Rheumatoid ArthritisTOFATNCT04175886
Effects of Tofacitinib on Body Composition, Bone Mineral Density and Bone Marrow Adiposity in Patients With Rheumatoid Arthritis: the TOFAT Project
An observational study of Rheumatoid Arthritis, run by University Hospital, Lille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Tofacitinib
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 25 Feb 2020to 8 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- • 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,
Show all 10Show fewer
- 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,
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Tofacitinib
- Keywords
- rheumatoid arthritis, tofacitinib, body composition, bone marrow adiposity, bone marrow density
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TofacitinibDrug
Patients will be treated with tofacitinib
| Study group | Role | What they receive |
|---|---|---|
| Patients with rheumatoid arthritis | Patients with rheumatoid arthritis with an indication for tofacitinib: 5mgx2 per day Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation in visceral adiposity (VAT or Visceral Adipose Tissue) in cm²
Variation in visceral adiposity (VAT or Visceral Adipose Tissue) in cm²
Measured: Between the measurement before and after 6 months of tofacitinib treatment (difference before/after).
Secondary outcomes (16)
Measurements of VAT in cm².
Measurements of VAT in cm²
Measured: at baseline
Measurements of total fat mass (TBF) in kg, total lean mass (TLM) in kg, appendicular lean mass (aLM) in kg
Measurements of total fat mass (TBF) in kg, total lean mass (TLM) in kg, appendicular lean mass (aLM) in kg
Measured: at baseline
Measurements of body fat percentage (%)
Measurements of body fat percentage (%)
Measured: at baseline
Measurements of fat mass index (FMI) in kg/m² and skeletal muscle mass index (SMI) in kg/m²
Measurements of fat mass index (FMI) in kg/m² and skeletal muscle mass index (SMI) in kg/m²
Measured: at baseline
Measurements of Bone mineral Density (BMD) in g/cm².
Measurements of Bone mineral Density (BMD) in g/cm².
Measured: at baseline
Change in body fat percentage (% between measurement
Change in body fat percentage (%) between measurement
Measured: Before and after 6 months of tofacitinib treatment (difference before/after).
Change in total fat mass (TBF) between measurement
Change in total fat mass (TBF) in kg between measurement
Measured: Before and after 6 months of tofacitinib treatment (difference before/after).
Change in fat mass index (FMI) in kg/m², between measurement
Change in fat mass index (FMI) in kg/m², between measurement
Measured: 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
Change in total lean mass (TLM, kg) and appendicular lean mass (aLM) in kg between measurement
Measured: Before and after 6 months of tofacitinib treatment (difference before/after).
Change in skeletal muscle mass index (SMI) in kg/m² between measurement
Change in skeletal muscle mass index (SMI) in kg/m² between measurement
Measured: 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
Change in BMD (in g/cm²) at the lumbar spine (L1-L4) and non-dominant total hip between measurement
Measured: 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
Variation of bone remodelling markers (Cross-laps (CTX) and Type I procollagen N-terminal propeptide (P1NP)) between measurement
Measured: Before and after 6 months of tofacitinib treatment.
Variation in leptin (ng/ml) between measurement.
Variation in leptin (ng/ml) between measurement.
Measured: Before and after 6 months of tofacitinib treatment
Change in bone marrow adiposity (%) at the lumbar spine between measurement
Change in bone marrow adiposity (%) at the lumbar spine between measurement
Measured: Before and after 6 months of tofacitinib treatment.
Variation in Short Physical Performance Battery Protocol (SPPB) between measurement
Variation in Short Physical Performance Battery Protocol (SPPB) between measurement
Measured: Before and after 6 months of tofacitinib treatment.
Changes in the parameters of the primary outcome and the secondary outcomes (n°2 to 8)
Changes in the parameters of the primary outcome and the secondary outcomes (n°2 to 8)
Measured: Before and after 12 months of tofacitinib treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2019
- Study start25 Feb 2020
- Primary completion8 May 2023
- Study completion8 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Jean-Guillaume Letarouilly, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04175886
- Sponsor's protocol ID
- 2018_38
- Other IDs
- 2019-001159-37, 2019
- Acronym
- TOFAT
- Status last verified
- May 2023
- First submitted
- 20 Nov 2019
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dodington DW, Desai HR, Woo M. JAK/STAT - Emerging Players in Metabolism. Trends Endocrinol Metab. 2018 Jan;29(1):55-65. doi: 10.1016/j.tem.2017.11.001. Epub 2017 Nov 27.
