Trial Outcomes & Findings for An Observational, Retrospective, Multicenter, National Study for the Monitoring of Subjects Who Participated in the LoadET Clinical Trial (NCT NCT01793285)
NCT ID: NCT01793285
Last Updated: 2013-02-15
Results Overview
Participants who discontinued etanercept following 3 years after finalization of LoadET study 0881A3-102090 (NCT00873730) due to any of these reason were reported: adverse events, failure in therapeutic response, disease remission and discontinued for other causes.
COMPLETED
85 participants
Baseline up to Year 3
2013-02-15
Participant Flow
Participants who completed the LoadET study 0881A3-102090 (NCT00873730), were eligible for this study.
Participant milestones
| Measure |
Etanercept
Participants who completed LoadET study 0881A3-102090 (NCT00873730) and received either etanercept 50 milligram (mg) weekly subcutaneously, etanercept 100 mg weekly subcutaneously, another drug, or abandoned medication as per standard clinical practice were observed retrospectively for 3 years.
|
|---|---|
|
Overall Study
STARTED
|
85
|
|
Overall Study
COMPLETED
|
85
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
An Observational, Retrospective, Multicenter, National Study for the Monitoring of Subjects Who Participated in the LoadET Clinical Trial
Baseline characteristics by cohort
| Measure |
Etanercept
n=85 Participants
Participants who completed LoadET study 0881A3-102090 (NCT00873730) and received either etanercept 50 mg weekly subcutaneously, etanercept 100 mg weekly subcutaneously, another drug, or abandoned medication as per standard clinical practice were observed retrospectively for 3 years.
|
|---|---|
|
Age Continuous
|
45.90 years
STANDARD_DEVIATION 10.67 • n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
68 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Year 3Population: Analysis population included all participants who had previously participated in the LoadET study (NCT00873730) and fulfilled all the eligibility criteria.
Participants who discontinued etanercept following 3 years after finalization of LoadET study 0881A3-102090 (NCT00873730) due to any of these reason were reported: adverse events, failure in therapeutic response, disease remission and discontinued for other causes.
Outcome measures
| Measure |
Etanercept
n=85 Participants
Participants who completed LoadET study 0881A3-102090 (NCT00873730) and received either etanercept 50 mg weekly subcutaneously, etanercept 100 mg weekly subcutaneously, another drug, or abandoned medication as per standard clinical practice were observed retrospectively for 3 years.
|
|---|---|
|
Percentage of Participants Who Discontinued Treatment With Etanercept
|
41.2 percentage of participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: Analysis population included all participants who had previously participated in the LoadET study (NCT00873730) and fulfilled all the eligibility criteria.
Time passed since the ankylosing spondylitis symptoms started until the participant arrived for the first time to visit the rheumatologist was reported. Ankylosing spondylitis symptoms may include pain, stiffness, axial manifestations, and enthesitis etc.
Outcome measures
| Measure |
Etanercept
n=85 Participants
Participants who completed LoadET study 0881A3-102090 (NCT00873730) and received either etanercept 50 mg weekly subcutaneously, etanercept 100 mg weekly subcutaneously, another drug, or abandoned medication as per standard clinical practice were observed retrospectively for 3 years.
|
|---|---|
|
Time Between the Onset of Ankylosing Spondylitis Symptoms and First Visit to the Rheumatologist
|
6.35 years
Standard Deviation 7.27
|
SECONDARY outcome
Timeframe: BaselinePopulation: Analysis population included all participants who had previously participated in the LoadET study (NCT00873730) and fulfilled all the eligibility criteria.
Time to first diagnosis of alkylosing spondylitis was reported.
Outcome measures
| Measure |
Etanercept
n=85 Participants
Participants who completed LoadET study 0881A3-102090 (NCT00873730) and received either etanercept 50 mg weekly subcutaneously, etanercept 100 mg weekly subcutaneously, another drug, or abandoned medication as per standard clinical practice were observed retrospectively for 3 years.
|
|---|---|
|
Time to Diagnosis of Ankylosing Spondylitis
|
7.53 years
Standard Deviation 8.01
|
SECONDARY outcome
Timeframe: Baseline up to Year 3Population: Analysis population included all participants who had previously participated in the LoadET study (NCT00873730) and fulfilled all the eligibility criteria.
