16-week Efficacy and 3-year Safety, Tolerability and Effi... | NCT02008916

ID	Type	Description	Link
2013-001090-24	EudraCT Number

Label	Type	Description	Intervention Names
Secukinumab 10 mg/kg i.v. / 300 mg s.c.	Experimental	Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.	Drug: Secukinumab
Secukinumab 10 mg/kg i.v. / 150 mg s.c.	Experimental	Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.	Drug: Secukinumab
Placebo i.v. and s.c.	Placebo Comparator	Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection at weeks 8 and 12. At week 16, patients were re-randomised to one of the active treatment arms, to receive secukinumab s.c. Q4W until the end of the study.	Drug: Placebo secukinumab

Name	Type	Description	Arm Group Labels	Other Names
Secukinumab	Drug	AIN457 (Secukinumab) is a human monoclonal antibody. Secukinumab binds and reduces the activity of Interleukin 17 (IL-17).	Secukinumab 10 mg/kg i.v. / 150 mg s.c.

Measure	Description	Time Frame
Number of Participants With 20% Improvement in the Assessment of Spondyloarthritis International Society Criteria Scale / ASAS 20 Response	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 was used to assess the efficacy of at least one dose of secukinumab versus placebo.	16 weeks

Measure	Description	Time Frame
ASAS 40 Response	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 was used to assess the efficacy of at least one dose of secukinumab versus placebo.

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Investigative Site		Mobile	Alabama	36604	United States
Novartis Investigative Site

PubMed Identifier	Type	Citation	Retractions
41965705	Derived	Ramiro S, Gaillez C, Kiltz U, Gensler LS, Pisal C, Braun J, Ogdie A. No major effect of age (< 40 vs. >/= 40 years) on response to secukinumab in patients with axSpA: a post hoc analysis of six phase 3 trials. Arthritis Res Ther. 2026 Apr 11;28(1):112. doi: 10.1186/s13075-026-03804-y.
35305260	Derived	Merola JF, McInnes IB, Deodhar AA, Dey AK, Adamstein NH, Quebe-Fehling E, Aassi M, Peine M, Mehta NN. Effect of Secukinumab on Traditional Cardiovascular Risk Factors and Inflammatory Biomarkers: Post Hoc Analyses of Pooled Data Across Three Indications. Rheumatol Ther. 2022 Jun;9(3):935-955. doi: 10.1007/s40744-022-00434-z. Epub 2022 Mar 19.

Label	URL
Introduction to clinical trials conducted by Novartis and to results of completed studies, with the aim of increasing the transparency of Novartis clinical research and making publicly available objective scientific information in a standardised format.	View source

ID	Title	Description
FG000	Secukinumab 10 mg/kg i.v. / 150 mg s.c.	Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
FG001	Secukinumab 10 mg/kg i.v. / 300 mg s.c.

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

Number of Participants With 20% Improvement in the Assessment of Spondyloarthritis International Society Criteria Scale / ASAS 20 Response

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 was used to assess the efficacy of at least one dose of secukinumab versus placebo.

FAS - Missing ASAS responses were considered as non-responder

Posted

Count of Participants

Participants

16 weeks

ID	Title	Description
OG000	Secukinumab 10 mg/kg i.v. / 150 mg s.c.	Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
OG001	Secukinumab 10 mg/kg i.v. / 300 mg s.c.	Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
OG002	Placebo i.v. and s.c.	Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection at weeks 8 and 12. At week 16, patients were re-randomised to one of the active treatment arms, to receive secukinumab s.c. Q4W until the end of the study.

Units	Counts
Participants	OG00074 OG00176 OG00276

Title

Denominators

Categories

Title	Measurements
Responder	OG00043 OG00146 OG00228
Non-Responder

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG002		Regression, Logistic		0.0093		Odds Ratio (OR)	2.41			2-Sided	95	1.24	4.69					Superiority
OG001 OG002		Regression, Logistic		0.0037

Secondary

ASAS 40 Response

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 was used to assess the efficacy of at least one dose of secukinumab versus placebo.

FAS - Missing ASAS responses were considered as non-responder

Posted

Count of Participants

Participants

16 weeks

ID	Title	Description
OG000	Secukinumab 10 mg/kg i.v. / 150 mg s.c.	Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
OG001	Secukinumab 10 mg/kg i.v. / 300 mg s.c.	Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
OG002	Placebo i.v. and s.c.	Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection at weeks 8 and 12. At week 16, patients were re-randomised to one of the active treatment arms, to receive secukinumab s.c. Q4W until the end of the study.

Secondary

Serum hsCRP

Blood levels of C-reactive protein (CRP), an acute phase reactant, are indicative of inflammation and of its severity, and can be used to monitor treatment response. A high sensitivity CRP (hsCRP) test was implemented in this study, to assess the efficacy of at least one dose of secukinumab versus placebo in reducing AS elicited systemic inflammation over the time.

FAS

Posted

Mean

Standard Deviation

mg/L

Baseline and 16 weeks

ID	Title	Description
OG000	Secukinumab 10 mg/kg i.v. / 150 mg s.c.	Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
OG001	Secukinumab 10 mg/kg i.v. / 300 mg s.c.	Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
OG002	Placebo i.v. and s.c.	Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection at weeks 8 and 12. At week 16, patients were re-randomised to one of the active treatment arms, to receive secukinumab s.c. Q4W until the end of the study.

Secondary

ASAS 5/6 Response

ASAS 5/6 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 5 of a conventional set of 6 clinical domains relevant to AS and no worsening in the remaining domain. In this study, ASAS 5/6 was used to assess the efficacy of at least one dose of secukinumab versus placebo.

FAS - Missing ASAS responses were considered as non-responder

Posted

Count of Participants

Participants

16 weeks

ID	Title	Description
OG000	Secukinumab 10 mg/kg i.v. / 150 mg s.c.	Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
OG001	Secukinumab 10 mg/kg i.v. / 300 mg s.c.	Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
OG002	Placebo i.v. and s.c.	Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection at weeks 8 and 12. At week 16, patients were re-randomised to one of the active treatment arms, to receive secukinumab s.c. Q4W until the end of the study.

Secondary

Bath Ankylosing Spondylitis Disease Activity Index / BASDAI

BASDAI is a validated assessment tool using 0 through 10 scales (0 indicating "no problem" and 10 indicating "worst problem"), to characterise six clinical domains pertaining to five major symptoms of AS perceived by the patients. Computed composite scores of 4 or greater indicate suboptimal disease control. In this study, the BASDAI index was used to assess the efficacy of at least one dose of secukinumab versus placebo.

FAS

Posted

Mean

Standard Deviation

units on a scale

Baseline and 16 weeks

ID	Title	Description
OG000	Secukinumab 10 mg/kg i.v. / 150 mg s.c.	Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
OG001	Secukinumab 10 mg/kg i.v. / 300 mg s.c.	Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
OG002	Placebo i.v. and s.c.	Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection at weeks 8 and 12. At week 16, patients were re-randomised to one of the active treatment arms, to receive secukinumab s.c. Q4W until the end of the study.

Secondary

Number of Participants With Successful Self-administration (to Measure Usability of Pre-filled Syringe)

Successful self-administration is defined as success in steps P8 (Removed Needle Cap from Safety Syringe), P10 (Pinched the Skin at Injection Site), P11 (Inserted the Needle into Skin), P12 (Held onto the Finger Flange), P13 (Fully Depressed Plunger until End Point), and P14 (Held Plunger Down and Syringe in Place) of the Instructions for Use, as observed by the site staff at applicable visits.

Safety Set

Posted

Count of Participants

Participants

Week 8 and Week 12

ID	Title	Description
OG000	Secukinumab 10 mg/kg i.v. / 150 mg s.c.	Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
OG001	Secukinumab 10 mg/kg i.v. / 300 mg s.c.	Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
OG002	Placebo i.v. and s.c.	Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection at weeks 8 and 12. At week 16, patients were re-randomised to one of the active treatment arms, to receive secukinumab s.c. Q4W until the end of the study.

Secondary

Pre-filled Syringe Possible Hazard

The number and percentage of subjects who experience any of the defined possible hazards are summarized, as defined in the Possible Hazard assessment check list and as observed by the site staff at applicable visits.

Safety Set

Posted

Count of Participants

Participants

Week 8 and Week 12

ID	Title	Description
OG000	Secukinumab 10 mg/kg i.v. / 150 mg s.c.	Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
OG001	Secukinumab 10 mg/kg i.v. / 300 mg s.c.	Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
OG002	Placebo i.v. and s.c.	Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection at weeks 8 and 12. At week 16, patients were re-randomised to one of the active treatment arms, to receive secukinumab s.c. Q4W until the end of the study.