PubMed 29191719Fleischmann RM, Huizinga TW, Kavanaugh AF, Wilkinson B, Kwok K, DeMasi R, van Vollenhoven RF. Efficacy of tofacitinib monotherapy in methotrexate-naive patients with early or established rheumatoid arthritis. RMD Open. 2016 Jul 26;2(2):e000262. doi: 10.1136/rmdopen-2016-000262. eCollection 2016.
PubMed 27493790Tatsumi Y, Nakao YM, Masuda I, Higashiyama A, Takegami M, Nishimura K, Watanabe M, Ohkubo T, Okamura T, Miyamoto Y. Risk for metabolic diseases in normal weight individuals with visceral fat accumulation: a cross-sectional study in Japan. BMJ Open. 2017 Jan 16;7(1):e013831. doi: 10.1136/bmjopen-2016-013831.
PubMed 28093438Letarouilly JG, Paccou J, Badr S, Chauveau C, Broux O, Clabaut A. Stimulatory Effect of Tofacitinib on Bone Marrow Adipocytes Differentiation. Front Endocrinol (Lausanne). 2022 Jul 6;13:881699. doi: 10.3389/fendo.2022.881699. eCollection 2022.
PubMed 35873000Book C, Karlsson MK, Akesson K, Jacobsson LT. Early rheumatoid arthritis and body composition. Rheumatology (Oxford). 2009 Sep;48(9):1128-32. doi: 10.1093/rheumatology/kep165. Epub 2009 Jul 13.
PubMed 19602478Haugeberg G, Uhlig T, Falch JA, Halse JI, Kvien TK. Bone mineral density and frequency of osteoporosis in female patients with rheumatoid arthritis: results from 394 patients in the Oslo County Rheumatoid Arthritis register. Arthritis Rheum. 2000 Mar;43(3):522-30. doi: 10.1002/1529-0131(200003)43:33.0.CO;2-Y.
PubMed 10728744Toussirot E, Mourot L, Dehecq B, Wendling D, Grandclement E, Dumoulin G; CBT-506. TNFalpha blockade for inflammatory rheumatic diseases is associated with a significant gain in android fat mass and has varying effects on adipokines: a 2-year prospective study. Eur J Nutr. 2014 Apr;53(3):951-61. doi: 10.1007/s00394-013-0599-2. Epub 2013 Oct 31.
PubMed 24173963Marouen S, Barnetche T, Combe B, Morel J, Daien CI. TNF inhibitors increase fat mass in inflammatory rheumatic disease: a systematic review with meta-analysis. Clin Exp Rheumatol. 2017 Mar-Apr;35(2):337-343. Epub 2016 Dec 13.
PubMed 27974099Engvall IL, Tengstrand B, Brismar K, Hafstrom I. Infliximab therapy increases body fat mass in early rheumatoid arthritis independently of changes in disease activity and levels of leptin and adiponectin: a randomised study over 21 months. Arthritis Res Ther. 2010;12(5):R197. doi: 10.1186/ar3169. Epub 2010 Oct 21.
PubMed 20964833Tournadre A, Pereira B, Dutheil F, Giraud C, Courteix D, Sapin V, Frayssac T, Mathieu S, Malochet-Guinamand S, Soubrier M. Changes in body composition and metabolic profile during interleukin 6 inhibition in rheumatoid arthritis. J Cachexia Sarcopenia Muscle. 2017 Aug;8(4):639-646. doi: 10.1002/jcsm.12189. Epub 2017 Mar 18.
PubMed 28316139
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Tofacitinib on Body Composition, Bone Mineral Density and Bone Marrow Adiposity in Patients With Rheumatoid Arthritis: the TOFAT Project
- ClinicalTrials.gov ID
- NCT04175886
- Acronym / sponsor ID
- TOFAT / 2018_38
- Conditions
- Rheumatoid Arthritis
- Keywords
- rheumatoid arthritis, tofacitinib, body composition, bone marrow adiposity, bone marrow density
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- 25 Feb 2020 (actual)
- Primary completion
- 8 May 2023 (actual)
- Study completion
- 8 May 2023 (actual)
- First posted
- 25 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with rheumatoid arthritis | – | Drug: TofacitinibPatients with rheumatoid arthritis with an indication for tofacitinib: 5mgx2 per day |
| 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- • 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TofacitinibPatients will be treated with tofacitinib | Drug | Patients with rheumatoid arthritis |
Primary outcome
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
16 secondary outcomes
Measurements of VAT in cm².
