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/AClinical Study ID
NCT04973787
MicroSpA
Ages 18-65 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 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 useof biological therapies in patients with axSpA and RA;
- Oral corticosteroids (equivalent to prednisolone ≤ 10mg/day) and/or nonsteroidalanti-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.
Exclusion
Exclusion Criteria:
- 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, unstableischemic heart disease);
- History of any documented gastrointestinal disease or tract surgery leaving permanentresidua (e.g., gastrectomy, bariatric surgery, or colectomy);
- Intraarticular injections of extra-axial joints and tendons within 28 days before orat 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 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
Connect with a study center
Centro Hospitalar Baixo Vouga - Hospital Infante D. Pedro
Aveiro,
PortugalSite Not Available
Hospital de Braga, E.P.E.
Braga,
PortugalSite Not Available
Hospital Sousa Martins - Unidade de Saúde Local da Guarda
Guarda,
PortugalSite Not Available
Centro Hospitalar Lisboa Ocidental - Hospital Egas Moniz
Lisboa,
PortugalActive - Recruiting
Centro Hospitalar Universitário de Lisboa Norte - Hospital Santa Maria
Lisboa,
PortugalSite Not Available
Instituto Português de Reumatologia
Lisboa,
PortugalSite Not Available
Centro Hospitalar Universitário São João
Oporto,
PortugalSite Not Available
Unidade Local de Saúde do Alto Minho, Hospital Conde de Bertiandos
Ponte de Lima,
PortugalSite Not Available
Centro Hospitalar de Médio Tejo - Hospital Rainha Santa Isabel - Torres Novas
Torres Novas,
PortugalSite Not Available
Centro Hospitalar de Vila Nova da Gaia/Espinho
Vila Nova De Gaia,
PortugalSite Not Available
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