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Axial SpondyloarthritisMicroSpA & RANCT04973787

The Role of Microbiome on Biological Therapy Efficacy in axSpA and RA

An observational study of Axial Spondyloarthritis and Arthritis, Rheumatoid, run by Universidade Nova de Lisboa at 10 sites in Portugal.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Spondyloarthritis (SpA) and Rheumatoid arthritis (RA) are among the most common chronic inflammatory rheumatic diseases. Introduction of Tumor Necrosis Factor alpha inhibitors (TNFi) to the therapeutic strategy improved acute inflammation and pain, but a significant percentage of patients develop severe adverse events… Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
What is being tested?
biological disease-modifying antirheumatic drugs (bDMARDs)
How many people
90 participants
Where
10 sitesPortugal
Study dates
1 Aug 2020to 31 Jan 2022
How long will I take part?
14 Weeks
Phase
Observational
Are there results?
None posted in the registry

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 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Patients with axSpA or RA according to ASAS and 2010 ACR/EULAR classification criteria, respectively, with indication to start bDMARD according to Portuguese Rheumatology Society.

Who may be able to join

  • Diagnosis of axSpA (according to ASAS classification criteria) or RA (according to 2010 ACR/EULAR classification criteria);
  • Indication for bDMARD therapy, according to the Portuguese recommendations for the use of biological therapies in patients with axSpA and RA;
  • Oral corticosteroids (equivalent to prednisolone ≤ 10mg/day) and/or nonsteroidal anti-inflammatory drugs allowed at stable dose ≥4 weeks before baseline;
  • Conventional DMARDs allowed at stable dose ≥12 weeks before baseline;
  • Ability to provide informed consent.

Who cannot join

  • History of rheumatic disorder other than axSpA or RA;
  • History of Inflammatory Bowel Disease;
  • Previous treatment with bDMARD;
  • Current pregnancy or breastfeeding;
  • Malignancy (except for completely treated squamous or basal cell carcinoma);
  • Any uncontrolled medical condition (e.g., uncontrolled diabetes mellitus, unstable ischemic heart disease);
Show all 10Show fewer
  • History of any documented gastrointestinal disease or tract surgery leaving permanent residua (e.g., gastrectomy, bariatric surgery, or colectomy);
  • Intraarticular injections of extra-axial joints and tendons within 28 days before or at baseline;
  • Recent (<3 months prior) use of any antibiotic therapy, current extreme diet (e.g., parenteral nutrition or macrobiotic diet), current consumption of probiotics.
  • Control group will be healthy participants, and the same inclusion and exclusion criteria will be applied except for rheumatic disease diagnosis.

Trial locations and contacts

10 sites in 1 country.

Ana Faria, PhD contact

00351218803033

ana.faria@nms.unl.pt

Fernando Pimentel-Santos, PhD Agg contact

00351917305093

pimentel.santos@nms.unl.pt

10 sites in 1 country

Portugal10 sites, 10 recruiting

  • Centro Hospitalar Baixo Vouga - Hospital Infante D. Pedro

    Aveiro

    Anabela Barcelos, MD, barcelos.anabela@gmail.com

    Not yet recruiting

  • Hospital de Braga, E.P.E.

    Braga

    Ana Ribeiro, MD, anaroxoribeiro@gmail.com

    Not yet recruiting

  • Hospital Sousa Martins - Unidade de Saúde Local da Guarda

    Guarda

    Cláudia Vaz, MD, claudiacvaz@gmail.com

    Not yet recruiting

  • Centro Hospitalar Lisboa Ocidental - Hospital Egas Moniz

    Lisbon

    Fernando Pimentel-Santos, PhD Agg, 00351917305093, pimentel.santos@nms.unl.pt

    Recruiting

  • Centro Hospitalar Universitário de Lisboa Norte - Hospital Santa Maria

    Lisbon

    Elsa Vieira-Sousa, MD, PhD, elsacvsousa@gmail.com

    Not yet recruiting

  • Instituto Português de Reumatologia

    Lisbon

    Helena Santos, MD, helena.santos@ipr.pt

    Not yet recruiting

  • Unidade Local de Saúde do Alto Minho, Hospital Conde de Bertiandos

    Ponte de Lima

    José Costa, MD, josecosta99@gmail.com

    Not yet recruiting

  • Centro Hospitalar Universitário São João

    Porto

    José Miguel Bernardes, PhD, mbernardes09@gmail.com

    Not yet recruiting

  • Centro Hospitalar de Médio Tejo - Hospital Rainha Santa Isabel - Torres Novas

    Torres Novas

    João Madruga-Dias, MD, joao_alexandre@hotmail.com

    Not yet recruiting

  • Centro Hospitalar de Vila Nova da Gaia/Espinho

    Vila Nova de Gaia

    Patrícia Pinto, MD, patriciaampinto@gmail.com

    Not yet recruiting

Other trials in Portugal

About this study

Official title: MicroSpA & MicroRA: The Role of Microbiome on Biological Therapy Efficacy in Axial Spondyloarthritis and Rheumatoid Arthritis - a New Paradigm

Spondyloarthritis (SpA) and Rheumatoid arthritis (RA) are among the most common chronic inflammatory rheumatic diseases. Introduction of Tumor Necrosis Factor alpha inhibitors (TNFi) to the therapeutic strategy improved acute inflammation and pain, but a significant percentage of patients develop severe adverse events or are still non responders or incomplete responders to these expensive treatments. There is an urgent need to identify new predictors of biological therapy response. It has been described the role of microbiota in some rheumatic diseases, however, clinical trials are scarce. We hypothesized that microbiota or their metabolites may play a role in therapeutic response to TNFi.

