Status:
COMPLETED
Evaluation of Pain Sensitization in Rheumatoid Arthritis: Analysis on a Cohort of Tofacitinib Treated Patients
Lead Sponsor:
University Hospital, Bordeaux
Collaborating Sponsors:
Pfizer
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
NA
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 clin...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 17 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 28 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03815578
Start Date
June 17 2019
End Date
April 28 2023
Last Update
May 6 2023
Active Locations (2)
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1
CHU de Bordeaux - Service de rhumatologie
Bordeaux, France
2
CHU de Limoges - service de rhumatologie
Limoges, France