Faecal Analyses in Spondyloarthritis Therapy

NCT03839862 | Recruiting FDA Drug

• 1 other identifier: FAST1
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the intestinal microbiome and disease activity in patients with spondyloarthropathies receiving immunosuppressive therapy. Patients will be analysed at two time points in reference to two predefined primary endpoints:

• Changes in intestinal microbiome
• Response to therapy The investigators want to evaluate if successful treatment of spondylarthropathy coincide with specific changes in the gut flora.

Conditions

Spondyloarthropathies; Ankylosing Spondylitis

Outcome Measures

Primary Outcomes (2)

• Change in gut flora

  Change in Dysbiosis Index Score att follow up compared to baseline. The Dysbiosis Index Score measures degree of intestinal dysbiosis on a scale from 1 to 5, where 5 indicates dysbiosis.

  Change from baseline Dysbiosis Index Score at 6 months

• Change in disease activity/treatment response at follow up

  Change in Bath Ankylosing Spondylitis Disease Activity Score (BASDAI), an established index of disease activity in spondylarthropathies between 0-10, where 10 equals maximum activity

  Change from baseline BASDAI at 6 months

Secondary Outcomes (3)

• Intestinal gut flora in spondyloarthropathies

  Analysis made at study start /baseline

• Intestinal gut inflammation

  Analysis made at study start /baseline

• Adherence to immunosuppressive therapy

  Analysis made at 6 months follow up

Study Arms (2)

Responder

Patient responding to TNF-inhibition

Drug: TNF-inhibition

non-Responder

Patient not responding to TNF-inhibition

Drug: TNF-inhibition

Interventions

TNF-inhibition DRUG

Initiation of immunosuppression with any TNF-inhibitor, e.g. infliximab, etanercept or adalimumab

Responder; non-Responder

Eligibility Criteria

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

Study Population

This study encompasses consecutive patients with spondyloarthropathy who by their physician at the Rheumatology Clinic, Skåne University Hospital, have been prescribed a TNF-inhibitor. Patients who are willing to comply with the study protocoll are included. The study population is consequently not a sample, but encompasses a majority of spondyloarthropathy patients being prescribed this medication at our University clinic.

You may qualify if:

• Fulfilling the Assessment of SpondyloArthritis International Society classification criteria for spondyloarthropathy.
• About to commence treatment with TNF-inhibition

You may not qualify if:

• Failure to understand protocol
• A history of alcohol abuse
• Any history of diverticulitis
• A history of failure to comply with prescribed medication
• Ongoing biological therapy

Sponsors & Collaborators

• Region Skane: lead

Study Sites (1)

Reumatologi SUS Lund, Region Skåne

Lund, 221 85, Sweden

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood and faecal sampling

MeSH Terms

Conditions

Spondylarthropathies; Spondylitis, Ankylosing

Condition Hierarchy (Ancestors)

Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Axial Spondyloarthritis; Ankylosis

Study Officials

• Kristofer Andréasson, MD PhD

  Lund University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristofer Andréasson, MD PhD

CONTACT

+4646172153; kristofer.andreasson@med.lu.se

Johan Karlsson Wallman, MD PhD

CONTACT

+4646172140; johan.81.karlsson@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2019
• First Posted: February 15, 2019
• Study Start: January 1, 2019
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 6, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)