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Influence of Therapeutic Education in Patients With Joint Inflammation Treated With a Biological Treatment (ALSASP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03360864
Recruitment Status : Not yet recruiting
First Posted : December 4, 2017
Last Update Posted : January 9, 2018
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

Brief Summary:

To describe, with a patient reported score (BIOSECURE), the influence of an approved therapeutic education program (TEP) in patients with joint inflammation requiring a biological treatment initiation.

The hypothesis is that patients attending the TEP will display better cognitive and adaptation competences than patients with no TEP.

Patient's reported quality of life, disease related stress management, treatment adherence, socio-demographic factors, biological home administration modalities and if the biologic treatment is maintained at 12 months, will also be described.

Condition or disease Intervention/treatment Phase
Non-radiographic Spondyloarthritis Other: Education program Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Impact of a Therapeutic Education Program in Patients With Non-radiological Spondyloarthritis Treated With Anti-tumor Necrosis Factor (TNF)
Estimated Study Start Date : February 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
Experimental: Therapeutic Education Program

Patient randomized in this arm will attend a 1 day long validated Therapeutic Education Program.

This program will take place within 6 months after biologic treatment initiation.

Other: Education program
Patient will participate to a education program.

No Intervention: No therapeutic Education Program
Patient randomized in this arm will not attend a Therapeutic Education Program within 12 months after biologic treatment initiation.

Primary Outcome Measures :
  1. BIOSECURE patient self-questionnaire [ Time Frame: Change from Baseline Biosecure's score at 6 months and at 12 month after biological treatment initiation ]
    Patients will address questions and role play scenario evaluating cognitive and adaptive competences. The Biosecure score is between 0 and 100.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Non-radiological spondyloarthritis diagnosis (ASAS criteria)
  • Anti-TNFalpha biological treatment initiation required
  • Adult patient (age>18years)
  • Capacity to understand self-questionnaires and address questions
  • Patient accepting to attend a therapeutic education program (TEP)

Exclusion Criteria:

  • Previous Anti-TNFalpha biological treatment
  • Previous attendance to a TEP concerning biological or spondyloarthritis
  • Contraindication to Anti-TNFalpha treatment
  • Associated and unbalanced diseases

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 identifier (NCT number): NCT03360864

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Contact: Christelle SORDET, MD +33 88 12 81 16

Sponsors and Collaborators
University Hospital, Strasbourg, France
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Principal Investigator: Christelle SORDET, MD CHU de Strasbourg

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Responsible Party: University Hospital, Strasbourg, France Identifier: NCT03360864     History of Changes
Other Study ID Numbers: 6661
First Posted: December 4, 2017    Key Record Dates
Last Update Posted: January 9, 2018
Last Verified: November 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Strasbourg, France:
Therapeutic education
Additional relevant MeSH terms:
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Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Joint Diseases