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

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ClinicalTrials.gov Identifier: NCT03360864
Recruitment Status : Not yet recruiting
First Posted : December 4, 2017
Last Update Posted : January 9, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

Tracking Information
First Submitted Date  ICMJE November 27, 2017
First Posted Date  ICMJE December 4, 2017
Last Update Posted Date January 9, 2018
Estimated Study Start Date  ICMJE February 2018
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 1, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03360864 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Influence of Therapeutic Education in Patients With Joint Inflammation Treated With a Biological Treatment
Official Title  ICMJE Impact of a Therapeutic Education Program in Patients With Non-radiological Spondyloarthritis Treated With Anti-tumor Necrosis Factor (TNF)
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Non-radiographic Spondyloarthritis
Intervention  ICMJE Other: Education program
Patient will participate to a education program.
Study Arms  ICMJE
  • 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.

    Intervention: Other: 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: December 1, 2017)
110
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Christelle SORDET, MD +33 88 12 81 16 christelle.sordet@chru-strasbourg.fr
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03360864
Other Study ID Numbers  ICMJE 6661
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Strasbourg, France
Study Sponsor  ICMJE University Hospital, Strasbourg, France
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Christelle SORDET, MD CHU de Strasbourg
PRS Account University Hospital, Strasbourg, France
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP