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NCT Number: NCT04190108

Frequency of Elevated Fecal Calprotectin Levels in Psoriatic Arthritis.

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.

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Key information

Conditions

Psoriatic Arthritis Arthritis Arthritis, Psoriatic Bone Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases Joint Diseases Musculoskeletal Diseases Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fabrizio Cantini

Prato, Tuscany, 59100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Fecal calprotectin assay

Diagnostic Test

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

Primary outcomes

  1. The percentage of elevated FC levels in cases and controls

    Time frame: 3 YEARS

    Comparison of FC levels between cases and controls

Secondary outcomes

  1. Correlations of FC levels with laboratory data

    Time frame: 3 YEARS

    Spearman's correlation (rs)

  2. The percentage of patients developing IBD over the follow up

    Time frame: 3 YEARS

    The occurrence of IBD over the follow up

Sponsors and collaborators

Lead sponsor

Hospital of Prato

Other

Collaborators

  • Antonio Carletto,Rheumatology Unit, AOUI, Verona.
  • Elisa Visalli,Rheumatology Unit, A.O.U. Policlinico Vittorio Emanuele, Catania
  • Francesco Caso, Rheumatology Unit, University of Naples Federico II, Naples
  • Giulia Franchi,Department of Rheumatology, Hospital of Prato
  • Laura Niccoli,Department of Rheumatology, Hospital of Prato
  • Maurizio Benucci,S.Giovanni di Dio Hospital
  • Raffaele Scarpa, Rheumatology Unit, University of Naples Federico II, Naples
  • Rosario Foti,Rheumatology Unit, A.O.U. Policlinico Vittorio Emanuele, Catania

Registry information

Official study 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.

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Dec 9, 2019
Registry last updated
Dec 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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