Rheumatoid ArthritisARPANCT00267852
Study Evaluating the Clinical Remission in Early Aggressive Rheumatoid Arthritis
An observational study of Rheumatoid Arthritis, run by Wyeth is now a wholly owned subsidiary of Pfizer at 16 sites in Italy.
Trial summary
This is an observational prospective, multicenter study. The aim of the study is to evaluate how the Italian population of patients are treated with early aggressive RA, defined by the Italian Society of Rheumatology Guidelines, (GIARA Registry Study Group. Clin Exp Rheumatol 2003;21(Suppl. 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?
- as clinical practice
- How many people
- 152 participants
- Where
- 16 sitesItaly
- Study dates
- Apr 2006to Jul 2010
- 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 aggressive RA, who are treated in 15 specialized sites
Who may be able to join
- Inclusion Criteria Based On Clinical Practice of Aggressive RA
- Diagnosis of early aggressive RA in accordance with local guideline
- Disease duration < 2 years and at least six months since onset of symptoms
- Patients naïve to anti-TNFa drugs and DMARDs, including MTX, or assuming one or more DMARD without complete response
Who cannot join
- Exclusion Criteria Based on Clinical Practice of Aggressive RA
- Patients should not be included in the study if they have participated in any interventional clinical trial within the previous 2 years.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
Italy16 sites
Pfizer Investigational Site
Arenzano, GE, 16011
Pfizer Investigational Site
Bari, Apulia, 70124
Pfizer Investigational Site
Brescia, 25125
Pfizer Investigational Site
Ferrara, Ferrara (FE), 44100
Pfizer Investigational Site
Genova
Pfizer Investigational Site
Iesi, Ancona, 60035
Pfizer Investigational Site
Messina, Messina, 98122
Pfizer Investigational Site
Messina, Sicily, 98127
Pfizer Investigational Site
Naples, Campania, 80131
Pfizer Investigational Site
Padova, Padova, 35128
Pfizer Investigational Site
Palermo, Palermo, 90100
Pfizer Investigational Site
Pavia, 27100
Pfizer Investigational Site
Pisa, Tuscany, 56126
Pfizer Investigational Site
Rome, Lazio, 00161
Pfizer Investigational Site
Siena, Siena, 53100
Pfizer Investigational Site
Torino, 10128
About this study
Official title: An Observational Study To Evaluate The Clinical Remission In Early Aggressive Rheumatoid Arthritis (Artrite Reumatoide Precoce Aggressiva Italian Study)
This is an observational prospective, multicenter study. The aim of the study is to evaluate how the Italian population of patients are treated with early aggressive RA, defined by the Italian Society of Rheumatology Guidelines, (GIARA Registry Study Group. Clin Exp Rheumatol 2003;21(Suppl. 31):S129-S132), in rheumatologic clinical practice and whether recent scientific evidence or new treatments available to rheumatologists can change their practice in a 2 year follow-up. The observation will primarily focus on the disease activity and clinical remission in patients who are receiving different treatment strategies. The primary goal is to define prevalence of clinical remission, according to the (Disease Activity Score) DAS 28 definition of clinical remission, in patients with early aggressive RA receiving different therapies at 1 year.
Secondary objective are assessment of:
- Prevalence of Remission at the second year
- Disease activity at the first and second year.
- ACR 20%, 50%, 70% response at the first and second year.
- Quality of Life in patients with or without remission at the first and second year
- Safety Evaluations
Read the detailed description
It was expected that approximate 200 patients were enrolled in the study. Have been enrolled 152 patients. A Statistical Analysis Plan will contain a detailed description of criteria for valuable patients for analyses and a description of statistical analyses. In general, all patients who respond inclusion/exclusion criteria at baseline will be considered valuable for the study. The summaries will include descriptive statistics (mean, standard deviation, sample size) for the continuous parameters, and absolute frequencies and percentages for the remaining categorical parameters.
- Conditions
- Rheumatoid Arthritis
- Being tested
- as clinical practice
- Keywords
- Arthritis
- Medical subject headings
- Arthritis, Rheumatoid, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
as clinical practiceOther
Also called observational study
Dosage, form, frequency and duration as per ordinary clinical practice
| Study group | Role | What they receive |
|---|---|---|
| 1.0 | As per routinary clinical practice Receives: Other: as clinical practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of clinical remission, according to the DAS 28 definition of clinical remission, in patients with early aggressive RA receiving different therapies at 1 year.
