{
  "id": "ctis:2024-513123-17-00",
  "euct": "2024-513123-17-00",
  "title": "CO-THEIA (COMBINATION THERAPY WITH METHOTREXATE AND ADALIMUMAB FOR UVEITIS): EFFICACY, SAFETY AND COST-EFFECTIVENESS OF METHOTREXATE, ADALIMUMAB, OR THEIR COMBINATION IN NON INFECTIOUS NON ANTERIOR UVEITIS: A MULTICENTER, RANDOMIZED, PARALLEL 3 ARMS, ACTIVE-CONTROLLED, PHASE 3 OPEN LABEL WITH BLINDED OUTCOME ASSESSMENT STUDY.",
  "publicTitle": "CO-THEIA (COMBINATION THERAPY WITH METHOTREXATE AND ADALIMUMAB FOR UVEITIS): EFFICACY, SAFETY AND COST-EFFECTIVENESS OF METHOTREXATE, ADALIMUMAB, OR THEIR COMBINATION IN NON INFECTIOUS NON ANTERIOR UVEITIS: A MULTICENTER, RANDOMIZED, PARALLEL 3 ARMS, ACTIVE-CONTROLLED, PHASE 3 OPEN LABEL WITH BLINDED OUTCOME ASSESSMENT STUDY.",
  "fullTitle": "CO-THEIA (COMBINATION THERAPY WITH METHOTREXATE AND ADALIMUMAB FOR UVEITIS): EFFICACY, SAFETY AND COST-EFFECTIVENESS OF METHOTREXATE, ADALIMUMAB, OR THEIR COMBINATION IN NON INFECTIOUS NON ANTERIOR UVEITIS: A MULTICENTER, RANDOMIZED, PARALLEL 3 ARMS, ACTIVE-CONTROLLED, PHASE 3 OPEN LABEL WITH BLINDED OUTCOME ASSESSMENT STUDY.",
  "shortTitle": null,
  "status": "Ended",
  "statusCode": "8",
  "startDateEU": "2022-01-12",
  "decisionDate": "2024-04-15T12:46:56.409",
  "publishDate": "2025-12-03T02:31:00.71228822",
  "trialRegion": "EEA",
  "trialRegionCode": "1",
  "medicalConditions": [
    {
      "name": "Non-infection uveitis",
      "rareDisease": true
    }
  ],
  "therapeuticAreas": [
    {
      "code": "11",
      "name": "Diseases [C] - Eye Diseases [C11]"
    }
  ],
  "trialCategory": {
    "phaseCode": "5",
    "categoryCode": "3",
    "lowIntervention": true
  },
  "duration": {
    "estimatedRecruitmentStartDate": "2021-09-01",
    "estimatedEndDate": "2025-09-30",
    "estimatedGlobalEndDate": null
  },
  "countries": [
    {
      "name": "Spain",
      "publicStatusCode": "8",
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      "lastDecisionDate": "2025-03-03T13:19:19.438",
      "history": [
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          "assessmentOutcome": "acceptable",
          "assessmentOutcomeDate": "2024-04-15",
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        },
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        },
        {
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          "isRMS": true
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        {
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      ]
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  ],
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      ],
      "countryStatuses": [
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          "decisionDate": "2024-04-15",
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      ]
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      "type": "SUBSTANTIAL MODIFICATION",
      "status": "Authorised",
      "trialStatus": "Ended",
      "submissionDate": "2024-12-19",
      "decisionDate": "2025-03-03",
      "decisions": [
        {
          "mscName": "Spain",
          "decisionDate": "2025-03-03T13:19:19.438",
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          "trialStatus": "Ended",
          "decision": "authorized",
          "decisionDate": "2024-04-15",
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          "assessmentOutcome": "acceptable",
          "assessmentOutcomeDate": "2025-02-13",
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        }
      ]
    }
  ],
  "evidence": [
    {
      "id": "evidence:67ea123bff83551f676f7fa0",
      "path": "authorizedApplication.authorizedPartI.trialDetails.trialInformation.trialObjective.secondaryObjectives[8].secondaryObjective",
      "term": "deep learning",
      "snippet": "To generate deep learning models based on convolutional neural networks to automatically quantify image biomarkers related to clinical manifestations, diagnosis and pharmacological response."
    },
    {
      "id": "evidence:3cc370ad69b3b933b89a0c07",
      "path": "authorizedApplication.authorizedPartI.trialDetails.trialInformation.trialObjective.secondaryObjectives[8].secondaryObjective",
      "term": "neural network",
      "snippet": "To generate deep learning models based on convolutional neural networks to automatically quantify image biomarkers related to clinical manifestations, diagnosis and pharmacological response."
    }
  ],
  "official": {
    "retrieveUrl": "https://euclinicaltrials.eu/ctis-public-api/retrieve/2024-513123-17-00",
    "publicUrl": "https://euclinicaltrials.eu/ctis-public/view/2024-513123-17-00?lang=en"
  },
  "slug": "2024-513123-17-00",
  "firstObservedAt": "2026-07-23T11:19:41.794Z",
  "lastObservedAt": "2026-07-23T13:03:56.000Z",
  "dateModified": "2026-07-23",
  "materialFingerprint": "b71b9a85591f14772a82c828683263176b083a2ff66d9a9f087f3dd56550f7cb"
}