Arthritis, PsoriaticNCT00195377
Study Evaluating Etanercept in Patients With Rheumatoid Arthritis(RA), Juvenile Idiopathic Arthritis (JIA), or Psoriatic Arthritis (PsA) in Spain
An observational study of Arthritis, Psoriatic and Arthritis, Rheumatoid, run by Wyeth is now a wholly owned subsidiary of Pfizer at 1 site in Spain.
Trial summary
The purpose of this study is to assess the safety of etanercept in patients with rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA) or psoriatic arthritis (PsA) in Spain Read more about this study
- Who is it for?
- Ages 4 years and older
- Conditions the study is for
- Arthritis, Psoriatic, Arthritis, Rheumatoid
- What is being tested?
- Etanercept
- How many people
- 1,000 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2003to Apr 2006
- Phase
- Observational
- 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 4 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with rheumatoid arthritis, psoriatic arthritis or AIJ, treated with etanercept in rheumatology units
Who may be able to join
- RA or PsA in whom DMARDs/antiTNF antibodies/anti IL1 has been insufficient or inappropriate
- Children from 4 to 17 years old with JIA polyarticular
Who cannot join
- Clinically significant abnormal screening lab values
- Patients who are planning to undergo elective surgery during the study period.
- Other current autoimmune connective tissue diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating Safety and QoL in Patients Treated With Etanercept: an Open Multicenter Study
The purpose of this study is to assess the safety of etanercept in patients with rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA) or psoriatic arthritis (PsA) in Spain
- Conditions
- Arthritis, Psoriatic, Arthritis, Rheumatoid
- Being tested
- Etanercept
- Medical subject headings
- Arthritis, Psoriatic, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtanerceptDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startApr 2003
- Primary completionApr 2006
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis, PsoriaticStudies 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
- 1,000 participants
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
- NCT00195377
- Sponsor's protocol ID
- 101393
- Status last verified
- Jun 2009
- First submitted
- 13 Sep 2005
- Last updated
- 18 Jun 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Safety and QoL in Patients Treated With Etanercept: an Open Multicenter Study
- ClinicalTrials.gov ID
- NCT00195377
- Acronym / sponsor ID
- 101393
- Conditions
- Arthritis, Psoriatic, Arthritis, Rheumatoid
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Apr 2003
- Primary completion
- Apr 2006 (actual)
- Study completion
- Apr 2006 (actual)
- First posted
- 19 Sep 2005 (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.
The purpose of this study is to assess the safety of etanercept in patients with rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA) or psoriatic arthritis (PsA) in Spain
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with rheumatoid arthritis, psoriatic arthritis or AIJ, treated with etanercept in rheumatology units
Key inclusion criteria (2 listed)
- RA or PsA in whom DMARDs/antiTNF antibodies/anti IL1 has been insufficient or inappropriate
- Children from 4 to 17 years old with JIA polyarticular
Key exclusion criteria (3 listed)
- Clinically significant abnormal screening lab values
- Patients who are planning to undergo elective surgery during the study period.
- Other current autoimmune connective tissue diseases
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
Not reported in the source record.
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 18 Jun 2009.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthritis, Psoriatic and Arthritis, Rheumatoid, run by Wyeth is now a wholly owned subsidiary of Pfizer at 1 site in Spain.
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 18 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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?
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.
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 18 Jun 2009.