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Design and evaluation of an individualized biodrug tapering strategy based on biodrug dosage: the MONITORA study_STEP1
EU CTIS ID: 2024-514313-35-00
What this study is testing
To estimate the average value of the minimal necessary adalimumab trough concentrations to maintain remission in patients in remission of RA for at least 6 months treated by adalimumab.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join 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
- Patients with ongoing adalimumab treatment for at least 6 months. the patient according to one the following 2 strategies: - (ADA 40 mg every other week) according to the standard regimen OR - ADA 40 mg every 3 week
- Affiliated person or beneficiary of a social security scheme
- Informed consent signed by the patient after information
You likely can't join 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
- Any dose of prednisone for RA treatment 6 months before inclusion
- Patient deprived of liberty or patient under guardianship or curatorship
See the full eligibility 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
- Patients with ongoing adalimumab treatment for at least 6 months. the patient according to one the following 2 strategies: - (ADA 40 mg every other week) according to the standard regimen OR - ADA 40 mg every 3 week
- Affiliated person or beneficiary of a social security scheme
- Informed consent signed by the patient after information
- A negative highly sensitive pregnancy test for women of Childbearing Potential
- 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 curatorship
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.