PsoriasisCARPAPANCT04173039
Anti-Carbamylated Protein Antibodies in Psoriatic Arthritis
A study testing Serum anti-CarP antibodies detection in people with Psoriasis and Arthritis, Psoriatic, run by Association pour la Recherche Clinique et Immunologique at 1 site in France.
Trial summary
Anti-carbamylated protein (anti-CarP) antibodies are present in approximately one-fourth of the patients who are seronegative for both rheumatoid factor and anti-citrullinated protein antibody and who may therefore have psoriatic arthritis. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Psoriasis, Arthritis, Psoriatic
- What is being tested?
- Serum anti-CarP antibodies detection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 29 Aug 2018to 24 Apr 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- "Controls" : Patients with a psoriasis confirmed by a dermatologist and with absence of psoriatic arthritis confirmed by a rheumatologist.
- "Cases" : Patients with psoriatic arthritis fulfilling the classification criteria for psoriatic arthritis (CASPAR), with a diagnosis confirmed by a rheumatologist and associated with personal or familial psoriasis.
Who cannot join
- "Controls": Presence of any chronic rheumatic inflammatory disease such as psoriatic arthritis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diagnostic Value of Antibodies Against Carbamylated Proteins in Psoriatic Arthritis.
Anti-carbamylated protein (anti-CarP) antibodies are present in approximately one-fourth of the patients who are seronegative for both rheumatoid factor and anti-citrullinated protein antibody and who may therefore have psoriatic arthritis. The investigators hypothesized that detection of anti-CarP antibodies in serum may be useful for diagnosis of psoriatic arthritis.
- Conditions
- Psoriasis, Arthritis, Psoriatic
- Being tested
- Serum anti-CarP antibodies detection
- Medical subject headings
- Psoriasis, Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum anti-CarP antibodies detectionDiagnostic test
Serum anti-CarP antibodies detection using an enzyme-linked immunosorbent assay (ELISA) from Inova Diagnostics.
| Study group | Role | What they receive |
|---|---|---|
| Controls | Other | Patients with psoriasis and without psoriatic arthritis. Receives: Diagnostic Test: Serum anti-CarP antibodies detection |
| Cases | Other | Patients with psoriatic arthritis and with personal or familial psoriasis. Receives: Diagnostic Test: Serum anti-CarP antibodies detection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of anti-carbamylated protein antibodies for the diagnosis of psoriatic arthritis in the psoriatic population
Measured: Anti-CarP antibodies will be assessed in the sera collected at the recruitment visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2019
- Study start29 Aug 2018
- Primary completion24 Apr 2019
- Study completion24 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Association pour la Recherche Clinique et Immunologique
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04173039
- Sponsor's protocol ID
- 18071A0003
- Acronym
- CARPAPA
- Status last verified
- Nov 2019
- First submitted
- 20 Nov 2019
- Last updated
- 22 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Value of Antibodies Against Carbamylated Proteins in Psoriatic Arthritis.
- ClinicalTrials.gov ID
- NCT04173039
- Acronym / sponsor ID
- CARPAPA / 18071A0003
- Conditions
- Psoriasis, Arthritis, Psoriatic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Association pour la Recherche Clinique et ImmunologiqueUniversity, hospital or other
- Study start
- 29 Aug 2018 (actual)
- Primary completion
- 24 Apr 2019 (actual)
- Study completion
- 24 Apr 2019 (actual)
- First posted
- 21 Nov 2019 (actual)
- 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.
Anti-carbamylated protein (anti-CarP) antibodies are present in approximately one-fourth of the patients who are seronegative for both rheumatoid factor and anti-citrullinated protein antibody and who may therefore have psoriatic arthritis. The investigators hypothesized that detection of anti-CarP antibodies in serum may be useful for diagnosis of psoriatic arthritis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Controls | Other | Diagnostic Test: Serum anti-CarP antibodies detectionPatients with psoriasis and without psoriatic arthritis. |
| Cases | Other | Diagnostic Test: Serum anti-CarP antibodies detectionPatients with psoriatic arthritis and with personal or familial psoriasis. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- "Controls" : Patients with a psoriasis confirmed by a dermatologist and with absence of psoriatic arthritis confirmed by a rheumatologist.
- "Cases" : Patients with psoriatic arthritis fulfilling the classification criteria for psoriatic arthritis (CASPAR), with a diagnosis confirmed by a rheumatologist and associated with personal or familial psoriasis.
Key exclusion criteria (1 listed)
- "Controls": Presence of any chronic rheumatic inflammatory disease such as psoriatic 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 |
|---|---|---|
| Serum anti-CarP antibodies detectionSerum anti-CarP antibodies detection using an enzyme-linked immunosorbent assay (ELISA) from Inova Diagnostics. | Diagnostic test | Cases, Controls |
Primary outcome
Sensitivity of anti-carbamylated protein antibodies for the diagnosis of psoriatic arthritis in the psoriatic population
Time frame: Anti-CarP antibodies will be assessed in the sera collected at the recruitment visit
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 22 Nov 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Serum anti-CarP antibodies detection in people with Psoriasis and Arthritis, Psoriatic, run by Association pour la Recherche Clinique et Immunologique 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 2 inclusion and 1 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 22 Nov 2019. 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?
Sensitivity of anti-carbamylated protein antibodies for the diagnosis of psoriatic arthritis in the psoriatic population (time frame: Anti-CarP antibodies will be assessed in the sera collected at the recruitment visit). 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 22 Nov 2019.