Prediction of the Answer to the Treatment by Biotherapies for Naive Spondyloarthritis by Combinatorial Analysis of Serum Biomarkers

NCT03033095 | Completed

• 1 other identifier: 38RC16.018
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this trial is the caracterisation of a predicting algorithm of the answering response for patients with etanercept treatment in spondyloarthritis disease. This algorithm will help to target patients patients who have a risk / benefit important for etanercept treatment.

Conditions

Spondylitis, Ankylosing

Keywords

TNF inhibitor; Etanercept; Spondyloarthritis; Biomarkers analysis; Personnalized medicine

Outcome Measures

Primary Outcomes (1)

• Measurement of disease activity with AS- DAS score (Ankylosing Spondylitis - Disease Activity Score )

  An important clinical ASAS response, corresponds to a variation of the ASDAS CRP ≥ 1.1

  6 months after inclusion

Secondary Outcomes (2)

• Measurement of BASDAI response

  6 months after inclusion

• biomarkers analysis for personalized medicine

  at the inclusion and 6 months after

Study Arms (1)

etanercept

EXPERIMENTAL

The etanercept is not the experimental study drug. Etanercept is a treatment justifying the inclusion of patients and is used in accordance with its marketing authorization. Modality of administration : Etanercept : 50 mg / week subcutaneously, every 7 days The clinical response will be evaluated after 6 months of etanercept treatment, at the M6 visit.

Drug: Etanercept ® 50 mg

Interventions

Etanercept ® 50 mg DRUG

The etanercept is not the experimental study drug. Etanercept is a treatment justifying the inclusion of patients and is used in accordance with its marketing authorization.

Also known as: ENBREL

etanercept

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with spondylarthritis validating ASAS or New York modified critera, and for who etanercept is indicated.
• Naïve from biological Drug Modifying Anti Rheumatic Drugs
• patients between 18 and 70 years old
• patients who can be monitored at 6 months ;
• patients who can observe the entire treatment ;
• patiens with age to procreate under effective contraception ((abstinence, oral contraceptives , intrauterine devices , implants, spermicide or surgical sterilization ) during the study and for 6 months, 3 weeks after the last injection.
• patients able to understand and accept the terms of the study
• patients having signed the informed consent.
• patients insured under social security

You may not qualify if:

• patients of age protected ;
• patients with difficulties for understanding french language ;
• patients with high function disorders incompatible with an education program (dementia Alzheimer's type , etc ...) ;
• patients with psycho- social instability incompatible with regular monitoring (homeless , addictive behavior ,etc.) ;
• patients in a socio- professional situation incompatible with optimal attendance to the program - - Pregnant or nursing patients
• contraindication to the use of anti- TNF treatment
• Surgery scheduled during the study.
• Persons mentioned in Articles L.1121-5 to L.1121-8 of the Public Health Code

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

University Hospital Grenoble

Grenoble, 38043, France

Location

Related Publications (3)

• Aaltonen KJ, Virkki LM, Malmivaara A, Konttinen YT, Nordstrom DC, Blom M. Systematic review and meta-analysis of the efficacy and safety of existing TNF blocking agents in treatment of rheumatoid arthritis. PLoS One. 2012;7(1):e30275. doi: 10.1371/journal.pone.0030275. Epub 2012 Jan 17.

  PMID: 22272322 BACKGROUND

• Braun J, Sieper J. Biological therapies in the spondyloarthritides--the current state. Rheumatology (Oxford). 2004 Sep;43(9):1072-84. doi: 10.1093/rheumatology/keh205. Epub 2004 Jun 8.

  PMID: 15187239 BACKGROUND

• Kristensen LE, Saxne T, Nilsson JA, Geborek P. Impact of concomitant DMARD therapy on adherence to treatment with etanercept and infliximab in rheumatoid arthritis. Results from a six-year observational study in southern Sweden. Arthritis Res Ther. 2006;8(6):R174. doi: 10.1186/ar2084.

  PMID: 17121678 BACKGROUND

MeSH Terms

Conditions

Spondylitis, Ankylosing; Spondylarthritis

Interventions

Etanercept

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins

Study Officials

• Athan BAILLET

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2016
• First Posted: January 26, 2017
• Study Start: July 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: March 28, 2018
• Last Updated: June 14, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)