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

Study acronym: MONITORA
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated December 26, 2025 (before its estimated September 19, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Primary completion date: Sep 19, 2025 to Sep 19, 2026 Completion date: Dec 19, 2026 to Dec 19, 2027 · Site details revised at 6 of 8 sitesv8 Show 2 more changesShow less
    • Completion date: Dec 19, 2026 to Dec 19, 2027
    • Site details revised at 6 of 8 sites
  2. Re-verified, no change to tracked fieldsv7
  3. Study sites: 6 to 8 Primary completion date: Sep 2025 to Sep 19, 2025 · Completion date: Sep 2026 to Dec 19, 2026 · Eligibility criteria expanded, about 22 wordsv6 Show 3 more changesShow less
    • Primary completion date: Sep 2025 to Sep 19, 2025
    • Completion date: Sep 2026 to Dec 19, 2026
    • Eligibility criteria expanded, about 22 words

    See this version in full on ClinicalTrials.gov ↗

  4. Primary completion date: Apr 2025 to Sep 2025 Completion date: Jun 2026 to Sep 2026v5 Show 1 more changeShow less
    • Completion date: Jun 2026 to Sep 2026
  5. Primary completion date: Mar 2025 to Apr 2025v4
Show 2 earlier versionsHide 2 earlier versions
  1. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Dec 2024 to Dec 19, 2024 · Site details revised at 6 of 6 sitesv3 Show 2 more changesShow less
    • Start date changed from estimate of Dec 2024 to Dec 19, 2024
    • Site details revised at 6 of 6 sites
  2. Phase: Phase 3 to Phase 4 Primary endpoint revised · Eligibility criteria expanded, about 16 wordsv2 Show 2 more changesShow less
    • Primary endpoint revised
    • Eligibility criteria expanded, about 16 words

    See this version in full on ClinicalTrials.gov ↗

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06528431
Lead Sponsor Centre Hospitalier Universitaire de Saint Etienne
Collaborators: AAP MESSIDOR
Conditions Arthritis, Rheumatoid
Enrollment 180 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov