Evaluation of Pain Sensitization in Rheumatoid Arthritis: Analysis on a Cohort of Tofacitinib Treated Patients

NCT03815578

Last updated date
Study Location
CHU de Bordeaux - Service de rhumatologie
Bordeaux, , , France
Contact
(0)556795556

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Rheumatoid Arthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Patients aged over 18 year-old ;

- Diagnosis of RA according to the ACR/EULAR 2010 classification criteria ;

- Active rheumatoid arthritis defined by a Disease Activity Score (DAS28) > 3.2 at inclusion ;

- Patient eligible for tofacitinib treatment in agreement with European treatment labelling and French recommendation for RA treatment ;

- Oral prednisone intake is allowed until 10 mg, stable for at least 1 week at study entry ;

- Starting tofacitinib treatment for an active RA defined by a DAS28-ESR > 3.2 ;

- Affiliated person or beneficiary of a social security scheme ;

- Having signed an informed consent (at the latest on the day of inclusion and before any examination required by research).

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Diagnosis of a systemic autoimmune disease other than RA ;


- Peripheral neuropathy ;


- Centrally-acting pain medications use within 3 months of enrolment (amitriptyline,
gabapentin, duloxetine), or during the study ;


- Any opioid use within 1 month of enrolment or during the study ;


- Corticosteroid treatment over 10 mg of prednisone or equivalent ;


- Patient who present contraindications to tofacitinib treatment ;


- Patient presenting with a history of active tuberculosis or chronic infectious disease
with a need of regular use of antibiotic ;


- Patients with active bacterial or viral infection, or presenting with an episode of
infection that required treatment with antibiotics within 30 days prior to screening ;


- Patient presenting with a history of lymphoma or leukaemia or other malignancy besides
non-melanoma skin cancer within 5 years ;


- Patient presenting with any uncontrolled medical condition ;


- Pregnancy or breast-feeding ;


- Patient unable to understand and follow recommendations or unable to perform
self-evaluation ;


- Patient who refuse to participate to the study.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Evaluation of Pain Sensitization in Rheumatoid Arthritis: Analysis on a Cohort of Tofacitinib Treated Patients
Official Title  ICMJE Evaluation of Pain Sensitization in Rheumatoid Arthritis: Analysis on a Cohort of Tofacitinib Treated Patients
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE
  • Other: Clinical examination
    • Number of painful joints,
    • Number of swollen joints,
    • Patient Global assessment VAS (0 - 100)
    • and Physician Global assessment VAS (0 - 100)
  • Other: Pain assessment
    • Pressure Pain Thresholds (PPTs),
    • Mechanical Temporal Summation (MTS)
    • and Diffuse Noxious Inhibitory Control (DNIC)
  • Other: blood sample
    18 ml whole blood for ELISA analysis and miRNAs detection
  • Other: Patient Reported Outcomes
    • Health Assessment Questionnaire (HAQ),
    • Rheumatoid Arthritis Impact of Disease score (RAID),
    • Daily joint pain intensity VAS (0-100),
    • Hospital Anxiety and Depression scale
    • and Coping Strategy Questionnaire.
Study Arms  ICMJE Experimental: Rheumatoid Arthritis (RA) patients
RA according to the ACR/EULAR 2010 classification criteria
Interventions:
  • Other: Clinical examination
  • Other: Pain assessment
  • Other: blood sample
  • Other: Patient Reported Outcomes
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 23, 2019)
55
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2022
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients aged over 18 year-old ;
  • Diagnosis of RA according to the ACR/EULAR 2010 classification criteria ;
  • Active rheumatoid arthritis defined by a Disease Activity Score (DAS28) > 3.2 at inclusion ;
  • Patient eligible for tofacitinib treatment in agreement with European treatment labelling and French recommendation for RA treatment ;
  • Oral prednisone intake is allowed until 10 mg, stable for at least 1 week at study entry ;
  • Starting tofacitinib treatment for an active RA defined by a DAS28-ESR > 3.2 ;
  • Affiliated person or beneficiary of a social security scheme ;
  • Having signed an informed consent (at the latest on the day of inclusion and before any examination required by research).

Exclusion Criteria:

  • Diagnosis of a systemic autoimmune disease other than RA ;
  • Peripheral neuropathy ;
  • Centrally-acting pain medications use within 3 months of enrolment (amitriptyline, gabapentin, duloxetine), or during the study ;
  • Any opioid use within 1 month of enrolment or during the study ;
  • Corticosteroid treatment over 10 mg of prednisone or equivalent ;
  • Patient who present contraindications to tofacitinib treatment ;
  • Patient presenting with a history of active tuberculosis or chronic infectious disease with a need of regular use of antibiotic ;
  • Patients with active bacterial or viral infection, or presenting with an episode of infection that required treatment with antibiotics within 30 days prior to screening ;
  • Patient presenting with a history of lymphoma or leukaemia or other malignancy besides non-melanoma skin cancer within 5 years ;
  • Patient presenting with any uncontrolled medical condition ;
  • Pregnancy or breast-feeding ;
  • Patient unable to understand and follow recommendations or unable to perform self-evaluation ;
  • Patient who refuse to participate to the study.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Thierry SCHAEVERBEKE, Prof(0)556795556 ext +33[email protected]
Contact: Thomas BARNETCHE, PhD[email protected]
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03815578
Other Study ID Numbers  ICMJE CHUBX 2017/39
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Responsible Party University Hospital, Bordeaux
Study Sponsor  ICMJE University Hospital, Bordeaux
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Thierry SCHAEVERBEKE, ProfCHU Bordeaux
PRS Account University Hospital, Bordeaux
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP