38 Week Extension Study to CAIN457C2303 | NCT01093846

ID	Type	Description	Link
2009-013901-33

Status Module

Label	Type	Intervention Names
AIN457 300 mg every 2 weeks	Experimental	Drug: AIN457
AIN457 300 mg monthly	Experimental	Drug: AIN457
Placebo	Placebo Comparator	Drug: Placebo AIN457

Name	Type	Description	Arm Group Labels	Other Names
AIN457	Drug	300mg every 4 weeks	AIN457 300 mg monthly
AIN457

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	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 .	62 weeks

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Investigative Site		Baltimore	Maryland	21205-2005	United States
Novartis Investigative Site

ID	Title	Description
FG000	AIN457 300 mg Every 2 Weeks	300 mg every two weeks
FG001	AIN457 300 mg Monthly	300 mg monthly

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

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.

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 .

Posted

62 weeks

ID	Title	Description
OG000	Early Termination

Units	Counts
Participants	OG0000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Supraventricular tachycardia	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected39 at risk EG0010 affected39 at risk EG0020 affected39 at risk
Vertigo	Ear and labyrinth disorders	MedDRA	Systematic Assessment	EG0000 affected39 at risk EG0011 affected39 at risk EG0020 affected39 at risk
Cataract cortical (Fellow eye)	Eye disorders	MedDRA	Systematic Assessment	EG0000 affected39 at risk EG0010 affected39 at risk EG0021 affected39 at risk
Cataract nuclear (Fellow eye)	Eye disorders	MedDRA	Systematic Assessment	EG0000 affected39 at risk EG0010 affected39 at risk EG0021 affected39 at risk
Cataract subcapsular (Fellow eye)	Eye disorders	MedDRA	Systematic Assessment	EG0000 affected39 at risk EG0010 affected39 at risk EG0021 affected39 at risk
Choroiditis (Fellow eye)	Eye disorders	MedDRA	Systematic Assessment	EG0001 affected39 at risk EG0010 affected39 at risk EG0020 affected39 at risk
Glaucoma (Fellow eye)	Eye disorders	MedDRA	Systematic Assessment	EG0000 affected39 at risk EG0010 affected39 at risk EG0021 affected39 at risk
Retinal infiltrates (Fellow eye)	Eye disorders	MedDRA	Systematic Assessment	EG0001 affected39 at risk EG0010 affected39 at risk EG0020 affected39 at risk
Retinal infiltrates (Study eye)	Eye disorders	MedDRA	Systematic Assessment	EG0001 affected39 at risk EG0010 affected39 at risk EG0020 affected39 at risk
Uveitis (Fellow eye)	Eye disorders	MedDRA	Systematic Assessment	EG0001 affected39 at risk EG0011 affected39 at risk EG0020 affected39 at risk
Uveitis (Study eye)	Eye disorders	MedDRA	Systematic Assessment	EG0000 affected39 at risk EG0011 affected39 at risk EG0021 affected39 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected39 at risk EG0011 affected39 at risk EG0020 affected39 at risk
Aphthous stomatitis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected39 at risk EG0011 affected39 at risk EG0020 affected39 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected39 at risk EG0011 affected39 at risk EG0020 affected39 at risk
Diarrhoea haemorrhagic	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected39 at risk EG0010 affected39 at risk EG0021 affected39 at risk
Enteritis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected39 at risk EG0011 affected39 at risk EG0020 affected39 at risk
Haematemesis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected39 at risk EG0011 affected39 at risk EG0020 affected39 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected39 at risk EG0011 affected39 at risk EG0020 affected39 at risk
Fatigue	General disorders	MedDRA	Systematic Assessment	EG0001 affected39 at risk EG0010 affected39 at risk EG0020 affected39 at risk
Behcet's syndrome	Immune system disorders	MedDRA	Systematic Assessment	EG0000 affected39 at risk EG0011 affected39 at risk EG0020 affected39 at risk
Behcet's syndrome (Fellow eye)	Immune system disorders	MedDRA	Systematic Assessment	EG0000 affected39 at risk EG0011 affected39 at risk EG0020 affected39 at risk
Behcet's syndrome (Study eye)	Immune system disorders	MedDRA	Systematic Assessment	EG0000 affected39 at risk EG0011 affected39 at risk EG0020 affected39 at risk
