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

Phase 1

• Conditions: on infectious non anterior uveitis; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2020-000130-18-ES
• Lead Sponsor: Fundación para la Inv. Biomédica Hospital Clínico San Carlos

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-03-09
• Last Update Posted: 17 March 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 192

Inclusion Criteria

1.Subjects diagnosed with non-infectious intermediate-, posterior-, or pan-uveitis in at least one eye;
2.Adult patients (=18 years);
3.Subjects with at least one flare of active eye inflammation in the previous 180 days before Baseline visit, defined by the presence of at least 1 of the following parameters in either eye:
a.Active chorioretinal or retinal vascular lesion, AND/OR
b.Presence of macular edema by optical coherence tomography (OCT: thickness >350 µm AND cysts or intraretinal fluid), AND/OR
c.= 2+ anterior chamber cells , AND/OR
d.= 2+ vitreous haze
4.Subjects with active eye inflammation at Baseline visit, defined by the presence of at least 1 of the following parameters in either eye:
a.Active chorioretinal or retinal vascular lesion, AND/OR
b.Presence of macular edema by OCT (thickness >350 µm AND cysts or intraretinal fluid), AND/OR
c.= 1+ ACC, AND/OR
d.= 1+ vitreous haze.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 140
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 52

Exclusion Criteria

1.Subjects with confirmed or suspected infectious uveitis, including ocular histoplasmosis syndrome
2.Subjects with previous intolerability, safety issues according to investigator criteria, AND/OR previous failure to control ocular or other inflammation with MTX
3.Subjects with previous exposure to any biological therapy at any time (excluding anti-VEGF and denosumab), including those with that have a potential or known association with progressive multifocal leukoencephalopathy (i.e. natalizumab, rituximab or efalizumab);
4.Subjects with previous exposure to synthetic immunosuppressive therapy (such as mycophenolate or cyclosporine) other than corticosteroids in the past 6 months before Baseline;
5.Subjects with chronic structural eye damage considered by the Site’s Investigator to:
a.Interfere with the measurement of any of the study outcomes, AND/OR
b.Cause eye damage regardless of the inflammatory process, AND/OR
c.Prevent the normalization of the eye structures;

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified