← Back to the studies fieldPERMANENT CTIS TRIAL DOSSIER

2024-513123-17-00

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.

Public registry stateEnded
CLAIM BOUNDARY

This dossier documents a medicinal trial—not proof of efficacy.

Registration, authorisation of a trial application, trial start, result disclosure and marketing authorisation are different facts. The dossier claims neither clinical efficacy nor safety, deployment or causality.

CTIS record ≠ efficacy ≠ marketing authorisation
REGISTRY FACTS

What CTIS publishes about this trial

EUCT number
2024-513123-17-00
Trial status
Ended
Sponsor
not published
Trial region
EEA
Phase
5
Trial category
3
Low-intervention trial
yes
Estimated EU start
12 January 2022
Decision date
15 April 2024
Published
03 December 2025
Estimated end
30 September 2025
EXACT AI EVIDENCE

The original text determines inclusion.

Terms count only in allowlisted public CTIS fields. Sponsor, medical condition, phase or a generic software reference alone is not AI evidence.

“To generate deep learning models based on convolutional neural networks to automatically quantify image biomarkers related to clinical manifestations, diagnosis and pharmacological response.”
Source field
authorizedApplication.authorizedPartI.trialDetails.trialInformation.trialObjective.secondaryObjectives[8].secondaryObjective
Matched term
deep learning
“To generate deep learning models based on convolutional neural networks to automatically quantify image biomarkers related to clinical manifestations, diagnosis and pharmacological response.”
Source field
authorizedApplication.authorizedPartI.trialDetails.trialInformation.trialObjective.secondaryObjectives[8].secondaryObjective
Matched term
neural network
MEDICAL CONTEXT

Conditions and therapeutic areas

Reported medical conditions

  • Non-infection uveitismarked as rare disease

Therapeutic areas

  • Diseases [C] - Eye Diseases [C11]11
COUNTRY TRACKS

Every country retains its own published state.

A status in one country is not transferred to another. Decision dates and status histories remain separate source facts.

Spain

Ended
First decision
15 April 2024
Latest decision
03 March 2025
  1. Ended
  2. Ended
  3. Ended
  4. Ended
  5. Ended
  6. Ended
TRIAL APPLICATIONS

Submission, decision and country state remain separate

IN

INITIAL

Authorised
Trial status
Ended
Submitted
09 April 2024
Decided
15 April 2024

Decisions15 April 2024 · Authorized

Country statusSpain · Ended

SM-1

SUBSTANTIAL MODIFICATION

Authorised
Trial status
Ended
Submitted
17 October 2024
Decided
24 October 2024

Decisions24 October 2024 · Authorized

Country statusSpain · Ended

SM-3

SUBSTANTIAL MODIFICATION

Authorised
Trial status
Ended
Submitted
19 December 2024
Decided
03 March 2025

Decisions03 March 2025 · Authorized

Country statusSpain · Ended

SOURCE-DATED CHRONICLE

Official dates, not an efficacy narrative.

The chronicle sorts published CTIS events. i6eal observation times follow on a separate clock.

  1. Application Submitted

    Application IN · Ended

  2. Country Assessment

    Spain · Application IN · Authorized

  3. Application Status

    Application IN · Ended

  4. Country Decision

    Spain · Application IN · Authorized

  5. Application Submitted

    Application SM-1 · Ended

  6. Application Status

    Application SM-1 · Ended

  7. Country Assessment

    Spain · Application SM-1 · Authorized

  8. Country Decision

    Spain · Application SM-1 · Authorized

  9. Application Submitted

    Application SM-3 · Ended

  10. Country Assessment

    Spain · Application SM-3 · Authorized

  11. Application Status

    Application SM-3 · Ended

  12. Country Decision

    Spain · Application SM-3 · Authorized

  13. Trial Status Observed

    Ended

Observed by i6eal
First observed
23 Jul 2026, 13:19
Last observed
23 Jul 2026, 15:03
Materially modified
23 July 2026
RESULT DISCLOSURE

Disclosure is a separate registry fact.

No result disclosure is published in this projection. This means neither that results do not exist nor that a deadline has been missed.

PROVENANCE

From the dossier back to the official record

The public CTIS record remains authoritative. The i6eal files are a deterministic, bounded projection.

i6eal (2026): EU AI Studies Monitor, CTIS trial 2024-513123-17-00, data state 23 July 2026. https://i6eal.de/en/tools/ki-studienmonitor/studie/2024-513123-17-00/