Behcet Disease
Conditions
Keywords
Behçet's disease,, intermediate uveitis, panuveitis, posterior uveitis, uveitis
Brief summary
The purpose of this pivotal trial is to evaluate subcutaneous (SQ) AIN457 as an adjunctive therapy to reduce the rate of exacerbations of posterior uveitis or panuveitis secondary to Behçet's disease during the 24 weeks of study therapy as compared to standard of care alone.
Interventions
DRUGAIN457
DRUGPlacebo
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with Behçet's disease and with a history of recurrent uveitis in a least one eye. * Documented evidence of \>2 recurrent exacerbations of either intermediate uveitis, posterior uveitis or panuveitis in the study eye within the past 6 months (this could include the current exacerbation for patients having an acute exacerbation at screening). Exacerbations fulfilling the study inclusion criteria must have one or more of the following recorded in the patients patients medical record for each recurrent exacerbation: * \>2+ vitreous haze with \<2+ anterior chamber cell grade (intermediate or posterior uveitis) or \>2+ vitreous haze with \>2+ anterior chamber cell grade (panuveitis) * presence of retinal infiltrates or vasculitis or hemorrhages * documented \>10 ETDRS letter or 2 line Snellen decrease in visual acuity attributed to ocular inflammation secondary to the recurrent exacerbation of Behçet's disease. * Requirement for either of the following immunosuppressive therapies for at least 3 of the past 6 months for the treatment of or to prevent an exacerbation of ocular inflammation related to Behçet's disease: * Prednisone or equivalent \>10 mg daily * The need for at least \>1 periocular injection or \>1 intravitreal corticosteroid injection in the study eye within the past 6 months (the last injection must have not been given within 6 weeks of screening) * Treatment with cyclosporine, tacrolimus, azathioprine, mycophenolate mofetil, mycophenolic acid or methotrexate either as monotherapy or in combination with or without steroids. (Patients treated at any time with chlorambucil or cyclophosphamide are not eligible for the study.) * Patients not meeting the above specified criteria for immunomodulatory therapies are eligible for enrollment if they are intolerant to systemic immunomodulatory therapy as determined by the study investigator.
Exclusion criteria
* Subjects with infectious uveitis, uveitis due to other causes than Behçet's disease, or uveitis of unknown etiology. * Less severe (i.e. anterior) uveitis associated with Behçet's disease. Ocular treatments * Treatment with intravitreal anti-VEGF agents administered to the study eye within 3 months prior to study screening. * Treatment with any injected or implantable corticosteroid releasing device (i.e., flucinolone acetonide implant, Retisert®) in the study eye within the last 3 years. * Intraocular surgery or laser photocoagulation in the study eye within the last 6 weeks prior to screening except for a diagnostic vitreous or aqueous tap with a small-gauge needle. Systemic conditions or treatments * Treatment with any live or live-attenuated vaccine (including vaccine for varicella-zoster virus or measles) within 2 months prior to screening. * Any systemic biologic therapy (e.g. interferon, infliximab, daclizumab, etanercept, or adalimumab) given intravenously or subcutaneously within 3 months prior to screening and no prior treatment with AIN457. * Any prior treatment with systemic alkylating agents (cyclophosphamide, chlorambucil). Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of Recurrent Ocular Exacerbations in the Study Eye During 24 Weeks by Treatment | Baseline to week 24 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline for Composite Immunosuppressive Medication Score at Week 24 by Treatment (Full Analysis Set) | 24 weeks | For each corticosteroid medication, dose of the corticosteroid was first converted to a prednisone-equivalent dose. To determine the prednisone equivalent dose, the corticosteroid dose was multiplied by a conversion factor. . The total prednisone equivalent dose was calculated as the sum of the prednisone equivalent doses of all corticosteroids. Consequently, the total converted prednisone equivalent dose was used to obtain the immunosuppressive score. The key secondary efficacy variable was the change in total post-baseline immunosuppressive medication score from baseline.The score is actually the prednisoone equivalents taken by patient as calculated by conversion table. A reduction in prenisone or prenisone equivalents is a positive outcome. An increase in the number of prednisone equivalents suggests that the treatment is not efficacious or that there is disease progression. A score of 0 would be the lowest ( no steriods taken) and the upper limit is indeterminate. |
| To Determine the Effect of AIN457 on Macular Edema and Visual Acuity in Patients With Posterior Segment Uveitis Secondary to Behçet's Disease as Determined by Optical Coherence Tomography. | baseline, and wk 24 (end of study) | Optical coherence tomography (OCT) is amedical imaging technique that uses light to capture micrometer-resolution, three-dimensional images from within optical scattering media (e.g., biological tissue). OCT is based on low-coherence interferometry, typically employing near-infrared light. The use of relatively long wavelength light allows it to penetrate into the scattering medium. OCT is a noninvasive procedure that uses optical interferometry to visualize the structures within the retina. Following dilation of the pupil, a light source operating at 850nm provides probe illumination which is split and detected with and without the refraction of the retinal tissues. Cross-sectional imaging is accomplished in 1.3 second by acquiring a sequence of interferometric A-scans. A false color tomogram of optical reflectivity is produced by the computer. Central foveal thickness will be the primary variable derived from OCT. A increase in thickness could translate to disease progression. |
| To Establish the Impact of AIN457 on Quality of Life of Posterior Segment Uveitis Patients Secondary to Behçet's Disease Refractory to Systemic Immunomodulatory Therapy as Measured by National Eye Institute Visual Function Questionaire-25 and Euroqol. | screening, and wk 24 (end of study) | The VFQ-25 is a reliable and valid 25-item version of the 51-item National Eye Institute Visual Function Questionnaire (NEI-VFQ). It is especially useful in settings such as clinical trials, where interview length is a critical consideration. Scores range from 0 to 100, with higher scores indicating better visual function. |
| To Observe the Effect of AIN457 on the Systemic Non-ocular Manifestations of Behçet's Disease in Patients With Posterior Segment Uveitis Requiring Systemic Immunosuppression as Measured by the Bechet's Disease Current Activity Form. | baseline and wk 24 (end of study) | The BDCAF scores oral and genital ulceration, skin, joint and gastrointestinal involvement, presence of fatigue and headache according to the duration of symptoms. The presence and type of large-vessel and central nervous system (CNS) involvement are documented. Eye activity was deemed present if there was a history of blurring of vision or if the eye was painful or red. . The BDCAF score was calculated by adding the score of each index and ranged between 0 and 12 A reduction in score signifies a lessening of the disease. |
Countries
Egypt, France, Germany, Greece, Hong Kong, India, Israel, Italy, Jordan, Singapore, South Korea, Spain, Switzerland, Taiwan, Tunisia, Turkey (Türkiye), United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| AIN457C 300 mg Every 2 Week Dosage Regimen AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each. | 39 |
| AIN457C 300 mg Monthly Dosage Regimen (a) AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each | 40 |
| Placebo to AIN457C Placebo was administered in 2 s.c. injections | 39 |
| Total | 118 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 4 | 2 | 0 |
| Overall Study | Death | 0 | 1 | 0 |
| Overall Study | Lack of Efficacy | 0 | 1 | 4 |
| Overall Study | Lost to Follow-up | 1 | 0 | 0 |
| Overall Study | Protocol Violation | 2 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 4 | 1 |
Baseline characteristics
| Characteristic | Total | AIN457C 300 mg Every 2 Week Dosage Regimen | AIN457C 300 mg Monthly Dosage Regimen (a) | Placebo to AIN457C |
|---|---|---|---|---|
| Age, Continuous | 34.2 Years STANDARD_DEVIATION 11.09 | 36.2 Years STANDARD_DEVIATION 10.96 | 34.0 Years STANDARD_DEVIATION 11.86 | 32.5 Years STANDARD_DEVIATION 10.34 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 115 Participants | 39 Participants | 39 Participants | 37 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 1 Participants | 1 Participants |
| Region of Enrollment Egypt | 5 Participants | 1 Participants | 2 Participants | 2 Participants |
| Region of Enrollment France | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Germany | 3 Participants | 1 Participants | 1 Participants | 1 Participants |
| Region of Enrollment Greece | 12 Participants | 3 Participants | 5 Participants | 4 Participants |
| Region of Enrollment Hong Kong | 3 Participants | 1 Participants | 1 Participants | 1 Participants |
| Region of Enrollment India | 4 Participants | 1 Participants | 2 Participants | 1 Participants |
| Region of Enrollment Israel | 3 Participants | 2 Participants | 0 Participants | 1 Participants |
| Region of Enrollment Italy | 7 Participants | 3 Participants | 2 Participants | 2 Participants |
| Region of Enrollment Jordan | 3 Participants | 0 Participants | 2 Participants | 1 Participants |
| Region of Enrollment Korea, Republic Of | 10 Participants | 2 Participants | 4 Participants | 4 Participants |
| Region of Enrollment Singapore | 2 Participants | 1 Participants | 0 Participants | 1 Participants |
| Region of Enrollment Spain | 2 Participants | 1 Participants | 0 Participants | 1 Participants |
| Region of Enrollment Taiwan, Province Of China | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Tunisia | 5 Participants | 2 Participants | 1 Participants | 2 Participants |
| Region of Enrollment Turkey | 55 Participants | 19 Participants | 18 Participants | 18 Participants |
| Region of Enrollment United States | 2 Participants | 0 Participants | 2 Participants | 0 Participants |
| Sex: Female, Male Female | 38 Participants | 12 Participants | 11 Participants | 15 Participants |
| Sex: Female, Male Male | 80 Participants | 27 Participants | 29 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 28 / 39 | 25 / 39 | 22 / 39 |
| serious Total, serious adverse events | 6 / 39 | 8 / 39 | 5 / 39 |
Outcome results
Primary
Rate of Recurrent Ocular Exacerbations in the Study Eye During 24 Weeks by Treatment
Time frame: Baseline to week 24
Population: Full Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AIN457C 300 mg Every 2 Week Dosage Regimen | Rate of Recurrent Ocular Exacerbations in the Study Eye During 24 Weeks by Treatment | 7.7 Ocular Exacerbations | Standard Deviation 22.4 |
| AIN457C 300 mg Monthly Dosage Regimen (a) | Rate of Recurrent Ocular Exacerbations in the Study Eye During 24 Weeks by Treatment | 11.5 Ocular Exacerbations | Standard Deviation 28.19 |
| Placebo to AIN457C | Rate of Recurrent Ocular Exacerbations in the Study Eye During 24 Weeks by Treatment | 7.7 Ocular Exacerbations | Standard Deviation 22.35 |
Primary
Rate of Recurrent Ocular Exacerbations in the Study Eye During 24 Weeks by Treatment
Patients number of occurences during a 24 week period.
Time frame: 24 weeks
Population: Full analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AIN457C 300 mg Every 2 Week Dosage Regimen | Rate of Recurrent Ocular Exacerbations in the Study Eye During 24 Weeks by Treatment | 3 or more recurrences | 8 Participants |
| AIN457C 300 mg Every 2 Week Dosage Regimen | Rate of Recurrent Ocular Exacerbations in the Study Eye During 24 Weeks by Treatment | 2 recurrences | 8 Participants |
| AIN457C 300 mg Every 2 Week Dosage Regimen | Rate of Recurrent Ocular Exacerbations in the Study Eye During 24 Weeks by Treatment | 1 recurrence | 8 Participants |
| AIN457C 300 mg Every 2 Week Dosage Regimen | Rate of Recurrent Ocular Exacerbations in the Study Eye During 24 Weeks by Treatment | 0 recurrences | 15 Participants |
| AIN457C 300 mg Monthly Dosage Regimen (a) | Rate of Recurrent Ocular Exacerbations in the Study Eye During 24 Weeks by Treatment | 2 recurrences | 3 Participants |
| AIN457C 300 mg Monthly Dosage Regimen (a) | Rate of Recurrent Ocular Exacerbations in the Study Eye During 24 Weeks by Treatment | 1 recurrence | 14 Participants |
| AIN457C 300 mg Monthly Dosage Regimen (a) | Rate of Recurrent Ocular Exacerbations in the Study Eye During 24 Weeks by Treatment | 0 recurrences | 15 Participants |
| AIN457C 300 mg Monthly Dosage Regimen (a) | Rate of Recurrent Ocular Exacerbations in the Study Eye During 24 Weeks by Treatment | 3 or more recurrences | 7 Participants |
| Placebo to AIN457C | Rate of Recurrent Ocular Exacerbations in the Study Eye During 24 Weeks by Treatment | 1 recurrence | 13 Participants |
| Placebo to AIN457C | Rate of Recurrent Ocular Exacerbations in the Study Eye During 24 Weeks by Treatment | 0 recurrences | 11 Participants |
| Placebo to AIN457C | Rate of Recurrent Ocular Exacerbations in the Study Eye During 24 Weeks by Treatment | 3 or more recurrences | 10 Participants |
| Placebo to AIN457C | Rate of Recurrent Ocular Exacerbations in the Study Eye During 24 Weeks by Treatment | 2 recurrences | 5 Participants |
Secondary
Change From Baseline for Composite Immunosuppressive Medication Score at Week 24 by Treatment (Full Analysis Set)
For each corticosteroid medication, dose of the corticosteroid was first converted to a prednisone-equivalent dose. To determine the prednisone equivalent dose, the corticosteroid dose was multiplied by a conversion factor. . The total prednisone equivalent dose was calculated as the sum of the prednisone equivalent doses of all corticosteroids. Consequently, the total converted prednisone equivalent dose was used to obtain the immunosuppressive score. The key secondary efficacy variable was the change in total post-baseline immunosuppressive medication score from baseline.The score is actually the prednisoone equivalents taken by patient as calculated by conversion table. A reduction in prenisone or prenisone equivalents is a positive outcome. An increase in the number of prednisone equivalents suggests that the treatment is not efficacious or that there is disease progression. A score of 0 would be the lowest ( no steriods taken) and the upper limit is indeterminate.
Time frame: 24 weeks
Population: Full Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AIN457C 300 mg Every 2 Week Dosage Regimen | Change From Baseline for Composite Immunosuppressive Medication Score at Week 24 by Treatment (Full Analysis Set) | Week 24 (n=34,32,34) | 7.441 immunosuppressive medication score | Standard Deviation 4.4641 |
| AIN457C 300 mg Every 2 Week Dosage Regimen | Change From Baseline for Composite Immunosuppressive Medication Score at Week 24 by Treatment (Full Analysis Set) | Baseline Score (n=39,39,39) | 7.769 immunosuppressive medication score | Standard Deviation 4.306 |
| AIN457C 300 mg Every 2 Week Dosage Regimen | Change From Baseline for Composite Immunosuppressive Medication Score at Week 24 by Treatment (Full Analysis Set) | LOCF (n=39,39,39) | 7.769 immunosuppressive medication score | Standard Deviation 4.3036 |
| AIN457C 300 mg Monthly Dosage Regimen (a) | Change From Baseline for Composite Immunosuppressive Medication Score at Week 24 by Treatment (Full Analysis Set) | Week 24 (n=34,32,34) | 10.09 immunosuppressive medication score | Standard Deviation 5.3331 |
| AIN457C 300 mg Monthly Dosage Regimen (a) | Change From Baseline for Composite Immunosuppressive Medication Score at Week 24 by Treatment (Full Analysis Set) | Baseline Score (n=39,39,39) | 10.11 immunosuppressive medication score | Standard Deviation 5.3236 |
| AIN457C 300 mg Monthly Dosage Regimen (a) | Change From Baseline for Composite Immunosuppressive Medication Score at Week 24 by Treatment (Full Analysis Set) | LOCF (n=39,39,39) | 10.11 immunosuppressive medication score | Standard Deviation 5.3236 |
| Placebo to AIN457C | Change From Baseline for Composite Immunosuppressive Medication Score at Week 24 by Treatment (Full Analysis Set) | Baseline Score (n=39,39,39) | 9.231 immunosuppressive medication score | Standard Deviation 3.8064 |
| Placebo to AIN457C | Change From Baseline for Composite Immunosuppressive Medication Score at Week 24 by Treatment (Full Analysis Set) | LOCF (n=39,39,39) | 9.231 immunosuppressive medication score | Standard Deviation 3.8064 |
| Placebo to AIN457C | Change From Baseline for Composite Immunosuppressive Medication Score at Week 24 by Treatment (Full Analysis Set) | Week 24 (n=34,32,34) | 8.722 immunosuppressive medication score | Standard Deviation 3.2027 |
Secondary
To Determine the Effect of AIN457 on Macular Edema and Visual Acuity in Patients With Posterior Segment Uveitis Secondary to Behçet's Disease as Determined by Optical Coherence Tomography.
Optical coherence tomography (OCT) is amedical imaging technique that uses light to capture micrometer-resolution, three-dimensional images from within optical scattering media (e.g., biological tissue). OCT is based on low-coherence interferometry, typically employing near-infrared light. The use of relatively long wavelength light allows it to penetrate into the scattering medium. OCT is a noninvasive procedure that uses optical interferometry to visualize the structures within the retina. Following dilation of the pupil, a light source operating at 850nm provides probe illumination which is split and detected with and without the refraction of the retinal tissues. Cross-sectional imaging is accomplished in 1.3 second by acquiring a sequence of interferometric A-scans. A false color tomogram of optical reflectivity is produced by the computer. Central foveal thickness will be the primary variable derived from OCT. A increase in thickness could translate to disease progression.
Time frame: baseline, and wk 24 (end of study)
Population: (Full Analysis Set)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AIN457C 300 mg Every 2 Week Dosage Regimen | To Determine the Effect of AIN457 on Macular Edema and Visual Acuity in Patients With Posterior Segment Uveitis Secondary to Behçet's Disease as Determined by Optical Coherence Tomography. | -26.5 change from baseline : micrometers | Standard Deviation 131.32 |
| AIN457C 300 mg Monthly Dosage Regimen (a) | To Determine the Effect of AIN457 on Macular Edema and Visual Acuity in Patients With Posterior Segment Uveitis Secondary to Behçet's Disease as Determined by Optical Coherence Tomography. | 3.6 change from baseline : micrometers | Standard Deviation 75.29 |
| Placebo to AIN457C | To Determine the Effect of AIN457 on Macular Edema and Visual Acuity in Patients With Posterior Segment Uveitis Secondary to Behçet's Disease as Determined by Optical Coherence Tomography. | -49.4 change from baseline : micrometers | Standard Deviation 174.25 |
Secondary
To Establish the Impact of AIN457 on Quality of Life of Posterior Segment Uveitis Patients Secondary to Behçet's Disease Refractory to Systemic Immunomodulatory Therapy as Measured by National Eye Institute Visual Function Questionaire-25 and Euroqol.
The VFQ-25 is a reliable and valid 25-item version of the 51-item National Eye Institute Visual Function Questionnaire (NEI-VFQ). It is especially useful in settings such as clinical trials, where interview length is a critical consideration. Scores range from 0 to 100, with higher scores indicating better visual function.
Time frame: screening, and wk 24 (end of study)
Population: Full Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AIN457C 300 mg Every 2 Week Dosage Regimen | To Establish the Impact of AIN457 on Quality of Life of Posterior Segment Uveitis Patients Secondary to Behçet's Disease Refractory to Systemic Immunomodulatory Therapy as Measured by National Eye Institute Visual Function Questionaire-25 and Euroqol. | Baseline (n= 38,35,39) | 62.46 Score | Standard Deviation 21.817 |
| AIN457C 300 mg Every 2 Week Dosage Regimen | To Establish the Impact of AIN457 on Quality of Life of Posterior Segment Uveitis Patients Secondary to Behçet's Disease Refractory to Systemic Immunomodulatory Therapy as Measured by National Eye Institute Visual Function Questionaire-25 and Euroqol. | Week 24 (n=38,35,38) | 66.09 Score | Standard Deviation 24.295 |
| AIN457C 300 mg Monthly Dosage Regimen (a) | To Establish the Impact of AIN457 on Quality of Life of Posterior Segment Uveitis Patients Secondary to Behçet's Disease Refractory to Systemic Immunomodulatory Therapy as Measured by National Eye Institute Visual Function Questionaire-25 and Euroqol. | Baseline (n= 38,35,39) | 64.17 Score | Standard Deviation 25.549 |
| AIN457C 300 mg Monthly Dosage Regimen (a) | To Establish the Impact of AIN457 on Quality of Life of Posterior Segment Uveitis Patients Secondary to Behçet's Disease Refractory to Systemic Immunomodulatory Therapy as Measured by National Eye Institute Visual Function Questionaire-25 and Euroqol. | Week 24 (n=38,35,38) | 73.68 Score | Standard Deviation 22.634 |
| Placebo to AIN457C | To Establish the Impact of AIN457 on Quality of Life of Posterior Segment Uveitis Patients Secondary to Behçet's Disease Refractory to Systemic Immunomodulatory Therapy as Measured by National Eye Institute Visual Function Questionaire-25 and Euroqol. | Baseline (n= 38,35,39) | 62.11 Score | Standard Deviation 24.416 |
| Placebo to AIN457C | To Establish the Impact of AIN457 on Quality of Life of Posterior Segment Uveitis Patients Secondary to Behçet's Disease Refractory to Systemic Immunomodulatory Therapy as Measured by National Eye Institute Visual Function Questionaire-25 and Euroqol. | Week 24 (n=38,35,38) | 69.29 Score | Standard Deviation 21.858 |
Secondary
To Observe the Effect of AIN457 on the Systemic Non-ocular Manifestations of Behçet's Disease in Patients With Posterior Segment Uveitis Requiring Systemic Immunosuppression as Measured by the Bechet's Disease Current Activity Form.
The BDCAF scores oral and genital ulceration, skin, joint and gastrointestinal involvement, presence of fatigue and headache according to the duration of symptoms. The presence and type of large-vessel and central nervous system (CNS) involvement are documented. Eye activity was deemed present if there was a history of blurring of vision or if the eye was painful or red. . The BDCAF score was calculated by adding the score of each index and ranged between 0 and 12 A reduction in score signifies a lessening of the disease.
Time frame: baseline and wk 24 (end of study)
Population: Full Analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AIN457C 300 mg Every 2 Week Dosage Regimen | To Observe the Effect of AIN457 on the Systemic Non-ocular Manifestations of Behçet's Disease in Patients With Posterior Segment Uveitis Requiring Systemic Immunosuppression as Measured by the Bechet's Disease Current Activity Form. | -1.3 change from baseline score | Standard Deviation 1.81 |
| AIN457C 300 mg Monthly Dosage Regimen (a) | To Observe the Effect of AIN457 on the Systemic Non-ocular Manifestations of Behçet's Disease in Patients With Posterior Segment Uveitis Requiring Systemic Immunosuppression as Measured by the Bechet's Disease Current Activity Form. | -1.7 change from baseline score | Standard Deviation 1.49 |
| Placebo to AIN457C | To Observe the Effect of AIN457 on the Systemic Non-ocular Manifestations of Behçet's Disease in Patients With Posterior Segment Uveitis Requiring Systemic Immunosuppression as Measured by the Bechet's Disease Current Activity Form. | -1.1 change from baseline score | Standard Deviation 1.22 |