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

Last updated: July 12, 2021
Sponsor: Universidade Nova de Lisboa
Overall Status: Active - Recruiting

Phase

N/A

Condition

Rheumatoid Arthritis

Ankylosing Spondylitis

Joint Injuries

Treatment

N/A

Clinical Study ID

NCT04973787
MicroSpA
  • Ages 18-65
  • All Genders
  • Accepts Healthy Volunteers

Study 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 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  1. History of rheumatic disorder other than axSpA or RA;
  2. History of Inflammatory Bowel Disease;
  3. Previous treatment with bDMARD;
  4. Current pregnancy or breastfeeding;
  5. Malignancy (except for completely treated squamous or basal cell carcinoma);
  6. Any uncontrolled medical condition (e.g., uncontrolled diabetes mellitus, unstableischemic heart disease);
  7. History of any documented gastrointestinal disease or tract surgery leaving permanentresidua (e.g., gastrectomy, bariatric surgery, or colectomy);
  8. Intraarticular injections of extra-axial joints and tendons within 28 days before orat baseline;
  9. 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 criteriawill be applied except for rheumatic disease diagnosis.

Study Design

Total Participants: 90
Study Start date:
August 01, 2020
Estimated Completion Date:
January 31, 2022

Study 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.

Connect with a study center

  • Centro Hospitalar Baixo Vouga - Hospital Infante D. Pedro

    Aveiro,
    Portugal

    Site Not Available

  • Hospital de Braga, E.P.E.

    Braga,
    Portugal

    Site Not Available

  • Hospital Sousa Martins - Unidade de Saúde Local da Guarda

    Guarda,
    Portugal

    Site Not Available

  • Centro Hospitalar Lisboa Ocidental - Hospital Egas Moniz

    Lisboa,
    Portugal

    Active - Recruiting

  • Centro Hospitalar Universitário de Lisboa Norte - Hospital Santa Maria

    Lisboa,
    Portugal

    Site Not Available

  • Instituto Português de Reumatologia

    Lisboa,
    Portugal

    Site Not Available

  • Centro Hospitalar Universitário São João

    Oporto,
    Portugal

    Site Not Available

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

    Ponte de Lima,
    Portugal

    Site Not Available

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

    Torres Novas,
    Portugal

    Site Not Available

  • Centro Hospitalar de Vila Nova da Gaia/Espinho

    Vila Nova De Gaia,
    Portugal

    Site Not Available

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