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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-016095-68 | EudraCT Number |
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A study comparing the safety and efficacy of adalimumab compared with placebo in patients with active uveitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adalimumab | Experimental | Participants received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15. |
|
| Placebo | Placebo Comparator | Participants received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adalimumab | Biological | Administered subcutaneously as an 80 mg loading dose (2 syringes) at Baseline followed by a 40 mg dose eow starting at Week 1. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Treatment Failure on or After Week 6 | Time to treatment failure was analyzed using Kaplan-Meier methods. Treatment failures on or after Week 6 were counted as events. Dropouts for reasons other than treatment failure at any time during the study were censored at the dropout date. To be considered a treatment failure, ≥ 1 of these criteria had to be present in at least 1 eye:
Per protocol, the primary analysis was performed in the Main Study population which included all randomized participants recruited outside Japan; for completeness results are also reported below for the Integrated dataset which includes participants recruited in Japan. | From Baseline until end of study (up to 80 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Anterior Chamber (AC) Cell Grade in Each Eye From Best State Achieved Prior to Week 6 to the Final/Early Termination Visit | Slit lamp examinations were conducted at each visit to assess AC cell count. The number of AC cells observed within a 1 mm × 1 mm slit beam was used to determine the grade according to the Standardization of Uveitis Nomenclature (SUN) criteria: Grade 0 = < 1 cell; Grade 0.5+ = 1-5 cells; Grade 1+ = 6-15 cells; Grade 2+ = 16-25 cells; Grade 3+ = 26-50 cells; Grade 4+ = > 50 cells. |
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Inclusion Criteria:
Subject is at least 18 years of age.
Subject is diagnosed with non-infectious intermediate-, posterior-, or panuveitis.
Subject must have active disease at the Baseline visit as defined by the presence of at least 1 of the following parameters in at least one eye despite at least 2 weeks of maintenance therapy with oral prednisone ≥ 10 mg/day to ≤ 60 mg/day (or oral corticosteroid equivalent):
Subject is on oral prednisone ≥ 10 mg/day to ≤ 60 mg/day (or oral corticosteroid equivalent) for at least 2 weeks prior to Screening and remains on the same dose from Screening to Baseline visit.
Subject with documented prior adequate response to oral corticosteroids (equivalent of oral prednisone up to 1 mg/kg/day).
Subjects who do not have previous, active or latent tuberculosis (TB). Only one TB test is required to allow the subject in the study. Subjects with either negative purified protein derivative (PPD) (< 5 mm of induration) or negative QuantiFERON®-TB Gold test (or interferon-gamma release assay (IGRA) equivalent) are eligible. Subjects with a repeat indeterminate QuantiFERON®-TB Gold test (or IGRA equivalent) result are not eligible. Note, that only one TB screening test is allowed and required. A repeat QuantiFERON® TB Gold test (or IGRA equivalent) is not permitted if the PPD skin test is positive. The TB screening tests are diagnostic tests. In the event of a negative TB screening test, the results are to be interpreted in the context of the patient's epidemiology, history, exam findings, etc. and it is the responsibility of the investigator to determine if a patient has previous, active or latent tuberculosis or not. Under no circumstances can a patient with a positive PPD result or positive QuantiFERON®-TB Gold test (or IGRA equivalent) enter the study.
Exclusion Criteria:
Subject with isolated anterior uveitis.
Subject with prior inadequate response to high-dose oral corticosteroids
Subject with confirmed or suspected infectious uveitis, including but not limited to infectious uveitis due to TB, cytomegalovirus (CMV), Human T-Lymphotropic Virus Type 1 (HTLV-1), Whipple's disease, Herpes Zoster virus (HZV), Lyme disease, toxoplasmosis and herpes simplex virus (HSV).
Subject with serpiginous choroidopathy.
Subject with corneal or lens opacity that precludes visualization of the fundus or that likely requires cataract surgery during the duration of the trial.
Subject with intraocular pressure of ≥ 25 mmHg and on ≥ 2 glaucoma medications or evidence of glaucomatous optic nerve injury.
Subject with Best Corrected Visual Acuity (BCVA) less than 20 letters (Early Treatment Diabetic Retinopathy Study) in at least one eye at the Baseline Visit.
Subject with intermediate uveitis or panuveitis that has signs of intermediate uveitis (e.g.presence or history of snowbanking or snowballs) and symptoms and/or magnetic resonance imaging (MRI) findings suggestive of a demyelinating disease such as multiple sclerosis. All subjects with intermediate uveitis or panuveitis that have signs of intermediate uveitis (e.g., presence or history of snowbanking or snowballs) must have had a brain MRI within 90 days prior to the Baseline Visit.
Subject has previous exposure to anti-tumor necrosis factor (TNF) therapy or any biologic therapy (except intravitreal anti-vascular endothelial growth factor [VEGF] therapy) with a potential therapeutic impact on non-infectious uveitis.
If entering the study on 1 concomitant immunosuppressive therapy, dose has been increased within the last 28 days prior to Baseline visit or is not within the following allowable doses at the Baseline visit:
Subject has received Retisert® (glucocorticosteroids implant) within 3 years prior to the Baseline visit or that has had complications related to the device. Subject has had Retisert® (glucocorticosteroids implant) removed within 90 days prior to the Baseline visit or has had complications related to the removal of the device.
Subject has received intraocular or periocular corticosteroids within 30 days prior to Baseline visit.
Subject with proliferative or severe non-proliferative diabetic retinopathy or clinically significant macular edema due to diabetic retinopathy.
Subject with neovascular/wet age-related macular degeneration
Subject 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.
Subject with severe vitreous haze that precludes visualization of the fundus at the Baseline visit.
Subject has received Ozurdex® (dexamethasone implant) within 6 months prior to the Baseline visit.
Subject has received intravitreal anti-VEGF therapy within 45 days of the Baseline visit for Lucentis® (ranibizumab) or Avastin® (bevacizumab) or within 60 days of the Baseline visit for anti-VEGF Trap (aflibercept).
Subject has received intravitreal methotrexate within 90 days prior to the Baseline visit
Subject on systemic carbonic anhydrase inhibitor within 1 week prior to Screening visit.
Subject with macular edema as the only sign of uveitis.
Subject with a history of scleritis.
Subject with intolerance to high-dose oral corticosteroids (equivalent of oral prednisone 1 mg/kg/day or 60 to 80 mg/day).
Subject on cyclophosphamide within 30 days prior to the Baseline visit.
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| Name | Affiliation | Role |
|---|---|---|
| Andy Payne, PhD | AbbVie | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27602665 | Result | Jaffe GJ, Dick AD, Brezin AP, Nguyen QD, Thorne JE, Kestelyn P, Barisani-Asenbauer T, Franco P, Heiligenhaus A, Scales D, Chu DS, Camez A, Kwatra NV, Song AP, Kron M, Tari S, Suhler EB. Adalimumab in Patients with Active Noninfectious Uveitis. N Engl J Med. 2016 Sep 8;375(10):932-43. doi: 10.1056/NEJMoa1509852. | |
| 28426849 | Derived |
| Label | URL |
|---|---|
| This clinical study may be evaluating a usage that is not currently FDA-approved. Please see US Prescribing Information for approved uses. | View source |
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Participants were randomized in a 1:1 ratio double-masked fashion stratified by baseline immunosuppressant usage. Participants recruited in the Japan sub-study were randomized in a separate stratum with no stratification by baseline immunosuppressant usage.
Study completion was defined as meeting treatment failure or reaching study Week 80.
This study includes a Japan sub-study. 239 participants with active non-infectious intermediate uveitis, posterior uveitis, or panuveitis were randomized worldwide, including 223 participants at 67 sites in Australia, Europe, Israel, Latin America, and North America (Main Study), and 16 participants randomized at 7 sites in Japan (Japan sub-study).
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received placebo subcutaneous injection at Baseline followed by every other week (eow) dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15. |
| FG001 | Adalimumab | Participants received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to Treatment Failure on or After Week 6 | Time to treatment failure was analyzed using Kaplan-Meier methods. Treatment failures on or after Week 6 were counted as events. Dropouts for reasons other than treatment failure at any time during the study were censored at the dropout date. To be considered a treatment failure, ≥ 1 of these criteria had to be present in at least 1 eye:
Per protocol, the primary analysis was performed in the Main Study population which included all randomized participants recruited outside Japan; for completeness results are also reported below for the Integrated dataset which includes participants recruited in Japan. | The intent-to-treat (ITT) population which included all randomized participants; 6 participants at 2 sites were excluded from the ITT due to incomplete efficacy source data and compliance issues. | Posted | Median | Inter-Quartile Range | months | From Baseline until end of study (up to 80 weeks) |
From the first study drug administration until 70 days following the last study drug administration or until rollover into the extension study. Median duration of treatment was 91 days in the placebo arm and 129 days in the adalimumab arm.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participants received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANGLE CLOSURE GLAUCOMA | Eye disorders | MedDRA (17.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CYSTOID MACULAR OEDEMA | Eye disorders | MedDRA (17.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie (prior sponsor, Abbott) | 800-633-9110 |
| ID | Term |
|---|---|
| D014605 | Uveitis |
| ID | Term |
|---|---|
| D014603 | Uveal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000068879 | Adalimumab |
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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|
| Prednisone | Drug | Administered orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper schedule in which all participants continuing in the study were to discontinue prednisone no later than Week 15. |
|
| Placebo | Drug | Administered by subcutaneous injection |
|
| From Baseline to Week 6 and at the Final/Early Termination Visit (up to 80 weeks) |
| Change in Vitreous Haze (VH) Grade in Each Eye From Best State Achieved Prior to Week 6 to the Final/Early Termination Visit | Vitreous haze was measured using dilated indirect ophthalmoscopy (DIO) and assessed by the Investigator according to National Eye Institute (NEI) and SUN criteria: Grade 0: No evident vitreous haze; Grade 0.5+: Slight blurring of the optic disc margin because of the haze; normal striations and reflex of the nerve fiber layer cannot be visualized; Grade 1+: Permits a better definition of both the optic nerve head and the retinal vessels (compared to higher grades); Grade 2+: Permits better visualization of the retinal vessels (compared to higher grades); Grade 3+: Permits the observer to see the optic nerve head, but the borders are quite blurry; Grade 4+: Optic nerve head is obscured. | From Baseline to Week 6 and Final/Early Termination Visit (up to 80 weeks) |
| Change In Logarithm of the Minimum Angle of Resolution (LogMAR) Best Corrected Visual Acuity (BCVA) In Each Eye From Best State Achieved Prior to Week 6 to the Final/Early Termination Visit | Using corrective lenses based on that visit's refraction testing, participant's best corrected visual acuity was measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) logMAR chart. | From Baseline to Week 6 and Final/Early Termination Visit (up to 80 weeks) |
| Time to Optical Coherence Tomography (OCT) Evidence of Macular Edema in At Least 1 Eye On or After Week 6 | Optical coherence tomography was performed at every visit using 1 of 3 approved machines. Images were evaluated by a central reader. Macular edema was defined as cystoid macular edema. OCT evidence of macular edema on or after Week 6 was to be counted as an event. Dropouts due to reasons other than OCT evidence of macular edema were to be considered as censored observations at the time of dropping out. | From Baseline until the Final Visit (up to 80 weeks) |
| Percent Change in Central Retinal Thickness in Each Eye From Best State Achieved Prior to Week 6 to the Final/Early Termination Visit | Central retinal thickness was measured using optical coherence tomography and assessed by a central reader. | Baseline to Week 6 and Final/Early Termination Visit (up to 80 weeks) |
| Change in Visual Functioning Questionnaire 25 (VFQ-25) Composite Score From Best State Achieved Prior to Week 6 to the Final/Early Termination Visit | The National Eye Institute VFQ-25 is an ocular disease-specific survey that measures the influence of visual disability and visual symptoms on generic health domains such as emotional well-being and social functioning, in addition to task-oriented domains related to daily visual functioning. The VFQ-25 consists of a base set of 25 vision-targeted questions plus an additional single-item general health rating question. The overall composite score ranges from 0 to 100, where higher scores or increases in score indicate better vision-related functioning. | Baseline to Week 6 and Final/Early Termination Visit (up 80 weeks) |
| Change in VFQ-25 Distance Vision Subscore From Best State Achieved Prior to Week 6 to the Final/Early Termination Visit | The National Eye Institute VFQ-25 is an ocular disease-specific survey that measures the influence of visual disability and visual symptoms on generic health domains such as emotional well-being and social functioning, in addition to task-oriented domains related to daily visual functioning. The VFQ-25 consists of a base set of 25 vision-targeted questions plus an additional single-item general health rating question. The distance vision subscore is calculated from the answers to 3 distance vision-related questions and ranges from 0 to 100, where higher scores or increases in score indicate better vision-related functioning. | Baseline to Week 6 and Final/Early Termination Visit (up 80 weeks) |
| Change in VFQ-25 Near Vision Subscore From Best State Achieved Prior to Week 6 to the Final/Early Termination Visit | The National Eye Institute VFQ-25 is an ocular disease-specific survey that measures the influence of visual disability and visual symptoms on generic health domains such as emotional well-being and social functioning, in addition to task-oriented domains related to daily visual functioning. The VFQ-25 consists of a base set of 25 vision-targeted questions plus an additional single-item general health rating question. The distance vision subscore is calculated from the answers to 3 near vision-related questions and ranges from 0 to 100, where higher scores or increases in score indicate better vision-related functioning. | Baseline to Week 6 and Final/Early Termination Visit (up 80 weeks) |
| Change in VFQ-25 Ocular Pain Subscore From Best State Achieved Prior to Week 6 to the Final/Early Termination Visit | The National Eye Institute VFQ-25 is an ocular disease-specific survey that measures the influence of visual disability and visual symptoms on generic health domains such as emotional well-being and social functioning, in addition to task-oriented domains related to daily visual functioning. The VFQ-25 consists of a base set of 25 vision-targeted questions plus an additional single-item general health rating question. The ocular pain subscore is calculated from the answers to 2 ocular pain-related questions and ranges from 0 to 100, where higher scores or increases in score indicate less pain. | Baseline to Week 6 and Final/Early Termination Visit (up 80 weeks) |
| Sheppard J, Joshi A, Betts KA, Hudgens S, Tari S, Chen N, Skup M, Dick AD. Effect of Adalimumab on Visual Functioning in Patients With Noninfectious Intermediate Uveitis, Posterior Uveitis, and Panuveitis in the VISUAL-1 and VISUAL-2 Trials. JAMA Ophthalmol. 2017 Jun 1;135(6):511-518. doi: 10.1001/jamaophthalmol.2017.0603. |
| 28237411 | Derived | Grewal DS, O'Sullivan ML, Kron M, Jaffe GJ. Association of Disorganization of Retinal Inner Layers With Visual Acuity In Eyes With Uveitic Cystoid Macular Edema. Am J Ophthalmol. 2017 May;177:116-125. doi: 10.1016/j.ajo.2017.02.017. Epub 2017 Feb 22. |
| Lost to Follow-up |
|
| Miscellaneous Reasons |
|
| Adalimumab |
Participants received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Number | participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Type of Uveitis | Number | participants |
|
| Diagnosis | Number | participants |
|
| Eye Affected | Number | participants |
|
| Duration of Uveitis | Mean | Standard Deviation | months |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Main Study: Placebo | Participants, excluding those enrolled in the Japan sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15. |
| OG001 | Main Study: Adalimumab | Participants, excluding those enrolled in the Japan sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15. |
| OG002 | Integrated Study (Main + Japan Sub-study): Placebo | Participants, including those enrolled in the Main Study and the Japan Sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15. |
| OG003 | Integrated Study (Main + Japan Sub-study): Adalimumab | Participants, including those enrolled in the Main Study and the Japan Sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15. |
|
|
|
| Secondary | Change in Anterior Chamber (AC) Cell Grade in Each Eye From Best State Achieved Prior to Week 6 to the Final/Early Termination Visit | Slit lamp examinations were conducted at each visit to assess AC cell count. The number of AC cells observed within a 1 mm × 1 mm slit beam was used to determine the grade according to the Standardization of Uveitis Nomenclature (SUN) criteria: Grade 0 = < 1 cell; Grade 0.5+ = 1-5 cells; Grade 1+ = 6-15 cells; Grade 2+ = 16-25 cells; Grade 3+ = 26-50 cells; Grade 4+ = > 50 cells. | Intent-to-treat population with values at both time points (best state achieved prior to Week 6 and at least 1 post-week 6 value); last observation carried forward (LOCF) imputation was used; participants with no values after Week 6 were excluded. | Posted | Mean | Standard Deviation | units on a scale | From Baseline to Week 6 and at the Final/Early Termination Visit (up to 80 weeks) |
|
|
|
|
| Secondary | Change in Vitreous Haze (VH) Grade in Each Eye From Best State Achieved Prior to Week 6 to the Final/Early Termination Visit | Vitreous haze was measured using dilated indirect ophthalmoscopy (DIO) and assessed by the Investigator according to National Eye Institute (NEI) and SUN criteria: Grade 0: No evident vitreous haze; Grade 0.5+: Slight blurring of the optic disc margin because of the haze; normal striations and reflex of the nerve fiber layer cannot be visualized; Grade 1+: Permits a better definition of both the optic nerve head and the retinal vessels (compared to higher grades); Grade 2+: Permits better visualization of the retinal vessels (compared to higher grades); Grade 3+: Permits the observer to see the optic nerve head, but the borders are quite blurry; Grade 4+: Optic nerve head is obscured. | Intent-to-treat population with values at both time points; last observation carried forward (LOCF) imputation was used; participants with no values after Week 6 were excluded. | Posted | Mean | Standard Deviation | units on a scale | From Baseline to Week 6 and Final/Early Termination Visit (up to 80 weeks) |
|
|
|
|
| Secondary | Change In Logarithm of the Minimum Angle of Resolution (LogMAR) Best Corrected Visual Acuity (BCVA) In Each Eye From Best State Achieved Prior to Week 6 to the Final/Early Termination Visit | Using corrective lenses based on that visit's refraction testing, participant's best corrected visual acuity was measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) logMAR chart. | Intent-to-treat population with values at both time points; last observation carried forward (LOCF) imputation was used; participants with no values after Week 6 were excluded. | Posted | Mean | Standard Deviation | logMAR | From Baseline to Week 6 and Final/Early Termination Visit (up to 80 weeks) |
|
|
|
|
| Secondary | Time to Optical Coherence Tomography (OCT) Evidence of Macular Edema in At Least 1 Eye On or After Week 6 | Optical coherence tomography was performed at every visit using 1 of 3 approved machines. Images were evaluated by a central reader. Macular edema was defined as cystoid macular edema. OCT evidence of macular edema on or after Week 6 was to be counted as an event. Dropouts due to reasons other than OCT evidence of macular edema were to be considered as censored observations at the time of dropping out. | Intent to treat population with no macular edema at Baseline | Posted | Median | Inter-Quartile Range | months | From Baseline until the Final Visit (up to 80 weeks) |
|
|
|
|
| Secondary | Percent Change in Central Retinal Thickness in Each Eye From Best State Achieved Prior to Week 6 to the Final/Early Termination Visit | Central retinal thickness was measured using optical coherence tomography and assessed by a central reader. | Intent-to-treat population with values at both time points; last observation carried forward (LOCF) imputation was used; participants with no values after Week 6 were excluded. | Posted | Mean | Standard Deviation | percent change | Baseline to Week 6 and Final/Early Termination Visit (up to 80 weeks) |
|
|
|
|
| Secondary | Change in Visual Functioning Questionnaire 25 (VFQ-25) Composite Score From Best State Achieved Prior to Week 6 to the Final/Early Termination Visit | The National Eye Institute VFQ-25 is an ocular disease-specific survey that measures the influence of visual disability and visual symptoms on generic health domains such as emotional well-being and social functioning, in addition to task-oriented domains related to daily visual functioning. The VFQ-25 consists of a base set of 25 vision-targeted questions plus an additional single-item general health rating question. The overall composite score ranges from 0 to 100, where higher scores or increases in score indicate better vision-related functioning. | Intent-to-treat population with values at both time points; last observation carried forward (LOCF) imputation was used; participants with no values after Week 6 were excluded. | Posted | Mean | Standard Deviation | units on a scale | Baseline to Week 6 and Final/Early Termination Visit (up 80 weeks) |
