Psoriatic ArthritisNCT04190108
Frequency of Elevated Fecal Calprotectin Levels in Psoriatic Arthritis.
An observational study of Psoriatic Arthritis and Inflammatory Bowel Diseases, run by Hospital of Prato at 1 site in Italy.
Trial summary
Background.Recent epidemiologic studies have shown an association between psoriasis, psoriatic arthritis (PsA) and inflammatory bowel diseases (IBD). Recently, measurement of fecal calprotectin (FC) demonstrated a good sensitivity and specificity for intestinal inflammation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Psoriatic Arthritis, Inflammatory Bowel Diseases
- What is being tested?
- Fecal calprotectin assay
- How many people
- 259 participants
- Where
- 1 siteItaly
- Study dates
- 2 Jan 2016to 31 Oct 2019
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Both cases and controls were abdominal symptom-free.
Who may be able to join
- age >18 years
- absence of any abdominal symptoms or diarrhoea
- non-steroidal anti-inflammatory drug (NSAIDs) interruption 10 days before enrollment
- Corticosteroids (CS) at stable low dose (prednisone 10 mg/day or equivalent) during the preceding 2 weeks were permitted in both groups.
Who cannot join
- age < 18 years
- previous diagnosis of CD or UC or current diagnosis of infectious colitis
- previous therapy with traditional DMARDs or any biologic therapies
- CS at high doses.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Frequency of Elevated Fecal Calprotectin Levels in Psoriatic Arthritis and Its Predictive Role for Inflammatory Bowel Disease Occurrence: a Prospective, Long-term, Controlled Study.
Background.Recent epidemiologic studies have shown an association between psoriasis, psoriatic arthritis (PsA) and inflammatory bowel diseases (IBD). Recently, measurement of fecal calprotectin (FC) demonstrated a good sensitivity and specificity for intestinal inflammation.
Primary objective of present study was to evaluate the presence of occult bowel inflammation in patients with PsA as expressed by elevated levels of FC. Secondary objectives were to investigate the correlation between the levels FC and clinical and laboratory features, and the outcome of CF-positive patients in terms of IBD development.
Read the detailed description
A number of studies evaluated the presence of occult intestinal inflammation by using FC assay in patients with axial SpA. In 2000, a study conducted in PsA patients without bowel symptoms showed at mucosa biopsies the presence of microscopic changes, increase in lamina propria cellularity, consisting of plasma cells and lymphocytes, and lymphoid aggregates.Present prospective case-control study was designed to investigate occult intestinal inflammation by using FC assay in consecutive patients with PsA at onset, and who had no abdominal symptoms. Five Italian Centers contributed to patients recruitment adopting the same inclusion and exclusion criteria over a 3 year period.
FC levels were measured at baseline with Bühlmann fCAL Turbo, Switzerland® kit. This automated method is a particle enhanced turbidimetric immunoassay employing polyclonal antibodies. The manufacturer cut-off for FC positivity was 50 μg/g, with a sensitivity of 100% and a specificity of 53.1%.
The number of patients developing IBD was evaluated at the end of follow-up. Clinical and laboratory data collection was centralized and two experts statisticians performed the data analysis.
Statistical analysis. All demographic, clinical, and laboratory data were collected and descriptive statistics, presented as mean value and standard deviation, were calculated using Microsoft ® Office Excel for Windows and ©2019 Minitabs, LLC for Windows. Chi-square test was used for categorical variables. FC test sensitivity, specificity, positive (PPV) and negative (NPV) predictive values were calculated. Bayes's theorem was used to calculate the 95% confidence interval (95%CI). Correlations were calculated using Spearman's correlation (rs). P values ≤ 0.05 were accepted as statistically significant.
The median follow-up was 30 months.
- Conditions
- Psoriatic Arthritis, Inflammatory Bowel Diseases
- Being tested
- Fecal calprotectin assay
- Medical subject headings
- Arthritis, Psoriatic, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal calprotectin assayDiagnostic test
FC levels were measured at baseline with Bühlmann fCAL Turbo, Switzerland® kit.
