PolyarthritisPhase 3ADEMNCT01068405
Erosive Osteoarthritis of the Hands: Treatment by Methotrexate Versus Placebo
A Phase 3 study testing Methotrexate in people with Polyarthritis, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
Interest of methotrexate in inflammatory rheumatisms was demonstrated since several years. At present time,there is no effective treatment against digital arthritis. The investigators purpose to measure the efficacy of methotrexate on digital arthritis. In this aim, two groups were compared. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Polyarthritis
- What is being tested?
- Methotrexate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteFrance
- Study dates
- 25 May 2010to 15 Oct 2018
- 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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- hand arthritis
- pain over 40/100
- stable treatment since 4 weeks at least with non-steroid analgesic
- between 45 et 85 years
Who cannot join
- pregnancy or breast feeding women
- hyaluronic acid injection within the past 6 months
- cortisonic derivated injection within the past 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Erosive Osteoarthritis of the Hands: Treatment by Methotrexate Versus Placebo - Assessment of Structural and Clinical Action of Magnetic Resonance Imaging
Interest of methotrexate in inflammatory rheumatisms was demonstrated since several years.
At present time,there is no effective treatment against digital arthritis. The investigators purpose to measure the efficacy of methotrexate on digital arthritis.
In this aim, two groups were compared. The first group receive 10mg/week of methotrexate administered in one shot (every Monday for example)during 12 months. The second group receive 10mg/week of placebo according to the same procedure
- Conditions
- Polyarthritis
- Being tested
- Methotrexate, Placebo
- Medical subject headings
- Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethotrexateDrug
Methotrexate: 10mg/week administered in one time, the same day each week (every monday for example)during 12 months
PlaceboDrug
Placebo:10mg/week administered in one time, the same day each week (every monday for example)during 12 months
| Study group | Role | What they receive |
|---|---|---|
| Methotrexate | Experimental | Patients with digital arthritis receiving methotrexate treatment at 10mg/week during 12 months Receives: Drug: Methotrexate |
| Placebo | Placebo comparator | Patients with digital arthritis receiving placebo at 10mg/week during 12 months Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain assessed with EVA
Measured: at screening visit, inclusion visit, first month, and every month during one year
Secondary outcomes (1)
Quality of life survey : SF-36
Measured: at inclusion visit, first month, and every month during one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2010 (estimated)
- Study start25 May 2010
- Primary completion15 Jun 2014
- Study completion15 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PolyarthritisStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christian H ROUX, PhD, Principal investigator, Nice University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01068405
- Sponsor's protocol ID
- 06-API-07
- Acronym
- ADEM
- Status last verified
- Jun 2026
- First submitted
- 12 Jan 2010
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Ferrero S, Wittoek R, Allado E, Cruzel C, Fontas E, Breuil V, Ziegler L, Kremer J, Loeuille D, Roux CH. Methotrexate treatment in hand osteoarthritis refractory to usual treatments: A randomised, double-blind, placebo-controlled trial. Semin Arthritis Rheum. 2021 Aug;51(4):831-838. doi: 10.1016/j.semarthrit.2021.04.016. Epub 2021 May 6.
PubMed 34157578Allado E, Wittoek R, Albuisson E, Ferrero S, Chenuel B, Chary-Valckenaere I, Roux C, Loeuille D. Topographical analysis of structural lesions between dominant and non-dominant hands in erosive osteoarthritis. Rheumatol Int. 2021 Mar;41(3):617-623. doi: 10.1007/s00296-020-04784-1. Epub 2021 Jan 27.
PubMed 33501510
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erosive Osteoarthritis of the Hands: Treatment by Methotrexate Versus Placebo - Assessment of Structural and Clinical Action of Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT01068405
- Acronym / sponsor ID
- ADEM / 06-API-07
- Conditions
- Polyarthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 25 May 2010 (actual)
- Primary completion
- 15 Jun 2014 (actual)
- Study completion
- 15 Oct 2018 (actual)
- First posted
- 15 Feb 2010 (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.
Interest of methotrexate in inflammatory rheumatisms was demonstrated since several years.
At present time,there is no effective treatment against digital arthritis. The investigators purpose to measure the efficacy of methotrexate on digital arthritis.
In this aim, two groups were compared. The first group receive 10mg/week of methotrexate administered in one shot (every Monday for example)during 12 months. The second group receive 10mg/week of placebo according to the same procedure
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methotrexate | Experimental | Drug: MethotrexatePatients with digital arthritis receiving methotrexate treatment at 10mg/week during 12 months |
| Placebo | Placebo comparator | Drug: PlaceboPatients with digital arthritis receiving placebo at 10mg/week during 12 months |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- hand arthritis
- pain over 40/100
- stable treatment since 4 weeks at least with non-steroid analgesic
- between 45 et 85 years
Key exclusion criteria (3 listed)
- pregnancy or breast feeding women
- hyaluronic acid injection within the past 6 months
- cortisonic derivated injection within the past 3 months
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 |
|---|---|---|
| MethotrexateMethotrexate: 10mg/week administered in one time, the same day each week (every monday for example)during 12 months | Drug | Methotrexate |
| PlaceboPlacebo:10mg/week administered in one time, the same day each week (every monday for example)during 12 months | Drug | Placebo |
Primary outcome
pain assessed with EVA
Time frame: at screening visit, inclusion visit, first month, and every month during one year
1 secondary outcome
Quality of life survey : SF-36
Time frame: at inclusion visit, first month, and every month during one year
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 17 Jun 2026.
- Results publication: PubMed 34157578Ferrero S, Wittoek R, Allado E, Cruzel C, Fontas E, Breuil V, Ziegler L, Kremer J, Loeuille D, Roux CH. Methotrexate treatment in hand osteoarthritis refractory to usual treatments: A randomised, double-blind, placebo-controlled trial. Semin Arthritis Rheum. 2021 Aug;51(4):831-838. doi: 10.1016/j.semarthrit.2021.04.016. Epub 2021 May 6.
- Derived from this study: PubMed 33501510Allado E, Wittoek R, Albuisson E, Ferrero S, Chenuel B, Chary-Valckenaere I, Roux C, Loeuille D. Topographical analysis of structural lesions between dominant and non-dominant hands in erosive osteoarthritis. Rheumatol Int. 2021 Mar;41(3):617-623. doi: 10.1007/s00296-020-04784-1. Epub 2021 Jan 27.
Related trials for Polyarthritis
Enrolling by invitationObservational study
Persona SoluTion PPS Femur PMCF
Rhematoid Arthritis, Osteo Arthritis of the Knee
RecruitingObservational study
Observational Study of Pediatric Rheumatic Diseases: The CARRA Registry
Rheumatic Joint Disease
Active, not recruitingObservational study
Persona OsseoTi Keel Compatibility Study (Total Knee Arthroplasty)
Knee Pain Chronic, Osteoarthritis, Knee
Active, not recruitingObservational study
The Medacta Quadra-P Anteverted Study
Arthrosis, Traumatic Arthritis
RecruitingObservational study
The Medacta International SMS Post-Marketing Surveillance Study
Arthrosis, Traumatic Arthritis
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, PhD principal investigator
Nice University Hospital
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 Methotrexate in people with Polyarthritis, 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 4 inclusion and 3 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 17 Jun 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. Some participants in this study may receive a placebo. 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 assessed with EVA (time frame: at screening visit, inclusion visit, first month, and every month during one year). 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 NCT01068405, which also lists 2 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 17 Jun 2026.