Trial Outcomes & Findings for Tailoring Maintenance Therapy to Cluster of Differentiation 5 Positive (CD5+) Regulatory B Cell Recovery in ANCA Vasculitis (NCT NCT03906227)
NCT ID: NCT03906227
Last Updated: 2025-11-26
Results Overview
The primary outcome measure is time to first relapse defined as recurrence of any signs or symptoms attributable to active vasculitis after a period of complete remission, with at least 2 minor or 1 major item on the BVAS score (BVAS≥2). Per protocol, complete remission is defined as a BVAS score = 0. Birmingham Vasculitis Activity Score (BVAS, range 0-64). The total score is composed of 34 predefined items, units on a scale, grouped into 9 organ systems. Each item carries a weight from 1-3, depending on disease severity. A score of 0 indicates no disease activity; a higher score indicates worsening disease.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
9 participants
Primary outcome timeframe
from complete remission to end of study, approximately 2 years
Results posted on
2025-11-26
Participant Flow
Individuals who signed informed consent and then completed all baseline measurement procedures and remained eligible were considered enrolled and were randomized. One consented participant experienced a Serious Adverse Event and was withdrawn before randomization and another consented participant was screen failed because they were not in remission.
Participant milestones
| Measure |
Low CD5+ /on Maintenance
Participants in remission with Cluster of Differentiation (CD)19+CD5+ lower than 43% will continue on maintenance immunosuppression (Maintenance Therapy Group)- no randomization.
ENUMERATION OF CD5+ B Cells: A blood test is done to assess what percentage of CD5+ is present within CD19+. The result is then used to guide choice of arm.
|
High CD5/ on Maintenance
Participants in remission with Cluster of Differentiation 19 positive (CD19+)CD5+ 43% or greater, randomized to continue on maintenance immunosuppression (Maintenance Therapy Group)
ENUMERATION OF CD5+ B Cells: A blood test is done to assess what percentage of CD5+ is present within CD19+. The result is then used to guide choice of arm.
|
High CD5 / NO Maintenance
Participants in remission with CD19+CD5+ 43% or greater , randomized to NO maintenance immunosuppression (NO Maintenance Therapy Group)
ENUMERATION OF CD5+ B Cells: A blood test is done to assess what percentage of CD5+ is present within CD19+. The result is then used to guide choice of arm.
|
|---|---|---|---|
|
Overall Study
STARTED
|
1
|
4
|
2
|
|
Overall Study
COMPLETED
|
1
|
2
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Tailoring Maintenance Therapy to Cluster of Differentiation 5 Positive (CD5+) Regulatory B Cell Recovery in ANCA Vasculitis
Baseline characteristics by cohort
| Measure |
Low CD5+ /on Maintenance
n=1 Participants
Participants in remission with Cluster of Differentiation (CD)19+CD5+ lower than 43% will continue on maintenance immunosuppression (Maintenance Therapy Group)- no randomization.
ENUMERATION OF CD5+ B Cells: A blood test is done to assess what percentage of CD5+ is present within CD19+. The result is then used to guide choice of arm.
|
High CD5/ on Maintenance
n=4 Participants
Participants in remission with CD19+CD5+ 43% or greater, randomized to continue on maintenance immunosuppression (Maintenance Therapy Group)
ENUMERATION OF CD5+ B Cells: A blood test is done to assess what percentage of CD5+ is present within CD19+. The result is then used to guide choice of arm.
|
High CD5 / NO Maintenance
n=2 Participants
Participants in remission with CD19+CD5+ 43% or greater , randomized to NO maintenance immunosuppression (NO Maintenance Therapy Group)
ENUMERATION OF CD5+ B Cells: A blood test is done to assess what percentage of CD5+ is present within CD19+. The result is then used to guide choice of arm.
