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Report for D014605: Uveitis NIH
(Synonyms: Uveit, Uveitis)
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (3)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug1039 | Placebo to match filgotinib Wiki | 0.71 |
| drug517 | Filgotinib Wiki | 0.71 |
| drug1070 | Prednisone Wiki | 0.58 |
Correlated MeSH Terms (0)
| Name (Synonyms) | Correlation |
|---|
There is one clinical trial.
Clinical Trials
1 A Phase 2, Randomized, Placebo-Controlled Trial Evaluating the Efficacy and Safety of Filgotinib in Subjects With Active Noninfectious Uveitis
The primary objective of this study is to evaluate the efficacy of filgotinib versus placebo for the treatment of the signs and symptoms of noninfectious uveitis in participants failing treatment for active noninfectious uveitis.
NCT03207815 Noninfectious Uveitis Drug: Filgotinib Drug: Placebo to match filgotinib Drug: Prednisone MeSH:Uveitis
HPO:Uveitis
Primary Outcomes
Description: Treatment failure will be defined as a participant meeting at least one of the following criteria in at least one eye:
New active, inflammatory lesions relative to Day 1/Baseline (during all visits beginning Week 6 visit)
Inability to achieve ≤ grade 0.5+ (at Week 6); or 2-step increase (all visits after Week 6) relative to best state achieved in Anterior Chamber Cell grade (SUN Criteria)
Inability to achieve ≤ grade 0.5+ (at Week 6); or 2-step increase (all visits after Week 6) relative to best state achieved in Vitreous Haze (VH) grade (NEI/SUN Criteria)
Worsening of best corrected visual acuity (BCVA) by ≥ 15 letters relative to best state achieved (during all visits beginning at Week 6 visit)
Measure: Proportion of Participants Failing Treatment for Active NonInfectious Uveitis by Week 24 Time: Baseline to Week 24
Secondary Outcomes
Description: Treatment failure will be defined as a participant meeting at least one of the following criteria in at least one eye:
New active, inflammatory lesions relative to Day 1/Baseline (during all visits beginning Week 6 visit)
Inability to achieve ≤ grade 0.5+ (at Week 6); or 2-step increase (all visits after Week 6) relative to best state achieved in Anterior Chamber Cell grade (SUN Criteria)
Inability to achieve ≤ grade 0.5+ (at Week 6); or 2-step increase (all visits after Week 6) relative to best state achieved in VH grade (NEI/SUN Criteria)
Worsening of best corrected visual acuity (BCVA) by ≥ 15 letters relative to best state achieved (during all visits beginning at Week 6 visit)
Measure: Time to Treatment Failure on or After Week 6 Time: Baseline to Week 52
Measure: Change in VH Grade in Each Eye (NEI/SUN criteria), from Best State Achieved Prior to Week 6 to Week 52 or End of Treatment (EOT) visit Time: Baseline to Week 52
Measure: Change in Anterior Chamber (AC) Cell Grade in Each Eye, from Best State Achieved Prior to Week 6 to Week 52 or EOT Visit Time: Baseline to Week 52
Measure: Change in Logarithm of the Minimal Angle of Resolution (logMAR) BCVA in Each Eye, from Best State Achieved Prior to Week 6 to Week 52 or EOT Visit Time: Baseline to Week 52
Measure: Log Change in Central Retinal Thickness in Each Eye, from Best State Achieved Prior to Week 6 to Week 52 or EOT Visit Time: Baseline to Week 52
Description: Macular edema is determined by optical coherence tomography (OCT)
Measure: Time to Development of Macular Edema in At Least One Eye on or After Week 6 Time: Baseline to Week 52
Measure: Pharmacokinetic Plasma Concentrations of Filgotinib and its Metabolite GS-829845 Time: Baseline to Week 52
HPO Nodes
HP:0000554: Uveitis
Genes 47
TNFAIP3 LACC1 MBTPS2 TKT ANKRD55 ATOH7 MST1 MALT1 IL2RA HLA-DRB1 STAT4 NOD2 IKBKG BIRC3 PTPN2 TCF4 NLRP3 HLA-DRB1 TNFRSF1A FAS DNASE1L3 BTNL2 IKBKG FOXP1 CD247 IL6 IGH NOD2 FAS HLA-B NLRP1 FASLG STUB1 TKT NLRC4 GPR35 RASGRP1 BCL10 CASP10 HLA-DRB1 PTPN22 CAPN5 PRKCD IL2RB NLRP3 MIF BTNL2 Protein Mutations 0
SNP 0
Primary Outcomes
Description: Treatment failure will be defined as a participant meeting at least one of the following criteria in at least one eye: New active, inflammatory lesions relative to Day 1/Baseline (during all visits beginning Week 6 visit) Inability to achieve ≤ grade 0.5+ (at Week 6); or 2-step increase (all visits after Week 6) relative to best state achieved in Anterior Chamber Cell grade (SUN Criteria) Inability to achieve ≤ grade 0.5+ (at Week 6); or 2-step increase (all visits after Week 6) relative to best state achieved in Vitreous Haze (VH) grade (NEI/SUN Criteria) Worsening of best corrected visual acuity (BCVA) by ≥ 15 letters relative to best state achieved (during all visits beginning at Week 6 visit)
Measure: Proportion of Participants Failing Treatment for Active NonInfectious Uveitis by Week 24 Time: Baseline to Week 24Secondary Outcomes
Description: Treatment failure will be defined as a participant meeting at least one of the following criteria in at least one eye: New active, inflammatory lesions relative to Day 1/Baseline (during all visits beginning Week 6 visit) Inability to achieve ≤ grade 0.5+ (at Week 6); or 2-step increase (all visits after Week 6) relative to best state achieved in Anterior Chamber Cell grade (SUN Criteria) Inability to achieve ≤ grade 0.5+ (at Week 6); or 2-step increase (all visits after Week 6) relative to best state achieved in VH grade (NEI/SUN Criteria) Worsening of best corrected visual acuity (BCVA) by ≥ 15 letters relative to best state achieved (during all visits beginning at Week 6 visit)
Measure: Time to Treatment Failure on or After Week 6 Time: Baseline to Week 52Measure: Change in VH Grade in Each Eye (NEI/SUN criteria), from Best State Achieved Prior to Week 6 to Week 52 or End of Treatment (EOT) visit Time: Baseline to Week 52
Measure: Change in Anterior Chamber (AC) Cell Grade in Each Eye, from Best State Achieved Prior to Week 6 to Week 52 or EOT Visit Time: Baseline to Week 52
Measure: Change in Logarithm of the Minimal Angle of Resolution (logMAR) BCVA in Each Eye, from Best State Achieved Prior to Week 6 to Week 52 or EOT Visit Time: Baseline to Week 52
Measure: Log Change in Central Retinal Thickness in Each Eye, from Best State Achieved Prior to Week 6 to Week 52 or EOT Visit Time: Baseline to Week 52
Description: Macular edema is determined by optical coherence tomography (OCT)
Measure: Time to Development of Macular Edema in At Least One Eye on or After Week 6 Time: Baseline to Week 52Measure: Pharmacokinetic Plasma Concentrations of Filgotinib and its Metabolite GS-829845 Time: Baseline to Week 52