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

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What is this study about?

The study focuses on Rheumatoid arthritis, a condition in which the immune system attacks the joints, causing pain, swelling, and stiffness. Participants are older adults (70 years or older) whose disease has been stable with low activity. A wide range of medicines that are normally used to control the disease may be involved, including filgotinib, baricitinib, infliximab, certolizumab pegol, hydroxychloroquine, upadacitinib, adalimumab, sulfasalazine, sarilumab, tocilizumab, methotrexate, golimumab, abatacept, prednisolone, tofacitinib, leflunomide and etanercept. These drugs fall into three groups: csDMARD (traditional oral medicines), bDMARD (biologic injections or infusions), and tsDMARD (targeted oral agents). The purpose of the study is to find out whether gradually lowering the dose of these medicines, based on what patients prefer, can keep the arthritis under control while reducing overall drug exposure.

Participants will be followed for up to 24 months. Some will slowly reduce their medication doses (the tapering group), while others will continue taking their medicines as they have been (the usual‑care group). Throughout the study, regular visits will include simple checks of joint pain and swelling, blood tests, and a score called DAS28-CRP, which combines the number of tender and swollen joints with a blood marker of inflammation to show how active the arthritis is. Safety will be monitored, and the study will compare how much medication each group saves and whether disease activity stays similar over time.

1 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).

2 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.

3 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).

4 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.

5 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.

6 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.

7 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.

8 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.

Who Can Join the Study?

  • You can read and understand study information written in Danish.
  • You are 70 years old or older.
  • You have been diagnosed with rheumatoid arthritis according to the national guidelines.
  • You have been taking your arthritis medicines (called cs‑DMARDs, b‑DMARDs, or ts‑DMARDs) at the same dose for at least the past 12 months, without any changes.
  • Your disease has been in low disease activity (a score called DAS28‑CRP lower than 3.2) for at least the past 12 months, as recorded in the DANBIO registry.
  • You have not had any active joint inflammation in the last 12 months, according to your doctor’s assessment.
  • You are either not using the steroid medication prednisolone or you are taking a low dose (5 mg per day or less) and have been on that stable dose for at least the past 12 months.

Who Cannot Join the Study?

  • Unable to give informed consent (meaning you cannot understand and agree to take part) or not willing to follow the study rules.
  • Doctors think reducing your medication (DMARD tapering) is not safe for you, such as if you have had rheumatoid arthritis that was hard to control in the past (difficult‑to‑treat RA).

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name City Country Status
Regionshospital Nordjylland Hjørring Denmark
Aalborg University Hospital Aalborg Denmark

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Denmark Denmark
Not yet recruiting
01.10.2026

Trial locations

Filgotinib is an oral medication that belongs to a group called targeted synthetic DMARDs. It works by blocking specific enzymes that cause inflammation in the joints. In this study it is one of the drugs that may be reduced in dose for patients who choose to taper their treatment.

Baricitinib is another oral targeted synthetic DMARD. It reduces inflammation by inhibiting enzymes involved in the immune response. The trial examines whether patients can safely lower the amount of baricitinib they take while keeping their arthritis under control.

Infliximab is a biologic drug given by infusion. It is an antibody that blocks a protein called tumor necrosis factor (TNF), which drives joint inflammation. Participants may have their infliximab dose decreased as part of the tapering strategy.

Certolizumab pegol is an injectable biologic that also targets TNF to reduce inflammation. In the study it is used as a treatment that could be tapered down for patients who prefer to reduce their medication load.

Hydroxychloroquine is an oral conventional DMARD that has anti‑inflammatory effects and is often used in rheumatoid arthritis. The trial looks at whether the dose of hydroxychloroquine can be lowered without worsening disease activity.

Upadacitinib is an oral targeted synthetic DMARD that blocks a pathway called JAK, helping to control joint inflammation. The study tests if patients can safely taper the amount of upadacitinib they receive.

Adalimumab is an injectable biologic that neutralizes TNF, reducing swelling and pain in the joints. Researchers are evaluating whether the dose of adalimumab can be reduced while maintaining disease control.

Sulfasalazine is an oral conventional DMARD that works by decreasing inflammation in the body. In this trial it may be part of the medication regimen that participants try to taper.

Sarilumab is an injectable biologic that blocks the interleukin‑6 (IL‑6) receptor, a key driver of joint inflammation. The study includes sarilumab as a drug that could be tapered for patients who choose that option.

Tocilizumab is an injectable or infusion biologic that also blocks the IL‑6 receptor, helping to lessen joint damage. Participants may have their tocilizumab dose reduced as part of the tapering approach.

Methotrexate is a cornerstone conventional DMARD taken either by injection or orally. It works by slowing down the immune system’s attack on joint tissue. The trial investigates whether patients can lower their methotrexate dose while staying in low disease activity.

Golimumab is an injectable biologic that targets TNF to reduce inflammation. In the study it is considered for dose reduction in the tapering group.

Abatacept is a biologic given by infusion that interferes with a specific step in T‑cell activation, which helps control rheumatoid arthritis. The trial examines if the amount of abatacept can be safely tapered.

Prednisolone is an oral steroid that quickly reduces inflammation and pain. Although not a DMARD, it is used in the study to manage symptoms and may be adjusted as part of the overall treatment plan.

Tofacitinib is an oral targeted synthetic DMARD that inhibits JAK enzymes, lowering inflammatory activity in the joints. The study assesses whether patients can decrease their tofacitinib dose while keeping disease activity stable.

Leflunomide is an oral conventional DMARD that reduces the production of immune cells that cause joint damage. In this trial it may be one of the medications that participants try to taper.

Etanercept is an injectable biologic that binds to TNF, preventing it from causing inflammation. The research looks at whether the dose of etanercept can be reduced without worsening rheumatoid arthritis symptoms.

Investigated Diseases:

Rheumatoid arthritis – Rheumatoid arthritis is a long‑lasting condition that causes inflammation of the joints. It usually starts with pain, swelling and stiffness in the small joints of the hands and feet. Over time the inflammation can spread to larger joints and lead to gradual loss of joint shape and function. The disease may also cause fatigue and a feeling of overall discomfort. Symptoms often come and go, with periods of increased activity followed by quieter phases. The ongoing inflammation can slowly reduce the ability to move joints smoothly.

Trial ID:
2026-525221-21-01
Trial Phase:
Therapeutic confirmatory (Phase III)

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