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

April 17, 2026 updated by: University Hospital, Lille

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lille, France
        • Lille University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The study population is composed of adult patients with moderately to severely active RA for whom tofacitinib is indicated and who are followed in the department of rheumatology at Lille University Hospital

Description

Inclusion Criteria:

  • Adult patient's ≥18 years old with moderately to severely active Rheumatoid Arthritis (RA) (ACR/EULAR criteria )
  • Previously untreated with Janus Kinase (JAK) inhibitors
  • With an indication for tofacitinib will be eligible.
  • All patients will have to be treated with tofacitinib either alone or with methotrexate. -Healthy volunteers should be ≥18 years old.

Exclusion Criteria:

  • • treatment with more than three anti-Tumor Necrosis Factor alpha (TNFα). Patients who were receiving anti-TNFα will be required a washout period lasting at least five-half-lives before to start tofacitinib,

    • previously exposed to JAK inhibitors,
    • patients who were receiving non-anti-TNFα biologics (abatacept, tocilizumab, sarilumab or rituximab) will be required a washout period lasting at least five-half-lives before to start tofacitinib
    • Concomitant methotrexate (MTX) will be permitted if started ≥3 months prior to study start and at a stable dose (≤25 mg/week) for ≥4 weeks.
    • history or discovery of an osteoporotic fracture AND/OR T-score≤-3 if ≥50 years AND/OR Z-score ≤-3 if <50 years during the screening phase,
    • current treatment with oral corticosteroids higher than 10 mg prednisone/day,
    • pathologies or treatments that could affect the bone metabolism (breast cancer with aromatase inhibitors, gastrointestinal malabsorption, stomach cancer, primary hyperparathyroidism, uncontrolled hyperthyroidism…),
    • weight> 160 kg,
    • patients on restrictive diets or considering such a diet during the study period,
    • patients with an intense exercise program or planning to benefit from it during the study period,

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with rheumatoid arthritis
Patients with rheumatoid arthritis with an indication for tofacitinib: 5mgx2 per day
Drug: Tofacitinib
Patients will be treated with tofacitinib
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)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurements of VAT in cm².
Time Frame: at baseline
Measurements of VAT in cm²
at baseline
Measurements of total fat mass (TBF) in kg, total lean mass (TLM) in kg, appendicular lean mass (aLM) in kg
Time Frame: at baseline
Measurements of total fat mass (TBF) in kg, total lean mass (TLM) in kg, appendicular lean mass (aLM) in kg
at baseline
Measurements of body fat percentage (%)
Time Frame: at baseline
Measurements of body fat percentage (%)
at baseline
Measurements of fat mass index (FMI) in kg/m² and skeletal muscle mass index (SMI) in kg/m²
Time Frame: at baseline
Measurements of fat mass index (FMI) in kg/m² and skeletal muscle mass index (SMI) in kg/m²
at baseline
Measurements of Bone mineral Density (BMD) in g/cm².
Time Frame: at baseline
Measurements of Bone mineral Density (BMD) in g/cm².
at baseline
Change in body fat percentage (% between measurement
Time Frame: Before and after 6 months of tofacitinib treatment (difference before/after).
Change in body fat percentage (%) between measurement
Before and after 6 months of tofacitinib treatment (difference before/after).
Change in total fat mass (TBF) between measurement
Time Frame: Before and after 6 months of tofacitinib treatment (difference before/after).
Change in total fat mass (TBF) in kg between measurement
Before and after 6 months of tofacitinib treatment (difference before/after).
Change in fat mass index (FMI) in kg/m², between measurement
Time Frame: Before and after 6 months of tofacitinib treatment (difference before/after).
Change in fat mass index (FMI) in kg/m², between measurement
Before and after 6 months of tofacitinib treatment (difference before/after).
Change in total lean mass (TLM, kg) and appendicular lean mass (aLM) in kg between measurement
Time Frame: Before and after 6 months of tofacitinib treatment (difference before/after).
Change in total lean mass (TLM, kg) and appendicular lean mass (aLM) in kg between measurement
Before and after 6 months of tofacitinib treatment (difference before/after).
Change in skeletal muscle mass index (SMI) in kg/m² between measurement
Time Frame: Before and after 6 months of tofacitinib treatment (difference before/after).
Change in skeletal muscle mass index (SMI) in kg/m² between measurement
Before and after 6 months of tofacitinib treatment (difference before/after).
Change in BMD (in g/cm²) at the lumbar spine (L1-L4) and non-dominant total hip between measurement
Time Frame: Before and after 6 months of tofacitinib treatment (difference before/after).
Change in BMD (in g/cm²) at the lumbar spine (L1-L4) and non-dominant total hip between measurement
Before and after 6 months of tofacitinib treatment (difference before/after).
Variation of bone remodelling markers (Cross-laps (CTX) and Type I procollagen N-terminal propeptide (P1NP)) between measurement
Time Frame: Before and after 6 months of tofacitinib treatment.
Variation of bone remodelling markers (Cross-laps (CTX) and Type I procollagen N-terminal propeptide (P1NP)) between measurement
Before and after 6 months of tofacitinib treatment.
Variation in leptin (ng/ml) between measurement.
Time Frame: Before and after 6 months of tofacitinib treatment
Variation in leptin (ng/ml) between measurement.
Before and after 6 months of tofacitinib treatment
Change in bone marrow adiposity (%) at the lumbar spine between measurement
Time Frame: Before and after 6 months of tofacitinib treatment.
Change in bone marrow adiposity (%) at the lumbar spine between measurement
Before and after 6 months of tofacitinib treatment.
Variation in Short Physical Performance Battery Protocol (SPPB) between measurement
Time Frame: Before and after 6 months of tofacitinib treatment.
Variation in Short Physical Performance Battery Protocol (SPPB) between measurement
Before and after 6 months of tofacitinib treatment.
Changes in the parameters of the primary outcome and the secondary outcomes (n°2 to 8)
Time Frame: Before and after 12 months of tofacitinib treatment.
Changes in the parameters of the primary outcome and the secondary outcomes (n°2 to 8)
Before and after 12 months of tofacitinib treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Collaborators

Pfizer

Investigators

  • Principal Investigator: Jean-Guillaume Letarouilly, MD, University Hospital, Lille

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 25, 2020

Primary Completion (Actual)

May 8, 2023

Study Completion (Actual)

May 8, 2023

Study Registration Dates

First Submitted

November 20, 2019

First Submitted That Met QC Criteria

November 21, 2019

First Posted (Actual)

November 25, 2019

Study Record Updates

Last Update Posted (Actual)

April 22, 2026

Last Update Submitted That Met QC Criteria

April 17, 2026

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018_38
  • 2019-001159-37 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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