Arthritis, RheumatoidCASPERNCT02894047
Study of the Influence of the Expression of the Calcium-sensitive Receptor (CaSR) by Monocytes in the Synovial Liquid on Structural Alterations in Patients Diagnosed With Rheumatoid Arthritis in the Previous Two Years
An observational study of Arthritis, Rheumatoid, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Rheumatoid arthritis (RA) is the most frequent form of chronic inflammatory rheumatism in adults. The erosive damage influences the functional prognosis in patients with RA. At present, there are no sufficiently sensitive and specific predictive markers of erosive damage. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis, Rheumatoid
- What is being tested?
- blood
- How many people
- 42 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2013to Oct 2015
- Phase
- Observational
- 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
Study population: - Patients consulting in the Department of Rheumatology at Amiens University Hospital
Who may be able to join
- Patients consulting in the Department of Rheumatology at Amiens University Hospital
- Age ≥ 18
- RA meeting the 2010 ACR/EULAR criteria
- Less than 2 years of RA progression
- Effusion in at least 1 joint
Who cannot join
- Inability to give informed consent
- Ongoing pregnancy
- Previous treatment with an anti-osteoporosis medication
- Intra-articular corticoid or hyaluronic acid injection in the previous 6 months
- Coagulation disorders preventing arthrocentesis
- Incarceration or legal guardianship
Trial locations and contacts
1 site in 1 country.
About this study
Rheumatoid arthritis (RA) is the most frequent form of chronic inflammatory rheumatism in adults. The erosive damage influences the functional prognosis in patients with RA. At present, there are no sufficiently sensitive and specific predictive markers of erosive damage.
- Conditions
- Arthritis, Rheumatoid
- Being tested
- blood
- Keywords
- calcium-sensitive receptor
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bloodBiological
measurement of CaSR expression levels on synovial fluid monocytes
What is being measured
The primary outcome is the main question the study is designed to answer.
CaSR expression rate level on synovial monocytes
measured by flow cytometry
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2016 (estimated)
- Study startJul 2013
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis, RheumatoidStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent GOEB, MD, PhD, Principal investigator, CHU Amiens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02894047
- Sponsor's protocol ID
- PI2013_843_0014
- Acronym
- CASPER
- Status last verified
- Sep 2016
- First submitted
- 5 Sep 2016
- Last updated
- 9 Sep 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Influence of the Expression of the Calcium-sensitive Receptor (CaSR) by Monocytes in the Synovial Liquid on Structural Alterations in Patients Diagnosed With Rheumatoid Arthritis in the Previous Two Years
- ClinicalTrials.gov ID
- NCT02894047
- Acronym / sponsor ID
- CASPER / PI2013_843_0014
- Conditions
- Arthritis, Rheumatoid
- Keywords
- calcium-sensitive receptor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 9 Sep 2016 (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.
Rheumatoid arthritis (RA) is the most frequent form of chronic inflammatory rheumatism in adults. The erosive damage influences the functional prognosis in patients with RA. At present, there are no sufficiently sensitive and specific predictive markers of erosive damage.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- - Patients consulting in the Department of Rheumatology at Amiens University Hospital
Key inclusion criteria (5 listed)
- Patients consulting in the Department of Rheumatology at Amiens University Hospital
- Age ≥ 18
- RA meeting the 2010 ACR/EULAR criteria
- Less than 2 years of RA progression
- Effusion in at least 1 joint
Key exclusion criteria (6 listed)
- Inability to give informed consent
- Ongoing pregnancy
- Previous treatment with an anti-osteoporosis medication
- Intra-articular corticoid or hyaluronic acid injection in the previous 6 months
- Coagulation disorders preventing arthrocentesis
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 |
|---|---|---|
| bloodmeasurement of CaSR expression levels on synovial fluid monocytes | Biological | – |
Primary outcome
CaSR expression rate level on synovial monocytes
Time frame: 1 year
measured by flow cytometry
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 9 Sep 2016.
Related trials for Arthritis, Rheumatoid
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
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.
Vincent GOEB, MD, PhD principal investigator
CHU Amiens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthritis, Rheumatoid, run by Centre Hospitalier Universitaire, Amiens 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 6 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 9 Sep 2016. 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?
CaSR expression rate level on synovial monocytes (time frame: 1 year). 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 9 Sep 2016.