Participants who received any non-pharmacological treatment (participant education, regular exercises and physical therapy) in the 3 years since the last LoadET study 0881A3-102090 (NCT00873730) visit were reported.
Outcome measures
| Measure |
Etanercept
n=85 Participants
Participants who completed LoadET study 0881A3-102090 (NCT00873730) and received either etanercept 50 mg weekly subcutaneously, etanercept 100 mg weekly subcutaneously, another drug, or abandoned medication as per standard clinical practice were observed retrospectively for 3 years.
|
|---|---|
|
Number of Participants Who Received Non-pharmacological Treatment
|
3 participants
|
SECONDARY outcome
Timeframe: Baseline up to Year 3Population: Analysis population included all participants who had previously participated in the LoadET study (NCT00873730) and fulfilled all the eligibility criteria.
Participants who received any pharmacological treatment (non-steroidal anti-inflammatory drugs \[NSAIDs\], disease-modifying antirheumatic drugs \[DMARDs\], corticosteroids and other treatments including anti-tumor necrosis factor-alpha \[TNFalpha\] or other biological agents etc.) in the 3 years since the last LoadET study 0881A3-102090 (NCT00873730) visit were reported.
Outcome measures
| Measure |
Etanercept
n=85 Participants
Participants who completed LoadET study 0881A3-102090 (NCT00873730) and received either etanercept 50 mg weekly subcutaneously, etanercept 100 mg weekly subcutaneously, another drug, or abandoned medication as per standard clinical practice were observed retrospectively for 3 years.
|
|---|---|
|
Number of Participants Who Received Pharmacological Treatment
NSAIDs
|
55 participants
|
|
Number of Participants Who Received Pharmacological Treatment
DMARDs
|
15 participants
|
|
Number of Participants Who Received Pharmacological Treatment
Corticosteroids
|
7 participants
|
|
Number of Participants Who Received Pharmacological Treatment
Other
|
26 participants
|
SECONDARY outcome
Timeframe: Baseline, Year 1, 2, 3Population: Analysis population included all evaluable participants who continued the treatment at 3 years after the finalizing of the LoadET study (0881A3-102090). Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable for this measure at specified time point.
Participants disease activity assessed using a 100 millimeter (mm) Visual Analog Scale (VAS), ranging from 0 = very good to 100 = very bad.
Outcome measures
| Measure |
Etanercept
n=49 Participants
Participants who completed LoadET study 0881A3-102090 (NCT00873730) and received either etanercept 50 mg weekly subcutaneously, etanercept 100 mg weekly subcutaneously, another drug, or abandoned medication as per standard clinical practice were observed retrospectively for 3 years.
|
|---|---|
|
Patient Global Assessment (PtGA) of Disease Activity Score
Baseline (n=43)
|
1.70 mm
Interval 0.8 to 3.7
|
|
Patient Global Assessment (PtGA) of Disease Activity Score
Year 1 (n=33)
|
2.00 mm
Interval 0.2 to 4.0
|
|
Patient Global Assessment (PtGA) of Disease Activity Score
Year 2 (n=32)
|
2.00 mm
Interval 1.0 to 3.0
|
|
Patient Global Assessment (PtGA) of Disease Activity Score
Year 3 (n=49)
|
1.40 mm
Interval 0.9 to 3.0
|
SECONDARY outcome
Timeframe: Baseline, Year 1, 2, 3Population: Analysis population included all evaluable participants who continued the treatment at 3 years after the finalizing of the LoadET study (0881A3-102090). Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable for this measure at specified time point.
BASFI is a validated self-assessment tool that determines the degree of functional limitation in ankylosing spondylitis. Utilizing a VAS of 0-10, 0 = easy, 10 = impossible, participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a sum of the scores of the 10 questions, final score ranged from 0-100, where higher score referred to higher impairment in the functional ability.
Outcome measures
| Measure |
Etanercept
n=48 Participants
Participants who completed LoadET study 0881A3-102090 (NCT00873730) and received either etanercept 50 mg weekly subcutaneously, etanercept 100 mg weekly subcutaneously, another drug, or abandoned medication as per standard clinical practice were observed retrospectively for 3 years.
|
|---|---|
|
Bath Ankylosing Spondylitis Functional Index (BASFI)
Baseline (n=45)
|
26.00 units on a scale
Interval 8.9 to 47.0
|
|
Bath Ankylosing Spondylitis Functional Index (BASFI)
Year 1 (n=30)
|
23.10 units on a scale
Interval 8.0 to 43.5
|
|
Bath Ankylosing Spondylitis Functional Index (BASFI)
Year 2 (n=25)
|
23.00 units on a scale
Interval 10.0 to 42.5
|
|
Bath Ankylosing Spondylitis Functional Index (BASFI)
Year 3 (n=48)
|
24.05 units on a scale
Interval 13.05 to 35.8
|
SECONDARY outcome
Timeframe: Baseline, Year 1, 2, 3Population: Analysis population included all evaluable participants who continued the treatment at 3 years after the finalizing of the LoadET study (0881A3-102090). Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable for this measure at specified time point.
BASDAI is a validated self-assessment tool used to determine disease activity in participant with ankylosing spondylitis. Utilizing a VAS of 0-10, 0=none and 10=very severe participant's answered 6 questions measuring discomfort, pain and fatigue. The final BASDAI score is a sum of the individual assessments. Final score ranged from 0-60, higher score indicates higher disease activity.
Outcome measures
| Measure |
Etanercept
n=48 Participants
Participants who completed LoadET study 0881A3-102090 (NCT00873730) and received either etanercept 50 mg weekly subcutaneously, etanercept 100 mg weekly subcutaneously, another drug, or abandoned medication as per standard clinical practice were observed retrospectively for 3 years.
|
|---|---|
|
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Baseline (n=45)
|
9.90 units on a scale
Interval 5.3 to 21.0
|
|
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Year 1 (n=34)
|
10.60 units on a scale
Interval 4.0 to 16.7
|
|
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Year 2 (n=28)
|
10.50 units on a scale
Interval 5.05 to 17.1
|
|
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Year 3 (n=48)
|
9.30 units on a scale
Interval 4.09 to 17.25
|
SECONDARY outcome
Timeframe: Baseline, Year 1, 2, 3Population: Analysis population included all evaluable participants who continued the treatment at 3 years after the finalizing of the LoadET study (0881A3-102090). Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable for this measure at specified time point.
Participant's spinal pain - was assessed by answering question 2 of BASDAI on a 0 to10 VAS; participants were asked: "How would you describe the overall level of ankylosing spondylitis neck, back or hip pain you have had?" 0 =none and 10 =very severe.
Outcome measures
| Measure |
Etanercept
n=48 Participants
Participants who completed LoadET study 0881A3-102090 (NCT00873730) and received either etanercept 50 mg weekly subcutaneously, etanercept 100 mg weekly subcutaneously, another drug, or abandoned medication as per standard clinical practice were observed retrospectively for 3 years.
|
|---|---|
|
Spinal Pain as Assessed Using Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Baseline (n=45)
|
2.20 units on a scale
Interval 0.8 to 5.2
|
|
Spinal Pain as Assessed Using Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Year 1 (n=33)
|
2.90 units on a scale
Interval 1.0 to 4.4
|
|
Spinal Pain as Assessed Using Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Year 2 (n=27)
|
3.00 units on a scale
Interval 1.0 to 4.3
|
|
Spinal Pain as Assessed Using Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Year 3 (n=48)
|
2.00 units on a scale
Interval 0.75 to 4.0
|
SECONDARY outcome
Timeframe: Baseline, Year 1, 2, 3Population: Analysis population included all evaluable participants who continued the treatment at 3 years after the finalizing of the LoadET study (0881A3-102090). Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable for this measure at specified time point.
Participant's fatigue was assessed by answering question 1 of BASDAI on a 0 to 10 VAS; participants were asked: "How would you describe the overall level of fatigue/tiredness you have experienced?" 0=none and 10=very severe.
Outcome measures
| Measure |
Etanercept
n=48 Participants
Participants who completed LoadET study 0881A3-102090 (NCT00873730) and received either etanercept 50 mg weekly subcutaneously, etanercept 100 mg weekly subcutaneously, another drug, or abandoned medication as per standard clinical practice were observed retrospectively for 3 years.
|
|---|---|
|
Fatigue as Assessed Using Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Baseline (n=45)
|
1.70 units on a scale
Interval 0.8 to 5.0
|
|
Fatigue as Assessed Using Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Year 1 (n=33)
|
2.00 units on a scale
Interval 0.6 to 4.1
|
|
Fatigue as Assessed Using Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Year 2 (n=27)
|
1.50 units on a scale
Interval 1.0 to 3.0
|
|
Fatigue as Assessed Using Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Year 3 (n=48)
|
2.00 units on a scale
Interval 0.9 to 4.0
|
SECONDARY outcome
Timeframe: Baseline, Year 1, 2, 3Population: Analysis population included all evaluable participants who continued the treatment at 3 years after the finalizing of the LoadET study (0881A3-102090). Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable for this measure at specified time point.
Measurement in centimeters (cm) of the distance between marks originally placed while the participant was standing erect 10 cm above and 5 cm below the midpoint of a line that joints the posterior superior iliac spines. Distance between marks was re-measured (in cm rounded to the nearest 0.1 cm) with participant maximally bend forward, knees fully extended, with spine in full flexion. The measurement of two attempts was made.
Outcome measures
| Measure |
Etanercept
n=44 Participants
Participants who completed LoadET study 0881A3-102090 (NCT00873730) and received either etanercept 50 mg weekly subcutaneously, etanercept 100 mg weekly subcutaneously, another drug, or abandoned medication as per standard clinical practice were observed retrospectively for 3 years.
|
|---|---|
|
Modified Schober's Test
Year 2 (n=25)
|
11.00 cm
Interval 5.0 to 18.0
|
|
Modified Schober's Test
Baseline (n=43)
|
17.75 cm
Interval 4.65 to 20.0
|
|
Modified Schober's Test
Year 1 (n=25)
|
13.00 cm
Interval 5.5 to 18.8
|
|
Modified Schober's Test
Year 3 (n=44)
|
15.45 cm
Interval 4.75 to 19.13
|
SECONDARY outcome
Timeframe: Baseline, Year 1, 2, 3Population: Analysis population included all evaluable participants who continued the treatment at 3 years after the finalizing of the LoadET study (0881A3-102090). Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable for this measure at specified time point.
Occiput-to-wall distance: distance between the occiput (posterior or back portion of the head) and the wall when the participant stood with heels and shoulder against the wall and the back straight. The distance between the occiput and the wall was measured in cm (rounded to the nearest 0.1 cm), in two attempts.
Outcome measures
| Measure |
Etanercept
n=45 Participants
Participants who completed LoadET study 0881A3-102090 (NCT00873730) and received either etanercept 50 mg weekly subcutaneously, etanercept 100 mg weekly subcutaneously, another drug, or abandoned medication as per standard clinical practice were observed retrospectively for 3 years.
|
|---|---|
|
Occiput-to-wall Distance
Year 3 (n=45)
|
0.00 cm
Interval 0.0 to 3.5
|
|
Occiput-to-wall Distance
Baseline (n=43)
|
0.00 cm
Interval 0.0 to 8.5
|
|
Occiput-to-wall Distance
Year 1 (n=25)
|
0.00 cm
Interval 0.0 to 8.0
|
|
Occiput-to-wall Distance
Year 2 (n=22)
|
2.00 cm
Interval 0.0 to 9.0
|
SECONDARY outcome
Timeframe: Baseline, Year 1, 2, 3Population: Analysis population included all evaluable participants who continued the treatment at 3 years after the finalizing of the LoadET study (0881A3-102090). Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable for this measure at specified time point.
Chest expansion, measured in cm (rounded to the nearest 0.1 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. The measurement of two attempts was made.
Outcome measures
| Measure |
Etanercept
n=39 Participants
Participants who completed LoadET study 0881A3-102090 (NCT00873730) and received either etanercept 50 mg weekly subcutaneously, etanercept 100 mg weekly subcutaneously, another drug, or abandoned medication as per standard clinical practice were observed retrospectively for 3 years.
|
|---|---|
|
Chest Expansion Measurement
Baseline: Maximum Inspiration (n=39)
|
98.00 cm
Interval 86.25 to 106.0
|
|
Chest Expansion Measurement
Baseline: Minimum Inspiration (n=32)
|
98.13 cm
Interval 88.25 to 105.5
|
|
Chest Expansion Measurement
Year 1: Maximum Inspiration (n=5)
|
96.25 cm
Interval 86.75 to 108.0
|
|
Chest Expansion Measurement
Year 1: Minimum Inspiration (n=5)
|
101.00 cm
Interval 80.75 to 104.5
|
|
Chest Expansion Measurement
Year 2: Maximum Inspiration (n=6)
|
100.50 cm
Interval 82.0 to 113.0
|
|
Chest Expansion Measurement
Year 2: Minimum Inspiration (n=7)
|
86.00 cm
Interval 8.0 to 109.0
|
|
Chest Expansion Measurement
Year 3: Maximum Inspiration (n=36)
|
96.75 cm
Interval 85.75 to 106.5
|
|
Chest Expansion Measurement
Year 3: Minimum Inspiration (n=32)
|
94.38 cm
Interval 86.63 to 104.0
|
SECONDARY outcome
Timeframe: Baseline, Year 1, 2, 3Population: Analysis population included all evaluable participants who continued the treatment at 3 years after the finalizing of the LoadET study (0881A3-102090). Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable for this measure at specified time point.
The test for 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.
Outcome measures
| Measure |
Etanercept
n=49 Participants
Participants who completed LoadET study 0881A3-102090 (NCT00873730) and received either etanercept 50 mg weekly subcutaneously, etanercept 100 mg weekly subcutaneously, another drug, or abandoned medication as per standard clinical practice were observed retrospectively for 3 years.
|
|---|---|
|
C-reactive Protein (CRP)
Baseline (n=45)
|
0.27 milligram per milliliter (mg/mL)
Interval 0.1 to 0.84
|
|
C-reactive Protein (CRP)
Year 1 (n=46)
|
0.25 milligram per milliliter (mg/mL)
Interval 0.1 to 0.82
|
|
C-reactive Protein (CRP)
Year 2 (n=47)
|
0.47 milligram per milliliter (mg/mL)
Interval 0.16 to 0.95
|
|
C-reactive Protein (CRP)
Year 3 (n=49)
|
0.40 milligram per milliliter (mg/mL)
Interval 0.18 to 1.19
|
SECONDARY outcome
Timeframe: Baseline, Year 1, 2, 3Population: Analysis population included all evaluable participants who continued the treatment at 3 years after the finalizing of the LoadET study (0881A3-102090). Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable for this measure at specified 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 millimeter/hour (mm/hr). A higher rate is consistent with inflammation.
Outcome measures
| Measure |
Etanercept
n=50 Participants
Participants who completed LoadET study 0881A3-102090 (NCT00873730) and received either etanercept 50 mg weekly subcutaneously, etanercept 100 mg weekly subcutaneously, another drug, or abandoned medication as per standard clinical practice were observed retrospectively for 3 years.
|
|---|---|
|
Erythrocyte Sedimentation Rate (ESR)
Baseline (n=50)
|
2.00 mm/hr
Interval 2.0 to 7.0
|
|
Erythrocyte Sedimentation Rate (ESR)
Year 1 (n=44)
|
4.00 mm/hr
Interval 2.0 to 7.5
|
|
Erythrocyte Sedimentation Rate (ESR)
Year 2 (n=49)
|
4.00 mm/hr
Interval 2.0 to 8.0
|
|
Erythrocyte Sedimentation Rate (ESR)
Year 3 (n=46)
|
6.00 mm/hr
Interval 3.0 to 11.0
|
SECONDARY outcome
Timeframe: Baseline, Year 1, 2, 3Population: Analysis population included all evaluable participants who continued the treatment at 3 years after the finalizing of the LoadET study (0881A3-102090). Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable for each parameter at specified time point.
