Study of Efficacy and Safety of Secukinumab in Psoriatic... | NCT02771210

NCT02771210

ID	Type	Description	Link
2016-000972-91	EudraCT Number

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
AIN457/Secukinumab	Experimental	Secukinumab 150 mg s.c. or Secukinumab 300 mg s.c., respective dose was assigned according to underlying condition, in case of PsA according to severity of concomitant Psoriasis or pre-exposure to anti-TNFα	Biological: Secukinumab
AIN457/Secukinumab Placebo	Placebo Comparator	Secukinumab Placebo s.c.	Drug: Secukinumab Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Secukinumab	Biological	Induction: Week 0,1,2,3 150 mg or 300 mg Secukinumab s.c. Maintenance: 150 mg or 300 mg Secukinumab s.c. every 4 weeks starting at Week 4	AIN457/Secukinumab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number (%) of Patients With Resolution of Achilles Tendon Enthesitis	Number (%) of patients with resolution of Achilles tendon enthesitis (affected foot) as assessed by respective subcomponent of Leeds enthesitis index (LEI) at Week 24. The primary analysis was performed via a logistic regression model with the factors treatment, country, and stratification factor diagnosis (PsA or axSpA); patients with a missing assessment were considered as responders if they had already met the response criterion at the time of last assessment.	Week 24

Secondary Outcomes

Measure	Description	Time Frame
Mean Change of Heel Pain	Mean change of heel pain from baseline to Week 24 measured by Numeric Rating Scale (NRS) ranging from 0 to 10, with 0 representing no pain and 10 representing worst pain (e.g. "pain as bad as you can imagine" or "worst pain imaginable").	Week 24
Number (%) of Patients With Improvement of Bone Marrow Edema

Eligibility Module

Eligibility Criteria

Key Inclusion Criteria:

- Patients with Psoriatic arthritis: Diagnosis of Psoriatic arthritis as per the Classification criteria for Psoriatic Arthritis (CASPAR criteria) with symptoms for at least 6 months and active Psoriatic arthritis as assessed by ≥ 1 tender joints out of 78 and ≥ 1 swollen joints out of 76 at Baseline (dactylitis of a digit counts as one joint each).

- Patients with Axial Spondyloarthritis: Diagnosis of Axial Spondyloarthritis as per the classification of the Assessment of Spondyloarthritis International Society axial Spondyloarthritis (ASAS) criteria and objective signs of inflammation at Screening (magnetic resonance imaging (MRI) or definite radiographic sacroilitis and/or abnormal C-Reactive Protein) and active disease assessed by total Bath ankylosing spondylitis disease activity index (BASDAI) ≥ 4 (0-10) at Baseline.

Diagnosis of Achilles tendon enthesitis according to swelling and tenderness at the insertional site of the Achilles tendon into the calcaneus.
Onset of heel pain ≥ 1 month at Baseline.
Heel enthesitis that is magnetic resonance imaging (MRI)-positive according to the investigator's judgement.
Patients who have been exposed to up to two TNFα inhibitors.

Key Exclusion Criteria:

Chest X-ray or chest magnetic resonance imaging (MRI) with evidence of ongoing infectious or malignant process.
Previous exposure to secukinumab or other biologic drug directly targeting Interleukin (IL)-17 or Interleukin (IL)-17 receptor.
Ongoing use of psoriasis treatments / medications (e.g. topical corticosteroids, ultraviolet (UV) therapy) at randomization.
Patients who have previously been exposed to more than two Tumor necrosis factor (TNF) inhibitors (investigational or approved).
Patients who have ever received biologic immunomodulating agents (investigational or approved), except those targeting Tumor necrosis factor (TNF) inhibitors.
Pregnant or nursing (lactating) women.
History of ongoing, chronic or recurrent infectious disease or evidence of tuberculosis infection.

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Investigative Site		Plovdiv		4002	Bulgaria
Novartis Investigative Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35578245	Derived	Baraliakos X, Sewerin P, de Miguel E, Pournara E, Kleinmond C, Shekhawat A, Jentzsch C, Wiedon A, Behrens F; ACHILLES study group. Magnetic resonance imaging characteristics in patients with spondyloarthritis and clinical diagnosis of heel enthesitis: post hoc analysis from the phase 3 ACHILLES trial. Arthritis Res Ther. 2022 May 16;24(1):111. doi: 10.1186/s13075-022-02797-8.
34730795

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Secukinumab	Secukinumab 150 mg or 300 mg s.c., administered at baseline, weeks 1, 2, 3, 4 and every 4 weeks until week 24, followed by Secukinumab 150 or 300 mg s.c. every 4 weeks; respective dose was assigned according to underlying condition, in case of PsA according to severity of concomitant Psoriasis or preexposure to anti-TNFα

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jun 19, 2017	Dec 3, 2020

Arm/Group Information

ID	Title	Description
BG000	Secukinumab	Secukinumab 150 mg or 300 mg s.c., administered at baseline, weeks 1, 2, 3, 4 and every 4 weeks until week 24, followed by Secukinumab 150 or 300 mg s.c. every 4 weeks; respective dose was assigned according to underlying condition, in case of PsA according to severity of concomitant Psoriasis or preexposure to anti-TNFα
BG001	Placebo	Placebo 150 mg or 300 mg s.c., administered at baseline, weeks 1, 2, 3, 4 and every 4 weeks until week 24, followed by Secukinumab 150 or 300 mg s.c. every 4 weeks; respective dose was assigned according to underlying condition, in case of PsA according to severity of concomitant Psoriasis or preexposure to anti-TNFα
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Number of participants in each age group

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG0000 BG0010 BG0020
Between 18 and 65 years

Age, Continuous

Mean age of participants in each group

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	BG00047.8± 11.33 BG00147.7± 11.02 BG002

Sex/Gender, Customized

Number of males vs females in Randomized set

Count of Participants

Participants

Title

Denominators

Categories

Female

Title	Measurements
	BG00058 BG00155 BG002

Race/Ethnicity, Customized

Number of participants (Randomized set) by race

Number

Participants

Title

Denominators

Categories

Caucasian

Title	Measurements
	BG00099 BG00199 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

Number (%) of Patients With Resolution of Achilles Tendon Enthesitis

Number (%) of patients with resolution of Achilles tendon enthesitis (affected foot) as assessed by respective subcomponent of Leeds enthesitis index (LEI) at Week 24.

The primary analysis was performed via a logistic regression model with the factors treatment, country, and stratification factor diagnosis (PsA or axSpA); patients with a missing assessment were considered as responders if they had already met the response criterion at the time of last assessment.

Full analysis set (FAS) included all patients to whom study medication had been assigned.

Posted

Count of Participants

Participants

Week 24

ID	Title	Description
OG000	Secukinumab	Secukinumab 150 mg or 300 mg s.c., administered at baseline, weeks 1, 2, 3, 4 and every 4 weeks until week 24, followed by Secukinumab 150 or 300 mg s.c. every 4 weeks; respective dose was assigned according to underlying condition, in case of PsA according to severity of concomitant Psoriasis or preexposure to anti-TNFα
OG001	Placebo	Placebo 150 mg or 300 mg s.c., administered at baseline, weeks 1, 2, 3, 4 and every 4 weeks until week 24, followed by Secukinumab 150 or 300 mg s.c. every 4 weeks; respective dose was assigned according to underlying condition, in case of PsA according to severity of concomitant Psoriasis or preexposure to anti-TNFα

Units	Counts
Participants	OG000102 OG001102

Title

Denominators

Categories

Title	Measurements
	OG00043 OG00132

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 OG001		Regression, Logistic		0.136		Odds Ratio (OR)	1.63			2-Sided	95	0.87	3.08					Superiority

Secondary

Mean Change of Heel Pain

Mean change of heel pain from baseline to Week 24 measured by Numeric Rating Scale (NRS) ranging from 0 to 10, with 0 representing no pain and 10 representing worst pain (e.g. "pain as bad as you can imagine" or "worst pain imaginable").

