Recruiting PHASE4 Rheumatoid Arthritis (RA)

New treatment option for Rheumatoid Arthritis (RA)

Official title REDO-JAK: Dose Reduction of Janus Kinase Inhibitors in Patients With Inflammatory Rheumatic Diseases

ClinicalTrials.gov ID: NCT07160231

What this study is testing

What is JAKi dose reduction strategy?

JAKi dose reduction strategy is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for rheumatoid arthritis (ra).

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
The goal of this clinical trial is to assess the effectiveness of a disease activity guided dose reduction strategy of Janus kinase inhibitor (JAKi) compared to disease activity guided JAKi continuation in patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA) who are in a state of low disease activity or remission while on JAKi. The main question it aims to answer is: Is a disease activity guided dose reduction strategy for JAKi not inferior in terms of efficacy compared to disease activity guided JAKi continuation in patients with RA/PsA/axSpA that are currently in a low disease activity/remission state?
  • Phase 4: studies an already-approved treatment
  • Which group you join is decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 16 and older

You may be able to join if

  • Patients ≥ 16 years of age
  • Clinical diagnosis of RA, PsA or axSpA
  • Treated with a JAKi (monotherapy or combination with csDMARDwith a JAKi dose ≥ 50% of the authorised dose)
  • LDA or remission for at least 6 months according to accepted criteria for the specific disease and/or the judgement of the treating rheumatologist...

You likely can't join if

  • Comorbidity for which continued JAKi treatment is expected to be necessary (e.g. active Crohn's disease, ulcerative colitis)
  • Life expectancy ≤12 months
  • Pregnancy (JAKi are contra-indicated during pregnancy, therefore we do not expect patients using a JAKi while pregnant)
  • Patients who are enrolled in other trials that might mutually interfere
  • Not able to provide informed consent

The study team makes the final eligibility decision.

Where it's taking place

  • Nijmegen, Gelderland, Netherlands
  • Maastricht, Limburg, Netherlands
  • Tilburg, North Brabant, Netherlands
  • Enschede, Overijssel, Netherlands
  • Zwolle, Overijssel, Netherlands
  • Rotterdam, South Holland, Netherlands

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 16 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Nijmegen, Gelderland, Netherlands; Maastricht, Limburg, Netherlands; Tilburg, North Brabant, Netherlands; Enschede, Overijssel, Netherlands; Zwolle, Overijssel, Netherlands; Rotterdam, South Holland, Netherlands. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.