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

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.

Conditions

• Axial Spondyloarthritis
• Arthritis, Rheumatoid

Interventions

BIOLOGICAL

biological disease-modifying antirheumatic drugs (bDMARDs)

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

Sponsors & Collaborators

• Centro Hospitalar Lisboa Ocidental Hospital Egas Moniz

  collaborator UNKNOWN

• Centro Hospitalar De São João, E.P.E.

  collaborator OTHER

• Centro Hospitalar de Vila Nova de Gaia/Espinho

  collaborator OTHER

• Centro Hospitalar Universitário de Lisboa Norte - Hospital de Santa Maria

  collaborator UNKNOWN

• Instituto Português de Reumatologia

  collaborator UNKNOWN

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

  collaborator UNKNOWN

• Centro Hospitalar Baixo Vouga - Hospital Infante D. Pedro

  collaborator UNKNOWN

• Comprehensive Health Research Center

  collaborator OTHER

• iNOVA4Health - Rheumatic Diseases Lab

  collaborator UNKNOWN

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

  collaborator UNKNOWN

• Hospital de Braga E.P.E.

  collaborator UNKNOWN

• Hospital Sousa Martins - Unidade de Saúde Local da Guarda

  collaborator UNKNOWN

• Universidade Nova de Lisboa

  lead OTHER

Principal Investigators

• Ana Faria, PhD · Universidade Nova de Lisboa

• Fernando Pimentel-Santos, PhD Agg · NOVA Medical School, Universidade NOVA de Lisboa; CHLO Hospital Egas Moniz

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-08-01

Primary Completion

2022-01-31

Completion

2022-01-31

Countries

• Portugal

Study Locations