Trial reportArthritis research & therapy2018
A single determination of C-reactive protein does not suffice to declare a patient with a diagnosis of axial spondyloarthritis 'CRP-negative'.
Trial report in Arthritis research & therapy, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01087762 (Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of Certolizumab Pegol in Subjects With Active Axial Spondyloarthritis), which is not on this map. Cited by 15 papers, 1 of them a synthesis 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.
Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of Certolizumab Pegol in Subjects With Active Axial Spondyloarthritis
Who cites it
15 citing papers in PubMed, 1 synthesis or guideline pooled it.
- The correlations between C-reactive protein and MRI-detected inflammation in patients with axial spondyloarthritis: a systematic review and meta-analysis.Clinical rheumatology · 2023Pooled it
- A Comprehensive Clinical Decision Support System for the Early Diagnosis of Axial Spondyloarthritis: Multi-Sequence MRI, Clinical Risk Integration, and Explainable Segmentation.Diagnostics (Basel, Switzerland) · 2026Article
- Spondyloarthritis in Latin America: a difficult-to-diagnose challenge.Therapeutic advances in musculoskeletal disease · 2026Review
- Clinical and molecular links between chronic systemic inflammation and structural damage in axial spondyloarthritis.Arthritis research & therapy · 2025Article
- Platelet Indices as Unequivocal Markers of Active Disease in Patients With Nonradiographic Axial Spondyloarthritis: Protocol for a Cross-Sectional Study.JMIR research protocols · 2025Article
- The impact of gender and sex on diagnosis, treatment outcomes and health-related quality of life in patients with axial spondyloarthritis.Clinical rheumatology · 2022Review
- Certolizumab Pegol Efficacy in Patients With Non-Radiographic Axial Spondyloarthritis Stratified by Baseline MRI and C-Reactive Protein Status: An Analysis From the C-axSpAnd Study.ACR open rheumatology · 2022Article
- Australian Consensus Statements for the Assessment and Management of Non-radiographic Axial Spondyloarthritis.Rheumatology and therapy · 2022Article
- The Effect of Etanercept in Nonradiographic Axial Spondyloarthritis by Stratified C-Reactive Protein Levels.ACR open rheumatology · 2021Article
- Imaging in Axial Spondyloarthritis: What is Relevant for Diagnosis in Daily Practice?Current rheumatology reports · 2021Review
- Axial spondyloarthritis: concept, construct, classification and implications for therapy.Nature reviews. Rheumatology · 2021Review
- Aptamers for Proteins Associated with Rheumatic Diseases: Progress, Challenges, and Prospects of Diagnostic and Therapeutic Applications.Biomedicines · 2020Review
- Axial spondyloarthritis 10 years on: still looking for the lost tribe.Rheumatology (Oxford, England) · 2020Review
- Precision multiparameter tracking of inflammation on timescales of hours to years using serial dried blood spots.Bioanalysis · 2020Article
- [Axial spondyloarthritis and psoriatic arthritis : Current results and assessments].Zeitschrift fur Rheumatologie · 2020Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundTo be eligible to receive treatment with an anti-tumour necrosis factor (TNF), non-radiographic axial spondyloarthritis (nr-axSpA) patients require either elevated levels of C-reactive protein (CRP) (CRP > upper limit of normal (ULN)) or magnetic resonance imaging assessment showing inflammation of the sacroiliac joints, in addition to meeting criteria for high disease activity. Many axSpA patients are classified as 'CRP-negative', or CRP normal, despite having levels close to the ULN, and are therefore formally ineligible for treatment. The aim of this study was to investigate the likelihood of a CRP test indicating elevated levels in axSpA patients that have previously tested CRP normal.
methodsRAPID-axSpA (NCT01087762) enrolled patients who were either magnetic resonance imaging positive or had elevated CRP (> ULN: 7.9 mg/L). CRP data from the double-blind period for placebo-randomised patients until re-randomisation to certolizumab pegol (week 16 for ASAS20 non-responders/week 24 for ASAS20 responders) were analysed. CRP was assessed at screening, baseline, and nine time points to week 24. Linear mixed models were used to investigate time trends, variability, and correlations of CRP data.
resultsOf 106 placebo-randomised patients with baseline CRP assessments, 26 (25%) tested CRP normal at baseline, of whom 13 (50%) had ≥ 1 test indicating elevated CRP to week 16. Of 80/106 (75%) patients with elevated baseline CRP, 25 (31%) had ≥ 1 normal CRP test to week 16. Linear mixed models did not reveal changes in mean CRP across placebo patients from baseline to week 24.
conclusionsIn axSpA patients with CRP < ULN the CRP test should be repeated after ≥ 4 weeks as there is a substantial chance of finding a positive result for elevated CRP at subsequent testing, thereby allowing the patient access to treatment.
trial registrationClinicalTrials.gov, NCT01087762 . Registered on 16 March 2010.
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