Trial Outcomes & Findings for A Study to Evaluate the NSAIDS Sparing Effect of Etanercept in Subjects With Axial Spondyloarthritis (NCT NCT01298531)

Last Updated: 2014-07-29

Results Overview

Diary data from the 7 days prior to respective visit were used to evaluate the endpoint, where the score was only calculated if at least 5 of the 7 days data were available. Score was calculated from NSAID usage completed on diary cards considering NSAID type, total daily dose and number of days consumed. The Daily diclofenac-equivalent dose score was derived by converting each daily dose of NSAID to a percentage dose equivalent of 150 mg diclofenac; e.g. 1000 mg naproxen is equivalent to 150 mg diclofenac. For each NSAID, the percentage diclofenac-equivalent score is then multiplied by daily dose frequency and proportion of the period where dose was taken. Ie Score=M x F x n/N (M: Percentage dose equivalent to diclofenac; F=Daily Dose Frequency; n=number of days with NSAID; N=number of days in period). The NSAID ASAS score is the sum of all such scores for all NSAIDs taken during the period. The minimum value is 0 and a higher NSAID-ASAS value indicates greater NSAIDs consumption.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

90 participants

Primary outcome timeframe

Week 8

Results posted on

2014-07-29

Participant Flow

Out of 128 screened participants, 90 were assigned to either double-blind etanercept (ETN) 50 mg to open-label ETN 50 mg or placebo to open-label ETN 50 mg group. Participants entered an escape arm at Week 4 visit if the total back pain or the BASDAI score increased \>50% vs baseline or participants were with maximum tolerated NSAIDs.

Four participants who were randomized to receive placebo in the double-blind phase were withdrawn during this phase, and they did not enter the escape arm, so these four participants never received ETN.

Participant milestones

Participant milestones
Measure	Double Blind ETN 50 mg to Open Label ETN 50 mg Group Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks	Placebo to Open Label ETN 50 mg Group Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
Overall Study STARTED	42	48
Overall Study COMPLETED	33	41
Overall Study NOT COMPLETED	9	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Double Blind ETN 50 mg to Open Label ETN 50 mg Group Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks	Placebo to Open Label ETN 50 mg Group Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
Overall Study Lack of Efficacy	0	1
Overall Study Lost to Follow-up	2	0
Overall Study Protocol Violation	1	1
Overall Study Adverse Event	4	3
Overall Study Does not meet entrance criteria	0	1
Overall Study Other	2	1

Baseline Characteristics

A Study to Evaluate the NSAIDS Sparing Effect of Etanercept in Subjects With Axial Spondyloarthritis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Double Blind ETN 50 mg to Open Label ETN 50 mg Group n=42 Participants Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks	Placebo to Open Label ETN 50 mg Group n=48 Participants Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks	Total n=90 Participants Total of all reporting groups
Age, Customized 18 - 44 Years	31 Participants n=5 Participants	32 Participants n=7 Participants	63 Participants n=5 Participants
Age, Customized 45 - 64 Years	9 Participants n=5 Participants	15 Participants n=7 Participants	24 Participants n=5 Participants
Age, Customized ≥ 65 Years	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	16 Participants n=7 Participants	34 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants	32 Participants n=7 Participants	56 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 8

Population: The Intent To Treat (ITT) population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through last observation carried forward (LOCF).

Outcome measures

Outcome measures
Measure	Double Blind ETN 50 mg to Open Label ETN 50 mg Group n=39 Participants Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks	Placebo to Open Label ETN 50 mg Group n=42 Participants Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
Change From Baseline in Non Steroidal Anti Inflammatory Drug (NSAID) Assessment of the SpondyloArthritis International Society (ASAS) Score at Week 8.	-63.90 Scores on a scale Standard Error 6.09	-36.63 Scores on a scale Standard Error 5.87

SECONDARY outcome

Timeframe: Week 8

Population: The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.

The total NSAID score for the first 8 weeks of randomized treatment was calculated as an AUC using the linear trapezoidal rule. LOCF will only be applied where the subject is still in the study and the NSAID score is missing.

Outcome measures

Outcome measures
Measure	Double Blind ETN 50 mg to Open Label ETN 50 mg Group n=40 Participants Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks	Placebo to Open Label ETN 50 mg Group n=42 Participants Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
Total NSAID ASAS [Area Under Curve (AUC)] Score From Baseline to Week 8.	45.24 Unit on a scale * days Standard Error 5.44	65.02 Unit on a scale * days Standard Error 5.30

SECONDARY outcome

Timeframe: Week 4

A numeric rating scale was used, for questions 1-5 (Fatigue, Spinal Pain, Joint pain or Swelling, Discomfort and Morning stiffness severity respectively) on a scale from 0 (none) to 10 (very severe). Question 6 (morning stiffness duration) was recorded on a scale of 0 (0 or more hours) to 10 (2 hours). To give the five major Ankylosing Spondylitis (AS) symptoms equal weighting, the average of the two scores relating to morning stiffness was taken. This averaged morning stiffness score was then summed with the remaining 4 questions, resulting in a composite score on a scale of 0-50, which was then divided by 5 to give the final BASDAI score on a scale of 0-10.

Outcome measures

Outcome measures
Measure	Double Blind ETN 50 mg to Open Label ETN 50 mg Group n=39 Participants Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks	Placebo to Open Label ETN 50 mg Group n=44 Participants Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 4.	-1.50 Units on a scale Standard Error 0.27	-0.56 Units on a scale Standard Error 0.26

SECONDARY outcome

Timeframe: Week 8

A numeric rating scale was used, for questions 1-5 (Fatigue, Spinal Pain, Joint pain or Swelling, Discomfort and Morning stiffness severity respectively) on a scale from 0 (none) to 10 (very severe). Question 6 (morning stiffness duration) was recorded on a scale of 0 (0 or more hours) to 10 (2 hours). To give the five major AS symptoms equal weighting, the average of the two scores relating to morning stiffness was taken. This averaged morning stiffness score was then summed with the remaining 4 questions, resulting in a composite score on a scale of 0-50, which was then divided by 5 to give the final BASDAI score on a scale of 0-10.

Outcome measures

Outcome measures
Measure	Double Blind ETN 50 mg to Open Label ETN 50 mg Group n=41 Participants Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks	Placebo to Open Label ETN 50 mg Group n=45 Participants Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
Change From Baseline in BASDAI at Week 8	-2.01 Units on a scale Standard Error 0.32	-1.13 Units on a scale Standard Error 0.31

SECONDARY outcome

Timeframe: Week 12 and 16

A numeric rating scale was used, for questions 1-5 (Fatigue, Spinal Pain, Joint pain or Swelling, Discomfort and Morning stiffness severity respectively) on a scale from 0 (none) to 10 (very severe). Question 6 (morning stiffness duration) was recorded on a scale of 0 (0 or more hours) to 10 (2 hours). To give the five major AS symptoms equal weighting, the average of the two scores relating to morning stiffness was taken. This averaged morning stiffness score was then summed with the remaining 4 questions, resulting in a composite score on a scale of 0-50, which was then divided by 5 to give the final BASDAI score on a scale of 0-10.

Outcome measures

Outcome measures
Measure	Double Blind ETN 50 mg to Open Label ETN 50 mg Group n=42 Participants Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks	Placebo to Open Label ETN 50 mg Group n=48 Participants Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
Change From Baseline in BASDAI Score at Weeks 12 and 16. Week 12 (N=36, N=41)	-2.5 Units on a scale Standard Deviation 2.35	-2.6 Units on a scale Standard Deviation 2.12
Change From Baseline in BASDAI Score at Weeks 12 and 16. Week 16 (N=28, N=37)	-2.6 Units on a scale Standard Deviation 1.83	-3.0 Units on a scale Standard Deviation 2.14

SECONDARY outcome

Timeframe: Week 8

Participants who received NSAIDs at Week 8 were reported.

