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RECRUITING
NCT06687551
PHASE4

JAK Inhibitor Dose TAPering Strategy Study

Sponsor: University Hospital, Toulouse

View on ClinicalTrials.gov

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

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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

308

Start Date

2025-06-06

Completion Date

2029-04-01

Last Updated

2026-08-07

Healthy Volunteers

No

Interventions

DRUG

Baricitinib (LY3009104) 4 mg

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

DRUG

filgotinib 200mg/day

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

DRUG

Tofacitinib 5 mg twice daily

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

DRUG

Upadacitinib 15 MG

Treatment with upadacitinib 15 mg daily * Step 1 (after randomisation): upadacitinib 15 mg every other day * Step 2 (in case of CDAI≤ 10 AND CRP level below the laboratory standard; 6 months after starting step1): upadacitinib 15 mg every 4 days

DRUG

Baricitinib (LY3009104) 4 mg

use of JAK inhibitor at full dose until the end of the protocol

DRUG

filgotinib 200mg/day

use of JAK inhibitor at full dose until the end of the protocol

DRUG

Tofacitinib 5 mg twice daily

use of JAK inhibitor at full dose until the end of the protocol

DRUG

Upadacitinib 15 MG

use of JAK inhibitor at full dose until the end of the protocol

Locations (24)

UH Toulouse

Toulouse, Occitanie, France

CHU d'Amiens

Amiens, France

Hôpital Pellegrin

Bordeaux, France

La Cavale Blanche

Brest, France

CHU de Clermont-Ferrand

Clermont-Ferrand, France

CHU Le Mans

Le Mans, France

Hôpital Saint Philibert

Lille, France

CHU Dupuytren 2

Limoges, France

Hôpital Sainte Marguerite

Marseille, France

Hôpital LAPEYRONIE

Montpellier, France

CHRU de Nancy

Nancy, France

Hôpital Pasteur 2

Nice, France

Nouvel Hôpital Orléans La Source

Orléans, France

GH Paris Saint-Joseph

Paris, France

Groupe hospitalier Pitié-Salpêtrière

Paris, France

Hopital Cochin

Paris, France

Hopital Lariboisière

Paris, France

Hopital Saint Antoine

Paris, France

Hôpital Bicêtre

Paris, France

Hopital Maison Blanche

Reims, France

CHU de Rouen

Rouen, France

Hopital Nord

Saint-Etienne, France

Hôpital Hautepierre

Strasbourg, France

CHU de Tours

Tours, France