Measured: 12-24 months
Secondary outcomes (5)
-Prevalence of Remission at the second year.
Measured: 12-24 months
Disease activity at the 1st and 2nd year
Measured: 12-24 months
ACR 20%, 50%, 70% response at the 1st and 2nd year
Measured: 12-24 months
QoL in patients with or without remission at the first and second year
Measured: 12-24 months
Safety Evaluations
Measured: 12-24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2005 (estimated)
- Study startApr 2006
- Primary completionJul 2010
- Study completionJul 2010
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
- Prospective
- Enrolment
- 152 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
- NCT00267852
- Sponsor's protocol ID
- 0881A-101749
- Other IDs
- B1801108
- Acronym
- ARPA
- Status last verified
- Sep 2011
- First submitted
- 19 Dec 2005
- Last updated
- 15 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study To Evaluate The Clinical Remission In Early Aggressive Rheumatoid Arthritis (Artrite Reumatoide Precoce Aggressiva Italian Study)
- ClinicalTrials.gov ID
- NCT00267852
- Acronym / sponsor ID
- ARPA / 0881A-101749
- Conditions
- Rheumatoid Arthritis
- Keywords
- Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Apr 2006
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 21 Dec 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.
This is an observational prospective, multicenter study. The aim of the study is to evaluate how the Italian population of patients are treated with early aggressive RA, defined by the Italian Society of Rheumatology Guidelines, (GIARA Registry Study Group. Clin Exp Rheumatol 2003;21(Suppl. 31):S129-S132), in rheumatologic clinical practice and whether recent scientific evidence or new treatments available to rheumatologists can change their practice in a 2 year follow-up. The observation will primarily focus on the disease activity and clinical remission in patients who are receiving different treatment strategies. The primary goal is to define prevalence of clinical remission, according to the (Disease Activity Score) DAS 28 definition of clinical remission, in patients with early aggressive RA receiving different therapies at 1 year.
Secondary objective are assessment of:
- Prevalence of Remission at the second year
- Disease activity at the first and second year.
- ACR 20%, 50%, 70% response at the first and second year.
- Quality of Life in patients with or without remission at the first and second year
- Safety Evaluations
Detailed description
It was expected that approximate 200 patients were enrolled in the study. Have been enrolled 152 patients. A Statistical Analysis Plan will contain a detailed description of criteria for valuable patients for analyses and a description of statistical analyses. In general, all patients who respond inclusion/exclusion criteria at baseline will be considered valuable for the study. The summaries will include descriptive statistics (mean, standard deviation, sample size) for the continuous parameters, and absolute frequencies and percentages for the remaining categorical parameters.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1.0 | – | Other: as clinical practiceAs per routinary clinical practice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with early aggressive RA, who are treated in 15 specialized sites
Key inclusion criteria (4 listed)
- Inclusion Criteria Based On Clinical Practice of Aggressive RA
- Diagnosis of early aggressive RA in accordance with local guideline
- Disease duration < 2 years and at least six months since onset of symptoms
- Patients naïve to anti-TNFa drugs and DMARDs, including MTX, or assuming one or more DMARD without complete response
Key exclusion criteria (2 listed)
- Exclusion Criteria Based on Clinical Practice of Aggressive RA
- Patients should not be included in the study if they have participated in any interventional clinical trial within the previous 2 years.
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 |
|---|---|---|
| as clinical practiceAlso: observational studyDosage, form, frequency and duration as per ordinary clinical practice | Other | 1.0 |
Primary outcome
Prevalence of clinical remission, according to the DAS 28 definition of clinical remission, in patients with early aggressive RA receiving different therapies at 1 year.
Time frame: 12-24 months
5 secondary outcomes
-Prevalence of Remission at the second year.
Time frame: 12-24 months
Disease activity at the 1st and 2nd year
Time frame: 12-24 months
ACR 20%, 50%, 70% response at the 1st and 2nd year
Time frame: 12-24 months
QoL in patients with or without remission at the first and second year
Time frame: 12-24 months
Safety Evaluations
Time frame: 12-24 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 Sep 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
16 sites in 1 country: see every site and its status.
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 at 16 sites in Italy.
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 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 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 16 sites in Italy. 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.
What does the primary outcome measure?
Prevalence of clinical remission, according to the DAS 28 definition of clinical remission, in patients with early aggressive RA receiving different therapies at 1 year. (time frame: 12-24 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 Sep 2011.