Predicting safe tapering of biologic therapy for rheumatoid arthritis in remission

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In RA patients who achieve sustained remission on biologic therapy, this study evaluates the OPTIBIO model, which combines blood biomarkers and clinical data to estimate the risk of disease flare if treatment is tapered. Participants are randomized to either have tapering decisions made by their usual clinician or guided by the OPTIBIO tool. The trial aims to determine if using OPTIBIO can improve safety and confidence in dose reduction while maintaining disease control. The study focuses on adults with RA on TNF inhibitors and in at least six months of remission, evaluating whether the decision strategy affects flare rates, withdrawal sustainability, and overall treatment outcomes.

Why it matters

Who can join: the full rules

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.

Where it's running

• Complejo Hospitalario Universitario de A Coruña
  A Coruña, A Coruña, Spain Recruiting
• Hospital Universitario Araba
  Alava, Alava, Spain Recruiting
• Hospital del Mar
  Barcelona, Barcelona, Spain Recruiting
• Hospital Universitario La Princesa
  Madrid, Madrid, Spain Recruiting
• Hospital General Universitario Gregorio Marañón
  Madrid, Madrid, Spain Recruiting
• Hospital Clínico San Carlos
  Madrid, Madrid, Spain Recruiting

Study contacts

• Principal investigator: Francisco J. Blanco, MD, PhD — Complejo Hospitalario Universitario de A Coruña
• Study coordinator: Francisco J. Blanco, MD, PhD
• Email: fblagar@sergas.es
• Phone: +34981176399

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Heart Rate Variability and Rheumatoid Arthritis: What HRV Looks Like with RA

  This study checks whether continuous HRV data from an Oura ring can reflect RA disease activity in adults with RA.

  Recruiting University of Central Florida · Orlando, Florida · NCT07878975

• Discontinuing MTX or LEF in RA Patients on TNF Inhibitors

  This trial tests whether stopping methotrexate or leflunomide while continuing a TNF inhibitor is not worse for disease control in adults with rheumatoid arthritis.

  Recruiting Phase 4 Sint Maartenskliniek · Nijmegen, Gelderland and 3 other locations · NCT07802678

• FT839 therapy for autoimmune diseases

  This trial tests FT839, given alone or with rituximab, to see if it is safe and can help people with certain autoimmune diseases who have not responded to other treatments.

  Recruiting Phase 1/2 Fate Therapeutics · Fullerton, California · NCT07800871

• 24-Hour Movement and Atherosclerotic Risk in adults with rheumatoid arthritis

  This study tests how daily activity, sitting, and sleep relate to heart-related risk in adults with RA, using wearables and follow-up after a year.

  Recruiting São Paulo State University · Presidente Prudente, São Paulo · NCT07774507

• Integrative AI profiling of chronic RA pain

  This study tests whether an AI-driven multiomic and neurophysiological approach can help explain and predict persistent pain in adults with active rheumatoid arthritis.

  Recruiting 4th Military Clinical Hospital with Polyclinic, Poland · Wroclaw · NCT07769619

• Oxidative Stress and Heart Risk in People with Rheumatoid Arthritis

  This study tests whether certain markers of oxidative stress in people with rheumatoid arthritis are linked to subclinical atherosclerosis and arterial stiffness, which could relate to future heart disease risk.

  Recruiting University of La Laguna · Santa Cruz de Tenerife, Canary Islands · NCT07760662

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.