SpondyloarthropathiesFASTNCT03839862
Faecal Analyses in Spondyloarthritis Therapy
An observational study of Spondyloarthropathies and Ankylosing Spondylitis, run by Region Skane at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spondyloarthropathies, Ankylosing Spondylitis
- What is being tested?
- TNF-inhibition
- How many people
- 50 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2019to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Fulfilling the Assessment of SpondyloArthritis International Society classification criteria for spondyloarthropathy.
- About to commence treatment with TNF-inhibition
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Reumatologi SUS Lund, Region Skåne
Lund, 221 85
Kristofer Andréasson, MD PhD, +4646171000, kristofer.andreasson@med.lu.se
Johan Karlsson Wallman, MD PhD, +4646171000, johan.81.karlsson@gmail.com
About this study
Official title: Faecal Analyses in Spondyloarthritis Therapy: A Prospective Observational Study of the Intestinal Microbiome in Patients With Spondyloarthropathy Receiving TNF-inhibition.
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.
Read the detailed description
Tumor necrosis factor (TNF)-inhibition is an efficient medication for the treatment of spondyloarthropathy. In a substantial number of cases however, these medications remain ineffective. At present, the scientific community has limited understanding of why some patients are resistant to this medication. The purpose of this study is to understand if the gut flora may associate with treatment response.
Spondyloarthropathies are associated with inflammatory bowel diseases in terms of epidemiology and molecular pathogenesis. Recent studies have also associated spondyloarthropathies with intestinal dysbiosis.
This study is of observational character and integrated in the routine clinical care of patients with spondyloarthropathies at the Rheumatology Clinic, Skane University Hospital, Lund, Sweden. Study participants are asked to deliver blood and fecal sampling at two time-points together with clinical evaluation of disease activity. With an estimated inclusion of 50 patients, at least 20 responders and 20 non-responders are expected to be included and to be compared to each other.
Our primary goal is to investigate the association between change in intestinal microbiome and clinical response to therapy.
In our secondary analyses we will investigate if intestinal microbiome and intestinal inflammation at baseline may predict response to, and adherence to, therapy in these patients.
If successful treatment response of spondyloarthropathy is associated with specific alterations of the gut flora, these results may guide future studies on the impact of dysbiosis and probiotics on this disease.
- Conditions
- Spondyloarthropathies, Ankylosing Spondylitis
- Being tested
- TNF-inhibition
- Medical subject headings
- Spondylarthropathies, Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TNF-inhibitionDrug
Initiation of immunosuppression with any TNF-inhibitor, e.g. infliximab, etanercept or adalimumab
| Study group | Role | What they receive |
|---|---|---|
| Responder | Patient responding to TNF-inhibition Receives: Drug: TNF-inhibition | |
| non-Responder | Patient not responding to TNF-inhibition Receives: Drug: TNF-inhibition |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Change from baseline BASDAI at 6 months
Secondary outcomes (3)
Intestinal gut flora in spondyloarthropathies
Intestinal gut flora based on DNA-based microbial analysis of fecal samples (Dysbiosis Index Score). The Dysbiosis Index Score measures degree of intestinal dysbiosis on a scale from 1 to 5, where 5 indicates dysbiosis.
Measured: Analysis made at study start /baseline
Intestinal gut inflammation
Assessment of intestinal inflammation by measurement of faecal calprotectin, an established biomarker of intestinal inflammation
Measured: Analysis made at study start /baseline
Adherence to immunosuppressive therapy
Is the patient still prescribed the same immunosuppressant compared to baseline?
Measured: Analysis made at 6 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start1 Jan 2019
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SpondyloarthropathiesStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kristofer Andréasson, MD PhD, Principal investigator, Lund University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03839862
- Sponsor's protocol ID
- FAST1
- Acronym
- FAST
- Status last verified
- Mar 2024
- First submitted
- 11 Feb 2019
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Faecal Analyses in Spondyloarthritis Therapy: A Prospective Observational Study of the Intestinal Microbiome in Patients With Spondyloarthropathy Receiving TNF-inhibition.
- ClinicalTrials.gov ID
- NCT03839862
- Acronym / sponsor ID
- FAST / FAST1
- Conditions
- Spondyloarthropathies, Ankylosing Spondylitis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 15 Feb 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.
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.
Detailed description
Tumor necrosis factor (TNF)-inhibition is an efficient medication for the treatment of spondyloarthropathy. In a substantial number of cases however, these medications remain ineffective. At present, the scientific community has limited understanding of why some patients are resistant to this medication. The purpose of this study is to understand if the gut flora may associate with treatment response.
Spondyloarthropathies are associated with inflammatory bowel diseases in terms of epidemiology and molecular pathogenesis. Recent studies have also associated spondyloarthropathies with intestinal dysbiosis.
This study is of observational character and integrated in the routine clinical care of patients with spondyloarthropathies at the Rheumatology Clinic, Skane University Hospital, Lund, Sweden. Study participants are asked to deliver blood and fecal sampling at two time-points together with clinical evaluation of disease activity. With an estimated inclusion of 50 patients, at least 20 responders and 20 non-responders are expected to be included and to be compared to each other.
Our primary goal is to investigate the association between change in intestinal microbiome and clinical response to therapy.
In our secondary analyses we will investigate if intestinal microbiome and intestinal inflammation at baseline may predict response to, and adherence to, therapy in these patients.
If successful treatment response of spondyloarthropathy is associated with specific alterations of the gut flora, these results may guide future studies on the impact of dysbiosis and probiotics on this disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Responder | – | Drug: TNF-inhibitionPatient responding to TNF-inhibition |
| non-Responder | – | Drug: TNF-inhibitionPatient not responding to TNF-inhibition |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Fulfilling the Assessment of SpondyloArthritis International Society classification criteria for spondyloarthropathy.
- About to commence treatment with TNF-inhibition
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| TNF-inhibitionInitiation of immunosuppression with any TNF-inhibitor, e.g. infliximab, etanercept or adalimumab | Drug | Responder, non-Responder |
Primary outcome
Change in gut flora
Time frame: Change from baseline Dysbiosis Index Score at 6 months
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 in disease activity/treatment response at follow up
Time frame: Change from baseline BASDAI at 6 months
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
3 secondary outcomes
Intestinal gut flora in spondyloarthropathies
Time frame: Analysis made at study start /baseline
Intestinal gut inflammation
Time frame: Analysis made at study start /baseline
Adherence to immunosuppressive therapy
Time frame: Analysis made at 6 months follow up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Spondyloarthropathies
Active, not recruitingPhase 1
Safety and Pharmacokinetics of LPX-TI641 in Rheumatoid Arthritis and Psoriatic Arthritis
Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA)
Not yet recruitingObservational study
SLAMF1 Gene Expression in Ankylosing Spondylitis
Ankylosing Spondylitis
Not yet recruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
Recruiting
RENEW Intervention for Axial Spondyloarthritis
Axial Spondyloarthritis
RecruitingObservational study
Natural History and Development of Spondyloarthritis
Arthritis, Spondylitis, Ankylosing
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.
Kristofer Andréasson, MD PhD principal investigator
Lund University Hospital
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 Spondyloarthropathies and Ankylosing Spondylitis, run by Region Skane at 1 site in Sweden.
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 2 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 6 Mar 2024. 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 Sweden. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kristofer Andréasson, MD PhD (+4646172153, kristofer.andreasson@med.lu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in gut flora (time frame: Change from baseline Dysbiosis Index Score at 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Mar 2024.