JAK Inhibitor Dose TAPering Strategy Study

Condition(s) studied

Investigational drug(s) / intervention(s)

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

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

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

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

Baricitinib (LY3009104) 4 mg: use of JAK inhibitor at full dose until the end of the protocol

filgotinib 200mg/day: use of JAK inhibitor at full dose until the end of the protocol

Tofacitinib 5 mg twice daily: use of JAK inhibitor at full dose until the end of the protocol

Upadacitinib 15 MG: use of JAK inhibitor at full dose until the end of the protocol

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

Eligibility

Primary outcome measure(s)

• proportion of patients still receiving a JAK-inhibitor — 12 post baseline
  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.

Trial sites (24)

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