Biomarkers Identification of Anti-tumor Necrosis Factor (TNF) α Agent's Efficacy in Ankylosing Spondylitis Patients

• Status: Completed
• Trial end date: 2018-05-28
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universidade Nova de Lisboa
• Treatments: Adalimumab

Criteria

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