Knee OsteoarthritisPhase 4ARTISTNCT00462319
ARTIST: ARThrose Intervention STandardisée
A Phase 4 study testing Education, weight reduction and physical exercise in people with Knee Osteoarthritis, run by Almirall, SAS at 1 site in France.
Trial summary
International recommendations (ACR,EULAR) emphasize physical exercise and weight loss for patients suffering from knee osteoarthritis. Nevertheless, number of patients receiving advices for these 2 points still low. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Education, weight reduction and physical exercise
- Type of treatment
- Lifestyle or therapy programme
- How many people
- Not given
- Where
- 1 siteFrance
- Study dates
- May 2005to 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 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- symptomatic and ambulatory patients
- suffering from knee osteoarthritis (ACR criteria)
- 25<BMI<35
- signed informed consent
Who cannot join
- need to surgery within 6 next months
- co-morbidity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Standardized Management of Knee Arthritis Patients
International recommendations (ACR,EULAR) emphasize physical exercise and weight loss for patients suffering from knee osteoarthritis. Nevertheless, number of patients receiving advices for these 2 points still low. This study evaluates the impact of a standardized medical intervention (patient education, weight reduction and physical exercise) in knee osteoarthritis patients.
- Conditions
- Knee Osteoarthritis
- Being tested
- Education, weight reduction and physical exercise
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education, weight reduction and physical exerciseBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
Physical Exercise in Leisure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2007 (estimated)
- Study startMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Almirall, SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- René Marc FLIPO, Principal investigator, Hôpital Salengro - Lille, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00462319
- Sponsor's protocol ID
- 2004/07
- Acronym
- ARTIST
- Status last verified
- Apr 2007
- First submitted
- 18 Apr 2007
- Last updated
- 19 Apr 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Recommendations for the medical management of osteoarthritis of the hip and knee: 2000 update. American College of Rheumatology Subcommittee on Osteoarthritis Guidelines. Arthritis Rheum. 2000 Sep;43(9):1905-15. doi: 10.1002/1529-0131(200009)43:93.0.CO;2-P. No abstract available.
PubMed 11014340Messier SP, Gutekunst DJ, Davis C, DeVita P. Weight loss reduces knee-joint loads in overweight and obese older adults with knee osteoarthritis. Arthritis Rheum. 2005 Jul;52(7):2026-32. doi: 10.1002/art.21139.
PubMed 15986358Ravaud P, Flipo RM, Boutron I, Roy C, Mahmoudi A, Giraudeau B, Pham T. ARTIST (osteoarthritis intervention standardized) study of standardised consultation versus usual care for patients with osteoarthritis of the knee in primary care in France: pragmatic randomised controlled trial. BMJ. 2009 Feb 23;338:b421. doi: 10.1136/bmj.b421.
PubMed 19237406
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Standardized Management of Knee Arthritis Patients
- ClinicalTrials.gov ID
- NCT00462319
- Acronym / sponsor ID
- ARTIST / 2004/07
- Conditions
- Knee Osteoarthritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Almirall, SASIndustry (pharma, biotech, devices)
- Study start
- May 2005
- First posted
- 19 Apr 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.
International recommendations (ACR,EULAR) emphasize physical exercise and weight loss for patients suffering from knee osteoarthritis. Nevertheless, number of patients receiving advices for these 2 points still low. This study evaluates the impact of a standardized medical intervention (patient education, weight reduction and physical exercise) in knee osteoarthritis patients.
Study design
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- symptomatic and ambulatory patients
- suffering from knee osteoarthritis (ACR criteria)
- 25<BMI<35
- signed informed consent
Key exclusion criteria (2 listed)
- need to surgery within 6 next months
- co-morbidity
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 |
|---|---|---|
| Education, weight reduction and physical exercise | Behavioural | – |
Primary outcome
Weight
Physical Exercise in Leisure
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 19 Apr 2007.
- Background: PubMed 11014340Recommendations for the medical management of osteoarthritis of the hip and knee: 2000 update. American College of Rheumatology Subcommittee on Osteoarthritis Guidelines. Arthritis Rheum. 2000 Sep;43(9):1905-15. doi: 10.1002/1529-0131(200009)43:93.0.CO;2-P. No abstract available.
- Background: PubMed 15986358Messier SP, Gutekunst DJ, Davis C, DeVita P. Weight loss reduces knee-joint loads in overweight and obese older adults with knee osteoarthritis. Arthritis Rheum. 2005 Jul;52(7):2026-32. doi: 10.1002/art.21139.
- Derived from this study: PubMed 19237406Ravaud P, Flipo RM, Boutron I, Roy C, Mahmoudi A, Giraudeau B, Pham T. ARTIST (osteoarthritis intervention standardized) study of standardised consultation versus usual care for patients with osteoarthritis of the knee in primary care in France: pragmatic randomised controlled trial. BMJ. 2009 Feb 23;338:b421. doi: 10.1136/bmj.b421.
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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.
René Marc FLIPO principal investigator
Hôpital Salengro - Lille, France
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 Education, weight reduction and physical exercise in people with Knee Osteoarthritis, run by Almirall, SAS at 1 site in France.
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 19 Apr 2007. 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 France. 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?
Weight. The study lists 2 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 NCT00462319, which also lists 3 linked publications.
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 19 Apr 2007.