JAK Inhibitor Dose TAPering Strategy Study

Conditions

• Rhumatoid Arthisis

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• 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

Study Details

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

Key Dates

Start date

Jan 1, 2025

Status verified

Nov 2024

Primary completion

Apr 1, 2029

Completion

Apr 1, 2029

Study Design

Enrollment

308 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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

Primary Outcome Measure

proportion of patients still receiving a JAK-inhibitor [ Time Frame: 12 post baseline ]

Central Contacts

• Adeline RUYSSEN-WITRAND, MD
  05 61 77 56 26
  [email protected]
• Delphine THUILLEZ
  (+33 5 61 7)7 69 66
  [email protected]