Rheumatoid Arthritis (RA) Clinical Trials

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JAK Inhibitor Dose TAPering Strategy Study in Low Disease Activity Rheumatoid Arthritis Patients

Status: Recruiting
Location: See all (24) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

This study aims to assess the feasibility of tapering JAK inhibitors in rheumatoid arthritis patients in low disease activity by comparing a group of patients tapering the JAK inhibitor dosage to a group of patients continuing the full-dose. Participants will: * Either take 1. JAK inhibitor dose-tapering strategy. 2. JAK inhibitor continuous therapy strategy. * Visit the clinic once every 3 months for checkups and tests * Keep a diary of their treatment intake and symptoms

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
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• Aged ≥ 18 years at baseline.

• Rheumatoid arthritis defined by the ACR/EULAR criteria.

• Treated with a JAK inhibitor, full dose for at least 6 months.

• The JAK inhibitor is prescribed as monotherapy or combined with a csDMARD with a stable dosage for at least 3 months before inclusion.

• Being in LDA (CDAI≤10) for at least 6 months.

• With a CRP level below the laboratory standard within the month before the inclusion visit.

• Women of childbearing potential (WCBP) must have a negative pregnancy test before starting study

• Concomitant disease needing to be treated by the JAK inhibitor at full-dose (for example inflammatory bowel disease).

• Patient with a history of JAK-inhibitor dose reduction/spacing before enrollment in the study with the JAK-inhibitor currently being taken.

• Evidence of flare-up within the last 6 months prior to the inclusion.

• Patient who received glucocorticoids \> 5mg/day in the 3 months prior the inclusion because of the disease activity of the RA.

• Patient requiring corticoid joint injections in the 3 months prior to inclusion or with scheduled joint injections, to control disease activity.

• Patient at risk for complication according to the ANSM (60) (current or past smokers, patients at risk of VTE, cancer or major cardiovascular problems, aged ≥ 65 years) at baseline AND currently taking baricitinib or filgotinib.

• Patient taking associated bDMARD (including anti-TNF, anti-IL6, anti-CD20, abatacept, anti-IL17, anti-IL12/23, anti-IL23, anti-IL1, anti-BAFF, anti-IL5 pathways).

• Patient taking immunotherapy for neoplasia.

• Surgery scheduled in the next 12 months.

⁃ Fibromyalgia according to the physician's opinion.

⁃ Anticipated poor compliance with the strategy.

⁃ Patient with any condition that would prevent participation in the study and completion of the study procedures, including language limitation.

⁃ Alcohol and/or drug misuse as determined by the investigator.

⁃ Pregnancy or breastfeeding.

⁃ Non-affiliation to the French Social Security System.

⁃ Patient unwilling to sign the informed consent form.

⁃ Patient under legal protection.

Locations
Other Locations
France
CHU d'Amiens
RECRUITING
Amiens
Hôpital Pellegrin
RECRUITING
Bordeaux
La Cavale Blanche
RECRUITING
Brest
CHU de Clermont-Ferrand
RECRUITING
Clermont-ferrand
CHU Le Mans
RECRUITING
Le Mans
Hôpital Saint Philibert
RECRUITING
Lille
CHU Dupuytren 2
RECRUITING
Limoges
Hôpital Sainte Marguerite
RECRUITING
Marseille
Hôpital LAPEYRONIE
RECRUITING
Montpellier
CHRU de Nancy
RECRUITING
Nancy
Hôpital Pasteur 2
RECRUITING
Nice
Nouvel Hôpital Orléans La Source
RECRUITING
Orléans
GH Paris Saint-Joseph
RECRUITING
Paris
Groupe hospitalier Pitié-Salpêtrière
RECRUITING
Paris
Hôpital Bicêtre
RECRUITING
Paris
Hopital Cochin
RECRUITING
Paris
Hopital Lariboisière
RECRUITING
Paris
Hopital Saint Antoine
RECRUITING
Paris
Hopital Maison Blanche
RECRUITING
Reims
CHU de Rouen
RECRUITING
Rouen
Hopital Nord
RECRUITING
Saint-etienne
Hôpital Hautepierre
RECRUITING
Strasbourg
UH Toulouse
RECRUITING
Toulouse
CHU de Tours
RECRUITING
Tours
Contact Information
Primary
Adeline RUYSSEN-WITRAND, MD
ruyssen-witrand.a@chu-toulouse.fr
05 61 77 56 26
Backup
Delphine THUILLEZ
thuillez.d@chu-toulouse.fr
33 5 61 77 69 66
Time Frame
Start Date: 2025-06-06
Estimated Completion Date: 2029-04-01
Participants
Target number of participants: 308
Treatments
Experimental: JAK inhibitor dose-tapering strategy
The dose-tapering strategy will depend on the JAK inhibitor taken by the patient. It will be based on a 50% dose-reduction every 6 months and will comprise 2 steps:~A. Treatment with baricitinib 4 mg daily:~* Step 1 (after randomization): baricitinib 2mg daily.~* Step 2 (in case of CDAI ≤ 10 AND CRP level below the laboratory standard; 6 months after starting step1): baricitinib 2mg every other day.~B. Treatment with filgotinib 200 mg daily:~* Step 1 (after randomisation): filgotinib 100 mg daily.~* Step 2 (in case of CDAI ≤ 10 AND CRP level below the laboratory standard; 6 months after starting step1): filgotinib 100mg every other day.~C. Treatment with tofacitinib 5 mg twice daily or tofacitinib 11mg daily:~* Step 1 (after randomisation): tofacitinib 5 mg once daily.~* Step 2 (in case of CDAI ≤ 10 AND CRP level below the laboratory standard; 6 months after starting step1): tofacitinib 5 mg every other day.~D. Treatment with upadacitinib 15 mg daily:~• Step 1 (after randomisat
Active_comparator: JAK inhibitor continuous therapy strategy
Full dose will be considered in patient taking:~* Baricitinib 4mg/day~* Filgotinib: 200mg/day~* Tofacitinib : 5mg twice daily or 11mg/day~* Upadacitinib: 15mg/day
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Toulouse

This content was sourced from clinicaltrials.gov