Ankylosing Spondylitis MedDRA version: 20.0 Level: PT Classification code 10002556 Term: Ankylosing spondylitis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Trade Name: Humira
Product Name: Humira
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-1
Sponsors
Faculdade de Ciências Médicas da Universidade Nova de Lisboa
Eligibility
Sex/Gender
All
Inclusion 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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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; Secondary Objective: 1) QoL evaluation 2) MRI progression under TNF-alpha therapy ;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;Timepoint(s) of evaluation of this end point: Response at 14 weeks will be compared with genetic profile. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) QoL evaluation 2) MRI progression under TNF-alpha therapy ;Timepoint(s) of evaluation of this end point: 14 weeks. | — |
Countries
Portugal
Contacts
Public ContactFernando Pimentel Santos
Centro de Estudo de Doenças Crónicas
Outcome results
None listed