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

NCT06528431 | Recruiting Phase 4

• 2 other identifiers: 24CH0462024-514313-35-00
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 8

Brief Summary

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.

Conditions

Arthritis, Rheumatoid

Keywords

Arthritis, Rheumatoid; Adalimumab; Remission management; step wedge trial

Outcome Measures

Primary Outcomes (1)

• Rheumatoid arthritis flare-up

  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 Outcomes (1)

• Infection

  15 months

Study Arms (3)

Single arm trial

EXPERIMENTAL

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

Maintenance arm

NO INTERVENTION

Maintenance arm: the same adalimumab regimen

Optimized tapering adalimumab

EXPERIMENTAL

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

Interventions

Clinical tapering strategy DRUG

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

Single arm trial

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

Optimized tapering adalimumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Patient deprived of liberty or patient under guardianship or curator ship.

Sponsors & Collaborators

• AAP MESSIDOR: collaborator
• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (8)

Infirmerie Protestante

Caluire-et-Cuire, 69300, France

RECRUITING

Chd Vendee

La Roche-sur-Yon, 85925, France

RECRUITING

Hopital Philibert

Lomme, 59160, France

RECRUITING

Chu Montpellier

Montpellier, 34295, France

RECRUITING

Ap-Hp Pitie Salpetriere

Paris, 75013, France

RECRUITING

Chu Reims

Reims, 51100, France

NOT YET RECRUITING

Chu Saint Etienne

Saint-Etienne, 42055, France

RECRUITING

Chru Tours

Tours, 37170, France

NOT YET RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Hubert MAROTTE, MD PhD

CONTACT

(0)4 77 12 76 49; hubert.marotte@chu-st-etienne.fr

Madjid AKROUR

CONTACT

(0)4 77 12 78 37; madjid.akrour@chu-st-etienne.fr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomization comparing 2 therapeutic strategies

Study Record Dates

• First Submitted: July 19, 2024
• First Posted: July 30, 2024
• Study Start: December 19, 2024
• Primary Completion (Estimated): September 19, 2026
• Study Completion (Estimated): December 19, 2027
• Last Updated: December 26, 2025

Record last verified: 2025-12

Locations

FR (8)