NCT04798755: Co-THEIA

Efficacy, Safety and Costs of Methotrexate, Adalimumab, or Their Combination in Non-infectious Non-anterior Uveitis

Status unknown Phase 3 Last updated 21 September 2023

What this trial tests

Phase 3 trial testing Methotrexate in Uveitis in 192 participants. Status unknown.

Timeline

12 January 2022

Primary endpoint
1 October 2024

1 October 2025

Quick facts

Lead sponsor	Hospital San Carlos, Madrid
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	192
Start date	12 January 2022
Primary completion	1 October 2024
Estimated completion	1 October 2025
Sites	14 locations across Spain

Drugs / interventions tested

• Methotrexate — full drug profile →
• Adalimumab (ADALIMUMAB) — full drug profile →
• Adalimumab+Methotrexate — full drug profile →

Conditions studied

• Uveitis — all drugs for Uveitis →

Sponsor

Hospital San Carlos, Madrid

Who can join

18 and older, any sex, with Uveitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Introduction: Non-infectious uveitis (NIUs) include a heterogeneous group of sight-threatening conditions. NIUs can be highly disabling and be associated with a profound impact in the quality-of-life (QoL) and wellbeing. Their correct management sometimes requires the use of immunosuppressive drugs (ISDs), which can be prescribed in monotherapy or in combination. Several observational studies have provided evidence that the use of ISDs in combination could be more effective than and as safe as their use in monotherapy. However, a direct comparison between these two treatment strategies has not been carried out yet.

Methods and analysis: The Combination THerapy with mEthotrexate and adalImumAb for uveitis (CoTHEIA) study is a phase III, multicenter, prospective, randomized, single-blinded with masked outcome assessment, parallel three arms with 1:1:1 allocation, active-controlled, superiority study design, comparing the efficacy, safety and cost-effectiveness of methotrexate (MTX), adalimumab (ADA), or their combination in non-infectious non-anterior uveitis. The duration of the treatment and follow-up will last up to 52 weeks. The complete and maintained resolution of the ocular inflammation will be assessed by masked evaluators (primary outcome). In addition to other secundray measures of efficacy (QoL, visual acuity, costs) and safety, we will identify subjects' subgroups with different treatment responses by developing prediction models based on machine learning techniques using genetic and proteomic biomarkers.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Ocular immune-related diseases: molecular mechanisms and therapy.
   Wang Y, Gao S, Cao F, Yang H, et al · · 2024 · cited 10× · PMID 39611043 · DOI 10.1002/mco2.70021
2. Efficacy, safety and cost-effectiveness of methotrexate, adalimumab or their combination in non-infectious non-anterior uveitis: a protocol for a multicentre, randomised, parallel three arms, active-controlled, phase III open label with blinded outcome assessment study.
   Rivas AB, Lopez-Picado A, Calamia V, Carreño E, et al · · 2022 · cited 2× · PMID 35318229 · DOI 10.1136/bmjopen-2021-051378
3. Pharmacotherapy for non-infectious uveitis: spotlight on phase III clinical trials of locally injected or implanted therapeutics and systemic immunomodulatory drugs.
   Shields MK, Ferreira LB, Ali SB, Dedina L, et al · · 2025 · PMID 40473986 · DOI 10.1186/s12348-025-00502-9