal fistula closure and improvement within 12 weeks of treatment, with rates that were sustained for more than 5 years. The safety profile of adalimumab in patients with fistulae at baseline was similar to that of the overall population in IMAgINE 1/2. ClinicalTrials.gov identifiers: IMAgINE 1 (NCT00409682); IMAgINE 2 (NCT00686374).
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
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.