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NCT Number: NCT07674134

Comparison of 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.

Recruiting

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Key information

Conditions

Rheumatoid Arthritis (RA) Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Princesse Grace

Monaco, 98000

Location status: Recruiting

Location contact

Nicolas RIJO

CONTACT

[email protected]

97 98 99 00 ext. +377

Olivier BROCQ, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. EULAR response criteria between the two groups

    Time frame: 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 outcomes

  1. Percentage of remission (DAS<2.6) or low disease activity

    Time frame: 3 months and 6 months

  2. Adverse events related to study treatment

    Time frame: From Baseline through study completion

    number of adverse events between the two groups that led to a dose reduction or discontinuation of treatment

  3. Continuation of treatments

    Time frame: From baseline to 3 months and from 3 months to 6 months

  4. EULAR response at Month 3

    Time frame: from baseline to third month

    Percentage of patients meeting EULAR response criteria after 3 months of treatment.

  5. EULAR response at Month 6

    Time frame: from baseline to six month

    Percentage of patients meeting EULAR response criteria after 6 months of treatment.

Study contacts

Contact information is provided by the study sponsor or research team.

Nicolas RIJO

CONTACT

[email protected]

97 98 99 00 ext. +377

Olivier BROCQ, MD

CONTACT

[email protected]

97 98 99 00 ext. +377

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Princesse Grace

Other

Registry information

Official study title

Comparison of Morning Versus Evening Oral Administration of a JAK Inhibitor in Rheumatoid Arthritis

Acronym: JAK-INHI

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 29, 2026
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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