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VISUAL III: A Study of the Long-term Safety and Efficacy of Adalimumab in Subjects With Intermediate-, Posterior-, or Pan-uveitis

Sponsor
AbbVie (Industry)
Overall Status
Completed
CT.gov ID
NCT01148225
Collaborator
(none)
424
Enrollment
1
Arm
89.9
Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

This study was initially planned to run for 78 weeks but was extended for ethical reasons, to avoid leaving participants untreated who had responded well to adalimumab treatment, so that participants were allowed to remain in the study until regulatory and/or reimbursement approval for the treatment of uveitis in adults was obtained for their respective countries. Data were collected through Week 366 (maximum), but because of decreasing sample size that became too small toward the end of the study to allow for meaningful conclusion, data cut off for efficacy analyses (intent to treat [ITT] population) occurred at Week 246, as less than 10% of participants in the ITT set had visits beyond this timepoint.

Study Design

Study Type:
Interventional
Actual Enrollment :
424 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official 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
Actual Study Start Date :
Nov 23, 2010
Actual Primary Completion Date :
May 21, 2018
Actual Study Completion Date :
May 21, 2018

Arms and Interventions

Arm Intervention/Treatment
Other: Adalimumab

Participants received open label (OL) adalimumab 40 mg by subcutaneous (SC) injection every other week (eow) until the final visit.

Drug: adalimumab
Adalimumab, pre-filled syringe, administered by SC injection
Other Names:
  • ABT-D2E7
  • Humira

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants With Adverse Events [Baseline to Final Visit (up to 366 weeks)]

      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.

    2. Hematology: Number of Participants With Potentially Clinically Significant (PCS) Values [Baseline to Final Visit (Up to 366 weeks)]

      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.

    3. Chemistry: Number of Participants With PCS Values [Baseline to Final Visit (Up to 366 weeks)]

      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.

    4. Pulse (Sitting): Mean Change (Beats Per Minute) From Baseline To Final Visit [Baseline to Final Visit (Up to 366 weeks)]

      Heart rate (beats per minute) was measured while the participant was sitting.

    5. Respiratory Rate (Sitting): Mean Change (Respirations Per Minute) From Baseline To Final Visit [Baseline to Final Visit (Up to 366 weeks)]

      Respiratory rate (respirations per minute) was measured while the participant was sitting.

    6. Temperature (Sitting): Mean Change (Centigrade) From Baseline To Final Visit [Baseline to Final Visit (Up to 366 weeks)]

      Temperature was measured while the participant was sitting.

    7. Diastolic and Systolic Blood Pressure (Sitting): Mean Change (mmHg) From Baseline To Final Visit [Baseline to Final Visit (Up to 366 weeks)]

      Blood pressure was measured while the participant was sitting. Abbreviations used include mmHg=millimeters of mercury.

    Secondary Outcome Measures

    1. Percentage of Participants in Quiescence Over Time [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]

      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.

    2. Percentage of Participants With Uveitis Flare Among Participants With Inactive Uveitis at Study Start [366 Weeks]

      Uveitis flare is defined as no quiescence (active inflammatory lesions and AC cell grade > 0.5+ and/or VH grade >0.5+).

    3. Percentage of Participants With Uveitis Flare From Week 8 Through Last Visit Among Participants With Active Uveitis at Study Start [Weeks 8 to 246 (238 Weeks)]

      Uveitis flare is defined as no quiescence (active inflammatory lesions and AC cell grade > 0.5+ and/or VH grade >0.5+).

    4. 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 [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]

      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.

    5. Percentage of Participants With Steroid-free Quiescence Over Time [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]

      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.

    6. 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 [366 Weeks]

      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.

    7. 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 [366 Weeks]

      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.

    8. Percentage of Participants Who Started Uveitis-related Systemic Corticosteroids During the Study [366 Weeks]

      Percentage of participants who started uveitis-related systemic corticosteroids during the study.

    9. Mean Daily Dose in Milligrams (mg) of Uveitis-related Systemic Corticosteroids in Participants With Active Uveitis Over Time [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]

      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.

    10. Mean Daily Dose (mg) of Uveitis-related Systemic Corticosteroids in Participants With Inactive Uveitis Over Time [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]

      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.

    11. 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 [Weeks 0, 2, 4, 8, 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, and 198]

      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.

    12. 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 [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]

      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.

    13. Percentage of Participants Not Using Systemic Corticosteroids Over Time [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]

      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.

    14. 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 [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]

      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.

    15. 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 [Weeks 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246]

      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.

    16. Mean of Both Eyes of the Logarithm of the Minimum Angle of Resolution (LogMAR) BCVA Over Time [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]

      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.

    Other Outcome Measures

    1. Percent Change in Left Eye in Central Retinal Thickness (1 mm Subfield) From Baseline to Each Study Time Point Relative to Baseline for Participants Who Had Inactive Uveitis at Study Entry Over Time [Baseline (Week 0) and 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]

      Central retinal thickness was measured using optical coherence tomography (OCT) and assessed by a central reader. Percent change in left eye from baseline (Week 0) to each study time point relative to baseline for participants who had inactive uveitis at study entry is presented.

    2. Percent Change in Right Eye in Central Retinal Thickness (1 mm Subfield) From Baseline to Each Study Time Point Relative to Baseline for Participants Who Had Inactive Uveitis at Study Entry Over Time [Baseline (Week 0) and 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]

      Central retinal thickness was measured using optical coherence tomography (OCT) and assessed by a central reader. Percent change in right eye from baseline (Week 0) to each study time point relative to baseline for participants who had inactive uveitis at study entry is presented.

    3. Percent Change in Left Eye of Central Retinal Thickness (1 mm Subfield) at Each Study Time Point Relative to Week 8 for Participants Who Had Active Uveitis at Study Entry Over Time [Baseline (Week 8) and Weeks 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246]

      Central retinal thickness was measured using OCT and assessed by a central reader. Percent change in left eye at each study time point relative to Week 8 (baseline) for participants who had active uveitis at study entry is presented.

    4. Percent Change in Right Eye of Central Retinal Thickness (1 mm Subfield) at Each Study Time Point Relative to Week 8 for Participants Who Had Active Uveitis at Study Entry Over Time [Baseline (Week 8) and Weeks 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246]

      Central retinal thickness was measured using OCT and assessed by a central reader. Percent change in right eye at each study time point relative to Week 8 (baseline) for participants who had active uveitis at study entry is presented.

    5. Percentage of Participants With Grade ≤0.5+ in Anterior Chamber (AC) Cells in Both Eyes on Slit Lamp Exam According to Standardization of Uveitis Nomenclature (SUN) Criteria Over Time [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]

      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; and Grade 4+: ≥ 50 cells.

    6. Percentage of Participants Achieving a ≥50% Reduction in Immunosuppression Load Relative to Baseline Over Time Among Participants With Inactive Uveitis at Study Entry [Weeks 2, 4, 8, 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, and 234]

      Immunosuppression load was assessed using a weighted semiquantitative scale, applying grades ranging from 0 to 9 for each immunosuppressive agent on a scale for the total daily dose in milligrams per kilogram per day or per week if dosed weekly. A higher score indicating a higher immunosuppression load and a lower or decreased score indicated improvement or less need for immunosuppressive therapy. The grading scheme was used to accommodate the simultaneous use of multiple agents and provided a combined, single numeric score for the total immunosuppression load per unit body weight per day at each visit. For participants receiving multiple medications, the sum of the grading scores for each drug was used to calculate a total immunosuppression score at each visit. Data not presented after Week 234 as no participants remained on study as of Week 234.

    7. Percentage of Participants Achieving a ≥50% Reduction in Immunosuppression Load Relative to Week 8 Over Time Among Participants With Active Uveitis at Study Entry [Weeks 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246]

      Immunosuppression load was assessed using a weighted semiquantitative scale, applying grades ranging from 0 to 9 for each immunosuppressive agent on a scale for the total daily dose in milligrams per kilogram per day or per week if dosed weekly. A higher score indicating a higher immunosuppression load and a lower or decreased score indicated improvement or less need for immunosuppressive therapy. The grading scheme was used to accommodate the simultaneous use of multiple agents and provided a combined, single numeric score for the total immunosuppression load per unit body weight per day at each visit. For participants receiving multiple medications, the sum of the grading scores for each drug was used to calculate a total immunosuppression score at each visit.

    8. Percentage of Participants With No New Active, Inflammatory Chorioretinal or Inflammatory Retinal Vascular Lesion in Both Eyes Relative to Baseline Over Time Among Participants With Inactive Uveitis at Study Entry [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]

      Percentage of participants at each study time point with no new active, inflammatory chorioretinal or inflammatory retinal vascular lesion in both eyes relative to Baseline for participants who had inactive uveitis when they entered the study.

    9. Percentage of Participants With No New Active, Inflammatory Chorioretinal or Inflammatory Retinal Vascular Lesion in Both Eyes Relative to Week 8 Over Time Among Participants With Active Uveitis at Study Entry [Weeks 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246]

      Percentage of participants at each study time point with no new active, inflammatory chorioretinal or inflammatory retinal vascular lesion in both eyes relative to Week 8 for participants who had active uveitis when they entered the study.

    10. Percentage of Participants With Grade ≤0.5+ in VH in Both Eyes on Indirect Ophthalmoscopy According to NEI/SUN Criteria Over Time [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]

      Vitreous haze was measured using dilated indirect ophthalmoscopy (DIO) and assessed by the Investigator according to 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.

    11. Change in National Eye Institute (NEI) Visual Functioning Questionnaire (VFQ-25) Score at Each Study Time Point Relative to Baseline for Participants Who Had Inactive Uveitis at Study Entry Over Time [Weeks 0, 8, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246]

      The National Eye Institute (NEI) Visual Functioning Questionnaire (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 was defined as Week 0 for participants with inactive uveitis.

    12. Change in NEI VFQ-25 Score at Each Study Time Point Relative to Week 8 for Participants Who Had Active Uveitis at Study Entry Over Time [Weeks 0, 8, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246]

      The National Eye Institute (NEI) Visual Functioning Questionnaire (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 was defined as Week 8 for participants with active uveitis.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • AbbVie

    Investigators

    • Study Director: AbbVie Inc., AbbVie

    Study Documents (Full-Text)

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    AbbVie
    ClinicalTrials.gov Identifier:
    NCT01148225
    Other Study ID Numbers:
    • M11-327
    • 2009-016196-29
    First Posted:
    Jun 22, 2010
    Last Update Posted:
    Jul 12, 2021
    Last Verified:
    Jul 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by AbbVie
    Intermediate-Uveitis
    Non-infectious Uveitis
    Posterior-Uveitis
    Active Uveitis
    Pan-uveitis
    Uveitis
    Additional relevant MeSH terms:
    Uveitis
    Panuveitis
    Adalimumab

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail A total of 424 participants were enrolled and received ≥1 dose of study drug (Safety population); 364 participants were included in the intent-to-treat (ITT) population (reasons for exclusion: incomplete efficacy data or GCP compliance issues at 2 sites (n=7); diabetic retinopathy [n=1]; cataract surgery [n=26]; and previous vitrectomy [n=26]).
    Arm/Group Title Adalimumab
    Arm/Group Description Participants received open label (OL) adalimumab 40 mg by subcutaneous (SC) injection every other week (eow) until the final visit.
    Period Title: Overall Study
    STARTED 424
    COMPLETED 239
    NOT COMPLETED 185

    Baseline Characteristics

    Arm/Group Title Adalimumab
    Arm/Group Description Participants received open label (OL) adalimumab 40 mg by subcutaneous (SC) injection every other week (eow) until the final visit.
    Overall Participants 424
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    43.44
    (14.066)
    Sex: Female, Male (Count of Participants)
    Female
    249
    58.7%
    Male
    175
    41.3%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    77
    18.2%
    Not Hispanic or Latino
    347
    81.8%
    Unknown or Not Reported
    0
    0%

    Outcome Measures

    1. Primary Outcome
    Title Number of Participants With Adverse Events
    Description 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.
    Time Frame Baseline to Final Visit (up to 366 weeks)

    Outcome Measure Data

    Analysis Population Description
    Safety analysis set: includes all participants who received at least one dose of study medication.
    Arm/Group Title Adalimumab
    Arm/Group Description Participants received open label (OL) adalimumab 40 mg by subcutaneous (SC) injection every other week (eow) until the final visit.
    Measure Participants 424
    Any TEAE
    398
    93.9%
    Any TESAE
    101
    23.8%
    2. Primary Outcome
    Title Hematology: Number of Participants With Potentially Clinically Significant (PCS) Values
    Description 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.
    Time Frame Baseline to Final Visit (Up to 366 weeks)

    Outcome Measure Data

    Analysis Population Description
    Safety analysis set.
    Arm/Group Title Adalimumab
    Arm/Group Description Participants received open label (OL) adalimumab 40 mg by subcutaneous (SC) injection every other week (eow) until the final visit.
    Measure Participants 424
    Hemoglobin (Low: <80-65 g/L)
    3
    0.7%
    Neutrophils (Low: <1.0-0.5*10^9/L)
    6
    1.4%
    Lymphocytes (Low: <0.5-0.2*10^9/L)
    7
    1.7%
    3. Primary Outcome
    Title Chemistry: Number of Participants With PCS Values
    Description 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.
    Time Frame Baseline to Final Visit (Up to 366 weeks)

    Outcome Measure Data

    Analysis Population Description
    Safety analysis set.
    Arm/Group Title Adalimumab
    Arm/Group Description Participants received open label (OL) adalimumab 40 mg by subcutaneous (SC) injection every other week (eow) until the final visit.
    Measure Participants 424
    ALT/SGPT (High: >5.0-20.0*ULN)
    2
    0.5%
    AST/SGOT (High: >5.0-20.0*ULN)
    3
    0.7%
    Bilirubin, Total (High: >3.0-10.0*ULN)
    1
    0.2%
    Creatinine (High: >3.0-6.0*ULN)
    2
    0.5%
    Phosphate Inorganic (Low:<0.6-0.3 mmol/L)
    5
    1.2%
    Sodium (Low: <130-120 mmol/L)
    4
    0.9%
    Potassium (Low:<3.0-2.5 mmol/L)
    7
    1.7%
    Glucose (High: >13.9-27.8 mmol/L)
    18
    4.2%
    Albumin (Low: <20.0 g/L)
    2
    0.5%
    Cholesterol (High: >10.34-12.92 mmol/L)
    3
    0.7%
    Triglycerides (High: >5.0-10*ULN)
    8
    1.9%
    4. Primary Outcome
    Title Pulse (Sitting): Mean Change (Beats Per Minute) From Baseline To Final Visit
    Description Heart rate (beats per minute) was measured while the participant was sitting.
    Time Frame Baseline to Final Visit (Up to 366 weeks)

    Outcome Measure Data

    Analysis Population Description
    Safety analysis set.
    Arm/Group Title Adalimumab
    Arm/Group Description Participants received open label (OL) adalimumab 40 mg by subcutaneous injection(SC) every other week (eow) until the final visit.
    Measure Participants 424
    Mean (Standard Deviation) [beats per minute]
    -1.0
    (11.92)
    5. Primary Outcome
    Title Respiratory Rate (Sitting): Mean Change (Respirations Per Minute) From Baseline To Final Visit
    Description Respiratory rate (respirations per minute) was measured while the participant was sitting.
    Time Frame Baseline to Final Visit (Up to 366 weeks)

    Outcome Measure Data

    Analysis Population Description
    Safety analysis set.
    Arm/Group Title Adalimumab
    Arm/Group Description Participants received open label (OL) adalimumab 40 mg by subcutaneous injection(SC) every other week (eow) until the final visit.
    Measure Participants 424
    Mean (Standard Deviation) [respirations per minute]
    -0.1
    (2.94)
    6. Primary Outcome
    Title Temperature (Sitting): Mean Change (Centigrade) From Baseline To Final Visit
    Description Temperature was measured while the participant was sitting.
    Time Frame Baseline to Final Visit (Up to 366 weeks)

    Outcome Measure Data

    Analysis Population Description
    Safety analysis set.
    Arm/Group Title Adalimumab
    Arm/Group Description Participants received open label (OL) adalimumab 40 mg by subcutaneous injection(SC) every other week (eow) until the final visit.
    Measure Participants 424
    Mean (Standard Deviation) [Centigrade]
    -0.03
    (0.516)
    7. Primary Outcome
    Title Diastolic and Systolic Blood Pressure (Sitting): Mean Change (mmHg) From Baseline To Final Visit
    Description Blood pressure was measured while the participant was sitting. Abbreviations used include mmHg=millimeters of mercury.
    Time Frame Baseline to Final Visit (Up to 366 weeks)

    Outcome Measure Data

    Analysis Population Description
    Safety analysis set.
    Arm/Group Title Adalimumab
    Arm/Group Description Participants received open label (OL) adalimumab 40 mg by subcutaneous injection(SC) every other week (eow) until the final visit.
    Measure Participants 424
    Diastolic Blood Pressure (Sitting)
    1.443
    (10.4373)
    Systolic Blood Pressure (Sitting)
    1.955
    (14.6281)
    8. Secondary Outcome
    Title Percentage of Participants in Quiescence Over Time
    Description 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.
    Time Frame 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

