Trial Outcomes & Findings for GOLimumab and Methotrexate Versus Methotrexate in Very Early PsA (NCT NCT04108468)

NCT ID: NCT04108468

Last Updated: 2025-12-02

Results Overview

The Psoriatic Arthritis Disease Activity Score ranges from 0-10; higher scores represent a worse outcome.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 84 participants
• Primary outcome timeframe: 24 weeks
• Results posted on: 2025-12-02

Participant Flow

Participant milestones

Measure	Methotrexate Methotrexate: Methotrexate	Golimumab & Methotrexate Methotrexate: Methotrexate Golimumab: Simponi
Overall Study STARTED	41	43
Overall Study COMPLETED	38	39
Overall Study NOT COMPLETED	3	4

Reasons for withdrawal

Measure	Methotrexate Methotrexate: Methotrexate	Golimumab & Methotrexate Methotrexate: Methotrexate Golimumab: Simponi
Overall Study Physician Decision	0	1
Overall Study Lost to Follow-up	0	1
Overall Study Non-compliance	1	1
Overall Study Unable to attend final visit	2	0
Overall Study Missed study medication	0	1

Baseline Characteristics

GOLimumab and Methotrexate Versus Methotrexate in Very Early PsA

Baseline characteristics by cohort

Measure	Methotrexate n=41 Participants Methotrexate: Methotrexate	Golimumab & Methotrexate n=43 Participants Methotrexate: Methotrexate Golimumab: Simponi	Total n=84 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=121 Participants	0 Participants n=122 Participants	0 Participants n=243 Participants
Age, Categorical Between 18 and 65 years	39 Participants n=121 Participants	40 Participants n=122 Participants	79 Participants n=243 Participants
Age, Categorical >=65 years	2 Participants n=121 Participants	3 Participants n=122 Participants	5 Participants n=243 Participants
Age, Continuous	42.9 years STANDARD_DEVIATION 12.5 • n=121 Participants	42.1 years STANDARD_DEVIATION 12.5 • n=122 Participants	42.5 years STANDARD_DEVIATION 12.4 • n=243 Participants
Sex: Female, Male Female	19 Participants n=121 Participants	19 Participants n=122 Participants	38 Participants n=243 Participants
Sex: Female, Male Male	22 Participants n=121 Participants	24 Participants n=122 Participants	46 Participants n=243 Participants
Race/Ethnicity, Customized White	32 Participants n=121 Participants	29 Participants n=122 Participants	61 Participants n=243 Participants
Race/Ethnicity, Customized Asian	2 Participants n=121 Participants	3 Participants n=122 Participants	5 Participants n=243 Participants
Race/Ethnicity, Customized Other	1 Participants n=121 Participants	1 Participants n=122 Participants	2 Participants n=243 Participants
Race/Ethnicity, Customized Not stated	6 Participants n=121 Participants	10 Participants n=122 Participants	16 Participants n=243 Participants
Region of Enrollment United Kingdom	41 participants n=121 Participants	43 participants n=122 Participants	84 participants n=243 Participants
PASDAS	5.6 units on a scale STANDARD_DEVIATION 1.1 • n=121 Participants	5.9 units on a scale STANDARD_DEVIATION 1.3 • n=122 Participants	5.7 units on a scale STANDARD_DEVIATION 1.2 • n=243 Participants
Leeds Enthesitis Index	1.51 score on a scale STANDARD_DEVIATION 1.76 • n=121 Participants	1.37 score on a scale STANDARD_DEVIATION 1.47 • n=122 Participants	1.44 score on a scale STANDARD_DEVIATION 1.62 • n=243 Participants
Leeds Dactylitis Index	26.60 units on a scale STANDARD_DEVIATION 30.56 • n=121 Participants	38.04 units on a scale STANDARD_DEVIATION 50.85 • n=122 Participants	32.45 units on a scale STANDARD_DEVIATION 42.32 • n=243 Participants
Psoriatic Arthritis Skin Index Score	2.6 units on a scale n=121 Participants	3.4 units on a scale n=122 Participants	2.7 units on a scale n=243 Participants
Modified Nail Psoriasis Severity Index (mNAPSI)	7.25 units on a scale STANDARD_DEVIATION 11.26 • n=121 Participants	11.36 units on a scale STANDARD_DEVIATION 18.15 • n=122 Participants	9.35 units on a scale STANDARD_DEVIATION 15.23 • n=243 Participants
Composite Psoriatic Disease Activity Index (CPDAI)	6.4 units on a scale STANDARD_DEVIATION 2.7 • n=121 Participants	7.0 units on a scale STANDARD_DEVIATION 2.6 • n=122 Participants	6.7 units on a scale STANDARD_DEVIATION 2.6 • n=243 Participants
Ultrasound Global OMERACT-EULAR System Score (GLOESS)	21.6 units on a scale STANDARD_DEVIATION 11.2 • n=121 Participants	24.8 units on a scale STANDARD_DEVIATION 13.0 • n=122 Participants	23.2 units on a scale STANDARD_DEVIATION 12.2 • n=243 Participants
Ultrasound Entheseal Inflammatory Score	4.2 units on a scale STANDARD_DEVIATION 3.7 • n=121 Participants	5.4 units on a scale STANDARD_DEVIATION 3.9 • n=122 Participants	4.8 units on a scale STANDARD_DEVIATION 3.8 • n=243 Participants
Ultrasound Entheseal Chronicity Score	3.0 units on a scale STANDARD_DEVIATION 3.1 • n=121 Participants	3.5 units on a scale STANDARD_DEVIATION 3.0 • n=122 Participants	3.2 units on a scale STANDARD_DEVIATION 3.0 • n=243 Participants
Participant Disease Activity Visual Analogue Scale	52.1 units on a scale STANDARD_DEVIATION 25.2 • n=121 Participants	59.1 units on a scale STANDARD_DEVIATION 21.4 • n=122 Participants	55.7 units on a scale STANDARD_DEVIATION 23.5 • n=243 Participants
Dermatology Life Quality Index (DLQI)	3.0 units on a scale n=121 Participants	5.0 units on a scale n=122 Participants	3.5 units on a scale n=243 Participants
36-Item Short Form Health Survey (SF-36) Physical Component Summary	37.5 units on a scale STANDARD_DEVIATION 9.9 • n=121 Participants	32.5 units on a scale STANDARD_DEVIATION 10.0 • n=122 Participants	34.9 units on a scale STANDARD_DEVIATION 10.2 • n=243 Participants
36-Item Short Form Health Survey (SF-36) Mental Component Summary	46.6 units on a scale STANDARD_DEVIATION 12.5 • n=121 Participants	46.7 units on a scale STANDARD_DEVIATION 10.7 • n=122 Participants	46.7 units on a scale STANDARD_DEVIATION 11.5 • n=243 Participants

PRIMARY outcome

Timeframe: 24 weeks

Population: Full analysis set

The Psoriatic Arthritis Disease Activity Score ranges from 0-10; higher scores represent a worse outcome.

Outcome measures

Measure	Golimumab & Methotrexate n=43 Participants Methotrexate: Methotrexate Golimumab: Simponi	Methotrexate n=41 Participants Methotrexate: Methotrexate
Psoriatic Arthritis Disease Activity Score (PASDAS) at 24 Weeks	2.70 score on a scale Standard Deviation 1.38	3.09 score on a scale Standard Deviation 1.32

SECONDARY outcome

Timeframe: 12 weeks

Population: Full analysis set

The Psoriatic Arthritis Disease Activity Score ranges from 0-10; higher scores represent a worse outcome.

Outcome measures

Measure	Golimumab & Methotrexate n=43 Participants Methotrexate: Methotrexate Golimumab: Simponi	Methotrexate n=41 Participants Methotrexate: Methotrexate
Psoriatic Arthritis Disease Activity Score (PASDAS) at 12 Weeks.	3.01 score on a scale Standard Deviation 1.31	3.70 score on a scale Standard Deviation 1.62

SECONDARY outcome

Timeframe: 36 weeks

Population: Full analysis set

The Psoriatic Arthritis Disease Activity Score ranges from 0-10; higher scores represent a worse outcome.

Outcome measures

Measure	Golimumab & Methotrexate n=43 Participants Methotrexate: Methotrexate Golimumab: Simponi	Methotrexate n=41 Participants Methotrexate: Methotrexate
Psoriatic Arthritis Disease Activity Score (PASDAS) at 36 Weeks.	2.93 score on a scale Standard Deviation 3.42	3.30 score on a scale Standard Deviation 1.70

SECONDARY outcome

Timeframe: 52 weeks

Population: Full analysis set

The Psoriatic Arthritis Disease Activity Score ranges from 0-10; higher scores represent a worse outcome.

Outcome measures

Measure	Golimumab & Methotrexate n=43 Participants Methotrexate: Methotrexate Golimumab: Simponi	Methotrexate n=41 Participants Methotrexate: Methotrexate
Psoriatic Arthritis Disease Activity Score (PASDAS) at 52 Weeks.	3.42 score on a scale Standard Deviation 1.55	3.36 score on a scale Standard Deviation 1.39

SECONDARY outcome

Timeframe: 12 weeks

Population: Full analysis set

The Composite Psoriatic Disease Activity Index ranges from 0-15; higher scores represent a worse outcome.

Outcome measures

Measure	Golimumab & Methotrexate n=43 Participants Methotrexate: Methotrexate Golimumab: Simponi	Methotrexate n=41 Participants Methotrexate: Methotrexate
Composite Psoriatic Disease Activity Index (CPDAI) at 12 Weeks.	3.49 score on a scale Standard Deviation 2.41	4.10 score on a scale Standard Deviation 2.76

SECONDARY outcome

Timeframe: 24 weeks

Population: Full analysis set

The Composite Psoriatic Disease Activity Index ranges from 0-15; higher scores represent a worse outcome.

Outcome measures

Measure	Golimumab & Methotrexate n=43 Participants Methotrexate: Methotrexate Golimumab: Simponi	Methotrexate n=41 Participants Methotrexate: Methotrexate
Composite Psoriatic Disease Activity Index (CPDAI) at 24 Weeks.	3.12 score on a scale Standard Deviation 2.45	3.24 score on a scale Standard Deviation 2.58

SECONDARY outcome

Timeframe: 36 weeks

Population: Full analysis set

The Composite Psoriatic Disease Activity Index ranges from 0-15; higher scores represent a worse outcome.

Outcome measures

Measure	Golimumab & Methotrexate n=43 Participants Methotrexate: Methotrexate Golimumab: Simponi	Methotrexate n=41 Participants Methotrexate: Methotrexate
Composite Psoriatic Disease Activity Index (CPDAI) at 36 Weeks.	3.17 score on a scale Standard Deviation 2.80	2.97 score on a scale Standard Deviation 2.69

SECONDARY outcome

Timeframe: 52 weeks

Population: Full analysis set

The Composite Psoriatic Disease Activity Index ranges from 0-15; higher scores represent a worse outcome.

Outcome measures

Measure	Golimumab & Methotrexate n=43 Participants Methotrexate: Methotrexate Golimumab: Simponi	Methotrexate n=41 Participants Methotrexate: Methotrexate
Composite Psoriatic Disease Activity Index (CPDAI) at 52 Weeks.	3.49 score on a scale Standard Deviation 2.75	3.03 score on a scale Standard Deviation 2.71

SECONDARY outcome

Timeframe: 24 weeks

Population: Full analysis set

The Participant Disease Activity Visual Analogue Score ranges from 0-100; higher scores represent a worse outcome.

Outcome measures

Measure	Golimumab & Methotrexate n=43 Participants Methotrexate: Methotrexate Golimumab: Simponi	Methotrexate n=41 Participants Methotrexate: Methotrexate
Participant Disease Activity Visual Analogue Score at 24 Weeks.	27.72 score on a scale Standard Deviation 23.42	27.56 score on a scale Standard Deviation 23.54

SECONDARY outcome

Timeframe: 52 weeks

Population: Full analysis set

The Participant Disease Activity Visual Analogue Score ranges from 0-100; higher scores represent a worse outcome.

Outcome measures

Measure	Golimumab & Methotrexate n=43 Participants Methotrexate: Methotrexate Golimumab: Simponi	Methotrexate n=41 Participants Methotrexate: Methotrexate
Participant Disease Activity Visual Analogue Score at 52 Weeks.	36.57 score on a scale Standard Deviation 26.06	32.73 score on a scale Standard Deviation 25.62

SECONDARY outcome

Timeframe: 24 weeks

Population: Full analysis set

The 36-item Short Form Health Survey (SF-36) Physical Component Score ranges from 0-100; higher scores represent a better outcome.

Outcome measures

Measure	Golimumab & Methotrexate n=43 Participants Methotrexate: Methotrexate Golimumab: Simponi	Methotrexate n=41 Participants Methotrexate: Methotrexate
36-item Short Form Health Survey (SF-36) Physical Component Score at 24 Weeks.	46.10 score on a scale Standard Deviation 9.32	45.62 score on a scale Standard Deviation 9.45

SECONDARY outcome

Timeframe: 52 weeks

Population: Full analysis set

The 36-item Short Form Health Survey (SF-36) Physical Component Score ranges from 0-100; higher scores represent a better outcome.

Outcome measures

Measure	Golimumab & Methotrexate n=43 Participants Methotrexate: Methotrexate Golimumab: Simponi	Methotrexate n=41 Participants Methotrexate: Methotrexate
36-item Short Form Health Survey (SF-36) Physical Component Score at 52 Weeks.	42.80 score on a scale Standard Deviation 10.38	44.44 score on a scale Standard Deviation 10.25

SECONDARY outcome

Timeframe: 24 weeks

Population: Full analysis set

The 36-item Short Form Health Survey (SF-36) Mental Component Score ranges from 0-100; higher scores represent a better outcome.

Outcome measures

Measure	Golimumab & Methotrexate n=43 Participants Methotrexate: Methotrexate Golimumab: Simponi	Methotrexate n=41 Participants Methotrexate: Methotrexate
36-item Short Form Health Survey (SF-36) Mental Component Score at 24 Weeks.	51.27 score on a scale Standard Deviation 8.84	52.11 score on a scale Standard Deviation 9.34

SECONDARY outcome

Timeframe: 52 weeks

Population: Full analysis set

The 36-item Short Form Health Survey (SF-36) Mental Component Score ranges from 0-100; higher scores represent a better outcome.

Outcome measures

Measure	Golimumab & Methotrexate n=43 Participants Methotrexate: Methotrexate Golimumab: Simponi	Methotrexate n=41 Participants Methotrexate: Methotrexate
36-item Short Form Health Survey (SF-36) Mental Component Score at 52 Weeks.	51.65 score on a scale Standard Deviation 9.75	52.44 score on a scale Standard Deviation 10.03

SECONDARY outcome

Timeframe: 12 weeks

Population: Full analysis set

In the joint set scanned in the Full Analysis Set, the Ultrasound Global OMERACT-EULAR System Score ranged from 0-72; higher scores represent a worse outcome.

Outcome measures

Measure	Golimumab & Methotrexate n=43 Participants Methotrexate: Methotrexate Golimumab: Simponi	Methotrexate n=41 Participants Methotrexate: Methotrexate
Ultrasound Global OMERACT-EULAR System Score (GLOESS) at 12 Weeks.	23.07 score on a scale Standard Deviation 11.74	18.74 score on a scale Standard Deviation 10.12

SECONDARY outcome

Timeframe: 24 weeks

Population: Full analysis set

In the joint set scanned in the Full Analysis Set, the Ultrasound Global OMERACT-EULAR System Score ranged from 0-72; higher scores represent a worse outcome.

Outcome measures

Measure	Golimumab & Methotrexate n=43 Participants Methotrexate: Methotrexate Golimumab: Simponi	Methotrexate n=41 Participants Methotrexate: Methotrexate
Ultrasound Global OMERACT-EULAR System Score (GLOESS) at 24 Weeks.	22.44 score on a scale Standard Deviation 10.26	20.63 score on a scale Standard Deviation 10.06

SECONDARY outcome

Timeframe: 36 weeks

Population: Full analysis set

In the joint set scanned in the Full Analysis Set, the Ultrasound Global OMERACT-EULAR System Score ranged from 0-72; higher scores represent a worse outcome.

Outcome measures

Measure	Golimumab & Methotrexate n=43 Participants Methotrexate: Methotrexate Golimumab: Simponi	Methotrexate n=41 Participants Methotrexate: Methotrexate
Ultrasound Global OMERACT-EULAR System Score (GLOESS) at 36 Weeks.	24.20 score on a scale Standard Deviation 7.96	22.46 score on a scale Standard Deviation 9.83

SECONDARY outcome

Timeframe: 12 weeks

Population: Full analysis set

The Ultrasound Entheseal Inflammatory Score ranged from 0-70; a higher score represents a worse outcome.

Outcome measures

Measure	Golimumab & Methotrexate n=43 Participants Methotrexate: Methotrexate Golimumab: Simponi	Methotrexate n=41 Participants Methotrexate: Methotrexate
Ultrasound Entheseal Inflammatory Score at 12 Weeks.	4.68 score on a scale Standard Deviation 4.28	4.86 score on a scale Standard Deviation 4.80

SECONDARY outcome

Timeframe: 24 weeks

Population: Full analysis set

The Ultrasound Entheseal Inflammatory Score ranged from 0-70; a higher score represents a worse outcome.

Outcome measures

Measure	Golimumab & Methotrexate n=43 Participants Methotrexate: Methotrexate Golimumab: Simponi	Methotrexate n=41 Participants Methotrexate: Methotrexate
Ultrasound Entheseal Inflammatory Score at 24 Weeks.	4.90 score on a scale Standard Deviation 3.92	4.89 score on a scale Standard Deviation 4.49

SECONDARY outcome

Timeframe: 36 weeks

Population: Full analysis set

The Ultrasound Entheseal Inflammatory Score ranged from 0-70; a higher score represents a worse outcome.

Outcome measures

Measure	Golimumab & Methotrexate n=43 Participants Methotrexate: Methotrexate Golimumab: Simponi	Methotrexate n=41 Participants Methotrexate: Methotrexate
Ultrasound Entheseal Inflammatory Score at 36 Weeks.	4.14 score on a scale Standard Deviation 3.45	6.17 score on a scale Standard Deviation 6.49

SECONDARY outcome

Timeframe: 12 weeks

Population: Full analysis set

The Ultrasound Entheseal Chronicity Score ranged from 0-50; a higher score represents a worse outcome.

Outcome measures

Measure	Golimumab & Methotrexate n=43 Participants Methotrexate: Methotrexate Golimumab: Simponi	Methotrexate n=41 Participants Methotrexate: Methotrexate
Ultrasound Entheseal Chronicity Score at 12 Weeks.	2.50 score on a scale Standard Deviation 2.79	3.17 score on a scale Standard Deviation 2.38

SECONDARY outcome

Timeframe: 24 weeks

Population: Full analysis set

The Ultrasound Entheseal Chronicity Score ranged from 0-50; a higher score represents a worse outcome.

Outcome measures

Measure	Golimumab & Methotrexate n=43 Participants Methotrexate: Methotrexate Golimumab: Simponi	Methotrexate n=41 Participants Methotrexate: Methotrexate
Ultrasound Entheseal Chronicity Score at 24 Weeks.	2.63 score on a scale Standard Deviation 2.21	2.85 score on a scale Standard Deviation 2.31

SECONDARY outcome

Timeframe: 36 weeks

Population: Full analysis set

The Ultrasound Entheseal Chronicity Score ranged from 0-50; a higher score represents a worse outcome.

Outcome measures

Measure	Golimumab & Methotrexate n=43 Participants Methotrexate: Methotrexate Golimumab: Simponi	Methotrexate n=41 Participants Methotrexate: Methotrexate
Ultrasound Entheseal Chronicity Score at 36 Weeks.	2.97 score on a scale Standard Deviation 2.66	2.79 score on a scale Standard Deviation 2.64

SECONDARY outcome

Timeframe: 12 Weeks

Population: Full Analysis Set

The Leeds Enthesitis Index ranges from 0-6; a higher score represents a worse outcome.

Outcome measures

Measure	Golimumab & Methotrexate n=43 Participants Methotrexate: Methotrexate Golimumab: Simponi	Methotrexate n=41 Participants Methotrexate: Methotrexate
Leeds Enthesitis Index at 12 Weeks	0.74 score on a scale Standard Deviation 1.35	0.95 score on a scale Standard Deviation 1.76

SECONDARY outcome

Timeframe: 24 Weeks

Population: Full Analysis Set

The Leeds Enthesitis Index ranges from 0-6; a higher score represents a worse outcome.

Outcome measures

Measure	Golimumab & Methotrexate n=43 Participants Methotrexate: Methotrexate Golimumab: Simponi	Methotrexate n=41 Participants Methotrexate: Methotrexate
Leeds Enthesitis Index at 24 Weeks	0.53 score on a scale Standard Deviation 0.98	0.61 score on a scale Standard Deviation 1.34

SECONDARY outcome

Timeframe: 36 Weeks

Population: Full Analysis Set

The Leeds Enthesitis Index ranges from 0-6; a higher score represents a worse outcome.

Outcome measures

Measure	Golimumab & Methotrexate n=43 Participants Methotrexate: Methotrexate Golimumab: Simponi	Methotrexate n=41 Participants Methotrexate: Methotrexate
Leeds Enthesitis Index at 36 Weeks	0.74 score on a scale Standard Deviation 1.43	0.65 score on a scale Standard Deviation 1.37

SECONDARY outcome

Timeframe: 52 Weeks

Population: Full Analysis Set

The Leeds Enthesitis Index ranges from 0-6; a higher score represents a worse outcome.

Outcome measures

Measure	Golimumab & Methotrexate n=43 Participants Methotrexate: Methotrexate Golimumab: Simponi	Methotrexate n=41 Participants Methotrexate: Methotrexate
Leeds Enthesitis Index at 52 Weeks	0.50 score on a scale Standard Deviation 0.97	0.43 score on a scale Standard Deviation 1.09

SECONDARY outcome

Timeframe: 12 Weeks

Population: Full Analysis Set

The Leeds Dactylitis Index ranges from 0-~40; a higher score represents a worse outcome.

Outcome measures

Measure	Golimumab & Methotrexate n=43 Participants Methotrexate: Methotrexate Golimumab: Simponi	Methotrexate n=41 Participants Methotrexate: Methotrexate
Leeds Dactylitis Index at 12 Weeks	2.22 units on a scale Standard Deviation 7.92	11.46 units on a scale Standard Deviation 19.88

SECONDARY outcome

Timeframe: 24 Weeks

Population: Full Analysis Set

The Leeds Dactylitis Index ranges from 0-~40; a higher score represents a worse outcome.

Outcome measures

Measure	Golimumab & Methotrexate n=43 Participants Methotrexate: Methotrexate Golimumab: Simponi	Methotrexate n=41 Participants Methotrexate: Methotrexate
Leeds Dactylitis Index at 24 Weeks	0.48 units on a scale Standard Deviation 2.52	5.04 units on a scale Standard Deviation 17.10

SECONDARY outcome

Timeframe: 36 Weeks

Population: Full Analysis Set

The Leeds Dactylitis Index ranges from 0-~40; a higher score represents a worse outcome.

Outcome measures

Measure	Golimumab & Methotrexate n=43 Participants Methotrexate: Methotrexate Golimumab: Simponi	Methotrexate n=41 Participants Methotrexate: Methotrexate
Leeds Dactylitis Index at 36 Weeks	3.36 units on a scale Standard Deviation 15.15	4.38 units on a scale Standard Deviation 11.31

SECONDARY outcome

Timeframe: 52 Weeks

Population: Full Analysis Set

The Leeds Dactylitis Index ranges from 0-~40; a higher score represents a worse outcome.

Outcome measures

Measure	Golimumab & Methotrexate n=43 Participants Methotrexate: Methotrexate Golimumab: Simponi	Methotrexate n=41 Participants Methotrexate: Methotrexate
Leeds Dactylitis Index at 52 Weeks	3.45 units on a scale Standard Deviation 14.76	6.58 units on a scale Standard Deviation 14.89

SECONDARY outcome

Timeframe: 12 Weeks

Population: Full Analysis Set

The Modified Nail Psoriasis Severity Index ranges from 0-140; a higher score represents a worse outcome.

Outcome measures

Measure	Golimumab & Methotrexate n=43 Participants Methotrexate: Methotrexate Golimumab: Simponi	Methotrexate n=41 Participants Methotrexate: Methotrexate
The Modified Nail Psoriasis Severity Index (mNAPSI) at 12 Weeks	6.37 units on a scale Standard Deviation 10.66	4.78 units on a scale Standard Deviation 8.73

SECONDARY outcome

Timeframe: 24 Weeks

Population: Full Analysis Set

The Modified Nail Psoriasis Severity Index ranges from 0-140; a higher score represents a worse outcome.

Outcome measures

Measure	Golimumab & Methotrexate n=43 Participants Methotrexate: Methotrexate Golimumab: Simponi	Methotrexate n=41 Participants Methotrexate: Methotrexate
The Modified Nail Psoriasis Severity Index (mNAPSI) at 24 Weeks	3.12 units on a scale Standard Deviation 6.88	4.02 units on a scale Standard Deviation 6.41

SECONDARY outcome

Timeframe: 36 Weeks

Population: Full Analysis Set

The Modified Nail Psoriasis Severity Index ranges from 0-140; a higher score represents a worse outcome.

Outcome measures

Measure	Golimumab & Methotrexate n=43 Participants Methotrexate: Methotrexate Golimumab: Simponi	Methotrexate n=41 Participants Methotrexate: Methotrexate
The Modified Nail Psoriasis Severity Index (mNAPSI) at 36 Weeks	5.50 units on a scale Standard Deviation 11.16	4.47 units on a scale Standard Deviation 7.73

SECONDARY outcome

Timeframe: 52 Weeks

Population: Full Analysis Set

The Modified Nail Psoriasis Severity Index ranges from 0-140; a higher score represents a worse outcome.

Outcome measures

Measure	Golimumab & Methotrexate n=43 Participants Methotrexate: Methotrexate Golimumab: Simponi	Methotrexate n=41 Participants Methotrexate: Methotrexate
The Modified Nail Psoriasis Severity Index (mNAPSI) at 52 Weeks	7.72 units on a scale Standard Deviation 12.27	3.91 units on a scale Standard Deviation 7.32

SECONDARY outcome

Timeframe: 12 Weeks

Population: Full Analysis Set

The Psoriasis Area and Severity Index ranges from 0-72; a higher score represents a worse outcome.

Outcome measures

Measure	Golimumab & Methotrexate n=43 Participants Methotrexate: Methotrexate Golimumab: Simponi	Methotrexate n=41 Participants Methotrexate: Methotrexate
Psoriasis Area and Severity Index (PASI) Score at 12 Weeks	0.20 score on a scale Interval 0.0 to 1.2	1.00 score on a scale Interval 0.0 to 2.1

SECONDARY outcome

Timeframe: 24 Weeks

Population: Full Analysis Set

The Psoriasis Area and Severity Index ranges from 0-72; a higher score represents a worse outcome.

Outcome measures

Measure	Golimumab & Methotrexate n=43 Participants Methotrexate: Methotrexate Golimumab: Simponi	Methotrexate n=41 Participants Methotrexate: Methotrexate
Psoriasis Area and Severity Index (PASI) Score at 24 Weeks	0.00 score on a scale Interval 0.0 to 0.7	0.60 score on a scale Interval 0.0 to 1.6

SECONDARY outcome

Timeframe: 36 Weeks

Population: Full Analysis Set

The Psoriasis Area and Severity Index ranges from 0-72; a higher score represents a worse outcome.

Outcome measures

Measure	Golimumab & Methotrexate n=43 Participants Methotrexate: Methotrexate Golimumab: Simponi	Methotrexate n=41 Participants Methotrexate: Methotrexate
Psoriasis Area and Severity Index (PASI) Score at 36 Weeks	0.00 score on a scale Interval 0.0 to 0.6	0.70 score on a scale Interval 0.0 to 1.75

SECONDARY outcome

Timeframe: 52 Weeks

Population: Full Analysis Set

The Psoriasis Area and Severity Index ranges from 0-72; a higher score represents a worse outcome.

Outcome measures

Measure	Golimumab & Methotrexate n=43 Participants Methotrexate: Methotrexate Golimumab: Simponi	Methotrexate n=41 Participants Methotrexate: Methotrexate
Psoriasis Area and Severity Index (PASI) Score at 52 Weeks	0.55 score on a scale Interval 0.0 to 1.8	0.40 score on a scale Interval 0.0 to 1.6

SECONDARY outcome

Timeframe: 24 Weeks

Population: Full Analysis Set

The Dermatology Life Quality Index ranges from 0-30; a higher score represents a worse outcome.

Outcome measures

Measure	Golimumab & Methotrexate n=43 Participants Methotrexate: Methotrexate Golimumab: Simponi	Methotrexate n=41 Participants Methotrexate: Methotrexate
Dermatology Life Quality Index (DLQI) Score at 24 Weeks	1.00 score on a scale Interval 0.0 to 1.0	1.00 score on a scale Interval 0.0 to 2.0

SECONDARY outcome

Timeframe: 52 Weeks

Population: Full Analysis Set

The Dermatology Life Quality Index ranges from 0-30; a higher score represents a worse outcome.

Outcome measures

Measure	Golimumab & Methotrexate n=43 Participants Methotrexate: Methotrexate Golimumab: Simponi	Methotrexate n=41 Participants Methotrexate: Methotrexate
Dermatology Life Quality Index (DLQI) Score at 52 Weeks	1.00 score on a scale Interval 0.0 to 4.0	1.00 score on a scale Interval 0.0 to 2.0

SECONDARY outcome

Timeframe: 12 Weeks

Minimal Disease Activity (coded 0=No, 1=Yes) is achieved when at least 5 of the 7 following criteria are met: Tender joint count (/68) ≤1 Swollen joint count (/66) ≤1 PASI ≤1 or BSA≤3 Patient pain VAS ≤15 Patient global disease activity VAS ≤20 HAQ ≤0.5 Enthesitis count ≤1.

Outcome measures

Measure	Golimumab & Methotrexate n=43 Participants Methotrexate: Methotrexate Golimumab: Simponi	Methotrexate n=41 Participants Methotrexate: Methotrexate
Minimal Disease Activity (MDA) at 12 Weeks	20 Participants	18 Participants

SECONDARY outcome

Timeframe: 24 Weeks

Minimal Disease Activity (coded 0=No, 1=Yes) is achieved when at least 5 of the 7 following criteria are met: Tender joint count (/68) ≤1 Swollen joint count (/66) ≤1 PASI ≤1 or BSA≤3 Patient pain VAS ≤15 Patient global disease activity VAS ≤20 HAQ ≤0.5 Enthesitis count ≤1.

Outcome measures

Measure	Golimumab & Methotrexate n=43 Participants Methotrexate: Methotrexate Golimumab: Simponi	Methotrexate n=41 Participants Methotrexate: Methotrexate
Minimal Disease Activity (MDA) at 24 Weeks	24 Participants	24 Participants

SECONDARY outcome

Timeframe: 36 Weeks

Minimal Disease Activity (coded 0=No, 1=Yes) is achieved when at least 5 of the 7 following criteria are met: Tender joint count (/68) ≤1 Swollen joint count (/66) ≤1 PASI ≤1 or BSA≤3 Patient pain VAS ≤15 Patient global disease activity VAS ≤20 HAQ ≤0.5 Enthesitis count ≤1.

Outcome measures

Measure	Golimumab & Methotrexate n=43 Participants Methotrexate: Methotrexate Golimumab: Simponi	Methotrexate n=41 Participants Methotrexate: Methotrexate
Minimal Disease Activity (MDA) at 36 Weeks	25 Participants	22 Participants

SECONDARY outcome

Timeframe: 52 Weeks

Minimal Disease Activity (coded 0=No, 1=Yes) is achieved when at least 5 of the 7 following criteria are met: Tender joint count (/68) ≤1 Swollen joint count (/66) ≤1 PASI ≤1 or BSA≤3 Patient pain VAS ≤15 Patient global disease activity VAS ≤20 HAQ ≤0.5 Enthesitis count ≤1.

Outcome measures

Measure	Golimumab & Methotrexate n=43 Participants Methotrexate: Methotrexate Golimumab: Simponi	Methotrexate n=41 Participants Methotrexate: Methotrexate
Minimal Disease Activity (MDA) at 52 Weeks	17 Participants	20 Participants

SECONDARY outcome

Timeframe: 12 Weeks

Population: Full Analysis Set

American College of Rheumatology 20 Response (coded 0=No, 1=Yes) is achieved when there is:

• 20% improvement in both TJC (68 joints count) and SJC (66 joints count) and
• 20% improvement in at least 3 of the following 5 ACR Core set criteria:

1. Patient's Assessment of Pain Visual Analogue Scale (VAS)

2. Patient's Global Assessment of Disease Activity VAS

3. Physician's Global Assessment of Disease Activity VAS

4. Patient's Assessment of Physical Function as measured by the HAQ-DI

5. Acute phase reactant as measured by CRP

Outcome measures

Measure	Golimumab & Methotrexate n=43 Participants Methotrexate: Methotrexate Golimumab: Simponi	Methotrexate n=41 Participants Methotrexate: Methotrexate
American College of Rheumatology 20 (ACR20) Response at 12 Weeks	28 Participants	23 Participants

SECONDARY outcome

Timeframe: 24 Weeks

Population: Full Analysis Set

American College of Rheumatology 20 Response (coded 0=No, 1=Yes) is achieved when there is:

• 20% improvement in both TJC (68 joints count) and SJC (66 joints count) and
• 20% improvement in at least 3 of the following 5 ACR Core set criteria:

1. Patient's Assessment of Pain Visual Analogue Scale (VAS)

2. Patient's Global Assessment of Disease Activity VAS

3. Physician's Global Assessment of Disease Activity VAS

4. Patient's Assessment of Physical Function as measured by the HAQ-DI

5. Acute phase reactant as measured by CRP

Outcome measures

Measure	Golimumab & Methotrexate n=43 Participants Methotrexate: Methotrexate Golimumab: Simponi	Methotrexate n=41 Participants Methotrexate: Methotrexate
American College of Rheumatology 20 (ACR20) Response at 24 Weeks	28 Participants	27 Participants

SECONDARY outcome

Timeframe: 36 Weeks

Population: Full Analysis Set

American College of Rheumatology 20 Response (coded 0=No, 1=Yes) is achieved when there is:

• 20% improvement in both TJC (68 joints count) and SJC (66 joints count) and
• 20% improvement in at least 3 of the following 5 ACR Core set criteria:

1. Patient's Assessment of Pain Visual Analogue Scale (VAS)

2. Patient's Global Assessment of Disease Activity VAS

3. Physician's Global Assessment of Disease Activity VAS

4. Patient's Assessment of Physical Function as measured by the HAQ-DI

5. Acute phase reactant as measured by CRP

Outcome measures

Measure	Golimumab & Methotrexate n=43 Participants Methotrexate: Methotrexate Golimumab: Simponi	Methotrexate n=41 Participants Methotrexate: Methotrexate
American College of Rheumatology 20 (ACR20) Response at 36 Weeks	27 Participants	24 Participants

SECONDARY outcome

Timeframe: 52 Weeks

Population: Full Analysis Set

American College of Rheumatology 20 Response (coded 0=No, 1=Yes) is achieved when there is:

• 20% improvement in both TJC (68 joints count) and SJC (66 joints count) and
• 20% improvement in at least 3 of the following 5 ACR Core set criteria:

1. Patient's Assessment of Pain Visual Analogue Scale (VAS)

2. Patient's Global Assessment of Disease Activity VAS

3. Physician's Global Assessment of Disease Activity VAS

4. Patient's Assessment of Physical Function as measured by the HAQ-DI

5. Acute phase reactant as measured by CRP

Outcome measures

Measure	Golimumab & Methotrexate n=43 Participants Methotrexate: Methotrexate Golimumab: Simponi	Methotrexate n=41 Participants Methotrexate: Methotrexate
American College of Rheumatology 20 (ACR20) Response at 52 Weeks	23 Participants	28 Participants

SECONDARY outcome

Timeframe: 12 Weeks

Population: Full Analysis Set

American College of Rheumatology 50 Response (coded 0=No, 1=Yes) is achieved when there is:

• 50% improvement in both TJC (68 joints count) and SJC (66 joints count) and
• 50% improvement in at least 3 of the following 5 ACR Core set criteria:

1. Patient's Assessment of Pain Visual Analogue Scale (VAS)

2. Patient's Global Assessment of Disease Activity VAS

3. Physician's Global Assessment of Disease Activity VAS

4. Patient's Assessment of Physical Function as measured by the HAQ-DI

5. Acute phase reactant as measured by CRP

Outcome measures

Measure	Golimumab & Methotrexate n=43 Participants Methotrexate: Methotrexate Golimumab: Simponi	Methotrexate n=41 Participants Methotrexate: Methotrexate
American College of Rheumatology 50 (ACR50) Response at 12 Weeks	20 Participants	12 Participants

SECONDARY outcome

Timeframe: 24 Weeks

Population: Full Analysis Set

American College of Rheumatology 50 Response (coded 0=No, 1=Yes) is achieved when there is:

• 50% improvement in both TJC (68 joints count) and SJC (66 joints count) and
• 50% improvement in at least 3 of the following 5 ACR Core set criteria:

1. Patient's Assessment of Pain Visual Analogue Scale (VAS)

2. Patient's Global Assessment of Disease Activity VAS

3. Physician's Global Assessment of Disease Activity VAS

4. Patient's Assessment of Physical Function as measured by the HAQ-DI

5. Acute phase reactant as measured by CRP

Outcome measures

Measure	Golimumab & Methotrexate n=43 Participants Methotrexate: Methotrexate Golimumab: Simponi	Methotrexate n=41 Participants Methotrexate: Methotrexate
American College of Rheumatology 50 (ACR50) Response at 24 Weeks	21 Participants	15 Participants

SECONDARY outcome

Timeframe: 36 Weeks

Population: Full Analysis Set

American College of Rheumatology 50 Response (coded 0=No, 1=Yes) is achieved when there is:

• 50% improvement in both TJC (68 joints count) and SJC (66 joints count) and
• 50% improvement in at least 3 of the following 5 ACR Core set criteria:

1. Patient's Assessment of Pain Visual Analogue Scale (VAS)

2. Patient's Global Assessment of Disease Activity VAS

3. Physician's Global Assessment of Disease Activity VAS

4. Patient's Assessment of Physical Function as measured by the HAQ-DI

5. Acute phase reactant as measured by CRP

Outcome measures

Measure	Golimumab & Methotrexate n=43 Participants Methotrexate: Methotrexate Golimumab: Simponi	Methotrexate n=41 Participants Methotrexate: Methotrexate
American College of Rheumatology 50 (ACR50) Response at 36 Weeks	21 Participants	16 Participants

SECONDARY outcome

Timeframe: 52 Weeks

Population: Full Analysis Set

American College of Rheumatology 50 Response (coded 0=No, 1=Yes) is achieved when there is:

• 50% improvement in both TJC (68 joints count) and SJC (66 joints count) and
• 50% improvement in at least 3 of the following 5 ACR Core set criteria:

1. Patient's Assessment of Pain Visual Analogue Scale (VAS)

2. Patient's Global Assessment of Disease Activity VAS

3. Physician's Global Assessment of Disease Activity VAS

4. Patient's Assessment of Physical Function as measured by the HAQ-DI

5. Acute phase reactant as measured by CRP

Outcome measures

Measure	Golimumab & Methotrexate n=43 Participants Methotrexate: Methotrexate Golimumab: Simponi	Methotrexate n=41 Participants Methotrexate: Methotrexate
American College of Rheumatology 50 (ACR50) Response at 52 Weeks	16 Participants	15 Participants

SECONDARY outcome

Timeframe: 12 Weeks

Population: Full Analysis Set

American College of Rheumatology 70 Response (coded 0=No, 1=Yes) is achieved when there is:

• 70% improvement in both TJC (68 joints count) and SJC (66 joints count) and
• 70% improvement in at least 3 of the following 5 ACR Core set criteria:

1. Patient's Assessment of Pain Visual Analogue Scale (VAS)

2. Patient's Global Assessment of Disease Activity VAS

3. Physician's Global Assessment of Disease Activity VAS

4. Patient's Assessment of Physical Function as measured by the HAQ-DI

5. Acute phase reactant as measured by CRP

Outcome measures

Measure	Golimumab & Methotrexate n=43 Participants Methotrexate: Methotrexate Golimumab: Simponi	Methotrexate n=41 Participants Methotrexate: Methotrexate
American College of Rheumatology 70 (ACR70) Response at 12 Weeks	15 Participants	6 Participants

SECONDARY outcome

Timeframe: 24 Weeks

Population: Full Analysis Set

American College of Rheumatology 70 Response (coded 0=No, 1=Yes) is achieved when there is:

• 70% improvement in both TJC (68 joints count) and SJC (66 joints count) and
• 70% improvement in at least 3 of the following 5 ACR Core set criteria:

1. Patient's Assessment of Pain Visual Analogue Scale (VAS)

2. Patient's Global Assessment of Disease Activity VAS

3. Physician's Global Assessment of Disease Activity VAS

4. Patient's Assessment of Physical Function as measured by the HAQ-DI

5. Acute phase reactant as measured by CRP

Outcome measures

Measure	Golimumab & Methotrexate n=43 Participants Methotrexate: Methotrexate Golimumab: Simponi	Methotrexate n=41 Participants Methotrexate: Methotrexate
American College of Rheumatology 70 (ACR70) Response at 24 Weeks	19 Participants	10 Participants

SECONDARY outcome

Timeframe: 36 Weeks

Population: Full Analysis Set

American College of Rheumatology 70 Response (coded 0=No, 1=Yes) is achieved when there is:

• 70% improvement in both TJC (68 joints count) and SJC (66 joints count) and
• 70% improvement in at least 3 of the following 5 ACR Core set criteria:

1. Patient's Assessment of Pain Visual Analogue Scale (VAS)

2. Patient's Global Assessment of Disease Activity VAS

3. Physician's Global Assessment of Disease Activity VAS

4. Patient's Assessment of Physical Function as measured by the HAQ-DI

5. Acute phase reactant as measured by CRP

Outcome measures

Measure	Golimumab & Methotrexate n=43 Participants Methotrexate: Methotrexate Golimumab: Simponi	Methotrexate n=41 Participants Methotrexate: Methotrexate
American College of Rheumatology 70 (ACR70) Response at 36 Weeks	14 Participants	9 Participants

SECONDARY outcome

Timeframe: 52 Weeks

Population: Full Analysis Set

American College of Rheumatology 70 Response (coded 0=No, 1=Yes) is achieved when there is:

• 70% improvement in both TJC (68 joints count) and SJC (66 joints count) and
• 70% improvement in at least 3 of the following 5 ACR Core set criteria:

1. Patient's Assessment of Pain Visual Analogue Scale (VAS)

2. Patient's Global Assessment of Disease Activity VAS

3. Physician's Global Assessment of Disease Activity VAS

4. Patient's Assessment of Physical Function as measured by the HAQ-DI

5. Acute phase reactant as measured by CRP

Outcome measures

Measure	Golimumab & Methotrexate n=43 Participants Methotrexate: Methotrexate Golimumab: Simponi	Methotrexate n=41 Participants Methotrexate: Methotrexate
American College of Rheumatology 70 (ACR70) Response at 52 Weeks	11 Participants	8 Participants

SECONDARY outcome

Timeframe: 12 Weeks

Population: Full Analysis Set

Psoriatic Arthritis Response Criteria Response (coded 0=No, 1=Yes) is defined by improvement from baseline assessment in 2 of 4 criteria, 1 of which must be a joint count; there must not be worsening in any of the 4 criteria:

1. At least 30% reduction in tender joint grade (total of 68 joints graded 0-3)

2. At least 30% reduction in swollen joint grade (total of 66 joints graded 0-3)

3. At least a 1 point reduction in physician's assessment of articular disease (1-5 Likert scale)

4. At least a 1 point reduction in patient's assessment of articular disease (1-5 Likert scale)

Outcome measures

Measure	Golimumab & Methotrexate n=43 Participants Methotrexate: Methotrexate Golimumab: Simponi	Methotrexate n=41 Participants Methotrexate: Methotrexate
Psoriatic Arthritis Response Criteria (PsARC) Response at 12 Weeks	37 Participants	26 Participants

SECONDARY outcome

Timeframe: 24 Weeks

Population: Full Analysis Set

Psoriatic Arthritis Response Criteria Response (coded 0=No, 1=Yes) is defined by improvement from baseline assessment in 2 of 4 criteria, 1 of which must be a joint count; there must not be worsening in any of the 4 criteria:

1. At least 30% reduction in tender joint grade (total of 68 joints graded 0-3)

2. At least 30% reduction in swollen joint grade (total of 66 joints graded 0-3)

3. At least a 1 point reduction in physician's assessment of articular disease (1-5 Likert scale)

4. At least a 1 point reduction in patient's assessment of articular disease (1-5 Likert scale)

Outcome measures

Measure	Golimumab & Methotrexate n=43 Participants Methotrexate: Methotrexate Golimumab: Simponi	Methotrexate n=41 Participants Methotrexate: Methotrexate
Psoriatic Arthritis Response Criteria (PsARC) Response at 24 Weeks	38 Participants	36 Participants

SECONDARY outcome

Timeframe: 36 Weeks

Population: Full Analysis Set

Psoriatic Arthritis Response Criteria Response (coded 0=No, 1=Yes) is defined by improvement from baseline assessment in 2 of 4 criteria, 1 of which must be a joint count; there must not be worsening in any of the 4 criteria:

1. At least 30% reduction in tender joint grade (total of 68 joints graded 0-3)

2. At least 30% reduction in swollen joint grade (total of 66 joints graded 0-3)

3. At least a 1 point reduction in physician's assessment of articular disease (1-5 Likert scale)

4. At least a 1 point reduction in patient's assessment of articular disease (1-5 Likert scale)

Outcome measures

Measure	Golimumab & Methotrexate n=43 Participants Methotrexate: Methotrexate Golimumab: Simponi	Methotrexate n=41 Participants Methotrexate: Methotrexate
Psoriatic Arthritis Response Criteria (PsARC) Response at 36 Weeks	38 Participants	33 Participants

SECONDARY outcome

Timeframe: 52 Weeks

Population: Full Analysis Set

Psoriatic Arthritis Response Criteria Response (coded 0=No, 1=Yes) is defined by improvement from baseline assessment in 2 of 4 criteria, 1 of which must be a joint count; there must not be worsening in any of the 4 criteria:

1. At least 30% reduction in tender joint grade (total of 68 joints graded 0-3)

2. At least 30% reduction in swollen joint grade (total of 66 joints graded 0-3)

3. At least a 1 point reduction in physician's assessment of articular disease (1-5 Likert scale)

4. At least a 1 point reduction in patient's assessment of articular disease (1-5 Likert scale)

Outcome measures

Measure	Golimumab & Methotrexate n=43 Participants Methotrexate: Methotrexate Golimumab: Simponi	Methotrexate n=41 Participants Methotrexate: Methotrexate
Psoriatic Arthritis Response Criteria (PsARC) Response at 52 Weeks	28 Participants	27 Participants

SECONDARY outcome

Timeframe: 12 Weeks

Population: Full Analysis Set (restricted to those with \>=3% body surface area affected by psoriasis at baseline)

Psoriatic Arthritis Skin Index (PASI) Response (coded 0=No, 1=Yes) is defined as an improvement of at least 75% in the PASI compared to baseline.

Outcome measures

Measure	Golimumab & Methotrexate n=13 Participants Methotrexate: Methotrexate Golimumab: Simponi	Methotrexate n=8 Participants Methotrexate: Methotrexate
Psoriatic Arthritis Skin Index (PASI) Response at 12 Weeks	7 Participants	0 Participants

SECONDARY outcome

Timeframe: 24 Weeks

Population: Full Analysis Set (restricted to those with \>=3% body surface area affected by psoriasis at baseline)

Psoriatic Arthritis Skin Index (PASI) Response (coded 0=No, 1=Yes) is defined as an improvement of at least 75% in the PASI compared to baseline.

Outcome measures

Measure	Golimumab & Methotrexate n=13 Participants Methotrexate: Methotrexate Golimumab: Simponi	Methotrexate n=8 Participants Methotrexate: Methotrexate
Psoriatic Arthritis Skin Index (PASI) Response at 24 Weeks	11 Participants	3 Participants

SECONDARY outcome

Timeframe: 36 Weeks

Population: Full Analysis Set (restricted to those with \>=3% body surface area affected by psoriasis at baseline)

Psoriatic Arthritis Skin Index (PASI) Response (coded 0=No, 1=Yes) is defined as an improvement of at least 75% in the PASI compared to baseline.

Outcome measures

Measure	Golimumab & Methotrexate n=13 Participants Methotrexate: Methotrexate Golimumab: Simponi	Methotrexate n=8 Participants Methotrexate: Methotrexate
Psoriatic Arthritis Skin Index (PASI) Response at 36 Weeks	9 Participants	2 Participants

SECONDARY outcome

Timeframe: 52 Weeks

Population: Full Analysis Set (restricted to those with \>=3% body surface area affected by psoriasis at baseline)

Psoriatic Arthritis Skin Index (PASI) Response (coded 0=No, 1=Yes) is defined as an improvement of at least 75% in the PASI compared to baseline.

Outcome measures

Measure	Golimumab & Methotrexate n=13 Participants Methotrexate: Methotrexate Golimumab: Simponi	Methotrexate n=8 Participants Methotrexate: Methotrexate
Psoriatic Arthritis Skin Index (PASI) Response at 52 Weeks	6 Participants	2 Participants

SECONDARY outcome

Timeframe: 12 Weeks

Population: Full Analysis Set

Ultrasound Imaging Remission (coded 0=No, 1=Yes) is achieved when all joints and entheses score grey scale<=1 & power Doppler=0.

