Trial reportBMC gastroenterology2009
Interferon beta-1a for the maintenance of remission in patients with Crohn's disease: results of a phase II dose-finding study.
Trial report in BMC gastroenterology, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00304252 (A Phase II, Multicenter, Randomised, Double-blind, Placebo Controlled, Dose Finding Study of Subcutaneously Administered Interferon Beta-1a for Maintenance of Remission in Patients With Crohn's Disease), which is not on this map. Cited by 24 papers, 2 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 Phase II, Multicenter, Randomised, Double-blind, Placebo Controlled, Dose Finding Study of Subcutaneously Administered Interferon Beta-1a for Maintenance of Remission in Patients With Crohn's Disease
Who cites it
24 citing papers in PubMed, 2 syntheses or guidelines pooled it, 49 citations in OpenAlex.
- Interventions for fatigue in inflammatory bowel disease.The Cochrane database of systematic reviews · 2020Pooled it
- Systematic review: outcomes and adverse events from randomised trials in Crohn's disease.Alimentary pharmacology & therapeutics · 2019Pooled it
- Deep representation learning for clustering longitudinal survival data from electronic health records.Nature communications · 2025Article
- Type I interferons in inflammatory bowel diseases: balancing barrier integrity, repair and inflammation in the intestinal epithelium.Frontiers in medicine · 2025Review
- Maximizing Treatment Options for IBD through Drug Repurposing.Current pharmaceutical design · 2024Review
- Exposing the Two Contrasting Faces of STAT2 in Inflammation.Journal of interferon & cytokine research : the official journal of the International Society for Interferon and Cytokine Research · 2022Review
- IL-23 Monoclonal Antibodies for IBD: So Many, So Different?Journal of Crohn's & colitis · 2022Review
- An Integrated Taxonomy for Monogenic Inflammatory Bowel Disease.Gastroenterology · 2022Article
- Loss of Nckx3 Exacerbates Experimental DSS-Induced Colitis in Mice through p53/NF-κB Pathway.International journal of molecular sciences · 2021Article
- Contradictory Effects of NLRP3 Inflammasome Regulatory Mechanisms in Colitis.International journal of molecular sciences · 2020Review
- Intestinal Stem Cells and Immune Cell Relationships: Potential Therapeutic Targets for Inflammatory Bowel Diseases.Frontiers in immunology · 2020Review
- Cell type-specific gene expression patterns associated with posttraumatic stress disorder in World Trade Center responders.Translational psychiatry · 2019Article
- Genetic polymorphism in ATG16L1 gene is associated with adalimumab use in inflammatory bowel disease.Journal of translational medicine · 2017Article
- Activation of NLRP3 Inflammasome in Inflammatory Bowel Disease: Differences Between Crohn's Disease and Ulcerative Colitis.Digestive diseases and sciences · 2017Article
- Type I and III Interferon in the Gut: Tight Balance between Host Protection and Immunopathology.Frontiers in immunology · 2017Review
- Gp96 Peptide Antagonist gp96-II Confers Therapeutic Effects in Murine Intestinal Inflammation.Frontiers in immunology · 2017Article
- The Protective Role of Type I Interferons in the Gastrointestinal Tract.Frontiers in immunology · 2017Review
- Type I IFN induces protein ISGylation to enhance cytokine expression and augments colonic inflammation.Proceedings of the National Academy of Sciences of the United States of America · 2015Article
- Current stage in inflammatory bowel disease: What is next?World journal of gastroenterology · 2015Review
- The role of type I interferons in intestinal infection, homeostasis, and inflammation.Immunological reviews · 2014Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 5 institutions in 5 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundCrohn's disease (CD) and multiple sclerosis (MS) share common pathogenic processes. Interferon (IFN) beta-1a is effective and generally well tolerated in patients with MS and has been shown to down-regulate the expression of interleukin-12, a cytokine that is thought to be involved in mucosal degeneration in CD. IFN beta-1a therefore offers promise as a treatment for CD.
methodsIn this multicentre, double-blind, placebo-controlled, phase II, dose-finding study, patients with steroid-induced clinical remissions of CD were randomized 1:1:1:1 to subcutaneous IFN beta-1a: 66 mcg three times weekly (tiw), 44 mcg tiw, 44 mcg twice weekly (biw), or matching placebo tiw with steroid tapering. The primary endpoint was the proportion of patients relapse-free at Week 26. Safety was also assessed.
resultsThis study was terminated early following a planned interim analysis at 26 weeks. Of the planned 192 patients, 67 were randomized to treatment: placebo (n = 16), or IFN beta-1a 44 mcg biw (n = 17), 44 mcg tiw (n = 16) or 66 mcg tiw (n = 18). In total, 20/67 patients (29.9%) completed 26 weeks and 7 patients (10.4%) completed 52 weeks. The proportion of patients who remained relapse-free at Week 26 did not differ significantly between the placebo group (5/16, 31%) and the IFN beta-1a 44 mcg biw (6/17, 35%; p = 0.497), 44 mcg tiw (7/16, 44%; p = 0.280) or 66 mcg tiw (2/18, 11%; p = 0.333) groups. There was little difference between treatment groups in secondary efficacy endpoints. IFN beta-1a was generally well tolerated at all doses. Adverse events (AEs) were generally mild or moderate in IFN beta-1a-treated patients, with the most common AEs (influenza-like symptoms, headache, injection-site reactions) being similar to those reported with IFN beta-1a in MS.
conclusionThere was no difference in efficacy between patients with CD receiving IFN beta-1a or placebo. However, these results should be considered in the context of the low patient numbers and high dropout rate. Overall, IFN beta-1a was generally well tolerated, with a safety profile that was consistent with previous experience in MS.
trial registrationClinicalTrials.gov NCT00304252.
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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.