    Outcome Measure Data

    Analysis Population Description
    ITT analysis set: includes all participants who received at least one dose of study medication with evaluable data at a given timepoint.
    Arm/Group Title Adalimumab
    Arm/Group Description Participants received open label (OL) adalimumab 40 mg by subcutaneous injection (SC) every other week (eow) until the final visit.
    Measure Participants 364
    Week 0
    33.5
    7.9%
    Week 2
    56.3
    13.3%
    Week 4
    63.8
    15%
    Week 8
    72.0
    17%
    Week 12
    72.4
    17.1%
    Week 18
    75.2
    17.7%
    Week 30
    79.9
    18.8%
    Week 42
    81.3
    19.2%
    Week 54
    81.1
    19.1%
    Week 66
    85.9
    20.3%
    Week 78
    86.3
    20.4%
    Week 90
    87.4
    20.6%
    Week 102
    87.3
    20.6%
    Week 114
    87.9
    20.7%
    Week 126
    88.4
    20.8%
    Week 138
    89.3
    21.1%
    Week 150
    85.0
    20%
    Week 162
    87.0
    20.5%
    Week 174
    87.3
    20.6%
    Week 186
    90.6
    21.4%
    Week 198
    89.4
    21.1%
    Week 210
    88.6
    20.9%
    Week 222
    92.9
    21.9%
    Week 234
    96.1
    22.7%
    Week 246
    95.2
    22.5%
    9. Secondary Outcome
    Title Percentage of Participants With Uveitis Flare Among Participants With Inactive Uveitis at Study Start
    Description Uveitis flare is defined as no quiescence (active inflammatory lesions and AC cell grade > 0.5+ and/or VH grade >0.5+).
    Time Frame 366 Weeks

    Outcome Measure Data

    Analysis Population Description
    All participants in the ITT analysis set with inactive uveitis with evaluable data at a given timepoint.
    Arm/Group Title Adalimumab
    Arm/Group Description Participants received open label (OL) adalimumab 40 mg by subcutaneous injection (SC) every other week (eow) until the final visit.
    Measure Participants 124
    Number (95% Confidence Interval) [percentage of participants]
    38.7
    9.1%
    10. Secondary Outcome
    Title Percentage of Participants With Uveitis Flare From Week 8 Through Last Visit Among Participants With Active Uveitis at Study Start
    Description Uveitis flare is defined as no quiescence (active inflammatory lesions and AC cell grade > 0.5+ and/or VH grade >0.5+).
    Time Frame Weeks 8 to 246 (238 Weeks)

    Outcome Measure Data

    Analysis Population Description
    All participants in the ITT analysis set with active uveitis at study start with evaluable data at a given timepoint.
    Arm/Group Title Adalimumab
    Arm/Group Description Participants received open label (OL) adalimumab 40 mg by subcutaneous injection (SC) every other week (eow) until the final visit.
    Measure Participants 232
    Number (95% Confidence Interval) [percentage of participants]
    67.7
    16%
    11. Secondary Outcome
    Title 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
    Description 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.
    Time Frame 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

    Outcome Measure Data

    Analysis Population Description
    All participants in the ITT analysis set with evaluable data at a given time point.
    Arm/Group Title Adalimumab
    Arm/Group Description Participants received open label (OL) adalimumab 40 mg by subcutaneous injection (SC) every other week (eow) until the final visit.
    Measure Participants 364
    Week 2
    11.8
    2.8%
    Week 4
    8.4
    2%
    Week 8
    7.6
    1.8%
    Week 12
    6.9
    1.6%
    Week 18
    3.6
    0.8%
    Week 30
    5.3
    1.3%
    Week 42
    4.2
    1%
    Week 54
    4.1
    1%
    Week 66
    1.4
    0.3%
    Week 78
    4.1
    1%
    Week 90
    4.6
    1.1%
    Week 102
    4.1
    1%
    Week 114
    4.8
    1.1%
    Week 126
    3.3
    0.8%
    Week 138
    2.0
    0.5%
    Week 150
    4.4
    1%
    Week 162
    3.2
    0.8%
    Week 174
    1.4
    0.3%
    Week 186
    1.6
    0.4%
    Week 198
    0
    0%
    Week 210
    3.4
    0.8%
    Week 222
    1.4
    0.3%
    Week 234
    0
    0%
    Week 246
    0
    0%
    12. Secondary Outcome
    Title Percentage of Participants With Steroid-free Quiescence Over Time
    Description 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.
    Time Frame 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

    Outcome Measure Data

    Analysis Population Description
    All participants in the ITT analysis set in steroid-free quiescence with evaluable data at a given timepoint.
    Arm/Group Title Adalimumab
    Arm/Group Description Participants received open label (OL) adalimumab 40 mg by subcutaneous injection (SC) every other week (eow) until the final visit.
    Measure Participants 364
    Week 0
    30.5
    7.2%
    Week 2
    34.8
    8.2%
    Week 4
    35.6
    8.4%
    Week 8
    41.4
    9.8%
    Week 12
    44.4
    10.5%
    Week 18
    47.6
    11.2%
    Week 30
    52.4
    12.4%
    Week 42
    55.8
    13.2%
    Week 54
    55.7
    13.1%
    Week 66
    56.7
    13.4%
    Week 78
    57.7
    13.6%
    Week 90
    60.2
    14.2%
    Week 102
    65.7
    15.5%
    Week 114
    66.2
    15.6%
    Week 126
    66.0
    15.6%
    Week 138
    67.9
    16%
    Week 150
    65.0
    15.3%
    Week 162
    63.0
    14.9%
    Week 174
    65.5
    15.4%
    Week 186
    68.0
    16%
    Week 198
    64.6
    15.2%
    Week 210
    64.0
    15.1%
    Week 222
    69.0
    16.3%
    Week 234
    78.4
    18.5%
    Week 246
    83.3
    19.6%
    13. Secondary Outcome
    Title 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
    Description 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.
    Time Frame 366 Weeks

    Outcome Measure Data

    Analysis Population Description
    All participants in the ITT analysis set with inactive uveitis at Week 0 in nonquiescence with evaluable data at a given timepoint.
    Arm/Group Title Adalimumab
    Arm/Group Description Participants received open label (OL) adalimumab 40 mg by subcutaneous injection (SC) every other week (eow) until the final visit.
    Measure Participants 124
    NQ With CM Change and quiescence at next visit
    10.5
    2.5%
    NQ With CM Change and nonquiescence at next visit
    2.4
    0.6%
    NQ Without CM Change and quiescence at next visit
    13.7
    3.2%
    NQ Without CM Change and NQ at next visit
    8.9
    2.1%
    NQ With Premature Discontinuation
    3.2
    0.8%
    NQ And Completion
    0.8
    0.2%
    14. Secondary Outcome
    Title 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
    Description 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.
    Time Frame 366 Weeks

    Outcome Measure Data

    Analysis Population Description
    All participants in the ITT analysis set with active uveitis at Week 0 in nonquiescence with evaluable data at a given timepoint.
    Arm/Group Title Adalimumab
    Arm/Group Description Participants received open label (OL) adalimumab 40 mg by subcutaneous injection (SC) every other week (eow) until the final visit.
    Measure Participants 240
    NQ With CM Change and quiescence at next visit
    19.2
    4.5%
    NQ With CM Change and nonquiescence at next visit
    10.8
    2.5%
    NQ Without CM Change and quiescence at next visit
    15.0
    3.5%
    NQ Without CM Change and NQ at next visit
    15.4
    3.6%
    NQ With Premature Discontinuation
    6.7
    1.6%
    NQ And Completion
    0.4
    0.1%
    15. Secondary Outcome
    Title Percentage of Participants Who Started Uveitis-related Systemic Corticosteroids During the Study
    Description Percentage of participants who started uveitis-related systemic corticosteroids during the study.
    Time Frame 366 Weeks

    Outcome Measure Data

    Analysis Population Description
    All participants in the ITT analysis set without systemic corticosteroids at baseline with evaluable data at a given timepoint.
    Arm/Group Title Adalimumab
    Arm/Group Description Participants received open label (OL) adalimumab 40 mg by subcutaneous injection (SC) every other week (eow) until the final visit.
    Measure Participants 364
    Number (95% Confidence Interval) [percentage of participants]
    20.3
    4.8%
    16. Secondary Outcome
    Title Mean Daily Dose in Milligrams (mg) of Uveitis-related Systemic Corticosteroids in Participants With Active Uveitis Over Time
    Description 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.
    Time Frame 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

    Outcome Measure Data

    Analysis Population Description
    All participants in the ITT analysis set with active uveitis with a daily dose of uveitis-related systemic corticosteroids with evaluable data at a given timepoint.
    Arm/Group Title Adalimumab
    Arm/Group Description Participants received open label (OL) adalimumab 40 mg by subcutaneous injection (SC) every other week (eow) until the final visit.
    Measure Participants 235
    Week 0
    13.6
    (19.21)
    Week 2
    14.8
    (17.12)
    Week 4
    10.1
    (12.27)
    Week 8
    7.3
    (9.75)
    Week 12
    6.0
    (9.34)
    Week 18
    5.1
    (8.47)
    Week 30
    4.4
    (7.12)
    Week 42
    3.5
    (5.54)
    Week 54
    3.5
    (6.71)
    Week 66
    3.1
    (6.32)
    Week 78
    2.6
    (5.10)
    Week 90
    2.2
    (4.47)
    Week 102
    2.1
    (4.80)
    Week 114
    1.8
    (4.50)
    Week 126
    1.6
    (4.16)
    Week 138
    2.2
    (5.65)
    Week 150
    2.0
    (4.49)
    Week 162
    1.9
    (4.31)
    Week 174
    1.9
    (4.46)
    Week 186
    1.6
    (4.27)
    Week 198
    1.6
    (4.05)
    Week 210
    1.4
    (3.57)
    Week 222
    2.3
    (8.48)
    Week 234
    1.1
    (3.17)
    Week 246
    0.6
    (1.69)
    17. Secondary Outcome
    Title Mean Daily Dose (mg) of Uveitis-related Systemic Corticosteroids in Participants With Inactive Uveitis Over Time
    Description 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.
    Time Frame 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

    Outcome Measure Data

    Analysis Population Description
    All participants in the ITT analysis set with inactive uveitis with a daily dose of uveitis-related systemic corticosteroids with evaluable data at a given timepoint.
    Arm/Group Title Adalimumab
    Arm/Group Description Participants received open label (OL) adalimumab 40 mg by subcutaneous injection (SC) every other week (eow) until the final visit.
    Measure Participants 124
    Week 0
    1.5
    (7.32)
    Week 2
    1.6
    (6.65)
    Week 4
    1.4
    (4.89)
    Week 8
    0.9
    (3.41)
    Week 12
    0.9
    (4.12)
    Week 18
    0.8
    (3.29)
    Week 30
    0.7
    (2.74)
    Week 42
    0.7
    (2.64)
    Week 54
    1.8
    (7.09)
    Week 66
    1.3
    (5.32)
    Week 78
    1.1
    (4.36)
    Week 90
    1.2
    (4.54)
    Week 102
    0.6
    (2.63)
    Week 114
    0.6
    (2.67)
    Week 126
    0.7
    (2.95)
    Week 138
    0.5
    (2.09)
    Week 150
    0.5
    (1.91)
    Week 162
    0.2
    (1.00)
    Week 174
    0.2
    (1.07)
    Week 186
    0.3
    (1.12)
    Week 198
    0.3
    (1.23)
    Week 210
    0.4
    (1.50)
    Week 222
    0.5
    (1.73)
    Week 234
    0.5
    (1.57)
    Week 246
    0.0
    (0.00)
    18. Secondary Outcome
    Title 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
    Description 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.
    Time Frame Weeks 0, 2, 4, 8, 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, and 198

    Outcome Measure Data

    Analysis Population Description
    All participants in the ITT analysis set who received systemic corticosteroids at Week 0 with evaluable data at a given timepoint.
    Arm/Group Title Adalimumab
    Arm/Group Description Participants received open label (OL) adalimumab 40 mg by subcutaneous injection (SC) every other week (eow) until the final visit.
    Measure Participants 7
    Week 2
    -11.8
    Week 4
    -46.6
    Week 8
    -64.5
    Week 12
    -29.7
    Week 18
    -30.8
    Week 30
    -25.0
    Week 42
    -36.7
    Week 54
    -11.9
    Week 66
    -25.1
    Week 78
    -28.3
    Week 90
    -27.5
    Week 102
    -78.1
    Week 114
    -84.2
    Week 126
    -88.9
    Week 138
    -95.9
    Week 150
    -99.5
    Week 162
    -100.0
    Week 174
    -100.0
    Week 186
    -100.0
    Week 198
    -100.0
    19. Secondary Outcome
    Title 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
    Description 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.
    Time Frame 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

    Outcome Measure Data

    Analysis Population Description
    All participants in the ITT analysis set receiving systemic corticosteroids at Week 0 with evaluable data at a given timepoint.
    Arm/Group Title Adalimumab
    Arm/Group Description Participants received open label (OL) adalimumab 40 mg by subcutaneous injection (SC) every other week (eow) until the final visit.
    Measure Participants 114
    Week 2
    -4.6
    Week 4
    -25.0
    Week 8
    -41.7
    Week 12
    -46.3
    Week 18
    -55.1
    Week 30
    -62.8
    Week 42
    -73.4
    Week 54
    -73.2
    Week 66
    -77.1
    Week 78
    -77.3
    Week 90
    -82.1
    Week 102
    -78.8
    Week 114
    -82.0
    Week 126
    -82.8
    Week 138
    -87.8
    Week 150
    -86.9
    Week 162
    -90.7
    Week 174
    -91.4
    Week 186
    -90.3
    Week 198
    -91.0
    Week 210
    -89.9
    Week 222
    -87.1
    Week 234
    -93.8
    Week 246
    -98.3
    20. Secondary Outcome
    Title Percentage of Participants Not Using Systemic Corticosteroids Over Time
    Description 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.
    Time Frame 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

    Outcome Measure Data

    Analysis Population Description
    All participants in the ITT analysis set with evaluable data at each timepoint.
    Arm/Group Title Adalimumab
    Arm/Group Description Participants received open label (OL) adalimumab 40 mg by subcutaneous injection (SC) every other week (eow) until the final visit.
    Measure Participants 359
    Week 0
    66.3
    15.6%
    Week 2
    58.7
    13.8%
    Week 4
    60.2
    14.2%
    Week 8
    61.9
    14.6%
    Week 12
    64.7
    15.3%
    Week 18
    68.3
    16.1%
    Week 30
    70.2
    16.6%
    Week 42
    70.9
    16.7%
    Week 54
    71.9
    17%
    Week 66
    73.1
    17.2%
    Week 78
    75.2
    17.7%
    Week 90
    77.0
    18.2%
    Week 102
    80.8
    19.1%
    Week 114
    83.6
    19.7%
    Week 126
    84.2
    19.9%
    Week 138
    82.1
    19.4%
    Week 150
    81.5
    19.2%
    Week 162
    80.5
    19%
    Week 174
    79.4
    18.7%
    Week 186
    80.5
    19%
    Week 198
    80.4
    19%
    Week 210
    81.7
    19.3%
    Week 222
    86.4
    20.4%
    Week 234
    89.6
    21.1%
    Week 246
    94.1
    22.2%
    21. Secondary Outcome
    Title 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
    Description 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.
    Time Frame 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

    Outcome Measure Data

    Analysis Population Description
    All participants in the ITT analysis set with evaluable data at each timepoint.
    Arm/Group Title Adalimumab
    Arm/Group Description Participants received open label (OL) adalimumab 40 mg by subcutaneous (SC) injection every other week (eow) until the final visit.
    Measure Participants 124
    Week 2
    100
    23.6%
    Week 4
    99.1
    23.4%
    Week 8
    100
    23.6%
    Week 12
    100
    23.6%
    Week 18
    100
    23.6%
    Week 30
    99.1
    23.4%
    Week 42
    98.2
    23.2%
    Week 54
    97.2
    22.9%
    Week 66
    98.1
    23.1%
    Week 78
    97.0
    22.9%
    Week 90
    98.9
    23.3%
    Week 102
    97.8
    23.1%
    Week 114
    97.6
    23%
    Week 126
    96.1
    22.7%
    Week 138
    96.9
    22.9%
    Week 150
    100
    23.6%
    Week 162
    100
    23.6%
    Week 174
    100
    23.6%
    Week 186
    100
    23.6%
    Week 198
    100
    23.6%
    Week 210
    100
    23.6%
    Week 222
    91.7
    21.6%
    Week 234
    88.9
    21%
    Week 246
    85.7
    20.2%
    22. Secondary Outcome
    Title 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
    Description 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.
    Time Frame Weeks 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246

    Outcome Measure Data

    Analysis Population Description
    All participants in the ITT analysis set with evaluable data at each timepoint.
    Arm/Group Title Adalimumab
    Arm/Group Description Participants received open label (OL) adalimumab 40 mg by subcutaneous (SC) injection every other week (eow) until the final visit.
    Measure Participants 222
    Week 12
    96.8
    22.8%
    Week 18
    96.3
    22.7%
    Week 30
    96.6
    22.8%
    Week 42
    94.9
    22.4%
    Week 54
    94.7
    22.3%
    Week 66
    93.3
    22%
    Week 78
    93.6
    22.1%
    Week 90
    96.4
    22.7%
    Week 102
    94.8
    22.4%
    Week 114
    93.8
    22.1%
    Week 126
    95.0
    22.4%
    Week 138
    93.9
    22.1%
    Week 150
    92.7
    21.9%
    Week 162
    93.9
    22.1%
    Week 174
    91.6
    21.6%
    Week 186
    92.7
    21.9%
    Week 198
    95.3
    22.5%
    Week 210
    95.8
    22.6%
    Week 222
    96.6
    22.8%
    Week 234
    95.2
    22.5%
    Week 246
    91.2
    21.5%
    23. Secondary Outcome
    Title Mean of Both Eyes of the Logarithm of the Minimum Angle of Resolution (LogMAR) BCVA Over Time
    Description 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.
    Time Frame 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

    Outcome Measure Data

    Analysis Population Description
    All participants in the ITT analysis set with evaluable data at each study timepoint.
    Arm/Group Title Adalimumab
    Arm/Group Description Participants received open label (OL) adalimumab 40 mg by subcutaneous injection (SC) every other week (eow) until the final visit.
    Measure Participants 364
    Week 0
    0.20
    (0.275)
    Week 2
    0.17
    (0.265)
    Week 4
    0.15
    (0.248)
    Week 8
    0.14
    (0.247)
    Week 12
    0.13
    (0.244)
    Week 18
    0.12
    (0.240)
    Week 30
    0.12
    (0.249)
    Week 42
    0.12
    (0.227)
    Week 54
    0.11
    (0.238)
    Week 66
    0.11
    (0.241)
    Week 78
    0.11
    (0.238)
    Week 90
    0.09
    (0.214)
    Week 102
    0.09
    (0.219)
    Week 114
    0.09
    (0.233)
    Week 126
    0.09
    (0.231)
    Week 138
    0.09
    (0.224)
    Week 150
    0.10
    (0.255)
    Week 162
    0.09
    (0.249)
    Week 174
    0.09
    (0.261)
    Week 186
    0.09
    (0.244)
    Week 198
    0.07
    (0.205)
    Week 210
    0.07
    (0.211)
    Week 222
    0.07
    (0.218)
    Week 234
    0.07
    (0.222)
    Week 246
    0.08
    (0.217)
    24. Other Pre-specified Outcome
    Title Percent Change in Left Eye in Central Retinal Thickness (1 mm Subfield) From Baseline to Each Study Time Point Relative to Baseline for Participants Who Had Inactive Uveitis at Study Entry Over Time
    Description Central retinal thickness was measured using optical coherence tomography (OCT) and assessed by a central reader. Percent change in left eye from baseline (Week 0) to each study time point relative to baseline for participants who had inactive uveitis at study entry is presented.
    Time Frame Baseline (Week 0) and 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

    Outcome Measure Data

    Analysis Population Description
    All participants in the ITT analysis set with evaluable data at each timepoint.
    Arm/Group Title Adalimumab
    Arm/Group Description Participants received open label (OL) adalimumab 40 mg by subcutaneous (SC) injection every other week (eow) until the final visit.
    Measure Participants 111
    Week 2
    0.3
    Week 4
    -0.2
    Week 8
    -0.7
    Week 12
    -1.0
    Week 18
    -0.5
    Week 30
    -1.9
    Week 42
    -1.3
    Week 54
    -2.1
    Week 66
    -1.9
    Week 78
    -1.4
    Week 90
    -2.9
    Week 102
    -3.1
    Week 114
    -2.8
    Week 126
    -3.7
    Week 138
    -3.4
    Week 150
    -3.5
    Week 162
    -3.3
    Week 174
    -3.0
    Week 186
    -3.8
    Week 198
    -3.2
    Week 210
    -5.2
    Week 222
    -4.6
    Week 234
    -3.6
    Week 246
    -3.4
    25. Other Pre-specified Outcome
    Title Percent Change in Right Eye in Central Retinal Thickness (1 mm Subfield) From Baseline to Each Study Time Point Relative to Baseline for Participants Who Had Inactive Uveitis at Study Entry Over Time
    Description Central retinal thickness was measured using optical coherence tomography (OCT) and assessed by a central reader. Percent change in right eye from baseline (Week 0) to each study time point relative to baseline for participants who had inactive uveitis at study entry is presented.
    Time Frame Baseline (Week 0) and 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

    Outcome Measure Data

    Analysis Population Description
    All participants in the ITT analysis set with evaluable data at each timepoint.
    Arm/Group Title Adalimumab
    Arm/Group Description Participants received open label (OL) adalimumab 40 mg by subcutaneous (SC) injection every other week (eow) until the final visit.
    Measure Participants 109
    Week 2
    -0.2
    Week 4
    -0.8
    Week 8
    -1.5
    Week 12
    -1.0
    Week 18
    -0.4
    Week 30
    -2.8
    Week 42
    -2.2
    Week 54
    -3.7
    Week 66
    -3.3
    Week 78
    -3.9
    Week 90
    -3.8
    Week 102
    -5.3
    Week 114
    -5.6
    Week 126
    -5.4
    Week 138
    -4.7
    Week 150
    -2.1
    Week 162
    -2.9
    Week 174
    -2.7
    Week 186
    -2.0
    Week 198
    -1.2
    Week 210
    -2.3
    Week 222
    -1.7
    Week 234
    -1.3
    Week 246
    1.6
    26. Other Pre-specified Outcome
    Title Percent Change in Left Eye of Central Retinal Thickness (1 mm Subfield) at Each Study Time Point Relative to Week 8 for Participants Who Had Active Uveitis at Study Entry Over Time
    Description Central retinal thickness was measured using OCT and assessed by a central reader. Percent change in left eye at each study time point relative to Week 8 (baseline) for participants who had active uveitis at study entry is presented.
    Time Frame Baseline (Week 8) and Weeks 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246

    Outcome Measure Data

    Analysis Population Description
    All participants in the ITT analysis set with evaluable data at each timepoint.
    Arm/Group Title Adalimumab
    Arm/Group Description Participants received open label (OL) adalimumab 40 mg by subcutaneous (SC) injection every other week (eow) until the final visit.
    Measure Participants 206
    Week 12
    1.0
    Week 18
    -0.3
    Week 30
    -2.4
    Week 42
    -2.8
    Week 54
    -3.2
    Week 66
    -2.3
    Week 78
    -3.5
    Week 90
    -4.8
    Week 102
    -5.3
    Week 114
    -6.6
    Week 126
    -5.3
    Week 138
    -7.0
    Week 150
    -7.3
    Week 162
    -7.5
    Week 174
    -9.5
    Week 186
    -7.6
    Week 198
    -8.4
    Week 210
    -6.6
    Week 222
    -9.3
    Week 234
    -8.2
    Week 246
    -9.1
    27. Other Pre-specified Outcome
    Title Percent Change in Right Eye of Central Retinal Thickness (1 mm Subfield) at Each Study Time Point Relative to Week 8 for Participants Who Had Active Uveitis at Study Entry Over Time
    Description Central retinal thickness was measured using OCT and assessed by a central reader. Percent change in right eye at each study time point relative to Week 8 (baseline) for participants who had active uveitis at study entry is presented.
    Time Frame Baseline (Week 8) and Weeks 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246

    Outcome Measure Data

    Analysis Population Description
    All participants in the ITT analysis set with evaluable data at each timepoint.
    Arm/Group Title Adalimumab
    Arm/Group Description Participants received open label (OL) adalimumab 40 mg by subcutaneous (SC) injection every other week (eow) until the final visit.
    Measure Participants 205
    Week 12
    0.4
    Week 18
    -0.7
    Week 30
    -0.7
    Week 42
    -2.4
    Week 54
    -2.4
    Week 66
    -1.3
    Week 78
    -2.1
    Week 90
    -3.6
    Week 102
    -3.4
    Week 114
    -2.2
    Week 126
    -3.5
    Week 138
    -4.6
    Week 150
    -6.5
    Week 162
    -4.8
    Week 174
    -5.4
    Week 186
    -7.9
    Week 198
    -8.2
    Week 210
    -6.6
    Week 222
    -9.7
    Week 234
    -9.7
    Week 246
    -9.9
    28. Other Pre-specified Outcome
    Title Percentage of Participants With Grade ≤0.5+ in Anterior Chamber (AC) Cells in Both Eyes on Slit Lamp Exam According to Standardization of Uveitis Nomenclature (SUN) Criteria Over Time
    Description 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; and Grade 4+: ≥ 50 cells.
    Time Frame 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

