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

Sponsor
Universidade Nova de Lisboa
Study ID
NCT02492217
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
May 31, 2015
Status verified
Oct 2020
Primary completion
May 31, 2018
Completion
May 28, 2018

Study Design

Enrollment
69 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 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 Measure

Clinical response biomarkers (Assessment of Spondyloarthritis International Society (ASAS) 20 and Ankylosing Spondylitis Disease Activity Score (ASDAS) [ Time Frame: 14 weeks ]

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