Trial · NCT00995709
Phase III Study in Refractory Behcet's Disease
NCT00995709, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2015-08-31
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Phase III Study in Refractory Behcet's Disease. Trials, record NCT00995709. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00995709
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase III Study in Refractory Behcet's Disease
- NCT number
- NCT00995709
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 118 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Behcet Disease
- Interventions
- AIN457, AIN457, Placebo
- First posted
- 2009-10-15
- Last updated
- 2015-08-31
- Other registries' IDs
- eudract:2009-011237-27
- Results first posted
- 2015-08-31
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Rate of Recurrent Ocular Exacerbations in the Study Eye During 24 Weeks by Treatment | Baseline to week 24 | |
| Primary | Rate of Recurrent Ocular Exacerbations in the Study Eye During 24 Weeks by Treatment | 24 weeks | Patients number of occurences during a 24 week period. |
| Secondary | 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. |
| 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. | 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. |
| 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. | 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. |
| 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. | 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. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Rate of Recurrent Ocular Exacerbations in the Study Eye During 24 Weeks by Treatment | Baseline to week 24 | Full Analysis Set | Ocular Exacerbations | MEAN |
| SECONDARY | Change From Baseline for Composite Immunosuppressive Medication Score at Week 24 by Treatment (Full Analysis Set) | 24 weeks | Full Analysis Set | immunosuppressive medication score | MEAN |
| 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. | baseline, and wk 24 (end of study) | (Full Analysis Set) | change from baseline : micrometers | MEAN |
| 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. | screening, and wk 24 (end of study) | Full Analysis Set | Score | MEAN |
| 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. | baseline and wk 24 (end of study) | Full Analysis set | change from baseline score | MEAN |
| PRIMARY | Rate of Recurrent Ocular Exacerbations in the Study Eye During 24 Weeks by Treatment | 24 weeks | Full analysis set | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Rate of Recurrent Ocular Exacerbations in the Study Eye During 24 Weeks by Treatment | AIN457C 300 mg Every 2 Week Dosage Regimen | 7.7 | Standard Deviation 22.40 | Ocular Exacerbations | |
| Rate of Recurrent Ocular Exacerbations in the Study Eye During 24 Weeks by Treatment | AIN457C 300 mg Monthly Dosage Regimen (a) | 11.5 | Standard Deviation 28.19 | Ocular Exacerbations | |
| Rate of Recurrent Ocular Exacerbations in the Study Eye During 24 Weeks by Treatment | Placebo to AIN457C | 7.7 | Standard Deviation 22.35 | Ocular Exacerbations | |
| Change From Baseline for Composite Immunosuppressive Medication Score at Week 24 by Treatment (Full Analysis Set) | AIN457C 300 mg Every 2 Week Dosage Regimen | Baseline Score (n=39,39,39) | 7.769 | Standard Deviation 4.306 | immunosuppressive medication score |
| Change From Baseline for Composite Immunosuppressive Medication Score at Week 24 by Treatment (Full Analysis Set) | AIN457C 300 mg Monthly Dosage Regimen (a) | Baseline Score (n=39,39,39) | 10.11 | Standard Deviation 5.3236 | immunosuppressive medication score |
| Change From Baseline for Composite Immunosuppressive Medication Score at Week 24 by Treatment (Full Analysis Set) | Placebo to AIN457C | Baseline Score (n=39,39,39) | 9.231 | Standard Deviation 3.8064 | immunosuppressive medication score |
| Change From Baseline for Composite Immunosuppressive Medication Score at Week 24 by Treatment (Full Analysis Set) | AIN457C 300 mg Every 2 Week Dosage Regimen | Week 24 (n=34,32,34) | 7.441 | Standard Deviation 4.4641 | immunosuppressive medication score |
| Change From Baseline for Composite Immunosuppressive Medication Score at Week 24 by Treatment (Full Analysis Set) | AIN457C 300 mg Monthly Dosage Regimen (a) | Week 24 (n=34,32,34) | 10.09 | Standard Deviation 5.3331 | immunosuppressive medication score |
| Change From Baseline for Composite Immunosuppressive Medication Score at Week 24 by Treatment (Full Analysis Set) | Placebo to AIN457C | Week 24 (n=34,32,34) | 8.722 | Standard Deviation 3.2027 | immunosuppressive medication score |
| Change From Baseline for Composite Immunosuppressive Medication Score at Week 24 by Treatment (Full Analysis Set) | AIN457C 300 mg Every 2 Week Dosage Regimen | LOCF (n=39,39,39) | 7.769 | Standard Deviation 4.3036 | immunosuppressive medication score |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | AIN457C 300 mg Every 2 Week Dosage Regimen | 39 | |
| Overall Study | STARTED | AIN457C 300 mg Monthly Dosage Regimen | 40 | |
| Overall Study | STARTED | Placebo to AIN457C | 39 | |
| Overall Study | COMPLETED | AIN457C 300 mg Every 2 Week Dosage Regimen | 32 | |
| Overall Study | COMPLETED | AIN457C 300 mg Monthly Dosage Regimen | 31 | |
| Overall Study | COMPLETED | Placebo to AIN457C | 34 | |
| Overall Study | NOT COMPLETED | AIN457C 300 mg Every 2 Week Dosage Regimen | 7 | |
| Overall Study | NOT COMPLETED | AIN457C 300 mg Monthly Dosage Regimen | 9 | |
| Overall Study | NOT COMPLETED | Placebo to AIN457C | 5 |
Source ClinicalTrials.gov
Adverse events207
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Cataract subcapsular (Fellow eye) | Eye disorders | AIN457 300mg Every 2 Weeks | 3 | 39 | |
| other | Cataract subcapsular (Fellow eye) | Eye disorders | AIN457 300mg Monthly | 1 | 39 | |
| other | Cataract subcapsular (Fellow eye) | Eye disorders | Placebo | 0 | 39 | |
| other | Cataract subcapsular (Study eye) | Eye disorders | AIN457 300mg Every 2 Weeks | 4 | 39 | |
| other | Cataract subcapsular (Study eye) | Eye disorders | AIN457 300mg Monthly | 1 | 39 | |
| other | Cataract subcapsular (Study eye) | Eye disorders | Placebo | 0 | 39 | |
| other | Eye pain (Study eye) | Eye disorders | AIN457 300mg Every 2 Weeks | 1 | 39 | |
| other | Eye pain (Study eye) | Eye disorders | AIN457 300mg Monthly | 2 | 39 | |
| other | Eye pain (Study eye) | Eye disorders | Placebo | 2 | 39 | |
| other | Retinal vasculitis (Study eye) | Eye disorders | AIN457 300mg Every 2 Weeks | 2 | 39 |
1 to 10 of 207Source ClinicalTrials.gov
See all 207 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | AIN457 300mg Every 2 Weeks | ||
| Total, all-cause mortality | AIN457 300mg Monthly | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | AIN457 300mg Every 2 Weeks | 28 | 39 |
| Total, other adverse events | AIN457 300mg Monthly | 25 | 39 |
| Total, other adverse events | Placebo | 22 | 39 |
| Total, serious adverse events | AIN457 300mg Every 2 Weeks | 6 | 39 |
| Total, serious adverse events | AIN457 300mg Monthly | 8 | 39 |
| Total, serious adverse events | Placebo | 5 | 39 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23290985 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00995709
GET https://conductscience.org/api/trials/v1/NCT00995709/results?page=2