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

NCT04175886

Last updated date
Study Location
Lille University Hospital
Lille, , , France
Contact
0320445962

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

0320445962

By email

Contact

[email protected]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Rheumatoid Arthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- • 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,

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Rheumatoid ArthritisCONfident Treatment Decisions in Living With Rheumatoid Arthritis
NCT03317756
  1. Birmingham, Alabama
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Rheumatoid ArthritisEffect of the Inhibitors of the Way JAK-STAT on Regulatory B Cells
NCT03755297
  1. Montpellier,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Rheumatoid ArthritisRheumatoid Arthritis DMARD Intervention and UtilizationStudy
NCT00116727
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title Effects of Tofacitinib on Body Composition, Bone Mineral Density and Bone Marrow Adiposity in Patients With Rheumatoid Arthritis: the TOFAT Project
Official Title Effects of Tofacitinib on Body Composition, Bone Mineral Density and Bone Marrow Adiposity in Patients With Rheumatoid Arthritis: the TOFAT Project
Brief Summary

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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Whole blood, serum
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
Condition Rheumatoid Arthritis
Intervention Drug: Tofacitinib
Patients will be treated with tofacitinib
Study Groups/Cohorts
  • Patients with rheumatoid arthritis
    Patients with rheumatoid arthritis with an indication for tofacitinib: 5mgx2 per day
    Intervention: Drug: 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)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: November 21, 2019)
72
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 2023
Estimated Primary Completion Date March 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria

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 (TNF?). Patients who were receiving anti-TNF? 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-TNF? 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,
Sex/Gender
Sexes Eligible for Study:All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Jean-Guillaume Letarouilly, MD0320445962 ext +33[email protected]
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT04175886
Other Study ID Numbers 2018_38
2019-001159-37 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party University Hospital, Lille
Study Sponsor University Hospital, Lille
Collaborators Pfizer
Investigators
Principal Investigator:Jean-Guillaume Letarouilly, MDUniversity Hospital, Lille
PRS Account University Hospital, Lille
Verification Date June 2020