Extension in AS: Sustainability of Benefits, Safety and T... | NCT01863732

NCT01863732

ID	Type	Description	Link
2013-001089-40	EudraCT Number

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Secukinumab (AIN457) 75mg Grp1	Experimental	Group 1: AIN457 75 mg plus placebo 150 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), only AIN457 75 mg was dosed. Secukinumab in PFS for s.c. self-administration Q4W	Biological: Secukinumab Other: Placebo (Pbo)
Secukinumab (AIN457) 75 to 150mg Grp1	Experimental	Group 1: AIN457 75 mg plus placebo 150 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), was up titrated to AIN457 150 mg only. Secukinumab in PFS for s.c. self-administration Q4W	Biological: Secukinumab Other: Placebo (Pbo)
Secukinumab (AIN457) 150mg Grp2	Experimental	Group 2: AIN457 150 mg plus placebo 75 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), only AIN457 150 mg was dosed. Secukinumab in PFS for s.c. self-administration Q4W	Biological: Secukinumab Other: Placebo (Pbo)
Pbo in Core then AIN457 75mg Grp1	Experimental	Participants were on Placebo (Pbo) in Core and then in extension randomized to Group 1: secukinumab (AIN457) 75 mg plus placebo 150 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), only AIN457 75 mg was dosed.Secukinumab in PFS for s.c. self-administration Q4W

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Secukinumab	Biological	Group 1: secukinumab 75 mg plus placebo 150 mg or Group 2 secukinumab 150 mg plus placebo 75m dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), only secukinumab 75 mg or 150 mg were dosed. Secukinumab in PFS for s.c. self-administration Q4W

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Assessment of Spondyloarthritis International Society Criteria (ASAS) 20 Response From Week 104 to Week 260	ASAS 20 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined time frame at least 20% improvement in score in at least 3 of a conventional set of 4 clinical domains relevant to AS and no worsening in the fourth domain. In this study, ASAS 20 is used to assess quantitatively the sustainability of clinical benefits of two dosage regimens of secukinumab over the treatment period from Week 104 to Week 260 No Statistical Analysis was performed This was the total for Group 1 Participants that up-titrated are counted only at the originally randomized treatment group.	Week 104 to Week 260

Secondary Outcomes

Measure	Description	Time Frame
Assessment of Spondyloarthritis International Society Criteria (ASAS) 40 Response From Week 104 to Week 260	ASAS 40 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined time frame at least 40% improvement in score in at least 3 of a conventional set of 4 clinical domains relevant to AS and no worsening in the fourth domain. In this study, ASAS 40 is used to assess quantitatively the sustainability of clinical benefits of two dosage regimens of secukinumab over the treatment period from Week 104 to Week 260 No Statistical Analysis was performed This was the total for Group 1 Participants that up-titrated are counted only at the originally randomized treatment group

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Investigative Site		Portland	Oregon	97239	United States
Novartis Investigative Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33351179	Derived	Baraliakos X, Van den Bosch F, Machado PM, Gensler LS, Marzo-Ortega H, Sherif B, Quebe-Fehling E, Porter B, Gaillez C, Deodhar A. Achievement of Remission Endpoints with Secukinumab Over 3 Years in Active Ankylosing Spondylitis: Pooled Analysis of Two Phase 3 Studies. Rheumatol Ther. 2021 Mar;8(1):273-288. doi: 10.1007/s40744-020-00269-6. Epub 2020 Dec 22.
33324394

Label	URL
Introduction to clinical research conducted by Novartis and to the results of completed studies. For the sake of transparency, objective scientific information is made publicly available in a standardised format.	View source

ID	Title	Description
FG000	Secukinumab (AIN457) 75mg Group 1	AIN457 75 mg plus placebo to AIN457 150 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), AIN457 75 mg was dosed or uptitration to AIN457 150 mg. Secukinumab in PFS for s.c. self-administration Q4W. Participants that up-titrated to AIN457 150 mg were counted only at the originally randomized AIN457 75 mg treatment group.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Aug 31, 2015	Mar 13, 2019

Categories

Title	Measurements
American Indian or Alaska Native	BG0003 BG0017 BG002

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

Assessment of Spondyloarthritis International Society Criteria (ASAS) 20 Response From Week 104 to Week 260

ASAS 20 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined time frame at least 20% improvement in score in at least 3 of a conventional set of 4 clinical domains relevant to AS and no worsening in the fourth domain. In this study, ASAS 20 is used to assess quantitatively the sustainability of clinical benefits of two dosage regimens of secukinumab over the treatment period from Week 104 to Week 260 No Statistical Analysis was performed This was the total for Group 1 Participants that up-titrated are counted only at the originally randomized treatment group.

Extension Full Analysis Set (FAS): all participants enrolled in the extension study. No Statistical Analysis was performed

Posted

Number

% of responders

Week 104 to Week 260

ID	Title	Description
OG000	Secukinumab (AIN457) 75mg Group 1	AIN457 75 mg plus placebo to AIN457 150 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), AIN457 75 mg was dosed or uptitration to AIN457 150 mg. Secukinumab in PFS for s.c. self-administration Q4W. Participants that up-titrated to AIN457 150 mg were counted only at the originally randomized AIN457 75 mg treatment group.
OG001	Secukinumab (AIN457) 150mg Group 2	AIN457 150 mg plus placebo to AIN457 75 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), only AIN457 150 mg was dosed. Secukinumab in PFS for s.c. self-administration Q4W.
OG002	Pbo in Core Then AIN457 75mg Group 1	Participants were randomized on Placebo (Pbo) in Core and then re-randomized to Group 1: secukinumab (AIN457) 75 mg plus placebo to AIN457 150 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), AIN457 75 mg was dosed or uptitration to AIN457 150mg. Secukinumab in PFS for s.c. self-administration Q4W. Participants that up-titrated to AIN457 150 mg were counted only at the originally randomized AIN457 75 mg treatment group.
OG003	Pbo in Core Then AIN457 150mg Group 2	Participants were randomized on Placebo (Pbo) in Core and then re-randomized to Group 2: AIN457 150 mg plus placebo to AIN457 75 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), only AIN457 150 mg was dosed. Secukinumab in PFS for s.c. self-administration Q4W.

Units	Counts
Participants	OG000100 OG00187 OG00246 OG003

Title	Denominators	Categories
Week 104	ParticipantsOG00084 ParticipantsOG00180 ParticipantsOG00242 ParticipantsOG003

Secondary

Assessment of Spondyloarthritis International Society Criteria (ASAS) 40 Response From Week 104 to Week 260

ASAS 40 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined time frame at least 40% improvement in score in at least 3 of a conventional set of 4 clinical domains relevant to AS and no worsening in the fourth domain. In this study, ASAS 40 is used to assess quantitatively the sustainability of clinical benefits of two dosage regimens of secukinumab over the treatment period from Week 104 to Week 260 No Statistical Analysis was performed This was the total for Group 1 Participants that up-titrated are counted only at the originally randomized treatment group

Extension Full Analysis Set (FAS): all participants enrolled in the extension study. No Statistical Analysis was performed

Posted

Number

% of responders

Week 104 to Week 260

ID	Title	Description
OG000	Secukinumab (AIN457) 75mg Group 1	AIN457 75 mg plus placebo to AIN457 150 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), AIN457 75 mg was dosed or uptitration to AIN457 150 mg. Secukinumab in PFS for s.c. self-administration Q4W. Participants that up-titrated to AIN457 150 mg were counted only at the originally randomized AIN457 75 mg treatment group.
OG001	Secukinumab (AIN457) 150mg Group 2	AIN457 150 mg plus placebo to AIN457 75 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), only AIN457 150 mg was dosed. Secukinumab in PFS for s.c. self-administration Q4W.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Any Secukinumab (AIN457) 75 mg	Any Secukinumab (AIN457) 75 mg safety in Core Study CAIN457F2305 and this extension study.	2	179	36	179	126	179
EG001	Any Secukinumab (AIN457) 150 mg	Any Secukinumab (AIN457) 150 mgsafety in Core Study CAIN457F2305 and this extension study	1	263	33	263	157	263
EG002	Placebo	Placebo in Core study CAIN457F2305E1	1	122	5	122	45	122

