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

NCT04973787 | Unknown

• 1 other identifier: MicroSpA
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 10

Brief 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

Keywords

Tumor Necrosis Factor alpha inhibitor; Microbiota; Biomarker

Outcome Measures

Primary Outcomes (3)

• Oral and gut microbiota characterization in axSpA and RA patients at baseline

  Before bDMARD

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

  14 weeks after start bDMARD

• Disease activity measured by ASAS20 in axSpA and ACR20 in RA

  14 weeks after start bDMARD

Secondary Outcomes (10)

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

  Before bDMARD and 14-week after start bDMARD

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

  Before bDMARD and 14-week after start bDMARD

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

  Before bDMARD and 14-week after start bDMARD

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

  Before bDMARD and 14-week after start bDMARD

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

  Before bDMARD and 14-week after start bDMARD

Study Arms (3)

axSpA

Patients with clinical diagnosis of axialSpondyloarthritis according to ASAS criteria, with indication for bDMARD (Portuguese Rheumatology Society Guidelines)

Biological: biological disease-modifying antirheumatic drugs (bDMARDs)

RA

Patients with clinical diagnosis of Rheumatoid arthritis according to 2010 ACR/EULAR classification criteria, with indication for bDMARD (Portuguese Rheumatology Society Guidelines)

Biological: biological disease-modifying antirheumatic drugs (bDMARDs)

Control

Healthy participants, e.g. with no clinical diagnosis of rheumatic inflammatory disease, crossed by age, gender and diet profile

Interventions

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

RA; axSpA

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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);
• 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.

Sponsors & Collaborators

• Universidade Nova de Lisboa: lead
• Centro Hospitalar Lisboa Ocidental Hospital Egas Moniz: collaborator
• Centro Hospitalar De São João, E.P.E.: collaborator
• Centro Hospitalar de Vila Nova de Gaia/Espinho: collaborator
• Centro Hospitalar Universitário de Lisboa Norte - Hospital de Santa Maria: collaborator
• Instituto Português de Reumatologia: collaborator
• Centro Hospitalar Médio Tejo - Hospital Rainha Santa Isabel - Torres Novas: collaborator
• Centro Hospitalar Baixo Vouga - Hospital Infante D. Pedro: collaborator
• Comprehensive Health Research Center: collaborator
• iNOVA4Health - Rheumatic Diseases Lab: collaborator
• Unidade Local de Saúde do Alto Minho, Hospital Conde de Bertiandos: collaborator
• Hospital de Braga E.P.E.: collaborator
• Hospital Sousa Martins - Unidade de Saúde Local da Guarda: collaborator

Study Sites (10)

Centro Hospitalar Baixo Vouga - Hospital Infante D. Pedro

Aveiro, Portugal

NOT YET RECRUITING

Hospital de Braga, E.P.E.

Braga, Portugal

NOT YET RECRUITING

Hospital Sousa Martins - Unidade de Saúde Local da Guarda

Guarda, Portugal

NOT YET RECRUITING

Centro Hospitalar Lisboa Ocidental - Hospital Egas Moniz

Lisbon, Portugal

RECRUITING

Centro Hospitalar Universitário de Lisboa Norte - Hospital Santa Maria

Lisbon, Portugal

NOT YET RECRUITING

Instituto Português de Reumatologia

Lisbon, Portugal

NOT YET RECRUITING

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

Ponte de Lima, Portugal

NOT YET RECRUITING

Centro Hospitalar Universitário São João

Porto, Portugal

NOT YET RECRUITING

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

Torres Novas, Portugal

NOT YET RECRUITING

Centro Hospitalar de Vila Nova da Gaia/Espinho

Vila Nova de Gaia, Portugal

NOT YET RECRUITING

MeSH Terms

Conditions

Axial Spondyloarthritis; Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Ana Faria, PhD

  Universidade Nova de Lisboa

  PRINCIPAL INVESTIGATOR

• Fernando Pimentel-Santos, PhD Agg

  NOVA Medical School, Universidade NOVA de Lisboa; CHLO Hospital Egas Moniz

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ana Faria, PhD

CONTACT

00351218803033; ana.faria@nms.unl.pt

Fernando Pimentel-Santos, PhD Agg

CONTACT

00351917305093; pimentel.santos@nms.unl.pt

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 14 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2021
• First Posted: July 22, 2021
• Study Start: August 1, 2020
• Primary Completion: January 31, 2022
• Study Completion: January 31, 2022
• Last Updated: July 22, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

PT (10)