Read the detailed description

Thus, this project aimed to evaluate the influence of oral and gut microbiota in the therapeutic response to biologic therapies, in 60 patients.

It is expected to enrolled 30 SpA and 30 RA patients and 30 controls, crossed by gender, age and diet profile. Oral and fecal microbiota will be characterized before TNFi therapeutic. Patients will have an additional microbiota and metabolic profile characterization 14 weeks late after.

This will allow to identify specific profiles of oral and gut microbiome and/or specific biochemical patterns in these patients. At week 14 it will be possible to identify changes induced by TNFi. In addition, it will be possible to identify microbiota pattern associated clinical therapeutic TNFi response vs non-response.

This will allow to predict isolate microbe or microbes patterns at baseline associated to clinical response obtained at week 14. These results may additionally contribute to clinical decision and a better evidenced-based treatment.

Being tested
biological disease-modifying antirheumatic drugs (bDMARDs)
Keywords
Tumor Necrosis Factor alpha inhibitor, Microbiota, Biomarker
Medical subject headings
Axial Spondyloarthritis, Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • biological disease-modifying antirheumatic drugs (bDMARDs)Biological

    bDMARD therapy (TNF inhibitors), according to the Portuguese recommendations for the use of biological therapies in patients with axSpA and RA

Study groups in NCT04973787
Study groupRoleWhat they receive
axSpAPatients with clinical diagnosis of axialSpondyloarthritis according to ASAS criteria, with indication for bDMARD (Portuguese Rheumatology Society Guidelines)
Receives: Biological: biological disease-modifying antirheumatic drugs (bDMARDs)
RAPatients with clinical diagnosis of Rheumatoid arthritis according to 2010 ACR/EULAR classification criteria, with indication for bDMARD (Portuguese Rheumatology Society Guidelines)
Receives: Biological: biological disease-modifying antirheumatic drugs (bDMARDs)
ControlHealthy participants, e.g. with no clinical diagnosis of rheumatic inflammatory disease, crossed by age, gender and diet profile

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Oral and gut microbiota characterization in axSpA and RA patients at baseline

    Measured: Before bDMARD

  2. Oral and gut microbiota characterization in axSpA and RA patients at week 14

    Measured: 14 weeks after start bDMARD

  3. Disease activity measured by ASAS20 in axSpA and ACR20 in RA

    Measured: 14 weeks after start bDMARD

Secondary outcomes (10)

  1. Changes in Erythrocyte Sedimentation Rate (ESR, measured in mm/h)

    Measured: Before bDMARD and 14-week after start bDMARD

  2. Changes in High-sensitivity C-reactive protein (hsCRP, measured in mg/dL)

    Measured: Before bDMARD and 14-week after start bDMARD

  3. Disease activity characterization using Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in axSpA

    Scale from 0 (worse outcome) to 10 (better outcome)

    Measured: Before bDMARD and 14-week after start bDMARD

  4. Disease activity characterization using Ankylosing Spondylitis Disease Activity Score - C-Reactive Protein (ASDAS-CRP) in axSpA

    < 1.3 Inactive disease; > 3.5 Very high disease activity

    Measured: Before bDMARD and 14-week after start bDMARD

  5. Disease activity characterization using Disease Activity Score-28 for Rheumatoid Arthritis with C-Reactive Protein (DAS28-CRP) for RA

    Score greater than 5.1 implies active disease, less than 3.2 low disease activity, and less than 2.6 remission

    Measured: Before bDMARD and 14-week after start bDMARD

  6. Quality of life evaluation with Short form 36 (SF36) at baseline and week 14

    Score from 0 (worse outcome) to 100 (better outcome)

    Measured: Before bDMARD and 14-week after start bDMARD

  7. Quality of life evaluation with Ankylosing Spondylitis Quality of Life (ASQOL) at baseline and week 14

    Range from 0 -18 - High scores indicate worse quality of life

    Measured: Before bDMARD and 14-week after start bDMARD

  8. Quality of life evaluation with Health Assessment Questionnaire (HAQ) at baseline and week 14

    Scores of 0 to 1 are generally considered to represent mild to moderate difficulty, 1 to 2 moderate to severe disability, and 2 to 3 severe to very severe disability

    Measured: Before bDMARD and 14-week after start bDMARD

  9. Quality of life evaluation regarding depression and anxiety using Hospital Anxiety and Depression Scale (HADS) at baseline and week 14

    Scores of less than 7 indicate non-cases; 8-10 Mild; 11-14 Moderate;15-21 Severe

    Measured: Before bDMARD and 14-week after start bDMARD

  10. Fatigue evaluation at baseline and week 14

    Visual analogic scale (0-10)

    Measured: Before bDMARD and 14-week after start bDMARD

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2021
  2. Study start1 Aug 2020
  3. Primary completion31 Jan 2022 (estimated)
  4. Study completion31 Jan 2022 (estimated)

Resources

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
90 participants (estimated)
Target duration
14 Weeks
IDs, dates and publications
ClinicalTrials.gov ID
NCT04973787
Sponsor's protocol ID
MicroSpA
Acronym
MicroSpA & RA
Status last verified
Jul 2021
First submitted
22 Jun 2021
Last updated
22 Jul 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Axial Spondyloarthritis and Arthritis, Rheumatoid, run by Universidade Nova de Lisboa at 10 sites in Portugal.

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 5 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 22 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Portugal. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ana Faria, PhD (00351218803033, ana.faria@nms.unl.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Oral and gut microbiota characterization in axSpA and RA patients at baseline (time frame: Before bDMARD). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04973787.

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 22 Jul 2021.

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