|
|
|
|
| Secondary | Change in VFQ-25 Distance Vision Subscore From Best State Achieved Prior to Week 6 to the Final/Early Termination Visit | The National Eye Institute VFQ-25 is an ocular disease-specific survey that measures the influence of visual disability and visual symptoms on generic health domains such as emotional well-being and social functioning, in addition to task-oriented domains related to daily visual functioning. The VFQ-25 consists of a base set of 25 vision-targeted questions plus an additional single-item general health rating question. The distance vision subscore is calculated from the answers to 3 distance vision-related questions and ranges from 0 to 100, where higher scores or increases in score indicate better vision-related functioning. | Intent-to-treat population with values at both time points; last observation carried forward (LOCF) imputation was used; participants with no values after Week 6 were excluded. | Posted | Mean | Standard Deviation | units on a scale | Baseline to Week 6 and Final/Early Termination Visit (up 80 weeks) |
|
|
|
|
| Secondary | Change in VFQ-25 Near Vision Subscore From Best State Achieved Prior to Week 6 to the Final/Early Termination Visit | The National Eye Institute VFQ-25 is an ocular disease-specific survey that measures the influence of visual disability and visual symptoms on generic health domains such as emotional well-being and social functioning, in addition to task-oriented domains related to daily visual functioning. The VFQ-25 consists of a base set of 25 vision-targeted questions plus an additional single-item general health rating question. The distance vision subscore is calculated from the answers to 3 near vision-related questions and ranges from 0 to 100, where higher scores or increases in score indicate better vision-related functioning. | Intent-to-treat population with values at both time points; last observation carried forward (LOCF) imputation was used; participants with no values after Week 6 were excluded. | Posted | Mean | Standard Deviation | units on a scale | Baseline to Week 6 and Final/Early Termination Visit (up 80 weeks) |
|
|
|
|
| Secondary | Change in VFQ-25 Ocular Pain Subscore From Best State Achieved Prior to Week 6 to the Final/Early Termination Visit | The National Eye Institute VFQ-25 is an ocular disease-specific survey that measures the influence of visual disability and visual symptoms on generic health domains such as emotional well-being and social functioning, in addition to task-oriented domains related to daily visual functioning. The VFQ-25 consists of a base set of 25 vision-targeted questions plus an additional single-item general health rating question. The ocular pain subscore is calculated from the answers to 2 ocular pain-related questions and ranges from 0 to 100, where higher scores or increases in score indicate less pain. | Intent-to-treat population with values at both time points; last observation carried forward (LOCF) imputation was used; participants with no values after Week 6 were excluded. | Posted | Mean | Standard Deviation | units on a scale | Baseline to Week 6 and Final/Early Termination Visit (up 80 weeks) |
|
|
|
|
| 5 |
| 120 |
| 61 |
| 120 |
| EG001 | Adalimumab | Participants received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15. | 16 | 119 | 71 | 119 |
| HEPATITIS ACUTE | Hepatobiliary disorders | MedDRA (17.0) | Systematic Assessment |
|
| ANAPHYLACTIC REACTION | Immune system disorders | MedDRA (17.0) | Systematic Assessment |
|
| GASTROENTERITIS VIRAL | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
|
| PILONIDAL CYST | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
|
| PNEUMONIA | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
|
| PYELONEPHRITIS ACUTE | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
|
| SEPSIS | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
|
| TUBERCULOSIS | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
|
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
|
| URINARY TRACT INFECTION | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
|
| ACCIDENTAL OVERDOSE | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
|
| LIGAMENT RUPTURE | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
|
| TENDON RUPTURE | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
|
| WRIST FRACTURE | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
|
| FLUID OVERLOAD | Metabolism and nutrition disorders | MedDRA (17.0) | Systematic Assessment |
|
| LUPUS-LIKE SYNDROME | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
|
| CARCINOID TUMOUR OF THE GASTROINTESTINAL TRACT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Systematic Assessment |
