Spondylitis, AnkylosingNCT01188655
Observational Non-Interventional Study With Enbrel (Etanercept) in Patients With Ankylosing Spondylitis
An observational study of Spondylitis, Ankylosing, run by Pfizer.
Trial summary
This observational study will be a documentation of the prescribing and administration practices of Enbrel® and their impact on ankylosing spondylitis patients outcome in a real life setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spondylitis, Ankylosing
- What is being tested?
- Enbrel
- How many people
- 89 participants
- Where
- No sites listed yet
- Study dates
- May 2008to Mar 2010
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patient cohort in this non-interventional study will reflect the kind of patients seen in routine clinical practice and will not be specifically pre-selected as it is the case in clinical studies.
Who may be able to join
- Proven diagnosis of Ankylosing Spondylitisin accordance with local guidelines
- Patients treated as an outpatient
Who cannot join
- Patients who suffer from hypersensitivity to the active substance Etanercept or to any of the excipients of Enbrel®.
- Treatment with Enbrel® should not be initiated in patients with active infections including chronic or localised infections.
- Patients with sepsis or risk of sepsis should not be treated.
About this study
Official title: Observational Non-Interventional Study With Enbrel in Patients With Ankylosing Spondylitis
This observational study will be a documentation of the prescribing and administration practices of Enbrel® and their impact on ankylosing spondylitis patients outcome in a real life setting.
Read the detailed description
The study population will be described using standard descriptive statistics for demographic, clinical, medical, characteristics, as well as for standard health-related quality of life and functional disability questionnaires .
- Conditions
- Spondylitis, Ankylosing
- Being tested
- Enbrel
- Keywords
- Ankylosing Spondylitis
- Medical subject headings
- Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnbrelDrug
Also called etanercept
The patients will be treated in accordance with the requirements of the labeling of Enbrel® in Austria. The dosage and duration of therapy is to be determined by the physician to meet the patients' individual needs for treatment.
To record complete dosing information, initial dose will be documented at baseline and any change will be documented with date, dose and reason at the subsequent visits.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group Enbrel | Not described Receives: Drug: Enbrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Achieving BASDAI 40 Response at Week 24
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.
Measured: Week 24
Secondary outcomes (11)
Change From Baseline in BASDAI at Week 12 and 24
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.
Measured: Baseline, Week 12 and Week 24
Change From Baseline in the BASFI at Weeks 12 and 24
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.
Measured: Baseline, Week 12 and Week 24
Participant's Global Assessment Visual Analog Scale at Weeks 12 and 24
Measured using a 100mm VAS ranging from 0=very good to 100=very bad.
Measured: Week 12 and Week 24
Physician's Global Assessment Visual Analog Scale at Weeks 12 and 24
Physician Global Assessment of Disease Activity was measured on a 0 to 100 mm VAS, with 0 mm= no disease activity.
Measured: Week 12 and Week 24
Mean Duration of Morning Stiffness
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).
Measured: Week 12 and Week 24
Change From Baseline in ASQoL at Week 12 and Week 24
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).
Measured: Baseline, Week 12 and Week 24
Percentage of Participants Without Enthesitis
Measured: Week 12 and Week 24
Percentage of Participants Without Peripheral Arthritis
Measured: Week 12 and Week 24
Mean Occiput-to-wall Distance at Week 12 and Week 24
Measured: Week 12 and Week 24
Spine Agility Function by Schober Test
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.
Measured: Week 12 and Week 24
Spine Agility Function by Ott Test
The Ott index determines the agility of the thoracic spine.
Measured: Week 12 and Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2010 (estimated)
- Study startMay 2008
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Spondylitis, AnkylosingStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01188655
- Sponsor's protocol ID
- 0881X1-4456
- Other IDs
- B1801095
- Status last verified
- Sep 2011
- First submitted
- 24 Aug 2010
- Last updated
- 12 Sep 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Non-Interventional Study With Enbrel in Patients With Ankylosing Spondylitis
- ClinicalTrials.gov ID
- NCT01188655
- Acronym / sponsor ID
- 0881X1-4456
- Conditions
- Spondylitis, Ankylosing
- Keywords
- Ankylosing Spondylitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 25 Aug 2010 (estimated)
- Results
- Posted 26 Apr 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This observational study will be a documentation of the prescribing and administration practices of Enbrel® and their impact on ankylosing spondylitis patients outcome in a real life setting.
Detailed description
The study population will be described using standard descriptive statistics for demographic, clinical, medical, characteristics, as well as for standard health-related quality of life and functional disability questionnaires .
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Group Enbrel | – | Drug: Enbrel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patient cohort in this non-interventional study will reflect the kind of patients seen in routine clinical practice and will not be specifically pre-selected as it is the case in clinical studies.
Key inclusion criteria (2 listed)
- Proven diagnosis of Ankylosing Spondylitisin accordance with local guidelines
- Patients treated as an outpatient
Key exclusion criteria (3 listed)
- Patients who suffer from hypersensitivity to the active substance Etanercept or to any of the excipients of Enbrel®.
- Treatment with Enbrel® should not be initiated in patients with active infections including chronic or localised infections.
- Patients with sepsis or risk of sepsis should not be treated.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EnbrelAlso: etanerceptThe patients will be treated in accordance with the requirements of the labeling of Enbrel® in Austria. The dosage and duration of therapy is to be determined by the physician to meet the patients' individual needs for treatment. To record complete dosing information, initial dose will be documented at baseline and any change will be documented with date, dose and reason at the subsequent visits. | Drug | Treatment Group Enbrel |
Primary outcome
Percentage of Participants Achieving BASDAI 40 Response at Week 24
Time frame: Week 24
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.
11 secondary outcomes
Change From Baseline in BASDAI at Week 12 and 24
Time frame: Baseline, Week 12 and Week 24
Change From Baseline in the BASFI at Weeks 12 and 24
Time frame: Baseline, Week 12 and Week 24
Participant's Global Assessment Visual Analog Scale at Weeks 12 and 24
Time frame: Week 12 and Week 24
Physician's Global Assessment Visual Analog Scale at Weeks 12 and 24
Time frame: Week 12 and Week 24
Mean Duration of Morning Stiffness
Time frame: Week 12 and Week 24
Change From Baseline in ASQoL at Week 12 and Week 24
Time frame: Baseline, Week 12 and Week 24
Percentage of Participants Without Enthesitis
Time frame: Week 12 and Week 24
Percentage of Participants Without Peripheral Arthritis
Time frame: Week 12 and Week 24
Mean Occiput-to-wall Distance at Week 12 and Week 24
Time frame: Week 12 and Week 24
Spine Agility Function by Schober Test
Time frame: Week 12 and Week 24
Spine Agility Function by Ott Test
Time frame: Week 12 and Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
Questions about this trial
What is this clinical trial studying?
An observational study of Spondylitis, Ankylosing, run by Pfizer.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Apr 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Achieving BASDAI 40 Response at Week 24 (time frame: Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2011.