Rheumatoid Arthritis (RA)
Conditions
Keywords
JAK inhibitor
Brief summary
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.
Interventions
None listed
Sponsors
Centre Hospitalier Princesse Grace
Study design
Observational model
CASE_CROSSOVER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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 * Patient unable to be followed-up in the study during 6 months * Minors or adults under guardianship or curatorship, or deprived of their liberty * Pregnant or breastfeeding patient * Patient refusing to use an effective method of contraception for the duration of the study * Person not affiliated with a social security scheme.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| EULAR response criteria between the two groups | From first intake to six months | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of remission (DAS<2.6) or low disease activity | 3 months and 6 months | — |
| Adverse events related to study treatment | From Baseline through study completion | number of adverse events between the two groups that led to a dose reduction or discontinuation of treatment |
| Continuation of treatments | From baseline to 3 months and from 3 months to 6 months | — |
| EULAR response at Month 3 | from baseline to third month | Percentage of patients meeting EULAR response criteria after 3 months of treatment. |
| EULAR response at Month 6 | from baseline to six month | Percentage of patients meeting EULAR response criteria after 6 months of treatment. |
Countries
Monaco
Contacts
CONTACTOlivier BROCQ, MD
CONTACTNicolas RIJO
PRINCIPAL_INVESTIGATOROlivier BROCQ, MD
Centre Hospitalier Princesse Grace
Outcome results
None listed