A randomized, double-blind, placebo-controlled 12-Week trial of Infliximab in patients with Juvenile-Onset Spondyloarthritis or Enthesitis Related Arthritis
Bibliographic record
Abstract
Abstract Objective. To assess the efficacy and safety of infliximab versus placebo in the treatment of patients with Juvenile-onset Spondyloarthritis and enthesitis-related arthritis (JoSpA/ERA). Methods. Phase III, randomised, double-blind, placebo-controlled-trial of 12-weeks that included patients <18-year-old with JoSpA/ERA not-responding to nonsteroidal-anti-inflammatory drugs, sulfasalazine, or methotrexate. Patients were randomly assigned 1:1 to the infusion of Infliximab 5mg/kg or placebo; completers entered then an open-label extension (OLE) period of 42 weeks. The primary endpoint was the number of active joints. Secondary outcomes included the assessment of disease activity, tender entheses, spinal mobility, serum C reactive protein (CRP), the Bath Ankylosing Spondylitis Disease Activity and Functional Index, and the Childhood Health Assessment Questionnaire (CHAQ). Results. We randomized 12 patients to Infliximab and 14 to placebo. No significant differences were found between groups at baseline. At week 12, the mean number of active joints was 1.4 (SD 2.4) in the Infliximab group and 4.1 (SD 3.0) in the placebo group (p=0.0002). A repeated measures mixed model analysis that included all endpoints in the study demonstrated sustained favourable outcomes of Infliximab for active joints, tender joints, swollen joints and tender entheses counts, as well as for CHAQ and CRP (p<0.01). Adverse events were more frequent in the Infliximab group, including infections and infusion reactions, but none of them were serious.Conclusion. Infliximab is efficacious for patients with JoSpA/ERA with an inadequate response to conventional treatment. No serious adverse events with the use of infliximab were observed.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.004 | 0.004 |
| Meta-epidemiology (narrow) | 0.003 | 0.002 |
| Meta-epidemiology (broad) | 0.007 | 0.002 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.003 |
| Scholarly communication | 0.002 | 0.002 |
| Open science | 0.002 | 0.001 |
| Research integrity | 0.004 | 0.004 |
| Insufficient payload (model declined to judge) | 0.008 | 0.002 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".