Biomarkers identification of efficacy in Ankylosing Spondylitis

Phase 1

• Conditions: Ankylosing Spondylitis; MedDRA version: 20.0 Level: PT Classification code 10002556 Term: Ankylosing spondylitis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2013-004406-25-PT
• Lead Sponsor: Faculdade de Ciências Médicas da Universidade Nova de Lisboa

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-02-21
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 70

Inclusion Criteria

•AS according to 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, dose stable in 4 weeks before study iniciation
•Adequate contraception (barrier or hormonal) in men and women of childbearing age (patients and their partners
•Adequate renal and hepatic function (2 times ULN)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 70
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 70

Exclusion Criteria

•Current pregnancy or breastfeeding
•Any persistent or severe infection within 30 days of baseline
•Previous treatment with biologic DMARD's
•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
•Active or latent tuberculosis (TB) or histoplasmosis
•Malignancy (except for completely treated squamous or basal cell carcinoma)
•Positive serology for hepatitis B, hepatitis C, or human immunodeficiency virus
•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 (sindesmophytes presence at all levels from D12 to S1 in XR lateral view)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To identify new candidate genes that are differentially expressed in responders’ vs non-responders to anti-TNF alpha therapy at the several time points we will use the transcriptomic and proteomic analyses;<br> Secondary Objective: 1) QoL evaluation<br> 2) MRI progression under TNF-alpha therapy<br> ;Primary end point(s): To identify new candidate genes that are differentially expressed in responders’ vs non-responders to anti-TNF alpha therapy at the several time points we will use the transcriptomic and proteomic analyses;Timepoint(s) of evaluation of this end point: Response at 14 weeks will be compared with genetic profile.

Secondary Outcome Measures

Name	Time	Method
<br> Secondary end point(s): 1) QoL evaluation<br> 2) MRI progression under TNF-alpha therapy<br> ;Timepoint(s) of evaluation of this end point: 14 weeks.