|
Total
n=7 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=492 Participants
|
0 Participants
n=492 Participants
|
0 Participants
n=984 Participants
|
0 Participants
n=3 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=492 Participants
|
1 Participants
n=492 Participants
|
2 Participants
n=984 Participants
|
4 Participants
n=3 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=492 Participants
|
3 Participants
n=492 Participants
|
0 Participants
n=984 Participants
|
3 Participants
n=3 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=492 Participants
|
2 Participants
n=492 Participants
|
0 Participants
n=984 Participants
|
3 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=492 Participants
|
2 Participants
n=492 Participants
|
2 Participants
n=984 Participants
|
4 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=492 Participants
|
0 Participants
n=492 Participants
|
0 Participants
n=984 Participants
|
1 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=492 Participants
|
4 Participants
n=492 Participants
|
2 Participants
n=984 Participants
|
6 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=492 Participants
|
0 Participants
n=492 Participants
|
0 Participants
n=984 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=492 Participants
|
0 Participants
n=492 Participants
|
0 Participants
n=984 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=492 Participants
|
0 Participants
n=492 Participants
|
0 Participants
n=984 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=492 Participants
|
0 Participants
n=492 Participants
|
0 Participants
n=984 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=492 Participants
|
0 Participants
n=492 Participants
|
1 Participants
n=984 Participants
|
1 Participants
n=3 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=492 Participants
|
4 Participants
n=492 Participants
|
1 Participants
n=984 Participants
|
6 Participants
n=3 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=492 Participants
|
0 Participants
n=492 Participants
|
0 Participants
n=984 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=492 Participants
|
0 Participants
n=492 Participants
|
0 Participants
n=984 Participants
|
0 Participants
n=3 Participants
|
|
Region of Enrollment
United States
|
1 Participants
n=492 Participants
|
4 Participants
n=492 Participants
|
2 Participants
n=984 Participants
|
7 Participants
n=3 Participants
|
|
Anti-Neutrophilic Cytoplasmic Antibodies (ANCA) Positive at Enrollment
|
0 Participants
n=492 Participants
|
3 Participants
n=492 Participants
|
0 Participants
n=984 Participants
|
3 Participants
n=3 Participants
|
PRIMARY outcome
Timeframe: from complete remission to end of study, approximately 2 yearsThe primary outcome measure is time to first relapse defined as recurrence of any signs or symptoms attributable to active vasculitis after a period of complete remission, with at least 2 minor or 1 major item on the BVAS score (BVAS≥2). Per protocol, complete remission is defined as a BVAS score = 0. Birmingham Vasculitis Activity Score (BVAS, range 0-64). The total score is composed of 34 predefined items, units on a scale, grouped into 9 organ systems. Each item carries a weight from 1-3, depending on disease severity. A score of 0 indicates no disease activity; a higher score indicates worsening disease.
Outcome measures
| Measure |
High CD5 / NO Maintenance
n=2 Participants
Participants in remission with CD19+CD5+ 43% or greater , randomized to NO maintenance immunosuppression (NO Maintenance Therapy Group)
ENUMERATION OF CD5+ B Cells: A blood test is done to assess what percentage of CD5+ is present within CD19+. The result is then used to guide choice of arm.
|
Non-Randomized
Participants who signed informed consent but could not be randomized.
|
High CD5/ on Maintenance
n=4 Participants
Participants in remission with CD19+CD5+ 43% or greater, randomized to continue on maintenance immunosuppression (Maintenance Therapy Group)
ENUMERATION OF CD5+ B Cells: A blood test is done to assess what percentage of CD5+ is present within CD19+. The result is then used to guide choice of arm.
|
Low CD5+ /on Maintenance
n=1 Participants
Participants in remission with Cluster of Differentiation (CD)19+CD5+ lower than 43% will continue on maintenance immunosuppression (Maintenance Therapy Group)- no randomization.
ENUMERATION OF CD5+ B Cells: A blood test is done to assess what percentage of CD5+ is present within CD19+. The result is then used to guide choice of arm.
|
|---|---|---|---|---|
|
Time to First Relapse
|
NA months
Standard Deviation NA
No participants in this Arm/Group experienced relapse
|
—
|
NA months
Standard Deviation NA
No participants in this Arm/Group experienced relapse
|
7.1 months
Standard Deviation 0
|
SECONDARY outcome
Timeframe: from complete remission to end of study, approximately 2 yearsRelapse in each group was determined using the Birmingham Vasculitis Activity Score for Wegener's Granulomatosis(BVAS, range 0-64). The total score is composed of 34 predefined items grouped into 9 organ systems. Each item has a specified weight of either 3 or 1, depending on whether it reflects major or minor disease activity. A score of 0 indicates no disease activity; a higher score indicates worsening disease. Per protocol relapse is defined as BVAS \>/= 2; however for reporting purposes relapse was defined as BVAS \>/= 1 because the participant was treated based on the clinical relapse.