Outcome measures

Outcome measures
Measure	Double Blind ETN 50 mg to Open Label ETN 50 mg Group n=33 Participants Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks	Placebo to Open Label ETN 50 mg Group n=40 Participants Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
Number of Participants Using NSAIDs at Week 8.	17 Participants	32 Participants

SECONDARY outcome

Timeframe: Week 8

Population: The ITT population comprised all participants who received at least one dose of the randomized treatment. The efficacy analysis was based on the ITT population. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis.

A numeric rating scale was used, for questions 1-5 (Fatigue, Spinal Pain, Joint pain or Swelling, Discomfort and Morning stiffness severity respectively) on a scale from 0 (none) to 10 (very severe). Question 6 (morning stiffness duration) was recorded on a scale of 0 (0 or more hours) to 10 (2 hours). To give the five major AS symptoms equal weighting, the average of the two scores relating to morning stiffness was taken. This averaged morning stiffness score was then summed with the remaining 4 questions, resulting in a composite score on a scale of 0-50, which was then divided by 5 to give the final BASDAI score on a scale of 0-10.

Outcome measures

Outcome measures
Measure	Double Blind ETN 50 mg to Open Label ETN 50 mg Group n=41 Participants Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks	Placebo to Open Label ETN 50 mg Group n=46 Participants Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
Change From Baseline in Mini BASDAI at Week 8 (AUC).	275.68 Unit on a scale * days Standard Error 13.64	329.37 Unit on a scale * days Standard Error 12.88

SECONDARY outcome

Timeframe: Week 8

Response was defined as a 50% improvement of the baseline BASDAI after 8 Weeks.

Outcome measures

Outcome measures
Measure	Double Blind ETN 50 mg to Open Label ETN 50 mg Group n=41 Participants Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks	Placebo to Open Label ETN 50 mg Group n=45 Participants Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
Number of Participants Achieved BASDAI 50 at Week 8.	16 Participants	8 Participants

SECONDARY outcome

Timeframe: Weeks 4, 12 and 16

Response was defined as a 50% improvement of the baseline BASDAI after 4, 12 and 16 Weeks.

Outcome measures

Outcome measures
Measure	Double Blind ETN 50 mg to Open Label ETN 50 mg Group n=42 Participants Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks	Placebo to Open Label ETN 50 mg Group n=48 Participants Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
Number of Participants Achieved BASDAI 50 at Weeks 4, 12 and 16. Week 4 (N=39, N=44)	10 Participants	3 Participants
Number of Participants Achieved BASDAI 50 at Weeks 4, 12 and 16. Week 12 (N=36, N=41)	17 Participants	19 Participants
Number of Participants Achieved BASDAI 50 at Weeks 4, 12 and 16. Week 16 (N=28, N=37)	15 Participants	18 Participants

SECONDARY outcome

Timeframe: Weeks 4, 12 and 16

ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 20 = 20% improvement from baseline and an absolute change ≥ 10 units on a 0-100 scale (0=no disease activity; 100=high disease activity) for ≥ 3 domains, and no worsening in remaining domain.

Outcome measures

Outcome measures
Measure	Double Blind ETN 50 mg to Open Label ETN 50 mg Group n=42 Participants Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks	Placebo to Open Label ETN 50 mg Group n=48 Participants Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
Number of Participants Achieving ASAS 20 (Assessment of the Spondylo Arthritis International Society 20) at Weeks 4, 12 and 16 Week 4 (N = 38, 42)	14 Participants	5 Participants
Number of Participants Achieving ASAS 20 (Assessment of the Spondylo Arthritis International Society 20) at Weeks 4, 12 and 16 Week 12 (N = 35, 37)	17 Participants	21 Participants
Number of Participants Achieving ASAS 20 (Assessment of the Spondylo Arthritis International Society 20) at Weeks 4, 12 and 16 Week 16 (N = 28, 36)	18 Participants	23 Participants

SECONDARY outcome

Timeframe: Week 8

Outcome measures

Outcome measures
Measure	Double Blind ETN 50 mg to Open Label ETN 50 mg Group n=36 Participants Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks	Placebo to Open Label ETN 50 mg Group n=42 Participants Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
Number of Participants Achieving ASAS 20 at Week 8	16 Participants	10 Participants

SECONDARY outcome

Timeframe: Weeks 4, 12 and 16

ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 40 = 40% improvement from baseline and an absolute change ≥ 20 units on a 0-100 scale (0=no disease activity, 100=high disease activity) for ≥ 3 domains, and no worsening in remaining domain.

Outcome measures

Outcome measures
Measure	Double Blind ETN 50 mg to Open Label ETN 50 mg Group n=42 Participants Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks	Placebo to Open Label ETN 50 mg Group n=48 Participants Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
Number of Participants Achieving ASAS 40 at Weeks 4, 12 and 16. Week 4 (N = 38, 42)	9 Participants	3 Participants
Number of Participants Achieving ASAS 40 at Weeks 4, 12 and 16. Week 12 (N = 35, 37)	17 Participants	20 Participants
Number of Participants Achieving ASAS 40 at Weeks 4, 12 and 16. Week 16 (N = 28, 36)	16 Participants	20 Participants

SECONDARY outcome

Timeframe: Week 8

ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 40 = 40% improvement from baseline and an absolute change ≥ 20 units on a 0-100 scale (0=no disease activity, 100=high disease activity) for ≥ 3 domains, and no worsening in remaining domain.

Outcome measures

Outcome measures
Measure	Double Blind ETN 50 mg to Open Label ETN 50 mg Group n=36 Participants Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks	Placebo to Open Label ETN 50 mg Group n=42 Participants Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
Number of Participants Achieving ASAS 40 at Week 8	16 Participants	9 Participants

SECONDARY outcome

Timeframe: Weeks 4, 12 and 16

ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 70 = 70% improvement from baseline and an absolute change ≥ 20 units on a 0-100 scale (0=no disease activity, 100=high disease activity) for ≥ 3 domains, and no worsening in remaining domain.

Outcome measures

Outcome measures
Measure	Double Blind ETN 50 mg to Open Label ETN 50 mg Group n=42 Participants Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks	Placebo to Open Label ETN 50 mg Group n=48 Participants Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
Number of Participants Achieving ASAS 70 at Weeks 4, 12 and 16. Week 4 (N = 38, 42)	2 Participants	1 Participants
Number of Participants Achieving ASAS 70 at Weeks 4, 12 and 16. Week 12 (N = 35, 37)	8 Participants	7 Participants
Number of Participants Achieving ASAS 70 at Weeks 4, 12 and 16. Week 16 (N = 28, 36)	5 Participants	11 Participants

SECONDARY outcome

Timeframe: Week 8

ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 70 = 70% improvement from baseline and an absolute change ≥ 20 units on a 0-100 scale (0=no disease activity, 100=high disease activity)

Outcome measures

Outcome measures
Measure	Double Blind ETN 50 mg to Open Label ETN 50 mg Group n=36 Participants Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks	Placebo to Open Label ETN 50 mg Group n=42 Participants Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
Number of Participants Achieving ASAS 70 at Week 8	5 Participants	3 Participants

SECONDARY outcome

Timeframe: Week 4

The ASDAS-CRP was derived from back pain, duration of morning stiffness, patient global score and peripheral pain/swelling. The scores were categorized as follows : inactive disease(\< 1.3), moderate (1.3 - \< 2.1), high (2.1 - 3.5) and very high disease activity ( \> 3.5). ASDAS CRP is calculated as follows: ASDAS CRP=0.12\*Total Back Pain+0.06\*Duration of Morning Stiffness+0.11\*Patient Global+0.07\*Peripheral Pain/Swelling+0.58\*ln(CRP+1).

