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Rheumatoid ArthritisTOPRANCT03815578

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

A study testing Clinical examination, Pain assessment and blood sample in people with Rheumatoid Arthritis, run by University Hospital, Bordeaux at 2 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
Clinical examination, Pain assessment and blood sample
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
2 sitesFrance
Study dates
17 Jun 2019to 28 Apr 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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 ;
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  • 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.

Trial locations and contacts

2 sites in 1 country.

France2 sites

  • CHU de Bordeaux - Service de rhumatologie

    Bordeaux

  • CHU de Limoges - service de rhumatologie

    Limoges

Other trials in France

About this study

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.

Being tested
Clinical examination, Pain assessment, blood sample, Patient Reported Outcomes
Keywords
pain sensitization, Tofacitinib, miRNA
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Clinical examinationOther

    • Number of painful joints,
    • Number of swollen joints,
    • Patient Global assessment VAS (0 - 100)
    • and Physician Global assessment VAS (0 - 100)

  • Pain assessmentOther

    • Pressure Pain Thresholds (PPTs),
    • Mechanical Temporal Summation (MTS)
    • and Diffuse Noxious Inhibitory Control (DNIC)

  • blood sampleOther

    18 ml whole blood for ELISA analysis and miRNAs detection

  • Patient Reported OutcomesOther

    • 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 groups in NCT03815578
Study groupRoleWhat they receive
Rheumatoid Arthritis (RA) patientsExperimentalRA according to the ACR/EULAR 2010 classification criteria
Receives: Other: Clinical examination; Other: Pain assessment; Other: blood sample; Other: Patient Reported Outcomes

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Variation of the mean Pressure Pain Thresholds (PPTs)

    Measured: At 6 months from baseline

Secondary outcomes (14)

  1. Variation of Mechanical Temporal Summation (MTS)

    Measured: At 1, 3 and 6 months from baseline

  2. Variation of Pressure Pain Thresholds (PPTs)

    Measured: At 1, 3 and 6 months from baseline

  3. Variation of Diffuse noxious inhibitory control (DNIC) values

    Measured: At 1, 3 and 6 months from baseline

  4. Variation of Daily joint pain intensity

    daily evaluation of the previous 24h pain on a numeric pain scale 0 to 100

    Measured: At 1, 3 and 6 months from baseline

  5. Disease activity evaluated by the Disease Activity Score on 28 joints (DAS28)

    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.

    Measured: At 1, 3 and 6 months from baseline

  6. Disease activity evaluated by the Simple Disease Activity Index (SDAI)

    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.

    Measured: At 1, 3 and 6 months from baseline

  7. Disease activity evaluated by the Clinical Disease Activity Index (SDAI)

    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).

    Measured: At 1, 3 and 6 months from baseline

  8. Health Assessment Questionnaire (HAQ)

    Measured: At 1, 3 and 6 months from baseline

  9. Rheumatoid Arthritis Impact of Disease score (RAID)

    Measured: At 1, 3 and 6 months from baseline

  10. Hospital Anxiety and Depression scale

    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

    Measured: At 1, 3 and 6 months from baseline

  11. Coping Strategy Questionnaire: a 21-items self-report

    Measured: At 1, 3 and 6 months from baseline

  12. Levels of cytokines

    Measured: At 3 and 6 months from baseline

  13. Levels of neurotrophins

    Measured: At 3 and 6 months from baseline

  14. Levels of miR21, miR-124, miR-146a and miR-155

    Measured: At 3 and 6 months from baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jan 2019
  2. Study start17 Jun 2019
  3. Primary completion28 Apr 2023
  4. Study completion28 Apr 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03815578
Sponsor's protocol ID
CHUBX 2017/39
Acronym
TOPRA
Status last verified
May 2023
First submitted
11 Jan 2019
Last updated
6 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Clinical examination, Pain assessment and blood sample in people with Rheumatoid Arthritis, run by University Hospital, Bordeaux at 2 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Variation of the mean Pressure Pain Thresholds (PPTs) (time frame: At 6 months from baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03815578.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.

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