Arthritis, RheumatoidPhase 4OSRANCT00451971
Objective Study in Rheumatoid Arthritis
A Phase 4 study testing LEFLUNOMIDE in people with Arthritis, Rheumatoid, run by Sanofi at 1 site in Australia.
Trial summary
Primary Objectives 1. To test the feasibility, in patients with active rheumatoid arthritis, of using an 'aggressive' treatment algorithm to bring a short term treatment objective (STO) within the normal or an arbitrarily defined 'desirable' range. 2. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Arthritis, Rheumatoid
- What is being tested?
- LEFLUNOMIDE
- How many people
- 249 participants
- Where
- 1 siteAustralia
- Study dates
- Mar 2002to not given
- Phase
- Phase 4
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Rheumatoid Arthritis as defined by the American College of Rhemuatology criteria and either
- Active disease: ≥6/28 swollen joints or
- Erythrocyte sedimantation or C-Reactive Protein > normal
- Disease duration ≤ 15 yrs
- Any therapy
- Females of child-bearing potential must be adequate contraception
Who cannot join
- Frailty, limiting co-morbidity
- Obesity limiting ability to have MRI
- Geographical difficulty preventing follow-up and visits
- Women at risk of becoming pregnant
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Primary Objectives
- To test the feasibility, in patients with active rheumatoid arthritis, of using an 'aggressive' treatment algorithm to bring a short term treatment objective (STO) within the normal or an arbitrarily defined 'desirable' range.
- To determine whether patients with active rheumatoid arthritis randomly allocated to a particular STO show a reduced rate of Magnetic resonance imaging damage progression at two years compared to those randomly allocated to usual care.
Read more
Secondary Objectives
- To establish the relationship between achieving a given STO or combination of STOs and damage progression.
- To identify the characteristics of responders and non-responders with respect to STO achievement and predictors of greater and lesser degrees of damage progression.
- Conditions
- Arthritis, Rheumatoid
- Being tested
- LEFLUNOMIDE
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LEFLUNOMIDEDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Long Term Objective (damage) is the MRI which will be undertaken at baseline, 12 months and 24 months.
The Short Term Objectives are: swollen joint count - target:(28) ≤ 2 joints
C-Reactive Protein - target: within the normal range (provided elevation is not due clinically to an intercurrent event)
Secondary outcomes (1)
Safety: Full blood count and erythrocyte sedimentation, blood urea, electrolytes, creatinine and Liver function test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2007 (estimated)
- Study startMar 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Arthritis, RheumatoidStudies of the same condition, open and under way.
- More trials run by SanofiThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Enrolment
- 249 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- J Edmonds, Principal investigator, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00451971
- Sponsor's protocol ID
- HWA486_4020
- Acronym
- OSRA
- Status last verified
- Sep 2008
- First submitted
- 23 Mar 2007
- Last updated
- 5 Sep 2008
- Results posted
- No
Publications
Poh MQ, Lassere M, Bird P, Edmonds J. Reliability and longitudinal validity of computer-assisted methods for measuring joint damage progression in subjects with rheumatoid arthritis. J Rheumatol. 2013 Jan;40(1):23-9. doi: 10.3899/jrheum.120549. Epub 2012 Nov 1.
PubMed 23118111
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Objective Study in Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT00451971
- Acronym / sponsor ID
- OSRA / HWA486_4020
- Conditions
- Arthritis, Rheumatoid
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 249 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Mar 2002
- First posted
- 26 Mar 2007 (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.
Primary Objectives
- To test the feasibility, in patients with active rheumatoid arthritis, of using an 'aggressive' treatment algorithm to bring a short term treatment objective (STO) within the normal or an arbitrarily defined 'desirable' range.
- To determine whether patients with active rheumatoid arthritis randomly allocated to a particular STO show a reduced rate of Magnetic resonance imaging damage progression at two years compared to those randomly allocated to usual care.
Secondary Objectives
- To establish the relationship between achieving a given STO or combination of STOs and damage progression.
- To identify the characteristics of responders and non-responders with respect to STO achievement and predictors of greater and lesser degrees of damage progression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Rheumatoid Arthritis as defined by the American College of Rhemuatology criteria and either
- Active disease: ≥6/28 swollen joints or
- Erythrocyte sedimantation or C-Reactive Protein > normal
- Disease duration ≤ 15 yrs
- Any therapy
Key exclusion criteria (5 listed)
- Frailty, limiting co-morbidity
- Obesity limiting ability to have MRI
- Geographical difficulty preventing follow-up and visits
- Women at risk of becoming pregnant
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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 |
|---|---|---|
| LEFLUNOMIDE | Drug | – |
Primary outcome
Long Term Objective (damage) is the MRI which will be undertaken at baseline, 12 months and 24 months.
The Short Term Objectives are: swollen joint count - target:(28) ≤ 2 joints
C-Reactive Protein - target: within the normal range (provided elevation is not due clinically to an intercurrent event)
1 secondary outcome
Safety: Full blood count and erythrocyte sedimentation, blood urea, electrolytes, creatinine and Liver function test
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 5 Sep 2008.
- Derived from this study: PubMed 23118111Poh MQ, Lassere M, Bird P, Edmonds J. Reliability and longitudinal validity of computer-assisted methods for measuring joint damage progression in subjects with rheumatoid arthritis. J Rheumatol. 2013 Jan;40(1):23-9. doi: 10.3899/jrheum.120549. Epub 2012 Nov 1.
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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.
J Edmonds principal investigator
Sanofi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing LEFLUNOMIDE in people with Arthritis, Rheumatoid, run by Sanofi at 1 site in Australia.
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 6 inclusion and 5 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 5 Sep 2008. 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 Australia. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Long Term Objective (damage) is the MRI which will be undertaken at baseline, 12 months and 24 months.. 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?
On the ClinicalTrials.gov record for NCT00451971, which also lists 1 linked publication.
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 5 Sep 2008.