Trial · NCT01093846
38 Week Extension Study to CAIN457C2303
NCT01093846, Phase 3, Terminated, Novartis Pharmaceuticals; results first posted 2016-02-22
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. 38 Week Extension Study to CAIN457C2303. Trials, record NCT01093846. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01093846
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 38 Week Extension Study to CAIN457C2303
- NCT number
- NCT01093846
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 59 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Uveitis
- Interventions
- AIN457, AIN457, Placebo AIN457
- First posted
- 2010-03-26
- Last updated
- 2016-02-22
- Results first posted
- 2016-02-22
- Limitations and caveats
Due to early termination of the study AIN457C2303E1, the analysis of extension period was changed. No efficacy analyses were completed, the safety analyses were reduced to summary of AEs occurred during the extension and safety follow-up periods.
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Effect of Continuous Treatment With Subcutaneous AIN457 Compared to Placebo in Reducing the Rate of Recurrent Ocular Exacerbations in Behçet's Patients With Intermediate Uveitis, Posterior Uveitis or Panuveitis in Group 1. | 62 weeks | The primary objective of the study was to determine the effect of continuous treatment with subcutaneous AIN457 compared to placebo in reducing the rate of recurrent ocular exacerbations in Behçet's patients with intermediate uveitis, posterior uveitis or panuveitis in patients who completed the core study and continued treatment in the extension study (Group 1).Due to early termination of the study AIN457C2303E1, the analysis of extension period was changed. No efficacy analyses were completed, the safety analyses are available in the summary of AEs which occurred during the extension and safety follow-up periods and are shown in the safety section . |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Effect of Continuous Treatment With Subcutaneous AIN457 Compared to Placebo in Reducing the Rate of Recurrent Ocular Exacerbations in Behçet's Patients With Intermediate Uveitis, Posterior Uveitis or Panuveitis in Group 1. | 62 weeks |
Source ClinicalTrials.gov
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | AIN457 300 mg Every 2 Weeks | 19 | |
| Overall Study | STARTED | AIN457 300 mg Monthly | 18 | |
| Overall Study | STARTED | AIN457 Placebo | 22 | |
| Overall Study | COMPLETED | AIN457 300 mg Every 2 Weeks | 0 | |
| Overall Study | COMPLETED | AIN457 300 mg Monthly | 0 | |
| Overall Study | COMPLETED | AIN457 Placebo | 1 | |
| Overall Study | NOT COMPLETED | AIN457 300 mg Every 2 Weeks | 19 | |
| Overall Study | NOT COMPLETED | AIN457 300 mg Monthly | 18 | |
| Overall Study | NOT COMPLETED | AIN457 Placebo | 21 |
Source ClinicalTrials.gov
Adverse events234
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 | 4 | 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 | 1 | 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 234Source ClinicalTrials.gov
See all 234 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 | 27 | 39 |
| Total, other adverse events | Placebo | 25 | 39 |
| Total, serious adverse events | AIN457 300mg Every 2 Weeks | 7 | 39 |
| Total, serious adverse events | AIN457 300mg Monthly | 8 | 39 |
| Total, serious adverse events | Placebo | 5 | 39 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT01093846
GET https://conductscience.org/api/trials/v1/NCT01093846/events?page=2