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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02492217
Recruitment Status : Completed
First Posted : July 8, 2015
Last Update Posted : November 3, 2020
Information provided by (Responsible Party):
Universidade Nova de Lisboa

Brief 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.

Condition or disease Intervention/treatment Phase
Ankylosing Spondylitis Drug: Adalimumab Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 69 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Biomarkers Identification of Anti-TNF α Agent's Efficacy in Ankylosing Spondylitis Patients Using a Transcriptome Analysis and Mass Spectrometry
Actual Study Start Date : May 2015
Actual Primary Completion Date : May 2018
Actual Study Completion Date : May 28, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Adalimumab

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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. QoL evaluation [ Time Frame: 14 weeks ]
    To evaluate quality of life using ASQOL and SF-36 questionnaires

  2. MRI progression [ Time Frame: 14 weeks ]
    Rachis evaluation according to acute and structural lesions

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02492217

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Faculdade de Ciências Médicas da Universidade Nova de Lisboa
Lisbon, Portugal
Sponsors and Collaborators
Universidade Nova de Lisboa
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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
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Responsible Party: Universidade Nova de Lisboa Identifier: NCT02492217    
Other Study ID Numbers: UniversidadeNL
First Posted: July 8, 2015    Key Record Dates
Last Update Posted: November 3, 2020
Last Verified: October 2020
Keywords provided by Universidade Nova de Lisboa:
Ankylosing Spondylitis
TNF-alpha agents
biologic therapies
efficacy prediction
Additional relevant MeSH terms:
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Spondylitis, Ankylosing
Bone Diseases, Infectious
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Joint Diseases
Anti-Inflammatory Agents
Antirheumatic Agents