Ankylosing Spondylitis
Conditions
Keywords
Ankylosing Spondylitis, adalimumab, TNF-alpha agents, spondyloarthritis, biologic therapies, AS, biomarkers, efficacy prediction
Brief summary
To identify new candidate genes and proteins that are differentially expressed in responders' vs non-responders to anti-TNF alpha therapy at the several time points the investigators will use the transcriptomic and proteomic analyses. Demonstrate a link between gene expression and protein markers regarding prediction to anti-TNF alpha therapy efficacy.
Interventions
DRUGAdalimumab
Sponsors
Universidade Nova de Lisboa
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* AS according to Portuguese Society of Rheumatology (SPR) guidelines (1984 modified New York Criteria, but allowing the use of MRI as imagiological criteria) * Patient enrolment followed national guidelines for TNF antagonist use for the treatment of AS * Adults between 18 to 75 years * Ability to provide informed consent * Corticosteroid therapy allowed (equivalent to ≤ 10 mg prednisone) and / or NSAID(nonsteroidal antiinflammatory drug), stable dose in 4 weeks before study initiation * Adequate contraception (barrier or hormonal) in men and women of childbearing age (patients and their partners * Adequate renal and hepatic function (2 times ULN)
Exclusion criteria
* Current pregnancy or breastfeeding * Previous treatment with biologic DMARD's (disease-modifying antirheumatic drug) * Intraarticular injections or infiltrations of extraaxial joints and tendons within 28 days before or at screening, or intraarticular injections of sacroiliac joints ≤ 28 days before screening * History of rheumatic disorder other than AS * Other forms of spondylarthritis than AS * Any uncontrolled medical condition (e.g., uncontrolled diabetes mellitus, unstable ischemic heart disease) * History or signs of demyelinating disease * Malignancy (except for completely treated squamous or basal cell carcinoma) * Moderate to severe heart failure (NYHA class III/IV) Positive serology for hepatitis B, hepatitis C, or human immunodeficiency virus * Active or latent tuberculosis (TB) or histoplasmosis or other severe infections such as sepsis, and opportunistic infections * Infections requiring hospitalization or intravenous treatment with antibiotics within 30 days or oral treatment with antibiotics within 14 days before enrollment * Ankylosis of the spine (syndesmophytes presence at all levels from D12 to S1 in X-ray (XR) lateral view) * Hypersensitivity to the active substance or to any of the excipients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical response biomarkers (Assessment of Spondyloarthritis International Society (ASAS) 20 and Ankylosing Spondylitis Disease Activity Score (ASDAS) | 14 weeks | To identify anti-TNF alpha clinical response biomarkers by microarrays and proteomics technology. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| QoL evaluation | 14 weeks | To evaluate quality of life using ASQOL and SF-36 questionnaires |
| MRI progression | 14 weeks | Rachis evaluation according to acute and structural lesions |
Countries
Portugal
Outcome results
None listed