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JAK Inhibitor Dose TAPering Strategy Study

NCT06687551 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 308

Last updated 2024-11-13

No results posted yet for this study

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

Conditions

  • Rhumatoid Arthisis

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

Sponsors & Collaborators

  • University Hospital, Toulouse

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-01
Primary Completion
2029-04-01
Completion
2029-04-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06687551 on ClinicalTrials.gov