Trial | NCT02492217  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    adalimumab ...

  • Study Participants

    69
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.
Study Started
May 31
2015
Primary Completion
May 31
2018
Study Completion
May 28
2018
Last Update
Nov 03
2020

Drug Adalimumab

Adalimumab Experimental

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.

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
No Results Posted