Biomarkers identification of efficacy in Ankylosing Spondylitis

• Register: EUCTR
• Last refreshed on: 10 December 2019
• Main ID: EUCTR2013-004406-25-PT
• Date of registration: 21/02/2014
• Prospective Registration: Yes
• Primary sponsor: Faculdade de Ciências Médicas da Universidade Nova de Lisboa
• Public title: Biomarkers identification of efficacy in Ankylosing Spondylitis
• 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: 19/09/2014
• Target sample size: 70
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-004406-25
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no; Randomised: no; Open: yes; Single blind: no; Double blind: no; Parallel group: no; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

Portugal

Contacts

• Name: Fernando Pimentel Santos
• Affiliation: Centro de Estudo de Doenças Crónicas

• Name: Fernando Pimentel Santos
• Affiliation: Centro de Estudo de Doenças Crónicas

Key inclusion & exclusion criteria

Inclusion criteria:
• AS according to 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, dose stable in 4 weeks before study iniciation
• Adequate contraception (barrier or hormonal) in men and women of childbearing age (patients and their partners
• Adequate renal and hepatic function (2 times ULN)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 70
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 70

Exclusion criteria:
• Current pregnancy or breastfeeding
• Any persistent or severe infection within 30 days of baseline
• Previous treatment with biologic DMARD's
• 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
• Active or latent tuberculosis (TB) or histoplasmosis
• Malignancy (except for completely treated squamous or basal cell carcinoma)
• Positive serology for hepatitis B, hepatitis C, or human immunodeficiency virus
• 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 (sindesmophytes presence at all levels from D12 to S1 in XR lateral view)



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Ankylosing Spondylitis
MedDRA version: 20.0 Level: PT Classification code 10002556 Term: Ankylosing spondylitis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Intervention(s)

Trade Name: Humira
Product Name: Humira
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 40-

Primary Outcome(s)

Secondary Objective: 1) QoL evaluation
2) MRI progression under TNF-alpha therapy

Timepoint(s) of evaluation of this end point: Response at 14 weeks will be compared with genetic profile.

Main Objective: To identify new candidate genes that are differentially expressed in responders’ vs non-responders to anti-TNF alpha therapy at the several time points we will use the transcriptomic and proteomic analyses

Primary end point(s): To identify new candidate genes that are differentially expressed in responders’ vs non-responders to anti-TNF alpha therapy at the several time points we will use the transcriptomic and proteomic analyses

Secondary Outcome(s)

Secondary end point(s): 1) QoL evaluation
2) MRI progression under TNF-alpha therapy

Timepoint(s) of evaluation of this end point: 14 weeks.

Secondary ID(s)

FCM-RHEUMA-001

Source(s) of Monetary Support

Abbvie

Ethics review

Status: Approved
Approval date:
Contact: