Comparison of Oral Administration of a JAK Inhibitor in Rheumatoid Arthritis
ConditionRheumatoid Arthritis (RA)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentre Hospitalier Princesse Grace
About this trial
The aim of this study is to offer patients two treatment options: morning or evening administration of a JAK inhibitor prescribed within the framework of its marketing authorization, according to the EULAR response.
The objective is to determine whether evening administration in our patients with rheumatoid arthritis provides greater efficacy than morning administration in our patients taking JAK inhibitors once daily.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient aged over 18 years
Patient with Rheumatoid Arthritis according to the 2010 ACR/EULAR criteria
Patient meeting the criteria for initiation of a JAK inhibitor according to the marketing authorization and international recommendations
Patient capable of providing informed, written, dated, and signed consent before the start of any trial-related procedure.
Disqualifiers
No contraindication to a bDMARD
Not stable dose of corticosteroids in the 4 weeks preceding enrollment
Not stable dose of maintenance therapy (methotrexate, leflunomide, hydroxychloroquine, cyclosporine, gold salts) in the 4 weeks preceding enrollment
Prior treatment with a JAK inhibitor
Trial population
Patients with rheumatoid arthritis, treated at the Princess Grace Hospital Centre. It will take place in the Rheumatology department.
Trial design
Design model
Case-crossover
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
90 Participants
are grouped into 2 trial groupsGroup A: JAK inhibitor morning then evening
Group B: JAK inhibitor evening then morning
Trial outcomes
Primary outcomes
1
EULAR response criteria between the two groups
Comparison of the evolution of the response rate (according to EULAR response criteria) between the two treatment modalities between the two groups (morning + evening vs evening + morning)
Time frame
From first intake to six monthsSecondary outcomes
1
Percentage of remission (DAS<2.6) or low disease activity
Time frame
3 months and 6 months2
Adverse events related to study treatment
number of adverse events between the two groups that led to a dose reduction or discontinuation of treatment
Time frame
From Baseline through study completion3
Continuation of treatments
Time frame
From baseline to 3 months and from 3 months to 6 months4
EULAR response at Month 3
Percentage of patients meeting EULAR response criteria after 3 months of treatment.
Time frame
from baseline to third monthSponsors and contacts
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Source ClinicalTrials.gov