ENDURE: Safety and Efficacy of AIN457 in Patients With Quiescent Non-infectious Uveitis

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Terminated

CT.gov ID

NCT01090310

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

2.5

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This extension study will assess the safety and efficacy of AIN457 versus placebo for maintaining uveitis suppression when reducing systemic immunosuppression

Condition or Disease	Intervention/Treatment	Phase
Non-infectious Uveitis	Drug: AIN457 Drug: Placebo	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

86 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A 38-week Extension to a 24-week Multicenter, Randomized, Double-masked, Placebo Controlled, Dose-ranging Phase III Study of AIN457 Versus Placebo for Maintaining Uveitis Suppression When Reducing Systemic Immunosuppression in Patients With Quiescent, Non-infectious Intermediate, Posterior or Panuveitis

Study Start Date :

Aug 1, 2010

Actual Primary Completion Date :

Jul 1, 2011

Actual Study Completion Date :

Jul 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AIN457 300mg every 2 weeks AIN457 300 mg subcutaneous (s.c.) weekly for 3 weeks followed by AIN457 300 mg s.c. every 2 weeks	Drug: AIN457 AIN457 150 mg powder for solution was provided in glass vials each containing 150 mg AIN457 as a lyophilized cake
Experimental: AIN457 300 mg every 4 weeks AIN457 300 mg s.c. at baseline for Week 2 followed by AIN457 300 mg s.c. monthly, alternating with placebo s.c. at Weeks 1 and 4 and then monthly	Drug: AIN457 AIN457 150 mg powder for solution was provided in glass vials each containing 150 mg AIN457 as a lyophilized cake
Experimental: AIN457 150 mg every 4 weeks AIN457 150 mg s.c. and placebo s.c. at Baseline and Week 2 followed by AIN457 150 mg s.c. monthly, alternating with placebo s.c. at Weeks 1 and 4 and then monthly	Drug: AIN457 AIN457 150 mg powder for solution was provided in glass vials each containing 150 mg AIN457 as a lyophilized cake
Placebo Comparator: Placebo Placebo s.c. every 2 weeks	Drug: Placebo Matching placebo to AIN457

Outcome Measures

Primary Outcome Measures

The Time to the First Recurrence in Any Eye of Active Intermediate, Posterior, or Panuveitis From Baseline [Baseline to 52 weeks]
Kaplan-Meier estimates for the time to the first recurrence in any eye of active intermediate, posterior, or panuveitis from baseline defined by either: ≥ 2 step increase in vitreous haze with or without an increase in anterior chamber cell grade or decrease in best corrected visual acuity, core and extension

Secondary Outcome Measures

Change in Vitreous Haze Score for the Study Eye From Baseline to the Highest Post-baseline Value [Baseline to 52 weeks]
The changes in steps (0, 1, or >= 2) from previous visit for vitreous haze, where the score is evaluated based on NEI Vitreous Haze Grading Scale (0 -4). Vitreous haze was recorded as 0-clear; to 4+ as dense opacity obscuring the optic nerve head. A 1 step increase is defined as any of the following changes: 0-1, 0.5-1, 1-2, 2-3, 3-4. A 2 step increase is defined as any of the following changes: 0-2, 0.5-2, 1-3, 2-4. A recurrent episode of active intermediate, posterior or panuveitis was considered to be resolved, if the eye returns and maintains in a quiescent state (<1+ anterior chamber cell grade and <1+ vitreous haze) for at least 2 weeks
Mean Change in Best Corrected Visual Acuity From Baseline, Core and Extension [Baseline to 52 weeks]
The Best Corrected Visual Acuity (BCVA) is tested using the Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity (VA) testing protocol. VA measurements are taken in a sitting position at an initial test distance of 4 meters using ETDRS charts. The overall BCVA score is calculated using the BCVA worksheet 0-100 letter score
Number of Participants With First Recurrence in in Any Eye of Active Intermediate, Posterior, or Panuveitis From Baseline During the Core and Extension Studies [Baseline to 52 weeks]
Evaluation of recurrence until resolution is ascertained, based on the first criteria (a >2 step increase in vitreous haze with or without an increase in anterior chamber cell grade in either eye). A 2 step increase is defined as any of the following changes: 0-2, 0.5-2, 1-3, 2-4
Composite Immunosuppressive Medication Score From Baseline to Week 52, Core and Extension [Baseline to 52 weeks]
IMS is a combined, single numeric score derived on the basis of the total daily dose of specific immunosuppressive agents per unit body weight, ranged on a scale from 0 to 9 for the total daily dose in milligrams per kilogram. The total IMS is the sum of the scores derived for the agents included into the score. The treatment groups will be compared using an analysis of covariance with treatment, region, and baseline IMS as covariate. The total IMS is the sum of scores derived from the agents included into the score, and ranged from 0 to 55. Treatment groups compared using analysis of covariance with treatment & baseline IMS as covariate, where the lower IMS showed better clinical outcome.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients who have completed the entire treatment period of the 24 week core study

Exclusion Criteria:

Inability or unwillingness to undergo repeated subcutaneous injections; inability to comply with study or follow-up procedures; any medical or psychiatric condition which, in the investigator's opinion wouldpreclude the participant from adhering to the protocol or completing the study per protocol.

Other protocol-defined inclusion/exclusion criteria may apply.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novartis Investigative Site	Beverly Hills	California	United States	90211
2	Novartis Investigative Site	Atlanta	Georgia	United States	30322
3	Novartis Investigative Site	Louisville	Kentucky	United States	40202
4	Novartis Investigative Site	Baltimore	Maryland	United States	21205-2005
5	Novartis Investigative Site	Cambridge	Massachusetts	United States	02142
6	Novartis Investigative Site	Teaneck	New Jersey	United States	07666
7	Novartis Investigative Site	Charlotte	North Carolina	United States	28210
8	Novartis Investigative Site	Portland	Oregon	United States	97239
9	Novartis Investigative Site	Arlington	Texas	United States	76012
10	Novartis Investigative Site	Houston	Texas	United States	77025
11	Novartis Investigative Site	Sao Paulo	SP	Brazil	05403-000
12	Novartis Investigative Site	São Paulo	SP	Brazil	04023-900
13	Novartis Investigative Site	Berlin		Germany	13353
14	Novartis Investigative Site	Kiel		Germany	24105
15	Novartis Investigative Site	Tübingen		Germany	72076
16	Novartis Investigative Site	New Delhi		India	110 029
17	Novartis Investigative Site	Jerusalem		Israel	9112001
18	Novartis Investigative Site	Petach Tikva		Israel	49100
19	Novartis Investigative Site	Ramat Gan		Israel	5266202
20	Novartis Investigative Site	Tel-Aviv		Israel	6423906
21	Novartis Investigative Site	Barcelona	Catalunya	Spain	08035
22	Novartis Investigative Site	Barcelona	Catalunya	Spain	08036
23	Novartis Investigative Site	Santiago de Compostela	Galicia	Spain	15705
24	Novartis Investigative Site	Madrid		Spain	28040
25	Novartis Investigative Site	Lausanne	CHE	Switzerland	1004
26	Novartis Investigative Site	Bern		Switzerland	3010
27	Novartis Investigative Site	Bern		Switzerland	3012
28	Novartis Investigative Site	Lausanne		Switzerland	1003
29	Novartis Investigative Site	Luzern		Switzerland	6000
30	Novartis Investigative Site	St. Gallen		Switzerland	9007
31	Novartis Investigative Site	Zuerich		Switzerland	8063
32	Novartis Investigative Site	Birmingham		United Kingdom	B18 7QU
33	Novartis Investigative Site	Liverpool		United Kingdom	L7 8XP
34	Novartis Investigative Site	London		United Kingdom	SE1 7EH
35	Novartis Investigative Site	York		United Kingdom	YO31 8HE

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Novartis Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT01090310

Other Study ID Numbers:

CAIN457C2301E1
2009-015508-24

First Posted:

Mar 19, 2010

Last Update Posted:

Jan 14, 2016

Last Verified:

Dec 1, 2015

Keywords provided by Novartis Pharmaceuticals

NVS Definition: Words or phrases that best describe the protocol. Keywords help users find studies in the database.

Avoid acronyms, abbreviations and trade names.

Examples: Heart failure, aliskiren, heart attack, cardiovascular diseases

Psoriasis, inflammatory skin disease, scaly patches

Additional relevant MeSH terms:

Uveitis

Study Results

Participant Flow

Recruitment Details	Between August 2010 and March 2011, 70 patients were enrolled from 51 centers in 9 countries (United States, Germany, Switzerland, India, Spain, United Kingdom, Israel, Brazil, Italy). Recruitment was stopped due to study termination, therefore 16 out of 86 patients signed informed consent while being in core study were not enrolled into extension
Pre-assignment Detail	In total, 125 patients were randomized to the core study with 1 patient misrandomized. Of these 124 patients 70 patients entered the extension period of the study. Core study NCT01032915

Arm/Group Title	AIN457 300mg Every 2 Weeks	AIN457 300 mg Every 4 Weeks	AIN457 150 mg Every 4 Weeks	Placebo
Arm/Group Description	AIN457 300 mg s.c. every 2 weeks	AIN457 300 mg s.c. monthly, alternating with placebo s.c. at Weeks 1 and 4 and then monthly	AIN457 150 mg s.c. monthly, alternating with placebo s.c. at Weeks 1 and 4 and then monthly	Placebo s.c. every 2 weeks
Period Title: Core Study
STARTED	29	31	31	34
COMPLETED	21	20	24	27
NOT COMPLETED	8	11	7	7
Period Title: Core Study
STARTED	17	16	16	21
COMPLETED	3	0	1	1
NOT COMPLETED	14	16	15	20

Baseline Characteristics

Arm/Group Title	AIN457 300mg Every 2 Weeks	AIN457 300 mg Every 4 Weeks	AIN457 150 mg Every 4 Weeks	Placebo	Total
Arm/Group Description	AIN457 300 mg s.c. every 2 weeks	AIN457 300 mg s.c. monthly, alternating with placebo s.c. at Weeks 1 and 4 and then monthly	AIN457 150 mg s.c. monthly, alternating with placebo s.c. at Weeks 1 and 4 and then monthly	Placebo s.c. every 2 weeks	Total of all reporting groups
Overall Participants	29	31	31	34	125
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	46.2 (14.29)	49.2 (11.14)	47.7 (13.50)	47.3 (15.46)	47.6 (13.60)
Sex: Female, Male (Count of Participants)
Female	17 58.6%	16 51.6%	20 64.5%	18 52.9%	71 56.8%
Male	12 41.4%	15 48.4%	11 35.5%	16 47.1%	54 43.2%

Outcome Measures

1. Primary Outcome

Title	The Time to the First Recurrence in Any Eye of Active Intermediate, Posterior, or Panuveitis From Baseline
Description	Kaplan-Meier estimates for the time to the first recurrence in any eye of active intermediate, posterior, or panuveitis from baseline defined by either: ≥ 2 step increase in vitreous haze with or without an increase in anterior chamber cell grade or decrease in best corrected visual acuity, core and extension
Time Frame	Baseline to 52 weeks

Outcome Measure Data

Analysis Population Description
Full analysis set (FAS): all randomized patients who received at least one dose of study drug in the core study and had at least one post-baseline assessment for the primary efficacy parameter or any of its components. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization

Arm/Group Title	AIN457 300mg Every 2 Weeks	AIN457 300 mg Every 4 Weeks	AIN457 150 mg Every 4 Weeks	Placebo
Arm/Group Description	AIN457 300 mg s.c. every 2 weeks	AIN457 300 mg s.c. monthly, alternating with placebo s.c. at Weeks 1 and 4 and then monthly	AIN457 150 mg s.c. monthly, alternating with placebo s.c. at Weeks 1 and 4 and then monthly	Placebo s.c. every 2 weeks
Measure Participants	29	31	31	33
Median (95% Confidence Interval) [Days]	NA	NA	NA	NA

2. Secondary Outcome

Title	Change in Vitreous Haze Score for the Study Eye From Baseline to the Highest Post-baseline Value
Description	The changes in steps (0, 1, or >= 2) from previous visit for vitreous haze, where the score is evaluated based on NEI Vitreous Haze Grading Scale (0 -4). Vitreous haze was recorded as 0-clear; to 4+ as dense opacity obscuring the optic nerve head. A 1 step increase is defined as any of the following changes: 0-1, 0.5-1, 1-2, 2-3, 3-4. A 2 step increase is defined as any of the following changes: 0-2, 0.5-2, 1-3, 2-4. A recurrent episode of active intermediate, posterior or panuveitis was considered to be resolved, if the eye returns and maintains in a quiescent state (<1+ anterior chamber cell grade and <1+ vitreous haze) for at least 2 weeks
Time Frame	Baseline to 52 weeks

Outcome Measure Data

Analysis Population Description
Full analysis set (FAS): all randomized patients who received at least one dose of study drug in the core study and had at least one post-baseline assessment for the primary efficacy parameter or any of its components. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization

Arm/Group Title	AIN457 300mg Every 2 Weeks	AIN457 300 mg Every 4 Weeks	AIN457 150 mg Every 4 Weeks	Placebo
Arm/Group Description	AIN457 300 mg s.c. every 2 weeks	AIN457 300 mg s.c. monthly, alternating with placebo s.c. at Weeks 1 and 4 and then monthly	AIN457 150 mg s.c. monthly, alternating with placebo s.c. at Weeks 1 and 4 and then monthly	Placebo s.c. every 2 weeks
Measure Participants	29	31	31	33
2 or more steps increase	4 13.8%	2 6.5%	1 3.2%	2 5.9%
1 step increase	4 13.8%	8 25.8%	7 22.6%	11 32.4%
No changes	21 72.4%	21 67.7%	23 74.2%	20 58.8%
1 step decrease	0 0%	0 0%	0 0%	0 0%
2 or more steps decrease	0 0%	0 0%	0 0%	0 0%

3. Secondary Outcome

Title	Mean Change in Best Corrected Visual Acuity From Baseline, Core and Extension
Description	The Best Corrected Visual Acuity (BCVA) is tested using the Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity (VA) testing protocol. VA measurements are taken in a sitting position at an initial test distance of 4 meters using ETDRS charts. The overall BCVA score is calculated using the BCVA worksheet 0-100 letter score
Time Frame	Baseline to 52 weeks

Outcome Measure Data

Analysis Population Description
Full analysis set (FAS): all randomized patients who received at least one dose of study drug in the core study and had at least one post-baseline assessment for the primary efficacy parameter or any of its components. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization

Arm/Group Title	AIN457 300mg Every 2 Weeks	AIN457 300 mg Every 4 Weeks	AIN457 150 mg Every 4 Weeks	Placebo
Arm/Group Description	AIN457 300 mg s.c. every 2 weeks	AIN457 300 mg s.c. monthly, alternating with placebo s.c. at Weeks 1 and 4 and then monthly	AIN457 150 mg s.c. monthly, alternating with placebo s.c. at Weeks 1 and 4 and then monthly	Placebo s.c. every 2 weeks
Measure Participants	3	0	1	1
Mean (Standard Deviation) [Letters]	9 (4.36)	16 (NA)	5 (NA)

4. Secondary Outcome

Title	Number of Participants With First Recurrence in in Any Eye of Active Intermediate, Posterior, or Panuveitis From Baseline During the Core and Extension Studies
Description	Evaluation of recurrence until resolution is ascertained, based on the first criteria (a >2 step increase in vitreous haze with or without an increase in anterior chamber cell grade in either eye). A 2 step increase is defined as any of the following changes: 0-2, 0.5-2, 1-3, 2-4
Time Frame	Baseline to 52 weeks

Outcome Measure Data

Analysis Population Description
Full analysis set (FAS): all randomized patients who received at least one dose of study drug in the core study and had at least one post-baseline assessment for the primary efficacy parameter or any of its components. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization

Arm/Group Title	AIN457 300mg Every 2 Weeks	AIN457 300 mg Every 4 Weeks	AIN457 150 mg Every 4 Weeks	Placebo
Arm/Group Description	AIN457 300 mg s.c. every 2 weeks	AIN457 300 mg s.c. monthly, alternating with placebo s.c. at Weeks 1 and 4 and then monthly	AIN457 150 mg s.c. monthly, alternating with placebo s.c. at Weeks 1 and 4 and then monthly	Placebo s.c. every 2 weeks
Measure Participants	29	31	31	33
Patients with recurrence	8 27.6%	11 35.5%	10 32.3%	11 32.4%
Patients with only vitreous haze criterion	2 6.9%	3 9.7%	4 12.9%	2 5.9%
Patients with only visual acuity criterion	5 17.2%	8 25.8%	6 19.4%	9 26.5%
Both criteria at the same time	1 3.4%	0 0%	0 0%	0 0%

5. Secondary Outcome

Title	Composite Immunosuppressive Medication Score From Baseline to Week 52, Core and Extension
Description	IMS is a combined, single numeric score derived on the basis of the total daily dose of specific immunosuppressive agents per unit body weight, ranged on a scale from 0 to 9 for the total daily dose in milligrams per kilogram. The total IMS is the sum of the scores derived for the agents included into the score. The treatment groups will be compared using an analysis of covariance with treatment, region, and baseline IMS as covariate. The total IMS is the sum of scores derived from the agents included into the score, and ranged from 0 to 55. Treatment groups compared using analysis of covariance with treatment & baseline IMS as covariate, where the lower IMS showed better clinical outcome.
Time Frame	Baseline to 52 weeks

Outcome Measure Data

Analysis Population Description
Full analysis set (FAS): all randomized patients who received at least one dose of study drug in the core study and had at least one post-baseline assessment for the primary efficacy parameter or any of its components. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization

Arm/Group Title	AIN457 300mg Every 2 Weeks	AIN457 300 mg Every 4 Weeks	AIN457 150 mg Every 4 Weeks	Placebo
Arm/Group Description	AIN457 300 mg s.c. every 2 weeks	AIN457 300 mg s.c. monthly, alternating with placebo s.c. at Weeks 1 and 4 and then monthly	AIN457 150 mg s.c. monthly, alternating with placebo s.c. at Weeks 1 and 4 and then monthly	Placebo s.c. every 2 weeks
Measure Participants	3	0	1	1
Mean (Standard Deviation) [Units on a scale]	-5.67 (4.163)	-1 (NA)	-1 (NA)

Adverse Events

	AIN457 300mg Every 2 Weeks		AIN457 300mg Every 4 Weeks		AIN457 150mg Every 4 Weeks		Placebo Every 2 Weeks
Time Frame
Adverse Event Reporting Description

Arm/Group Title	AIN457 300mg Every 2 Weeks		AIN457 300mg Every 4 Weeks		AIN457 150mg Every 4 Weeks		Placebo Every 2 Weeks
Arm/Group Description	AIN457 300mg every 2 weeks		AIN457 300mg every 4 weeks		AIN457 150mg every 4 weeks		Placebo every 2 weeks
All Cause Mortality
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	AIN457 300mg Every 2 Weeks		AIN457 300mg Every 4 Weeks		AIN457 150mg Every 4 Weeks		Placebo Every 2 Weeks
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/29 (13.8%)		1/31 (3.2%)		1/31 (3.2%)		2/33 (6.1%)
Eye disorders
Uveitis (Fellow eye)	0/29 (0%)		0/31 (0%)		1/31 (3.2%)		0/33 (0%)
Uveitis (Study eye)	1/29 (3.4%)		0/31 (0%)		1/31 (3.2%)		0/33 (0%)
Immune system disorders
Sarcoidosis	0/29 (0%)		0/31 (0%)		0/31 (0%)		1/33 (3%)
Infections and infestations
Lower respiratory tract infection	1/29 (3.4%)		0/31 (0%)		0/31 (0%)		0/33 (0%)
Injury, poisoning and procedural complications
Joint dislocation	1/29 (3.4%)		0/31 (0%)		0/31 (0%)		0/33 (0%)
Metabolism and nutrition disorders
Diabetes mellitus	0/29 (0%)		0/31 (0%)		0/31 (0%)		1/33 (3%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease	0/29 (0%)		0/31 (0%)		0/31 (0%)		1/33 (3%)
Breast cancer	1/29 (3.4%)		0/31 (0%)		0/31 (0%)		0/33 (0%)
Seborrhoeic keratosis	0/29 (0%)		0/31 (0%)		0/31 (0%)		1/33 (3%)
Nervous system disorders
Mononeuropathy multiplex	0/29 (0%)		1/31 (3.2%)		0/31 (0%)		0/33 (0%)
Skin and subcutaneous tissue disorders
Dermal cyst	0/29 (0%)		0/31 (0%)		0/31 (0%)		1/33 (3%)
Lentigo	0/29 (0%)		0/31 (0%)		0/31 (0%)		1/33 (3%)
Other (Not Including Serious) Adverse Events
	AIN457 300mg Every 2 Weeks		AIN457 300mg Every 4 Weeks		AIN457 150mg Every 4 Weeks		Placebo Every 2 Weeks
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	20/29 (69%)		19/31 (61.3%)		22/31 (71%)		22/33 (66.7%)
Eye disorders
Cataract subcapsular (Study eye)	1/29 (3.4%)		0/31 (0%)		2/31 (6.5%)		1/33 (3%)
Conjunctivitis (Fellow eye)	0/29 (0%)		1/31 (3.2%)		2/31 (6.5%)		0/33 (0%)
Cystoid macular oedema (Study eye)	0/29 (0%)		2/31 (6.5%)		0/31 (0%)		0/33 (0%)
Dry eye (Fellow eye)	1/29 (3.4%)		2/31 (6.5%)		1/31 (3.2%)		0/33 (0%)
Dry eye (Study eye)	1/29 (3.4%)		2/31 (6.5%)		1/31 (3.2%)		0/33 (0%)
Macular oedema (Fellow eye)	1/29 (3.4%)		0/31 (0%)		1/31 (3.2%)		3/33 (9.1%)
Macular oedema (Study eye)	1/29 (3.4%)		1/31 (3.2%)		0/31 (0%)		2/33 (6.1%)
Vision blurred (Fellow eye)	2/29 (6.9%)		1/31 (3.2%)		1/31 (3.2%)		2/33 (6.1%)
Vision blurred (Study eye)	2/29 (6.9%)		0/31 (0%)		1/31 (3.2%)		2/33 (6.1%)
Visual acuity reduced (Fellow eye)	2/29 (6.9%)		1/31 (3.2%)		1/31 (3.2%)		0/33 (0%)
Visual impairment (Study eye)	0/29 (0%)		0/31 (0%)		0/31 (0%)		2/33 (6.1%)
Vitreous floaters (Fellow eye)	1/29 (3.4%)		1/31 (3.2%)		1/31 (3.2%)		2/33 (6.1%)
Vitreous floaters (Study eye)	0/29 (0%)		2/31 (6.5%)		1/31 (3.2%)		2/33 (6.1%)
Gastrointestinal disorders
Abdominal pain	2/29 (6.9%)		0/31 (0%)		0/31 (0%)		0/33 (0%)
Abdominal pain upper	0/29 (0%)		0/31 (0%)		1/31 (3.2%)		2/33 (6.1%)
Diarrhoea	2/29 (6.9%)		2/31 (6.5%)		1/31 (3.2%)		1/33 (3%)
Dyspepsia	0/29 (0%)		1/31 (3.2%)		0/31 (0%)		2/33 (6.1%)
Nausea	0/29 (0%)		2/31 (6.5%)		2/31 (6.5%)		4/33 (12.1%)