Outcome measures

Measure	Golimumab & Methotrexate n=43 Participants Methotrexate: Methotrexate Golimumab: Simponi	Methotrexate n=41 Participants Methotrexate: Methotrexate
Ultrasound Imaging Remission at 12 Weeks	1 Participants	4 Participants

SECONDARY outcome

Timeframe: 24 Weeks

Population: Full Analysis Set

Ultrasound Imaging Remission (coded 0=No, 1=Yes) is achieved when all joints and entheses score grey scale<=1 & power Doppler=0.

Outcome measures

Measure	Golimumab & Methotrexate n=43 Participants Methotrexate: Methotrexate Golimumab: Simponi	Methotrexate n=41 Participants Methotrexate: Methotrexate
Ultrasound Imaging Remission at 24 Weeks	3 Participants	3 Participants

SECONDARY outcome

Timeframe: 36 Weeks

Population: Full Analysis Set

Ultrasound Imaging Remission (coded 0=No, 1=Yes) is achieved when all joints and entheses score grey scale<=1 & power Doppler=0.

Outcome measures

Measure	Golimumab & Methotrexate n=43 Participants Methotrexate: Methotrexate Golimumab: Simponi	Methotrexate n=41 Participants Methotrexate: Methotrexate
Ultrasound Imaging Remission at 36 Weeks	1 Participants	2 Participants

SECONDARY outcome

Timeframe: 12 Weeks

Population: Full Analysis Set

Participants were eligible for additional steroid at weeks 8 and 12 if they had not achieved a PsARC response; this variable was coded 0=No, 1=Yes.

Outcome measures

Measure	Golimumab & Methotrexate n=43 Participants Methotrexate: Methotrexate Golimumab: Simponi	Methotrexate n=41 Participants Methotrexate: Methotrexate
Additional Steroid Received Before 24 Weeks	9 Participants	20 Participants

Adverse Events

Methotrexate

Serious events: 0 serious events

Other events: 38 other events

Deaths: 0 deaths

Golimumab & Methotrexate

Serious events: 0 serious events

Other events: 41 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Methotrexate n=41 participants at risk Methotrexate: Methotrexate	Golimumab & Methotrexate n=43 participants at risk Methotrexate: Methotrexate Golimumab: Simponi
Blood and lymphatic system disorders Anemia	0.00% 0/41 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	2.3% 1/43 • Number of events 1 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Blood and lymphatic system disorders Leukocytosis	2.4% 1/41 • Number of events 1 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	0.00% 0/43 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Eye disorders Blurred vision	0.00% 0/41 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	2.3% 1/43 • Number of events 1 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Eye disorders Cataract	2.4% 1/41 • Number of events 1 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	0.00% 0/43 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Eye disorders Dry eye	4.9% 2/41 • Number of events 2 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	7.0% 3/43 • Number of events 3 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Eye disorders Flashing lights	2.4% 1/41 • Number of events 1 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	0.00% 0/43 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Eye disorders Glaucoma	0.00% 0/41 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	2.3% 1/43 • Number of events 1 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Eye disorders Vitreous hemorrage	0.00% 0/41 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	2.3% 1/43 • Number of events 1 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Gastrointestinal disorders Abdominal pain	4.9% 2/41 • Number of events 3 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	2.3% 1/43 • Number of events 1 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Gastrointestinal disorders Bloating	4.9% 2/41 • Number of events 2 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	0.00% 0/43 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Gastrointestinal disorders Constipation	4.9% 2/41 • Number of events 2 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	0.00% 0/43 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Gastrointestinal disorders Dental caries	0.00% 0/41 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	2.3% 1/43 • Number of events 1 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Gastrointestinal disorders Diarrhea	14.6% 6/41 • Number of events 7 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	23.3% 10/43 • Number of events 10 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Gastrointestinal disorders Dyspepsia	4.9% 2/41 • Number of events 2 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	7.0% 3/43 • Number of events 3 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Gastrointestinal disorders Gastritis	2.4% 1/41 • Number of events 1 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	0.00% 0/43 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Gastrointestinal disorders Inguinal hernia	2.4% 1/41 • Number of events 1 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	0.00% 0/43 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Gastrointestinal disorders Lower gastrointestinal hemorrhage	4.9% 2/41 • Number of events 2 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	0.00% 0/43 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Hepatobiliary disorders Other: Fatty liver	2.4% 1/41 • Number of events 1 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	0.00% 0/43 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Gastrointestinal disorders Mucositis oral	7.3% 3/41 • Number of events 3 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	2.3% 1/43 • Number of events 1 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Gastrointestinal disorders Nausea	26.8% 11/41 • Number of events 14 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	37.2% 16/43 • Number of events 24 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Gastrointestinal disorders Other: Broken tooth	0.00% 0/41 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	2.3% 1/43 • Number of events 1 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
General disorders Non-cardiac chest pain	2.4% 1/41 • Number of events 1 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	2.3% 1/43 • Number of events 1 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Gastrointestinal disorders Other: Fatty infiltration of pancreas	2.4% 1/41 • Number of events 1 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	0.00% 0/43 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Gastrointestinal disorders Other: Loose stools	2.4% 1/41 • Number of events 1 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	0.00% 0/43 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Gastrointestinal disorders Other: Mouth ulcers	4.9% 2/41 • Number of events 2 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	0.00% 0/43 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Gastrointestinal disorders Stomach pain	4.9% 2/41 • Number of events 2 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	0.00% 0/43 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Gastrointestinal disorders Vomiting	14.6% 6/41 • Number of events 8 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	2.3% 1/43 • Number of events 1 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
General disorders Fatigue	7.3% 3/41 • Number of events 3 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	23.3% 10/43 • Number of events 10 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
General disorders Flu like symptoms	9.8% 4/41 • Number of events 4 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	4.7% 2/43 • Number of events 2 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Hepatobiliary disorders Other: Hepatic steatosis	0.00% 0/41 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	2.3% 1/43 • Number of events 1 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Hepatobiliary disorders Other: Liver fibrosis	2.4% 1/41 • Number of events 1 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	0.00% 0/43 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Hepatobiliary disorders Other: Steatohepatitis	0.00% 0/41 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	2.3% 1/43 • Number of events 1 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Immune system disorders Allergic reaction	2.4% 1/41 • Number of events 1 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	2.3% 1/43 • Number of events 1 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Infections and infestations Abdominal Infection	2.4% 1/41 • Number of events 2 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	0.00% 0/43 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Infections and infestations Bladder infection	0.00% 0/41 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	2.3% 1/43 • Number of events 1 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Infections and infestations Enterocolitis infectious	0.00% 0/41 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	4.7% 2/43 • Number of events 2 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Infections and infestations Herpes simplex reactivation	2.4% 1/41 • Number of events 1 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	0.00% 0/43 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Infections and infestations Laryngitis	0.00% 0/41 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	2.3% 1/43 • Number of events 1 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Infections and infestations Lung infection	2.4% 1/41 • Number of events 1 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	0.00% 0/43 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Infections and infestations Mucosal infection	0.00% 0/41 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	7.0% 3/43 • Number of events 4 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Infections and infestations Nail infection	0.00% 0/41 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	2.3% 1/43 • Number of events 1 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Infections and infestations Other: Genital thrush	0.00% 0/41 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	2.3% 1/43 • Number of events 1 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Infections and infestations Otitis externa	0.00% 0/41 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	2.3% 1/43 • Number of events 2 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Infections and infestations Papulopustular rash	2.4% 1/41 • Number of events 1 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	0.00% 0/43 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Infections and infestations Pharyngitis	4.9% 2/41 • Number of events 2 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	2.3% 1/43 • Number of events 1 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Infections and infestations Shingles	0.00% 0/41 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	2.3% 1/43 • Number of events 1 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Infections and infestations Skin infection	12.2% 5/41 • Number of events 6 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	7.0% 3/43 • Number of events 3 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Infections and infestations Soft tissue infection	4.9% 2/41 • Number of events 2 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	0.00% 0/43 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Infections and infestations Upper respiratory infection	29.3% 12/41 • Number of events 13 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	41.9% 18/43 • Number of events 26 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Infections and infestations Urinary tract infection	12.2% 5/41 • Number of events 7 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	0.00% 0/43 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Infections and infestations Vaginal infection	0.00% 0/41 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	2.3% 1/43 • Number of events 1 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Injury, poisoning and procedural complications Bruising	0.00% 0/41 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	2.3% 1/43 • Number of events 1 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Injury, poisoning and procedural complications Burn	2.4% 1/41 • Number of events 1 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	0.00% 0/43 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Injury, poisoning and procedural complications Fall	4.9% 2/41 • Number of events 2 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	2.3% 1/43 • Number of events 1 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Injury, poisoning and procedural complications Fracture	4.9% 2/41 • Number of events 2 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	0.00% 0/43 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Injury, poisoning and procedural complications Other: Skin injury	2.4% 1/41 • Number of events 1 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	0.00% 0/43 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Injury, poisoning and procedural complications Other: Spider bite	0.00% 0/41 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	2.3% 1/43 • Number of events 1 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Injury, poisoning and procedural complications Other: Twisted right knee	2.4% 1/41 • Number of events 1 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	0.00% 0/43 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Injury, poisoning and procedural complications Other: Vaccine complication	0.00% 0/41 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	2.3% 1/43 • Number of events 1 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Injury, poisoning and procedural complications Wrist fracture	0.00% 0/41 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	2.3% 1/43 • Number of events 1 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Investigations Alanine aminotransferase increased	36.6% 15/41 • Number of events 23 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	48.8% 21/43 • Number of events 35 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Investigations Aspartate Aminotransferase increased	0.00% 0/41 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	2.3% 1/43 • Number of events 1 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Investigations Blood bilirubin increased	2.4% 1/41 • Number of events 1 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	2.3% 1/43 • Number of events 2 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Investigations Creatinine increased	2.4% 1/41 • Number of events 1 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	0.00% 0/43 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Investigations Neutrophil count decreased	4.9% 2/41 • Number of events 2 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	11.6% 5/43 • Number of events 6 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Investigations Other: HBA1C elevated	2.4% 1/41 • Number of events 1 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	0.00% 0/43 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Investigations Other: Macrocytosis	0.00% 0/41 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	7.0% 3/43 • Number of events 3 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Investigations Other: Vitamin D insufficiency	17.1% 7/41 • Number of events 8 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	2.3% 1/43 • Number of events 1 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Investigations Platelet count decreased	0.00% 0/41 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	7.0% 3/43 • Number of events 3 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Investigations Weight gain	9.8% 4/41 • Number of events 4 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	4.7% 2/43 • Number of events 3 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Investigations Weight loss	0.00% 0/41 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	2.3% 1/43 • Number of events 1 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Investigations White blood cell decreased	2.4% 1/41 • Number of events 1 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	7.0% 3/43 • Number of events 3 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Metabolism and nutrition disorders Anorexia	2.4% 1/41 • Number of events 1 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	0.00% 0/43 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Metabolism and nutrition disorders Glucose intolerance	0.00% 0/41 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	2.3% 1/43 • Number of events 1 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Musculoskeletal and connective tissue disorders Arthralgia	2.4% 1/41 • Number of events 1 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	2.3% 1/43 • Number of events 1 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Musculoskeletal and connective tissue disorders Muscle cramp	0.00% 0/41 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	2.3% 1/43 • Number of events 1 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Musculoskeletal and connective tissue disorders Other: Mass right forearm	2.4% 1/41 • Number of events 1 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	0.00% 0/43 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Musculoskeletal and connective tissue disorders Other: Muscle spasm	2.4% 1/41 • Number of events 1 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	0.00% 0/43 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Musculoskeletal and connective tissue disorders Other: Raynaud's phenomenon	0.00% 0/41 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	2.3% 1/43 • Number of events 1 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Musculoskeletal and connective tissue disorders Other: Trigger finger	2.4% 1/41 • Number of events 1 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	0.00% 0/43 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Nervous system disorders Dizziness	4.9% 2/41 • Number of events 2 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	7.0% 3/43 • Number of events 3 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Nervous system disorders Headache	7.3% 3/41 • Number of events 3 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	9.3% 4/43 • Number of events 4 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Nervous system disorders Other: Restless legs syndrome	2.4% 1/41 • Number of events 1 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	0.00% 0/43 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Nervous system disorders Paresthesia	0.00% 0/41 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	2.3% 1/43 • Number of events 1 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Nervous system disorders Somnolence	0.00% 0/41 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	4.7% 2/43 • Number of events 2 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Psychiatric disorders Anxiety	0.00% 0/41 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	7.0% 3/43 • Number of events 3 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Psychiatric disorders Depression	0.00% 0/41 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	7.0% 3/43 • Number of events 3 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Psychiatric disorders Insomnia	0.00% 0/41 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	7.0% 3/43 • Number of events 3 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Psychiatric disorders Libido decreased	2.4% 1/41 • Number of events 1 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	0.00% 0/43 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Psychiatric disorders Other: Mood swings	2.4% 1/41 • Number of events 1 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	0.00% 0/43 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Renal and urinary disorders Urinary frequency	0.00% 0/41 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	4.7% 2/43 • Number of events 2 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Reproductive system and breast disorders Dyspareunia	2.4% 1/41 • Number of events 1 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	0.00% 0/43 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Reproductive system and breast disorders Erectile Dysfunction	0.00% 0/41 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	2.3% 1/43 • Number of events 1 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Reproductive system and breast disorders Irregular menstruation	0.00% 0/41 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	2.3% 1/43 • Number of events 1 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Reproductive system and breast disorders Menorrhagia	0.00% 0/41 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	2.3% 1/43 • Number of events 1 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Reproductive system and breast disorders Other: Erythematous lesion at the tip of penis, balanitis (dermatologist confirmed)	0.00% 0/41 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	2.3% 1/43 • Number of events 1 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Reproductive system and breast disorders Other: High secretion from the breast	2.4% 1/41 • Number of events 1 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	0.00% 0/43 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Reproductive system and breast disorders Uterine haemorrhage	0.00% 0/41 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	2.3% 1/43 • Number of events 1 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Respiratory, thoracic and mediastinal disorders Cough	4.9% 2/41 • Number of events 2 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	0.00% 0/43 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Respiratory, thoracic and mediastinal disorders Dyspnea	2.4% 1/41 • Number of events 1 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	2.3% 1/43 • Number of events 1 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/41 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	2.3% 1/43 • Number of events 1 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Respiratory, thoracic and mediastinal disorders Pharyngeal mucositis	2.4% 1/41 • Number of events 1 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	2.3% 1/43 • Number of events 1 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	0.00% 0/41 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	2.3% 1/43 • Number of events 1 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Respiratory, thoracic and mediastinal disorders Postnasal drip	2.4% 1/41 • Number of events 1 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	0.00% 0/43 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/41 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	2.3% 1/43 • Number of events 1 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Respiratory, thoracic and mediastinal disorders Sneezing	2.4% 1/41 • Number of events 1 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	2.3% 1/43 • Number of events 1 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Respiratory, thoracic and mediastinal disorders Sore throat	2.4% 1/41 • Number of events 1 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	0.00% 0/43 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Skin and subcutaneous tissue disorders Alopecia	4.9% 2/41 • Number of events 2 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	4.7% 2/43 • Number of events 2 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Skin and subcutaneous tissue disorders Dyshidrotic eczema	2.4% 1/41 • Number of events 2 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	0.00% 0/43 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Skin and subcutaneous tissue disorders Other: Contact dermatitis	0.00% 0/41 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	2.3% 1/43 • Number of events 1 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Skin and subcutaneous tissue disorders Rash maculo-papular	4.9% 2/41 • Number of events 2 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	2.3% 1/43 • Number of events 1 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	2.4% 1/41 • Number of events 1 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	0.00% 0/43 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Skin and subcutaneous tissue disorders Urticaria	2.4% 1/41 • Number of events 1 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	0.00% 0/43 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Vascular disorders Flushing	0.00% 0/41 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	4.7% 2/43 • Number of events 2 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Vascular disorders Hematoma	2.4% 1/41 • Number of events 1 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	0.00% 0/43 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Vascular disorders Hypertension	7.3% 3/41 • Number of events 4 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	7.0% 3/43 • Number of events 3 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.
Vascular disorders Other: Varicose veins	2.4% 1/41 • Number of events 1 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.	0.00% 0/43 • 52 Weeks Determination of AEs was based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participants, and was assessed and recorded at every visit. AEs and SAEs were collected from first dose of protocol treatment until week 52. Participants were instructed to report AEs and SAEs during this time period.

Additional Information

Professor Helena Marzo-Ortega

Leeds Teaching Hospital Trust

Phone: +44 (0) 113 392 4848

Email: H.Marzo-Ortega@leeds.ac.uk

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place