Design and Evaluation of an Individualized Biodrug Tapering Strategy Based on Biodrug Dosage: the MONITORA Study (MONITORA)

December 19, 2025 updated by: Centre Hospitalier Universitaire de Saint Etienne
Rheumatoid arthritis (RA) is the most common inflammatory joint disorder. Since twenty year and the use of synthetic disease-modifying anti-rheumatic drugs (csDMARDs) and biological (b)DMARD, remission can be reached. When remission is obtained, the physician has no recommendations for managing a step-down, and future guidelines will be useful to assist the clinician. Recent data suggest that tapering is feasible, but with high risk of flares. Flares are less frequent when bDMARD blood concentration is high. But, the optimal adalimumab concentration to keep before a step of tapering no targeting personal is unknown.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

180

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Caluire-et-Cuire, France, 69300
        • Recruiting
        • Infirmerie Protestante
        • Contact:
      • La Roche-sur-Yon, France, 85925
      • Lomme, France, 59160
        • Recruiting
        • Hopital Philibert
        • Contact:
      • Montpellier, France, 34295
        • Recruiting
        • CHU Montpellier
        • Contact:
        • Sub-Investigator:
          • Christian JORGENSEN, MD PhD
        • Sub-Investigator:
          • Laurene BERNARD, MD
        • Sub-Investigator:
          • Adriano LERCARA, MD
        • Sub-Investigator:
          • Angélique NALLET, MD
        • Sub-Investigator:
          • Marina THIRION, MD
      • Paris, France, 75013
        • Recruiting
        • AP-HP Pitié Salpêtrière
        • Contact:
        • Sub-Investigator:
          • Camille FIAUX, MD
      • Reims, France, 51100
        • Not yet recruiting
        • CHU Reims
        • Contact:
      • Saint-Etienne, France, 42055
      • Tours, France, 37170

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patient over 18 years of age
  • Patients with a diagnosis of RA according to ACR/EULAR 2010 criteria
  • Remission according to DAS28<=2.6 for at least 6 months
  • Patient treated with ADA for at least 6 months. The patient is treated according to one of the following two strategies:
  • ADA 40 mg every two weeks (= every 14 days) according to the standard regimen
  • or ADA 40 mg every 3 weeks (= every 21 days)
  • A negative highly sensitive pregnancy test for women of Childbearing Potential*
  • Affiliated person or beneficiary of a social security scheme
  • Informed consent signed by the patient after information

Exclusion Criteria:

  • Incapacity or refusal to understand and / or sign informed consent to participate in the study.
  • Existing pregnancy, lactation, or intended pregnancy within the next 15 months
  • Fibromyalgia associated to RA
  • Any dose of prednisone for RA treatment 6 months before inclusion
  • Patient deprived of liberty or patient under guardianship or curator ship.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single arm trial
Single arm trial in patients with established RA who achieved clinical remission with subcutaneous injection of adalimumab in combination with MTX (methotrexate). Patients will undergo a tapering strategy based only on the clinical status (flare /no flare) during 12 months.
Drug: Clinical tapering strategy
Clinical Tapering strategy : Adalimumab injections will be progressively spaced out according to DAS28 assessment every 3 months
No Intervention: Maintenance arm
Maintenance arm: the same adalimumab regimen
Experimental: Optimized tapering adalimumab
An optimized tapering adalimumab strategy based on the disease activity and the adalimumab trough concentration. The tapering strategy will rely on the adalimumab trough concentration. Spacing will be performed only if adalimumab trough concentration is above the pre-specified concentration threshold
Drug: Step Wedge trial
Step Wedge trial : At baseline, all the patients will receive in this study the standard adalimumab dosing regimen. At subsequent time points (steps), patients will begin the intervention of interest, here the tapering adalimumab strategy. The time at which a patient begins the intervention will be randomized. We fixed the time steps duration to 3 months that corresponds the frequency of there commended follow-up of RA patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rheumatoid arthritis flare-up
Time Frame: 15 Months

The RA flare-up will be defined as previously by:

  1. a disease activity score (DAS)28 that increase above 2.6 for patient previously in remission (DAS28≤2.6) and a DAS28 increase (ΔDAS28) of 0.6 or greater for patients with low disease activity (2.6<DAS28<3.2) : YES/NO
  2. Use of a glucocorticoid for the symptoms of RA, regarless of the DAS28 : YES/NO

DAS28 is calculated according to the formula that is composed of the number of tender joints (TJC) and swollen joints (SJC), patient's global assessment of disease activity on a visual analogue scale (PGA, 0-10), and C-reactive protein (CRP).

Formula for calculating DAS28 using C-reactive protein (CRP) :

DAS28-CRP=(0.56 × √TJC) + (0.28 × √SJC) + (0.014 × PGA [mm]) + (0.36 × ln(CRP in mg/L+1) + 0.96,
15 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infection
Time Frame: 15 months
Number of infection
15 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Collaborators

AAP MESSIDOR

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 19, 2024

Primary Completion (Estimated)

September 19, 2026

Study Completion (Estimated)

December 19, 2027

Study Registration Dates

First Submitted

July 19, 2024

First Submitted That Met QC Criteria

July 25, 2024

First Posted (Actual)

July 30, 2024

Study Record Updates

Last Update Posted (Actual)

December 26, 2025

Last Update Submitted That Met QC Criteria

December 19, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24CH046
  • 2024-514313-35-00 (Ctis)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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