Lipid profile included following parameters: Total Cholesterol (TC), high-density lipoprotein (HDL) and triglycerides (TGs).
Outcome measures
| Measure |
Etanercept
n=42 Participants
Participants who completed LoadET study 0881A3-102090 (NCT00873730) and received either etanercept 50 mg weekly subcutaneously, etanercept 100 mg weekly subcutaneously, another drug, or abandoned medication as per standard clinical practice were observed retrospectively for 3 years.
|
|---|---|
|
Lipid Profile: Total Cholesterol (TC), High Density Lipoprotein (HDL) and Triglycerides Levels
Baseline: Total Cholesterol (n=42)
|
189.50 milligram per deciliter (mg/dL)
Interval 167.0 to 210.0
|
|
Lipid Profile: Total Cholesterol (TC), High Density Lipoprotein (HDL) and Triglycerides Levels
Baseline: High Density Lipoprotein (n=18)
|
53.00 milligram per deciliter (mg/dL)
Interval 45.0 to 59.0
|
|
Lipid Profile: Total Cholesterol (TC), High Density Lipoprotein (HDL) and Triglycerides Levels
Baseline: Triglycerides (n=34)
|
77.00 milligram per deciliter (mg/dL)
Interval 61.0 to 113.0
|
|
Lipid Profile: Total Cholesterol (TC), High Density Lipoprotein (HDL) and Triglycerides Levels
Year 1: Total Cholesterol (n=35)
|
191.00 milligram per deciliter (mg/dL)
Interval 170.0 to 210.0
|
|
Lipid Profile: Total Cholesterol (TC), High Density Lipoprotein (HDL) and Triglycerides Levels
Year 1: High Density Lipoprotein (n=24)
|
58.00 milligram per deciliter (mg/dL)
Interval 47.5 to 66.0
|
|
Lipid Profile: Total Cholesterol (TC), High Density Lipoprotein (HDL) and Triglycerides Levels
Year 1: Triglycerides (n=32)
|
89.50 milligram per deciliter (mg/dL)
Interval 73.0 to 147.0
|
|
Lipid Profile: Total Cholesterol (TC), High Density Lipoprotein (HDL) and Triglycerides Levels
Year 2: Total Cholesterol (n=39)
|
191.00 milligram per deciliter (mg/dL)
Interval 166.0 to 209.0
|
|
Lipid Profile: Total Cholesterol (TC), High Density Lipoprotein (HDL) and Triglycerides Levels
Year 2: High Density Lipoprotein (n=28)
|
57.00 milligram per deciliter (mg/dL)
Interval 45.0 to 64.5
|
|
Lipid Profile: Total Cholesterol (TC), High Density Lipoprotein (HDL) and Triglycerides Levels
Year 2: Triglycerides (n=34)
|
103.50 milligram per deciliter (mg/dL)
Interval 72.0 to 134.0
|
|
Lipid Profile: Total Cholesterol (TC), High Density Lipoprotein (HDL) and Triglycerides Levels
Year 3: Total Cholesterol (n=40)
|
184.00 milligram per deciliter (mg/dL)
Interval 172.0 to 205.5
|
|
Lipid Profile: Total Cholesterol (TC), High Density Lipoprotein (HDL) and Triglycerides Levels
Year 3: High Density Lipoprotein (n=23)
|
51.00 milligram per deciliter (mg/dL)
Interval 43.0 to 59.0
|
|
Lipid Profile: Total Cholesterol (TC), High Density Lipoprotein (HDL) and Triglycerides Levels
Year 3: Triglycerides (n=32)
|
102.50 milligram per deciliter (mg/dL)
Interval 79.0 to 124.0
|
SECONDARY outcome
Timeframe: Year 3Population: Analysis population included all evaluable participants who continued the treatment at 3 years after the finalizing of the LoadET study (0881A3-102090). Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure.
Time to treatment discontinuation with etanercept was assessed retrospectively at Year 3 for participants who did not discontinue treatment at the end of previous LoadET study 0881A3-102090 (NCT00873730). It was defined as time from first dose of etanercept received in the previous LoadET study 0881A3-102090 (NCT00873730) to last dose of etanercept.
Outcome measures
| Measure |
Etanercept
n=78 Participants
Participants who completed LoadET study 0881A3-102090 (NCT00873730) and received either etanercept 50 mg weekly subcutaneously, etanercept 100 mg weekly subcutaneously, another drug, or abandoned medication as per standard clinical practice were observed retrospectively for 3 years.
|
|---|---|
|
Time to Treatment Discontinuation With Etanercept
|
3.56 years
Interval 3.2 to 3.91
|
Adverse Events
Etanercept
Serious adverse events
| Measure |
Etanercept
n=85 participants at risk
Participants who completed LoadET study 0881A3-102090 (NCT00873730) and received either etanercept 50 mg weekly subcutaneously, etanercept 100 mg weekly subcutaneously, another drug, or abandoned medication as per standard clinical practice were observed retrospectively for 3 years.
|
|---|---|
|
Gastrointestinal disorders
Cronhn's disease
|
1.2%
1/85
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
Cholesystectomy
|
1.2%
1/85
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
| Measure |
Etanercept
n=85 participants at risk
Participants who completed LoadET study 0881A3-102090 (NCT00873730) and received either etanercept 50 mg weekly subcutaneously, etanercept 100 mg weekly subcutaneously, another drug, or abandoned medication as per standard clinical practice were observed retrospectively for 3 years.
|
|---|---|
|
General disorders
Treatment failure
|
11.8%
10/85
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.
|
|
Nervous system disorders
Dizziness
|
7.1%
6/85
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.
|
|
Eye disorders
Uveitis
|
5.9%
5/85
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.
|
|
Infections and infestations
Respiratory tract infection
|
3.5%
3/85
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.
|
|
Eye disorders
Iridocyclitis
|
3.5%
3/85
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.
|
|
Infections and infestations
Chickenpox
|
2.4%
2/85
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.
|
|
Renal and urinary disorders
Renal colic
|
2.4%
2/85
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.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
2.4%
2/85
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.
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.4%
2/85
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.
|
|
Nervous system disorders
Headache
|
1.2%
1/85
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.
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
2.4%
2/85
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
Epicondylitis
|
2.4%
2/85
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.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.2%
1/85
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
Surgery
|
1.2%
1/85
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.
|
|
Cardiac disorders
Sinus tachycardia
|
1.2%
1/85
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.
|
|
Skin and subcutaneous tissue disorders
Pustular psoriasis
|
1.2%
1/85
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.
|
|
Infections and infestations
Pharyngitis
|
1.2%
1/85
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
Pain
|
1.2%
1/85
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.
|
|
Musculoskeletal and connective tissue disorders
Osteochondritis
|
1.2%
1/85
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.
|
|
Gastrointestinal disorders
Oesophageal spasm
|
1.2%
1/85
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.
|
|
Musculoskeletal and connective tissue disorders
Muscle tension
|
1.2%
1/85
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.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasm
|
1.2%
1/85
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.
|
|
Musculoskeletal and connective tissue disorders
Muscle contracture
|
1.2%
1/85
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.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
1.2%
1/85
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.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
1.2%
1/85
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.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
1.2%
1/85
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.
|
|
Vascular disorders
Hypertension
|
1.2%
1/85
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.
|
|
Infections and infestations
Gingival abscess
|
1.2%
1/85
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.
|
|
Infections and infestations
Gastroenteritis
|
1.2%
1/85
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.
|
|
Eye disorders
Episcleritis
|
1.2%
1/85
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.
|
|
Reproductive system and breast disorders
Epididymitis
|
1.2%
1/85
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
Oedema administration
|
1.2%
1/85
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.
|
|
Renal and urinary disorders
Dysuria
|
1.2%
1/85
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.
|
|
Nervous system disorders
Dysaesthesia
|
1.2%
1/85
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.
|
|
Infections and infestations
Bronchitis
|
1.2%
1/85
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.
|
|
Gastrointestinal disorders
Barrett's oesophagus
|
1.2%
1/85
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.
|
|
Reproductive system and breast disorders
Balanitis
|
1.2%
1/85
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.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.2%
1/85
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.
|
|
Infections and infestations
Acute sinusitis
|
1.2%
1/85
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.
|
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