Spondylarthropathies, EnthesitisPhase 4NCT00420303
Study Evaluating Etanercept for the Treatment of Refractory Heel Enthesitis in Spondylarthropathy
A Phase 4 study testing Etanercept in people with Spondylarthropathies, Enthesitis, run by Wyeth is now a wholly owned subsidiary of Pfizer at 15 sites in 3 countries.
Trial summary
To assess the efficacy and safety of Etanercept in patients with spondylarthropathy and refractory heel enthesitis. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Spondylarthropathies, Enthesitis
- What is being tested?
- Etanercept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 15 sitesin 3 countries
- Study dates
- Jan 2007to Sep 2008
- Phase
- Phase 4
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Spondylarthropathy
- Heel enthesitis refractory to standard treatment
- Between 18 and 70 years of age
- The patient global assessment of the disease activity (measured by a 100 mm VAS) must be >40 in the last 48 hours
Who cannot join
- Use of > 1 local steroid injection within 2 weeks of screening
- Prior exposure to any TNF-inhibitor, including etanercept
- Dose of NSAIDs changed within two weeks of study drug evaluation
Trial locations and contacts
15 sites in 3 countries.
15 sites in 3 countries
France12 sites
Study site
Arles, 13200
Study site
Avignon, 84000
Study site
Bordeaux, 33076
Study site
Grenoble, 38130
Study site
Montpellier, 34295
Study site
Nice, 6202
Study site
Orléans, 45032
Study site
Paris (Bichat), 75018
Study site
Paris (cochin), 75679
Study site
Paris (Pitie Salpetriere), 75651
Study site
Strasbourg, 67098
Study site
Toulouse, 31000
About this study
Official title: A Multicentre, Double-Blind, Placebo-Controlled, Randomized Study of Etanercept in the Treatment of Adults Patients With Refractory Heel Enthesitis in Spondylarthropathy
To assess the efficacy and safety of Etanercept in patients with spondylarthropathy and refractory heel enthesitis.
- Conditions
- Spondylarthropathies, Enthesitis
- Being tested
- Etanercept, Placebo
- Keywords
- Refractory Heel Enthesitis in Spondylarthropathy, Spondylarthropathy, Refractory Heel Enthesitis
- Medical subject headings
- Spondylarthropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtanerceptDrug
50 mg injection once weekly
PlaceboOther
placebo
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: Etanercept |
| B | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Normalized Net Incremental Area Under the Curve (AUC) for Patient Global Assessment of Disease Activity (PGA) Between Randomization and Week 12
PGA was measured using a 100mm Visual Analog Scale (VAS) ranging from 0=very good to 100=very bad. The normalized net incremental area under the curve of the PGA is the area between the baseline and the PGA curve as a function of time (week 2, 4, 8, 12). AUC was computed using the linear trapezoidal method. All the areas above the baseline and under the curve are positive and all the area below the baseline and above the curve are negative. The net incremental AUC is the sum of these areas. This result is then divided by the study duration of the patients. (negative value = improvement).
Measured: 12 weeks
Change From Baseline in Patient Global Assessment of Disease Activity Score at Week 12
The patient global assessment of disease activity was measured using a 100mm Visual Analog Scale (VAS) ranging from 0=very good to 100=very bad. Change=12 week score minus baseline score. A negative score indicates an improvement in disease activity and a positive score indicates worsening.
Measured: Baseline and 12 weeks
Secondary outcomes (1)
Number of Patients Achieving a 50% Response on the Patient Global Assessment of Disease Activity
A response is defined as at least a 50% improvement (decrease) from baseline in the patient global assessment of disease activity. The patient global assessment of disease activity was measured using a 100mm Visual Analog Scale (VAS) ranging from 0=very good to 100=very bad.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2007 (estimated)
- Study startJan 2007
- Primary completionSep 2008
- Study completionSep 2008
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spondylarthropathies, EnthesitisStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 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 PfizerTrial Manager, Principal investigator, For France, infomedfrance@wyeth.comTrial Manager, Principal investigator, For Germany, medinfoDEU@wyeth.comTrial Manager, Principal investigator, For Netherlands, trials-NL@wyeth.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00420303
- Sponsor's protocol ID
- 0881A3-404
- Status last verified
- Jul 2010
- First submitted
- 8 Jan 2007
- Last updated
- 20 Jul 2010
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Dougados M, Combe B, Braun J, Landewe R, Sibilia J, Cantagrel A, Feydy A, van der Heijde D, Leblanc V, Logeart I. A randomised, multicentre, double-blind, placebo-controlled trial of etanercept in adults with refractory heel enthesitis in spondyloarthritis: the HEEL trial. Ann Rheum Dis. 2010 Aug;69(8):1430-5. doi: 10.1136/ard.2009.121533. Epub 2010 May 28.
PubMed 20511606
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Double-Blind, Placebo-Controlled, Randomized Study of Etanercept in the Treatment of Adults Patients With Refractory Heel Enthesitis in Spondylarthropathy
- ClinicalTrials.gov ID
- NCT00420303
- Acronym / sponsor ID
- 0881A3-404
- Conditions
- Spondylarthropathies, Enthesitis
- Keywords
- Refractory Heel Enthesitis in Spondylarthropathy, Spondylarthropathy, Refractory Heel Enthesitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Jan 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 11 Jan 2007 (estimated)
- Results
- Posted 10 Nov 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the efficacy and safety of Etanercept in patients with spondylarthropathy and refractory heel enthesitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Etanercept |
| B | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Spondylarthropathy
- Heel enthesitis refractory to standard treatment
- Between 18 and 70 years of age
- The patient global assessment of the disease activity (measured by a 100 mm VAS) must be >40 in the last 48 hours
Key exclusion criteria (3 listed)
- Use of > 1 local steroid injection within 2 weeks of screening
- Prior exposure to any TNF-inhibitor, including etanercept
- Dose of NSAIDs changed within two weeks of study drug evaluation
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 |
|---|---|---|
| Etanercept50 mg injection once weekly | Drug | A |
| Placeboplacebo | Other | B |
Primary outcome
Normalized Net Incremental Area Under the Curve (AUC) for Patient Global Assessment of Disease Activity (PGA) Between Randomization and Week 12
Time frame: 12 weeks
PGA was measured using a 100mm Visual Analog Scale (VAS) ranging from 0=very good to 100=very bad. The normalized net incremental area under the curve of the PGA is the area between the baseline and the PGA curve as a function of time (week 2, 4, 8, 12). AUC was computed using the linear trapezoidal method. All the areas above the baseline and under the curve are positive and all the area below the baseline and above the curve are negative. The net incremental AUC is the sum of these areas. This result is then divided by the study duration of the patients. (negative value = improvement).
Change From Baseline in Patient Global Assessment of Disease Activity Score at Week 12
Time frame: Baseline and 12 weeks
The patient global assessment of disease activity was measured using a 100mm Visual Analog Scale (VAS) ranging from 0=very good to 100=very bad. Change=12 week score minus baseline score. A negative score indicates an improvement in disease activity and a positive score indicates worsening.
1 secondary outcome
Number of Patients Achieving a 50% Response on the Patient Global Assessment of Disease Activity
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 20511606Dougados M, Combe B, Braun J, Landewe R, Sibilia J, Cantagrel A, Feydy A, van der Heijde D, Leblanc V, Logeart I. A randomised, multicentre, double-blind, placebo-controlled trial of etanercept in adults with refractory heel enthesitis in spondyloarthritis: the HEEL trial. Ann Rheum Dis. 2010 Aug;69(8):1430-5. doi: 10.1136/ard.2009.121533. Epub 2010 May 28.
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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
Trial Manager principal investigator
For France, infomedfrance@wyeth.com
Trial Manager principal investigator
For Germany, medinfoDEU@wyeth.com
15 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Etanercept in people with Spondylarthropathies, Enthesitis, run by Wyeth is now a wholly owned subsidiary of Pfizer at 15 sites in 3 countries.
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 4 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 20 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in France, Germany, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 10 Nov 2009). 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?
Normalized Net Incremental Area Under the Curve (AUC) for Patient Global Assessment of Disease Activity (PGA) Between Randomization and Week 12 (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00420303, which also lists 1 linked publication.
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 20 Jul 2010.