JAK Inhibitor Dose TAPering Strategy Study

ConditionRheumatoid Arthritis (RA

Trial statusRecruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age18-65

SponsorUniversity Hospital, Toulouse

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

Baricitinib (LY3009104) 4 mg
Drug
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
filgotinib 200mg/day
Drug
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
Tofacitinib 5 mg twice daily
Drug
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
Upadacitinib 15 MG
Drug
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
Baricitinib (LY3009104) 4 mg
Drug
use of JAK inhibitor at full dose until the end of the protocol
filgotinib 200mg/day
Drug
use of JAK inhibitor at full dose until the end of the protocol
Tofacitinib 5 mg twice daily
Drug
use of JAK inhibitor at full dose until the end of the protocol
Upadacitinib 15 MG
Drug
use of JAK inhibitor at full dose until the end of the protocol

Treatment groups

308 Participants

are divided into 2 treatment groups

Group A: JAK inhibitor dose-tapering strategyExperimental treatment 4 interventions

Group B: JAK inhibitor continuous therapy strategyActive comparator 4 interventions

Trial outcomes

Primary outcomes

proportion of patients still receiving a JAK-inhibitor

The primary outcome of this study will be the proportion of patients still receiving a JAK-inhibitor and being in CDAI low disease activity at 12 months. The size of the effect will be given in the form of the difference in proportion between the two treatment groups with a two-sided confidence interval at 95%. Non-inferiority will be assessed with this interval. Non-inferiority will be concluded if the lower limit of the 95% confidence interval does not exceed the non-inferiority margin of 10% of the difference in proportion.

Time frame

12 post baseline

Secondary outcomes

Flare occurence

The delay between the inclusion visit and the first flare diagnosed by a physician. Two definitions of flare can be used for this criterion: * A flare defined by a CDAI \> 10 at any visit. * A major flare at any visit, based on the OMERACT definition which is: * An increase in the DAS28-ESR score of more than 1.2 compared to baseline score, * OR a DAS28-ESR score increase of more than 0.6 compared to the baseline score AND the current DAS28-ESR score being above 3.2.

Time frame

first flare post baseline

Locations24

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Sponsors and contacts

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University Hospital, Toulouse

Lead sponsor

Source ClinicalTrials.gov

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