    Outcome Measure Data

    Analysis Population Description
    All participants in the ITT analysis set with evaluable data at each timepoint.
    Arm/Group Title Adalimumab
    Arm/Group Description Participants received open label (OL) adalimumab 40 mg by subcutaneous (SC) injection every other week (eow) until the final visit. adalimumab: Adalimumab, pre-filled syringe, administered by SC injection
    Measure Participants 364
    Week 0
    65.4
    15.4%
    Week 2
    85.9
    20.3%
    Week 4
    90.4
    21.3%
    Week 8
    91.5
    21.6%
    Week 12
    91.3
    21.5%
    Week 18
    90.9
    21.4%
    Week 30
    94.7
    22.3%
    Week 42
    92.3
    21.8%
    Week 54
    92.9
    21.9%
    Week 66
    95.1
    22.4%
    Week 78
    93.0
    21.9%
    Week 90
    94.3
    22.2%
    Week 102
    93.5
    22.1%
    Week 114
    93.5
    22.1%
    Week 126
    94.0
    22.2%
    Week 138
    93.4
    22%
    Week 150
    94.5
    22.3%
    Week 162
    95.5
    22.5%
    Week 174
    94.4
    22.3%
    Week 186
    96.1
    22.7%
    Week 198
    94.7
    22.3%
    Week 210
    96.6
    22.8%
    Week 222
    98.6
    23.3%
    Week 234
    100
    23.6%
    Week 246
    95.2
    22.5%
    29. Other Pre-specified Outcome
    Title Percentage of Participants Achieving a ≥50% Reduction in Immunosuppression Load Relative to Baseline Over Time Among Participants With Inactive Uveitis at Study Entry
    Description Immunosuppression load was assessed using a weighted semiquantitative scale, applying grades ranging from 0 to 9 for each immunosuppressive agent on a scale for the total daily dose in milligrams per kilogram per day or per week if dosed weekly. A higher score indicating a higher immunosuppression load and a lower or decreased score indicated improvement or less need for immunosuppressive therapy. The grading scheme was used to accommodate the simultaneous use of multiple agents and provided a combined, single numeric score for the total immunosuppression load per unit body weight per day at each visit. For participants receiving multiple medications, the sum of the grading scores for each drug was used to calculate a total immunosuppression score at each visit. Data not presented after Week 234 as no participants remained on study as of Week 234.
    Time Frame Weeks 2, 4, 8, 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, and 234

    Outcome Measure Data

    Analysis Population Description
    All participants in the ITT analysis set with an immunosuppression load greater than 0 at baseline (Week 0) with evaluable data at each timepoint.
    Arm/Group Title Adalimumab
    Arm/Group Description Participants received open label (OL) adalimumab 40 mg by subcutaneous (SC) injection every other week (eow) until the final visit.
    Measure Participants 55
    Week 2
    3.6
    0.8%
    Week 4
    9.1
    2.1%
    Week 8
    17.3
    4.1%
    Week 12
    17.3
    4.1%
    Week 18
    21.6
    5.1%
    Week 30
    24.5
    5.8%
    Week 42
    22.9
    5.4%
    Week 54
    17.8
    4.2%
    Week 66
    15.0
    3.5%
    Week 78
    15.0
    3.5%
    Week 90
    13.5
    3.2%
    Week 102
    14.7
    3.5%
    Week 114
    25.0
    5.9%
    Week 126
    25.0
    5.9%
    Week 138
    25.0
    5.9%
    Week 150
    23.8
    5.6%
    Week 162
    18.8
    4.4%
    Week 174
    12.5
    2.9%
    Week 186
    12.5
    2.9%
    Week 198
    0
    0%
    Week 210
    12.5
    2.9%
    Week 222
    25.0
    5.9%
    Week 234
    50.0
    11.8%
    30. Other Pre-specified Outcome
    Title Percentage of Participants Achieving a ≥50% Reduction in Immunosuppression Load Relative to Week 8 Over Time Among Participants With Active Uveitis at Study Entry
    Description Immunosuppression load was assessed using a weighted semiquantitative scale, applying grades ranging from 0 to 9 for each immunosuppressive agent on a scale for the total daily dose in milligrams per kilogram per day or per week if dosed weekly. A higher score indicating a higher immunosuppression load and a lower or decreased score indicated improvement or less need for immunosuppressive therapy. The grading scheme was used to accommodate the simultaneous use of multiple agents and provided a combined, single numeric score for the total immunosuppression load per unit body weight per day at each visit. For participants receiving multiple medications, the sum of the grading scores for each drug was used to calculate a total immunosuppression score at each visit.
    Time Frame Weeks 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246

    Outcome Measure Data

    Analysis Population Description
    All participants in the ITT analysis set with an immunosuppression load greater than 0 at baseline (Week 8) with evaluable data at each timepoint.
    Arm/Group Title Adalimumab
    Arm/Group Description Participants received open label (OL) adalimumab 40 mg by subcutaneous (SC) injection every other week (eow) until the final visit.
    Measure Participants 140
    Week 12
    17.1
    4%
    Week 18
    27.2
    6.4%
    Week 30
    33.6
    7.9%
    Week 42
    41.6
    9.8%
    Week 54
    44.5
    10.5%
    Week 66
    48.7
    11.5%
    Week 78
    48.6
    11.5%
    Week 90
    53.8
    12.7%
    Week 102
    54.1
    12.8%
    Week 114
    51.1
    12.1%
    Week 126
    52.9
    12.5%
    Week 138
    52.5
    12.4%
    Week 150
    53.9
    12.7%
    Week 162
    53.5
    12.6%
    Week 174
    55.6
    13.1%
    Week 186
    55.9
    13.2%
    Week 198
    52.0
    12.3%
    Week 210
    51.2
    12.1%
    Week 222
    54.8
    12.9%
    Week 234
    56.5
    13.3%
    Week 246
    63.2
    14.9%
    31. Other Pre-specified Outcome
    Title Percentage of Participants With No New Active, Inflammatory Chorioretinal or Inflammatory Retinal Vascular Lesion in Both Eyes Relative to Baseline Over Time Among Participants With Inactive Uveitis at Study Entry
    Description Percentage of participants at each study time point with no new active, inflammatory chorioretinal or inflammatory retinal vascular lesion in both eyes relative to Baseline for participants who had inactive uveitis when they entered the study.
    Time Frame 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

    Outcome Measure Data

    Analysis Population Description
    All participants in the ITT analysis set that had evaluable data at each timepoint.
    Arm/Group Title Adalimumab
    Arm/Group Description Participants received open label (OL) adalimumab 40 mg by subcutaneous injection (SC) every other week (eow) until the final visit.
    Measure Participants 124
    Week 2
    100
    23.6%
    Week 4
    99.1
    23.4%
    Week 8
    100
    23.6%
    Week 12
    100
    23.6%
    Week 18
    98.2
    23.2%
    Week 30
    100
    23.6%
    Week 42
    98.2
    23.2%
    Week 54
    99.1
    23.4%
    Week 66
    100
    23.6%
    Week 78
    100
    23.6%
    Week 90
    98.9
    23.3%
    Week 102
    98.9
    23.3%
    Week 114
    100
    23.6%
    Week 126
    100
    23.6%
    Week 138
    98.4
    23.2%
    Week 150
    96.5
    22.8%
    Week 162
    97.4
    23%
    Week 174
    100
    23.6%
    Week 186
    100
    23.6%
    Week 198
    100
    23.6%
    Week 210
    100
    23.6%
    Week 222
    100
    23.6%
    Week 234
    100
    23.6%
    Week 246
    100
    23.6%
    32. Other Pre-specified Outcome
    Title Percentage of Participants With No New Active, Inflammatory Chorioretinal or Inflammatory Retinal Vascular Lesion in Both Eyes Relative to Week 8 Over Time Among Participants With Active Uveitis at Study Entry
    Description Percentage of participants at each study time point with no new active, inflammatory chorioretinal or inflammatory retinal vascular lesion in both eyes relative to Week 8 for participants who had active uveitis when they entered the study.
    Time Frame Weeks 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246

    Outcome Measure Data

    Analysis Population Description
    All participants in the ITT analysis set with evaluable data at each timepoint.
    Arm/Group Title Adalimumab
    Arm/Group Description Participants received open label (OL) adalimumab 40 mg by subcutaneous (SC) injection every other week (eow) until the final visit.
    Measure Participants 225
    Week 12
    97.7
    23%
    Week 18
    99.1
    23.4%
    Week 30
    97.1
    22.9%
    Week 42
    99.0
    23.3%
    Week 54
    98.9
    23.3%
    Week 66
    98.3
    23.2%
    Week 78
    97.7
    23%
    Week 90
    97.6
    23%
    Week 102
    99.4
    23.4%
    Week 114
    97.3
    22.9%
    Week 126
    99.3
    23.4%
    Week 138
    100
    23.6%
    Week 150
    96.7
    22.8%
    Week 162
    97.4
    23%
    Week 174
    100
    23.6%
    Week 186
    99.0
    23.3%
    Week 198
    100
    23.6%
    Week 210
    100
    23.6%
    Week 222
    100
    23.6%
    Week 234
    100
    23.6%
    Week 246
    100
    23.6%
    33. Other Pre-specified Outcome
    Title Percentage of Participants With Grade ≤0.5+ in VH in Both Eyes on Indirect Ophthalmoscopy According to NEI/SUN Criteria Over Time
    Description Vitreous haze was measured using dilated indirect ophthalmoscopy (DIO) and assessed by the Investigator according to 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.
    Time Frame 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

