Rheumatoid ArthritisPhase 3NCT00522184
Intra-articular Injection of Etanercept in Patient Suffering From Rheumatoid Arthritis : a Double-blind Randomized Study
A Phase 3 study testing intra-articular injection of etanercept and intra-articular injection of steroid in people with Rheumatoid Arthritis, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
Intra-articular injection of etanercept in patient suffering from rheumatoid arthritis: a double-blind randomized study for evaluation of efficacy and safety of etanercept versus intra-articular steroid injection in acute synovitis (knee,wrist,ankle,elbow) 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?
- intra-articular injection of etanercept and intra-articular injection of steroid
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2005to Nov 2006
- Phase
- Phase 3
- 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
Who may be able to join
- must be able to understand the information about the study
- diagnosis of rheumatoid arthritis for 6 month at least
- suffering for 2 weeks at least
- with evaluation of pain over 4/10
- with stable DMARDs treatment for three month at least
Who cannot join
- infection or surgery on the target joint
- treated with infliximab,adalimumab or anakinra
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intra-articular Injection of Etanercept in Patient Suffering From Rheumatoid Arthritis : a Double-blind Randomized Study for Evaluation of Efficacy and Safety of Etanercept Versus Intra-articular Steroid Injection in Acute Synovitis
Intra-articular injection of etanercept in patient suffering from rheumatoid arthritis: a double-blind randomized study for evaluation of efficacy and safety of etanercept versus intra-articular steroid injection in acute synovitis (knee,wrist,ankle,elbow)
- Conditions
- Rheumatoid Arthritis
- Being tested
- intra-articular injection of etanercept, intra-articular injection of steroid
- Keywords
- intra-articular injection, acute synovitis, etanercept
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intra-articular injection of etanerceptProcedure or surgery
intra-articular injection of steroidProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | patient receiving etanercept intra-articular injection Receives: Procedure: intra-articular injection of etanercept |
| 2 | Active comparator | patient receiving steroid intra-articular injection Receives: Procedure: intra-articular injection of steroid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
Measured: every month during six month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2007 (estimated)
- Study startFeb 2005
- Study completionNov 2006
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 Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Collaborators
- Wyeth is now a wholly owned subsidiary of Pfizer
- Responsible party
- Sponsor
- Investigators
- Christian H ROUX, Principal investigator, Rheumatology department, Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00522184
- Sponsor's protocol ID
- 02-PP-04
- Status last verified
- Mar 2026
- First submitted
- 27 Aug 2007
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Roux CH, Breuil V, Valerio L, Amoretti N, Brocq O, Albert C, Grisot C, Allam Y, Chevalier P, Pradier C, Euller-Ziegler L. Etanercept compared to intraarticular corticosteroid injection in rheumatoid arthritis: double-blind, randomized pilot study. J Rheumatol. 2011 Jun;38(6):1009-11. doi: 10.3899/jrheum.100828. Epub 2011 Mar 16.
PubMed 21406499
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-articular Injection of Etanercept in Patient Suffering From Rheumatoid Arthritis : a Double-blind Randomized Study for Evaluation of Efficacy and Safety of Etanercept Versus Intra-articular Steroid Injection in Acute Synovitis
- ClinicalTrials.gov ID
- NCT00522184
- Acronym / sponsor ID
- 02-PP-04
- Conditions
- Rheumatoid Arthritis
- Keywords
- intra-articular injection, acute synovitis, etanercept
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Collaborators
- Wyeth is now a wholly owned subsidiary of Pfizer
- Study start
- Feb 2005
- Study completion
- Nov 2006 (actual)
- First posted
- 29 Aug 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.
Intra-articular injection of etanercept in patient suffering from rheumatoid arthritis: a double-blind randomized study for evaluation of efficacy and safety of etanercept versus intra-articular steroid injection in acute synovitis (knee,wrist,ankle,elbow)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: intra-articular injection of etanerceptpatient receiving etanercept intra-articular injection |
| 2 | Active comparator | Procedure: intra-articular injection of steroidpatient receiving steroid intra-articular injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- must be able to understand the information about the study
- diagnosis of rheumatoid arthritis for 6 month at least
- suffering for 2 weeks at least
- with evaluation of pain over 4/10
- with stable DMARDs treatment for three month at least
Key exclusion criteria (2 listed)
- infection or surgery on the target joint
- treated with infliximab,adalimumab or anakinra
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 |
|---|---|---|
| intra-articular injection of etanercept | Procedure or surgery | 1 |
| intra-articular injection of steroid | Procedure or surgery | 2 |
Primary outcome
Pain
Time frame: every month during six month
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 31 Mar 2026.
- Results publication: PubMed 21406499Roux CH, Breuil V, Valerio L, Amoretti N, Brocq O, Albert C, Grisot C, Allam Y, Chevalier P, Pradier C, Euller-Ziegler L. Etanercept compared to intraarticular corticosteroid injection in rheumatoid arthritis: double-blind, randomized pilot study. J Rheumatol. 2011 Jun;38(6):1009-11. doi: 10.3899/jrheum.100828. Epub 2011 Mar 16.
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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.
Christian H ROUX principal investigator
Rheumatology department, Nice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing intra-articular injection of etanercept and intra-articular injection of steroid in people with Rheumatoid Arthritis, run by Centre Hospitalier Universitaire de Nice 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 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 31 Mar 2026. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Pain (time frame: every month during six month). 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 NCT00522184, 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 31 Mar 2026.