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

NCT ID: NCT06528431

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-19

Study Completion Date

2027-12-19

Brief Summary

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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.

Detailed Description

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Conditions

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Arthritis, Rheumatoid

Keywords

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Arthritis, Rheumatoid Adalimumab Remission management step wedge trial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Randomization comparing 2 therapeutic strategies
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Clinical tapering strategy

Intervention Type DRUG

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

Maintenance arm

Maintenance arm: the same adalimumab regimen

Group Type NO_INTERVENTION

No interventions assigned to this group

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

Group Type EXPERIMENTAL

Step Wedge trial

Intervention Type 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

Interventions

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Clinical tapering strategy

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

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AAP MESSIDOR

UNKNOWN

Sponsor Role collaborator

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Infirmerie Protestante

Caluire-et-Cuire, , France

Site Status RECRUITING

Chd Vendee

La Roche-sur-Yon, , France

Site Status RECRUITING

Hopital Philibert

Lomme, , France

Site Status RECRUITING

Chu Montpellier

Montpellier, , France

Site Status RECRUITING

Ap-Hp Pitie Salpetriere

Paris, , France

Site Status RECRUITING

Chu Reims

Reims, , France

Site Status NOT_YET_RECRUITING

Chu Saint Etienne

Saint-Etienne, , France

Site Status RECRUITING

Chru Tours

Tours, , France

Site Status NOT_YET_RECRUITING

Countries

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France

Central Contacts

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Hubert MAROTTE, MD PhD

Role: CONTACT

Phone: (0)4 77 12 76 49

Email: [email protected]

Madjid AKROUR

Role: CONTACT

Phone: (0)4 77 12 78 37

Email: [email protected]

Facility Contacts

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André BASCH, MD

Role: primary

Grégoire CORMIER, MD

Role: primary

Tristan PASCART, MD PhD

Role: primary

Yves-Marie PERS, MD PhD

Role: primary

Bruno FAUTREL, MD PhD

Role: primary

Jean-Hugues SALMON, MD PhD

Role: primary

Hubert MAROTTE, PhD

Role: primary

Madjid Akrour

Role: backup

Denis MULLEMAN, MD PhD

Role: primary

Other Identifiers

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2024-514313-35-00

Identifier Type: CTIS

Identifier Source: secondary_id

24CH046

Identifier Type: -

Identifier Source: org_study_id