| Study group | Role | What they receive |
|---|---|---|
| Case patients | All consecutive, new patients older than 18 years with PsA (CASPAR criteria) at onset observed over 3-year period, who had any abdominal symptoms. Receives: Diagnostic Test: Fecal calprotectin assay | |
| Controls | All consecutive new patients meeting the ACR/EULAR 2010 classification criteria for rheumatoid arthritis (RA) at onset. Receives: Diagnostic Test: Fecal calprotectin assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of elevated FC levels in cases and controls
Comparison of FC levels between cases and controls
Measured: 3 YEARS
Secondary outcomes (2)
Correlations of FC levels with laboratory data
Spearman's correlation (rs)
Measured: 3 YEARS
The percentage of patients developing IBD over the follow up
The occurrence of IBD over the follow up
Measured: 3 YEARS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2019
- Study start2 Jan 2016
- Primary completion31 Dec 2018
- Study completion31 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Psoriatic ArthritisStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 259 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital of Prato
- Sponsor type
- University, hospital or other
- Collaborators
- Giulia Franchi,Department of Rheumatology, Hospital of Prato, Maurizio Benucci,S.Giovanni di Dio Hospital, Raffaele Scarpa, Rheumatology Unit, University of Naples Federico II, Naples, Francesco Caso, Rheumatology Unit, University of Naples Federico II, Naples, Rosario Foti,Rheumatology Unit, A.O.U. Policlinico Vittorio Emanuele, Catania, Antonio Carletto,Rheumatology Unit, AOUI, Verona., Elisa Visalli,Rheumatology Unit, A.O.U. Policlinico Vittorio Emanuele, Catania, Laura Niccoli,Department of Rheumatology, Hospital of Prato
- Responsible party
- Principal investigator, Fabrizio Cantini, Hospital of Prato
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04190108
- Sponsor's protocol ID
- HPrato-2
- Status last verified
- Dec 2019
- First submitted
- 26 Nov 2019
- Last updated
- 11 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fu Y, Lee CH, Chi CC. Association of Psoriasis With Inflammatory Bowel Disease: A Systematic Review and Meta-analysis. JAMA Dermatol. 2018 Dec 1;154(12):1417-1423. doi: 10.1001/jamadermatol.2018.3631.
PubMed 30422277Scher JU, Ubeda C, Artacho A, Attur M, Isaac S, Reddy SM, Marmon S, Neimann A, Brusca S, Patel T, Manasson J, Pamer EG, Littman DR, Abramson SB. Decreased bacterial diversity characterizes the altered gut microbiota in patients with psoriatic arthritis, resembling dysbiosis in inflammatory bowel disease. Arthritis Rheumatol. 2015 Jan;67(1):128-39. doi: 10.1002/art.38892.
PubMed 25319745Klingberg E, Strid H, Stahl A, Deminger A, Carlsten H, Ohman L, Forsblad-d'Elia H. A longitudinal study of fecal calprotectin and the development of inflammatory bowel disease in ankylosing spondylitis. Arthritis Res Ther. 2017 Feb 2;19(1):21. doi: 10.1186/s13075-017-1223-2.
PubMed 28148281Adarsh MB, Dogra S, Vaiphei K, Vaishnavi C, Sinha SK, Sharma A. Evaluation of subclinical gut inflammation using faecal calprotectin levels and colonic mucosal biopsy in patients with psoriasis and psoriatic arthritis. Br J Dermatol. 2019 Aug;181(2):401-402. doi: 10.1111/bjd.17745. Epub 2019 May 6. No abstract available.
PubMed 30729502Scarpa R, Manguso F, D'Arienzo A, D'Armiento FP, Astarita C, Mazzacca G, Ayala F. Microscopic inflammatory changes in colon of patients with both active psoriasis and psoriatic arthritis without bowel symptoms. J Rheumatol. 2000 May;27(5):1241-6.
PubMed 10813294
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frequency of Elevated Fecal Calprotectin Levels in Psoriatic Arthritis and Its Predictive Role for Inflammatory Bowel Disease Occurrence: a Prospective, Long-term, Controlled Study.
- ClinicalTrials.gov ID
- NCT04190108
- Acronym / sponsor ID
- HPrato-2
- Conditions
- Psoriatic Arthritis, Inflammatory Bowel Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 259 participants (actual)
- Lead sponsor
- Hospital of PratoUniversity, hospital or other
- Collaborators
- Giulia Franchi,Department of Rheumatology, Hospital of Prato, Maurizio Benucci,S.Giovanni di Dio Hospital, Raffaele Scarpa, Rheumatology Unit, University of Naples Federico II, Naples, Francesco Caso, Rheumatology Unit, University of Naples Federico II, Naples, Rosario Foti,Rheumatology Unit, A.O.U. Policlinico Vittorio Emanuele, Catania, Antonio Carletto,Rheumatology Unit, AOUI, Verona., Elisa Visalli,Rheumatology Unit, A.O.U. Policlinico Vittorio Emanuele, Catania, Laura Niccoli,Department of Rheumatology, Hospital of Prato
- Study start
- 2 Jan 2016 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Oct 2019 (actual)
- First posted
- 9 Dec 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.
Background.Recent epidemiologic studies have shown an association between psoriasis, psoriatic arthritis (PsA) and inflammatory bowel diseases (IBD). Recently, measurement of fecal calprotectin (FC) demonstrated a good sensitivity and specificity for intestinal inflammation.
Primary objective of present study was to evaluate the presence of occult bowel inflammation in patients with PsA as expressed by elevated levels of FC. Secondary objectives were to investigate the correlation between the levels FC and clinical and laboratory features, and the outcome of CF-positive patients in terms of IBD development.
Detailed description
A number of studies evaluated the presence of occult intestinal inflammation by using FC assay in patients with axial SpA. In 2000, a study conducted in PsA patients without bowel symptoms showed at mucosa biopsies the presence of microscopic changes, increase in lamina propria cellularity, consisting of plasma cells and lymphocytes, and lymphoid aggregates.Present prospective case-control study was designed to investigate occult intestinal inflammation by using FC assay in consecutive patients with PsA at onset, and who had no abdominal symptoms. Five Italian Centers contributed to patients recruitment adopting the same inclusion and exclusion criteria over a 3 year period.
FC levels were measured at baseline with Bühlmann fCAL Turbo, Switzerland® kit. This automated method is a particle enhanced turbidimetric immunoassay employing polyclonal antibodies. The manufacturer cut-off for FC positivity was 50 μg/g, with a sensitivity of 100% and a specificity of 53.1%.
The number of patients developing IBD was evaluated at the end of follow-up. Clinical and laboratory data collection was centralized and two experts statisticians performed the data analysis.
Statistical analysis. All demographic, clinical, and laboratory data were collected and descriptive statistics, presented as mean value and standard deviation, were calculated using Microsoft ® Office Excel for Windows and ©2019 Minitabs, LLC for Windows. Chi-square test was used for categorical variables. FC test sensitivity, specificity, positive (PPV) and negative (NPV) predictive values were calculated. Bayes's theorem was used to calculate the 95% confidence interval (95%CI). Correlations were calculated using Spearman's correlation (rs). P values ≤ 0.05 were accepted as statistically significant.
The median follow-up was 30 months.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case patients | – | Diagnostic Test: Fecal calprotectin assayAll consecutive, new patients older than 18 years with PsA (CASPAR criteria) at onset observed over 3-year period, who had any abdominal symptoms. |
| Controls | – | Diagnostic Test: Fecal calprotectin assayAll consecutive new patients meeting the ACR/EULAR 2010 classification criteria for rheumatoid arthritis (RA) at onset. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Both cases and controls were abdominal symptom-free.
Key inclusion criteria (4 listed)
- age >18 years
- absence of any abdominal symptoms or diarrhoea
- non-steroidal anti-inflammatory drug (NSAIDs) interruption 10 days before enrollment
- Corticosteroids (CS) at stable low dose (prednisone 10 mg/day or equivalent) during the preceding 2 weeks were permitted in both groups.
Key exclusion criteria (4 listed)
- age < 18 years
- previous diagnosis of CD or UC or current diagnosis of infectious colitis
- previous therapy with traditional DMARDs or any biologic therapies
- CS at high doses.
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 |
|---|---|---|
| Fecal calprotectin assayFC levels were measured at baseline with Bühlmann fCAL Turbo, Switzerland® kit. | Diagnostic test | Case patients, Controls |
Primary outcome
The percentage of elevated FC levels in cases and controls
Time frame: 3 YEARS
Comparison of FC levels between cases and controls
2 secondary outcomes
Correlations of FC levels with laboratory data
Time frame: 3 YEARS
The percentage of patients developing IBD over the follow up
Time frame: 3 YEARS
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 11 Dec 2019.
- Background: PubMed 30422277Fu Y, Lee CH, Chi CC. Association of Psoriasis With Inflammatory Bowel Disease: A Systematic Review and Meta-analysis. JAMA Dermatol. 2018 Dec 1;154(12):1417-1423. doi: 10.1001/jamadermatol.2018.3631.
- Background: PubMed 25319745Scher JU, Ubeda C, Artacho A, Attur M, Isaac S, Reddy SM, Marmon S, Neimann A, Brusca S, Patel T, Manasson J, Pamer EG, Littman DR, Abramson SB. Decreased bacterial diversity characterizes the altered gut microbiota in patients with psoriatic arthritis, resembling dysbiosis in inflammatory bowel disease. Arthritis Rheumatol. 2015 Jan;67(1):128-39. doi: 10.1002/art.38892.
- Background: PubMed 28148281Klingberg E, Strid H, Stahl A, Deminger A, Carlsten H, Ohman L, Forsblad-d'Elia H. A longitudinal study of fecal calprotectin and the development of inflammatory bowel disease in ankylosing spondylitis. Arthritis Res Ther. 2017 Feb 2;19(1):21. doi: 10.1186/s13075-017-1223-2.
- Background: PubMed 30729502Adarsh MB, Dogra S, Vaiphei K, Vaishnavi C, Sinha SK, Sharma A. Evaluation of subclinical gut inflammation using faecal calprotectin levels and colonic mucosal biopsy in patients with psoriasis and psoriatic arthritis. Br J Dermatol. 2019 Aug;181(2):401-402. doi: 10.1111/bjd.17745. Epub 2019 May 6. No abstract available.
- Background: PubMed 10813294Scarpa R, Manguso F, D'Arienzo A, D'Armiento FP, Astarita C, Mazzacca G, Ayala F. Microscopic inflammatory changes in colon of patients with both active psoriasis and psoriatic arthritis without bowel symptoms. J Rheumatol. 2000 May;27(5):1241-6.
- Individual participant dataSharing planned: No
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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?
An observational study of Psoriatic Arthritis and Inflammatory Bowel Diseases, run by Hospital of Prato at 1 site in Italy.
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 4 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 11 Dec 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 Italy. 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?
The percentage of elevated FC levels in cases and controls (time frame: 3 YEARS). 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 NCT04190108, which also lists 5 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 11 Dec 2019.