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

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ClinicalTrials.gov Identifier: NCT03033095
Recruitment Status : Completed
First Posted : January 26, 2017
Last Update Posted : June 6, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

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.


Condition or disease Intervention/treatment Phase
Spondylitis, Ankylosing Drug: Etanercept ® 50 mg Not Applicable

Detailed Description:

Spondyloarthritis (or spondyloarthropathy) is an inflammatory rheumatic disease that causes arthritis. It differs from other types of arthritis because it involves the sites where ligaments and tendons are attached to bones called "entheses."

All patients should get physical therapy and make exercises for joints. Exercises that promote spinal extension and mobility are the most recommended.

Non-steroidal anti-inflammatory drugs (NSAIDs) are the first line treatment for spondylarthritis. NSAIDs are effective when they are used continuously or at the request, in a short or long-term use. However, physicians have to be aware of potential cardiovascular, renal or gastro-intestinal secondary effects when they prescribe NSAIDs. After NSAIDs failure, TNF inhibitors can be used, like infliximab or etanercept. Before starting an anti-TNF treatment, a screening is mandatory. Indeed, patients treated with an anti-TNF must be followed regularly. Until now, there is no algorithm which can predict the response to TNF-inhibitors, and more especially for etanercept treatment.

In this clinical trial, the investigators want to caracterise an algorithm which can predict the response to etanercept for a cohort of patients who suffer from spondyloarthritis.

The development of a predictive algorithm for etanercept treatment will be set up from biological data and finalized with the availibility of clinical data (M6) of the patients .

A modelling by logistic regression will be used, incorporing the set of available variables.

In this clinical trial, the investigators want to caracterise an algorithm which can predict the response to TNF-inhibitors for a cohort of patients with Spondyloarthritis and for an indicated treatment of etanercept.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Prediction of the Answer to the Treatment by Biotherapies for Naive Spondyloarthritis Disease During 6 Months by Combinatorial Analysis of Serum Biomarkers
Actual Study Start Date : July 2016
Actual Primary Completion Date : July 2017
Actual Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Etanercept

Arm Intervention/treatment
Experimental: etanercept

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
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.
Other Name: ENBREL




Primary Outcome Measures :
  1. Measurement of disease activity with AS- DAS score (Ankylosing Spondylitis - Disease Activity Score ) [ Time Frame: 6 months after inclusion ]
    An important clinical ASAS response, corresponds to a variation of the ASDAS CRP ≥ 1.1


Secondary Outcome Measures :
  1. Measurement of BASDAI response [ Time Frame: 6 months after inclusion ]
    Sensitivity and specificity of the algorithm for BASDAI response : BASDAI response 50, that means an improvement of BASDAI response of 50% or more

  2. biomarkers analysis for personalized medicine [ Time Frame: at the inclusion and 6 months after ]

    8 biomarkers will be analysed :

    • calcium-binding protein complex S100A8/A9,
    • prealbumin,
    • haptoglobin (Hapto),
    • protéine C-réactive (CRP),
    • α1 anti-trypsin
    • apolipoprotéinA1 (ApoA1),
    • platelet factor 4 (PF4),
    • S100A12 protein,



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • patients who received previously a biotherapy treatment . There is no other exclusion criteria taking into account previous treatments and the duration of them.
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03033095


Locations
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France
University Hospital Grenoble
Grenoble, France, 38043
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
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Principal Investigator: Athan BAILLET University Hospital, Grenoble
Publications:
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Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT03033095    
Other Study ID Numbers: 38RC16.018
First Posted: January 26, 2017    Key Record Dates
Last Update Posted: June 6, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University Hospital, Grenoble:
TNF inhibitor
Etanercept
Spondyloarthritis
Biomarkers analysis
Personnalized medicine
Additional relevant MeSH terms:
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Spondylitis
Spondylarthritis
Spondylitis, Ankylosing
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Arthritis
Joint Diseases
Spondylarthropathies
Ankylosis
Etanercept
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors