Frequency of Elevated Fecal Calprotectin Levels in Psoriatic Arthritis.

NCT04190108 | Completed

• 1 other identifier: HPrato-2
• Study Type: observational
• Target: 259
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Psoriatic Arthritis; Inflammatory Bowel Diseases

Outcome Measures

Primary Outcomes (1)

• The percentage of elevated FC levels in cases and controls

  Comparison of FC levels between cases and controls

  3 YEARS

Secondary Outcomes (2)

• Correlations of FC levels with laboratory data

  3 YEARS

• The percentage of patients developing IBD over the follow up

  3 YEARS

Study Arms (2)

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.

Diagnostic Test: Fecal calprotectin assay

Controls

All consecutive new patients meeting the ACR/EULAR 2010 classification criteria for rheumatoid arthritis (RA) at onset.

Diagnostic Test: Fecal calprotectin assay

Interventions

Fecal calprotectin assay DIAGNOSTIC_TEST

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

Case patients; Controls

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Both cases and controls were abdominal symptom-free.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Fabrizio Cantini

Prato, Tuscany, 59100, Italy

Location

Related Publications (5)

• 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.

  PMID: 30422277 BACKGROUND

• Scher 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.

  PMID: 25319745 BACKGROUND

• Klingberg 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.

  PMID: 28148281 BACKGROUND

• Adarsh 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.

  PMID: 30729502 BACKGROUND

• Scarpa 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.

  PMID: 10813294 BACKGROUND

MeSH Terms

Conditions

Arthritis, Psoriatic; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 26, 2019
• First Posted: December 9, 2019
• Study Start: January 2, 2016
• Primary Completion: December 31, 2018
• Study Completion: October 31, 2019
• Last Updated: December 11, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)