    Outcome Measure Data

    Analysis Population Description
    All participants in the ITT analysis set with evaluable data at each timepoint.
    Arm/Group Title Adalimumab
    Arm/Group Description Participants received open label (OL) adalimumab 40 mg by subcutaneous (SC) injection every other week (eow) until the final visit.
    Measure Participants 364
    Week 0
    58.0
    13.7%
    Week 2
    75.6
    17.8%
    Week 4
    77.7
    18.3%
    Week 8
    84.2
    19.9%
    Week 12
    84.4
    19.9%
    Week 18
    87.3
    20.6%
    Week 30
    87.1
    20.5%
    Week 42
    90.3
    21.3%
    Week 54
    89.5
    21.1%
    Week 66
    92.2
    21.7%
    Week 78
    93.3
    22%
    Week 90
    93.5
    22.1%
    Week 102
    93.9
    22.1%
    Week 114
    93.1
    22%
    Week 126
    94.9
    22.4%
    Week 138
    95.4
    22.5%
    Week 150
    92.2
    21.7%
    Week 162
    91.6
    21.6%
    Week 174
    92.3
    21.8%
    Week 186
    96.1
    22.7%
    Week 198
    93.8
    22.1%
    Week 210
    92.0
    21.7%
    Week 222
    95.7
    22.6%
    Week 234
    96.1
    22.7%
    Week 246
    97.6
    23%
    34. Other Pre-specified Outcome
    Title Change in National Eye Institute (NEI) Visual Functioning Questionnaire (VFQ-25) Score at Each Study Time Point Relative to Baseline for Participants Who Had Inactive Uveitis at Study Entry Over Time
    Description The National Eye Institute (NEI) Visual Functioning Questionnaire (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 was defined as Week 0 for participants with inactive uveitis.
    Time Frame Weeks 0, 8, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246

    Outcome Measure Data

    Analysis Population Description
    All participants in the ITT analysis set with evaluable data at each timepoint.
    Arm/Group Title Adalimumab
    Arm/Group Description Participants received open label (OL) adalimumab 40 mg by subcutaneous (SC) injection every other week (eow) until the final visit.
    Measure Participants 122
    Week 0
    84.77
    Week 8
    84.37
    Week 18
    85.21
    Week 30
    84.75
    Week 42
    84.41
    Week 54
    84.87
    Week 66
    84.09
    Week 78
    83.59
    Week 90
    83.66
    Week 102
    84.19
    Week 114
    84.09
    Week 126
    84.44
    Week 138
    84.85
    Week 150
    83.90
    Week 162
    86.60
    Week 174
    87.25
    Week 186
    87.25
    Week 198
    85.30
    Week 210
    85.71
    Week 222
    85.67
    Week 234
    82.90
    Week 246
    79.83
    35. Other Pre-specified Outcome
    Title Change in NEI VFQ-25 Score at Each Study Time Point Relative to Week 8 for Participants Who Had Active Uveitis at Study Entry Over Time
    Description The National Eye Institute (NEI) Visual Functioning Questionnaire (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 was defined as Week 8 for participants with active uveitis.
    Time Frame Weeks 0, 8, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246

    Outcome Measure Data

    Analysis Population Description
    All participants in the ITT analysis set with evaluable data at each timepoint.
    Arm/Group Title Adalimumab
    Arm/Group Description Participants received open label (OL) adalimumab 40 mg by subcutaneous (SC) injection every other week (eow) until the final visit.
    Measure Participants 240
    Week 0
    72.00
    Week 8
    75.77
    Week 18
    78.12
    Week 30
    78.98
    Week 42
    79.77
    Week 54
    80.10
    Week 66
    80.42
    Week 78
    80.98
    Week 90
    81.85
    Week 102
    81.44
    Week 114
    81.76
    Week 126
    81.86
    Week 138
    81.76
    Week 150
    82.41
    Week 162
    81.87
    Week 174
    81.96
    Week 186
    81.27
    Week 198
    82.08
    Week 210
    80.75
    Week 222
    81.65
    Week 234
    81.86
    Week 246
    81.57

