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Smart dosing strategy could keep rheumatoid arthritis under control

NCT ID NCT06440629

Disease control Sponsor: Diakonhjemmet Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jul 02, 2026 · Updated 3 times

Summary

This study compares two ways of managing rheumatoid arthritis in people taking adalimumab. One group gets standard care, while the other has their dose adjusted based on regular blood tests that measure drug levels and antibodies. The goal is to see if personalized dosing helps maintain disease control without flares over 18 months. About 350 adults with stable, low disease activity will take part.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
adalimumab (a tumor necrosis factor inhibitor)
What this could lead to
If successful, this approach could help people with rheumatoid arthritis maintain disease control with fewer flares by personalizing their medication dose.
What could go wrong
This is a Phase 4 study, so the drug is already approved. The main uncertainty is whether routine dose adjustments will actually reduce flares more than standard care, and some patients may need to switch therapies if antibodies develop.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

387 people

The number who actually took part.

Started

Aug 2024

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 74 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. A clinical diagnosis of RA 2. ≥ 18 and under 75 years of age at screening 3. On stable therapy with standard dose of a SC TNFi (adalimumab) for a minimum of 3 months and a maximum of 24 months 4. In low disease activity or remission (DAS28-CRP under 3.2) and indication for continuation of treatment according to the treating physician 5. Subject capable of understanding and signing an informed consent form Exclusion Criteria: 1. Major comorbidities, such as previous malignancies within the last 5 years, uncontrolled diabetes mellitus, severe infections (including HIV), uncontrollable hypertension, severe cardiovascular disease (NYHA class 3 or 4), severe respiratory diseases, demyelinating disease, significant chronic widespread pain syndrome, significant renal or hepatic disease, and/or other diseases or conditions which either contraindicate treatment with SC TNFi or make adherence to the protocol difficult 2. Hypersensitivity to sc TNFi (adalimumab). 3. Pregnancy, or subject considering becoming pregnant during the study period 4. Psychiatric or mental disorders, alcohol abuse or other substance abuse, language barriers, or other factors that makes adherence to the study protocol difficult 5. Changes in csDMARD co-medication, including dose changes of csDMARD or changes in the dose of corticosteroids within the last 2 months 6. Co-medication with bDMARD, tsDMARD, or other immunosuppressive drugs (excluding csDMARD and corticosteroids ≤ 7.5 mg prednisolone (or equivalent) once daily). 7. Active participation in any other interventional study. 8. In need of live vaccines during the study period.

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Conditions

The condition(s) this trial relates to.

rheumatoid arthritis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Rheumatoid arthritis

Contacts and locations

Locations

  • Betanien Hospital

    Skien, 3722, Norway

  • Carol Davila University of Medicine and Pharmacy Bucharest

    Bucharest, Romania

  • Diakonhjemmet sykehus

    Oslo, N-0319, 0319, Norway

  • Drammen Hospital

    Drammen, 3004, Norway

  • Førde Hospital Trust

    Førde, 6812, Norway

  • Haugesund Rheumatism Hospital

    Haugesund, 5528, Norway

  • Haukeland University Hospital

    Bergen, 5009, Norway

  • Helgeland Hospital Trust

    Mo i Rana, 8613, Norway

  • Hospital of Southern Norway Trust

    Kristiansand, 4615, Norway

  • Humanitas Research Hospital

    Milan, Italy

  • Karolinska University Hospital

    Stockholm, 141 86, Sweden

  • Lillehammer Hospital for Rheumatic Diseases

    Lillehammer, 2609, Norway

  • Martina Hansen's Hospital

    Sandvika, Norway

  • Medical University Vienna

    Vienna, A-1090, Austria

  • Nordland Hospital Trust

    Bodø, 8005, Norway

  • Queen Mary

    London, SW15 5PN, SW15 5PN, United Kingdom

  • Sahlgrenska Universitetssjukehuset

    Gothenburg, 41345, Sweden

  • St.Olavs Hospital

    Trondheim, 7030, Norway

  • Stavanger University Hospital

    Stavanger, 4019, Norway

  • University Hospital of North Norway

    Tromsø, 9019, Norway

  • Ålesund Hospital

    Ålesund, 6017, Norway

  • Østfold Hospital Trust

    Moss, 1535, Norway

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