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

October 30, 2020 updated by: Universidade Nova de Lisboa

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

69

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Portugal
      • Lisbon, Portugal
        • Faculdade de Ciências Médicas da Universidade NOVA de Lisboa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Adalimumab
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.
Drug: Adalimumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical response biomarkers (Assessment of Spondyloarthritis International Society (ASAS) 20 and Ankylosing Spondylitis Disease Activity Score (ASDAS)
Time Frame: 14 weeks
To identify anti-TNF alpha clinical response biomarkers by microarrays and proteomics technology.
14 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
QoL evaluation
Time Frame: 14 weeks
To evaluate quality of life using ASQOL and SF-36 questionnaires
14 weeks
MRI progression
Time Frame: 14 weeks
Rachis evaluation according to acute and structural lesions
14 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Nova de Lisboa

Investigators

  • Study Chair: Fernando M. Pimentel-Santos, MD, PhD, NOVA Medical School/Faculdade de Ciências Médicas
  • Principal Investigator: Jaime C. Branco, MD, PhD, NOVA Medical School/Faculdade de Ciências Médicas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2015

Primary Completion (Actual)

May 1, 2018

Study Completion (Actual)

May 28, 2018

Study Registration Dates

First Submitted

July 3, 2015

First Submitted That Met QC Criteria

July 7, 2015

First Posted (Estimate)

July 8, 2015

Study Record Updates

Last Update Posted (Actual)

November 3, 2020

Last Update Submitted That Met QC Criteria

October 30, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UniversidadeNL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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