Clinical trial · Interventional
Biomarkers Identification of Anti-tumor Necrosis Factor (TNF) α Agent's Efficacy in Ankylosing Spondylitis Patients
Biomarkers Identification of Anti-TNF α Agent's Efficacy in Ankylosing Spondylitis Patients Using a Transcriptome Analysis and Mass Spectrometry
NCT02492217CI-TRIAL-00048067completedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- 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)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ankylosing Spondylitis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adalimumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Adalimumab
- description
- Adalimumab will be provided to trial participants as 0.8 ml single dose pre-filled syringes containing 40mg adalimumab each. A kit will be dispensed to he subject every two weeks, each kit containing one syringe.
- interventionNames
- Drug: Adalimumab
Primary outcomes (1)
- measure
- Clinical response biomarkers (Assessment of Spondyloarthritis International Society (ASAS) 20 and Ankylosing Spondylitis Disease Activity Score (ASDAS)
- timeFrame
- 14 weeks
- description
- To identify anti-TNF alpha clinical response biomarkers by microarrays and proteomics technology.
Secondary outcomes (2)
- measure
- QoL evaluation
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.