Secondary

Prefilled Syringe Patient Satisfaction Assessment

The self-injection assessment questionnaire (SIAQ) measures overall patient experience with subcutaneous self-injection at applicable visits. Domain scores ranging from 0 (worst experience) to 10 (best experience) are presented: Feeling about injections, Self-confidence, Satisfaction with self-injection.

Safety Set

Posted

Mean

Standard Deviation

Points

Baseline, weeks 8, 12 and 16

ID	Title	Description
OG000	Secukinumab 10 mg/kg i.v. / 150 mg s.c.	Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
OG001	Secukinumab 10 mg/kg i.v. / 300 mg s.c.	Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
OG002	Placebo i.v. and s.c.	Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection at weeks 8 and 12. At week 16, patients were re-randomised to one of the active treatment arms, to receive secukinumab s.c. Q4W until the end of the study.

Secondary

ASAS Partial Remission

ASAS partial remission is a composite assessment, reflecting the proportion of treated patients who achieve within a defined time frame a value not above 2 units in each of the 4 ASAS domains on a scale of 10. In this study, ASAS partial remission was used to assess the efficacy of at least one dose of secukinumab versus placebo.

FAS - Missing ASAS responses were considered as non-responder

Posted

Count of Participants

Participants

16 weeks

ID	Title	Description
OG000	Secukinumab 10 mg/kg i.v. / 150 mg s.c.	Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
OG001	Secukinumab 10 mg/kg i.v. / 300 mg s.c.	Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
OG002	Placebo i.v. and s.c.	Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection at weeks 8 and 12. At week 16, patients were re-randomised to one of the active treatment arms, to receive secukinumab s.c. Q4W until the end of the study.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Coronary artery disease	Cardiac disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected110 at risk EG0010 affected113 at risk EG0021 affected223 at risk EG0030 affected75 at risk
Myocardial infarction	Cardiac disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected110 at risk EG0011 affected113 at risk EG0021 affected223 at risk EG003
Sinus node dysfunction	Cardiac disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected110 at risk EG0010 affected113 at risk EG0021 affected223 at risk EG003
Supraventricular extrasystoles	Cardiac disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected110 at risk EG0010 affected113 at risk EG0021 affected223 at risk EG003
Supraventricular tachycardia	Cardiac disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected110 at risk EG0010 affected113 at risk EG0021 affected223 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected110 at risk EG0011 affected113 at risk EG0021 affected223 at risk EG003
Cataract	Eye disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected110 at risk EG0011 affected113 at risk EG0021 affected223 at risk EG003
Iridocyclitis	Eye disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected110 at risk EG0011 affected113 at risk EG0021 affected223 at risk EG003
Vogt-Koyanagi-Harada syndrome	Eye disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected110 at risk EG0011 affected113 at risk EG0021 affected223 at risk EG003
Haemorrhoids	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected110 at risk EG0011 affected113 at risk EG0021 affected223 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected110 at risk EG0011 affected113 at risk EG0021 affected223 at risk EG003
Fatigue	General disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected110 at risk EG0011 affected113 at risk EG0021 affected223 at risk EG003
Pneumonia	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected110 at risk EG0011 affected113 at risk EG0021 affected223 at risk EG003
Pyelonephritis acute	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0001 affected110 at risk EG0010 affected113 at risk EG0021 affected223 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0001 affected110 at risk EG0011 affected113 at risk EG0022 affected223 at risk EG003
Ankle fracture	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0001 affected110 at risk EG0010 affected113 at risk EG0021 affected223 at risk EG003
Cervical vertebral fracture	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0001 affected110 at risk EG0010 affected113 at risk EG0021 affected223 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0001 affected110 at risk EG0010 affected113 at risk EG0021 affected223 at risk EG003
Hand fracture	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0001 affected110 at risk EG0010 affected113 at risk EG0021 affected223 at risk EG003
Limb injury	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0001 affected110 at risk EG0010 affected113 at risk EG0021 affected223 at risk EG003
Rib fracture	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0001 affected110 at risk EG0010 affected113 at risk EG0021 affected223 at risk EG003
Tibia fracture	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0001 affected110 at risk EG0010 affected113 at risk EG0021 affected223 at risk EG003
Ankylosing spondylitis	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected110 at risk EG0011 affected113 at risk EG0021 affected223 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected110 at risk EG0011 affected113 at risk EG0021 affected223 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected110 at risk EG0011 affected113 at risk EG0021 affected223 at risk EG003
Sacroiliitis	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected110 at risk EG0011 affected113 at risk EG0021 affected223 at risk EG003
Spinal pain	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected110 at risk EG0011 affected113 at risk EG0021 affected223 at risk EG003
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.1)	Systematic Assessment	EG0001 affected110 at risk EG0010 affected113 at risk EG0021 affected223 at risk EG003
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.1)	Systematic Assessment	EG0001 affected110 at risk EG0010 affected113 at risk EG0021 affected223 at risk EG003
Loss of consciousness	Nervous system disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected110 at risk EG0011 affected113 at risk EG0021 affected223 at risk EG003
Migraine	Nervous system disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected110 at risk EG0011 affected113 at risk EG0021 affected223 at risk EG003
Syncope	Nervous system disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected110 at risk EG0010 affected113 at risk EG0021 affected223 at risk EG003
Schizophrenia	Psychiatric disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected110 at risk EG0011 affected113 at risk EG0021 affected223 at risk EG003
Cervical dysplasia	Reproductive system and breast disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected110 at risk EG0010 affected113 at risk EG0021 affected223 at risk EG003
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected110 at risk EG0010 affected113 at risk EG0021 affected223 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected110 at risk EG0011 affected113 at risk EG0021 affected223 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected110 at risk EG0010 affected113 at risk EG0021 affected223 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Iritis	Eye disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected110 at risk EG0013 affected113 at risk EG0023 affected223 at risk EG0030 affected75 at risk
Uveitis	Eye disorders	MedDRA (20.1)	Systematic Assessment	EG0003 affected110 at risk EG0015 affected113 at risk EG0028 affected223 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected110 at risk EG0013 affected113 at risk EG0024 affected223 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0005 affected110 at risk EG0013 affected113 at risk EG0028 affected223 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG00011 affected110 at risk EG0019 affected113 at risk EG00220 affected223 at risk EG003
Food poisoning	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0002 affected110 at risk EG0013 affected113 at risk EG0025 affected223 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0003 affected110 at risk EG0011 affected113 at risk EG0024 affected223 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0003 affected110 at risk EG0014 affected113 at risk EG0027 affected223 at risk EG003
Toothache	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0003 affected110 at risk EG0012 affected113 at risk EG0025 affected223 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected110 at risk EG0014 affected113 at risk EG0024 affected223 at risk EG003
Fatigue	General disorders	MedDRA (20.1)	Systematic Assessment	EG0005 affected110 at risk EG0014 affected113 at risk EG0029 affected223 at risk EG003
Influenza like illness	General disorders	MedDRA (20.1)	Systematic Assessment	EG0002 affected110 at risk EG0011 affected113 at risk EG0023 affected223 at risk EG003
Bronchitis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG00014 affected110 at risk EG0019 affected113 at risk EG00223 affected223 at risk EG003
Conjunctivitis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0001 affected110 at risk EG0013 affected113 at risk EG0024 affected223 at risk EG003
Ear infection	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected110 at risk EG0013 affected113 at risk EG0023 affected223 at risk EG003
Gastroenteritis viral	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0001 affected110 at risk EG0013 affected113 at risk EG0024 affected223 at risk EG003
Influenza	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0003 affected110 at risk EG0019 affected113 at risk EG00212 affected223 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG00027 affected110 at risk EG00127 affected113 at risk EG00254 affected223 at risk EG003
Oral herpes	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0001 affected110 at risk EG0013 affected113 at risk EG0024 affected223 at risk EG003
Pharyngitis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0003 affected110 at risk EG0016 affected113 at risk EG0029 affected223 at risk EG003
Pharyngotonsillitis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected110 at risk EG0013 affected113 at risk EG0023 affected223 at risk EG003
Pneumonia	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0001 affected110 at risk EG0013 affected113 at risk EG0024 affected223 at risk EG003
Pulpitis dental	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0004 affected110 at risk EG0011 affected113 at risk EG0025 affected223 at risk EG003
Respiratory tract infection	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG00012 affected110 at risk EG00110 affected113 at risk EG00222 affected223 at risk EG003
Rhinitis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0006 affected110 at risk EG0014 affected113 at risk EG00210 affected223 at risk EG003
Sinusitis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0008 affected110 at risk EG0011 affected113 at risk EG0029 affected223 at risk EG003
Tonsillitis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0004 affected110 at risk EG0014 affected113 at risk EG0028 affected223 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG00012 affected110 at risk EG00116 affected113 at risk EG00228 affected223 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0004 affected110 at risk EG0016 affected113 at risk EG00210 affected223 at risk EG003
Sunburn	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0000 affected110 at risk EG0013 affected113 at risk EG0023 affected223 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA (20.1)	Systematic Assessment	EG0003 affected110 at risk EG0012 affected113 at risk EG0025 affected223 at risk EG003
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA (20.1)	Systematic Assessment	EG0004 affected110 at risk EG0013 affected113 at risk EG0027 affected223 at risk EG003
Ankylosing spondylitis	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0005 affected110 at risk EG0013 affected113 at risk EG0028 affected223 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Systematic Assessment	EG00014 affected110 at risk EG00113 affected113 at risk EG00227 affected223 at risk EG003
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0004 affected110 at risk EG0013 affected113 at risk EG0027 affected223 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0007 affected110 at risk EG00112 affected113 at risk EG00219 affected223 at risk EG003
Fibromyalgia	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected110 at risk EG0013 affected113 at risk EG0024 affected223 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0003 affected110 at risk EG0015 affected113 at risk EG0028 affected223 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0003 affected110 at risk EG0011 affected113 at risk EG0024 affected223 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0002 affected110 at risk EG0014 affected113 at risk EG0026 affected223 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0004 affected110 at risk EG0012 affected113 at risk EG0026 affected223 at risk EG003
Spinal pain	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0004 affected110 at risk EG0014 affected113 at risk EG0028 affected223 at risk EG003
Spondylitis	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected110 at risk EG0013 affected113 at risk EG0023 affected223 at risk EG003
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0003 affected110 at risk EG0011 affected113 at risk EG0024 affected223 at risk EG003
Dizziness	Nervous system disorders	MedDRA (20.1)	Systematic Assessment	EG0002 affected110 at risk EG0014 affected113 at risk EG0026 affected223 at risk EG003
Headache	Nervous system disorders	MedDRA (20.1)	Systematic Assessment	EG00012 affected110 at risk EG00114 affected113 at risk EG00226 affected223 at risk EG003
Hypoaesthesia	Nervous system disorders	MedDRA (20.1)	Systematic Assessment	EG0002 affected110 at risk EG0010 affected113 at risk EG0022 affected223 at risk EG003
Migraine	Nervous system disorders	MedDRA (20.1)	Systematic Assessment	EG0005 affected110 at risk EG0011 affected113 at risk EG0026 affected223 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA (20.1)	Systematic Assessment	EG0004 affected110 at risk EG0010 affected113 at risk EG0024 affected223 at risk EG003
Depression	Psychiatric disorders	MedDRA (20.1)	Systematic Assessment	EG0003 affected110 at risk EG0013 affected113 at risk EG0026 affected223 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (20.1)	Systematic Assessment	EG0006 affected110 at risk EG0016 affected113 at risk EG00212 affected223 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA (20.1)	Systematic Assessment	EG0007 affected110 at risk EG0017 affected113 at risk EG00214 affected223 at risk EG003
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA (20.1)	Systematic Assessment	EG0003 affected110 at risk EG0011 affected113 at risk EG0024 affected223 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected110 at risk EG0013 affected113 at risk EG0024 affected223 at risk EG003
Hypertension	Vascular disorders	MedDRA (20.1)	Systematic Assessment	EG0007 affected110 at risk EG0015 affected113 at risk EG00212 affected223 at risk EG003

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	Title	Description
BG000	Secukinumab 10 mg/kg i.v. / 150 mg s.c.	Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
BG001	Secukinumab 10 mg/kg i.v. / 300 mg s.c.	Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
BG002	Placebo i.v. and s.c.	Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection at weeks 8 and 12. At week 16, patients were re-randomised to one of the active treatment arms, to receive secukinumab s.c. Q4W until the end of the study.
BG003	Total	Total of all reporting groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Any Secukinumab 150 mg	Includes Patients randomized to Secukinumab 150 mg at baseline + patients re-randomized to Secukinumab 150 mg at week 16 (for AEs occurring after rerandomization)	110	11	110	86	110
EG001	Any Secukinumab 300 mg	Includes Patients randomized to Secukinumab 300 mg at baseline + patients re-randomized to Secukinumab 300 mg at week 16 (for AEs occurring after rerandomization)	113	11	113	89	113
EG002	Any Secukinumab	Any Secukinumab 150 mg + Any Secukinumab 300 mg	223	22	223	175	223
EG003	Placebo	Includes Patients randomized to Placebo for AEs until time of re-randomization (Week 16) to Secukinumab.	75	1	75	28	75