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

NCT ID: NCT02492217

Last Updated: 2020-11-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 69 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2018-05-28

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.

Conditions

Ankylosing Spondylitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Adalimumab

Intervention Type: DRUG

Interventions

Adalimumab

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidade Nova de Lisboa

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fernando M. Pimentel-Santos, MD, PhD

Role: STUDY_CHAIR

NOVA Medical School/Faculdade de Ciências Médicas

Jaime C. Branco, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

NOVA Medical School/Faculdade de Ciências Médicas

Locations

Faculdade de Ciências Médicas da Universidade Nova de Lisboa

Lisbon, , Portugal

Countries

Portugal

Other Identifiers

UniversidadeNL

Identifier Type: -

Identifier Source: org_study_id