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

Ankylosing Spondylitis Clinical Trial

Official title:

Biomarkers Identification of Anti-TNF α Agent's Efficacy in Ankylosing Spondylitis Patients Using a Transcriptome Analysis and Mass Spectrometry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02492217
• Other study ID #: UniversidadeNL
• Status: Completed
• Phase: Phase 4
• Start date: May 2015
• Est. completion date: May 28, 2018

Study information

• Verified date: October 2020
• Source: Universidade Nova de Lisboa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: May 28, 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Spondylitis
• Spondylitis, Ankylosing

Intervention

Drug:
• Adalimumab

Locations

Country	Name	City	State
Portugal	Faculdade de Ciências Médicas da Universidade Nova de Lisboa	Lisbon

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Nova de Lisboa

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical response biomarkers (Assessment of Spondyloarthritis International Society (ASAS) 20 and Ankylosing Spondylitis Disease Activity Score (ASDAS)	To identify anti-TNF alpha clinical response biomarkers by microarrays and proteomics technology.	14 weeks
Secondary	QoL evaluation	To evaluate quality of life using ASQOL and SF-36 questionnaires	14 weeks
Secondary	MRI progression	Rachis evaluation according to acute and structural lesions	14 weeks