Disease-associated brain activation predicts clinical response to TNF inhibition in rheumatoid arthritis (PreCePra): a randomised, multicentre, double-blind, placebo-controlled phase 3 study
Authors' conclusion
High disease-associated fMRI CNS pain activation might predict clinical response of patients with rheumatoid arthritis to TNF inhibitor treatment.
Study context
- Population
- Adults (≥18 years) with active RA despite ≥1 csDMARD, six rheumatology centres in Germany, Portugal and Serbia99 [71%] women and 40 [29%] men
- Participants
- 139 adults
- Comparison
- Certolizumab pegol vs placebo
- High-volume certolizumab pegoln = 49
- Low-volume certolizumab pegoln = 43
- Placebon = 47reference
- Primary endpoint
- Proportion reaching low disease activity (DAS28 ≤3.2)
- Follow-up
- Week 12
Methodological detailsphase 3, multicentre, double-blind, placebo-controlled, parallel-group, stratified by functional MRI (fMRI) (high or low volume), 2:1 randomisation
- Phase 3
- Multicentre
- Double-blind
- Placebo-controlled
- Parallel-group
- Stratified by fMRI (high or low volume)
- 2:1 randomisation
Primary result
As reported in the abstract
Low disease activity (DAS28 ≤3.2)
High-volume certolizumab pegol vs Placebo: P = 0.0017 · Low-volume certolizumab pegol vs Placebo: P = 0.063
Safety
- Treatment-related adverse events — Placebo
- 3 events
- Treatment-related adverse events — Total treatment-related adverse events
- 25
- Treatment-related adverse events: Certolizumab pegol (both groups) 22 events
Original publication
Disease-associated brain activation predicts clinical response to TNF inhibition in rheumatoid arthritis (PreCePra): a randomised, multicentre, double-blind, placebo-controlled phase 3 study. Lancet Rheumatol. Published 23 June 2025. doi:10.
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