Ankylosing SpondylitisNCT00273858
Study Evaluating the Safety of Etanercept in Rheumatoid Arthritis, Ankylosing Spondylitis and Psoriatic Arthritis
An observational study of Ankylosing Spondylitis and Arthritis, Psoriatic, run by Wyeth is now a wholly owned subsidiary of Pfizer at 9 sites in Greece.
Trial summary
This is a Phase 4 open label, non-interventional, multi-center study to evaluate the safety of Enbrel (etanercept) treatment in patients receiving etanercept 25mg sc twice weekly or 50mg of etanercept once weekly. The improvement of health-related quality of life will also be evaluated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ankylosing Spondylitis, Arthritis, Psoriatic, Arthritis, Rheumatoid
- How many people
- 880 participants
- Where
- 9 sitesGreece
- Study dates
- Mar 2006to Jul 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: Rheumatoid Arthritis Patients, Psoriatic Arthritis Patients, Ankylosing Spondylitis Patients
Who may be able to join
- 18 years of age or older at time of consent
- Satisfies the 1987 ACR Revised Criteria for Rheumatoid Arthritis or has a diagnosis of ankylosing spondylitis or psoriatic arthritis, as determined by the doctor
- Provides informed consent
- Demonstrate a negative serum or urine pregnancy test prior to administration of etanercept. Sexually active women participating in the study must use a medically acceptable form of contraception.
- Patients already prescribed etanercept according to approved labelling
Who cannot join
- Has hypersensitivity to etanercept
- Has sepsis or risk of sepsis. Treatment with etanercept should not be initiated in patients with active infections (ie. hepatitis C, hepatitis B, active TBC)
- Is pregnant or breast-feeding
- Has significant concurrent medical diseases including, uncompensated congestive heart failure, myocardial infarction within 12 months, unstable angina pectoris, or history of human immunodeficiency virus (HIV) infection, immunodeficiency syndromes, or central nervous system (CNS) demyelinating events suggestive of multiple sclerosis
- Has a history of confirmed blood dyscrasias
- Received any live (attenuated) vaccines within 4 weeks of screening visit
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Greece9 sites
Pfizer Investigational Site
Athens, Maroussi, 145 61
Pfizer Investigational Site
Athens, 115 26
Pfizer Investigational Site
Athens, 115 27
Pfizer Investigational Site
Athens, 16673
Pfizer Investigational Site
Athens, 184 54
Pfizer Investigational Site
Karditsa, 43100
Pfizer Investigational Site
Larissa, 411 10
Pfizer Investigational Site
Thessaloniki, Asvestohori, 570 10
Pfizer Investigational Site
Thessaloniki, 546 42
About this study
Official title: Open Label Study To Evaluate The Safety Profile And The Quality Of Life In Patients Receiving Etanercept For The Treatment Of Rheumatoid Arthritis, Ankylosing Spondylitis And Psoriatic Arthritis
This is a Phase 4 open label, non-interventional, multi-center study to evaluate the safety of Enbrel (etanercept) treatment in patients receiving etanercept 25mg sc twice weekly or 50mg of etanercept once weekly. The improvement of health-related quality of life will also be evaluated.
Read the detailed description
Patients already prescribed to receive etanercept for the first time for treatment of Rheumatoid Arthritis, Ankylosing Spondylitis or Psoriatic Arthritis according to the Summary of Product Characteristics (SmPC).
Patients have been recruited sequentially based on eligibility criteria up to the number limit assigned to each site.
- Conditions
- Ankylosing Spondylitis, Arthritis, Psoriatic, Arthritis, Rheumatoid, Spondylitis, Ankylosing
- Being tested
- There is no Intervention. The study is observational.
- Keywords
- Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis
- Medical subject headings
- Spondylitis, Ankylosing, Arthritis, Psoriatic, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
There is no Intervention. The study is observational.Other
The study is observational and the prescription follows the SmPC of etanercept.
| Study group | Role | What they receive |
|---|---|---|
| etanercept | Patients already prescribed to receive etanercept for the first time for treatment of Rheumatoid Arthritis, Ankylosing Spondylitis or Psoriatic Arthritis according to the Summary of Product Characteristics (SmPC). Receives: Other: There is no Intervention. The study is observational. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any untoward medical occurrence in a participant who received study drug was considered an AE, without regard to possibility of causal relationship. An AE resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be a SAE: death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Measured: Baseline up to Month 24
Number of Participants Who Discontinued Treatment
Measured: Baseline up to Month 24
Number of Participants by Reasons for Discontinuation of Treatment
Measured: Baseline up to Month 24
Secondary outcomes (3)
Change From Baseline in Health Assessment Questionnaire (HAQ) at 24 Month
HAQ is a measure of functional limitations. Participants were rated on 4 point scale with scores as 'normal' (no difficulty=0), 'adequate' (some difficulty= 1), 'limited' (much difficulty=2), and 'unable to do' (=3) based on degree of difficulty they experienced with 20 tasks grouped into 8 areas of dressing, rising, hygiene, reach, walking, eating, grip and activities. HAQ total scores were expressed as overall mean score ranging from 0 to 3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; greater than 1=significant functional limitation.
Measured: Baseline, Month 24
Change From Baseline in Patient Global Assessment (PtGA) Visual Analog Scale (VAS) at 24 Month
PtGA measured using a 100 mm VAS ranging from 0 = very good to 100 = very bad.
Measured: Baseline, Month 24
Change From Baseline in Physician Global Assessment (PGA) VAS at 24 Month
PGA was measured on a 0 to 100 mm VAS, with 0 mm = no disease activity to 100 mm = worst disease activity possible.
Measured: Baseline, Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2006 (estimated)
- Study startMar 2006
- Primary completionJul 2010
- Study completionJul 2010
Why it stopped: The study was terminated because at least one year follow-up was achieved for each patient and the achievement of 965 exposure years to the drug.
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 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 880 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of 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
- NCT00273858
- Sponsor's protocol ID
- 0881A-101695
- Other IDs
- B1801106
- Status last verified
- Sep 2011
- First submitted
- 4 Jan 2006
- 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
- Open Label Study To Evaluate The Safety Profile And The Quality Of Life In Patients Receiving Etanercept For The Treatment Of Rheumatoid Arthritis, Ankylosing Spondylitis And Psoriatic Arthritis
- ClinicalTrials.gov ID
- NCT00273858
- Acronym / sponsor ID
- 0881A-101695
- Conditions
- Ankylosing Spondylitis, Arthritis, Psoriatic, Arthritis, Rheumatoid, Spondylitis, Ankylosing
- Keywords
- Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The study was terminated because at least one year follow-up was achieved for each patient and the achievement of 965 exposure years to the drug.
- Enrolment
- 880 participants (actual)
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Mar 2006
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 9 Jan 2006 (estimated)
- Results
- Posted 28 Jul 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 4 open label, non-interventional, multi-center study to evaluate the safety of Enbrel (etanercept) treatment in patients receiving etanercept 25mg sc twice weekly or 50mg of etanercept once weekly. The improvement of health-related quality of life will also be evaluated.
Detailed description
Patients already prescribed to receive etanercept for the first time for treatment of Rheumatoid Arthritis, Ankylosing Spondylitis or Psoriatic Arthritis according to the Summary of Product Characteristics (SmPC).
Patients have been recruited sequentially based on eligibility criteria up to the number limit assigned to each site.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| etanercept | – | Other: There is no Intervention. The study is observational.Patients already prescribed to receive etanercept for the first time for treatment of Rheumatoid Arthritis, Ankylosing Spondylitis or Psoriatic Arthritis according to the Summary of Product Characteristics (SmPC). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Rheumatoid Arthritis Patients, Psoriatic Arthritis Patients, Ankylosing Spondylitis Patients
Key inclusion criteria (5 listed)
- 18 years of age or older at time of consent
- Satisfies the 1987 ACR Revised Criteria for Rheumatoid Arthritis or has a diagnosis of ankylosing spondylitis or psoriatic arthritis, as determined by the doctor
- Provides informed consent
- Demonstrate a negative serum or urine pregnancy test prior to administration of etanercept. Sexually active women participating in the study must use a medically acceptable form of contraception.
- Patients already prescribed etanercept according to approved labelling
Key exclusion criteria (6 listed)
- Has hypersensitivity to etanercept
- Has sepsis or risk of sepsis. Treatment with etanercept should not be initiated in patients with active infections (ie. hepatitis C, hepatitis B, active TBC)
- Is pregnant or breast-feeding
- Has significant concurrent medical diseases including, uncompensated congestive heart failure, myocardial infarction within 12 months, unstable angina pectoris, or history of human immunodeficiency virus (HIV) infection, immunodeficiency syndromes, or central nervous system (CNS) demyelinating events suggestive of multiple sclerosis
- Has a history of confirmed blood dyscrasias
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 |
|---|---|---|
| There is no Intervention. The study is observational.The study is observational and the prescription follows the SmPC of etanercept. | Other | etanercept |
Primary outcome
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Baseline up to Month 24
Any untoward medical occurrence in a participant who received study drug was considered an AE, without regard to possibility of causal relationship. An AE resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be a SAE: death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Number of Participants Who Discontinued Treatment
Time frame: Baseline up to Month 24
Number of Participants by Reasons for Discontinuation of Treatment
Time frame: Baseline up to Month 24
3 secondary outcomes
Change From Baseline in Health Assessment Questionnaire (HAQ) at 24 Month
Time frame: Baseline, Month 24
Change From Baseline in Patient Global Assessment (PtGA) Visual Analog Scale (VAS) at 24 Month
Time frame: Baseline, Month 24
Change From Baseline in Physician Global Assessment (PGA) VAS at 24 Month
Time frame: Baseline, Month 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
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ankylosing Spondylitis and Arthritis, Psoriatic, run by Wyeth is now a wholly owned subsidiary of Pfizer at 9 sites in Greece.
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 5 inclusion and 6 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: stopped early, 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.
Where is the study taking place?
The record lists 9 sites in Greece. 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. 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 28 Jul 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?
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: Baseline up to Month 24). The study lists 3 primary outcomes in all. 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.