Arthritis, RheumatoidPhase 4MONITORANCT06528431
Design and Evaluation of an Individualized Biodrug Tapering Strategy Based on Biodrug Dosage: the MONITORA Study
A Phase 4 study testing Clinical tapering strategy and Step Wedge trial in people with Arthritis, Rheumatoid, run by Centre Hospitalier Universitaire de Saint Etienne at 8 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis, Rheumatoid
- What is being tested?
- Clinical tapering strategy and Step Wedge trial
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 8 sitesFrance
- Study dates
- 19 Dec 2024to 19 Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 9Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
France8 sites, 8 recruiting
- Recruiting
Infirmerie Protestante
Caluire-et-Cuire, 69300
André BASCH, MD, 04 72 00 71 52, andcroco@gmail.com
- Recruiting
Chd Vendee
La Roche-sur-Yon, 85925
Grégoire CORMIER, MD, +33 2 51 44 61 97, gregoire.cormier@ght85.fr
- Recruiting
Hopital Philibert
Lomme, 59160
Tristan PASCART, MD PhD, +33 3 20 22 50 59, pascart.tristan@ghicl.net
- Recruiting
Chu Montpellier
Montpellier, 34295
Yves-Marie PERS, MD PhD, +33 6 18 99 38 04, ym-pers@chu-montpellier.fr
Christian JORGENSEN, MD PhD
- Recruiting
Ap-Hp Pitie Salpetriere
Paris, 75013
Bruno FAUTREL, MD PhD, 01 42 17 78 01, bruno.fautrel@aphp.fr
Camille FIAUX, MD
- Not yet recruiting
Chu Reims
Reims, 51100
Jean-Hugues SALMON, MD PhD, +33 3 26 78 43 73, jhsalmon@chu-reims.fr
- Recruiting
Chu Saint Etienne
Saint-Etienne, 42055
Hubert MAROTTE, PhD, (0)477127649 ext. +33, hubert.marotte@chu-st-etienne.fr
Madjid Akrour, (0)4 77 12 78 37 ext. +33, madjid.akrour@chu-st-etienne.fr
- Not yet recruiting
Chru Tours
Tours, 37170
Denis MULLEMAN, MD PhD, 02 47 47 47 47, denis.mulleman@univ-tours.fr
About this 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.
- Conditions
- Arthritis, Rheumatoid
- Being tested
- Clinical tapering strategy, Step Wedge trial
- Keywords
- Arthritis, Rheumatoid, Adalimumab, Remission management, step wedge trial
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical tapering strategyDrug
Clinical Tapering strategy : Adalimumab injections will be progressively spaced out according to DAS28 assessment every 3 months
Step Wedge trialDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Drug: Step Wedge trial |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rheumatoid arthritis flare-up
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,
Measured: 15 Months
Secondary outcomes (1)
Infection
Number of infection
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study start19 Dec 2024
- Primary completion19 Sep 2026 (estimated)
- Study completion19 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis, RheumatoidStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Randomization comparing 2 therapeutic strategies
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- AAP MESSIDOR
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06528431
- Sponsor's protocol ID
- 24CH046
- Other IDs
- 2024-514313-35-00
- Acronym
- MONITORA
- Status last verified
- Dec 2025
- First submitted
- 19 Jul 2024
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Design and Evaluation of an Individualized Biodrug Tapering Strategy Based on Biodrug Dosage: the MONITORA Study
- ClinicalTrials.gov ID
- NCT06528431
- Acronym / sponsor ID
- MONITORA / 24CH046
- Conditions
- Arthritis, Rheumatoid
- Keywords
- Arthritis, Rheumatoid, Adalimumab, Remission management, step wedge trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- AAP MESSIDOR
- Study start
- 19 Dec 2024 (actual)
- Primary completion
- 19 Sep 2026 (estimated)
- Study completion
- 19 Dec 2027 (estimated)
- First posted
- 30 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Randomization comparing 2 therapeutic strategies
| Arm | Type | Receives |
|---|---|---|
| Single arm trial | Experimental | Drug: Clinical tapering strategySingle 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. |
| Maintenance arm | No intervention | –Maintenance arm: the same adalimumab regimen |
| Optimized tapering adalimumab | Experimental | Drug: Step Wedge trialAn 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical tapering strategyClinical Tapering strategy : Adalimumab injections will be progressively spaced out according to DAS28 assessment every 3 months | Drug | Single arm trial |
| Step Wedge trialStep 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 | Drug | Optimized tapering adalimumab |
Primary outcome
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,
1 secondary outcome
Infection
Time frame: 15 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Clinical tapering strategy and Step Wedge trial in people with Arthritis, Rheumatoid, run by Centre Hospitalier Universitaire de Saint Etienne at 8 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hubert MAROTTE, MD PhD ((0)4 77 12 76 49, hubert.marotte@chu-st-etienne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rheumatoid arthritis flare-up (time frame: 15 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2025.