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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02492217
• Date of registration: 03/07/2015
• Prospective Registration: No
• 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: Jaime C. Branco, MD, PhD
• Affiliation: NOVA Medical School/Faculdade de Ciências Médicas

• Name: Fernando M. Pimentel-Santos, MD, PhD
• 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