Trial Outcomes & Findings for Observational Non-Interventional Study With Enbrel (Etanercept) in Patients With Ankylosing Spondylitis (NCT NCT01188655)

NCT ID: NCT01188655

Last Updated: 2011-09-12

Results Overview

BASDAI is a validated self assessment tool used to determine disease activity in participant with Ankylosing Spondylitis (AS). Utilizing a Visual Analog Scale (VAS) of 0-10 (0=none and 10=very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The final BASDAI score averages the individual assessments for a final score range of 0-10. Participants who achieved a decrease of 40 percent or more from baseline to the following visits are called as responders.

• Recruitment status: COMPLETED
• Target enrollment: 89 participants
• Primary outcome timeframe: Week 24
• Results posted on: 2011-09-12

Participant Flow

Participant milestones

Measure	Etanercept Participants were treated in accordance with the requirements of the labeling of Enbrel in Austria. The dosage and duration of therapy was to be determined by the physician to meet participant's individual needs for treatment. To record complete dosing information, initial dose was documented at baseline and any change was documented with date, dose and reason at the subsequent visits.
Overall Study STARTED	89
Overall Study COMPLETED	76
Overall Study NOT COMPLETED	13

Reasons for withdrawal

Measure	Etanercept Participants were treated in accordance with the requirements of the labeling of Enbrel in Austria. The dosage and duration of therapy was to be determined by the physician to meet participant's individual needs for treatment. To record complete dosing information, initial dose was documented at baseline and any change was documented with date, dose and reason at the subsequent visits.
Overall Study Lack of Efficacy	1
Overall Study Lost to Follow-up	1
Overall Study Other	11

Baseline Characteristics

Observational Non-Interventional Study With Enbrel (Etanercept) in Patients With Ankylosing Spondylitis

Baseline characteristics by cohort

Measure	Etanercept n=89 Participants Participants were treated in accordance with the requirements of the labeling of Enbrel in Austria. The dosage and duration of therapy was to be determined by the physician to meet participant's individual needs for treatment. To record complete dosing information, initial dose was documented at baseline and any change was documented with date, dose and reason at the subsequent visits.
Age Continuous	41.6 Years STANDARD_DEVIATION 11.7 • n=5 Participants
Sex: Female, Male Female	32 Participants n=5 Participants
Sex: Female, Male Male	57 Participants n=5 Participants
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at baseline	5.3 units on a scale STANDARD_DEVIATION 1.6 • n=5 Participants
Bath Ankylosing Spondylitis Functional Index (BASFI) at baseline	4.7 Units on a scale STANDARD_DEVIATION 2.3 • n=5 Participants
Participant's Global Assessment Visual Analog Scale at baseline	6.7 Units on a scale STANDARD_DEVIATION 2.0 • n=5 Participants
Physician's Global Assessment Visual Analog Scale at baseline	6.6 mm STANDARD_DEVIATION 1.4 • n=5 Participants
Duration of morning stiffness at baseline	88.3 minutes STANDARD_DEVIATION 67.5 • n=5 Participants
Ankylosing Spondylitis Quality of Life Scale (ASQoL) at baseline	11.9 Units on a scale STANDARD_DEVIATION 3.9 • n=5 Participants
Percentage of Participants Without Enthesitis	57.5 Percentage of Participants n=5 Participants
Percentage of Participants Without Peripheral Arthritis	70.1 Percentage of Participants n=5 Participants
Occiput-to-wall distance	3.8 centimeter (cm) STANDARD_DEVIATION 6.0 • n=5 Participants
Spine agility function by Schober test	6.3 cm STANDARD_DEVIATION 5.5 • n=5 Participants
Spine agility function by Ott test	11.8 cm STANDARD_DEVIATION 14.3 • n=5 Participants

PRIMARY outcome

Timeframe: Week 24

Population: Safety population: all participants who recieved at least one dose of study medication during the study period, n equals number of participants analyzed at the given time point

BASDAI is a validated self assessment tool used to determine disease activity in participant with Ankylosing Spondylitis (AS). Utilizing a Visual Analog Scale (VAS) of 0-10 (0=none and 10=very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The final BASDAI score averages the individual assessments for a final score range of 0-10. Participants who achieved a decrease of 40 percent or more from baseline to the following visits are called as responders.

Outcome measures

Measure

Etanercept n=67 Participants Participants were treated in accordance with the requirements of the labeling of Enbrel in Austria. The dosage and duration of therapy was to be determined by the physician to meet participant's individual needs for treatment. To record complete dosing information, initial dose was documented at baseline and any change was documented with date, dose and reason at the subsequent visits.

Percentage of Participants Achieving BASDAI 40 Response at Week 24

83.6 Percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 12 and Week 24

Population: Safety population: all participants who recieved at least one dose of study medication during the study period, n equals number of participants analyzed at the given time point.

BASDAI is a validated self assessment tool used to determine disease activity in participant with Ankylosing Spondylitis (AS). Utilizing a Visual Analog Scale (VAS) of 0-10 (0=none and 10=very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The final BASDAI score averages the individual assessments for a final score range of 0-10.

Outcome measures

Measure	Etanercept n=67 Participants Participants were treated in accordance with the requirements of the labeling of Enbrel in Austria. The dosage and duration of therapy was to be determined by the physician to meet participant's individual needs for treatment. To record complete dosing information, initial dose was documented at baseline and any change was documented with date, dose and reason at the subsequent visits.
Change From Baseline in BASDAI at Week 12 and 24 Week 12 (n= 70)	-2.8 units on a scale Standard Deviation 2.4
Change From Baseline in BASDAI at Week 12 and 24 Week 24 (n= 68)	-3.5 units on a scale Standard Deviation 2.0

SECONDARY outcome

Timeframe: Baseline, Week 12 and Week 24

Population: Safety population: all participants who recieved at least one dose of study medication during the study period, n equals number of participants analyzed at the given time point.

BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. 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 mean score of the 10 questions.

Outcome measures

Measure	Etanercept n=83 Participants Participants were treated in accordance with the requirements of the labeling of Enbrel in Austria. The dosage and duration of therapy was to be determined by the physician to meet participant's individual needs for treatment. To record complete dosing information, initial dose was documented at baseline and any change was documented with date, dose and reason at the subsequent visits.
Change From Baseline in the BASFI at Weeks 12 and 24 Week 12 (n= 73)	-2.1 Units on a scale Standard Deviation 2.1
Change From Baseline in the BASFI at Weeks 12 and 24 Week 24 (n= 70)	-2.7 Units on a scale Standard Deviation 2.1

SECONDARY outcome

Timeframe: Week 12 and Week 24

Population: Safety population: all participants who recieved at least one dose of study medication during the study period, n equals number of participants analyzed at the given time point.

Measured using a 100mm VAS ranging from 0=very good to 100=very bad.

Outcome measures

Measure	Etanercept n=84 Participants Participants were treated in accordance with the requirements of the labeling of Enbrel in Austria. The dosage and duration of therapy was to be determined by the physician to meet participant's individual needs for treatment. To record complete dosing information, initial dose was documented at baseline and any change was documented with date, dose and reason at the subsequent visits.
Participant's Global Assessment Visual Analog Scale at Weeks 12 and 24 Week 12 (n= 73)	2.8 Units on a scale Standard Deviation 2.2
Participant's Global Assessment Visual Analog Scale at Weeks 12 and 24 Week 24 (n= 70)	1.9 Units on a scale Standard Deviation 2.2

SECONDARY outcome

Timeframe: Week 12 and Week 24

Population: Safety population: all participants who recieved at least one dose of study medication during the study period, n equals number of participants analyzed at the given time point.

Physician Global Assessment of Disease Activity was measured on a 0 to 100 mm VAS, with 0 mm= no disease activity.

Outcome measures

Measure	Etanercept n=89 Participants Participants were treated in accordance with the requirements of the labeling of Enbrel in Austria. The dosage and duration of therapy was to be determined by the physician to meet participant's individual needs for treatment. To record complete dosing information, initial dose was documented at baseline and any change was documented with date, dose and reason at the subsequent visits.
Physician's Global Assessment Visual Analog Scale at Weeks 12 and 24 Week 12 (n= 81)	2.5 mm Standard Deviation 1.6
Physician's Global Assessment Visual Analog Scale at Weeks 12 and 24 Week 24 (n= 78)	1.7 mm Standard Deviation 1.3

SECONDARY outcome

Timeframe: Week 12 and Week 24

Population: Safety population: all participants who recieved at least one dose of study medication during the study period, n equals number of participants analyzed at the given time point.

Duration of morning stiffness is defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes (24h x 60 minutes) was recorded).

Outcome measures

Measure	Etanercept n=80 Participants Participants were treated in accordance with the requirements of the labeling of Enbrel in Austria. The dosage and duration of therapy was to be determined by the physician to meet participant's individual needs for treatment. To record complete dosing information, initial dose was documented at baseline and any change was documented with date, dose and reason at the subsequent visits.
Mean Duration of Morning Stiffness Week 12 (n= 54)	34.2 minutes Standard Deviation 39.8
Mean Duration of Morning Stiffness Week 24 (n= 45)	30.0 minutes Standard Deviation 46.3

SECONDARY outcome

Timeframe: Baseline, Week 12 and Week 24

Population: Safety population: all participants who recieved at least one dose of study medication during the study period, n equals number of participants analyzed at the given time point.

ASQoL is a questionnaire that assesses disease-specific quality of life (QoL). It consists of 18 statements that are relevant to the physical and mental conditions for a participant with AS: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each statement is answered by the participant as a 'Yes' (scored as 1) or 'No' (scored as 0). All item scores are summed to give a total score. Total score can range from 0 (good QoL) to 18 (poor QoL).

Outcome measures

Measure	Etanercept n=70 Participants Participants were treated in accordance with the requirements of the labeling of Enbrel in Austria. The dosage and duration of therapy was to be determined by the physician to meet participant's individual needs for treatment. To record complete dosing information, initial dose was documented at baseline and any change was documented with date, dose and reason at the subsequent visits.
Change From Baseline in ASQoL at Week 12 and Week 24 Week 12	-6.8 Units on a scale Standard Deviation 4.2
Change From Baseline in ASQoL at Week 12 and Week 24 Week 24	-8.3 Units on a scale Standard Deviation 5.0

SECONDARY outcome

Timeframe: Week 12 and Week 24

Population: Safety population: all participants who recieved at least one dose of study medication during the study period, n equals number of participants analyzed at the given time point.

Outcome measures

Measure	Etanercept n=87 Participants Participants were treated in accordance with the requirements of the labeling of Enbrel in Austria. The dosage and duration of therapy was to be determined by the physician to meet participant's individual needs for treatment. To record complete dosing information, initial dose was documented at baseline and any change was documented with date, dose and reason at the subsequent visits.
Percentage of Participants Without Enthesitis Week 12 (n= 81)	86.4 Percentage of Participants
Percentage of Participants Without Enthesitis Week 24 (n= 78)	85.9 Percentage of Participants

SECONDARY outcome

Timeframe: Week 12 and Week 24

Population: Safety population: all participants who recieved at least one dose of study medication during the study period, n equals number of participants analyzed at the given time point.

Outcome measures

Measure	Etanercept n=87 Participants Participants were treated in accordance with the requirements of the labeling of Enbrel in Austria. The dosage and duration of therapy was to be determined by the physician to meet participant's individual needs for treatment. To record complete dosing information, initial dose was documented at baseline and any change was documented with date, dose and reason at the subsequent visits.
Percentage of Participants Without Peripheral Arthritis Week 12 (n= 81)	81.5 Percentage of Participants
Percentage of Participants Without Peripheral Arthritis Week 24 (n= 78)	85.9 Percentage of Participants

SECONDARY outcome

Timeframe: Week 12 and Week 24

Population: Safety population: all participants who recieved at least one dose of study medication during the study period, n equals number of participants analyzed at the given time point

Outcome measures

Measure	Etanercept n=67 Participants Participants were treated in accordance with the requirements of the labeling of Enbrel in Austria. The dosage and duration of therapy was to be determined by the physician to meet participant's individual needs for treatment. To record complete dosing information, initial dose was documented at baseline and any change was documented with date, dose and reason at the subsequent visits.
Mean Occiput-to-wall Distance at Week 12 and Week 24 Week 12 (n= 58)	3.2 cm Standard Deviation 5.5
Mean Occiput-to-wall Distance at Week 12 and Week 24 Week 24 (n= 56)	3.2 cm Standard Deviation 5.2

SECONDARY outcome

Timeframe: Week 12 and Week 24

Population: Safety population: all participants who recieved at least one dose of study medication during the study period, n equals number of participants analyzed at the given time point

Schober test determines agility of lumbar spine. It measures participant's ability to flex the lower back. Examiner makes a mark at fifth lumbar vertebra (L5); places 1 finger 5 cm below and another 10 cm above the mark. Participant is asked to touch the toes. Examiner measures the increase in distance between 2 fingers.

Outcome measures

Measure	Etanercept n=58 Participants Participants were treated in accordance with the requirements of the labeling of Enbrel in Austria. The dosage and duration of therapy was to be determined by the physician to meet participant's individual needs for treatment. To record complete dosing information, initial dose was documented at baseline and any change was documented with date, dose and reason at the subsequent visits.
Spine Agility Function by Schober Test Week 12 (n= 50)	7.6 cm Standard Deviation 5.7
Spine Agility Function by Schober Test Week 24 (n= 49)	7.7 cm Standard Deviation 5.9

SECONDARY outcome

Timeframe: Week 12 and Week 24

Population: Safety population: all participants who recieved at least one dose of study medication during the study period, n equals number of participants analyzed at the given time point

The Ott index determines the agility of the thoracic spine.

Outcome measures

Measure	Etanercept n=48 Participants Participants were treated in accordance with the requirements of the labeling of Enbrel in Austria. The dosage and duration of therapy was to be determined by the physician to meet participant's individual needs for treatment. To record complete dosing information, initial dose was documented at baseline and any change was documented with date, dose and reason at the subsequent visits.
Spine Agility Function by Ott Test Week 12 (n= 40)	13.6 cm Standard Deviation 14.8
Spine Agility Function by Ott Test Week 24 (n= 43)	13.3 cm Standard Deviation 14.6

Adverse Events

Etanercept

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Etanercept n=89 participants at risk Participants were treated in accordance with the requirements of the labeling of Enbrel in Austria. The dosage and duration of therapy was to be determined by the physician to meet participant's individual needs for treatment. To record complete dosing information, initial dose was documented at baseline and any change was documented with date, dose and reason at the subsequent visits.
General disorders Application site hypersensitivity	1.1% 1/89 • Number of events 1 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 Injection site erythema	1.1% 1/89 • Number of events 1 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 Prostatitis	1.1% 1/89 • Number of events 1 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

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: ClinicalTrials.gov_Inquiries@pfizer.com

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