    Adverse Events

    Time Frame Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks).
    Adverse Event Reporting Description TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
    Arm/Group Title Adalimumab
    Arm/Group Description Participants received open label (OL) adalimumab 40 mg by subcutaneous (SC) injection every other week (eow) until the final visit.
    All Cause Mortality
    Adalimumab
    Affected / at Risk (%) # Events
    Total 4/424 (0.9%)
    Serious Adverse Events
    Adalimumab
    Affected / at Risk (%) # Events
    Total 101/424 (23.8%)
    Blood and lymphatic system disorders
    PSEUDOLYMPHOMA 1/424 (0.2%) 1
    Cardiac disorders
    ACUTE MYOCARDIAL INFARCTION 1/424 (0.2%) 1
    AORTIC VALVE STENOSIS 1/424 (0.2%) 1
    CARDIAC FAILURE ACUTE 1/424 (0.2%) 1
    CORONARY ARTERY DISEASE 1/424 (0.2%) 1
    MYOCARDIAL INFARCTION 1/424 (0.2%) 1
    Congenital, familial and genetic disorders
    BICUSPID AORTIC VALVE 1/424 (0.2%) 1
    Eye disorders
    BLINDNESS 1/424 (0.2%) 1
    CATARACT 7/424 (1.7%) 11
    CILIARY ZONULAR DEHISCENCE 1/424 (0.2%) 1
    CORNEAL OEDEMA 1/424 (0.2%) 1
    EYE INFLAMMATION 1/424 (0.2%) 1
    GLAUCOMA 1/424 (0.2%) 1
    MACULAR FIBROSIS 1/424 (0.2%) 1
    OCULAR HYPERTENSION 1/424 (0.2%) 1
    OPTIC NEUROPATHY 1/424 (0.2%) 1
    PAPILLOEDEMA 1/424 (0.2%) 1
    RETINAL DETACHMENT 3/424 (0.7%) 3
    RETINAL VASCULITIS 1/424 (0.2%) 1
    UVEITIS 5/424 (1.2%) 5
    VISUAL ACUITY REDUCED 2/424 (0.5%) 2
    VITREOUS FLOATERS 1/424 (0.2%) 1
    VITREOUS HAEMORRHAGE 3/424 (0.7%) 3
    VITREOUS OPACITIES 1/424 (0.2%) 1
    Gastrointestinal disorders
    COLITIS 1/424 (0.2%) 1
    CROHN'S DISEASE 2/424 (0.5%) 2
    GASTRIC ULCER 1/424 (0.2%) 1
    GASTRITIS 1/424 (0.2%) 1
    INTESTINAL OBSTRUCTION 1/424 (0.2%) 1
    LARGE INTESTINE POLYP 2/424 (0.5%) 2
    PANCREATITIS 1/424 (0.2%) 1
    General disorders
    CHEST PAIN 2/424 (0.5%) 2
    DEATH 1/424 (0.2%) 1
    GENERALISED OEDEMA 1/424 (0.2%) 1
    Hepatobiliary disorders
    BILIARY COLIC 1/424 (0.2%) 1
    CHOLELITHIASIS 3/424 (0.7%) 3
    Immune system disorders
    SARCOIDOSIS 1/424 (0.2%) 1
    Infections and infestations
    APPENDICITIS 1/424 (0.2%) 1
    APPENDICITIS PERFORATED 1/424 (0.2%) 1
    ASPERGILLUS INFECTION 1/424 (0.2%) 1
    BRAIN ABSCESS 1/424 (0.2%) 1
    CELLULITIS 1/424 (0.2%) 1
    CYTOMEGALOVIRUS CHORIORETINITIS 1/424 (0.2%) 2
    CYTOMEGALOVIRUS INFECTION 1/424 (0.2%) 1
    DEVICE RELATED INFECTION 1/424 (0.2%) 1
    DIVERTICULITIS 2/424 (0.5%) 3
    ESCHERICHIA URINARY TRACT INFECTION 1/424 (0.2%) 1
    GASTROENTERITIS 1/424 (0.2%) 1
    INFECTION 1/424 (0.2%) 1
    LATENT TUBERCULOSIS 1/424 (0.2%) 1
    MENINGITIS 1/424 (0.2%) 1
    OPHTHALMIC HERPES ZOSTER 1/424 (0.2%) 1
    PERITONSILLAR ABSCESS 1/424 (0.2%) 1
    PNEUMONIA 3/424 (0.7%) 3
    PYELONEPHRITIS 2/424 (0.5%) 2
    PYONEPHROSIS 1/424 (0.2%) 1
    SEPTIC SHOCK 1/424 (0.2%) 1
    SINUSITIS 2/424 (0.5%) 2
    SINUSITIS FUNGAL 1/424 (0.2%) 1
    SOFT TISSUE INFECTION 1/424 (0.2%) 1
    SUBCUTANEOUS ABSCESS 1/424 (0.2%) 1
    TOOTH ABSCESS 1/424 (0.2%) 1
    TUBERCULOSIS 1/424 (0.2%) 1
    URINARY TRACT INFECTION 5/424 (1.2%) 5
    UROSEPSIS 1/424 (0.2%) 1
    Injury, poisoning and procedural complications
    COMMINUTED FRACTURE 1/424 (0.2%) 1
    CORNEAL ABRASION 1/424 (0.2%) 1
    ELSCHNIG'S BODIES 1/424 (0.2%) 1
    EPICONDYLITIS 1/424 (0.2%) 1
    FALL 1/424 (0.2%) 1
    FOREARM FRACTURE 1/424 (0.2%) 1
    JOINT DISLOCATION 1/424 (0.2%) 1
    LACERATION 1/424 (0.2%) 1
    POST PROCEDURAL HAEMORRHAGE 1/424 (0.2%) 1
    SPINAL COMPRESSION FRACTURE 2/424 (0.5%) 2
    STRESS FRACTURE 1/424 (0.2%) 1
    TIBIA FRACTURE 1/424 (0.2%) 1
    UPPER LIMB FRACTURE 1/424 (0.2%) 1
    Investigations
    CARDIAC MURMUR 1/424 (0.2%) 1
    HEPATIC ENZYME INCREASED 1/424 (0.2%) 1
    INTRAOCULAR PRESSURE INCREASED 1/424 (0.2%) 1
    MYCOBACTERIUM TUBERCULOSIS COMPLEX TEST POSITIVE 1/424 (0.2%) 1
    TUBERCULIN TEST POSITIVE 1/424 (0.2%) 1
    Metabolism and nutrition disorders
    HYPOGLYCAEMIA 1/424 (0.2%) 1
    OBESITY 3/424 (0.7%) 3
    Musculoskeletal and connective tissue disorders
    ARTHRALGIA 2/424 (0.5%) 2
    MUSCULOSKELETAL PAIN 1/424 (0.2%) 1
    MYOPATHY 1/424 (0.2%) 1
    OSTEOARTHRITIS 2/424 (0.5%) 2
    OSTEOLYSIS 1/424 (0.2%) 1
    PATELLOFEMORAL PAIN SYNDROME 1/424 (0.2%) 1
    SYNOVITIS 1/424 (0.2%) 1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    ADENOCARCINOMA OF COLON 1/424 (0.2%) 1
    B-CELL LYMPHOMA 1/424 (0.2%) 1
    BASAL CELL CARCINOMA 2/424 (0.5%) 2
    COLORECTAL CANCER 1/424 (0.2%) 1
    LOBULAR BREAST CARCINOMA IN SITU 1/424 (0.2%) 1
    PANCREATIC CARCINOMA METASTATIC 1/424 (0.2%) 1
    RECTAL ADENOCARCINOMA 1/424 (0.2%) 1
    SQUAMOUS CELL CARCINOMA OF SKIN 1/424 (0.2%) 1
    UTERINE LEIOMYOMA 1/424 (0.2%) 1
    Nervous system disorders
    ATAXIA 1/424 (0.2%) 1
    DEMYELINATION 1/424 (0.2%) 1
    ENCEPHALITIS AUTOIMMUNE 1/424 (0.2%) 1
    MULTIPLE SCLEROSIS 2/424 (0.5%) 2
    TENSION HEADACHE 1/424 (0.2%) 1
    TRANSIENT ISCHAEMIC ATTACK 1/424 (0.2%) 1
    Pregnancy, puerperium and perinatal conditions
    ECTOPIC PREGNANCY 1/424 (0.2%) 1
    HYPEREMESIS GRAVIDARUM 1/424 (0.2%) 1
    Product Issues
    DEVICE DISLOCATION 1/424 (0.2%) 1
    Renal and urinary disorders
    ACUTE KIDNEY INJURY 1/424 (0.2%) 1
    BLADDER DIVERTICULUM 1/424 (0.2%) 1
    MICTURITION DISORDER 1/424 (0.2%) 1
    NEPHROLITHIASIS 2/424 (0.5%) 4
    RENAL COLIC 1/424 (0.2%) 1
    URETEROLITHIASIS 1/424 (0.2%) 1
    Reproductive system and breast disorders
    CYSTOCELE 1/424 (0.2%) 1
    HYDROCELE FEMALE 1/424 (0.2%) 1
    RECTOCELE 1/424 (0.2%) 1
    VAGINAL HAEMORRHAGE 1/424 (0.2%) 1
    Respiratory, thoracic and mediastinal disorders
    ACUTE RESPIRATORY FAILURE 1/424 (0.2%) 1
    NASAL POLYPS 1/424 (0.2%) 1
    PLEURAL EFFUSION 1/424 (0.2%) 1
    PNEUMOTHORAX 1/424 (0.2%) 1
    PULMONARY EMBOLISM 1/424 (0.2%) 1
    PULMONARY FIBROSIS 1/424 (0.2%) 1
    SLEEP APNOEA SYNDROME 1/424 (0.2%) 1
    Skin and subcutaneous tissue disorders
    INGROWING NAIL 1/424 (0.2%) 1
    Vascular disorders
    AORTIC DILATATION 1/424 (0.2%) 1
    BEHCET'S SYNDROME 1/424 (0.2%) 1
    HYPERTENSION 1/424 (0.2%) 1
    Other (Not Including Serious) Adverse Events
    Adalimumab
    Affected / at Risk (%) # Events
    Total 332/424 (78.3%)
    Eye disorders
    CATARACT 30/424 (7.1%) 38
    CYSTOID MACULAR OEDEMA 43/424 (10.1%) 70
    DRY EYE 30/424 (7.1%) 33
    EYE PAIN 25/424 (5.9%) 27
    IRIDOCYCLITIS 22/424 (5.2%) 29
    MACULAR OEDEMA 24/424 (5.7%) 31
    UVEITIS 123/424 (29%) 217
    VISUAL ACUITY REDUCED 30/424 (7.1%) 36
    Gastrointestinal disorders
    DIARRHOEA 28/424 (6.6%) 33
    NAUSEA 32/424 (7.5%) 45
    General disorders
    FATIGUE 36/424 (8.5%) 42
    PYREXIA 24/424 (5.7%) 28
    Infections and infestations
    BRONCHITIS 38/424 (9%) 50
    INFLUENZA 36/424 (8.5%) 44
    NASOPHARYNGITIS 105/424 (24.8%) 214
    SINUSITIS 33/424 (7.8%) 43
    UPPER RESPIRATORY TRACT INFECTION 43/424 (10.1%) 65
    URINARY TRACT INFECTION 47/424 (11.1%) 66
    Investigations
    INTRAOCULAR PRESSURE INCREASED 23/424 (5.4%) 30
    Musculoskeletal and connective tissue disorders
    ARTHRALGIA 72/424 (17%) 94
    BACK PAIN 26/424 (6.1%) 30
    PAIN IN EXTREMITY 24/424 (5.7%) 25
    Nervous system disorders
    HEADACHE 63/424 (14.9%) 83
    Respiratory, thoracic and mediastinal disorders
    COUGH 42/424 (9.9%) 45
    OROPHARYNGEAL PAIN 32/424 (7.5%) 39
    Skin and subcutaneous tissue disorders
    RASH 24/424 (5.7%) 30
    Vascular disorders
    HYPERTENSION 27/424 (6.4%) 28

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    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.

    Results Point of Contact

    Name/Title Global Medical Services
    Organization AbbVie
    Phone 800-633-9110
    Email abbvieclinicaltrials@abbvie.com
    Responsible Party:
    AbbVie
    ClinicalTrials.gov Identifier:
    NCT01148225
    Other Study ID Numbers:
    • M11-327
    • 2009-016196-29
    First Posted:
    Jun 22, 2010
    Last Update Posted:
    Jul 12, 2021
    Last Verified:
    Jul 1, 2021