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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01148225
Registration number
NCT01148225
Ethics application status
Date submitted
14/05/2010
Date registered
22/06/2010
Date last updated
12/07/2021
Titles & IDs
Public title
A Study of the Long-term Safety and Efficacy of Adalimumab in Subjects With Intermediate-, Posterior-, or Pan-uveitis
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Scientific title
A Multicenter Open-Label Study of the Long-term Safety and Efficacy of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Non-infectious Intermediate Uveitis, Posterior Uveitis, or Panuveitis
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Secondary ID [1]
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2009-016196-29
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Secondary ID [2]
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M11-327
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Universal Trial Number (UTN)
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Trial acronym
VISUAL III
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Uveitis
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Condition category
Condition code
Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Eye
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Diseases / disorders of the eye
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - adalimumab
Other: Adalimumab - Participants received open label (OL) adalimumab 40 mg by subcutaneous (SC) injection every other week (eow) until the final visit.
Treatment: Drugs: adalimumab
Adalimumab, pre-filled syringe, administered by SC injection
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants With Adverse Events
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Assessment method [1]
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An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event with an onset date on or after the first dose of study drug and up to 70 days after the last dose. See the Adverse Event section for details.
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Timepoint [1]
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Baseline to Final Visit (up to 366 weeks)
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Primary outcome [2]
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Hematology: Number of Participants With Potentially Clinically Significant (PCS) Values
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Assessment method [2]
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PCS laboratory values were defined as Common Toxicity Criteria (CTC) according to the National Cancer Institute Common Terminology for Adverse Events (NCI CTCAE) v3.0 = Grade 3. Abbreviations used include g=grams; L=liters.
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Timepoint [2]
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Baseline to Final Visit (Up to 366 weeks)
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Primary outcome [3]
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Chemistry: Number of Participants With PCS Values
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Assessment method [3]
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PCS laboratory values were defined as Common Toxicity Criteria (CTC) according to the National Cancer Institute Common Terminology for Adverse Events (NCI CTCAE) v3.0 = Grade 3. Abbreviations include ALT/SGPT=alanine aminotransferase/serum glutamate pyruvate transaminase; AST/SGOT=aspartate aminotransferase/serum glutamate oxaloacetate transaminase; g/L=grams/liter; mmol/L=millimoles/liter; ULN=upper limit of normal.
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Timepoint [3]
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Baseline to Final Visit (Up to 366 weeks)
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Primary outcome [4]
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Pulse (Sitting): Mean Change (Beats Per Minute) From Baseline To Final Visit
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Assessment method [4]
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Heart rate (beats per minute) was measured while the participant was sitting.
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Timepoint [4]
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Baseline to Final Visit (Up to 366 weeks)
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Primary outcome [5]
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Respiratory Rate (Sitting): Mean Change (Respirations Per Minute) From Baseline To Final Visit
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Assessment method [5]
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Respiratory rate (respirations per minute) was measured while the participant was sitting.
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Timepoint [5]
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Baseline to Final Visit (Up to 366 weeks)
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Primary outcome [6]
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Temperature (Sitting): Mean Change (Centigrade) From Baseline To Final Visit
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Assessment method [6]
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Temperature was measured while the participant was sitting.
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Timepoint [6]
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Baseline to Final Visit (Up to 366 weeks)
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Primary outcome [7]
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Diastolic and Systolic Blood Pressure (Sitting): Mean Change (mmHg) From Baseline To Final Visit
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Assessment method [7]
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Blood pressure was measured while the participant was sitting. Abbreviations used include mmHg=millimeters of mercury.
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Timepoint [7]
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Baseline to Final Visit (Up to 366 weeks)
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Secondary outcome [1]
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Percentage of Participants in Quiescence Over Time
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Assessment method [1]
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Quiescence is defined as no active inflammatory lesions and anterior chamber (AC) cell grade = 0.5+ and vitreous haze (VH) grade =0.5+. Participants with active uveitis at study entry could have been in quiescence at Week 0 because all participants were evaluated for uveitis status at the Final/Early Termination visit of the lead-in study and the Week 0 visit could have occurred up to 28 days later during which time the participant's disease status may have changed.
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Timepoint [1]
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Weeks 0, 2, 4, 8, 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246
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Secondary outcome [2]
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Percentage of Participants With Uveitis Flare Among Participants With Inactive Uveitis at Study Start
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Assessment method [2]
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Uveitis flare is defined as no quiescence (active inflammatory lesions and AC cell grade > 0.5+ and/or VH grade >0.5+).
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Timepoint [2]
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366 Weeks
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Secondary outcome [3]
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Percentage of Participants With Uveitis Flare From Week 8 Through Last Visit Among Participants With Active Uveitis at Study Start
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Assessment method [3]
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Uveitis flare is defined as no quiescence (active inflammatory lesions and AC cell grade > 0.5+ and/or VH grade >0.5+).
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Timepoint [3]
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Weeks 8 to 246 (238 Weeks)
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Secondary outcome [4]
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Percentage of Participants With New Active Inflammatory Lesions or Grade =2 in Anterior Chamber (AC) Cells or Grade =2 in Vitreous Haze (VH) Over Time
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Assessment method [4]
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Dilated indirect ophthalmoscopy is performed to determine both vitreous haze grading and the absence/presence of inflammatory chorioretinal and/or inflammatory retinal vascular lesions. The number of AC cells observed within a 1 mm * 1 mm slit beam was recorded for each eye and this number was used to determine the grade according to Standardization of Uveitis Nomenclature (SUN) criteria. Grading of VH was based on the National Eye Institute (NEI) publication which was adapted by the SUN working group. The percentage of participants with new active inflammatory lesions or grade =2 in AC cells or grade =2 in VH are presented.
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Timepoint [4]
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Weeks 2, 4, 8, 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246
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Secondary outcome [5]
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Percentage of Participants With Steroid-free Quiescence Over Time
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Assessment method [5]
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Steroid-free quiescence is defined as no active inflammatory lesions and AC cell grade = 0.5+ and VH grade =0.5+ and no uveitis-related corticosteroids on the day of assessment.
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Timepoint [5]
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Weeks 0, 2, 4, 8, 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246
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Secondary outcome [6]
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Percentage of Participants in Non-quiescence (With/Without Change in Concomitant Medications Within 5 Days and With/Without Quiescence at Next Visit at Least 8 Weeks After Non-quiescence) Among Participants With Inactive Uveitis at Study Start
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Assessment method [6]
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Percentage of participants, without quiescence, with/without change in concomitant medications within 5 days after non-quiescence and with/without quiescence at next visit at least 8 weeks after non-quiescence among participants with inactive uveitis at study start. Quiescence is defined as no active inflammatory lesions and AC cell grade = 0.5+ and VH grade =0.5+. Abbreviations used are as follows: CM=concomitant medications; NQ=non-quiescence.
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Timepoint [6]
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366 Weeks
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Secondary outcome [7]
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Percentage of Participants in Non-quiescence (With/Without Change in Concomitant Medications Within 5 Days and With/Without Quiescence at Next Visit at Least 8 Weeks After Non-quiescence) Among Participants With Active Uveitis at Study Start
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Assessment method [7]
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Percentage of participants, without quiescence, with/without change in concomitant medications within 5 days after non-quiescence and with/without quiescence at next visit at least 8 weeks after non-quiescence, among participants with active uveitis at study start. Quiescence is defined as no active inflammatory lesions and AC cell grade = 0.5+ and VH grade =0.5+. Abbreviations used include: CM=concomitant medications, NQ=non-quiescence.
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Timepoint [7]
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366 Weeks
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Secondary outcome [8]
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Percentage of Participants Who Started Uveitis-related Systemic Corticosteroids During the Study
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Assessment method [8]
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Percentage of participants who started uveitis-related systemic corticosteroids during the study.
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Timepoint [8]
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366 Weeks
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Secondary outcome [9]
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Mean Daily Dose in Milligrams (mg) of Uveitis-related Systemic Corticosteroids in Participants With Active Uveitis Over Time
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Assessment method [9]
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Corticosteroid doses were converted into prednisone equivalents. Participants with uveitis-related systemic corticosteroid that could not be converted to prednisone equivalents were excluded. Individual mean daily doses were calculated within the respective visit windows. For Week 0, only uveitis-related systemic corticosteroids at Baseline (Day 1 for all participants) were considered. Baseline was defined as Week 0 for all participants.
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Timepoint [9]
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Weeks 0, 2, 4, 8, 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246
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Secondary outcome [10]
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Mean Daily Dose (mg) of Uveitis-related Systemic Corticosteroids in Participants With Inactive Uveitis Over Time
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Assessment method [10]
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Corticosteroid doses were converted into prednisone equivalents. Participants with uveitis-related systemic corticosteroid that could not be converted to prednisone equivalents were excluded. Individual mean daily doses were calculated within the respective visit windows. For Week 0, only uveitis-related systemic corticosteroids at Baseline (Day 1 for all participants) were considered. Baseline was defined as Week 0 for all participants.
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Timepoint [10]
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Weeks 0, 2, 4, 8, 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246
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Secondary outcome [11]
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Percent Change in Mean Daily Dose of Uveitis-related Systemic Corticosteroids Relative to Week 0 in Participants With Inactive Uveitis Using Systemic Corticosteroids at Week 0 Over Time
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Assessment method [11]
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Corticosteroid doses were converted into prednisone equivalents. Participants with uveitis-related systemic corticosteroid that could not be converted to prednisone equivalents were excluded. Individual mean daily doses were calculated within the respective visit windows. For Week 0, only uveitis-related systemic corticosteroids at Baseline (Day 1 for all participants) were considered. Baseline was defined as Week 0 for all participants. Data not presented after Week 198 as no participants remained on study as of Week 198.
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Timepoint [11]
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Weeks 0, 2, 4, 8, 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, and 198
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Secondary outcome [12]
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Percent Change in Mean Daily Dose of Uveitis-related Systemic Corticosteroids Relative to Week 0 in Participants With Active Uveitis Using Systemic Corticosteroids at Week 0 Over Time
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Assessment method [12]
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Corticosteroid doses were converted into prednisone equivalents. Participants with uveitis-related systemic corticosteroid that could not be converted to prednisone equivalents were excluded. Individual mean daily doses were calculated within the respective visit windows. For Week 0, only uveitis-related systemic corticosteroids at Baseline (Day 1 for all participants) were considered. Baseline was defined as Week 0 for all participants.
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Timepoint [12]
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Weeks 0, 2, 4, 8, 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246
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Secondary outcome [13]
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Percentage of Participants Not Using Systemic Corticosteroids Over Time
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Assessment method [13]
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Corticosteroid doses were converted into prednisone equivalents. Participants with uveitis-related systemic corticosteroid that could not be converted to prednisone equivalents were excluded. Individual mean daily doses were calculated within the respective visit windows. For Week 0, only uveitis-related systemic corticosteroids at Baseline (Day 1 for all participants) were considered. Baseline was defined as Week 0 for all participants. Data presented for participants not using systemic corticosteroids at each timepoint.
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Timepoint [13]
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Weeks 0, 2, 4, 8, 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246
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Secondary outcome [14]
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Percentage of Participants Without Worsening of Best Corrected Visual Acuity (BCVA) by =15 Letters on Early Treatment Diabetic Retinopathy Study (ETDRS) in Both Eyes Relative to Baseline Over Time Among Participants Who Had Inactive Uveitis at Study Entry
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Assessment method [14]
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Percentage of participants at each study time point without a worsening of Best Corrected Visual Acuity (BCVA) by =15 letters on the Early Treatment Diabetic Retinopathy Study (ETDRS) in both eyes relative to Baseline for participants who had inactive uveitis when they entered the study.
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Timepoint [14]
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Weeks 2, 4, 8, 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246
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Secondary outcome [15]
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Percentage of Participants Without Worsening of BCVA by =15 Letters on the ETDRS in Both Eyes Relative to Week 8 Over Time Among Participants With Active Uveitis at Study Entry
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Assessment method [15]
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Percentage of participants at each study time point without a worsening of BCVA by =15 letters on the ETDRS in both eyes relative to Week 8 for participant who had active uveitis when they entered the study.
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Timepoint [15]
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Weeks 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246
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Secondary outcome [16]
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Mean of Both Eyes of the Logarithm of the Minimum Angle of Resolution (LogMAR) BCVA Over Time
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Assessment method [16]
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Using corrective lenses based on that visit's refraction testing, participant's BCVA was measured using an ETDRS logMAR chart. On the logMAR scale, 0 is equivalent to 20/20 visual acuity, the range of normal vision is considered to be from -0.2 to 0.1; higher values indicate visual impairment. Data presented includes the mean of both eyes for all participants (active or inactive uveitis) for all study time points.
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Timepoint [16]
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Weeks 0, 2, 4, 8, 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246
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Eligibility
Key inclusion criteria
- Participant must have successfully enrolled in either study M10-877 or M10-880 and
either met the endpoint of "Treatment Failure" or completed the study
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- A participant will be excluded from this study if the participant discontinued from
study M10-877 or M10-880 for any reasons other than having a Treatment Failure event
- Participant with corneal or lens opacity that precludes visualization of the fundus or
that likely requires cataract surgery during the duration of the trial
- Participants with intraocular pressure of >= 25 mmHg and on >= 2 glaucoma medications
or evidence of glaucomatous optic nerve injury
- Participant with proliferative or severe non-proliferative diabetic retinopathy or
clinically significant macular edema due to diabetic retinopathy
- Participant with neovascular/wet age-related macular degeneration
- Participant with abnormality of vitreo-retinal interface (i.e., vitreomacular
traction, epiretinal membranes, etc.) with the potential for macular structural damage
independent of the inflammatory process
- Participant with a systemic inflammatory disease that requires therapy with a
prohibited immunosuppressive agent at the time of study entry
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
23/11/2010
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
21/05/2018
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Sample size
Target
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Accrual to date
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Final
424
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
AbbVie
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to evaluate the long term efficacy and safety of adalimumab
participants with non-infectious intermediate-, posterior- or pan-uveitis.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01148225
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
Name
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AbbVie Inc.
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Address
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AbbVie
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01148225
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