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Effect of Pharmaceutical Consultations Just Before Rheumatology Consultations on Improving Knowledge and Skills for Patients With Inflammatory Arthritis With Subcutaneous Biologic DMARDs

H

Hôpital Cochin

Status

Unknown

Conditions

Spondyloarthritis
Biological Therapy
Arthritis, Rheumatoid

Treatments

Other: Pharmacist's consultation

Study type

Observational

Funder types

Other

Identifiers

NCT04499001
2020-A01380-39

Details and patient eligibility

About

There is a lack of knowledge among patients concerning their treatment with bDMARDs. To increase knowledge and safety skills, patient education is essential.

The aim of this study is to assess the impact of a pharmacist's educational interview on on knowledge and safety skills to bDMARDs in patients with inflammatory arthritis.

Full description

This is an observational, controlled, open-label and monocentric study. 60 patients are planned to be included.

Knowledge are assessed three time by self-administered questionnaire:

at baseline before the pharmacist's educational interview at three months apart at six months apart

One primary end-point is defined:

the changes from baseline to M3 and M6 in the patients' knowledge score about subcutaneous bDMARD management (self-administered questionnaire, Biosecure)

As secondary end-points, the changes from baseline to M3 and M6 in patients' adherence, patients' satisfaction regarding the pharmacists' intervention and the effect of the interview on rate of patients treated by biosimilar are evaluated.

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients must be able to understand and communicate in French and comply with the requirements of the study and must give his agreement (non-opposition) before any study assessment is performed.
  • Patient at least 18 years of age
  • Patient with inflammatory arthritis (rheumatoid arthritis or ankylosing spondylitis or other)
  • Admission in medical consultation in the rheumatology department
  • Patient treated with subcutaneous biologic DMARDs (Tocilizumab, Adalimumab, Etanercept, Golimumab, Certolizumab, Abatacept, Sarilumab, Ustekinumab, Ixekizumab, Anakinra)

Exclusion criteria

  • Any medical or psychiatric condition which, in the Investigator's opinion, would preclude the participant from completing the study per protocol

Trial contacts and locations

1

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Central trial contact

Cécile Bottois, Dr; Ornella Conort, Dr

Data sourced from clinicaltrials.gov

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