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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT02492217
Date of registration: 03/07/2015
Prospective Registration: Yes
Primary sponsor: Universidade Nova de Lisboa
Public title: Biomarkers Identification of Anti-tumor Necrosis Factor (TNF) a Agent's Efficacy in Ankylosing Spondylitis Patients
Scientific title: Biomarkers Identification of Anti-TNF a Agent's Efficacy in Ankylosing Spondylitis Patients Using a Transcriptome Analysis and Mass Spectrometry
Date of first enrolment: May 2015
Target sample size: 69
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02492217
Study type:  Interventional
Study design:  Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 4
Countries of recruitment
Portugal
Contacts
Name:     Fernando M. Pimentel-Santos, MD, PhD
Address: 
Telephone:
Email:
Affiliation:  NOVA Medical School/Faculdade de Ciências Médicas
Name:     Jaime C. Branco, MD, PhD
Address: 
Telephone:
Email:
Affiliation:  NOVA Medical School/Faculdade de Ciências Médicas
Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All
Health Condition(s) or Problem(s) studied
Ankylosing Spondylitis
Intervention(s)
Drug: Adalimumab
Primary Outcome(s)
Clinical response biomarkers (Assessment of Spondyloarthritis International Society (ASAS) 20 and Ankylosing Spondylitis Disease Activity Score (ASDAS) [Time Frame: 14 weeks]
Secondary Outcome(s)
MRI progression [Time Frame: 14 weeks]
QoL evaluation [Time Frame: 14 weeks]
Secondary ID(s)
UniversidadeNL
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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