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal lymphadenopathy	Blood and lymphatic system disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected179 at risk EG0010 affected263 at risk EG0020 affected122 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected179 at risk EG0010 affected263 at risk EG0021 affected122 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected179 at risk EG0010 affected263 at risk EG0020 affected122 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected179 at risk EG0010 affected263 at risk EG0020 affected122 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected179 at risk EG0011 affected263 at risk EG0020 affected122 at risk
Atrial fibrillation	Cardiac disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected179 at risk EG0010 affected263 at risk EG0020 affected122 at risk
Atrial tachycardia	Cardiac disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected179 at risk EG0011 affected263 at risk EG0020 affected122 at risk
Cardiac failure	Cardiac disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected179 at risk EG0012 affected263 at risk EG0020 affected122 at risk
Cardiogenic shock	Cardiac disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected179 at risk EG0011 affected263 at risk EG0020 affected122 at risk
Cardiomyopathy	Cardiac disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected179 at risk EG0011 affected263 at risk EG0020 affected122 at risk
Cardiorenal syndrome	Cardiac disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected179 at risk EG0011 affected263 at risk EG0020 affected122 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected179 at risk EG0010 affected263 at risk EG0020 affected122 at risk
Mitral valve incompetence	Cardiac disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected179 at risk EG0011 affected263 at risk EG0020 affected122 at risk
Myocardial infarction	Cardiac disorders	MedDRA (21.0)	Systematic Assessment	EG0003 affected179 at risk EG0013 affected263 at risk EG0020 affected122 at risk
Sudden hearing loss	Ear and labyrinth disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected179 at risk EG0010 affected263 at risk EG0020 affected122 at risk
Vertigo	Ear and labyrinth disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected179 at risk EG0010 affected263 at risk EG0021 affected122 at risk
Hyperparathyroidism	Endocrine disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected179 at risk EG0010 affected263 at risk EG0020 affected122 at risk
Cataract	Eye disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected179 at risk EG0011 affected263 at risk EG0020 affected122 at risk
Iridocyclitis	Eye disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected179 at risk EG0012 affected263 at risk EG0020 affected122 at risk
Uveitis	Eye disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected179 at risk EG0012 affected263 at risk EG0020 affected122 at risk
Colitis	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected179 at risk EG0010 affected263 at risk EG0020 affected122 at risk
Crohn's disease	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected179 at risk EG0010 affected263 at risk EG0020 affected122 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected179 at risk EG0011 affected263 at risk EG0020 affected122 at risk
Epigastric discomfort	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected179 at risk EG0010 affected263 at risk EG0020 affected122 at risk
Gastritis	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected179 at risk EG0011 affected263 at risk EG0020 affected122 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected179 at risk EG0011 affected263 at risk EG0020 affected122 at risk
Hiatus hernia	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0002 affected179 at risk EG0010 affected263 at risk EG0020 affected122 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected179 at risk EG0010 affected263 at risk EG0020 affected122 at risk
Lumbar hernia	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected179 at risk EG0010 affected263 at risk EG0020 affected122 at risk
Obstructive pancreatitis	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected179 at risk EG0011 affected263 at risk EG0020 affected122 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected179 at risk EG0011 affected263 at risk EG0020 affected122 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected179 at risk EG0011 affected263 at risk EG0020 affected122 at risk
Adverse drug reaction	General disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected179 at risk EG0010 affected263 at risk EG0021 affected122 at risk
Application site pain	General disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected179 at risk EG0010 affected263 at risk EG0020 affected122 at risk
Chest discomfort	General disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected179 at risk EG0011 affected263 at risk EG0020 affected122 at risk
Pyrexia	General disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected179 at risk EG0010 affected263 at risk EG0020 affected122 at risk
Cholangitis acute	Hepatobiliary disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected179 at risk EG0010 affected263 at risk EG0020 affected122 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected179 at risk EG0011 affected263 at risk EG0020 affected122 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA (21.0)	Systematic Assessment	EG0003 affected179 at risk EG0010 affected263 at risk EG0020 affected122 at risk
Hepatitis toxic	Hepatobiliary disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected179 at risk EG0011 affected263 at risk EG0020 affected122 at risk
Hepatosplenomegaly	Hepatobiliary disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected179 at risk EG0010 affected263 at risk EG0020 affected122 at risk
Appendicitis	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0002 affected179 at risk EG0010 affected263 at risk EG0020 affected122 at risk
Appendicitis perforated	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0001 affected179 at risk EG0010 affected263 at risk EG0020 affected122 at risk
Cellulitis	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0001 affected179 at risk EG0010 affected263 at risk EG0020 affected122 at risk
Chronic sinusitis	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0001 affected179 at risk EG0010 affected263 at risk EG0020 affected122 at risk
Helicobacter gastritis	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0001 affected179 at risk EG0010 affected263 at risk EG0020 affected122 at risk
Pneumonia	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0001 affected179 at risk EG0011 affected263 at risk EG0020 affected122 at risk
Pulmonary tuberculoma	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0001 affected179 at risk EG0010 affected263 at risk EG0020 affected122 at risk
Pyelonephritis acute	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0001 affected179 at risk EG0011 affected263 at risk EG0020 affected122 at risk
Respiratory tract infection	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0001 affected179 at risk EG0010 affected263 at risk EG0020 affected122 at risk
Tonsillitis	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0000 affected179 at risk EG0012 affected263 at risk EG0020 affected122 at risk
Urinary tract infection	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0001 affected179 at risk EG0010 affected263 at risk EG0020 affected122 at risk
Cartilage injury	Injury, poisoning and procedural complications	MedDRA (21.0)	Systematic Assessment	EG0001 affected179 at risk EG0010 affected263 at risk EG0020 affected122 at risk
Cervical vertebral fracture	Injury, poisoning and procedural complications	MedDRA (21.0)	Systematic Assessment	EG0001 affected179 at risk EG0010 affected263 at risk EG0020 affected122 at risk
Craniocerebral injury	Injury, poisoning and procedural complications	MedDRA (21.0)	Systematic Assessment	EG0001 affected179 at risk EG0010 affected263 at risk EG0020 affected122 at risk
Dislocation of vertebra	Injury, poisoning and procedural complications	MedDRA (21.0)	Systematic Assessment	EG0001 affected179 at risk EG0010 affected263 at risk EG0020 affected122 at risk
Injury	Injury, poisoning and procedural complications	MedDRA (21.0)	Systematic Assessment	EG0000 affected179 at risk EG0011 affected263 at risk EG0020 affected122 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA (21.0)	Systematic Assessment	EG0001 affected179 at risk EG0010 affected263 at risk EG0020 affected122 at risk
Laceration	Injury, poisoning and procedural complications	MedDRA (21.0)	Systematic Assessment	EG0002 affected179 at risk EG0010 affected263 at risk EG0020 affected122 at risk
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA (21.0)	Systematic Assessment	EG0000 affected179 at risk EG0011 affected263 at risk EG0020 affected122 at risk
Postoperative thrombosis	Injury, poisoning and procedural complications	MedDRA (21.0)	Systematic Assessment	EG0000 affected179 at risk EG0011 affected263 at risk EG0020 affected122 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA (21.0)	Systematic Assessment	EG0000 affected179 at risk EG0012 affected263 at risk EG0020 affected122 at risk
Spinal fracture	Injury, poisoning and procedural complications	MedDRA (21.0)	Systematic Assessment	EG0000 affected179 at risk EG0011 affected263 at risk EG0020 affected122 at risk
Subarachnoid haemorrhage	Injury, poisoning and procedural complications	MedDRA (21.0)	Systematic Assessment	EG0001 affected179 at risk EG0010 affected263 at risk EG0020 affected122 at risk
Thoracic vertebral fracture	Injury, poisoning and procedural complications	MedDRA (21.0)	Systematic Assessment	EG0001 affected179 at risk EG0010 affected263 at risk EG0020 affected122 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA (21.0)	Systematic Assessment	EG0000 affected179 at risk EG0011 affected263 at risk EG0020 affected122 at risk
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA (21.0)	Systematic Assessment	EG0001 affected179 at risk EG0010 affected263 at risk EG0020 affected122 at risk
C-reactive protein increased	Investigations	MedDRA (21.0)	Systematic Assessment	EG0001 affected179 at risk EG0010 affected263 at risk EG0020 affected122 at risk
Ankylosing spondylitis	Musculoskeletal and connective tissue disorders	MedDRA (21.0)	Systematic Assessment	EG0002 affected179 at risk EG0013 affected263 at risk EG0020 affected122 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected179 at risk EG0011 affected263 at risk EG0020 affected122 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected179 at risk EG0011 affected263 at risk EG0020 affected122 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected179 at risk EG0011 affected263 at risk EG0020 affected122 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected179 at risk EG0011 affected263 at risk EG0020 affected122 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected179 at risk EG0012 affected263 at risk EG0020 affected122 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected179 at risk EG0010 affected263 at risk EG0020 affected122 at risk
Spinal column stenosis	Musculoskeletal and connective tissue disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected179 at risk EG0011 affected263 at risk EG0020 affected122 at risk
Spondylolisthesis	Musculoskeletal and connective tissue disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected179 at risk EG0011 affected263 at risk EG0020 affected122 at risk
B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.0)	Systematic Assessment	EG0001 affected179 at risk EG0010 affected263 at risk EG0020 affected122 at risk
Bladder transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.0)	Systematic Assessment	EG0000 affected179 at risk EG0011 affected263 at risk EG0020 affected122 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.0)	Systematic Assessment	EG0000 affected179 at risk EG0011 affected263 at risk EG0020 affected122 at risk
Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.0)	Systematic Assessment	EG0000 affected179 at risk EG0010 affected263 at risk EG0021 affected122 at risk
Thymoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.0)	Systematic Assessment	EG0000 affected179 at risk EG0011 affected263 at risk EG0020 affected122 at risk
Brain oedema	Nervous system disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected179 at risk EG0010 affected263 at risk EG0020 affected122 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected179 at risk EG0012 affected263 at risk EG0020 affected122 at risk
Embolic stroke	Nervous system disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected179 at risk EG0011 affected263 at risk EG0020 affected122 at risk
Generalised tonic-clonic seizure	Nervous system disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected179 at risk EG0011 affected263 at risk EG0020 affected122 at risk
Headache	Nervous system disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected179 at risk EG0011 affected263 at risk EG0020 affected122 at risk
Hemiparesis	Nervous system disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected179 at risk EG0011 affected263 at risk EG0020 affected122 at risk
Ischaemic stroke	Nervous system disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected179 at risk EG0010 affected263 at risk EG0020 affected122 at risk
Migraine	Nervous system disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected179 at risk EG0010 affected263 at risk EG0020 affected122 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected179 at risk EG0011 affected263 at risk EG0020 affected122 at risk
Stroke in evolution	Nervous system disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected179 at risk EG0010 affected263 at risk EG0020 affected122 at risk
Trigeminal neuralgia	Nervous system disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected179 at risk EG0010 affected263 at risk EG0020 affected122 at risk
Vocal cord paresis	Nervous system disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected179 at risk EG0010 affected263 at risk EG0021 affected122 at risk
Abortion incomplete	Pregnancy, puerperium and perinatal conditions	MedDRA (21.0)	Systematic Assessment	EG0000 affected179 at risk EG0011 affected263 at risk EG0020 affected122 at risk
Device failure	Product Issues	MedDRA (21.0)	Systematic Assessment	EG0001 affected179 at risk EG0010 affected263 at risk EG0020 affected122 at risk
Completed suicide	Psychiatric disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected179 at risk EG0010 affected263 at risk EG0021 affected122 at risk
Depression	Psychiatric disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected179 at risk EG0010 affected263 at risk EG0021 affected122 at risk
Renal colic	Renal and urinary disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected179 at risk EG0011 affected263 at risk EG0020 affected122 at risk
Ureterolithiasis	Renal and urinary disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected179 at risk EG0010 affected263 at risk EG0020 affected122 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected179 at risk EG0011 affected263 at risk EG0020 affected122 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected179 at risk EG0010 affected263 at risk EG0020 affected122 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected179 at risk EG0010 affected263 at risk EG0020 affected122 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected179 at risk EG0010 affected263 at risk EG0020 affected122 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected179 at risk EG0010 affected263 at risk EG0020 affected122 at risk
Laryngeal oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected179 at risk EG0011 affected263 at risk EG0020 affected122 at risk
Nasal septum deviation	Respiratory, thoracic and mediastinal disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected179 at risk EG0010 affected263 at risk EG0020 affected122 at risk
Pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected179 at risk EG0010 affected263 at risk EG0020 affected122 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected179 at risk EG0011 affected263 at risk EG0020 affected122 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected179 at risk EG0010 affected263 at risk EG0020 affected122 at risk
Peripheral venous disease	Vascular disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected179 at risk EG0010 affected263 at risk EG0020 affected122 at risk
Varicose vein	Vascular disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected179 at risk EG0011 affected263 at risk EG0020 affected122 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Leukopenia	Blood and lymphatic system disorders	MedDRA (21.0)	Systematic Assessment	EG00014 affected179 at risk EG00111 affected263 at risk EG0021 affected122 at risk
Uveitis	Eye disorders	MedDRA (21.0)	Systematic Assessment	EG00010 affected179 at risk EG00115 affected263 at risk EG0022 affected122 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0009 affected179 at risk EG0019 affected263 at risk EG0020 affected122 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG00026 affected179 at risk EG00129 affected263 at risk EG0027 affected122 at risk
Mouth ulceration	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG00010 affected179 at risk EG0018 affected263 at risk EG0023 affected122 at risk
Nausea	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG00012 affected179 at risk EG00112 affected263 at risk EG0022 affected122 at risk
Bronchitis	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0009 affected179 at risk EG00117 affected263 at risk EG0022 affected122 at risk
Gastroenteritis	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG00010 affected179 at risk EG00110 affected263 at risk EG0021 affected122 at risk
Influenza	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG00019 affected179 at risk EG00126 affected263 at risk EG0022 affected122 at risk
Nasopharyngitis	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG00045 affected179 at risk EG00163 affected263 at risk EG0029 affected122 at risk
Pharyngitis	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG00013 affected179 at risk EG00124 affected263 at risk EG0021 affected122 at risk
Rhinitis	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0006 affected179 at risk EG00114 affected263 at risk EG0020 affected122 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG00029 affected179 at risk EG00121 affected263 at risk EG0022 affected122 at risk
Urinary tract infection	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG00010 affected179 at risk EG00112 affected263 at risk EG0020 affected122 at risk
Dyslipidaemia	Metabolism and nutrition disorders	MedDRA (21.0)	Systematic Assessment	EG00018 affected179 at risk EG00114 affected263 at risk EG0025 affected122 at risk
Ankylosing spondylitis	Musculoskeletal and connective tissue disorders	MedDRA (21.0)	Systematic Assessment	EG00011 affected179 at risk EG00113 affected263 at risk EG0024 affected122 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (21.0)	Systematic Assessment	EG00017 affected179 at risk EG00124 affected263 at risk EG0024 affected122 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (21.0)	Systematic Assessment	EG00013 affected179 at risk EG00120 affected263 at risk EG0020 affected122 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA (21.0)	Systematic Assessment	EG0009 affected179 at risk EG0015 affected263 at risk EG0020 affected122 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (21.0)	Systematic Assessment	EG0009 affected179 at risk EG0017 affected263 at risk EG0022 affected122 at risk
Headache	Nervous system disorders	MedDRA (21.0)	Systematic Assessment	EG00026 affected179 at risk EG00128 affected263 at risk EG0027 affected122 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (21.0)	Systematic Assessment	EG00012 affected179 at risk EG00118 affected263 at risk EG0022 affected122 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA (21.0)	Systematic Assessment	EG00014 affected179 at risk EG00118 affected263 at risk EG0026 affected122 at risk
Hypertension	Vascular disorders	MedDRA (21.0)	Systematic Assessment	EG00013 affected179 at risk EG00111 affected263 at risk EG0021 affected122 at risk

