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Design and evaluation of an individualized biodrug tapering strategy based on biodrug dosage: the MONITORA study_STEP1

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-514313-35-00
Acronym
24CH046
Enrollment
60
Registered
2024-09-20
Start date
2024-12-03
Completion date
Unknown
Last updated
2025-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthritis rheumatoid

Brief summary

To assess the primary objective of the study, a regression analysis is necessary to characterize the relationship between i) the risk of RA flare and ii) adalimumab trough concentrations. RA flare-up : 1/ a DAS28 that increase above 2.6 for patient previously in remission (DAS28≤2.6) and a DAS28 increase (∆DAS28) of 0.6 or greater for patients with low disease activity (2.6

Detailed description

Presence of anti-adalimumab antibodies will be measured at each visit and at each disease flare. Tolerance will be actively collected at each study visit with an emphasis on any type of infection. All patients will note every infection to a booklet to reduce the memorisation bias.

Interventions

Sponsors

Centre Hospitalier Universitaire De Saint Etienne
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
To assess the primary objective of the study, a regression analysis is necessary to characterize the relationship between i) the risk of RA flare and ii) adalimumab trough concentrations. RA flare-up : 1/ a DAS28 that increase above 2.6 for patient previously in remission (DAS28≤2.6) and a DAS28 increase (∆DAS28) of 0.6 or greater for patients with low disease activity (2.6

Secondary

MeasureTime frame
Presence of anti-adalimumab antibodies will be measured at each visit and at each disease flare. Tolerance will be actively collected at each study visit with an emphasis on any type of infection. All patients will note every infection to a booklet to reduce the memorisation bias.

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026