Folliculitis	Infections and infestations	MedDRA	Systematic Assessment	EG0002 affected39 at risk EG0010 affected39 at risk EG0020 affected39 at risk
Hypopyon (Fellow eye)	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected39 at risk EG0010 affected39 at risk EG0020 affected39 at risk
Urinary tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected39 at risk EG0010 affected39 at risk EG0020 affected39 at risk
Fall	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected39 at risk EG0010 affected39 at risk EG0020 affected39 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected39 at risk EG0010 affected39 at risk EG0020 affected39 at risk
Intraocular pressure increased (Fellow eye)	Investigations	MedDRA	Systematic Assessment	EG0000 affected39 at risk EG0010 affected39 at risk EG0021 affected39 at risk
Weight decreased	Investigations	MedDRA	Systematic Assessment	EG0001 affected39 at risk EG0010 affected39 at risk EG0020 affected39 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 affected39 at risk EG0011 affected39 at risk EG0020 affected39 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected39 at risk EG0011 affected39 at risk EG0020 affected39 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 affected39 at risk EG0010 affected39 at risk EG0020 affected39 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected39 at risk EG0011 affected39 at risk EG0020 affected39 at risk
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0000 affected39 at risk EG0011 affected39 at risk EG0020 affected39 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Cataract subcapsular (Fellow eye)	Eye disorders	MedDRA	Systematic Assessment	EG0004 affected39 at risk EG0011 affected39 at risk EG0020 affected39 at risk
Cataract subcapsular (Study eye)	Eye disorders	MedDRA	Systematic Assessment	EG0004 affected39 at risk EG0011 affected39 at risk EG0021 affected39 at risk
Eye pain (Study eye)	Eye disorders	MedDRA	Systematic Assessment	EG0001 affected39 at risk EG0012 affected39 at risk EG0022 affected39 at risk
Retinal vasculitis (Study eye)	Eye disorders	MedDRA	Systematic Assessment	EG0002 affected39 at risk EG0010 affected39 at risk EG0021 affected39 at risk
Vision blurred (Fellow eye)	Eye disorders	MedDRA	Systematic Assessment	EG0000 affected39 at risk EG0016 affected39 at risk EG0021 affected39 at risk
Vision blurred (Study eye)	Eye disorders	MedDRA	Systematic Assessment	EG0000 affected39 at risk EG0012 affected39 at risk EG0023 affected39 at risk
Visual acuity reduced (Study eye)	Eye disorders	MedDRA	Systematic Assessment	EG0004 affected39 at risk EG0012 affected39 at risk EG0021 affected39 at risk
Vitreous floaters (Study eye)	Eye disorders	MedDRA	Systematic Assessment	EG0001 affected39 at risk EG0010 affected39 at risk EG0022 affected39 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected39 at risk EG0010 affected39 at risk EG0022 affected39 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0003 affected39 at risk EG0013 affected39 at risk EG0021 affected39 at risk
Aphthous stomatitis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0003 affected39 at risk EG0012 affected39 at risk EG0022 affected39 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 affected39 at risk EG0013 affected39 at risk EG0022 affected39 at risk
Mouth ulceration	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected39 at risk EG0010 affected39 at risk EG0022 affected39 at risk
Nausea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0004 affected39 at risk EG0013 affected39 at risk EG0022 affected39 at risk
Toothache	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 affected39 at risk EG0011 affected39 at risk EG0020 affected39 at risk
Vomiting	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 affected39 at risk EG0010 affected39 at risk EG0023 affected39 at risk
Fatigue	General disorders	MedDRA	Systematic Assessment	EG0002 affected39 at risk EG0012 affected39 at risk EG0024 affected39 at risk
Non-cardiac chest pain	General disorders	MedDRA	Systematic Assessment	EG0002 affected39 at risk EG0010 affected39 at risk EG0021 affected39 at risk
