Rheumatoid ArthritisSIERRANCT03027999
Efficiency of a Tight Monitoring by a Nurse Practitioner of Rheumatoid Arthritis (RA) Patients in Remission
A study testing tight nursing follow-up in people with Rheumatoid Arthritis, run by University Hospital, Rouen at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- tight nursing follow-up
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 2 sitesFrance
- Study dates
- 5 May 2017to 22 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
About this study
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
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.
Read more
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
- Conditions
- Rheumatoid Arthritis
- Being tested
- tight nursing follow-up
- Keywords
- Rituximab, tight monitoring
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tight nursing follow-upOther
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
| Study group | Role | What they receive |
|---|---|---|
| Patient with tight nursing follow-up | Experimental | Compared as usual, Patient with tight nursing follow-up will be contacted Receives: Other: tight nursing follow-up |
| Patient without tight nursing follow-up | No intervention | Compared as usual, Patient without tight nursing follow-up will not have interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference from baseline of disease activity specific score
The disease activity specific score is DAS28-CRP
Measured: Every 3 months during 2 years
Secondary outcomes (3)
Difference from baseline in quality of life
quality of life will be based on HAQ and SF36 questionnaire
Measured: Every 3 months during 2 years
Number of cumulative dose of corticosteroids drugs received
Measured: Every 3 months during 2 years
Number of cumulative dose of non-steroidal anti-inflammatory drugs received
Measured: Every 3 months during 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2017 (estimated)
- Study start5 May 2017
- Primary completion22 Sep 2022
- Study completion22 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier VITTECOQ, Pr, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03027999
- Sponsor's protocol ID
- 2015/0190/HP
- Acronym
- SIERRA
- Status last verified
- Apr 2026
- First submitted
- 19 Jan 2017
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
10.4103/2542-4157.248608
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03027999
- Acronym / sponsor ID
- SIERRA / 2015/0190/HP
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rituximab, tight monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 5 May 2017 (actual)
- Primary completion
- 22 Sep 2022 (actual)
- Study completion
- 22 Sep 2022 (actual)
- First posted
- 23 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient with tight nursing follow-up | Experimental | Other: tight nursing follow-upCompared as usual, Patient with tight nursing follow-up will be contacted |
| Patient without tight nursing follow-up | No intervention | –Compared as usual, Patient without tight nursing follow-up will not have interventions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tight nursing follow-upIn addition to the usual follow-up by their rheumatologist tight nursing follow-up patients will benefit of 1. 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. 2. 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 | Other | Patient with tight nursing follow-up |
Primary outcome
Difference from baseline of disease activity specific score
Time frame: Every 3 months during 2 years
The disease activity specific score is DAS28-CRP
3 secondary outcomes
Difference from baseline in quality of life
Time frame: Every 3 months during 2 years
Number of cumulative dose of corticosteroids drugs received
Time frame: Every 3 months during 2 years
Number of cumulative dose of non-steroidal anti-inflammatory drugs received
Time frame: Every 3 months during 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Results publication10.4103/2542-4157.248608
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivier VITTECOQ, Pr principal investigator
University Hospital, Rouen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tight nursing follow-up in people with Rheumatoid Arthritis, run by University Hospital, Rouen at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference from baseline of disease activity specific score (time frame: Every 3 months during 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03027999, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.