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NCT Number: NCT06528431

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

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.

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Key information

Conditions

Arthritis, Rheumatoid Arthritis Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Infirmerie Protestante, Caluire-et-Cuire, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Clinical tapering strategy

Drug

Clinical Tapering strategy : Adalimumab injections will be progressively spaced out according to DAS28 assessment every 3 months

Step Wedge trial

Drug

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

Primary outcomes

  1. Rheumatoid arthritis flare-up

    Time frame: 15 Months

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

    • 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
    • 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,

Secondary outcomes

  1. Infection

    Time frame: 15 months

    Number of infection

Study contacts

Contact information is provided by the study sponsor or research team.

Hubert MAROTTE, MD PhD

CONTACT

[email protected]

(0)4 77 12 76 49

Madjid AKROUR

CONTACT

[email protected]

(0)4 77 12 78 37 ext. +33

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Collaborators

  • AAP MESSIDOR

Registry information

Acronym: MONITORA

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Jul 30, 2024
Registry last updated
Dec 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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