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

Phase 4

Completed

• Conditions: Ankylosing Spondylitis
• Interventions: Drug: Adalimumab

• Registration Number: NCT02492217
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05
• Study First Submitted: 2015-07-03
• Study First Submitted QC: 2015-07-07
• Study First Posted: 2015-07-08
• Primary Completion: 2018-05
• Study Completion: 2018-05-28
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-30
• Last Update Posted: 2020-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Adalimumab	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.

Primary Outcome Measures

Name	Time	Method
Clinical response biomarkers (Assessment of Spondyloarthritis International Society (ASAS) 20 and Ankylosing Spondylitis Disease Activity Score (ASDAS)	14 weeks	To identify anti-TNF alpha clinical response biomarkers by microarrays and proteomics technology.

Secondary Outcome Measures

Name	Time	Method
QoL evaluation	14 weeks	To evaluate quality of life using ASQOL and SF-36 questionnaires
MRI progression	14 weeks	Rachis evaluation according to acute and structural lesions

Trial Locations

Locations (1)

Faculdade de Ciências Médicas da Universidade Nova de Lisboa; 🇵🇹 Lisbon, Portugal