Non infectious non anterior uveitis
Conditions
Interventions
Product Name: Adalimumab
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Product Name: Methotrexate
Pharmaceutical Form: Tablet
INN or Proposed INN
Sponsors
Fundación para la Inv. Biomédica Hospital Clínico San Carlos
Eligibility
Sex/Gender
All
Inclusion criteria
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
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;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the proportion of patients achieving a Good Clinical Response by week 16 that is maintained in every study visit until week 52.;Secondary Objective: To compare the clinical components of the Good Clinical Response variable between treatment strategies (see page 71 for a complete list of the components) To compare the proportion of patients achieving a Good Clinical Response by week 16 To compare several Patient Reported Outcomes Measures (health- and vision-related quality of life, anxiety and depression) between treatment strategies To compare the time to relapse after week 16 between treatment strategies To assess the safety of each treatment strategy To assess the cost-utility and cost-effectiveness from both a Health System and a Societal perspectives of the combination therapy and the ADA monotherapy compared with MTX given alone To identify genetic and proteomic biomarkers associated with drug response to each treatment strategy.;Primary end point(s): To compare the proportion of patients achieving a Good Clinical Response by week 16 that is maintained in every study visit until week 52.;Timepoint(s) of evaluation of this end point: 52 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To compare the clinical components of the Good Clinical Response variable between treatment strategies (see page 71 for a complete list of the components) To compare the proportion of patients achieving a Good Clinical Response by week 16 To compare several Patient Reported Outcomes Measures (health- and vision-related quality of life, anxiety and depression) between treatment strategies To compare the time to relapse after week 16 between treatment strategies To assess the safety of each treatment strategy To assess the cost-utility and cost-effectiveness from both a Health System and a Societal perspectives of the combination therapy and the ADA monotherapy compared with MTX given alone To identify genetic and proteomic biomarkers associated with drug response to each treatment strategy.;Timepoint(s) of evaluation of this end point: 52 weeks | — |
Countries
Spain
Contacts
Public ContactUICEC IdICSC
Fundación para la Investigación Biomédica del Hospital Clínico San Carlos
Outcome results
None listed