Outcome measures

Outcome measures
Measure	Double Blind ETN 50 mg to Open Label ETN 50 mg Group n=37 Participants Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks	Placebo to Open Label ETN 50 mg Group n=41 Participants Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
Change From Baseline in ASDAS CRP (Ankylosing Spondylitis Disease Activity Score-C Reactive Protein) Score at Week 4.	-0.94 Units on a scale Standard Error 0.12	-0.16 Units on a scale Standard Error 0.11

SECONDARY outcome

Timeframe: Week 8

Outcome measures

Outcome measures
Measure	Double Blind ETN 50 mg to Open Label ETN 50 mg Group n=41 Participants Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks	Placebo to Open Label ETN 50 mg Group n=42 Participants Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
Change From Baseline in ASDAS CRP Score at Week 8.	-1.21 Units on a scale Standard Error 0.14	-0.53 Units on a scale Standard Error 0.14

SECONDARY outcome

Timeframe: Weeks 12 and 16

Outcome measures

Outcome measures
Measure	Double Blind ETN 50 mg to Open Label ETN 50 mg Group n=42 Participants Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks	Placebo to Open Label ETN 50 mg Group n=43 Participants Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
Change From Baseline in ASDAS CRP Score at Weeks 12 and 16. Week 12 (N = 35, 36)	-1.4 Units on scale Standard Deviation 1.13	-1.2 Units on scale Standard Deviation 1.07
Change From Baseline in ASDAS CRP Score at Weeks 12 and 16. Week 16 (N = 28, 33)	-1.6 Units on scale Standard Deviation 0.92	-1.5 Units on scale Standard Deviation 1.02

SECONDARY outcome

Timeframe: Week 4

The ASDAS-ESR was derived from back pain, duration of morning stiffness, patient global score and peripheral pain/swelling. The scores were categorized as follows : inactive disease (\< 1.3), moderate (1.3 - \< 2.1), high (2.1 - 3.5) and very high disease activity ( \> 3.5). ASDAS ESR is calculated as follows: ASDAS ESR=0.08\*Total Back Pain+0.07\*Duration of Morning Stiffness+0.11\*Patient Global+0.09\*Peripheral Pain/Swelling+0.29\*√(ESR).

Outcome measures

Outcome measures
Measure	Double Blind ETN 50 mg to Open Label ETN 50 mg Group n=28 Participants Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks	Placebo to Open Label ETN 50 mg Group n=31 Participants Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
Change From Baseline in ASDAS ESR (Ankylosing Spondylitis Disease Activity Score-Erythrocyte Sedimentation Rate) Score at Week 4.	-0.76 Units on a scale Standard Error 0.12	-0.19 Units on a scale Standard Error 0.11

SECONDARY outcome

Timeframe: Week 8

Outcome measures

Outcome measures
Measure	Double Blind ETN 50 mg to Open Label ETN 50 mg Group n=33 Participants Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks	Placebo to Open Label ETN 50 mg Group n=36 Participants Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
Change From Baseline in ASDAS ESR Score at Week 8.	-1.05 Units on a scale Standard Error 0.16	-0.38 Units on a scale Standard Error 0.15

SECONDARY outcome

Timeframe: Weeks 12 and 16

Outcome measures

Outcome measures
Measure	Double Blind ETN 50 mg to Open Label ETN 50 mg Group n=37 Participants Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks	Placebo to Open Label ETN 50 mg Group n=37 Participants Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
Change From Baseline in ASDAS ESR Score at Weeks 12 and 16. Week 12 (N = 25, 32)	-1.0 Units on a scale Standard Deviation 1.10	-1.0 Units on a scale Standard Deviation 1.01
Change From Baseline in ASDAS ESR Score at Weeks 12 and 16. Week 16 (N = 23, 26)	-1.3 Units on a scale Standard Deviation 0.79	-1.3 Units on a scale Standard Deviation 1.21

SECONDARY outcome

Timeframe: Week 16

Outcome measures

Outcome measures
Measure	Double Blind ETN 50 mg to Open Label ETN 50 mg Group n=25 Participants Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks	Placebo to Open Label ETN 50 mg Group Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
Change in NSAID ASAS Score From Baseline to Week 16 (ETN Arm Only)	-65.93 Scores on a scale Standard Error 10.19	—

SECONDARY outcome

Timeframe: Week 16

Outcome measures

Outcome measures
Measure	Double Blind ETN 50 mg to Open Label ETN 50 mg Group n=17 Participants Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks	Placebo to Open Label ETN 50 mg Group Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
Change in NSAID ASAS Score From Week 8 to Week 16 (Placebo Only)	-39.22 Scores on a scale Standard Error 6.44	—

SECONDARY outcome

Timeframe: Week 8

Participants were requested to complete the BASDAI upon symptom return then every day for the first 15 days after first administration of test article and weekly thereafter. A numeric rating scale was used, for questions 1-5 (Fatigue, Spinal Pain, Joint pain or swelling, discomfort and morning stiffness severity respectively) it was on the scale from 0 (none) to 10 (very severe). For question 6 (morning stiffness duration) it was on the scale of 0 (0 or more hours) to 10 (2 hours). The analysis presented below is the change in morning stiffness severity.

Outcome measures

Outcome measures
Measure	Double Blind ETN 50 mg to Open Label ETN 50 mg Group n=41 Participants Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks	Placebo to Open Label ETN 50 mg Group n=45 Participants Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
Change From Baseline in BASDAI Level of Morning Stiffness-related Scores at Week 8	-2.74 Units on a scale Standard Error 0.39	-1.59 Units on a scale Standard Error 0.37

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 4

BAS-G was used to indicate the effect of disease has had on participant's well-being over the last 48 hours in a 0 (none) to 10 (very severe) point scale. Participants completed the BAS-G on a diary card following their Screening visit if they had a flare which required them to restart their NSAID. Participants were requested to complete the BAS-G upon symptom return (after stoppage of NSAIDs during screening phase) and weekly thereafter.

Outcome measures

Outcome measures
Measure	Double Blind ETN 50 mg to Open Label ETN 50 mg Group n=40 Participants Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks	Placebo to Open Label ETN 50 mg Group n=45 Participants Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
Change From Baseline in BAS-G (Bath Ankylosing Spondylitis-Global) Score at Week 4	-1.51 Units on a scale Standard Error 0.33	-0.21 Units on a scale Standard Error 0.31

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 8

Outcome measures

Outcome measures
Measure	Double Blind ETN 50 mg to Open Label ETN 50 mg Group n=41 Participants Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks	Placebo to Open Label ETN 50 mg Group n=45 Participants Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
Change From Baseline in BAS-G Score at Week 8	-2.29 Units on a scale Standard Error 0.40	-1.05 Units on a scale Standard Error 0.38

OTHER_PRE_SPECIFIED outcome

Timeframe: Weeks 12 and 16

Outcome measures

Outcome measures
Measure	Double Blind ETN 50 mg to Open Label ETN 50 mg Group n=42 Participants Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks	Placebo to Open Label ETN 50 mg Group n=48 Participants Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
Change From Baseline in BAS-G Score at Weeks 12 and 16. Week 12 (N = 36, 41)	-2.8 Units on a scale Standard Deviation 2.50	-2.4 Units on a scale Standard Deviation 2.72
Change From Baseline in BAS-G Score at Weeks 12 and 16. Week 16 (N = 28, 36)	-2.6 Units on a scale Standard Deviation 2.08	-2.6 Units on a scale Standard Deviation 3.12

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 4

Participants assessed the total back pain they had in the previous 48 hours on a scale from 0 (no pain) to 10 (most severe pain).

