Clinical examination
Other- Number of painful joints,
- Number of swollen joints,
- Patient Global assessment VAS (0 - 100)
- and Physician Global assessment VAS (0 - 100)
NCT Number: NCT03815578
Persistent pain and chronic fatigue are very common complaints in rheumatoid arthritis (RA) patients, whatever the anti-inflammatory treatment response. Interestingly, pain remaining despite good clinical response was associated with high disability and low inflammation at baseline, suggesting a mechanism of pain independent of inflammation in these patients. Such patients, with discordantly high patient-reported DAS28 components, fatigue and mood disturbance might represent a subgroup of RA patients who have specific clinical needs, not resolved by classical conventional or biologic DMARDs. In this way, neuropathic pain and pain sensitization have been demonstrated in 20 to 30% of RA patients, neuropathic pain scores being associated with worsen disease activity scores. Thus, pain sensitization may contribute to amplification of pain in active RA, and should be responsible for persisting pain and fatigue even after inflammation has resolved.
Pain sensitization is associated with neuroplastic changes in sensory pathways at peripheral and central levels. Interestingly, major mediators responsible for this neuroplasticity operate via a JAK/STAT signaling pathway, which is specifically targeted by new RA treatments. New drug targeting JAK/STAT signalling pathway have been recently designed for RA treatment, based on the implication of this pathway on the signaling of various cytokines implicated in the pathophysiology of RA, such as IL-6, IL-12, IL-23 and IFNs. Two Jak-inhibitors have been put on the market: Tofacitinib and Baricitinib. In randomized clinical trials, Tofacitinib have shown a remarkable efficacy on pain and other patient reported outcomes, suggesting a specific effect or jak-inhibitors on pain control. Recent data suggest that Jak-inhibitors could have a direct effect on sensory neurons.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
CHU de Bordeaux - Service de rhumatologie, Bordeaux, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
18 ml whole blood for ELISA analysis and miRNAs detection
Time frame: At 6 months from baseline
Time frame: At 1, 3 and 6 months from baseline
Time frame: At 1, 3 and 6 months from baseline
Time frame: At 1, 3 and 6 months from baseline
Time frame: At 1, 3 and 6 months from baseline
daily evaluation of the previous 24h pain on a numeric pain scale 0 to 100
Time frame: At 1, 3 and 6 months from baseline
which take into account the number of painful joints (on 28 joints), the number of swollen joints (on 28 joints), the patient global assessment of disease activity (between 0 and 100), and the erythrocyte sedimentation rate.
Time frame: At 1, 3 and 6 months from baseline
which take into account the number of painful joints (on 28 joints), the number of swollen joints (on 28 joints), the patient global assessment of disease activity (between 0 and 100), the physician global assessment of disease activity (between 0 and 100), and the C-reactive protein level.
Time frame: At 1, 3 and 6 months from baseline
which take into account the number of painful joints (on 28 joints), the number of swollen joints (on 28 joints), the patient global assessment of disease activity (between 0 and 100), and the physician global assessment of disease activity (between 0 and 100).
Time frame: At 1, 3 and 6 months from baseline
Time frame: At 1, 3 and 6 months from baseline
Time frame: At 1, 3 and 6 months from baseline
HAD scale aims at evaluating anxiety and depression symptoms with two separate scores (between 0 and 21) estimated grace to 14 items (7 for anxiety and 7 for depression) ranged between 0 and 3
Time frame: At 1, 3 and 6 months from baseline
Time frame: At 3 and 6 months from baseline
Time frame: At 3 and 6 months from baseline
Time frame: At 3 and 6 months from baseline
University Hospital, Bordeaux
Other
Acronym: TOPRA
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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