Rheumatoid ArthritisNCT00895050
Study Evaluating Impact of the Use of a Computer-based Tool on the Clinical Management of RA Patients
An observational study of Rheumatoid Arthritis, run by Pfizer.
Trial summary
The primary purpose of this study is to evaluate a computer-based tool on the clinical management of patients with rheumatoid arthritis in Spain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Review of clinical records
- How many people
- 321 participants
- Where
- No sites listed yet
- Study dates
- Mar 2009to Jan 2011
- 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 RA treated in rheumatology offices
Who may be able to join
- Main Inclusion Criteria:
- Patients, male or female, over 18 years old.
- Patients diagnosed with RA according to investigator criteria
- Patients with a disease evolution >= 1 year
- Patients with > = 5 affected joints
Who cannot join
- Patients with other muscle skeletal, rheumatic and/or degenerative diseases different from RA.
- Patients who are taking part or have taken part in a clinical trial or in a study with drugs within the last 12 months. Any condition that, in the investigator's judgment would interfere with the subject's ability to comply with protocol requirements or give informed consent.
About this study
Official title: Impact of the Use of a Computer-based Tools on the Clinical Management and Evolution of Patients With Rheumatoid Arthritis.
The primary purpose of this study is to evaluate a computer-based tool on the clinical management of patients with rheumatoid arthritis in Spain.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Review of clinical records
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Review of clinical recordsOther
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients diagnosed with RA Receives: Other: Review of clinical records |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global mean DAS28 at 6 and at 12 months of follow-up. Differences between global mean DAS28 at 6 and at 12 months compared to baseline
Measured: 12 months
Secondary outcomes (1)
Disease activity (DAS28; number affected joints; CRP; ESR; PGA).-Number of variables used in patient's follow-up; number of treatment adjustments. -Investigator's satisfaction with the computer-based tool (specific questionnaire)
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 posted7 May 2009 (estimated)
- Study startMar 2009
- Primary completionJan 2011
- Study completionJan 2011
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.
- More trials run by PfizerThe sponsor's other registered studies.
- 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
- 321 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00895050
- Sponsor's protocol ID
- 0881X1-4576
- Other IDs
- B1801084
- Status last verified
- Jul 2011
- First submitted
- 6 May 2009
- Last updated
- 15 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Use of a Computer-based Tools on the Clinical Management and Evolution of Patients With Rheumatoid Arthritis.
- ClinicalTrials.gov ID
- NCT00895050
- Acronym / sponsor ID
- 0881X1-4576
- Conditions
- Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 321 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 7 May 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.
The primary purpose of this study is to evaluate a computer-based tool on the clinical management of patients with rheumatoid arthritis in Spain.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: Review of clinical recordsPatients diagnosed with RA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with RA treated in rheumatology offices
Key inclusion criteria (5 listed)
- Patients, male or female, over 18 years old.
- Patients diagnosed with RA according to investigator criteria
- Patients with a disease evolution >= 1 year
- Patients with > = 5 affected joints
Key exclusion criteria (2 listed)
- Patients with other muscle skeletal, rheumatic and/or degenerative diseases different from RA.
- Patients who are taking part or have taken part in a clinical trial or in a study with drugs within the last 12 months. Any condition that, in the investigator's judgment would interfere with the subject's ability to comply with protocol requirements or give informed consent.
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 |
|---|---|---|
| Review of clinical records | Other | 1 |
Primary outcome
Global mean DAS28 at 6 and at 12 months of follow-up. Differences between global mean DAS28 at 6 and at 12 months compared to baseline
Time frame: 12 months
1 secondary outcome
Disease activity (DAS28; number affected joints; CRP; ESR; PGA).-Number of variables used in patient's follow-up; number of treatment adjustments. -Investigator's satisfaction with the computer-based tool (specific questionnaire)
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 Jul 2011.
- 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
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by 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 5 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 Jul 2011. 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?
Global mean DAS28 at 6 and at 12 months of follow-up. Differences between global mean DAS28 at 6 and at 12 months compared to baseline (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 Jul 2011.