Trial Outcomes & Findings for Effects of Etanercept on the Heart, Veins and Thickness of Certain Major Arteries In Ankylosing Spondylitis Patients (NCT NCT00910273)
NCT ID: NCT00910273
Last Updated: 2016-01-13
Results Overview
Brachial artery (BA) FMD equals (=)(maximum diameter minus\[-\] baseline diameter divided by baseline diameter) times (\*) 100 percent (%). Ultrasound images of BA at rest were followed by blood pressure (BP) cuff inflated to at least 50 millimeters of mercury (mm Hg) above participants systolic BP for 5 minutes. Cuff released and reactive hyperaemia was produced. BA was imaged continuously from 30 seconds prior cuff inflation to 2 minutes after cuff deflation. Higher scores indicate improved endothelial function.
TERMINATED
PHASE4
34 participants
Baseline, Week 12
2016-01-13
Participant Flow
Participant milestones
| Measure |
Etanercept
Participants received etanercept (50 milligrams \[mg\]) subcutaneous (sc) injection once per week for 52 weeks.
|
Placebo
Participants received matched placebo sc injection once per week for 52 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
16
|
|
Overall Study
COMPLETED
|
0
|
3
|
|
Overall Study
NOT COMPLETED
|
18
|
13
|
Reasons for withdrawal
| Measure |
Etanercept
Participants received etanercept (50 milligrams \[mg\]) subcutaneous (sc) injection once per week for 52 weeks.
|
Placebo
Participants received matched placebo sc injection once per week for 52 weeks.
|
|---|---|---|
|
Overall Study
Lack of Efficacy
|
6
|
9
|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Discontinuation of study by sponsor
|
8
|
2
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
Baseline Characteristics
Effects of Etanercept on the Heart, Veins and Thickness of Certain Major Arteries In Ankylosing Spondylitis Patients
Baseline characteristics by cohort
| Measure |
Etanercept
n=18 Participants
Participants received etanercept (50 milligrams \[mg\]) subcutaneous (sc) injection once per week for 52 weeks.
|
Placebo
n=16 Participants
Participants received matched placebo sc injection once per week for 52 weeks.
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39.47 years
STANDARD_DEVIATION 8.69 • n=5 Participants
|
46.83 years
STANDARD_DEVIATION 13.14 • n=7 Participants
|
42.93 years
STANDARD_DEVIATION 11.46 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: Modified Intent to Treat Population (mITT): all randomized participants who received at least one dose of test article followed by at least one available evaluation; n=number of participants evaluable at specific time point
Brachial artery (BA) FMD equals (=)(maximum diameter minus\[-\] baseline diameter divided by baseline diameter) times (\*) 100 percent (%). Ultrasound images of BA at rest were followed by blood pressure (BP) cuff inflated to at least 50 millimeters of mercury (mm Hg) above participants systolic BP for 5 minutes. Cuff released and reactive hyperaemia was produced. BA was imaged continuously from 30 seconds prior cuff inflation to 2 minutes after cuff deflation. Higher scores indicate improved endothelial function.
Outcome measures
| Measure |
Etanercept
n=17 Participants
Participants received etanercept (50 milligrams \[mg\]) subcutaneous (sc) injection once per week for 52 weeks.
|
Placebo
n=15 Participants
Participants received matched placebo sc injection once per week for 52 weeks.
|
|---|---|---|
|
Change From Baseline in Flow-Mediated Dilatation (FMD) at Week 12
Baseline (n=17, 15)
|
10.09 percentage of BA diameter
Standard Deviation 5.93
|
13.42 percentage of BA diameter
Standard Deviation 7.70
|
|
Change From Baseline in Flow-Mediated Dilatation (FMD) at Week 12
Change at Week 12 (n=16, 12)
|
4.10 percentage of BA diameter
Standard Deviation 11.41
|
0.25 percentage of BA diameter
Standard Deviation 7.35
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 24, 36, and 52 or Early Termination (ET)Population: mITT; n=number of participants evaluable at specific time point
BA FMD =(maximum diameter -baseline diameter divided by baseline diameter) \* 100%. Ultrasound images of BA at rest were followed by BP cuff inflated to at least 50 mm Hg above participants systolic BP for 5 minutes. Cuff released and reactive hyperaemia was produced. BA was imaged continuously from 30 seconds prior cuff inflation to 2 minutes after cuff deflation. Higher scores indicate improved endothelial function. Change: Week x observation minus Baseline observation.
Outcome measures
| Measure |
Etanercept
n=17 Participants
Participants received etanercept (50 milligrams \[mg\]) subcutaneous (sc) injection once per week for 52 weeks.
|
Placebo
n=15 Participants
Participants received matched placebo sc injection once per week for 52 weeks.
|
|---|---|---|
|
Change From Baseline in Flow-Mediated Dilatation at Weeks 4, 24, 36, and 52
Change at Week 4 (n=17, 13)
|
2.56 percentage of BA diameter
Standard Deviation 9.51
|
-0.68 percentage of BA diameter
Standard Deviation 4.75
|
|
Change From Baseline in Flow-Mediated Dilatation at Weeks 4, 24, 36, and 52
Change at Week 24 (n=9, 4)
|
3.89 percentage of BA diameter
Standard Deviation 10.56
|
3.20 percentage of BA diameter
Standard Deviation 5.75
|
|
Change From Baseline in Flow-Mediated Dilatation at Weeks 4, 24, 36, and 52
Change at Week 36 (n=7, 4)
|
6.24 percentage of BA diameter
Standard Deviation 5.53
|
5.18 percentage of BA diameter
Standard Deviation 7.33
|
|
Change From Baseline in Flow-Mediated Dilatation at Weeks 4, 24, 36, and 52
Change at Week 52 (n=4, 3)
|
8.14 percentage of BA diameter
Standard Deviation 5.65
|
12.13 percentage of BA diameter
Standard Deviation 5.28
|
SECONDARY outcome
Timeframe: Baseline, Week 12 and 52 or ETPopulation: mITT; n=number of participants evaluable at specific time point; N=number of participants evaluable
Change in IMT in the distal common carotid arteries (CCA), common bulbs (CB), and internal carotid arteries (ICA) as determined by ultrasound. Higher scores indicate worsening in cardiovascular risk assessment. Change: Week x observation minus Baseline observation.
Outcome measures
| Measure |
Etanercept
n=17 Participants
Participants received etanercept (50 milligrams \[mg\]) subcutaneous (sc) injection once per week for 52 weeks.
|
Placebo
n=14 Participants
Participants received matched placebo sc injection once per week for 52 weeks.
|
|---|---|---|
|
Change From Baseline in Carotid Intima Media Thickness (IMT) at Weeks 12 and 52
CCA Baseline (n=17, 14)
|
0.65 mm
Standard Deviation 0.20
|
0.77 mm
Standard Deviation 0.13
|
|
Change From Baseline in Carotid Intima Media Thickness (IMT) at Weeks 12 and 52
CCA Change at Week 12 (n=16, 11)
|
0.00 mm
Standard Deviation 0.15
|
-0.09 mm
Standard Deviation 0.16
|
|
Change From Baseline in Carotid Intima Media Thickness (IMT) at Weeks 12 and 52
CCA Change at Week 52 (n=4, 2)
|
0.00 mm
Standard Deviation 0.08
|
0.08 mm
Standard Deviation 0.01
|
|
Change From Baseline in Carotid Intima Media Thickness (IMT) at Weeks 12 and 52
CB Baseline (n=17, 14)
|
0.76 mm
Standard Deviation 0.16
|
0.89 mm
Standard Deviation 0.17
|
|
Change From Baseline in Carotid Intima Media Thickness (IMT) at Weeks 12 and 52
CB Change at Week 12 (n=16, 11)
|
-0.03 mm
Standard Deviation 0.11
|
-0.02 mm
Standard Deviation 0.12
|
|
Change From Baseline in Carotid Intima Media Thickness (IMT) at Weeks 12 and 52
CB Change at Week 52 (n=4, 2)
|
-0.05 mm
Standard Deviation 0.19
|
0.03 mm
Standard Deviation 0.46
|
|
Change From Baseline in Carotid Intima Media Thickness (IMT) at Weeks 12 and 52
ICA Baseline (n=17, 14)
|
0.67 mm
Standard Deviation 0.19
|
0.75 mm
Standard Deviation 0.32
|
|
Change From Baseline in Carotid Intima Media Thickness (IMT) at Weeks 12 and 52
ICA Change at Week 12 (n=16, 11)
|
-0.03 mm
Standard Deviation 0.16
|
-0.07 mm
Standard Deviation 0.28
|
|
Change From Baseline in Carotid Intima Media Thickness (IMT) at Weeks 12 and 52
ICA Change at Week 52 (n=4, 2)
|
-0.03 mm
Standard Deviation 0.19
|
-0.27 mm
Standard Deviation 0.90
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 12, 24, 36 and 52 or ETPopulation: mITT; n=number of participants evaluable at specific time point; N=number of participants evaluable
Mean Total Cholesterol (TC), Low Density Lipoprotein (LDL) and Triglyceride (TGL) blood concentrations, lower values indicated improvement in cardiovascular risk. Mean High Density Lipoprotein (HDL), higher values indicated improvement in cardiovascular risk. Change: Week x observation minus Baseline observation. Baseline value was used when present, otherwise valid screening value used as baseline if within 14 days of first test article injection.
Outcome measures
| Measure |
Etanercept
n=16 Participants
Participants received etanercept (50 milligrams \[mg\]) subcutaneous (sc) injection once per week for 52 weeks.
|
Placebo
n=15 Participants
Participants received matched placebo sc injection once per week for 52 weeks.
|
|---|---|---|
|
Change From Baseline Lipid Parameters at Weeks 4, 12, 24, 36 and 52
HDL Change at Week 12 (n=15, 12)
|
0.07 millimole/Liter (mmol/L)
Standard Deviation 0.19
|
-0.03 millimole/Liter (mmol/L)
Standard Deviation 0.16
|
|
Change From Baseline Lipid Parameters at Weeks 4, 12, 24, 36 and 52
TC Baseline (n=16, 15)
|
4.39 millimole/Liter (mmol/L)
Standard Deviation 0.97
|
4.53 millimole/Liter (mmol/L)
Standard Deviation 0.92
|
|
Change From Baseline Lipid Parameters at Weeks 4, 12, 24, 36 and 52
TC Change at Week 4 (n=16, 13)
|
0.25 millimole/Liter (mmol/L)
Standard Deviation 0.61
|
-0.16 millimole/Liter (mmol/L)
Standard Deviation 0.96
|
|
Change From Baseline Lipid Parameters at Weeks 4, 12, 24, 36 and 52
TC Change at Week 12 (n=15, 12)
|
0.30 millimole/Liter (mmol/L)
Standard Deviation 0.60
|
-0.06 millimole/Liter (mmol/L)
Standard Deviation 0.64
|
|
Change From Baseline Lipid Parameters at Weeks 4, 12, 24, 36 and 52
TC Change at Week 24 (n=9, 4)
|
0.27 millimole/Liter (mmol/L)
Standard Deviation 0.61
|
0.14 millimole/Liter (mmol/L)
Standard Deviation 0.29
|
|
Change From Baseline Lipid Parameters at Weeks 4, 12, 24, 36 and 52
TC Change at Week 36 (n=7, 4)
|
0.50 millimole/Liter (mmol/L)
Standard Deviation 0.61
|
0.03 millimole/Liter (mmol/L)
Standard Deviation 0.49
|
|
Change From Baseline Lipid Parameters at Weeks 4, 12, 24, 36 and 52
TC Change at Week 52 (n=4, 3)
|
-0.06 millimole/Liter (mmol/L)
Standard Deviation 0.55
|
0.14 millimole/Liter (mmol/L)
Standard Deviation 0.50
|
|
Change From Baseline Lipid Parameters at Weeks 4, 12, 24, 36 and 52
LDL Baseline (n=16, 15)
|
2.76 millimole/Liter (mmol/L)
Standard Deviation 1.25
|
3.02 millimole/Liter (mmol/L)
Standard Deviation 1.00
|
|
Change From Baseline Lipid Parameters at Weeks 4, 12, 24, 36 and 52
LDL Change at Week 4 (n=15, 12)
|
0.08 millimole/Liter (mmol/L)
Standard Deviation 0.62
|
0.08 millimole/Liter (mmol/L)
Standard Deviation 0.55
|
|
Change From Baseline Lipid Parameters at Weeks 4, 12, 24, 36 and 52
LDL Change at Week 12 (n=15, 12)
|
0.27 millimole/Liter (mmol/L)
Standard Deviation 1.34
|
0.03 millimole/Liter (mmol/L)
Standard Deviation 0.39
|
|
Change From Baseline Lipid Parameters at Weeks 4, 12, 24, 36 and 52
LDL Change at Week 24 (n=9, 4)
|
0.04 millimole/Liter (mmol/L)
Standard Deviation 0.40
|
0.34 millimole/Liter (mmol/L)
Standard Deviation 0.50
|
|
Change From Baseline Lipid Parameters at Weeks 4, 12, 24, 36 and 52
LDL Change at Week 36 (n=7, 4)
|
0.22 millimole/Liter (mmol/L)
Standard Deviation 0.48
|
-0.01 millimole/Liter (mmol/L)
Standard Deviation 0.99
|
|
Change From Baseline Lipid Parameters at Weeks 4, 12, 24, 36 and 52
LDL Change at Week 52 (n=4, 3)
|
-0.82 millimole/Liter (mmol/L)
Standard Deviation 0.96
|
0.46 millimole/Liter (mmol/L)
Standard Deviation 0.86
|
|
Change From Baseline Lipid Parameters at Weeks 4, 12, 24, 36 and 52
HDL Baseline (n=16, 15)
|
1.29 millimole/Liter (mmol/L)
Standard Deviation 0.63
|
1.18 millimole/Liter (mmol/L)
Standard Deviation 0.32
|
|
Change From Baseline Lipid Parameters at Weeks 4, 12, 24, 36 and 52
HDL Change at Week 4 (n=15, 12)
|
0.10 millimole/Liter (mmol/L)
Standard Deviation 0.28
|
-0.00 millimole/Liter (mmol/L)
Standard Deviation 0.14
|
|
Change From Baseline Lipid Parameters at Weeks 4, 12, 24, 36 and 52
HDL Change at Week 24 (n=9, 4)
|
0.11 millimole/Liter (mmol/L)
Standard Deviation 0.26
|
0.08 millimole/Liter (mmol/L)
Standard Deviation 0.15
|
|
Change From Baseline Lipid Parameters at Weeks 4, 12, 24, 36 and 52
HDL Change at Week 36 (n=7, 4)
|
0.19 millimole/Liter (mmol/L)
Standard Deviation 0.21
|
0.30 millimole/Liter (mmol/L)
Standard Deviation 0.54
|
|
Change From Baseline Lipid Parameters at Weeks 4, 12, 24, 36 and 52
HDL Change at Week 52 (n=4, 3)
|
-0.01 millimole/Liter (mmol/L)
Standard Deviation 0.24
|
-0.02 millimole/Liter (mmol/L)
Standard Deviation 0.23
|
|
Change From Baseline Lipid Parameters at Weeks 4, 12, 24, 36 and 52
TGL Baseline (n=16, 15)
|
0.96 millimole/Liter (mmol/L)
Standard Deviation 0.54
|
1.25 millimole/Liter (mmol/L)
Standard Deviation 0.67
|
|
Change From Baseline Lipid Parameters at Weeks 4, 12, 24, 36 and 52
TGL Change at Week 4 (n=15, 12)
|
0.14 millimole/Liter (mmol/L)
Standard Deviation 0.33
|
-0.06 millimole/Liter (mmol/L)
Standard Deviation 0.65
|
|
Change From Baseline Lipid Parameters at Weeks 4, 12, 24, 36 and 52
TGL Change at Week 12 (n=15, 12)
|
0.20 millimole/Liter (mmol/L)
Standard Deviation 0.50
|
-0.12 millimole/Liter (mmol/L)
Standard Deviation 0.71
|
|
Change From Baseline Lipid Parameters at Weeks 4, 12, 24, 36 and 52
TGL Change at Week 24 (n=9, 4)
|
0.24 millimole/Liter (mmol/L)
Standard Deviation 0.56
|
-0.91 millimole/Liter (mmol/L)
Standard Deviation 0.83
|
|
Change From Baseline Lipid Parameters at Weeks 4, 12, 24, 36 and 52
TGL Change at Week 36 (n=7, 4)
|
0.33 millimole/Liter (mmol/L)
Standard Deviation 0.50
|
-0.76 millimole/Liter (mmol/L)
Standard Deviation 0.43
|
|
Change From Baseline Lipid Parameters at Weeks 4, 12, 24, 36 and 52
TGL Change at Week 52 (n=4, 3)
|
0.45 millimole/Liter (mmol/L)
Standard Deviation 0.63
|
-0.99 millimole/Liter (mmol/L)
Standard Deviation 0.82
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 12, 24, 36 and 52 or ETPopulation: mITT; n= number of participants evaluable at specific time point; N=number of participants evaluable
Mean serum homocysteine blood concentrations. Lower values of homocysteine indicate improvement in inflammation. Change: Week x observation minus Baseline observation. Baseline value was used when present, otherwise valid screening value used as baseline if within 14 days of first test article injection.
Outcome measures
| Measure |
Etanercept
n=16 Participants
Participants received etanercept (50 milligrams \[mg\]) subcutaneous (sc) injection once per week for 52 weeks.
|
Placebo
n=15 Participants
Participants received matched placebo sc injection once per week for 52 weeks.
|
|---|---|---|
|
Change From Baseline in Total Serum Homocysteine at Weeks 4, 12, 24, 36 and 52
Baseline (n=16, 15)
|
11.31 micromole/liter (µmol/L)
Standard Deviation 4.18
|
14.59 micromole/liter (µmol/L)
Standard Deviation 9.63
|
|
Change From Baseline in Total Serum Homocysteine at Weeks 4, 12, 24, 36 and 52
Change at Week 4 (n=15, 11)
|
0.31 micromole/liter (µmol/L)
Standard Deviation 3.16
|
0.33 micromole/liter (µmol/L)
Standard Deviation 4.13
|
|
Change From Baseline in Total Serum Homocysteine at Weeks 4, 12, 24, 36 and 52
Change at Week 12 (n=15, 12)
|
-0.07 micromole/liter (µmol/L)
Standard Deviation 2.51
|
0.13 micromole/liter (µmol/L)
Standard Deviation 4.05
|
|
Change From Baseline in Total Serum Homocysteine at Weeks 4, 12, 24, 36 and 52
Change at Week 24 (n=8, 4)
|
-1.72 micromole/liter (µmol/L)
Standard Deviation 3.52
|
-1.40 micromole/liter (µmol/L)
Standard Deviation 10.40
|
|
Change From Baseline in Total Serum Homocysteine at Weeks 4, 12, 24, 36 and 52
Change at Week 36 (n=7, 4)
|
1.65 micromole/liter (µmol/L)
Standard Deviation 1.92
|
-2.58 micromole/liter (µmol/L)
Standard Deviation 8.05
|
|
Change From Baseline in Total Serum Homocysteine at Weeks 4, 12, 24, 36 and 52
Change at Week 52 (n=4, 3)
|
1.49 micromole/liter (µmol/L)
Standard Deviation 2.20
|
-6.98 micromole/liter (µmol/L)
Standard Deviation 10.79
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 12, 24, 36 and 52 or ETPopulation: mITT; N=number of participants evaluable; n= number of participants evaluable at specific time point
ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hour (hr). A higher rate is consistent with inflammation. Change: Week x observation minus Baseline observation. Baseline value was used when present, otherwise valid screening value used as baseline if within 14 days of first test article injection.
Outcome measures
| Measure |
Etanercept
n=16 Participants
Participants received etanercept (50 milligrams \[mg\]) subcutaneous (sc) injection once per week for 52 weeks.
|
Placebo
n=15 Participants
Participants received matched placebo sc injection once per week for 52 weeks.
|
|---|---|---|
|
Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 4, 12, 24, 36 and 52
Baseline (n=16, 15)
|
42.85 mm/hr
Standard Deviation 37.73
|
45.80 mm/hr
Standard Deviation 42.50
|
|
Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 4, 12, 24, 36 and 52
Change at Week 4 (n=16, 13)
|
-21.49 mm/hr
Standard Deviation 28.82
|
-1.25 mm/hr
Standard Deviation 27.53
|
|
Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 4, 12, 24, 36 and 52
Change at Week 12 (n=15, 12)
|
-29.47 mm/hr
Standard Deviation 36.84
|
4.40 mm/hr
Standard Deviation 17.39
|
|
Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 4, 12, 24, 36 and 52
Change at Week 24 (n=9, 4)
|
-31.89 mm/hr
Standard Deviation 28.62
|
4.73 mm/hr
Standard Deviation 15.60
|
|
Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 4, 12, 24, 36 and 52
Change at Week 36 (n=7, 4)
|
-31.06 mm/hr
Standard Deviation 25.13
|
-3.62 mm/hr
Standard Deviation 4.30
|
|
Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 4, 12, 24, 36 and 52
Change at Week 52 (n=5, 3)
|
-37.47 mm/hr
Standard Deviation 23.66
|
-6.15 mm/hr
Standard Deviation 7.52
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 12, 24, 36 and 52 or ETPopulation: mITT; N=number of participants evaluable; n= number of participants evaluable at specific time point
CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Change: Week x observation minus Baseline observation. Baseline value was used when present, otherwise valid screening value used as baseline if within 14 days of first test article injection.
Outcome measures
| Measure |
Etanercept
n=16 Participants
Participants received etanercept (50 milligrams \[mg\]) subcutaneous (sc) injection once per week for 52 weeks.
|
Placebo
n=15 Participants
Participants received matched placebo sc injection once per week for 52 weeks.
|
|---|---|---|
|
Change From Baseline in C-Reactive Protein (CRP) at Weeks 4, 12, 24, 36, 52
Baseline (n=16, 15)
|
19.66 mg/liter (mg/L)
Standard Deviation 31.66
|
11.83 mg/liter (mg/L)
Standard Deviation 24.64
|
|
Change From Baseline in C-Reactive Protein (CRP) at Weeks 4, 12, 24, 36, 52
Change at Week 4 (n=15, 13)
|
-17.46 mg/liter (mg/L)
Standard Deviation 30.80
|
-1.32 mg/liter (mg/L)
Standard Deviation 8.19
|
|
Change From Baseline in C-Reactive Protein (CRP) at Weeks 4, 12, 24, 36, 52
Change at Week 12 (n=14, 12)
|
-11.84 mg/liter (mg/L)
Standard Deviation 19.45
|
2.01 mg/liter (mg/L)
Standard Deviation 6.17
|
|
Change From Baseline in C-Reactive Protein (CRP) at Weeks 4, 12, 24, 36, 52
Change at Week 24 (n=9, 4)
|
-25.58 mg/liter (mg/L)
Standard Deviation 38.08
|
-2.55 mg/liter (mg/L)
Standard Deviation 6.45
|
|
Change From Baseline in C-Reactive Protein (CRP) at Weeks 4, 12, 24, 36, 52
Change at Week 36 (n=7, 4)
|
-20.96 mg/liter (mg/L)
Standard Deviation 37.81
|
-3.05 mg/liter (mg/L)
Standard Deviation 5.33
|
|
Change From Baseline in C-Reactive Protein (CRP) at Weeks 4, 12, 24, 36, 52
Change at Week 52 (n=5, 3)
|
-20.09 mg/liter (mg/L)
Standard Deviation 31.74
|
-3.58 mg/liter (mg/L)
Standard Deviation 6.42
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 12, 24, 36, and 52 or ETPopulation: mITT; n= number of participants evaluable at specific time point
BASDAI a validated self assessment tool to determine disease activity in participant with Ankylosing Spondylitis (AS) using a Visual Analog Scale (VAS) of 0 (none) to 10 (very severe) centimeter (cm). Participant answered 6 questions measuring discomfort, pain and fatigue. Final BASDAI score averages the individual assessments for a final score range of 0-10. Change: Week x observation minus Baseline observation. Higher score indicates greater disability. Baseline value was used when present, otherwise valid screening value used as baseline if within 14 days of first test article injection.
Outcome measures
| Measure |
Etanercept
n=17 Participants
Participants received etanercept (50 milligrams \[mg\]) subcutaneous (sc) injection once per week for 52 weeks.
|
Placebo
n=15 Participants
Participants received matched placebo sc injection once per week for 52 weeks.
|
|---|---|---|
|
Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 4, 12, 24, 36 and 52
Baseline (n= 17,15)
|
6.21 Units on a scale
Standard Deviation 1.63
|
6.30 Units on a scale
Standard Deviation 1.40
|
|
Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 4, 12, 24, 36 and 52
Change at Week 4 (n=17, 14)
|
-1.79 Units on a scale
Standard Deviation 1.81
|
-0.10 Units on a scale
Standard Deviation 1.63
|
|
Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 4, 12, 24, 36 and 52
Change at Week 12 (n=16, 13)
|
-3.19 Units on a scale
Standard Deviation 2.34
|
-1.31 Units on a scale
Standard Deviation 2.56
|
|
Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 4, 12, 24, 36 and 52
Change at Week 24 (n=9, 4)
|
-3.86 Units on a scale
Standard Deviation 1.30
|
-5.28 Units on a scale
Standard Deviation 1.09
|
|
Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 4, 12, 24, 36 and 52
Change at Week 36 (n=8, 4)
|
-4.05 Units on a scale
Standard Deviation 1.47
|
-3.06 Units on a scale
Standard Deviation 3.94
|
|
Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 4, 12, 24, 36 and 52
Change at Week 52 (n=5, 2)
|
-4.49 Units on a scale
Standard Deviation 0.96
|
-5.12 Units on a scale
Standard Deviation 2.07
|
SECONDARY outcome
Timeframe: Weeks 4, 12, 24, 36, and 52 or ETPopulation: mITT; N=number of participants evaluable; n=number of participants evaluable at specific time point
BASDAI a validated self assessment tool used to determine disease activity in participants with AS. Utilizing a VAS of 0 (none) to 10 cm (very severe), participant's answered 6 questions measuring discomfort, pain and fatigue. BASDAI 50 response defined as at least a 50% improvement (decrease) from baseline in BASDAI. Baseline score - score at observation divided by Baseline score \* 100 = greater than or equal to 50%.
Outcome measures
| Measure |
Etanercept
n=17 Participants
Participants received etanercept (50 milligrams \[mg\]) subcutaneous (sc) injection once per week for 52 weeks.
|
Placebo
n=14 Participants
Participants received matched placebo sc injection once per week for 52 weeks.
|
|---|---|---|
|
Percentage of Participants With BASDAI 50 Percent (%) Improvement at Weeks 4, 12, 24, 36, and 52
Week 4 (n= 17, 14)
|
29.4 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With BASDAI 50 Percent (%) Improvement at Weeks 4, 12, 24, 36, and 52
Week 12 (n=16, 13)
|
62.5 percentage of participants
|
23.1 percentage of participants
|
|
Percentage of Participants With BASDAI 50 Percent (%) Improvement at Weeks 4, 12, 24, 36, and 52
Week 24 (n=9, 4)
|
77.8 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants With BASDAI 50 Percent (%) Improvement at Weeks 4, 12, 24, 36, and 52
Week 36 (n=8, 4)
|
87.5 percentage of participants
|
75.0 percentage of participants
|
|
Percentage of Participants With BASDAI 50 Percent (%) Improvement at Weeks 4, 12, 24, 36, and 52
Week 52 (n=5, 2)
|
80.0 percentage of participants
|
100 percentage of participants
|
SECONDARY outcome
Timeframe: Week 4, 12, 24, 36, and 52 or ETPopulation: mITT; N=number of participants evaluable; n=number of participants evaluable at specific time point
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 greater than or equal to (≥) 10 units on a 0-100 millimeter (mm) scale (0 mm = no disease activity; 100 mm = high disease activity) for ≥ 3 domains, and no worsening in remaining domain.
Outcome measures
| Measure |
Etanercept
n=17 Participants
Participants received etanercept (50 milligrams \[mg\]) subcutaneous (sc) injection once per week for 52 weeks.
|
Placebo
n=14 Participants
Participants received matched placebo sc injection once per week for 52 weeks.
|
|---|---|---|
|
Percentage of Participants With Assessment in Ankylosing Spondylitis (ASAS) 20 at Weeks 4, 12, 24, 36, and 52
Week 4 (n=17, 14)
|
41.2 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Assessment in Ankylosing Spondylitis (ASAS) 20 at Weeks 4, 12, 24, 36, and 52
Week 12 (n=16, 13)
|
68.8 percentage of participants
|
46.2 percentage of participants
|
|
Percentage of Participants With Assessment in Ankylosing Spondylitis (ASAS) 20 at Weeks 4, 12, 24, 36, and 52
Week 24 (n=9, 4)
|
88.9 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants With Assessment in Ankylosing Spondylitis (ASAS) 20 at Weeks 4, 12, 24, 36, and 52
Week 36 (n=8, 4)
|
87.5 percentage of participants
|
75.0 percentage of participants
|
|
Percentage of Participants With Assessment in Ankylosing Spondylitis (ASAS) 20 at Weeks 4, 12, 24, 36, and 52
Week 52 (n=5, 2)
|
100 percentage of participants
|
100 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 4, 12, 24, 36, and 52 or ETPopulation: mITT; N=number of participants evaluable; n=number of participants evaluable at specific time point
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 mm scale (0 mm = no disease activity, 100 mm = high disease activity) for ≥ 3 domains, and no worsening in remaining domain.
Outcome measures
| Measure |
Etanercept
n=17 Participants
Participants received etanercept (50 milligrams \[mg\]) subcutaneous (sc) injection once per week for 52 weeks.
|
Placebo
n=14 Participants
Participants received matched placebo sc injection once per week for 52 weeks.
|
|---|---|---|
|
Percentage of Participants With ASAS 40 at Weeks 4, 12, 24, 36, and 52
Week 4 (n=17, 14)
|
29.4 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With ASAS 40 at Weeks 4, 12, 24, 36, and 52
Week 12 (n=16, 13)
|
56.3 percentage of participants
|
38.5 percentage of participants
|
|
Percentage of Participants With ASAS 40 at Weeks 4, 12, 24, 36, and 52
Week 24 (n=9, 4)
|
88.9 percentage of participants
|
75.0 percentage of participants
|
|
Percentage of Participants With ASAS 40 at Weeks 4, 12, 24, 36, and 52
Week 36 (n=8, 4)
|
75.0 percentage of participants
|
75.0 percentage of participants
|
|
Percentage of Participants With ASAS 40 at Weeks 4, 12, 24, 36, and 52
Week 52 (n=5, 2)
|
100 percentage of participants
|
100 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 4, 12, 24, 36 and 52 or ETPopulation: mITT; N=number of participants with evaluable; n=number of participants evaluable at specific time point
ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 50 = 50% improvement (vs. baseline) and an absolute change ≥ 20 units on a 0-100 mm scale (0 mm = no disease activity, 100 mm = high disease activity) for ≥ 3 domains, and no worsening in remaining domain.
Outcome measures
| Measure |
Etanercept
n=17 Participants
Participants received etanercept (50 milligrams \[mg\]) subcutaneous (sc) injection once per week for 52 weeks.
|
Placebo
n=14 Participants
Participants received matched placebo sc injection once per week for 52 weeks.
|
|---|---|---|
|
Percentage of Participants With ASAS 50 at Weeks 4, 12, 24, 36, and 52
Week 4 (n=17, 14)
|
29.4 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With ASAS 50 at Weeks 4, 12, 24, 36, and 52
Week 12 (n=16, 13)
|
56.3 percentage of participants
|
23.1 percentage of participants
|
|
Percentage of Participants With ASAS 50 at Weeks 4, 12, 24, 36, and 52
Week 24 (n=9, 4)
|
77.8 percentage of participants
|
75.0 percentage of participants
|
|
Percentage of Participants With ASAS 50 at Weeks 4, 12, 24, 36, and 52
Week 36 (n=8, 4)
|
75.0 percentage of participants
|
75.0 percentage of participants
|
|
Percentage of Participants With ASAS 50 at Weeks 4, 12, 24, 36, and 52
Week 52 (n=5, 2)
|
100 percentage of participants
|
100 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 4, 12, 24, 36 and 52 or ETPopulation: mITT; N=number of participants evaluable; n=number of participants evaluable at specific time point
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 (vs. baseline) and an absolute change ≥ 20 units on a 0-100 mm scale (0 mm = no disease activity, 100 mm = high disease activity) for ≥ 3 domains, and no worsening in remaining domain.
Outcome measures
| Measure |
Etanercept
n=17 Participants
Participants received etanercept (50 milligrams \[mg\]) subcutaneous (sc) injection once per week for 52 weeks.
|
Placebo
n=14 Participants
Participants received matched placebo sc injection once per week for 52 weeks.
|
|---|---|---|
|
Percentage of Participants With ASAS 70 at Weeks 4, 12, 24, 36, and 52
Week 4 (n=17, 14)
|
11.8 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With ASAS 70 at Weeks 4, 12, 24, 36, and 52
Week 12 (n=16, 13)
|
25.0 percentage of participants
|
7.7 percentage of participants
|
|
Percentage of Participants With ASAS 70 at Weeks 4, 12, 24, 36, and 52
Week 24 (n=9, 4)
|
44.4 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants With ASAS 70 at Weeks 4, 12, 24, 36, and 52
Week 36 (n=8, 4)
|
37.5 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants With ASAS 70 at Weeks 4, 12, 24, 36, and 52
Week 52 (n=5, 2)
|
40.0 percentage of participants
|
50.0 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 4, 12, 24, 36 and 52 or ETPopulation: mITT; N=number of participants evaluable; n=number of participants evaluable at specific time point
ASAS 5/6 consists of 6 domains: the 4 used in ASAS 20 (participant global assessment of disease activity, pain, function, inflammation measured on a 0-100 scale, where 0 = no disease activity and 100=high disease activity) plus spinal mobility and an acute phase reactant, C Reactive Protein (CRP). Achieving ASAS 5/6 requires a 20% improvement compared to baseline in ≥ 5 domains and no worsening in the remaining domain.
Outcome measures
| Measure |
Etanercept
n=17 Participants
Participants received etanercept (50 milligrams \[mg\]) subcutaneous (sc) injection once per week for 52 weeks.
|
Placebo
n=14 Participants
Participants received matched placebo sc injection once per week for 52 weeks.
|
|---|---|---|
|
Percentage of Participants With ASAS 5/6 at Weeks 4, 12, 24, 36, and 52
Week 4 (n=17, 14)
|
5.9 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With ASAS 5/6 at Weeks 4, 12, 24, 36, and 52
Week 12 (n=16, 13)
|
25.0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With ASAS 5/6 at Weeks 4, 12, 24, 36, and 52
Week 24 (n=9, 4)
|
22.2 percentage of participants
|
25.0 percentage of participants
|
|
Percentage of Participants With ASAS 5/6 at Weeks 4, 12, 24, 36, and 52
Week 36 (n=8, 4)
|
25.0 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants With ASAS 5/6 at Weeks 4, 12, 24, 36, and 52
Week 52 (n=5, 2)
|
40.0 percentage of participants
|
50.0 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 4, 12, 24, 36 and 52 or ETPopulation: mITT; N=number of participants evaluable; n=number of participants evaluable at specific time point
Partial remission defined as a score of less than 20 units (on a scale of 0-100, where 0 = no disease activity and 100 = high disease activity) in each of the 4 Assessment in Ankylosing Spondylitis (ASAS) domains: participant global assessment of disease activity, pain, function, and inflammation. For scale, 100=high disease activity.
Outcome measures
| Measure |
Etanercept
n=17 Participants
Participants received etanercept (50 milligrams \[mg\]) subcutaneous (sc) injection once per week for 52 weeks.
|
Placebo
n=14 Participants
Participants received matched placebo sc injection once per week for 52 weeks.
|
|---|---|---|
|
Percentage of Participants With ASAS Partial Remission at Weeks 4, 12, 24, 36, and 52
Week 24 (n=8, 4)
|
87.5 percentage of participants
|
75.0 percentage of participants
|
|
Percentage of Participants With ASAS Partial Remission at Weeks 4, 12, 24, 36, and 52
Week 4 (n=17, 14)
|
29.4 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With ASAS Partial Remission at Weeks 4, 12, 24, 36, and 52
Week 12 (n=15, 13)
|
46.7 percentage of participants
|
38.5 percentage of participants
|
|
Percentage of Participants With ASAS Partial Remission at Weeks 4, 12, 24, 36, and 52
Week 36 (n=7, 4)
|
71.4 percentage of participants
|
75.0 percentage of participants
|
|
Percentage of Participants With ASAS Partial Remission at Weeks 4, 12, 24, 36, and 52
Week 52 (n=4, 2)
|
75.0 percentage of participants
|
100 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 12, 24, 36 and 52 or ETPopulation: mITT; n=number of participants evaluable at specific time point
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. Lower score indicated better spinal mobility. Change: Week x observation minus Baseline observation. Baseline value was used when present, otherwise valid screening value used as baseline if within 14 days of first test article injection.
Outcome measures
| Measure |
Etanercept
n=17 Participants
Participants received etanercept (50 milligrams \[mg\]) subcutaneous (sc) injection once per week for 52 weeks.
|
Placebo
n=15 Participants
Participants received matched placebo sc injection once per week for 52 weeks.
|
|---|---|---|
|
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 4, 12, 24, 36, and 52
Baseline (n=17, 15)
|
3.47 Units on a scale
Standard Deviation 2.21
|
3.98 Units on a scale
Standard Deviation 2.48
|
|
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 4, 12, 24, 36, and 52
Change at Week 4 (n=17, 14)
|
-0.41 Units on a scale
Standard Deviation 0.91
|
0.63 Units on a scale
Standard Deviation 0.93
|
|
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 4, 12, 24, 36, and 52
Change at Week 12 (n=16, 12)
|
-0.73 Units on a scale
Standard Deviation 1.23
|
0.15 Units on a scale
Standard Deviation 1.06
|
|
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 4, 12, 24, 36, and 52
Change at Week 24 (n=9, 4)
|
-0.50 Units on a scale
Standard Deviation 1.06
|
-0.75 Units on a scale
Standard Deviation 0.96
|
|
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 4, 12, 24, 36, and 52
Change at Week 36 (n=8, 4)
|
-0.88 Units on a scale
Standard Deviation 1.13
|
-0.81 Units on a scale
Standard Deviation 0.55
|
|
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 4, 12, 24, 36, and 52
Change at Week 52 (n=5, 3)
|
-0.35 Units on a scale
Standard Deviation 1.58
|
-0.75 Units on a scale
Standard Deviation 0.66
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 12, 24, 36, 52 or ETPopulation: mITT; n= number of participants evaluable at specific time point
While in a neutral position, the participant turned the head as far as possible to the right and then to the left. Using a goniometer the degrees of movement were measured. Two measurements on the right and 2 on the left were made. The best of the two measurements for each side (corresponding to the highest value), were then averaged. Higher score indicated greater spinal mobility. Actual rotation ranged from 3.0 to 99.0 degrees. Change: Week x observation minus Baseline observation. Baseline value was used when present, otherwise valid screening value used as baseline if within 14 days of first test article injection.
Outcome measures
| Measure |
Etanercept
n=17 Participants
Participants received etanercept (50 milligrams \[mg\]) subcutaneous (sc) injection once per week for 52 weeks.
|
Placebo
n=15 Participants
Participants received matched placebo sc injection once per week for 52 weeks.
|
|---|---|---|
|
Change From Baseline in BASMI-Cervical Rotation at Weeks 4, 12, 24, 36 and 52
Baseline (n= 17, 15)
|
57.09 degrees of movement
Standard Deviation 23.30
|
54.80 degrees of movement
Standard Deviation 15.31
|
|
Change From Baseline in BASMI-Cervical Rotation at Weeks 4, 12, 24, 36 and 52
Change at Week 4 (n=17, 14)
|
3.79 degrees of movement
Standard Deviation 9.37
|
-2.61 degrees of movement
Standard Deviation 4.15
|
|
Change From Baseline in BASMI-Cervical Rotation at Weeks 4, 12, 24, 36 and 52
Change at Week 12 (n=16, 12)
|
4.97 degrees of movement
Standard Deviation 11.04
|
-2.79 degrees of movement
Standard Deviation 6.23
|
|
Change From Baseline in BASMI-Cervical Rotation at Weeks 4, 12, 24, 36 and 52
Change at Week 24 (n=9, 4)
|
4.67 degrees of movement
Standard Deviation 19.09
|
1.88 degrees of movement
Standard Deviation 2.59
|
|
Change From Baseline in BASMI-Cervical Rotation at Weeks 4, 12, 24, 36 and 52
Change at Week 36 (n=8, 4)
|
6.50 degrees of movement
Standard Deviation 18.94
|
7.50 degrees of movement
Standard Deviation 8.35
|
|
Change From Baseline in BASMI-Cervical Rotation at Weeks 4, 12, 24, 36 and 52
Change at Week 52 (n=5, 3)
|
9.30 degrees of movement
Standard Deviation 17.09
|
9.17 degrees of movement
Standard Deviation 9.41
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 12, 24, 36 and 52 or ETPopulation: mITT; n= number of participants evaluable at specific time point
Measurement in cm of the distance between the medial malleoli when participant was lying supine with knees straight and feet pointed straight up with legs separated as far as possible, 2 attempts were measured. The best of the two measurements which corresponds to the highest value were reported. Higher score indicated greater spinal mobility. Change: Week x observation minus Baseline observation. Baseline value was used when present, otherwise valid screening value used as baseline if within 14 days of first test article injection.
Outcome measures
| Measure |
Etanercept
n=17 Participants
Participants received etanercept (50 milligrams \[mg\]) subcutaneous (sc) injection once per week for 52 weeks.
|
Placebo
n=15 Participants
Participants received matched placebo sc injection once per week for 52 weeks.
|
|---|---|---|
|
Change From Baseline in BASMI-Intermalleolar Distance at Weeks 4, 12, 24, 36 and 52
Baseline (n= 17, 15)
|
103.02 cm
Standard Deviation 17.46
|
94.69 cm
Standard Deviation 15.38
|
|
Change From Baseline in BASMI-Intermalleolar Distance at Weeks 4, 12, 24, 36 and 52
Change at Week 4 (n=17, 14)
|
-0.34 cm
Standard Deviation 9.58
|
-4.21 cm
Standard Deviation 8.12
|
|
Change From Baseline in BASMI-Intermalleolar Distance at Weeks 4, 12, 24, 36 and 52
Change at Week 12 (n=16, 12)
|
2.01 cm
Standard Deviation 12.78
|
0.90 cm
Standard Deviation 7.17
|
|
Change From Baseline in BASMI-Intermalleolar Distance at Weeks 4, 12, 24, 36 and 52
Change at Week 24 (n=9, 4)
|
-0.54 cm
Standard Deviation 13.09
|
0.13 cm
Standard Deviation 1.75
|
|
Change From Baseline in BASMI-Intermalleolar Distance at Weeks 4, 12, 24, 36 and 52
Change at Week 36 (n=8, 4)
|
2.14 cm
Standard Deviation 13.18
|
-2.50 cm
Standard Deviation 8.69
|
|
Change From Baseline in BASMI-Intermalleolar Distance at Weeks 4, 12, 24, 36 and 52
Change at Week 52 (n=5, 3)
|
2.46 cm
Standard Deviation 21.22
|
1.33 cm
Standard Deviation 1.15
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 12, 24, 36 and 52 or ETPopulation: mITT; n= number of participants evaluable at specific time point
Measurement in cm of distance between marks originally placed while participant was standing erect 10 cm above and 5 cm below the midpoint of a line that joins the posterior superior iliac spines. Distance between marks was re-measured with participant maximally bent forward, knees fully extended, with supine in full flexion. The measurement was carried out two times and best of the two measurements which corresponds to the highest value were reported. Higher score indicated greater spinal mobility. Change: Week x observation minus Baseline observation. Baseline value was used when present, otherwise valid screening value used as baseline if within 14 days of first test article injection.
Outcome measures
| Measure |
Etanercept
n=17 Participants
Participants received etanercept (50 milligrams \[mg\]) subcutaneous (sc) injection once per week for 52 weeks.
|
Placebo
n=15 Participants
Participants received matched placebo sc injection once per week for 52 weeks.
|
|---|---|---|
|
Change From Baseline in BASMI-Modified Schober's Test at Weeks 4, 12, 24, 36 and 52
Baseline (n= 17, 15)
|
5.00 cm
Standard Deviation 4.31
|
4.77 cm
Standard Deviation 4.54
|
|
Change From Baseline in BASMI-Modified Schober's Test at Weeks 4, 12, 24, 36 and 52
Change at Week 4 (n=17, 14)
|
0.38 cm
Standard Deviation 0.78
|
0.11 cm
Standard Deviation 0.82
|
|
Change From Baseline in BASMI-Modified Schober's Test at Weeks 4, 12, 24, 36 and 52
Change at Week 12 (n=16, 12)
|
1.23 cm
Standard Deviation 3.02
|
-0.02 cm
Standard Deviation 0.86
|
|
Change From Baseline in BASMI-Modified Schober's Test at Weeks 4, 12, 24, 36 and 52
Change at Week 24 (n=9, 4)
|
1.41 cm
Standard Deviation 3.79
|
0.10 cm
Standard Deviation 0.34
|
|
Change From Baseline in BASMI-Modified Schober's Test at Weeks 4, 12, 24, 36 and 52
Change at Week 36 (n=8, 4)
|
1.39 cm
Standard Deviation 3.88
|
-0.05 cm
Standard Deviation 0.53
|
|
Change From Baseline in BASMI-Modified Schober's Test at Weeks 4, 12, 24, 36 and 52
Change at Week 52 (n=5, 3)
|
2.48 cm
Standard Deviation 4.51
|
0.07 cm
Standard Deviation 0.40
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 12, 24, 36 and 52 or ETPopulation: mITT; n= number of participants evaluable at specific time point
Measurement in cm of distance between the tragus and wall from the right and left side while participant was standing with back against the wall; knees straight; scapulae, buttocks, and heels against the wall; with head in a neutral position. Two measurements on the right and 2 on the left were made. The best of the two measurements for each side (corresponding to the smallest value), were then averaged. Higher score indicated greater spinal mobility. Change: Week x observation minus Baseline observation. Baseline value was used when present, otherwise valid screening value used as baseline if within 14 days of first test article injection.
Outcome measures
| Measure |
Etanercept
n=17 Participants
Participants received etanercept (50 milligrams \[mg\]) subcutaneous (sc) injection once per week for 52 weeks.
|
Placebo
n=15 Participants
Participants received matched placebo sc injection once per week for 52 weeks.
|
|---|---|---|
|
Change From Baseline in BASMI-Tragus to Wall Distance at Weeks 4, 12, 24, 36 and 52
Baseline (n= 17, 15)
|
14.31 cm
Standard Deviation 2.74
|
14.91 cm
Standard Deviation 5.49
|
|
Change From Baseline in BASMI-Tragus to Wall Distance at Weeks 4, 12, 24, 36 and 52
Change at Week 4 (n=17, 14)
|
-0.01 cm
Standard Deviation 0.82
|
0.43 cm
Standard Deviation 0.92
|
|
Change From Baseline in BASMI-Tragus to Wall Distance at Weeks 4, 12, 24, 36 and 52
Change at Week 12(n=16, 12)
|
-0.18 cm
Standard Deviation 0.90
|
-0.33 cm
Standard Deviation 0.81
|
|
Change From Baseline in BASMI-Tragus to Wall Distance at Weeks 4, 12, 24, 36 and 52
Change at Week 24 (n=9, 4)
|
-0.58 cm
Standard Deviation 0.65
|
-0.36 cm
Standard Deviation 0.82
|
|
Change From Baseline in BASMI-Tragus to Wall Distance at Weeks 4, 12, 24, 36 and 52
Change at Week 36 (n=8, 4)
|
-0.26 cm
Standard Deviation 1.00
|
-0.31 cm
Standard Deviation 0.80
|
|
Change From Baseline in BASMI-Tragus to Wall Distance at Weeks 4, 12, 24, 36 and 52
Change at Week 52 (n=5, 3)
|
0.55 cm
Standard Deviation 2.67
|
-0.10 cm
Standard Deviation 0.36
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 12, 24, 36 and 52 or ETPopulation: mITT; n= number of participants evaluable at specific time point
Measurement in cm of distance between participant's middle fingertip and the floor after bending sideways, without bending knees or lifting heels, while attempting to keep shoulders in same place (flexion position). Two measurements on the right and 2 on the left were made. The best of the two measurements for each side (corresponding to the highest value), were then averaged. Higher score indicated greater spinal mobility. Change: Week x observation minus Baseline observation. Baseline value was used when present, otherwise valid screening value used as baseline if within 14 days of first test article injection.
Outcome measures
| Measure |
Etanercept
n=17 Participants
Participants received etanercept (50 milligrams \[mg\]) subcutaneous (sc) injection once per week for 52 weeks.
|
Placebo
n=15 Participants
Participants received matched placebo sc injection once per week for 52 weeks.
|
|---|---|---|
|
Change From Baseline in BASMI-Lateral Flexion at Weeks 4, 12, 24, 36 and 52
Baseline (n= 17, 15)
|
10.25 cm
Standard Deviation 6.25
|
8.00 cm
Standard Deviation 6.32
|
|
Change From Baseline in BASMI-Lateral Flexion at Weeks 4, 12, 24, 36 and 52
Change at Week 4 (n=17, 14)
|
0.54 cm
Standard Deviation 1.48
|
0.33 cm
Standard Deviation 2.46
|
|
Change From Baseline in BASMI-Lateral Flexion at Weeks 4, 12, 24, 36 and 52
Change at Week 12(n=16, 12)
|
0.09 cm
Standard Deviation 3.40
|
0.48 cm
Standard Deviation 3.78
|
|
Change From Baseline in BASMI-Lateral Flexion at Weeks 4, 12, 24, 36 and 52
Change at Week 24 (n=9, 4)
|
3.01 cm
Standard Deviation 3.77
|
0.31 cm
Standard Deviation 0.58
|
|
Change From Baseline in BASMI-Lateral Flexion at Weeks 4, 12, 24, 36 and 52
Change at Week 36 (n=8, 4)
|
2.06 cm
Standard Deviation 2.35
|
-0.69 cm
Standard Deviation 1.25
|
|
Change From Baseline in BASMI-Lateral Flexion at Weeks 4, 12, 24, 36 and 52
Change at Week 52 (n=5, 3)
|
2.38 cm
Standard Deviation 2.84
|
-0.80 cm
Standard Deviation 1.63
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 12, 24, 36 and 52 or ETPopulation: mITT; n= number of participants evaluable at specific time point
While participant stood with back against the wall and during maximal effort to touch head to the wall, the distance between the occiput (back of head) and the wall was measured. The measurement of two attempts was made and best of the two measurements which corresponds to the highest value were reported. Lower scores indicated improvement in spinal mobility. Change: Week x observation minus Baseline observation. Baseline value was used when present, otherwise valid screening value used as baseline if within 14 days of first test article injection.
Outcome measures
| Measure |
Etanercept
n=17 Participants
Participants received etanercept (50 milligrams \[mg\]) subcutaneous (sc) injection once per week for 52 weeks.
|
Placebo
n=15 Participants
Participants received matched placebo sc injection once per week for 52 weeks.
|
|---|---|---|
|
Change From Baseline in Occiput-to-Wall Distance at Weeks 4, 12, 24, 36 and 52
Baseline (n=17, 15)
|
7.67 cm
Standard Deviation 3.98
|
9.77 cm
Standard Deviation 5.71
|
|
Change From Baseline in Occiput-to-Wall Distance at Weeks 4, 12, 24, 36 and 52
Change at Week 4 (n=17, 14)
|
-0.13 cm
Standard Deviation 0.88
|
0.89 cm
Standard Deviation 1.82
|
|
Change From Baseline in Occiput-to-Wall Distance at Weeks 4, 12, 24, 36 and 52
Change at Week 12 (n=16, 12)
|
-0.44 cm
Standard Deviation 1.11
|
0.53 cm
Standard Deviation 2.00
|
|
Change From Baseline in Occiput-to-Wall Distance at Weeks 4, 12, 24, 36 and 52
Change at Week 24 (n=9, 4)
|
-0.14 cm
Standard Deviation 1.89
|
0.18 cm
Standard Deviation 0.71
|
|
Change From Baseline in Occiput-to-Wall Distance at Weeks 4, 12, 24, 36 and 52
Change at Week 36 (n=8, 4)
|
0.78 cm
Standard Deviation 2.06
|
-0.40 cm
Standard Deviation 1.77
|
|
Change From Baseline in Occiput-to-Wall Distance at Weeks 4, 12, 24, 36 and 52
Change at Week 52 (n=5, 3)
|
-0.24 cm
Standard Deviation 1.64
|
-1.17 cm
Standard Deviation 1.61
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 12, 24, 36 and 52 or ETPopulation: mITT; n= number of participants evaluable at specific time point; Due to limited number of participants with visits after Week 12 analysis limited to Week 12
Chest expansion defined as the difference in thoracic circumference during full expiration versus full inspiration, measured in cm at the fourth intercostal space (nipple line) while participant was standing. Measurement taken twice and best of the two measurements (corresponding to the highest value of inspiration and smallest value for expiration), were then averaged. Greater chest circumference indicated improvement in spinal mobility. Change: Week x observation minus Baseline observation. Baseline value was used when present, otherwise valid screening value used as baseline if within 14 days of first test article injection.
Outcome measures
| Measure |
Etanercept
n=17 Participants
Participants received etanercept (50 milligrams \[mg\]) subcutaneous (sc) injection once per week for 52 weeks.
|
Placebo
n=15 Participants
Participants received matched placebo sc injection once per week for 52 weeks.
|
|---|---|---|
|
Change From Baseline in Chest Expansion at Weeks 4, 12, 24, 36 and 52
Baseline (n=17, 15)
|
4.75 cm
Standard Deviation 2.19
|
4.50 cm
Standard Deviation 1.75
|
|
Change From Baseline in Chest Expansion at Weeks 4, 12, 24, 36 and 52
Change at Week 4 (n=17, 14)
|
-0.33 cm
Standard Deviation 2.70
|
-0.42 cm
Standard Deviation 1.00
|
|
Change From Baseline in Chest Expansion at Weeks 4, 12, 24, 36 and 52
Change at Week 12 (n=16, 12)
|
0.22 cm
Standard Deviation 3.00
|
-0.37 cm
Standard Deviation 1.53
|
|
Change From Baseline in Chest Expansion at Weeks 4, 12, 24, 36 and 52
Change at Week 24 (n=9, 4)
|
0.68 cm
Standard Deviation 1.86
|
-0.73 cm
Standard Deviation 1.55
|
|
Change From Baseline in Chest Expansion at Weeks 4, 12, 24, 36 and 52
Change at Week 36 (n=8, 4)
|
0.31 cm
Standard Deviation 1.50
|
-0.60 cm
Standard Deviation 1.78
|
|
Change From Baseline in Chest Expansion at Weeks 4, 12, 24, 36 and 52
Change at Week 52 (n=5, 3)
|
0.58 cm
Standard Deviation 1.70
|
-0.13 cm
Standard Deviation 2.73
|
Adverse Events
Etanercept
Placebo
Serious adverse events
| Measure |
Etanercept
n=18 participants at risk
Participants received etanercept (50 milligrams \[mg\]) subcutaneous (sc) injection once per week for 52 weeks.
|
Placebo
n=16 participants at risk
Participants received matched placebo sc injection once per week for 52 weeks.
|
|---|---|---|
|
Renal and urinary disorders
Renal mass
|
5.6%
1/18
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/16
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
Other adverse events
| Measure |
Etanercept
n=18 participants at risk
Participants received etanercept (50 milligrams \[mg\]) subcutaneous (sc) injection once per week for 52 weeks.
|
Placebo
n=16 participants at risk
Participants received matched placebo sc injection once per week for 52 weeks.
|
|---|---|---|
|
Infections and infestations
Tooth abscess
|
11.1%
2/18
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/16
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Urinary tract infection
|
5.6%
1/18
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
6.2%
1/16
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Bronchitis
|
5.6%
1/18
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/16
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Febrile infection
|
5.6%
1/18
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/16
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Injection site erythema
|
16.7%
3/18
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/16
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.6%
1/18
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
6.2%
1/16
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/18
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
6.2%
1/16
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.6%
1/18
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/16
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
5.6%
1/18
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/16
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
5.6%
1/18
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/16
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
5.6%
1/18
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/16
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/18
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
6.2%
1/16
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
Additional Information
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.
- Publication restrictions are in place
Restriction type: OTHER