Reducing arthritis medicines versus usual care in older adults with rheumatoid arthritis

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for people aged 70 or older with rheumatoid arthritis whose disease has been quiet for at least 12 months while on stable arthritis medicines.

Age

70 years or older

Sex

All sexes

Disease stage

Rheumatoid arthritis with low disease activity (DAS28-CRP below 3.2) for at least 12 months, and no joint inflammation in the past 12 months.

Earlier treatment

Must have been on a stable dose of arthritis medicine (cs-/b-/tsDMARD) with no dose changes for at least 12 months. Prednisolone, if taken, must be a stable low dose of 5 mg a day or less for at least 12 months.

Main reasons for not taking part

• Cannot give informed consent or is unwilling to follow the trial plan
• Reducing the arthritis medicine is judged unwise by a medical expert, for example after earlier difficult-to-treat rheumatoid arthritis
• Cannot read and understand information material in Danish

What the trial wants to find out

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.