|
| GLIOBLASTOMA MULTIFORME | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Systematic Assessment |
|
| DEMYELINATION | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
|
| CALCULUS URETERIC | Renal and urinary disorders | MedDRA (17.0) | Systematic Assessment |
|
| RENAL FAILURE CHRONIC | Renal and urinary disorders | MedDRA (17.0) | Systematic Assessment |
|
| URTICARIA | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
|
| ABORTION INDUCED | Surgical and medical procedures | MedDRA (17.0) | Systematic Assessment |
|
| NEOVASCULARISATION | Vascular disorders | MedDRA (17.0) | Systematic Assessment |
|
| EYE PAIN | Eye disorders | MedDRA (17.0) | Systematic Assessment |
|
| UVEITIS | Eye disorders | MedDRA (17.0) | Systematic Assessment |
|
| VISION BLURRED | Eye disorders | MedDRA (17.0) | Systematic Assessment |
|
| DRY MOUTH | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| FATIGUE | General disorders | MedDRA (17.0) | Systematic Assessment |
|
| BRONCHITIS | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
|
| INFLUENZA | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
|
| NASOPHARYNGITIS | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
|
| URINARY TRACT INFECTION | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
|
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
|
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
|
| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
|
| HEADACHE | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
|
| PARAESTHESIA | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
|
| ANXIETY | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment |
|
| INSOMNIA | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment |
|
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| HYPERHIDROSIS | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
|
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| Right Eye |
|
| The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%. | ANOVA | ANOVA with treatment and race (Japanese versus non-Japanese) as factors adjusted for clustered observations (from each of the participant's eyes). | 0.019 | Mean Difference | -0.25 | 2-Sided | 95 | -0.46 | -0.04 | The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model. | Superiority or Other (legacy) |
| Right Eye |
|
| The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%. | ANOVA | ANOVA with treatment and race (Japanese versus non-Japanese) as factors adjusted for clustered observations. | <0.001 | Mean Difference | -0.28 | 2-Sided | 95 | -0.43 | -0.12 | The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model. | Superiority or Other (legacy) |
| Right Eye |
|
| The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%. | ANOVA | ANOVA with treatment and race (Japanese versus non-Japanese) as factors adjusted for clustered observations. | 0.008 | Mean Difference | -0.06 | 2-Sided | 95 | -0.10 | -0.02 | The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model. | Superiority or Other (legacy) |
The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%. |
| Log Rank |
| 0.191 |
| Hazard Ratio (HR) |
| 0.68 |
| 2-Sided |
| 95 |
| 0.38 |
| 1.21 |
The hazard ratio of adalimumab versus placebo was calculated using proportional hazards regression with treatment and race (Japanese versus non-Japanese) as factors. |
| Superiority or Other (legacy) |
| Right eye (n=102, 101, 108, 109) |
|
| The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%. | Chi-squared, Corrected | ANOVA with treatment, race (Japanese versus non-Japanese) and OCT machine as factors adjusted for clustered observations. | 0.428 | Mean Difference | -5.1 | 2-Sided | 95 | -17.7 | 7.5 | The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model. | Superiority or Other (legacy) |
The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%. |
| ANOVA |
ANOVA with treatment and race (Japanese versus non-Japanese) as factors. |
| 0.019 |
| Mean Difference |
| 3.67 |
| 2-Sided |
| 95 |
| 0.62 |
| 6.71 |
| Superiority or Other (legacy) |
The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%. |
| ANOVA |
ANOVA with treatment and race (Japanese versus non-Japanese) as factors. |
| 0.496 |
| Mean Difference |
| 1.31 |
| 2-Sided |
| 95 |
| -2.47 |
| 5.09 |
| Superiority or Other (legacy) |
The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%. |
| ANOVA |
ANOVA with treatment and race (Japanese versus non-Japanese) as factors. |
| 0.077 |
| Mean Difference |
| 4.14 |
| 2-Sided |
| 95 |
| -0.45 |
| 8.72 |
| Superiority or Other (legacy) |
The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5% |
| ANOVA |
ANOVA with treatment and race (Japanese versus non-Japanese) as factors. |
| <0.001 |
| Mean Difference |
| 8.83 |
| 2-Sided |
| 95 |
| 3.88 |
| 13.79 |
| Superiority or Other (legacy) |