General disorders
Asthenia	0/29 (0%)		0/31 (0%)		2/31 (6.5%)		1/33 (3%)
Malaise	0/29 (0%)		0/31 (0%)		2/31 (6.5%)		0/33 (0%)
Infections and infestations
Ear infection	2/29 (6.9%)		2/31 (6.5%)		1/31 (3.2%)		1/33 (3%)
Hordeolum	0/29 (0%)		0/31 (0%)		2/31 (6.5%)		0/33 (0%)
Influenza	3/29 (10.3%)		3/31 (9.7%)		2/31 (6.5%)		0/33 (0%)
Nasopharyngitis	6/29 (20.7%)		4/31 (12.9%)		4/31 (12.9%)		5/33 (15.2%)
Oral herpes	0/29 (0%)		2/31 (6.5%)		0/31 (0%)		0/33 (0%)
Sinusitis	0/29 (0%)		1/31 (3.2%)		2/31 (6.5%)		1/33 (3%)
Upper respiratory tract infection	2/29 (6.9%)		1/31 (3.2%)		1/31 (3.2%)		0/33 (0%)
Urinary tract infection	1/29 (3.4%)		2/31 (6.5%)		1/31 (3.2%)		1/33 (3%)
Injury, poisoning and procedural complications
Contusion	1/29 (3.4%)		2/31 (6.5%)		0/31 (0%)		1/33 (3%)
Investigations
Intraocular pressure increased (Fellow eye)	2/29 (6.9%)		0/31 (0%)		1/31 (3.2%)		0/33 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia	0/29 (0%)		4/31 (12.9%)		3/31 (9.7%)		2/33 (6.1%)
Back pain	2/29 (6.9%)		0/31 (0%)		0/31 (0%)		0/33 (0%)
Musculoskeletal pain	0/29 (0%)		0/31 (0%)		0/31 (0%)		2/33 (6.1%)
Musculoskeletal stiffness	0/29 (0%)		2/31 (6.5%)		0/31 (0%)		0/33 (0%)
Myalgia	1/29 (3.4%)		2/31 (6.5%)		0/31 (0%)		1/33 (3%)
Pain in extremity	0/29 (0%)		1/31 (3.2%)		4/31 (12.9%)		0/33 (0%)
Nervous system disorders
Dizziness	0/29 (0%)		3/31 (9.7%)		1/31 (3.2%)		4/33 (12.1%)
Headache	6/29 (20.7%)		4/31 (12.9%)		2/31 (6.5%)		0/33 (0%)
Migraine	0/29 (0%)		1/31 (3.2%)		0/31 (0%)		2/33 (6.1%)
Psychiatric disorders
Anxiety	0/29 (0%)		0/31 (0%)		2/31 (6.5%)		0/33 (0%)
Respiratory, thoracic and mediastinal disorders
Cough	1/29 (3.4%)		0/31 (0%)		3/31 (9.7%)		2/33 (6.1%)
Oropharyngeal pain	2/29 (6.9%)		3/31 (9.7%)		1/31 (3.2%)		2/33 (6.1%)
Skin and subcutaneous tissue disorders
Alopecia	0/29 (0%)		0/31 (0%)		1/31 (3.2%)		2/33 (6.1%)
Pruritus	0/29 (0%)		3/31 (9.7%)		0/31 (0%)		0/33 (0%)
Rash	0/29 (0%)		0/31 (0%)		2/31 (6.5%)		0/33 (0%)
Rash erythematous	0/29 (0%)		2/31 (6.5%)		0/31 (0%)		0/33 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety

Results Point of Contact

Name/Title	Study Director
Organization	Novartis
Phone	862-778-8300
Email

Responsible Party:

Novartis Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT01090310

Other Study ID Numbers:

CAIN457C2301E1
2009-015508-24

First Posted:

Mar 19, 2010

Last Update Posted:

Jan 14, 2016

Last Verified:

Dec 1, 2015

ENDURE: Safety and Efficacy of AIN457 in Patients With Quiescent Non-infectious Uveitis

Study Details

Study Description

Brief Summary

Study Design

Arms and Interventions

Outcome Measures

Primary Outcome Measures

Secondary Outcome Measures

Eligibility Criteria

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Locations

Sponsors and Collaborators

Investigators

Study Documents (Full-Text)

More Information

Publications

Study Results

Participant Flow

Baseline Characteristics

Outcome Measures

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Adverse Events

All Cause Mortality

Serious Adverse Events

Other (Not Including Serious) Adverse Events

Limitations/Caveats

More Information

Certain Agreements

Results Point of Contact