CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 259 enrolled
Drug / intervention
Fecal calprotectin assayother
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04190108
NCT04190108N/ACompleted
CompareCT.gov

Frequency of Elevated Fecal Calprotectin Levels in Psoriatic Arthritis and Its Predictive Role for Inflammatory Bowel Disease Occurrence: a Prospective, Long-term, Controlled Study.

Hospital of Prato·observational·Posted Dec 9, 2019·Updated Dec 11, 2019

In Brief

An observational study evaluating Fecal calprotectin assay for Psoriatic Arthritis and Inflammatory Bowel Diseases. Completed, enrolled 259 participants across 1 site.

Detailed 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. 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsPsoriatic Arthritis, Inflammatory Bowel Diseases
CountriesItaly
CollaboratorsGiulia 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

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedDec 9, 2019
Enrollment StartJan 2, 2016
Primary CompletionDec 31, 2018
Study CompletionOct 31, 2019
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 6.6 years ago

Interventions

Fecal calprotectin assayother

FC levels were measured at baseline with Bühlmann fCAL Turbo, Switzerland® kit.