Full analysis set (FAS)

Posted

Mean

Standard Deviation

Scores on a scale

Week 24

ID	Title	Description
OG000	Secukinumab	Secukinumab 150 mg or 300 mg s.c., administered at baseline, weeks 1, 2, 3, 4 and every 4 weeks until week 24, followed by Secukinumab 150 or 300 mg s.c. every 4 weeks; respective dose was assigned according to underlying condition, in case of PsA according to severity of concomitant Psoriasis or preexposure to anti-TNFα
OG001	Placebo	Placebo 150 mg or 300 mg s.c., administered at baseline, weeks 1, 2, 3, 4 and every 4 weeks until week 24, followed by Secukinumab 150 or 300 mg s.c. every 4 weeks; respective dose was assigned according to underlying condition, in case of PsA according to severity of concomitant Psoriasis or preexposure to anti-TNFα

Units	Counts
Participants

Secondary

Number (%) of Patients With Improvement of Bone Marrow Edema

Number (%) of patients with an improvement of bone marrow edema from baseline to Week 24 as assessed by the respective subcomponent of the Psoriatic Arthritis Magnetic Resonance Imaging Score (PsAMRIS) in the affected foot.

Full analysis set (FAS)

Posted

Count of Participants

Participants

Week 24

ID	Title	Description
OG000	Secukinumab	Secukinumab 150 mg or 300 mg s.c., administered at baseline, weeks 1, 2, 3, 4 and every 4 weeks until week 24, followed by Secukinumab 150 or 300 mg s.c. every 4 weeks; respective dose was assigned according to underlying condition, in case of PsA according to severity of concomitant Psoriasis or preexposure to anti-TNFα
OG001	Placebo	Placebo 150 mg or 300 mg s.c., administered at baseline, weeks 1, 2, 3, 4 and every 4 weeks until week 24, followed by Secukinumab 150 or 300 mg s.c. every 4 weeks; respective dose was assigned according to underlying condition, in case of PsA according to severity of concomitant Psoriasis or preexposure to anti-TNFα

Units	Counts
Participants

Secondary

Number (%) of Patients With Resolution of Enthesitis as Assessed by LEI

Number (%) of patients with resolution of enthesitis as assessed by the Leeds enthesitis index (LEI) at Week 24.

Full analysis set (FAS)

Posted

Count of Participants

Participants

Week 24

ID	Title	Description
OG000	Secukinumab	Secukinumab 150 mg or 300 mg s.c., administered at baseline, weeks 1, 2, 3, 4 and every 4 weeks until week 24, followed by Secukinumab 150 or 300 mg s.c. every 4 weeks; respective dose was assigned according to underlying condition, in case of PsA according to severity of concomitant Psoriasis or preexposure to anti-TNFα
OG001	Placebo	Placebo 150 mg or 300 mg s.c., administered at baseline, weeks 1, 2, 3, 4 and every 4 weeks until week 24, followed by Secukinumab 150 or 300 mg s.c. every 4 weeks; respective dose was assigned according to underlying condition, in case of PsA according to severity of concomitant Psoriasis or preexposure to anti-TNFα

Units	Counts
Participants

Secondary

Mean Change of Physician's Global Assessment of Disease Activity

Mean change of physician's global assessment (PhGA) of disease activity from baseline to Week 24 measured by Visual Analog Scale (VAS) ranging from 0 to 100, with 0 representing not severe and 100 representing very severe.

Full analysis set (FAS)

Posted

Mean

Standard Deviation

Week 24

ID	Title	Description
OG000	Secukinumab	Secukinumab 150 mg or 300 mg s.c., administered at baseline, weeks 1, 2, 3, 4 and every 4 weeks until week 24, followed by Secukinumab 150 or 300 mg s.c. every 4 weeks; respective dose was assigned according to underlying condition, in case of PsA according to severity of concomitant Psoriasis or preexposure to anti-TNFα
OG001	Placebo	Placebo 150 mg or 300 mg s.c., administered at baseline, weeks 1, 2, 3, 4 and every 4 weeks until week 24, followed by Secukinumab 150 or 300 mg s.c. every 4 weeks; respective dose was assigned according to underlying condition, in case of PsA according to severity of concomitant Psoriasis or preexposure to anti-TNFα

Units	Counts
Participants

Secondary

Mean Change of Patient's Global Assessment of Disease Activity

Mean change of patient's global assessment (PGA) of disease activity from baseline to Week 24 measured by Visual Analog Scale (VAS) ranging from 0 to 100, with 0 representing not severe and 100 representing very severe.

Full analysis set (FAS)

Posted

Mean

Standard Deviation

Week 24

ID	Title	Description
OG000	Secukinumab	Secukinumab 150 mg or 300 mg s.c., administered at baseline, weeks 1, 2, 3, 4 and every 4 weeks until week 24, followed by Secukinumab 150 or 300 mg s.c. every 4 weeks; respective dose was assigned according to underlying condition, in case of PsA according to severity of concomitant Psoriasis or preexposure to anti-TNFα
OG001	Placebo	Placebo 150 mg or 300 mg s.c., administered at baseline, weeks 1, 2, 3, 4 and every 4 weeks until week 24, followed by Secukinumab 150 or 300 mg s.c. every 4 weeks; respective dose was assigned according to underlying condition, in case of PsA according to severity of concomitant Psoriasis or preexposure to anti-TNFα

Units	Counts
Participants

Secondary

Mean Change of Physician's Assessment of Heel Enthesopathy Activity

Mean change of physician's assessment of heel enthesopathy activity from baseline to Week 24 measured by Visual Analog Scale (VAS) ranging from 0 to 100, with 0 representing not severe and 100 representing very severe.

Full analysis set (FAS)

Posted

Mean

Standard Deviation

Week 24

ID	Title	Description
OG000	Secukinumab	Secukinumab 150 mg or 300 mg s.c., administered at baseline, weeks 1, 2, 3, 4 and every 4 weeks until week 24, followed by Secukinumab 150 or 300 mg s.c. every 4 weeks; respective dose was assigned according to underlying condition, in case of PsA according to severity of concomitant Psoriasis or preexposure to anti-TNFα
OG001	Placebo	Placebo 150 mg or 300 mg s.c., administered at baseline, weeks 1, 2, 3, 4 and every 4 weeks until week 24, followed by Secukinumab 150 or 300 mg s.c. every 4 weeks; respective dose was assigned according to underlying condition, in case of PsA according to severity of concomitant Psoriasis or preexposure to anti-TNFα

Units	Counts
Participants

Secondary

Mean Change of Patient's Assessment of Heel Enthesopathy Activity

Mean change of patient's assessment of heel enthesopathy activity from baseline to Week 24 measured by Visual Analog Scale (VAS) ranging from 0 to 100, with 0 representing not severe and 100 representing very severe.

Full analysis set (FAS)

Posted

Mean

Standard Deviation

Week 24

ID	Title	Description
OG000	Secukinumab	Secukinumab 150 mg or 300 mg s.c., administered at baseline, weeks 1, 2, 3, 4 and every 4 weeks until week 24, followed by Secukinumab 150 or 300 mg s.c. every 4 weeks; respective dose was assigned according to underlying condition, in case of PsA according to severity of concomitant Psoriasis or preexposure to anti-TNFα
OG001	Placebo	Placebo 150 mg or 300 mg s.c., administered at baseline, weeks 1, 2, 3, 4 and every 4 weeks until week 24, followed by Secukinumab 150 or 300 mg s.c. every 4 weeks; respective dose was assigned according to underlying condition, in case of PsA according to severity of concomitant Psoriasis or preexposure to anti-TNFα

Units	Counts
Participants

Secondary

Mean Change in Short Form-36 (SF-36) v2

Mean change in Short Form-36 (SF-36) v2 as an indicator of overall health status

The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100 Lower scores = more disability, higher scores = less disability

Full analysis set (FAS)

Posted

Mean

Standard Deviation

scores on a scale

Week 24

ID	Title	Description
OG000	Secukinumab	Secukinumab 150 mg or 300 mg s.c., administered at baseline, weeks 1, 2, 3, 4 and every 4 weeks until week 24, followed by Secukinumab 150 or 300 mg s.c. every 4 weeks; respective dose was assigned according to underlying condition, in case of PsA according to severity of concomitant Psoriasis or preexposure to anti-TNFα
OG001	Placebo	Placebo 150 mg or 300 mg s.c., administered at baseline, weeks 1, 2, 3, 4 and every 4 weeks until week 24, followed by Secukinumab 150 or 300 mg s.c. every 4 weeks; respective dose was assigned according to underlying condition, in case of PsA according to severity of concomitant Psoriasis or preexposure to anti-TNFα

Units	Counts
Participants

Secondary

Percentage of Patients With Resolution of Achilles Tendon Enthesitis After Switching From Placebo to Secukinumab

Percentage of patients with resolution of Achilles tendon enthesitis (affected foot) after switching from placebo to secukinumab at Week 24

Full analysis set (FAS)

Posted

Count of Participants

Participants

Weeks 24 and 52

ID	Title	Description
OG000	Secukinumab	Secukinumab 150 mg or 300 mg s.c., administered at baseline, weeks 1, 2, 3, 4 and every 4 weeks until week 24, followed by Secukinumab 150 or 300 mg s.c. every 4 weeks; respective dose was assigned according to underlying condition, in case of PsA according to severity of concomitant Psoriasis or preexposure to anti-TNFα
OG001	Placebo	Placebo 150 mg or 300 mg s.c., administered at baseline, weeks 1, 2, 3, 4 and every 4 weeks until week 24, followed by Secukinumab 150 or 300 mg s.c. every 4 weeks; respective dose was assigned according to underlying condition, in case of PsA according to severity of concomitant Psoriasis or preexposure to anti-TNFα

Units	Counts
Participants

Secondary

Mean Change of Heel Pain After Switching From Placebo to Secukinumab

Mean change of heel pain after switching from placebo to secukinumab from Week 24 to week 52 measured by Numeric Rating Scale (NRS) ranging from 0 to 10, with 0 representing no pain and 10 representing worst pain (e.g. "pain as bad as you can imagine" or "worst pain imaginable").

Full analysis set (FAS)

Posted

Mean

Standard Deviation

Scores on a scale

Change from week 24 to week 52

ID	Title	Description
OG000	Secukinumab	Secukinumab 150 mg or 300 mg s.c., administered at baseline, weeks 1, 2, 3, 4 and every 4 weeks until week 24, followed by Secukinumab 150 or 300 mg s.c. every 4 weeks; respective dose was assigned according to underlying condition, in case of PsA according to severity of concomitant Psoriasis or preexposure to anti-TNFα
OG001	Placebo	Placebo 150 mg or 300 mg s.c., administered at baseline, weeks 1, 2, 3, 4 and every 4 weeks until week 24, followed by Secukinumab 150 or 300 mg s.c. every 4 weeks; respective dose was assigned according to underlying condition, in case of PsA according to severity of concomitant Psoriasis or preexposure to anti-TNFα

Units	Counts

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	Secukinumab	Secukinumab 150 mg or 300 mg s.c., administered at baseline, weeks 1, 2, 3, 4 and every 4 weeks until week 24, followed by Secukinumab 150 or 300 mg s.c. every 4 weeks; respective dose was assigned according to underlying condition, in case of PsA according to severity of concomitant Psoriasis or preexposure to anti-TNFα	0	102	7	102	33	102
EG001	Placebo-Secukinumab	Placebo 150 mg or 300 mg s.c., administered at baseline, weeks 1, 2, 3, 4 and every 4 weeks until week 24, followed by Secukinumab 150 or 300 mg s.c. every 4 weeks; respective dose was assigned according to underlying condition, in case of PsA according to severity of concomitant Psoriasis or preexposure to anti-TNFα	0	102	6	102	34	102

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Atrial fibrillation	Cardiac disorders	MedDRA (22.1)	Systematic Assessment	EG0001 affected102 at risk EG0011 affected102 at risk
Goitre	Endocrine disorders	MedDRA (22.1)	Systematic Assessment	EG0000 affected102 at risk EG0011 affected102 at risk
Abdominal adhesions	Gastrointestinal disorders	MedDRA (22.1)	Systematic Assessment	EG0000 affected102 at risk EG0011 affected102 at risk
Inflammatory bowel disease	Gastrointestinal disorders	MedDRA (22.1)	Systematic Assessment	EG0001 affected102 at risk EG0011 affected102 at risk
Large intestinal stenosis	Gastrointestinal disorders	MedDRA (22.1)	Systematic Assessment	EG0000 affected102 at risk EG0011 affected102 at risk
Cellulitis	Infections and infestations	MedDRA (22.1)	Systematic Assessment	EG0001 affected102 at risk EG0010 affected102 at risk
Diverticulitis	Infections and infestations	MedDRA (22.1)	Systematic Assessment	EG0000 affected102 at risk EG0011 affected102 at risk
Pyelonephritis acute	Infections and infestations	MedDRA (22.1)	Systematic Assessment	EG0000 affected102 at risk EG0011 affected102 at risk
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA (22.1)	Systematic Assessment	EG0000 affected102 at risk EG0011 affected102 at risk
Stress fracture	Injury, poisoning and procedural complications	MedDRA (22.1)	Systematic Assessment	EG0000 affected102 at risk EG0011 affected102 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA (22.1)	Systematic Assessment	EG0001 affected102 at risk EG0010 affected102 at risk
Invasive breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (22.1)	Systematic Assessment	EG0001 affected102 at risk EG0010 affected102 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (22.1)	Systematic Assessment	EG0001 affected102 at risk EG0010 affected102 at risk
Uterine cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (22.1)	Systematic Assessment	EG0000 affected102 at risk EG0011 affected102 at risk
Cauda equina syndrome	Nervous system disorders	MedDRA (22.1)	Systematic Assessment	EG0001 affected102 at risk EG0010 affected102 at risk
Migraine with aura	Nervous system disorders	MedDRA (22.1)	Systematic Assessment	EG0001 affected102 at risk EG0010 affected102 at risk
Venous thrombosis limb	Vascular disorders	MedDRA (22.1)	Systematic Assessment	EG0000 affected102 at risk EG0011 affected102 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	MedDRA (22.1)	Systematic Assessment	EG0008 affected102 at risk EG0015 affected102 at risk
Nasopharyngitis	Infections and infestations	MedDRA (22.1)	Systematic Assessment	EG00013 affected102 at risk EG00122 affected102 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (22.1)	Systematic Assessment	EG0006 affected102 at risk EG0015 affected102 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (22.1)	Systematic Assessment	EG0007 affected102 at risk EG0015 affected102 at risk
Headache	Nervous system disorders	MedDRA (22.1)	Systematic Assessment	EG0006 affected102 at risk EG00110 affected102 at risk

ID	Term
D025242	Spondylarthropathies
D025241	Spondylarthritis
D013166	Spondylitis
D013122	Spinal Diseases
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D001168	Arthritis
D007592	Joint Diseases
D011565	Psoriasis
D017444	Skin Diseases, Papulosquamous
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D000844	Ankylosis

ID	Term
D015535	Arthritis, Psoriatic
D000089183	Axial Spondyloarthritis