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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

2025-01-01

Completion Date

2029-04-01

Last Updated

2024-11-13

Healthy Volunteers

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

The inclusion criteria will be 1. Aged ≥ 18 years at baseline. 2. Rheumatoid arthritis defined by the ACR/EULAR criteria. 3. Treated with a JAK inhibitor, full dose for at least 6 months. 4. The JAK inhibitor is prescribed as monotherapy or combined with a csDMARD with a stable dosage for at least 3 months before inclusion. 5. Being in LDA (CDAI≤10) for at least 6 months. 6. With a CRP level below the laboratory standard within the month before the inclusion visit. 7. Women of childbearing potential (WCBP) must have a negative pregnancy test before starting study The non-inclusion criteria will be: 1. Concomitant disease needing to be treated by the JAK inhibitor at full-dose (for example inflammatory bowel disease). 2. Patient with a history of JAK-inhibitor dose reduction/spacing before enrollment in the study with the JAK-inhibitor currently being taken. 3. Evidence of flare-up within the last 6 months prior to the inclusion. 4. Patient who received glucocorticoids \> 5mg/day in the 3 months prior the inclusion because of the disease activity of the RA. 5. Patient requiring corticoid joint injections in the 3 months prior to inclusion or with scheduled joint injections, to control disease activity. 6. 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. 7. 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). 8. Patient taking immunotherapy for neoplasia. 9. Surgery scheduled in the next 12 months. 10. Fibromyalgia according to the physician's opinion. 11. Anticipated poor compliance with the strategy. 12. Patient with any condition that would prevent participation in the study and completion of the study procedures, including language limitation. 13. Alcohol and/or drug misuse as determined by the investigator. 14. Pregnancy or breastfeeding. 15. Non-affiliation to the French Social Security System. 16. Patient unwilling to sign the informed consent form. 17. Patient under legal protection.

Clinical Research Directory

JAK Inhibitor Dose TAPering Strategy Study

Summary

Key Details

Conditions

Interventions

Eligibility Criteria