Rheumatoid Arthritis (RA)JAK-INHINCT07674134
Comparison of Oral Administration of a JAK Inhibitor in Rheumatoid Arthritis
An observational study of Rheumatoid Arthritis (RA), run by Centre Hospitalier Princesse Grace at 1 site in Monaco.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis (RA)
- How many people
- 90 participants
- Where
- 1 siteMonaco
- Study dates
- 23 Apr 2024to Nov 2026
- Phase
- Observational
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
Study population: Patients with rheumatoid arthritis, treated at the Princess Grace Hospital Centre. It will take place in the Rheumatology department.
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Monaco1 site, 1 recruiting
- Recruiting
Centre Hospitalier Princesse Grace
Monaco, 98000
Nicolas RIJO, 97 98 99 00 ext. +377, recherche.clinique@chpg.mc
Olivier BROCQ, MD
About this study
Official title: Comparison of Morning Versus Evening Oral Administration of a JAK Inhibitor in Rheumatoid Arthritis
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.
- Conditions
- Rheumatoid Arthritis (RA)
- Keywords
- JAK inhibitor
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| JAK inhibitor morning then evening | JAK inhibitor intake every morning during 3 months then every evening during 3 months | |
| JAK inhibitor evening then morning | JAK inhibitor intake every evening during 3 months then every morning during 3 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: From first intake to six months
Secondary outcomes (5)
Percentage of remission (DAS<2.6) or low disease activity
Measured: 3 months and 6 months
Adverse events related to study treatment
number of adverse events between the two groups that led to a dose reduction or discontinuation of treatment
Measured: From Baseline through study completion
Continuation of treatments
Measured: From baseline to 3 months and from 3 months to 6 months
EULAR response at Month 3
Percentage of patients meeting EULAR response criteria after 3 months of treatment.
Measured: from baseline to third month
EULAR response at Month 6
Percentage of patients meeting EULAR response criteria after 6 months of treatment.
Measured: from baseline to six month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2026
- Study start23 Apr 2024
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid Arthritis (RA)Studies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Princesse Grace
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier BROCQ, MD, Principal investigator, Centre Hospitalier Princesse Grace
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07674134
- Sponsor's protocol ID
- 23-02
- Acronym
- JAK-INHI
- Status last verified
- Jun 2026
- First submitted
- 18 Jun 2026
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Deidentified dataset from the study