Efficiency of a Tight Monitoring by a Nurse Practitioner of Rheumatoid Arthritis (RA) Patients in Remission (SIERRA)
Primary Purpose
Rheumatoid Arthritis
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
tight nursing follow-up
Sponsored by
About this trial
This is an interventional supportive care trial for Rheumatoid Arthritis focused on measuring Rituximab, tight monitoring
Eligibility Criteria
Inclusion Criteria:
- Male or female (age 18 or older)
- Rheumatoid arthritis fulfilling the ACR/EULAR 2010 criteria
- Patient to whom the rheumatologist prescribed a treatment with rituximab or who received a treatment with rituximab in the last 6 months
- Patients with active rheumatoid arthritis prior to treatment with rituximab (DAS 28 CRP>2.7)
- Patient with a DAS 28 CRP of less than 2.7 at 6 months from the last administration of rituximab
Exclusion Criteria:
- Patient not responding to the last treatment with rituximab (DAS28 CRP> 2.7 at 6 months)
- Patient under the age of 18
- Patient with chronic pain due to another pathology than rheumatoid arthritis, which may interfere with the assessment
- Patient with a contraindication to treatment with rituximab
- Woman of childbearing age not taking effective contraception
- Pregnant or nursing woman
Sites / Locations
- Caen University HospitalRecruiting
- Rouen University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Patient with tight nursing follow-up
Patient without tight nursing follow-up
Arm Description
Compared as usual, Patient with tight nursing follow-up will be contacted
Compared as usual, Patient without tight nursing follow-up will not have interventions
Outcomes
Primary Outcome Measures
Difference from baseline of disease activity specific score
The disease activity specific score is DAS28-CRP
Secondary Outcome Measures
Difference from baseline in quality of life
quality of life will be based on HAQ and SF36 questionnaire
Number of cumulative dose of corticosteroids drugs received
Number of cumulative dose of non-steroidal anti-inflammatory drugs received
Full Information
NCT ID
NCT03027999
First Posted
January 19, 2017
Last Updated
August 29, 2017
Sponsor
University Hospital, Rouen
1. Study Identification
Unique Protocol Identification Number
NCT03027999
Brief Title
Efficiency of a Tight Monitoring by a Nurse Practitioner of Rheumatoid Arthritis (RA) Patients in Remission
Acronym
SIERRA
Official Title
Efficiency of a Tight Monitoring by a Nurse Practitioner of Rheumatoid Arthritis (RA) Patients in Remission (or Low Disease Activity) Under Rituximab to Detect Early Relapse of the Disease
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
May 5, 2017 (Actual)
Primary Completion Date
May 2021 (Anticipated)
Study Completion Date
May 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Rouen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Rheumatoid arthritis (RA) is a progressive disease that affects mainly small and medium joints and, in the absence of appropriate background therapy, leads to progressive joint destruction, functional, psychological, social and occupational repercussions.
Several biomedicine treat this pathology, including rituximab (RTX). It is recommended to evaluate the therapeutic response to RTX and re-administer it from the 24th week when the goal of remission has not been achieved. However, the optimal modality for reprocessing remains to be determined.
To this end, different approaches have been explored, such as lymphocyte typing or ultrasound monitoring. The pace of these examinations, however, remains wide and their cost is not negligible. This is why we propose here to explore the track of a tight follow-up nurse DAS28.
The hypothesis is that a tight nursing follow-up can detect the symptomatic recovery earlier than the current medical follow-up.
The hypothesis is that a tight nursing follow-up can detect the symptomatic recovery earlier than the current medical follow-up
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Rituximab, tight monitoring
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
88 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patient with tight nursing follow-up
Arm Type
Experimental
Arm Description
Compared as usual, Patient with tight nursing follow-up will be contacted
Arm Title
Patient without tight nursing follow-up
Arm Type
No Intervention
Arm Description
Compared as usual, Patient without tight nursing follow-up will not have interventions
Intervention Type
Other
Intervention Name(s)
tight nursing follow-up
Intervention Description
In addition to the usual follow-up by their rheumatologist tight nursing follow-up patients will benefit of
a training session to self-assess their RA: Self-assessment of the number of painful and swollen joints, of pain and disease activity (global assessment by the patient) (self-DAS). During this session, a scheduled dosage of ESR and CRP levels will be given to the patient.
A monthly call by a nurse who inquires about the results of the patient's self-assessment. As soon as she suspects a relapse of RA, she plans a consultation to confirm or not the relapse. For this purpose, she calculates the DAS28 taking into account the results of the biological test, the articular count and the disease activity. Clinical relapse is documented by a DAS28-CRP > 2.7
Primary Outcome Measure Information:
Title
Difference from baseline of disease activity specific score
Description
The disease activity specific score is DAS28-CRP
Time Frame
Every 3 months during 2 years
Secondary Outcome Measure Information:
Title
Difference from baseline in quality of life
Description
quality of life will be based on HAQ and SF36 questionnaire
Time Frame
Every 3 months during 2 years
Title
Number of cumulative dose of corticosteroids drugs received
Time Frame
Every 3 months during 2 years
Title
Number of cumulative dose of non-steroidal anti-inflammatory drugs received
Time Frame
Every 3 months during 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female (age 18 or older)
Rheumatoid arthritis fulfilling the ACR/EULAR 2010 criteria
Patient to whom the rheumatologist prescribed a treatment with rituximab or who received a treatment with rituximab in the last 6 months
Patients with active rheumatoid arthritis prior to treatment with rituximab (DAS 28 CRP>2.7)
Patient with a DAS 28 CRP of less than 2.7 at 6 months from the last administration of rituximab
Exclusion Criteria:
Patient not responding to the last treatment with rituximab (DAS28 CRP> 2.7 at 6 months)
Patient under the age of 18
Patient with chronic pain due to another pathology than rheumatoid arthritis, which may interfere with the assessment
Patient with a contraindication to treatment with rituximab
Woman of childbearing age not taking effective contraception
Pregnant or nursing woman
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Deborah LEBEDIEFF, Nurse
Phone
+3323288
Ext
8265
Email
deborah.lebedieff@chu-rouen.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Julien BLOT
Phone
+3323288
Ext
8265
Email
julien.blot@chu-rouen.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olivier VITTECOQ, Pr
Organizational Affiliation
Rouen University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Caen University Hospital
City
Caen
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian MARCELLI, Pr
First Name & Middle Initial & Last Name & Degree
Christian MARCELLI, Pr
Facility Name
Rouen University Hospital
City
Rouen
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deborah LEBEDIEFF
First Name & Middle Initial & Last Name & Degree
Olivier VITTECOQ, Pr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficiency of a Tight Monitoring by a Nurse Practitioner of Rheumatoid Arthritis (RA) Patients in Remission
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