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

New University of Lisbon

Status and phase: Completed; Phase 4

Conditions: Ankylosing Spondylitis

Treatments: Drug: Adalimumab

Study type: Interventional

Funder types: Other

Identifiers

NCT02492217

UniversidadeNL

Details and patient eligibility

About

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.

Enrollment: 69 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

69 participants in 1 patient group

Adalimumab

Experimental group

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.

Treatment:

Drug: Adalimumab