Erosive Hand OsteoarthritisPASEONCT02370771
Proteomic Analysis in Sera From Patients With Erosive Hand Osteoarthritis
A study testing Biological sampling and Radiographic evaluation in people with Erosive Hand Osteoarthritis, run by University Hospital, Rouen at 1 site in France.
Trial summary
Hand osteoarthritis is a common phenotype of osteoarthritis which affects about 70 % of the elderly population. Usually considered as a minor illness, it nevertheless leads to an important functional impairment. The mechanism of this disease is still poorly known. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Erosive Hand Osteoarthritis
- What is being tested?
- Biological sampling and Radiographic evaluation
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteFrance
- Study dates
- 9 Jun 2015to 17 Nov 2019
- Phase
- Interventional
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female gender
- Less than 70 years old
- Diagnosis of hand osteoarthritis according to ACR criteria ACR after exclusion of thumb base osteoarthritis:
- Hand pain, aching or stiffness most of the days during the preceding month
- Hard tissue enlargement of at least two of 8 selected joints *
- Hard tissue enlargement of at least two distal interphalangeal joint
Show all 11Show fewer
- Swelling of fewer than three metacarpophalangeal joint
- Deformity of at least one of 10 selected joints * Patients have to fulfil criteria 1, 2 AND 3 + 4 OR 5 * the 8 selected joints are the second and third distal interphalangeal joint and the second and third proximal interphalangeal of both hands Then confirm by experts' committee
- Exclusively symptomatic treatment
- For women of child-bearing age, use of an effective contraceptive method
- French spoken and read
Who cannot join
- Male gender
- More than 70 years old
- Hemochromatosis
- Inflammatory arthritis
- Cristal induced arthritis
- Active diseases such as infection or cancer
- Use of DMARDs
- Pregnant or breast-feeding woman
Trial locations and contacts
1 site in 1 country.
About this study
Hand osteoarthritis is a common phenotype of osteoarthritis which affects about 70 % of the elderly population. Usually considered as a minor illness, it nevertheless leads to an important functional impairment. The mechanism of this disease is still poorly known. Furthermore there are 2 different subtypes : erosive and non erosive hand osteoarthritis from which mechanisms may differ.
Methods:
Read more
This is a cross-sectional study recruiting patients with hand osteoarthritis addressed in consultation of rheumatology and plastic surgery in Rouen University Hospital.
Two groups of patients will be studied: 20 patients with non erosive subtype of hand osteoarthritis and 20 patients with erosive subtype of hand osteoarthritis.
A clinical evaluation of hand osteoarthritis will be performed. Blood sample for proteomic analysis will be taken. Hand MRI and Bone Mineral Analyser will be performed.
- Conditions
- Erosive Hand Osteoarthritis
- Being tested
- Biological sampling, Radiographic evaluation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological samplingProcedure or surgery
Biological sampling to identify by label-free proteomic analysis of a combination of serum biomarkers in patients with Erosive and non erosive hand Osteoarthritis
Radiographic evaluationDevice
Radiographic assessments using Bone Mineral Analyser and Hand MRI will be done in patients with Erosive and non erosive hand Osteoarthritis
| Study group | Role | What they receive |
|---|---|---|
| Patient with hand osteoarthritis | Experimental | Biological sampling and Radiographic evaluation of patient with erosive and non erosive hand osteoarthritis Receives: Procedure: Biological sampling; Device: Radiographic evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantification by label-free proteomic analysis of the serum of patients affected by hand osteoarthritis
Assessments done using biological sampling
Measured: day 1
Secondary outcomes (1)
Number of Erosion in patients affected by hand osteoarthritis
Number of Erosion in patients affected by hand osteoarthritis is evaluated using Bone Mineral Analyser
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2015 (estimated)
- Study start9 Jun 2015
- Primary completion17 Nov 2019
- Study completion17 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erosive Hand OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gilles AVENEL, MD, Principal investigator, UH Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02370771
- Sponsor's protocol ID
- 2014/059/HP
- Acronym
- PASEO
- Status last verified
- Jun 2020
- First submitted
- 18 Feb 2015
- Last updated
- 30 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proteomic Analysis in Sera From Patients With Erosive Hand Osteoarthritis
- ClinicalTrials.gov ID
- NCT02370771
- Acronym / sponsor ID
- PASEO / 2014/059/HP
- Conditions
- Erosive Hand Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 9 Jun 2015 (actual)
- Primary completion
- 17 Nov 2019 (actual)
- Study completion
- 17 Nov 2019 (actual)
- First posted
- 25 Feb 2015 (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.