Outcome measures

Outcome measures
Measure	Double Blind ETN 50 mg to Open Label ETN 50 mg Group n=40 Participants Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks	Placebo to Open Label ETN 50 mg Group n=45 Participants Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
Change From Baseline in Total Back Pain at Week 4	-1.59 Units on a scale Standard Error 0.36	-0.58 Units on a scale Standard Error 0.34

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 8

Participants assessed the total back pain they had in the previous 48 hours on a scale from 0 (no pain) to 10 (most severe pain).

Outcome measures

Outcome measures
Measure	Double Blind ETN 50 mg to Open Label ETN 50 mg Group n=41 Participants Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks	Placebo to Open Label ETN 50 mg Group n=45 Participants Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
Change From Baseline in Total Back Pain at Week 8	-2.24 Units on a scale Standard Error 0.39	-0.96 Units on a scale Standard Error 0.37

OTHER_PRE_SPECIFIED outcome

Timeframe: Weeks 4, 8, 12 and 16

Participants assessed the total back pain they had in the previous 48 hours on a scale from 0 (no pain) to 10 (most severe pain).

Outcome measures

Outcome measures
Measure	Double Blind ETN 50 mg to Open Label ETN 50 mg Group n=42 Participants Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks	Placebo to Open Label ETN 50 mg Group n=48 Participants Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
Change From Baseline in Total Back Pain at Weeks 4, 8, 12 and 16 Week 4 (N = 40, 45)	-1.1 Units on a scale Standard Deviation 2.10	-0.3 Units on a scale Standard Deviation 1.32
Change From Baseline in Total Back Pain at Weeks 4, 8, 12 and 16 Week 8 (N = 37, 43)	-1.7 Units on a scale Standard Deviation 2.28	-0.8 Units on a scale Standard Deviation 1.72
Change From Baseline in Total Back Pain at Weeks 4, 8, 12 and 16 Week 12 (N= 36, 42)	-2.6 Units on a scale Standard Deviation 2.62	-2.6 Units on a scale Standard Deviation 2.34
Change From Baseline in Total Back Pain at Weeks 4, 8, 12 and 16 Week 16 (N = 28, 37)	-2.9 Units on a scale Standard Deviation 2.17	-2.6 Units on a scale Standard Deviation 2.33

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 4

Participants assessed the nocturnal back pain they had in the previous 48 hours on a scale from 0 (no pain) to 10 (most severe pain).

Outcome measures

Outcome measures
Measure	Double Blind ETN 50 mg to Open Label ETN 50 mg Group n=40 Participants Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks	Placebo to Open Label ETN 50 mg Group n=45 Participants Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
Change From Baseline in Nocturnal Back Pain at Week 4	-2.13 Units on a scale Standard Error 0.40	-0.82 Units on a scale Standard Error 0.38

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 8

Participants assessed the nocturnal back pain they had in the previous 48 hours on a scale from 0 (no pain) to 10 (most severe pain).

Outcome measures

Outcome measures
Measure	Double Blind ETN 50 mg to Open Label ETN 50 mg Group n=41 Participants Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks	Placebo to Open Label ETN 50 mg Group n=45 Participants Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
Change From Baseline in Nocturnal Back Pain at Week 8	-2.71 Units on a scale Standard Error 0.43	-1.20 Units on a scale Standard Error 0.41

OTHER_PRE_SPECIFIED outcome

Timeframe: Weeks 12 and 16

Participants assessed the nocturnal back pain they had in the previous 48 hours on a scale from 0 (no pain) to 10 (most severe pain).

Outcome measures

Outcome measures
Measure	Double Blind ETN 50 mg to Open Label ETN 50 mg Group n=42 Participants Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks	Placebo to Open Label ETN 50 mg Group n=48 Participants Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
Change From Baseline in Nocturnal Back Pain at Weeks 12 and 16 Week 12 (N = 36, 42)	-3.0 Units on a scale Standard Deviation 2.88	-3.0 Units on a scale Standard Deviation 2.98
Change From Baseline in Nocturnal Back Pain at Weeks 12 and 16 Week 16 (N = 28, 37)	-2.9 Units on a scale Standard Deviation 2.14	-3.5 Units on a scale Standard Deviation 2.72

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 4

Participants assessed their level of ability to complete activities on a scale from 0 (easy) to 10 (impossible). These scales were collected at each visit in the CRF. The total score was calculated as the average score of the 10 questions.

Outcome measures

Outcome measures
Measure	Double Blind ETN 50 mg to Open Label ETN 50 mg Group n=40 Participants Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks	Placebo to Open Label ETN 50 mg Group n=45 Participants Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
Change From Baseline in BASFI (Bath Ankylosing Spondylitis Functional Index ) at Week 4	-1.13 Units on a scale Standard Error 0.25	-0.32 Units on a scale Standard Error 0.24

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 8

Outcome measures

Outcome measures
Measure	Double Blind ETN 50 mg to Open Label ETN 50 mg Group n=41 Participants Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks	Placebo to Open Label ETN 50 mg Group n=45 Participants Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
Change From Baseline in BASFI at Week 8	-1.68 Units on a scale Standard Error 0.30	-0.77 Units on a scale Standard Error 0.29

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 4

Outcome measures

Outcome measures
Measure	Double Blind ETN 50 mg to Open Label ETN 50 mg Group n=39 Participants Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks	Placebo to Open Label ETN 50 mg Group n=44 Participants Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
Change From Baseline in BASDAI Level of Morning Stiffness-related Scores at Week 4	-2.23 Units on a scale Standard Error 0.34	-1.07 Units on a scale Standard Error 0.32

OTHER_PRE_SPECIFIED outcome

Timeframe: Weeks 12 and 16

Outcome measures

Outcome measures
Measure	Double Blind ETN 50 mg to Open Label ETN 50 mg Group n=42 Participants Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks	Placebo to Open Label ETN 50 mg Group n=48 Participants Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
Change From Baseline in BASDAI Level of Morning Stiffness-related Scores at Weeks 12 and 16 Week 12 (N = 36, 42)	-3.4 Units on a scale Standard Deviation 2.75	-3.0 Units on a scale Standard Deviation 2.74
Change From Baseline in BASDAI Level of Morning Stiffness-related Scores at Weeks 12 and 16 Weel 16 (N = 28, 37)	-3.3 Units on a scale Standard Deviation 2.64	-3.9 Units on a scale Standard Deviation 2.46

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 4

The investigator assessed the overall disease activity using the scale of 0 (no disease activity) to 10 (severe disease activity).

Outcome measures

Outcome measures
Measure	Double Blind ETN 50 mg to Open Label ETN 50 mg Group n=40 Participants Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks	Placebo to Open Label ETN 50 mg Group n=44 Participants Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
Change From Baseline in PGA (Physician Global Assessment) at Week 4	-2.05 Units on a scale Standard Error 0.30	-0.71 Units on a scale Standard Error 0.28

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 8

Investigator assessed the overall disease activity using the scale of 0 (no disease activity) to 10 (severe disease activity).

Outcome measures

Outcome measures
Measure	Double Blind ETN 50 mg to Open Label ETN 50 mg Group n=40 Participants Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks	Placebo to Open Label ETN 50 mg Group n=44 Participants Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
Change From Baseline in PGA (Physician Global Assessment) at Week 8	-2.69 Units on a scale Standard Error 0.35	-1.58 Units on a scale Standard Error 0.33

OTHER_PRE_SPECIFIED outcome

Timeframe: Weeks 12 and 16

Investigator assessed the overall disease activity using the scale of 0 (no disease activity) to 10 (severe disease activity).

Outcome measures

Outcome measures
Measure	Double Blind ETN 50 mg to Open Label ETN 50 mg Group n=41 Participants Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks	Placebo to Open Label ETN 50 mg Group n=46 Participants Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
Change From Baseline in PGA at Weeks 12 and 16 Week 12 (N = 35, 38)	-3.5 Units on a scale Standard Deviation 2.73	-3.4 Units on a scale Standard Deviation 1.54
Change From Baseline in PGA at Weeks 12 and 16 Week 16 (N = 29, 37)	-3.7 Units on a scale Standard Deviation 2.22	-3.8 Units on a scale Standard Deviation 2.00

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 4

BASFI is to assess the prticipant's level of ability to complete the activities on a scale from 0 (easy) to 10 (impossible). The total score was calculated as the average score of the 10 questions.

Outcome measures

Outcome measures
Measure	Double Blind ETN 50 mg to Open Label ETN 50 mg Group n=42 Participants Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks	Placebo to Open Label ETN 50 mg Group n=48 Participants Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
Change From Baseline in Each BASFI Component at Week 4 Putting on socks (N = 40, 45)	-1.0 Units on a scale Standard Deviation 2.66	-0.4 Units on a scale Standard Deviation 1.72
Change From Baseline in Each BASFI Component at Week 4 Bending forward (N = 40, 45)	-1.0 Units on a scale Standard Deviation 3.19	-0.2 Units on a scale Standard Deviation 1.96
Change From Baseline in Each BASFI Component at Week 4 Reaching up high (N = 40, 45)	-1.3 Units on a scale Standard Deviation 2.43	-0.3 Units on a scale Standard Deviation 1.62
Change From Baseline in Each BASFI Component at Week 4 Getting out of an armless chair (N = 40, 45)	-1.3 Units on a scale Standard Deviation 2.58	-0.5 Units on a scale Standard Deviation 1.69
Change From Baseline in Each BASFI Component at Week 4 Getting up off floor from back (N = 40, 45)	-1.6 Units on a scale Standard Deviation 2.91	-0.4 Units on a scale Standard Deviation 1.69
Change From Baseline in Each BASFI Component at Week 4 Standing unsupported 10 min (N = 40, 45)	-1.0 Units on a scale Standard Deviation 2.57	0.0 Units on a scale Standard Deviation 2.57
Change From Baseline in Each BASFI Component at Week 4 Climbing steps without aid (N = 40, 45)	-0.4 Units on a scale Standard Deviation 3.00	-0.5 Units on a scale Standard Deviation 2.04
Change From Baseline in Each BASFI Component at Week 4 Looking over shoulder	-1.6 Units on a scale Standard Deviation 2.70	-0.2 Units on a scale Standard Deviation 2.15
Change From Baseline in Each BASFI Component at Week 4 Physically demanding activities (N = 40, 45)	-1.2 Units on a scale Standard Deviation 2.34	-0.4 Units on a scale Standard Deviation 1.93
Change From Baseline in Each BASFI Component at Week 4 Full day's activities (N = 40, 45)	-1.1 Units on a scale Standard Deviation 2.42	-0.4 Units on a scale Standard Deviation 1.75

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 8

BASFI is to assess the prticipant's level of ability to complete the activities on a scale from 0 (easy) to 10 (impossible). The total score was calculated as the average score of the 10 questions.

Outcome measures

Outcome measures
Measure	Double Blind ETN 50 mg to Open Label ETN 50 mg Group n=42 Participants Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks	Placebo to Open Label ETN 50 mg Group n=48 Participants Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
Change From Baseline in Each BASFI Component at Week 8 Putting on socks (N = 37, 43)	-1.3 Units on a scale Standard Deviation 2.64	-0.3 Units on a scale Standard Deviation 2.18
Change From Baseline in Each BASFI Component at Week 8 Bending forward (N = 37, 43)	-1.8 Units on a scale Standard Deviation 3.10	-0.4 Units on a scale Standard Deviation 2.08
Change From Baseline in Each BASFI Component at Week 8 Reaching up high (N = 37, 43)	-1.3 Units on a scale Standard Deviation 3.09	-0.7 Units on a scale Standard Deviation 2.02
Change From Baseline in Each BASFI Component at Week 8 Getting out of an armless chair (N = 37, 43)	-2.1 Units on a scale Standard Deviation 2.78	-1.0 Units on a scale Standard Deviation 2.23
Change From Baseline in Each BASFI Component at Week 8 Getting up off floor from back (N = 37, 43)	-2.3 Units on a scale Standard Deviation 3.01	-0.6 Units on a scale Standard Deviation 2.33
Change From Baseline in Each BASFI Component at Week 8 Standing unsupported 10 min (N = 37, 43)	-1.6 Units on a scale Standard Deviation 2.66	-0.8 Units on a scale Standard Deviation 2.67
Change From Baseline in Each BASFI Component at Week 8 Climbing steps without aid (N = 37, 43)	-1.2 Units on a scale Standard Deviation 3.22	-0.9 Units on a scale Standard Deviation 2.26
Change From Baseline in Each BASFI Component at Week 8 Looking over shoulder (N = 37, 43)	-2.4 Units on a scale Standard Deviation 2.79	-0.8 Units on a scale Standard Deviation 1.71
Change From Baseline in Each BASFI Component at Week 8 Physically demanding activities (N = 37, 41)	-1.8 Units on a scale Standard Deviation 2.11	-1.2 Units on a scale Standard Deviation 1.91
Change From Baseline in Each BASFI Component at Week 8 Full day's activities (N = 37, 41)	-1.4 Units on a scale Standard Deviation 2.63	-1.2 Units on a scale Standard Deviation 2.04

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 12

BASFI is to assess the prticipant's level of ability to complete the activities on a scale from 0 (easy) to 10 (impossible). The total score was calculated as the average score of the 10 questions.

Outcome measures

Outcome measures
Measure	Double Blind ETN 50 mg to Open Label ETN 50 mg Group n=42 Participants Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks	Placebo to Open Label ETN 50 mg Group n=48 Participants Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
Change From Baseline in Each BASFI Component at Week 12 Putting on socks (n = 36, 42)	-1.6 Units on a scale Standard Deviation 2.75	-1.6 Units on a scale Standard Deviation 2.39
Change From Baseline in Each BASFI Component at Week 12 Bending forward (N = 36, 42)	-2.2 Units on a scale Standard Deviation 3.25	-1.7 Units on a scale Standard Deviation 2.56
Change From Baseline in Each BASFI Component at Week 12 Reaching up high (N = 36,42)	-1.7 Units on a scale Standard Deviation 3.21	-1.5 Units on a scale Standard Deviation 2.35
Change From Baseline in Each BASFI Component at Week 12 Getting out of an armless chair (N = 36, 42)	-2.6 Units on a scale Standard Deviation 3.38	-2.0 Units on a scale Standard Deviation 2.50
Change From Baseline in Each BASFI Component at Week 12 Getting up off floor from back (N = 36, 42)	-2.5 Units on a scale Standard Deviation 3.09	-1.7 Units on a scale Standard Deviation 2.66
Change From Baseline in Each BASFI Component at Week 12 standing unsupported 10 min (N = 36,42)	-2.0 Units on a scale Standard Deviation 2.49	-2.1 Units on a scale Standard Deviation 2.95
Change From Baseline in Each BASFI Component at Week 12 Climbing steps without aid (N = 36, 42)	-1.6 Units on a scale Standard Deviation 3.18	-1.4 Units on a scale Standard Deviation 2.43
Change From Baseline in Each BASFI Component at Week 12 Looking over shoulder (N = 36, 42)	-2.6 Units on a scale Standard Deviation 2.92	-1.8 Units on a scale Standard Deviation 2.62
Change From Baseline in Each BASFI Component at Week 12 Physically demanding activities (N = 36, 41)	-2.2 Units on a scale Standard Deviation 2.68	-2.3 Units on a scale Standard Deviation 2.29
Change From Baseline in Each BASFI Component at Week 12 Full day's activities (N = 36, 40)	-1.8 Units on a scale Standard Deviation 2.45	-2.3 Units on a scale Standard Deviation 2.12

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 16

BASFI is to assess the prticipant's level of ability to complete the activities on a scale from 0 (easy) to 10 (impossible). The total score was calculated as the average score of the 10 questions.

Outcome measures

Outcome measures
Measure	Double Blind ETN 50 mg to Open Label ETN 50 mg Group n=42 Participants Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks	Placebo to Open Label ETN 50 mg Group n=48 Participants Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
Change From Baseline in Each BASFI Component at Week 16 Putting on socks (N = 28, 37)	-1.1 Units on a scale Standard Deviation 3.18	-2.1 Units on a scale Standard Deviation 2.40
Change From Baseline in Each BASFI Component at Week 16 Bending forward (N = 28, 37)	-2.0 Units on a scale Standard Deviation 3.36	-2.1 Units on a scale Standard Deviation 2.33
Change From Baseline in Each BASFI Component at Week 16 Reaching up high (N = 27, 37)	-1.0 Units on a scale Standard Deviation 3.55	-1.6 Units on a scale Standard Deviation 2.29
Change From Baseline in Each BASFI Component at Week 16 Getting out of an armless chair (N = 28, 37)	-2.0 Units on a scale Standard Deviation 3.42	-2.5 Units on a scale Standard Deviation 2.35
Change From Baseline in Each BASFI Component at Week 16 Getting up off floor from back (N = 28, 37)	-2.2 Units on a scale Standard Deviation 2.83	-2.3 Units on a scale Standard Deviation 2.60
Change From Baseline in Each BASFI Component at Week 16 Standing unsupported 10 min (N = 28, 37)	-2.2 Units on a scale Standard Deviation 2.5	-2.6 Units on a scale Standard Deviation 2.8
Change From Baseline in Each BASFI Component at Week 16 Climbing steps without aid (N = 28, 37)	-1.3 Units on a scale Standard Deviation 3.13	-1.9 Units on a scale Standard Deviation 2.53
Change From Baseline in Each BASFI Component at Week 16 Looking over shoulder (N = 28, 37)	-2.4 Units on a scale Standard Deviation 3.19	-2.3 Units on a scale Standard Deviation 2.62
Change From Baseline in Each BASFI Component at Week 16 Physically demanding activities (N = 28, 36)	-2.3 Units on a scale Standard Deviation 2.46	-2.6 Units on a scale Standard Deviation 2.38
Change From Baseline in Each BASFI Component at Week 16 Full day's activities (N = 28, 36)	-1.9 Units on a scale Standard Deviation 2.28	-2.6 Units on a scale Standard Deviation 2.07

OTHER_PRE_SPECIFIED outcome

Timeframe: Weeks 4, 8, 12 and 16

Swollen joint count was performed at each visit to assess the peripheral joint involvement according to ASAS recommendation.

Outcome measures

Outcome measures
Measure	Double Blind ETN 50 mg to Open Label ETN 50 mg Group n=28 Participants Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks	Placebo to Open Label ETN 50 mg Group n=35 Participants Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
Change From Baseline in Swollen Joint Counts at Weeks 4, 8, 12 and 16 Week 4 (N = 23, 22)	-0.6 Swollen joints Standard Deviation 1.65	0.0 Swollen joints Standard Deviation 1.09
Change From Baseline in Swollen Joint Counts at Weeks 4, 8, 12 and 16 Week 8 (N = 14, 22)	-0.1 Swollen joints Standard Deviation 2.09	0.0 Swollen joints Standard Deviation 1.25
Change From Baseline in Swollen Joint Counts at Weeks 4, 8, 12 and 16 Weel 12 (N = 11, 15)	-0.5 Swollen joints Standard Deviation 1.29	-0.3 Swollen joints Standard Deviation 1.23
Change From Baseline in Swollen Joint Counts at Weeks 4, 8, 12 and 16 Week 16 (N = 9, 9)	-1.1 Swollen joints Standard Deviation 2.89	2.3 Swollen joints Standard Deviation 6.65

OTHER_PRE_SPECIFIED outcome

Timeframe: Weeks 4, 8, 12 and 16

Tender joint count was performed at each visit to assess the peripheral joint involvement according to ASAS recommendation.

Outcome measures

Outcome measures
Measure	Double Blind ETN 50 mg to Open Label ETN 50 mg Group n=28 Participants Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks	Placebo to Open Label ETN 50 mg Group n=35 Participants Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
Change From Baseline in Tenderness Joint Counts at Weeks 4, 8, 12 and 16 Week 4 (N = 23, 22)	-1.2 Tender joints Standard Deviation 3.61	-2.4 Tender joints Standard Deviation 7.57
Change From Baseline in Tenderness Joint Counts at Weeks 4, 8, 12 and 16 Week 8 (N = 14, 22)	-2.3 Tender joints Standard Deviation 5.11	-3.1 Tender joints Standard Deviation 6.47
Change From Baseline in Tenderness Joint Counts at Weeks 4, 8, 12 and 16 Week 12 (N = 11, 15)	-1.3 Tender joints Standard Deviation 5.00	-1.4 Tender joints Standard Deviation 10.70
Change From Baseline in Tenderness Joint Counts at Weeks 4, 8, 12 and 16 Week 16 (N = 9, 9)	-1.9 Tender joints Standard Deviation 5.64	0.2 Tender joints Standard Deviation 9.93

OTHER_PRE_SPECIFIED outcome

Timeframe: Weeks 4, 8, 12 and 16

Assessment of enthesitis was performed in the following 7 domains: 1) 1st costochondral joint left and right, 2) 7th costochondral joint left and right, 3) posterior superior iliac spine left and right, 4) anterior superior iliac spine left and right, 5) iliac crest left and right, 6) 5th lumbar spinous process and 7) proximal insertion of Achilles tendon left and right. Each domain was graded for the presence (1) and absence (0) of tenderness yielding total MASES ranging from 0 (no tenderness) to 13 (worst possible score; severe tenderness).

Outcome measures

Outcome measures
Measure	Double Blind ETN 50 mg to Open Label ETN 50 mg Group n=35 Participants Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks	Placebo to Open Label ETN 50 mg Group n=35 Participants Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
Change From Baseline in MASES (Maastricht Ankylosing Spondylitis Entheses Score) Score at Weeks 4, 8, 12 and 16 Week 4 (N = 23, 27)	-0.7 Units on a scale Standard Deviation 2.55	-0.3 Units on a scale Standard Deviation 2.31
Change From Baseline in MASES (Maastricht Ankylosing Spondylitis Entheses Score) Score at Weeks 4, 8, 12 and 16 Week 8 (N = 20, 24)	-1.1 Units on a scale Standard Deviation 2.42	-0.7 Units on a scale Standard Deviation 2.55
Change From Baseline in MASES (Maastricht Ankylosing Spondylitis Entheses Score) Score at Weeks 4, 8, 12 and 16 Week 12 (N = 14, 13)	-1.0 Units on a scale Standard Deviation 2.94	0.0 Units on a scale Standard Deviation 2.77
Change From Baseline in MASES (Maastricht Ankylosing Spondylitis Entheses Score) Score at Weeks 4, 8, 12 and 16 Week 16 (N = 13, 10)	-0.6 Units on a scale Standard Deviation 2.57	-1.4 Units on a scale Standard Deviation 3.27

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 8

MCII was completed at visit weeks 4, 8, 12 and 16 or Early Discontinuation and once weekly between visits. MCII was converted to binary scores as follows: 1 = 'improved'/'very important' and 'improved'/'moderately important' 2 = 'improved'/'slightly important', 'improved'/'not at all important', 'no change' and 'worse-no pain'. MCII was determined based on participant's response on the following three items for the question of how have they been during the last 48 hours compared to when they started the study: improved or less pain, no change and worse-more pain. MCII was typically defined according to the patients perception of what was very important improvement, moderate important improvement, slightly important improvement or not at all improvement.

Outcome measures

Outcome measures
Measure	Double Blind ETN 50 mg to Open Label ETN 50 mg Group n=37 Participants Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks	Placebo to Open Label ETN 50 mg Group n=43 Participants Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
Number of Participants With Minimum Clinically Important Improvement (MCII) at Week 8	21 Participants	17 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Weeks 4, 12 and 16

MCII was completed at Weeks 4, 8, 12 and 16 or Early Discontinuation and once weekly between visits. MCII was converted to binary scores as follows: 1 = 'improved'/'very important' and 'improved'/'moderately important' 2 = 'improved'/'slightly important', 'improved'/'not at all important', 'no change' and 'worse-no pain. MCII was determined based on participant's response on the following three items for the question of how have they been during the last 48 hours compared to when they started the study: improved or less pain, no change and worse-more pain. MCII was typically defined according to the patients perception of what was very important improvement, moderate important improvement, slightly important improvement or not at all improvement.

Outcome measures

Outcome measures
Measure	Double Blind ETN 50 mg to Open Label ETN 50 mg Group n=42 Participants Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks	Placebo to Open Label ETN 50 mg Group n=48 Participants Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
Number of Participants With MCII at Weeks 4, 12 and 16 Week 4 (N = 40, 44)	19 Participants	11 Participants
Number of Participants With MCII at Weeks 4, 12 and 16 Week 12 (N = 36, 42)	25 Participants	25 Participants
Number of Participants With MCII at Weeks 4, 12 and 16 Week 16 (N = 28, 37)	22 Participants	22 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Weeks 4, 8, 12 and 16

MCID was completed at Weeks 4, 8, 12 and 16 or Early Discontinuation and once weekly between visits. MCID was converted to binary scores as follows: 1 = 'improved'/'very important' and 'improved'/'moderately important' 2 = 'improved'/'slightly important', 'improved'/'not at all important', 'no change' and 'worse-no pain. MCID was evaluated based on participant's opinion on the following three items for the question of how have they been during the last 48 hours compared to Screening visit: 'improved-less pain', 'no change', and 'worse-more pain'. Participants were further asked the importance of worsening i.e., very important, moderately important, slightly important and not at all important as MCID evaluation criteria.

Outcome measures

Outcome measures
Measure	Double Blind ETN 50 mg to Open Label ETN 50 mg Group n=42 Participants Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks	Placebo to Open Label ETN 50 mg Group n=48 Participants Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
Number of Participants With Minimum Clinically Important Deterioration (MCID) at Weeks 4, 8, 12 and 16 Week 4 (N = 40, 44)	3 Participants	9 Participants
Number of Participants With Minimum Clinically Important Deterioration (MCID) at Weeks 4, 8, 12 and 16 Week 8 (N = 37, 43)	0 Participants	3 Participants
Number of Participants With Minimum Clinically Important Deterioration (MCID) at Weeks 4, 8, 12 and 16 Week 12 (N = 36, 42)	0 Participants	0 Participants
Number of Participants With Minimum Clinically Important Deterioration (MCID) at Weeks 4, 8, 12 and 16 Week 16 (N = 28, 37)	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 8

PASS is defined as a symptom state that the participants consider acceptable. PASS was collected weekly in the diary card, but at each visit this was collected in the CRF. Participants assessed their health in the previous 48 hours and whether it would be acceptable to remain like that in the next few months.

Outcome measures

Outcome measures
Measure	Double Blind ETN 50 mg to Open Label ETN 50 mg Group n=37 Participants Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks	Placebo to Open Label ETN 50 mg Group n=43 Participants Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
Number of Participants With Patient Acceptable Symptom State (PASS) at Week 8	22 Participants	16 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Weeks 4, 12 and 16

PASS is defined as a symptom state that the participants consider acceptable. The PASS was collected weekly in the diary card, but at each visit this was collected in the CRF. Participants assessed their health in the previous 48 hours and whether it would be acceptable to remain like that in the next few months.

Outcome measures

Outcome measures
Measure	Double Blind ETN 50 mg to Open Label ETN 50 mg Group n=42 Participants Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks	Placebo to Open Label ETN 50 mg Group n=48 Participants Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
Number of Participants With PASS at Weeks 4, 12 and 16 Week 4 (N = 40, 44)	19 Participants	14 Participants
Number of Participants With PASS at Weeks 4, 12 and 16 Week 12 (N = 36, 42)	23 Participants	29 Participants
Number of Participants With PASS at Weeks 4, 12 and 16 Week 16 (N = 28, 37)	20 Participants	28 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 4

BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10.

Outcome measures

Outcome measures
Measure	Double Blind ETN 50 mg to Open Label ETN 50 mg Group n=39 Participants Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks	Placebo to Open Label ETN 50 mg Group n=45 Participants Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 4	-0.31 Units on a scale Standard Error 0.19	0.05 Units on a scale Standard Error 0.17

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 8

Outcome measures

Outcome measures
Measure	Double Blind ETN 50 mg to Open Label ETN 50 mg Group n=40 Participants Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks	Placebo to Open Label ETN 50 mg Group n=46 Participants Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
Change From Baseline in BASMI at Week 8	-0.40 Units on a scale Standard Error 0.21	-0.11 Units on a scale Standard Error 0.19

OTHER_PRE_SPECIFIED outcome

Timeframe: Weeks 12 and 16

Outcome measures

Outcome measures
Measure	Double Blind ETN 50 mg to Open Label ETN 50 mg Group n=41 Participants Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks	Placebo to Open Label ETN 50 mg Group n=48 Participants Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
Change From Baseline in BASMI at Weeks 12 and 16 Week 12 (N = 35, 43)	-0.4 Units on a scale Standard Deviation 1.44	-0.4 Units on a scale Standard Deviation 1.26
Change From Baseline in BASMI at Weeks 12 and 16 Week 16 (N = 28, 38)	-0.6 Units on a scale Standard Deviation 1.71	-0.6 Units on a scale Standard Deviation 1.23

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 4

BASMI is an objective measure of spinal mobility. The BASMI score was composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10. For each BASMI component, the best of the two tries was taken which corresponded to the highest value for cervical rotation, intermalleolar distance, modified Schober's test and lateral flexion and the smallest value for tragus to wall distance. For cervical rotation, lateral flexion and tragus to wall distance, a mean of the left and right measurements was taken.

Outcome measures

Outcome measures
Measure	Double Blind ETN 50 mg to Open Label ETN 50 mg Group n=42 Participants Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks	Placebo to Open Label ETN 50 mg Group n=48 Participants Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
Change From Baseline in BASMI Components at Week 4 Cervical rotation (N = 39, 45)	0.0 Units on a scale Standard Deviation 0.46	0.0 Units on a scale Standard Deviation 0.34
Change From Baseline in BASMI Components at Week 4 Tragus to wall distance (N=41, 43)	0.0 Units on a scale Standard Deviation 0.31	0.0 Units on a scale Standard Deviation 0.49
Change From Baseline in BASMI Components at Week 4 Lateral flexion (N = 40, 42)	-0.1 Units on a scale Standard Deviation 0.61	-0.1 Units on a scale Standard Deviation 0.50
Change From Baseline in BASMI Components at Week 4 Modified schober's test (N = 41, 45)	0.0 Units on a scale Standard Deviation 0.55	0.1 Units on a scale Standard Deviation 0.68
Change From Baseline in BASMI Components at Week 4 Intermalleolar distance (N = 38, 44)	-0.2 Units on a scale Standard Deviation 0.73	0.1 Units on a scale Standard Deviation 0.66

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 8

Outcome measures

Outcome measures
Measure	Double Blind ETN 50 mg to Open Label ETN 50 mg Group n=42 Participants Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks	Placebo to Open Label ETN 50 mg Group n=48 Participants Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
Change From Baseline in BASMI Components at Week 8 Cervical rotation (N = 37, 44)	-0.1 Units on a scale Standard Deviation 0.60	0.0 Units on a scale Standard Deviation 0.53
Change From Baseline in BASMI Components at Week 8 Tragus to wall distance (N = 38, 43)	0.1 Units on a scale Standard Deviation 0.40	-0.1 Units on a scale Standard Deviation 0.43
Change From Baseline in BASMI Components at Week 8 Lateral flexion (N = 38, 42)	-0.1 Units on a scale Standard Deviation 0.58	-0.1 Units on a scale Standard Deviation 0.55
Change From Baseline in BASMI Components at Week 8 Modified schober's test (N = 38, 44)	-0.1 Units on a scale Standard Deviation 0.54	0.1 Units on a scale Standard Deviation 0.67
Change From Baseline in BASMI Components at Week 8 Intermalleolar distance (N = 36, 43)	-0.2 Units on a scale Standard Deviation 0.75	0.0 Units on a scale Standard Deviation 0.76

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 12

Outcome measures

Outcome measures
Measure	Double Blind ETN 50 mg to Open Label ETN 50 mg Group n=42 Participants Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks	Placebo to Open Label ETN 50 mg Group n=48 Participants Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
Change From Baseline in BASMI Components at Week 12 Cervical rotation (N= 35, 43)	-0.1 Units on a scale Standard Deviation 0.66	-0.1 Units on a scale Standard Deviation 0.40
Change From Baseline in BASMI Components at Week 12 Tragus to wall distance (N = 36, 42)	0.2 Units on a scale Standard Deviation 0.51	0.0 Units on a scale Standard Deviation 0.41
Change From Baseline in BASMI Components at Week 12 Lateral flexion (N = 36, 42)	-0.2 Units on a scale Standard Deviation 0.56	-0.2 Units on a scale Standard Deviation 0.40
Change From Baseline in BASMI Components at Week 12 Modified schober's test (N = 36, 43)	-0.1 Units on a scale Standard Deviation 0.55	0.0 Units on a scale Standard Deviation 0.77
Change From Baseline in BASMI Components at Week 12 Intermalleolar distance (N = 33, 42)	-0.2 Units on a scale Standard Deviation 0.88	-0.1 Units on a scale Standard Deviation 0.77

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 16

Outcome measures

Outcome measures
Measure	Double Blind ETN 50 mg to Open Label ETN 50 mg Group n=42 Participants Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks	Placebo to Open Label ETN 50 mg Group n=48 Participants Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
Change From Baseline in BASMI Components at Week 16 Cervical rotation (N = 28, 38)	-0.1 Units on a scale Standard Deviation 0.54	-0.1 Units on a scale Standard Deviation 0.56
Change From Baseline in BASMI Components at Week 16 Tragus to wall distance (N = 29, 37)	0.0 Units on a scale Standard Deviation 0.33	-0.1 Units on a scale Standard Deviation 0.47
Change From Baseline in BASMI Components at Week 16 Lateral flexion (N= 29, 36)	-0.1 Units on a scale Standard Deviation 0.64	-0.2 Units on a scale Standard Deviation 0.47
Change From Baseline in BASMI Components at Week 16 Modified schober's test (N = 29, 38)	-0.1 Units on a scale Standard Deviation 0.49	0.0 Units on a scale Standard Deviation 0.77
Change From Baseline in BASMI Components at Week 16 Intermalleolar distance (N = 26, 37)	-0.3 Units on a scale Standard Deviation 0.87	-0.2 Units on a scale Standard Deviation 0.66

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 4

Chest expansion, measured in cm, is defined as the difference in thoracic circumference during full expiration versus full inspiration, measured at the fourth intercostal space (nipple line). Chest expansion was measured for both maximum and minimum inhalation and the data presented below combined both the values.

Outcome measures

Outcome measures
Measure	Double Blind ETN 50 mg to Open Label ETN 50 mg Group n=37 Participants Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks	Placebo to Open Label ETN 50 mg Group n=44 Participants Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
Change From Baseline in Chest Expansion at Week 4	2.61 cm Standard Error 1.61	0.21 cm Standard Error 1.48

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 8

Outcome measures

Outcome measures
Measure	Double Blind ETN 50 mg to Open Label ETN 50 mg Group n=39 Participants Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks	Placebo to Open Label ETN 50 mg Group n=45 Participants Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
Change From Baseline in Chest Expansion at Week 8	0.62 cm Standard Error 0.24	-0.06 cm Standard Error 0.23

OTHER_PRE_SPECIFIED outcome

Timeframe: Weeks 12 and 16

Outcome measures

Outcome measures
Measure	Double Blind ETN 50 mg to Open Label ETN 50 mg Group n=40 Participants Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks	Placebo to Open Label ETN 50 mg Group n=47 Participants Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
Change From Baseline in Chest Expansion at Weeks 12 and 16 Week 12 (N = 34, 42)	0.3 cm Standard Deviation 2.26	0.1 cm Standard Deviation 2.03
Change From Baseline in Chest Expansion at Weeks 12 and 16 Week 16 (N = 27, 37)	0.2 cm Standard Deviation 1.42	2.0 cm Standard Deviation 10.92

Adverse Events

Double Blind ETN 50 mg to Open Label ETN 50 mg Group

Serious events: 1 serious events

Other events: 34 other events

Deaths: 0 deaths

Placebo to Open Label ETN 50 mg Group

Serious events: 2 serious events

Other events: 34 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Double Blind ETN 50 mg to Open Label ETN 50 mg Group n=42 participants at risk Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks	Placebo to Open Label ETN 50 mg Group n=48 participants at risk Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
Gastrointestinal disorders Duodenitis	2.4% 1/42 • Up to Week 16 and safety follow-up at 4 weeks after the last visit The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/48 • Up to Week 16 and safety follow-up at 4 weeks after the last visit The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Chest Pain	0.00% 0/42 • Up to Week 16 and safety follow-up at 4 weeks after the last visit The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.1% 1/48 • Up to Week 16 and safety follow-up at 4 weeks after the last visit The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Road Traffic Accident	0.00% 0/42 • Up to Week 16 and safety follow-up at 4 weeks after the last visit The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.1% 1/48 • Up to Week 16 and safety follow-up at 4 weeks after the last visit The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Surgical and medical procedures Cyst Removal	0.00% 0/42 • Up to Week 16 and safety follow-up at 4 weeks after the last visit The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.1% 1/48 • Up to Week 16 and safety follow-up at 4 weeks after the last visit The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Other adverse events

Additional Information

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Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
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Restriction type: OTHER