Authorised Therapeutic use (Phase IV) Rheumatoid arthritis

The OASE study

EU CTIS ID: 2026-525221-21-01

What this study is testing

The co-primary objective is to evaluate cs-/b-/tsDMARD tapering (tapering group) compared to continuation of DMARDs as usual care (control group) based on patient preference in elderly patients (≥70 years) with RA in sustained LDA. The co-primary endpoint at 24 months will be met if: A. Superiority in ≥50% accumulated cs- and/or b-/tsDMARD dose reduction is demonstrated in the tapering group compared to the control group. The accumulated DMARD dose reduction will be calculated as the mean percentage reduction across cs- and b-/tsDMARD treatments relative to the baseline dosing. E.g., 25% reduction in csDMARD and 25% reduction in b-/tsDMARD = 25% total DMARD reduction, 100% reduction in cs-DMARD and 0% in b-/tsDMARD = 50% total reduction, and 75% reduction in cs-DMARD and 50% in b-/ts-DMARD = 63% total reduction. B. Equivalent disease activity is maintained measured by the average Disease Activity Score-28-C-Reactive Protein score (DAS28-CRP) across the 24-months observation period with predefined equivalence margins of ±0.5.

  • Therapeutic use (Phase IV)

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

Who can take part

You may be able to join if

  • Inclusion criteria are: • Able to read and understand information material in Danish. • ≥70 years of age. • Diagnosed with RA according to national guidelines. • Treated with cs-/b-/tsDMARD in stable dosage, i.e., no dose alterations during ≥12 months. • In LDA (DAS28-CRP <3.2) during ≥12 months measured by registrations in DANBIO. • No inflammatory joint activity during the past 12 months judged by the investigator. • Stable, low-dose prednisolone (≤5 mg/day) or no prednisolone during ≥12 months.

You likely can't join if

  • Exclusion criteria are: • Inability to provide informed consent or unwilling to comply with the trial protocol. • DMARD tapering is judged not to be suitable by medical expert assessment e.g. patients with previous difficult-to-treat RA.

The study team makes the final eligibility decision.

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, 65+ years. The study team makes the final eligibility decision.

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