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STUDY PROTOCOL
Year : 2018  |  Volume : 3  |  Issue : 4  |  Page : 107-112

Efficiency of tight monitoring by nurse practitioners in rheumatoid arthritis patients in remission after treatment with rituximab: study protocol for a randomized, open-label, controlled trial


1 Department of Rheumatology, Rouen University Hospital, Rouen, France
2 Department of Nursing, Rouen University Hospital, Rouen, France
3 Department of Rheumatology, Caen University Hospital, Caen, France

Correspondence Address:
Deborah Lebedieff
Department of Rheumatology, Rouen University Hospital, Rouen
France
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Source of Support: This study was supported by French Interregional Group of Clinical Research and Innovation (GIRCI)., Conflict of Interest: None


DOI: 10.4103/2542-4157.248608

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Background and objectives: Rituximab (RTX) is one of the biologics available for rheumatologists to treat patients with rheumatoid arthritis (RA). While the reprocessing procedures for other biologic agents are clearly established, this is not the case for RTX. RTX is currently re-administered when clinical relapse occurs (6 to 18 months after initiation of treatment, beyond 24 months for some patients). However, this reprocessing method is not satisfactory because the resumption of symptomatology is generally detected too late. For patients, this delay can lead to increased doses of background and symptomatic treatments, an altered quality of life due to increased pain intensity, joint swelling, nocturnal awakening and morning stiffness and an aggravation of joint destruction. We hypothesize that tight monitoring by a nurse practitioner of RA patients in remission after treatment with RTX is more effective to detect very early relapse of the disease than follow-up exclusively managed by the attending rheumatologist. Design: A prospective, controlled, randomized, open-label, bicentric clinical trial. Methods: Eighty-eight patients with RA in remission receiving RTX treatment are randomly assigned to an observation group or a control group at a 1:1 ratio. In the control group, patients are followed only by the attending rheumatologist every 3 to 4 months according to common practices. In the observation group, patients are subjected to tight monitoring every month by a nurse practitioner in addition to follow-up by the attending rheumatologist. When increased disease activity is observed (disease activity score based on 28 joints (DAS28)-C-reactive protein (CRP) > 2.7), a new cycle of RTX is prescribed by an independent hospital practitioner. Outcome measures: The primary outcome measure is the value of DAS28-CRP at the time of a new cycle of RTX. The secondary outcome measures are the cumulative dose of glucocorticosteroids and/or non-steroidal anti-inflammatory drugs between two cycles of RTX and quality of life questionnaires. Discussion: This study corresponds to the combined management of RA by a nurse practitioner and an attending rheumatologist. A monthly telephone interview conducted by the nurse practitioner enables discussion on all aspects of the disease and regular follow-up to allow frequent readjustments. Thus, patients with good response to RTX treatment at 6 months might benefit from nursing follow-up alone to detect relapse. Such a practice is easily reproducible for RA patients in clinical remission after other treatments. Ethics and dissemination: This trial was approved by the Northwestern France Ethics Committee (approval number: CPP-SC 02/2016) on June 1, 2016. The study protocol is conducted in accordance with the Declaration of Helsinki, formulated by the World Medical Association. Written informed consent is obtained from all participants. Subject recruitment is underway. Data collection began in May 2017 and will end in May 2021. Dissemination plans include presentations at scientific conferences and scientific publications. Trial registration: ClinicalTrials.gov identifier: NCT03027999 on January 23, 2017.


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