Trial Outcomes & Findings for An Assessment of Chronic Synovial-Based Inflammation and Its Role With Serum Urate Levels. (NCT NCT01112982)
NCT ID: NCT01112982
Last Updated: 2019-08-07
Results Overview
The primary aim of this study will be to determine the percentage of patients with known gout who have evidence of chronic ongoing synovial-based inflammatory disease, i.e. synovial pannus, in their "index joint", and determine if there is a correlation of the prevalence and severity of synovial pannus in the "index joint" with the patients' serum urate levels on the day of their MRI.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
74 participants
Primary outcome timeframe
MRI and baseline uric acid level will be performed upon enrollment in the study.
Results posted on
2019-08-07
Participant Flow
Participant milestones
| Measure |
MRI of Index Joint
All study participants: Standard demographics will be obtained including a baseline serum urate, creatinine, and hs-CRP. Study subjects will have their "index joint" determined (the joint that is most often involved with acute attacks of gout in each particular patient). A plain radiograph of the "index joint" will be obtained, as well as an MRI with and without gadolinium enhancement to assess for presence and degree synovial pannus.
Magnetic Resonance Imaging: An MRI (with and without gadolinium contrast) of index joint will be performed (T1, T2, and STIR images).
Plain Radiographs: Plain radiographs of "index joint" will be obtained and reviewed by two independent readers (radiologists)
|
|---|---|
|
Overall Study
STARTED
|
74
|
|
Overall Study
COMPLETED
|
72
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
MRI of Index Joint
All study participants: Standard demographics will be obtained including a baseline serum urate, creatinine, and hs-CRP. Study subjects will have their "index joint" determined (the joint that is most often involved with acute attacks of gout in each particular patient). A plain radiograph of the "index joint" will be obtained, as well as an MRI with and without gadolinium enhancement to assess for presence and degree synovial pannus.
Magnetic Resonance Imaging: An MRI (with and without gadolinium contrast) of index joint will be performed (T1, T2, and STIR images).
Plain Radiographs: Plain radiographs of "index joint" will be obtained and reviewed by two independent readers (radiologists)
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
exceeded weight limit to complete MRI
|
1
|
Baseline Characteristics
An Assessment of Chronic Synovial-Based Inflammation and Its Role With Serum Urate Levels.
Baseline characteristics by cohort
| Measure |
MRI of Index Joint
n=72 Participants
All study participants: Standard demographics will be obtained including a baseline serum urate, creatinine, and hs-CRP. Study subjects will have their "index joint" determined (the joint that is most often involved with acute attacks of gout in each particular patient). A plain radiograph of the "index joint" will be obtained, as well as an MRI with and without gadolinium enhancement to assess for presence and degree synovial pannus.
Magnetic Resonance Imaging: An MRI (with and without gadolinium contrast) of index joint will be performed (T1, T2, and STIR images).
Plain Radiographs: Plain radiographs of "index joint" will be obtained and reviewed by two independent readers (radiologists)
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
67 Participants
n=39 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=39 Participants
|
|
Age, Continuous
|
56.4 years
n=39 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
65 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
60 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=39 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=39 Participants
|
|
Race (NIH/OMB)
White
|
59 Participants
n=39 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=39 Participants
|
|
Region of Enrollment
United States
|
72 Participants
n=39 Participants
|
PRIMARY outcome
Timeframe: MRI and baseline uric acid level will be performed upon enrollment in the study.The primary aim of this study will be to determine the percentage of patients with known gout who have evidence of chronic ongoing synovial-based inflammatory disease, i.e. synovial pannus, in their "index joint", and determine if there is a correlation of the prevalence and severity of synovial pannus in the "index joint" with the patients' serum urate levels on the day of their MRI.
Outcome measures
| Measure |
MRI of Index Joint
n=72 Participants
All study participants: Standard demographics will be obtained including a baseline serum urate, creatinine, and hs-CRP. Study subjects will have their "index joint" determined (the joint that is most often involved with acute attacks of gout in each particular patient). A plain radiograph of the "index joint" will be obtained, as well as an MRI with and without gadolinium enhancement to assess for presence and degree synovial pannus.
Magnetic Resonance Imaging: An MRI (with and without gadolinium contrast) of index joint will be performed (T1, T2, and STIR images).
Plain Radiographs: Plain radiographs of "index joint" will be obtained and reviewed by two independent readers (radiologists)
|
Febuxostat Sub-Study
The primary endpoint of this sub-study was to determine if a nine month course of aggressive serum ULT in patients with gout significantly affects the severity of synovial pannus in the index joint as determined by comparing the baseline and month 9 MRI's using the aforementioned grading scale. Secondary endpoints included an assessment of significant change of the subjects' serum CRP and estimated Glomerular Filtration Rate (eGFR) from baseline to month 9. Other endpoints included assessing for significant change of erosive changes, intraosseous tophi, soft tissue tophi, joint effusion, bone marrow edema/lesions, and soft tissue edema on the MRI from baseline to month 9.
|
|---|---|---|
|
Number and Percentage of Participants With Evidence of Chronic Ongoing Synovial-Based Inflammatory Disease at Baseline.
|
63 Participants
|
—
|
SECONDARY outcome
Timeframe: Upon enrollment into study, and at month 9.A sub-study in a subgroup of patients will analyze the Number and Percentage of Substudy Participants for whom the Severity of Synovial Pannus was Significantly Reduced After 9 Months of Treatment with Febuxostat (Uloric) in the "index joint" by comparing the baseline MRI with a repeat MRI of the same joint.
Outcome measures
| Measure |
MRI of Index Joint
n=32 Participants
All study participants: Standard demographics will be obtained including a baseline serum urate, creatinine, and hs-CRP. Study subjects will have their "index joint" determined (the joint that is most often involved with acute attacks of gout in each particular patient). A plain radiograph of the "index joint" will be obtained, as well as an MRI with and without gadolinium enhancement to assess for presence and degree synovial pannus.
Magnetic Resonance Imaging: An MRI (with and without gadolinium contrast) of index joint will be performed (T1, T2, and STIR images).
Plain Radiographs: Plain radiographs of "index joint" will be obtained and reviewed by two independent readers (radiologists)
|
Febuxostat Sub-Study
The primary endpoint of this sub-study was to determine if a nine month course of aggressive serum ULT in patients with gout significantly affects the severity of synovial pannus in the index joint as determined by comparing the baseline and month 9 MRI's using the aforementioned grading scale. Secondary endpoints included an assessment of significant change of the subjects' serum CRP and estimated Glomerular Filtration Rate (eGFR) from baseline to month 9. Other endpoints included assessing for significant change of erosive changes, intraosseous tophi, soft tissue tophi, joint effusion, bone marrow edema/lesions, and soft tissue edema on the MRI from baseline to month 9.
|
|---|---|---|
|
Number and Percentage of Substudy Participants for Whom the Severity of Synovial Pannus Was Significantly Reduced After 9 Months of Treatment With Febuxostat (Uloric).
|
25 Participants
|
—
|
SECONDARY outcome
Timeframe: Upon enrollment into studyNumber of Participants with Other Characteristic Findings of Gout on these MRI's. These include erosive changes, intraosseous tophi, soft tissue tophi, joint effusion, bone marrow edema, and soft tissue edema. These secondary endpoints will also be summed with patients' serum urate levels.
Outcome measures
| Measure |
MRI of Index Joint
n=72 Participants
All study participants: Standard demographics will be obtained including a baseline serum urate, creatinine, and hs-CRP. Study subjects will have their "index joint" determined (the joint that is most often involved with acute attacks of gout in each particular patient). A plain radiograph of the "index joint" will be obtained, as well as an MRI with and without gadolinium enhancement to assess for presence and degree synovial pannus.
Magnetic Resonance Imaging: An MRI (with and without gadolinium contrast) of index joint will be performed (T1, T2, and STIR images).
Plain Radiographs: Plain radiographs of "index joint" will be obtained and reviewed by two independent readers (radiologists)
|
Febuxostat Sub-Study
The primary endpoint of this sub-study was to determine if a nine month course of aggressive serum ULT in patients with gout significantly affects the severity of synovial pannus in the index joint as determined by comparing the baseline and month 9 MRI's using the aforementioned grading scale. Secondary endpoints included an assessment of significant change of the subjects' serum CRP and estimated Glomerular Filtration Rate (eGFR) from baseline to month 9. Other endpoints included assessing for significant change of erosive changes, intraosseous tophi, soft tissue tophi, joint effusion, bone marrow edema/lesions, and soft tissue edema on the MRI from baseline to month 9.
|
|---|---|---|
|
Number of Participants With Other Characteristic Findings of Gout on MRI's Correlated With Serum Urate Levels.
Erosive Changes
|
31 Participants
|
—
|
|
Number of Participants With Other Characteristic Findings of Gout on MRI's Correlated With Serum Urate Levels.
Intraosseous tophi
|
25 Participants
|
—
|
|
Number of Participants With Other Characteristic Findings of Gout on MRI's Correlated With Serum Urate Levels.
Soft tissue tophi
|
11 Participants
|
—
|
|
Number of Participants With Other Characteristic Findings of Gout on MRI's Correlated With Serum Urate Levels.
Joint effusion
|
14 Participants
|
—
|
|
Number of Participants With Other Characteristic Findings of Gout on MRI's Correlated With Serum Urate Levels.
Bone marrow edema
|
40 Participants
|
—
|
|
Number of Participants With Other Characteristic Findings of Gout on MRI's Correlated With Serum Urate Levels.
Soft tissue edema
|
28 Participants
|
—
|
SECONDARY outcome
Timeframe: previous 2 years upon enrollment into studyDetermine if there is a correlation between the prevalence and severity of synovial pannus in the "index joint" with the patients' mean serum urate level from the previous 2 years at baseline.
Outcome measures
| Measure |
MRI of Index Joint
n=72 Participants
All study participants: Standard demographics will be obtained including a baseline serum urate, creatinine, and hs-CRP. Study subjects will have their "index joint" determined (the joint that is most often involved with acute attacks of gout in each particular patient). A plain radiograph of the "index joint" will be obtained, as well as an MRI with and without gadolinium enhancement to assess for presence and degree synovial pannus.
Magnetic Resonance Imaging: An MRI (with and without gadolinium contrast) of index joint will be performed (T1, T2, and STIR images).
Plain Radiographs: Plain radiographs of "index joint" will be obtained and reviewed by two independent readers (radiologists)
|
Febuxostat Sub-Study
The primary endpoint of this sub-study was to determine if a nine month course of aggressive serum ULT in patients with gout significantly affects the severity of synovial pannus in the index joint as determined by comparing the baseline and month 9 MRI's using the aforementioned grading scale. Secondary endpoints included an assessment of significant change of the subjects' serum CRP and estimated Glomerular Filtration Rate (eGFR) from baseline to month 9. Other endpoints included assessing for significant change of erosive changes, intraosseous tophi, soft tissue tophi, joint effusion, bone marrow edema/lesions, and soft tissue edema on the MRI from baseline to month 9.
|
|---|---|---|
|
Mean Serum Urate Levels for Previous 2 Years at Baseline.
|
7.93 mg/dL
Standard Deviation 2.13
|
—
|
SECONDARY outcome
Timeframe: Upon enrollment into study at screening.Population: Severity of Synovial Pannus in the "Index Joint"
Determine if the Number of Participants Prevalence and Severity of Synovial Pannus in the "Index Joint" with the patient's serum high-sensitivity C-Reactive Protein on the same day as the Magnetic Resonance Imaging. The Magnetic Resonance Imaging will be assessed for the severity of synovial pannus, which is graded on a scale of 1 to 6 (with 6 being the most severe).
Outcome measures
| Measure |
MRI of Index Joint
n=72 Participants
All study participants: Standard demographics will be obtained including a baseline serum urate, creatinine, and hs-CRP. Study subjects will have their "index joint" determined (the joint that is most often involved with acute attacks of gout in each particular patient). A plain radiograph of the "index joint" will be obtained, as well as an MRI with and without gadolinium enhancement to assess for presence and degree synovial pannus.
Magnetic Resonance Imaging: An MRI (with and without gadolinium contrast) of index joint will be performed (T1, T2, and STIR images).
Plain Radiographs: Plain radiographs of "index joint" will be obtained and reviewed by two independent readers (radiologists)
|
Febuxostat Sub-Study
n=25 Participants
The primary endpoint of this sub-study was to determine if a nine month course of aggressive serum ULT in patients with gout significantly affects the severity of synovial pannus in the index joint as determined by comparing the baseline and month 9 MRI's using the aforementioned grading scale. Secondary endpoints included an assessment of significant change of the subjects' serum CRP and estimated Glomerular Filtration Rate (eGFR) from baseline to month 9. Other endpoints included assessing for significant change of erosive changes, intraosseous tophi, soft tissue tophi, joint effusion, bone marrow edema/lesions, and soft tissue edema on the MRI from baseline to month 9.
|
|---|---|---|
|
The Severity of Synovial Pannus the Day of Serum High-sensitivity C-Reactive Protein and Magnetic Resonance Imaging
|
2.99 units on a scale
Standard Deviation 1.3
|
3.42 units on a scale
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: Upon enrollment into studyBaseline radiographs of the "index" joint will also be obtained on the same day as their MRI and assessed for the presence or absence of erosive changes, intraosseous tophi, soft tissue tophi, joint effusion, bone marrow edema, or soft tissue edema. This will be correlated with the presence and severity of synovial pannus in that same joint. The analysis will also be performed to see if there is a correlation with serum urate levels and the presence of erosions on their plain radiograph.
Outcome measures
| Measure |
MRI of Index Joint
n=72 Participants
All study participants: Standard demographics will be obtained including a baseline serum urate, creatinine, and hs-CRP. Study subjects will have their "index joint" determined (the joint that is most often involved with acute attacks of gout in each particular patient). A plain radiograph of the "index joint" will be obtained, as well as an MRI with and without gadolinium enhancement to assess for presence and degree synovial pannus.
Magnetic Resonance Imaging: An MRI (with and without gadolinium contrast) of index joint will be performed (T1, T2, and STIR images).
Plain Radiographs: Plain radiographs of "index joint" will be obtained and reviewed by two independent readers (radiologists)
|
Febuxostat Sub-Study
The primary endpoint of this sub-study was to determine if a nine month course of aggressive serum ULT in patients with gout significantly affects the severity of synovial pannus in the index joint as determined by comparing the baseline and month 9 MRI's using the aforementioned grading scale. Secondary endpoints included an assessment of significant change of the subjects' serum CRP and estimated Glomerular Filtration Rate (eGFR) from baseline to month 9. Other endpoints included assessing for significant change of erosive changes, intraosseous tophi, soft tissue tophi, joint effusion, bone marrow edema/lesions, and soft tissue edema on the MRI from baseline to month 9.
|
|---|---|---|
|
Presence or Absence of Erosive Changes on Baseline Radiographs of the "Index" Joint Correlated With the Presence and Severity of Synovial Pannus Correlation With Serum Urate Levels and the Presence of Erosions on Their Plain Radiograph.
Erosive Changes · Presence
|
31 Participants
|
—
|
|
Presence or Absence of Erosive Changes on Baseline Radiographs of the "Index" Joint Correlated With the Presence and Severity of Synovial Pannus Correlation With Serum Urate Levels and the Presence of Erosions on Their Plain Radiograph.
Erosive Changes · Absence
|
41 Participants
|
—
|
|
Presence or Absence of Erosive Changes on Baseline Radiographs of the "Index" Joint Correlated With the Presence and Severity of Synovial Pannus Correlation With Serum Urate Levels and the Presence of Erosions on Their Plain Radiograph.
Serum urate levels ≤6.8mg/dL · Presence
|
24 Participants
|
—
|
|
Presence or Absence of Erosive Changes on Baseline Radiographs of the "Index" Joint Correlated With the Presence and Severity of Synovial Pannus Correlation With Serum Urate Levels and the Presence of Erosions on Their Plain Radiograph.
Serum urate levels ≤6.8mg/dL · Absence
|
48 Participants
|
—
|
|
Presence or Absence of Erosive Changes on Baseline Radiographs of the "Index" Joint Correlated With the Presence and Severity of Synovial Pannus Correlation With Serum Urate Levels and the Presence of Erosions on Their Plain Radiograph.
Intraosseous Tophi · Presence
|
25 Participants
|
—
|
|
Presence or Absence of Erosive Changes on Baseline Radiographs of the "Index" Joint Correlated With the Presence and Severity of Synovial Pannus Correlation With Serum Urate Levels and the Presence of Erosions on Their Plain Radiograph.
Intraosseous Tophi · Absence
|
47 Participants
|
—
|
|
Presence or Absence of Erosive Changes on Baseline Radiographs of the "Index" Joint Correlated With the Presence and Severity of Synovial Pannus Correlation With Serum Urate Levels and the Presence of Erosions on Their Plain Radiograph.
Soft Tissue Tophi · Presence
|
11 Participants
|
—
|
|
Presence or Absence of Erosive Changes on Baseline Radiographs of the "Index" Joint Correlated With the Presence and Severity of Synovial Pannus Correlation With Serum Urate Levels and the Presence of Erosions on Their Plain Radiograph.
Soft Tissue Tophi · Absence
|
61 Participants
|
—
|
|
Presence or Absence of Erosive Changes on Baseline Radiographs of the "Index" Joint Correlated With the Presence and Severity of Synovial Pannus Correlation With Serum Urate Levels and the Presence of Erosions on Their Plain Radiograph.
Joint Effusion · Presence
|
14 Participants
|
—
|
|
Presence or Absence of Erosive Changes on Baseline Radiographs of the "Index" Joint Correlated With the Presence and Severity of Synovial Pannus Correlation With Serum Urate Levels and the Presence of Erosions on Their Plain Radiograph.
Joint Effusion · Absence
|
58 Participants
|
—
|
|
Presence or Absence of Erosive Changes on Baseline Radiographs of the "Index" Joint Correlated With the Presence and Severity of Synovial Pannus Correlation With Serum Urate Levels and the Presence of Erosions on Their Plain Radiograph.
Bone Marrow Edema · Presence
|
40 Participants
|
—
|
|
Presence or Absence of Erosive Changes on Baseline Radiographs of the "Index" Joint Correlated With the Presence and Severity of Synovial Pannus Correlation With Serum Urate Levels and the Presence of Erosions on Their Plain Radiograph.
Bone Marrow Edema · Absence
|
32 Participants
|
—
|
|
Presence or Absence of Erosive Changes on Baseline Radiographs of the "Index" Joint Correlated With the Presence and Severity of Synovial Pannus Correlation With Serum Urate Levels and the Presence of Erosions on Their Plain Radiograph.
Soft Tissue Edema · Presence
|
28 Participants
|
—
|
|
Presence or Absence of Erosive Changes on Baseline Radiographs of the "Index" Joint Correlated With the Presence and Severity of Synovial Pannus Correlation With Serum Urate Levels and the Presence of Erosions on Their Plain Radiograph.
Soft Tissue Edema · Absence
|
44 Participants
|
—
|
SECONDARY outcome
Timeframe: Upon enrollment into study at screening.Population: Serum High-Sensitivity C-Reactive Protein
The concentration of serum high-sensitivity C-Reactive Protein at enrollment.
