Clinical trial · Observational
The Role of Microbiome on Biological Therapy Efficacy in axSpA and RA
MicroSpA & MicroRA: The Role of Microbiome on Biological Therapy Efficacy in Axial Spondyloarthritis and Rheumatoid Arthritis - a New Paradigm
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Arthritis, Rheumatoid | — | UNRESOLVED | — |
| Axial Spondyloarthritis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| biological disease-modifying antirheumatic drugs (bDMARDs) | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- axSpA
- description
- Patients with clinical diagnosis of axialSpondyloarthritis according to ASAS criteria, with indication for bDMARD (Portuguese Rheumatology Society Guidelines)
- interventionNames
- Biological: biological disease-modifying antirheumatic drugs (bDMARDs)
- label
- RA
- description
- Patients with clinical diagnosis of Rheumatoid arthritis according to 2010 ACR/EULAR classification criteria, with indication for bDMARD (Portuguese Rheumatology Society Guidelines)
- interventionNames
- Biological: biological disease-modifying antirheumatic drugs (bDMARDs)
- label
- Control
- description
- Healthy participants, e.g. with no clinical diagnosis of rheumatic inflammatory disease, crossed by age, gender and diet profile
Primary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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 use of biological therapies in patients with axSpA and RA; 3. Oral corticosteroids (equivalent to prednisolone ≤ 10mg/day) and/or nonsteroidal anti-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 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, unstable ischemic heart disease); 7. History of any documented gastrointestinal disease or tract surgery leaving permanent residua (e.g., gastrectomy, bariatric surgery, or colectomy); 8. Intraarticular injections of extra-axial joints and tendons within 28 days before or at 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 criteria will be applied except for rheumatic disease diagnosis.
References
Publications (0)
Data not yet available