ID	Term
D013167	Spondylitis, Ankylosing

Ancestor Terms

ID	Term
D000089183	Axial Spondyloarthritis
D025242	Spondylarthropathies
D025241	Spondylarthritis
D013166	Spondylitis
D013122	Spinal Diseases
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D000844	Ankylosis
D007592	Joint Diseases
D001168	Arthritis

ID	Term
C555450	secukinumab

Title	Measurements
	OG00056.3 OG00159.5 OG00254.3 OG00351.2

Title	Measurements
	OG00054.6 OG00168.7 OG00258.7 OG00355.0

Title	Measurements
	OG00053.1 OG00160.7 OG00253.3 OG00360.0

Title	Measurements
	OG00050.0 OG00162.8 OG00254.3 OG00355.0

Title	Measurements
	OG00054.7 OG00167.5 OG00242.9 OG00362.2

Title	Measurements
	OG00052.7 OG00168.8 OG00252.4 OG00367.6

Title	Measurements
	OG00057.4 OG00169.6 OG00252.4 OG00362.2

Title	Measurements
	OG00052.1 OG00160.8 OG00262.5 OG00356.8

Title	Measurements
	OG00051.1 OG00167.5 OG00254.1 OG00363.9

Title	Measurements
	OG00062.2 OG00166.7 OG00259.5 OG00369.4

Title	Measurements
	OG00060.9 OG00170.5 OG00262.9 OG00361.8

Title	Measurements
	OG00050.6 OG00164.5 OG00263.2 OG00366.7

ID	Title	Description
BG000	Secukinumab (AIN457) 75mg Group 1	AIN457 75 mg plus placebo to AIN457 150 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), AIN457 75 mg was dosed or uptitration to AIN457 150 mg. Secukinumab in PFS for s.c. self-administration Q4W. Participants that up-titrated to AIN457 150 mg were counted only at the originally randomized AIN457 75 mg treatment group.
BG001	Secukinumab (AIN457) 150mg Group 2	AIN457 150 mg plus placebo to AIN457 75 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), only AIN457 150 mg was dosed. Secukinumab in PFS for s.c. self-administration Q4W.
BG002	Pbo in Core Then AIN457 75mg Group 1	Participants were randomized on Placebo (Pbo) in Core and then re-randomized to Group 1: secukinumab (AIN457) 75 mg plus placebo to AIN457 150 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), AIN457 75 mg was dosed or uptitration to AIN457 150mg. Secukinumab in PFS for s.c. self-administration Q4W. Participants that up-titrated to AIN457 150 mg were counted only at the originally randomized AIN457 75 mg treatment group.
BG003	Pbo in Core Then AIN457 150mg Group 2	Participants were randomized on Placebo (Pbo) in Core and then re-randomized to Group 2: AIN457 150 mg plus placebo to AIN457 75 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), only AIN457 150 mg was dosed. Secukinumab in PFS for s.c. self-administration Q4W.
BG004	Total	Total of all reporting groups