Oedema peripheral	General disorders	MedDRA	Systematic Assessment	EG0003 affected39 at risk EG0012 affected39 at risk EG0020 affected39 at risk
Pyrexia	General disorders	MedDRA	Systematic Assessment	EG0006 affected39 at risk EG0013 affected39 at risk EG0024 affected39 at risk
Conjunctivitis infective (Study eye)	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected39 at risk EG0012 affected39 at risk EG0021 affected39 at risk
Influenza	Infections and infestations	MedDRA	Systematic Assessment	EG0002 affected39 at risk EG0014 affected39 at risk EG0021 affected39 at risk
Nasopharyngitis	Infections and infestations	MedDRA	Systematic Assessment	EG0002 affected39 at risk EG0012 affected39 at risk EG0021 affected39 at risk
Oral herpes	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected39 at risk EG0010 affected39 at risk EG0022 affected39 at risk
Rash pustular	Infections and infestations	MedDRA	Systematic Assessment	EG0002 affected39 at risk EG0010 affected39 at risk EG0021 affected39 at risk
Sinusitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected39 at risk EG0012 affected39 at risk EG0021 affected39 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0003 affected39 at risk EG0015 affected39 at risk EG0021 affected39 at risk
Urinary tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected39 at risk EG0011 affected39 at risk EG0022 affected39 at risk
Alanine aminotransferase increased	Investigations	MedDRA	Systematic Assessment	EG0000 affected39 at risk EG0010 affected39 at risk EG0022 affected39 at risk
Blood glucose increased	Investigations	MedDRA	Systematic Assessment	EG0000 affected39 at risk EG0012 affected39 at risk EG0020 affected39 at risk
Intraocular pressure increased (Study eye)	Investigations	MedDRA	Systematic Assessment	EG0002 affected39 at risk EG0013 affected39 at risk EG0020 affected39 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0004 affected39 at risk EG0013 affected39 at risk EG0023 affected39 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0003 affected39 at risk EG0011 affected39 at risk EG0022 affected39 at risk
Dizziness	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected39 at risk EG0013 affected39 at risk EG0020 affected39 at risk
Headache	Nervous system disorders	MedDRA	Systematic Assessment	EG0009 affected39 at risk EG0017 affected39 at risk EG00210 affected39 at risk
Anxiety	Psychiatric disorders	MedDRA	Systematic Assessment	EG0000 affected39 at risk EG0013 affected39 at risk EG0020 affected39 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0002 affected39 at risk EG0010 affected39 at risk EG0020 affected39 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected39 at risk EG0012 affected39 at risk EG0022 affected39 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected39 at risk EG0011 affected39 at risk EG0022 affected39 at risk
Acne	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0001 affected39 at risk EG0010 affected39 at risk EG0022 affected39 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0001 affected39 at risk EG0011 affected39 at risk EG0022 affected39 at risk
Hirsutism	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0002 affected39 at risk EG0010 affected39 at risk EG0021 affected39 at risk
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0001 affected39 at risk EG0010 affected39 at risk EG0022 affected39 at risk
Hypertension	Vascular disorders	MedDRA	Systematic Assessment	EG0001 affected39 at risk EG0012 affected39 at risk EG0021 affected39 at risk

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	AIN457 300mg Every 2 Weeks	AIN457 300mg every 2 weeks. Safety is provided over the entire treatment period. This includes the core and extension period.	7	39	28	39
EG001	AIN457 300mg Monthly	AIN457 300mg monthly Safety is provided over the entire treatment period. This includes the core and extension period.	8	39	27	39
EG002	Placebo	Placebo Safety is provided over the entire treatment period. This includes the core and extension period.	5	39	25	39

ID	Term
D014603	Uveal Diseases
D005128	Eye Diseases

ID	Title	Description
BG000	AIN457 300 mg Every 2 Weeks	300 mg every two weeks
BG001	AIN457 300 mg Monthly	300 mg monthly
BG002	AIN457 Placebo
BG003	Total	Total of all reporting groups