Trial · NCT03088293
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | percentage of patients with resolution (score=0) of the scleral inflammation and with a prednisone dose lower than 0.1 mg/kg/day | Week 20 | Scleritis will be graded and scored according to the grading system defined by Sen for sclera inflammation (gradings from 0 to 4): these findings will be documented by drawings, photography or both for central review. |
| Secondary | percentage of patients with a decrease of at least 2 in sclera inflammation with a prednisone dose lower or equal to 0.1 mg/kg/day. | Week 20 | according to Sen and al gradation at week 20 and with a prednisone dose lower or equal to 0.1 mg/kg/day. |
| Secondary | Mean change in sclera inflammation from baseline to Week 20. | Week 20 | from baseline to Week 20 (according to Sen and al gradation) |
| Secondary | Time to response onset (total resolution in sclera inflammation). | Week 26 | |
| Secondary | Mean change in Best corrected visual acuity | Week 20 | from baseline to week 20 (ETDRS letter score) |
| Secondary | percentage of patients meeting targets: ≤ 0.1 mg/day prednisone | Week 20 | |
| Secondary | mean change dose of corticosteroid | Week 26 | * mean dose at week 20, * cumulative dose. |
| Secondary | Mean dose of corticosteroid | Week 20 | |
| Secondary | Cumulative dose of corticosteroid | Week 26 | |
| Secondary | Frequency to relapse of scleritis | Week 26 | Relapse will be diagnosed when inflammation will restart within 6 months of tapering or discontinuation of medication.Early relapse will be distinguished to later relapse. Early relapse corresponds to any scleritis relapse within the 3 months after discontinuation of medication and later relapse corresponds to any scleritis relapse after 3 months after discontinuation of medication. |
| Secondary | Characteristics of scleritis at worsening. | Week 26 | |
| Secondary | Frequency to relapse of scleritis and the characteristics of scleritis at worsening. | Week 52 | Relapse will be diagnosed when inflammation will restart within 6 months of tapering or discontinuation of medication.Early relapse will be distinguished to later relapse. Early relapse corresponds to any scleritis relapse within the 3 months after discontinuation of medication and later relapse corresponds to any scleritis relapse after 3 months after discontinuation of medication. |
| Secondary | Characteristics of scleritis at worsening. | Week 52 | |
| Secondary | Time to relapse of scleritis | Week 26 | Relapse will be diagnosed when inflammation will restart within 6 months of tapering or discontinuation of medication. Early relapse will be distinguished to later relapse. Early relapse corresponds to any scleritis relapse within the 3 months after discontinuation of medication and later relapse corresponds to any scleritis relapse after 3 months after discontinuation of medication. |
| Secondary | Time to relapse of scleritis | Week 52 | Relapse will be diagnosed when inflammation will restart within 6 months of tapering or discontinuation of medication. Early relapse will be distinguished to later relapse. Early relapse corresponds to any scleritis relapse within the 3 months after discontinuation of medication and later relapse corresponds to any scleritis relapse after 3 months after discontinuation of medication. |
| Secondary | Mean change in quality of life | Week 16 ; Week 26 | assessed using the 36-Item Short Form Health Survey (SF-36) - from baseline to W16 and W26 |
| Secondary | Mean change in of vision-related quality of life | Week 16 ; Week 26 | assessed by the National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25) - from baseline to W16 and W26 |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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