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Fluorescence Imaging of IBD and RA Using Adalimumab-800CW

Study acronym: STRATIFY
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated August 19, 2025 (before its estimated March 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Phase: Phase 1 to Phase 2 Trial status: Not Yet Recruiting to Recruiting · Primary completion date: Jun 2024 to Mar 2026 · Start date changed from estimate of Jun 2023 to Aug 6, 2024 · 5 morev8 Show 8 more changesShow less
    • Trial status: Not Yet Recruiting to Recruiting
    • Primary completion date: Jun 2024 to Mar 2026
    • Start date changed from estimate of Jun 2023 to Aug 6, 2024
    • Enrollment target: 30 to 36
    • Completion date: Dec 2024 to Aug 1, 2026
    • Eligibility criteria shortened, about 11 words
    • Site details revised
    • Study arms: 2 to 4

    See this version in full on ClinicalTrials.gov ↗

  2. Start date: Jan 2023 to Jun 2023 Primary endpoints revised (5) · Primary completion date: Dec 2023 to Jun 2024 · Completion date: Dec 2023 to Dec 2024 · 6 morev7 Show 9 more changesShow less
    • Primary endpoints revised (5)
    • Primary completion date: Dec 2023 to Jun 2024
    • Completion date: Dec 2023 to Dec 2024
    • Interventions: Fluorescence Imaging (Device), OTL38 (Drug) to Adalimumab-800CW (Drug), Fluorescence Imaging (Device)
    • Eligibility criteria shortened, about 163 words
    • Secondary endpoints: 11 to 9
    • Collaborators: 3 to 1
    • Study arms: 1 to 2
    • Study title shortened, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  3. Primary and study completion dates: Dec 2022 to Dec 2023 Start date: Jan 2022 to Jan 2023v6 Show 1 more changeShow less
    • Start date: Jan 2022 to Jan 2023
  4. Primary and study completion dates: Dec 2021 to Dec 2022 Start date: Sep 2021 to Jan 2022v5 Show 1 more changeShow less
    • Start date: Sep 2021 to Jan 2022
  5. Start date: Mar 2021 to Sep 2021v4
Show 2 earlier versionsHide 2 earlier versions
  1. Primary completion date: May 2020 to Dec 2021 Start date: Sep 2019 to Mar 2021 · Completion date: Sep 2020 to Dec 2021v3 Show 2 more changesShow less
    • Start date: Sep 2019 to Mar 2021
    • Completion date: Sep 2020 to Dec 2021
  2. Start date: May 2019 to Sep 2019 Secondary endpoints: 10 to 11 · Eligibility criteria expanded, about 2 wordsv2 Show 2 more changesShow less
    • Secondary endpoints: 10 to 11
    • Eligibility criteria expanded, about 2 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.
Inflammatory bowel disease (IBD) and rheumatoid arthritis (RA) are both auto-immune diseases that are characterized by chronic relapsing inflammation of respectively the ileocolonic tissue and the synovium. Pathogenesis of both auto-immune diseases is attributed to the proinflammatory cytokine tumor necrosis factor α (TNFa). Adalimumab is a human monoclonal anti-TNF antibody used for treating patients with moderate to severely active IBD and RA. However, current rates of therapeutic nonresponsiveness to this antibody are variable and difficult to predict in advance, whereas patients are potentially exposed to a non-effective treatment and its potential side effects; while clinical deterioration progresses. A key unmet need is the development of a predictive tool for assessment of a therapeutic (non-) response to patients and finding an optimal dose strategy in individual patients before initiating anti-TNF therapy. Unfortunately, we currently lack crucial information about drug distribution of the drug of interest throughout the targeted inflamed tissue itself. Therefore, it remains unknown in both IBD and RA, if the drug reaches its target (in sufficient amounts) and how local drug concentrations are related to therapeutic response. Thus, we linked adalimumab to a fluorescent dye (adalimumab-800CW) in order to create a fluorescent signal of the labelled drug in the diseased tissue that we can visualize and quantify with dedicated optical fluorescence imaging systems. We hypothesize that this tracer will bind to TNFa in the mucosa/synovium and thus create a map of medicine distribution in vivo due to colocalization of the fluorescent labelled compound. Therefore, the aim of this study is to assess the feasibility of fluorescent molecular imaging of adalimumab-800CW in IBD and RA patients.
Trial Details
NCT Number NCT03938701
Lead Sponsor University Medical Center Groningen
Collaborators: AbbVie
Conditions IBD, Rheumatoid Arthritis
Enrollment 36 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov