Methotrexate tapering versus usual care in elderly (≥70) patients with rheumatoid arthritis in low disease activity – drug combination study

Baseline assessment

You attend the first study visit after joining the trial. during this visit a clinician records your medical history, current rheumatoid arthritis status, and the medications you are already taking. the disease activity is measured using the disease activity score-28-c-reactive protein (das28-crp) questionnaire.

The list of possible medications includes oral tablets such as jyseleca 200 mg film-coated tablets (filgotinib 200 mg once daily), olumiant 4 mg film-coated tablets (baricitinib 4 mg once daily), hydroxychloroquine 400 mg tablets (hydroxychloroquine sulfate 400 mg once daily), leflunomide 20 mg tablets (leflunomide 20 mg once daily), methotrexate 3.6 mg tablets (methotrexate sodium 3.6 mg once weekly), and prednisolone 5 mg soluble tablets (prednisolone 5 mg once daily as needed). injectable or infusion drugs that may be part of your current regimen include adalimumab 2.86 mg solution for injection, infliximab 12.5 mg solution for infusion, certolizumab pegol 14.29 mg solution for injection, golimumab 1.67 mg solution for injection, etanercept 7.14 mg solution for injection, abatacept 35.71 mg solution for infusion, tocilizumab 23.14 mg solution for injection, sarilumab 14.3 mg solution for injection, and upadacitinib 15 mg prolonged‑release tablets (upadacitinib 15 mg once daily).

Choice of treatment approach

Based on your preference, you select either the tapering group, where the dose of disease‑modifying anti‑rheumatic drugs (dmards) will be gradually reduced, or the control group, where you continue your current dmard regimen without planned reductions.

Medication administration

You continue taking the oral medications exactly as prescribed: each tablet is taken by mouth at the dose and frequency listed in the baseline assessment.

For injectable or infusion medicines, you receive the medication in a clinic or infusion center according to the standard schedule for that drug (for example, infliximab is given as an infusion at the dose of 12.5 mg per administration).

Tapering schedule (if selected)

If you chose the tapering group, the study protocol reduces the dose of each dmard you are using in small steps. a typical reduction might be 25 % of the original dose every three months, but the exact amount depends on the specific drug and your disease activity.

Oral csdmards such as hydroxychloroquine, leflunomide, methotrexate, and sulfasalazine are lowered first. bdmards and tsdmards (for example, adalimumab, infliximab, baricitinib, filgotinib, upadacitinib) are reduced later, often by extending the interval between injections or decreasing the tablet dose.

Each reduction is followed by a clinical review to ensure that disease activity remains stable.

Regular follow‑up visits

You attend study visits every three months for the entire 24‑month period. at each visit the clinician records any side effects, checks your medication adherence, and repeats the disease activity score-28-c-reactive protein (das28-crp) assessment.

Blood tests may be taken to monitor safety, but no new medication changes are made unless required by your disease activity.

Mid‑study evaluation

At the 12‑month mark a formal evaluation is performed. the amount of dmard dose reduction achieved so far is calculated, and disease activity is compared with baseline to ensure that the condition remains under control.

Final assessment at 24 months

At the end of the 24‑month observation period a comprehensive assessment is completed. the total percentage reduction of csdmard and bdmard/tsdmard doses is calculated, and the average disease activity score-28-c-reactive protein (das28-crp) over the whole period is determined.

The study compares these results between the tapering group and the control group to evaluate whether dose reduction was achieved without loss of disease control.

Optional year‑5 follow‑up

Participants may be invited for a single follow‑up visit at five years after the start of the study to assess long‑term outcomes. this visit includes the same disease activity measurement and a review of any ongoing medication use.