Comparison of Oral Administration of a JAK Inhibitor in Rheumatoid Arthritis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Rheumatoid Arthritis (RA). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Monaco
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparison of Morning Versus Evening Oral Administration of a JAK Inhibitor in Rheumatoid Arthritis
Overview
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.
Primary outcome measures
- EULAR response criteria between the two groups [Time frame: From first intake to six months]
Secondary outcome measures (5)
- Percentage of remission (DAS<2.6) or low disease activity [Time frame: 3 months and 6 months]
- Adverse events related to study treatment [Time frame: From Baseline through study completion]
- Continuation of treatments [Time frame: From baseline to 3 months and from 3 months to 6 months]
- EULAR response at Month 3 [Time frame: from baseline to third month]
- EULAR response at Month 6 [Time frame: from baseline to six month]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-crossover
Study locations
Monaco · 1 center
- Centre Hospitalier Princesse Grace — Monaco
Identifiers
NCT: NCT07674134 · 23-02