Ankylosing SpondylitisPhase 4NCT00458185
Study Evaluating Etanercept in Patients With Ankylosing Spondylitis
A Phase 4 study testing etanercept in people with Ankylosing Spondylitis, run by Wyeth is now a wholly owned subsidiary of Pfizer.
Trial summary
This study will assess the efficacy of etanercept for the treatment of Ankylosing Spondylitis (AS). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Ankylosing Spondylitis
- What is being tested?
- etanercept
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Aug 2006to Apr 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of AS, as defined by Modified New York Criteria for Ankylosing Spondylitis, aged between 18 and 70 years of age.
- BASDAI greater than or equal to 40 (all scores on a scale of 0 to 100).
- Negative result of serum human chorionic gonadotropin (HCG) pregnancy test taken at screening in all women except those surgically sterile or at least 1 year postmenopausal.
Who cannot join
- Complete ankylosis (fusion) of spine.
- Previous receipt of etanercept, antibody to TNFα, or other TNFα inhibitors.
- Use of disease modifying antirheumatic drugs (DMARDs) other than hydroxychloroquine, sulphasalazine, and methotrexate within 4 weeks of baseline. Patients treated with hydroxychloroquine, sulphasalazine, and methotrexate may continue these drugs during this study but doses must be held stable for 4 weeks before baseline examination and for the duration of the study.
About this study
Official title: Multicentre, Open-Labeled Study Of Etanercept In The Treatment Of Patients With Ankylosing Spondylitis
This study will assess the efficacy of etanercept for the treatment of Ankylosing Spondylitis (AS).
- Conditions
- Ankylosing Spondylitis
- Being tested
- etanercept
- Medical subject headings
- Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
etanerceptDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the efficacy of etanercept (25 mg, twice weekly) based on the percentage of patients who achieve the Assessment in Ankylosing Spondylitis (ASAS) Response Criteria at 20% level at week 12.
Secondary outcomes (1)
Efficacy at 50% and 70% levels week 12; frequency and time to partial remission; safety; patient and physician global assessment, nocturnal and total back pain, BASFI, BASDAI; spinal mobility; complete joint assessment; hip involvement; ESR, CRP.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2007 (estimated)
- Study startAug 2006
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankylosing SpondylitisStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Monitor, Study director, Wyeth is now a wholly owned subsidiary of Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00458185
- Sponsor's protocol ID
- 0881A-101871
- Status last verified
- Mar 2008
- First submitted
- 5 Apr 2007
- Last updated
- 13 Mar 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre, Open-Labeled Study Of Etanercept In The Treatment Of Patients With Ankylosing Spondylitis
- ClinicalTrials.gov ID
- NCT00458185
- Acronym / sponsor ID
- 0881A-101871
- Conditions
- Ankylosing Spondylitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Aug 2006
- Study completion
- Apr 2007 (actual)
- First posted
- 9 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess the efficacy of etanercept for the treatment of Ankylosing Spondylitis (AS).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of AS, as defined by Modified New York Criteria for Ankylosing Spondylitis, aged between 18 and 70 years of age.
- BASDAI greater than or equal to 40 (all scores on a scale of 0 to 100).
- Negative result of serum human chorionic gonadotropin (HCG) pregnancy test taken at screening in all women except those surgically sterile or at least 1 year postmenopausal.
Key exclusion criteria (3 listed)
- Complete ankylosis (fusion) of spine.
- Previous receipt of etanercept, antibody to TNFα, or other TNFα inhibitors.
- Use of disease modifying antirheumatic drugs (DMARDs) other than hydroxychloroquine, sulphasalazine, and methotrexate within 4 weeks of baseline. Patients treated with hydroxychloroquine, sulphasalazine, and methotrexate may continue these drugs during this study but doses must be held stable for 4 weeks before baseline examination and for the duration of the study.
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 |
|---|---|---|
| etanercept | Drug | – |
Primary outcome
To determine the efficacy of etanercept (25 mg, twice weekly) based on the percentage of patients who achieve the Assessment in Ankylosing Spondylitis (ASAS) Response Criteria at 20% level at week 12.
1 secondary outcome
Efficacy at 50% and 70% levels week 12; frequency and time to partial remission; safety; patient and physician global assessment, nocturnal and total back pain, BASFI, BASDAI; spinal mobility; complete joint assessment; hip involvement; ESR, CRP.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2008.
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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.
Medical Monitor study director
Wyeth is now a wholly owned subsidiary of Pfizer
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing etanercept in people with Ankylosing Spondylitis, run by Wyeth is now a wholly owned subsidiary of 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 3 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 13 Mar 2008. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To determine the efficacy of etanercept (25 mg, twice weekly) based on the percentage of patients who achieve the Assessment in Ankylosing Spondylitis (ASAS) Response Criteria at 20% level at week 12.. 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 13 Mar 2008.