Outcome measures
| Measure |
MRI of Index Joint
n=72 Participants
All study participants: Standard demographics will be obtained including a baseline serum urate, creatinine, and hs-CRP. Study subjects will have their "index joint" determined (the joint that is most often involved with acute attacks of gout in each particular patient). A plain radiograph of the "index joint" will be obtained, as well as an MRI with and without gadolinium enhancement to assess for presence and degree synovial pannus.
Magnetic Resonance Imaging: An MRI (with and without gadolinium contrast) of index joint will be performed (T1, T2, and STIR images).
Plain Radiographs: Plain radiographs of "index joint" will be obtained and reviewed by two independent readers (radiologists)
|
Febuxostat Sub-Study
n=25 Participants
The primary endpoint of this sub-study was to determine if a nine month course of aggressive serum ULT in patients with gout significantly affects the severity of synovial pannus in the index joint as determined by comparing the baseline and month 9 MRI's using the aforementioned grading scale. Secondary endpoints included an assessment of significant change of the subjects' serum CRP and estimated Glomerular Filtration Rate (eGFR) from baseline to month 9. Other endpoints included assessing for significant change of erosive changes, intraosseous tophi, soft tissue tophi, joint effusion, bone marrow edema/lesions, and soft tissue edema on the MRI from baseline to month 9.
|
|---|---|---|
|
High-sensitivity C-Reactive Protein Concentrations
|
0.52 mg/dL
Standard Deviation 0.84
|
0.37 mg/dL
Standard Deviation 0.4
|
Adverse Events
MRI of Index Joint
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MRI of Index Joint
n=72 participants at risk
All study participants: Standard demographics will be obtained including a baseline serum urate, creatinine, and hs-CRP. Study subjects will have their "index joint" determined (the joint that is most often involved with acute attacks of gout in each particular patient). A plain radiograph of the "index joint" will be obtained, as well as an MRI with and without gadolinium enhancement to assess for presence and degree synovial pannus.
Magnetic Resonance Imaging: An MRI (with and without gadolinium contrast) of index joint will be performed (T1, T2, and STIR images).
Plain Radiographs: Plain radiographs of "index joint" will be obtained and reviewed by two independent readers (radiologists)
|
|---|---|
|
Cardiac disorders
exacerbation of congestive heart failure
|
1.4%
1/72 • Number of events 1 • At screening, baseline, week 2, month 1, month 3, month 6, and month 9 adverse events were collected on 72 study participants.
All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were monitored/assessed.
|
Other adverse events
| Measure |
MRI of Index Joint
n=72 participants at risk
All study participants: Standard demographics will be obtained including a baseline serum urate, creatinine, and hs-CRP. Study subjects will have their "index joint" determined (the joint that is most often involved with acute attacks of gout in each particular patient). A plain radiograph of the "index joint" will be obtained, as well as an MRI with and without gadolinium enhancement to assess for presence and degree synovial pannus.
Magnetic Resonance Imaging: An MRI (with and without gadolinium contrast) of index joint will be performed (T1, T2, and STIR images).
Plain Radiographs: Plain radiographs of "index joint" will be obtained and reviewed by two independent readers (radiologists)
|
|---|---|
|
Hepatobiliary disorders
increased liver function tests
|
11.1%
8/72 • Number of events 8 • At screening, baseline, week 2, month 1, month 3, month 6, and month 9 adverse events were collected on 72 study participants.
All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were monitored/assessed.
|
|
Cardiac disorders
thrombocytopenia
|
1.4%
1/72 • Number of events 1 • At screening, baseline, week 2, month 1, month 3, month 6, and month 9 adverse events were collected on 72 study participants.
All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were monitored/assessed.
|
|
Gastrointestinal disorders
mild nausea
|
2.8%
2/72 • Number of events 2 • At screening, baseline, week 2, month 1, month 3, month 6, and month 9 adverse events were collected on 72 study participants.
All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were monitored/assessed.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place