Hand osteoarthritis is a common phenotype of osteoarthritis which affects about 70 % of the elderly population. Usually considered as a minor illness, it nevertheless leads to an important functional impairment. The mechanism of this disease is still poorly known. Furthermore there are 2 different subtypes : erosive and non erosive hand osteoarthritis from which mechanisms may differ.
Methods:
This is a cross-sectional study recruiting patients with hand osteoarthritis addressed in consultation of rheumatology and plastic surgery in Rouen University Hospital.
Two groups of patients will be studied: 20 patients with non erosive subtype of hand osteoarthritis and 20 patients with erosive subtype of hand osteoarthritis.
A clinical evaluation of hand osteoarthritis will be performed. Blood sample for proteomic analysis will be taken. Hand MRI and Bone Mineral Analyser will be performed.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with hand osteoarthritis | Experimental | Procedure: Biological sampling, Device: Radiographic evaluationBiological sampling and Radiographic evaluation of patient with erosive and non erosive hand osteoarthritis |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Female gender
- Less than 70 years old
- Diagnosis of hand osteoarthritis according to ACR criteria ACR after exclusion of thumb base osteoarthritis:
- Exclusively symptomatic treatment
- For women of child-bearing age, use of an effective contraceptive method
Key exclusion criteria (8 listed)
- Male gender
- More than 70 years old
- Hemochromatosis
- Inflammatory arthritis
- Cristal induced arthritis
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 |
|---|---|---|
| Biological samplingBiological sampling to identify by label-free proteomic analysis of a combination of serum biomarkers in patients with Erosive and non erosive hand Osteoarthritis | Procedure or surgery | Patient with hand osteoarthritis |
| Radiographic evaluationRadiographic assessments using Bone Mineral Analyser and Hand MRI will be done in patients with Erosive and non erosive hand Osteoarthritis | Device | Patient with hand osteoarthritis |
Primary outcome
Quantification by label-free proteomic analysis of the serum of patients affected by hand osteoarthritis
Time frame: day 1
Assessments done using biological sampling
1 secondary outcome
Number of Erosion in patients affected by hand osteoarthritis
Time frame: Day 1
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 30 Jun 2020.
Related trials for Erosive Hand Osteoarthritis
Active, not recruitingPhase 4
Methotrexate in Erosive Inflammatory Hand Osteoarthritis
Hand Osteoarthritis, Erosive Osteoarthritis
RecruitingPhase 2/3
Methotrexate Treatment in Hand Osteoarthritis Refractory to Usual Treatments
Erosive Hand Osteoarthritis
Enrolling by invitationObservational study
A 30-month Follow-up of MERINO Participants to Evaluate Long-term Effects of Methotrexate in Erosive Hand OA.
Hand Osteoarthritis, Erosive Osteoarthritis
Active, not recruiting
DIGItal Cohort Osteoarthritis Design
Arthrosis of Hand
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.
Gilles AVENEL, MD principal investigator
UH Rouen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biological sampling and Radiographic evaluation in people with Erosive Hand Osteoarthritis, run by University Hospital, Rouen 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 11 inclusion and 8 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 30 Jun 2020. 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.
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?
Quantification by label-free proteomic analysis of the serum of patients affected by hand osteoarthritis (time frame: day 1). 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 30 Jun 2020.