Time frame: 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 body fat percentage (%)
Time frame: 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 Bone mineral Density (BMD) in g/cm².
Time frame: at baseline
Change in body fat percentage (% between measurement
Time frame: 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 fat mass index (FMI) in kg/m², 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
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
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
Time frame: 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 in leptin (ng/ml) between measurement.
Time frame: 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.
Variation in Short Physical Performance Battery Protocol (SPPB) between measurement
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Background: PubMed 29191719Dodington DW, Desai HR, Woo M. JAK/STAT - Emerging Players in Metabolism. Trends Endocrinol Metab. 2018 Jan;29(1):55-65. doi: 10.1016/j.tem.2017.11.001. Epub 2017 Nov 27.
- Background: PubMed 27493790Fleischmann RM, Huizinga TW, Kavanaugh AF, Wilkinson B, Kwok K, DeMasi R, van Vollenhoven RF. Efficacy of tofacitinib monotherapy in methotrexate-naive patients with early or established rheumatoid arthritis. RMD Open. 2016 Jul 26;2(2):e000262. doi: 10.1136/rmdopen-2016-000262. eCollection 2016.
- Background: PubMed 28093438Tatsumi Y, Nakao YM, Masuda I, Higashiyama A, Takegami M, Nishimura K, Watanabe M, Ohkubo T, Okamura T, Miyamoto Y. Risk for metabolic diseases in normal weight individuals with visceral fat accumulation: a cross-sectional study in Japan. BMJ Open. 2017 Jan 16;7(1):e013831. doi: 10.1136/bmjopen-2016-013831.
- Results publication: PubMed 35873000Letarouilly JG, Paccou J, Badr S, Chauveau C, Broux O, Clabaut A. Stimulatory Effect of Tofacitinib on Bone Marrow Adipocytes Differentiation. Front Endocrinol (Lausanne). 2022 Jul 6;13:881699. doi: 10.3389/fendo.2022.881699. eCollection 2022.
- Results publication: PubMed 19602478Book C, Karlsson MK, Akesson K, Jacobsson LT. Early rheumatoid arthritis and body composition. Rheumatology (Oxford). 2009 Sep;48(9):1128-32. doi: 10.1093/rheumatology/kep165. Epub 2009 Jul 13.
- Results publication: PubMed 10728744Haugeberg G, Uhlig T, Falch JA, Halse JI, Kvien TK. Bone mineral density and frequency of osteoporosis in female patients with rheumatoid arthritis: results from 394 patients in the Oslo County Rheumatoid Arthritis register. Arthritis Rheum. 2000 Mar;43(3):522-30. doi: 10.1002/1529-0131(200003)43:33.0.CO;2-Y.
- Results publication: PubMed 24173963Toussirot E, Mourot L, Dehecq B, Wendling D, Grandclement E, Dumoulin G; CBT-506. TNFalpha blockade for inflammatory rheumatic diseases is associated with a significant gain in android fat mass and has varying effects on adipokines: a 2-year prospective study. Eur J Nutr. 2014 Apr;53(3):951-61. doi: 10.1007/s00394-013-0599-2. Epub 2013 Oct 31.
- Results publication: PubMed 27974099Marouen S, Barnetche T, Combe B, Morel J, Daien CI. TNF inhibitors increase fat mass in inflammatory rheumatic disease: a systematic review with meta-analysis. Clin Exp Rheumatol. 2017 Mar-Apr;35(2):337-343. Epub 2016 Dec 13.
- Results publication: PubMed 20964833Engvall IL, Tengstrand B, Brismar K, Hafstrom I. Infliximab therapy increases body fat mass in early rheumatoid arthritis independently of changes in disease activity and levels of leptin and adiponectin: a randomised study over 21 months. Arthritis Res Ther. 2010;12(5):R197. doi: 10.1186/ar3169. Epub 2010 Oct 21.
- Results publication: PubMed 28316139Tournadre A, Pereira B, Dutheil F, Giraud C, Courteix D, Sapin V, Frayssac T, Mathieu S, Malochet-Guinamand S, Soubrier M. Changes in body composition and metabolic profile during interleukin 6 inhibition in rheumatoid arthritis. J Cachexia Sarcopenia Muscle. 2017 Aug;8(4):639-646. doi: 10.1002/jcsm.12189. Epub 2017 Mar 18.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Guillaume Letarouilly, MD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04175886, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026; AzTrials last refreshed its copy on 7 Nov 2026.