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Blood test could help rheumatoid arthritis patients safely reduce medication

NCT ID NCT07678112

Disease control Sponsor: Francisco J. Blanco Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 01, 2026 · Last updated Jul 02, 2026 · Updated 1 time

Summary

This study tests a new tool called OPTIBIO that uses blood markers and patient data to help doctors decide if it's safe to reduce biological therapy in rheumatoid arthritis patients who are in remission. About 184 adults with RA in stable remission will be randomly assigned to have their treatment decisions guided by the tool or by their usual doctor. The goal is to see if the tool can help more patients stay in remission while using less medication.

What this could mean

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

Active substance
Predictive model (OPTIBIO) using blood biomarkers and clinical data
What this could lead to
If successful, this tool could help doctors safely reduce medication for rheumatoid arthritis patients in remission, lowering costs and side effects while maintaining disease control.
What could go wrong
The tool is still being tested in a relatively small trial. It may not accurately predict flares for all patients, and reducing medication always carries a risk of disease worsening.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 184 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2025

Expected to finish

Aug 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 years and older

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: * Adults aged ≥18 years. * Diagnosis of rheumatoid arthritis according to either the 1987 American College of Rheumatology (ACR) criteria or the 2010 ACR/EULAR classification criteria. * Clinical remission for at least 6 months prior to the baseline visit, defined as DAS28-CRP \< 2.6. * Receiving biological anti-TNF therapy (infliximab, adalimumab, etanercept, golimumab, or certolizumab). * Ability and willingness to provide written informed consent to participate in the study. Exclusion Criteria: * Patients in whom biological therapy was prescribed due to systemic manifestations of rheumatoid arthritis. * Patients with rheumatoid arthritis and any known associated condition that may interfere with the assessment of study outcomes (e.g., fibromyalgia or concomitant chronic inflammatory diseases). * Patients receiving chronic anti-TNF biological therapy who are already undergoing treatment tapering or are on reduced or extended dosing regimens prior to study inclusion.

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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 (RA

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    9 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Complejo Hospitalario Universitario de A Coruña

    RECRUITING

    A Coruña, A Coruña, 15006, Spain

  • Hospital Clínico San Carlos

    RECRUITING

    Madrid, Madrid, 28040, Spain

  • Hospital General Universitario Gregorio Marañón

    RECRUITING

    Madrid, Madrid, 28007, Spain

  • Hospital Regional Universitario de Málaga

    RECRUITING

    Málaga, Málaga, 29010, Spain

  • Hospital Universitario 12 de Octubre

    RECRUITING

    Madrid, Madrid, 28041, Spain

  • Hospital Universitario Araba

    RECRUITING

    Alava, Alava, 01009, Spain

  • Hospital Universitario La Princesa

    RECRUITING

    Madrid, Madrid, 28006, Spain

  • Hospital Universitario de Canarias

    RECRUITING

    San Cristóbal de La Laguna, Santa Cruz de Tenerife, 38320, Spain

  • Hospital del Mar

    RECRUITING

    Barcelona, Barcelona, 08003, Spain

    Contact Email: •••••@•••••

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