Comparison of Oral Administration of a JAK Inhibitor in Rheumatoid Arthritis

NCT07674134 | Recruiting

• 1 other identifier: 23-02
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis (RA)

Keywords

JAK inhibitor

Outcome Measures

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)

  From first intake to six months

Secondary Outcomes (5)

• 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

• 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

• EULAR response at Month 6

  from baseline to six month

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with rheumatoid arthritis, treated at the Princess Grace Hospital Centre. It will take place in the Rheumatology department.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Princesse Grace: lead

Study Sites (1)

Centre Hospitalier Princesse Grace

Monaco, 98000, Monaco

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Olivier BROCQ, MD

  Centre Hospitalier Princesse Grace

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Olivier BROCQ, MD

CONTACT

97 98 99 00; recherche.clinique@chpg.mc

Nicolas RIJO

CONTACT

97 98 99 00; recherche.clinique@chpg.mc

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2026
• First Posted: June 29, 2026
• Study Start: April 23, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: June 29, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After one year from the first publication date and during 10 years after the end of the study.
• Access Criteria: Available upon reasonable request subject to applicable institutional and regulatory requirements and execution of data access agreement.

Locations

MO (1)