Effects of Tofacitinib on Body Composition, Bone Mineral Density and Bone Marrow Adiposity in Patients With Rheumatoid Arthritis: the TOFAT Project

Sponsor
University Hospital, Lille
Study ID
NCT04175886
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Tofacitinib — DRUG
    Patients will be treated with tofacitinib

Study Details

Inflammatory rheumatic diseases (IRD), such as rheumatoid arthritis, are characterized by adverse changes in body composition. Lean mass and bone mineral density are usually reduced while adiposity (total fat mass, visceral adiposity…) is increased in comparison with healthy controls. Many factors may influence the body composition of those patients such as aging, Disease Modifying Anti-Rheumatic Drugs (DMARDs), nutrition and physical activity. However, data on body composition and adverse changes under DMARDs in patients with rheumatoid arthritis (RA) are actually scarce. This is the case with tofacitinib (targeted synthetic DMARD or tsDMARD) while preliminary data let us think that this treatment may influence body composition and bone mineral density. This study is going to be the first to focus on changes in body composition (fat mass and lean mass), bone mineral density and bone marrow adiposity under tofacitinib.

Key Dates

Start date
Feb 25, 2020
Status verified
May 2023
Primary completion
May 8, 2023
Completion
May 8, 2023

Study Design

Enrollment
10 participants (actual)

Arms

  • Arm: Patients with rheumatoid arthritis
    Patients with rheumatoid arthritis with an indication for tofacitinib: 5mgx2 per day
  • Arm: Healthy subjects
    Healthy subjects matched to cases (1:1) on age (±5 years), sex, and menopausal status for women and body mass index (BMI, ±3 kg/m²)

Primary Outcome Measure

Variation in visceral adiposity (VAT or Visceral Adipose Tissue) in cm² [ Time Frame: Between the measurement before and after 6 months of tofacitinib treatment (difference before/after). ]

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