Rheumatoid ArthritisNCT00881881
Study Evaluating the Clinical and Therapeutic Management of Rheumatoid Arthritis in Spain
An observational study of Rheumatoid Arthritis, run by Wyeth is now a wholly owned subsidiary of Pfizer.
Trial summary
This is an epidemiological, multicenter, retrospective study to analyze the management of rheumatoid arthritis (RA) in usual clinical practice in Spain. Two groups of patients will be analyzed: individuals who have had RA for two years or less (the "early RA" group) and individuals who have had RA for more than 2… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- How many people
- 360 participants
- Where
- No sites listed yet
- Study dates
- Dec 2006to Apr 2007
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with early RA and established RA treated in Rheumatology units in a real-world setting
Who may be able to join
- Group 1: early RA : patients with disease lasting 2 years or less, considered by the investigator as an early RA
- Group 2: established RA: patients with disease lasting more than 2 years who meet the ACR criteria for RA
Who cannot join
- Patients with any rheumatic disease different from RA
- Participation in any clinical trial or study in the last 12 months
About this study
Official title: Clinical and Therapeutic Management of the Rheumatoid Arthritis in Spain
This is an epidemiological, multicenter, retrospective study to analyze the management of rheumatoid arthritis (RA) in usual clinical practice in Spain. Two groups of patients will be analyzed: individuals who have had RA for two years or less (the "early RA" group) and individuals who have had RA for more than 2 years and who currently meet the ACR criteria for RA (the "established RA" group).
- Conditions
- Rheumatoid Arthritis
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients with early RA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Therapeutic management of the RA (actual and 12 month follow-up) in a real-world setting. Descriptive analysis of sociodemographics and clinical variables for patients and sorted by group (early and established RA) for the last 12 months
Measured: 12 months
Secondary outcomes (1)
Measurements of diagnostic and outcomes used in the common clinical practice. Degree of follow-up of the actual Spanish consensus on clinical and therapeutic management of patients with RA
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2009 (estimated)
- Study startDec 2006
- Primary completionApr 2007
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies 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
- Retrospective
- Enrolment
- 360 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
- NCT00881881
- Sponsor's protocol ID
- 0881A-102388
- Status last verified
- Apr 2009
- First submitted
- 14 Apr 2009
- Last updated
- 15 Apr 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Therapeutic Management of the Rheumatoid Arthritis in Spain
- ClinicalTrials.gov ID
- NCT00881881
- Acronym / sponsor ID
- 0881A-102388
- Conditions
- Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Apr 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 15 Apr 2009 (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 is an epidemiological, multicenter, retrospective study to analyze the management of rheumatoid arthritis (RA) in usual clinical practice in Spain. Two groups of patients will be analyzed: individuals who have had RA for two years or less (the "early RA" group) and individuals who have had RA for more than 2 years and who currently meet the ACR criteria for RA (the "established RA" group).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Patients with early RA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with early RA and established RA treated in Rheumatology units in a real-world setting
Key inclusion criteria (2 listed)
- Group 1: early RA : patients with disease lasting 2 years or less, considered by the investigator as an early RA
- Group 2: established RA: patients with disease lasting more than 2 years who meet the ACR criteria for RA
Key exclusion criteria (2 listed)
- Patients with any rheumatic disease different from RA
- Participation in any clinical trial or study in the last 12 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Therapeutic management of the RA (actual and 12 month follow-up) in a real-world setting. Descriptive analysis of sociodemographics and clinical variables for patients and sorted by group (early and established RA) for the last 12 months
Time frame: 12 months
1 secondary outcome
Measurements of diagnostic and outcomes used in the common clinical practice. Degree of follow-up of the actual Spanish consensus on clinical and therapeutic management of patients with RA
Time frame: 12 months
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 15 Apr 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
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, 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 2 inclusion and 2 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 15 Apr 2009. 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?
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?
Therapeutic management of the RA (actual and 12 month follow-up) in a real-world setting. Descriptive analysis of sociodemographics and clinical variables for patients and sorted by group (early and established RA) for the last 12 months (time frame: 12 months). 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 15 Apr 2009.