Outcome measures
| Measure |
High CD5 / NO Maintenance
n=2 Participants
Participants in remission with CD19+CD5+ 43% or greater , randomized to NO maintenance immunosuppression (NO Maintenance Therapy Group)
ENUMERATION OF CD5+ B Cells: A blood test is done to assess what percentage of CD5+ is present within CD19+. The result is then used to guide choice of arm.
|
Non-Randomized
Participants who signed informed consent but could not be randomized.
|
High CD5/ on Maintenance
n=4 Participants
Participants in remission with CD19+CD5+ 43% or greater, randomized to continue on maintenance immunosuppression (Maintenance Therapy Group)
ENUMERATION OF CD5+ B Cells: A blood test is done to assess what percentage of CD5+ is present within CD19+. The result is then used to guide choice of arm.
|
Low CD5+ /on Maintenance
n=1 Participants
Participants in remission with Cluster of Differentiation (CD)19+CD5+ lower than 43% will continue on maintenance immunosuppression (Maintenance Therapy Group)- no randomization.
ENUMERATION OF CD5+ B Cells: A blood test is done to assess what percentage of CD5+ is present within CD19+. The result is then used to guide choice of arm.
|
|---|---|---|---|---|
|
Number of Participants Who Experience Relapse
|
0 Participants
|
—
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: from complete remission to end of study, approximately 2 yearsFrequency, as determined by number of relapse in each group. Per protocol relapse is defined as BVAS \>/= 2; however for reporting purposes relapse was defined as BVAS \>/= 1 because the participant was treated based on the clinical relapse.
Outcome measures
| Measure |
High CD5 / NO Maintenance
n=2 Participants
Participants in remission with CD19+CD5+ 43% or greater , randomized to NO maintenance immunosuppression (NO Maintenance Therapy Group)
ENUMERATION OF CD5+ B Cells: A blood test is done to assess what percentage of CD5+ is present within CD19+. The result is then used to guide choice of arm.
|
Non-Randomized
Participants who signed informed consent but could not be randomized.
|
High CD5/ on Maintenance
n=4 Participants
Participants in remission with CD19+CD5+ 43% or greater, randomized to continue on maintenance immunosuppression (Maintenance Therapy Group)
ENUMERATION OF CD5+ B Cells: A blood test is done to assess what percentage of CD5+ is present within CD19+. The result is then used to guide choice of arm.
|
Low CD5+ /on Maintenance
n=1 Participants
Participants in remission with Cluster of Differentiation (CD)19+CD5+ lower than 43% will continue on maintenance immunosuppression (Maintenance Therapy Group)- no randomization.
ENUMERATION OF CD5+ B Cells: A blood test is done to assess what percentage of CD5+ is present within CD19+. The result is then used to guide choice of arm.
|
|---|---|---|---|---|
|
Frequency of Relapse
|
0 relapse
|
—
|
0 relapse
|
1 relapse
|
SECONDARY outcome
Timeframe: from complete remission to end of study, approximately 2 yearsSeverity of relapse as determined by number of major relapse in each group. Major relapse is defined as involving a major organ
Outcome measures
| Measure |
High CD5 / NO Maintenance
n=2 Participants
Participants in remission with CD19+CD5+ 43% or greater , randomized to NO maintenance immunosuppression (NO Maintenance Therapy Group)
ENUMERATION OF CD5+ B Cells: A blood test is done to assess what percentage of CD5+ is present within CD19+. The result is then used to guide choice of arm.
|
Non-Randomized
Participants who signed informed consent but could not be randomized.
|
High CD5/ on Maintenance
n=4 Participants
Participants in remission with CD19+CD5+ 43% or greater, randomized to continue on maintenance immunosuppression (Maintenance Therapy Group)
ENUMERATION OF CD5+ B Cells: A blood test is done to assess what percentage of CD5+ is present within CD19+. The result is then used to guide choice of arm.
|
Low CD5+ /on Maintenance
n=1 Participants
Participants in remission with Cluster of Differentiation (CD)19+CD5+ lower than 43% will continue on maintenance immunosuppression (Maintenance Therapy Group)- no randomization.
ENUMERATION OF CD5+ B Cells: A blood test is done to assess what percentage of CD5+ is present within CD19+. The result is then used to guide choice of arm.
|
|---|---|---|---|---|
|
Severity of Relapse
Major
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
|
Severity of Relapse
Minor
|
0 Participants
|
—
|
0 Participants
|
1 Participants
|
|
Severity of Relapse
No relapse
|
2 Participants
|
—
|
4 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: from first negative ANCA test since start of study , if applicable- to end of study, maximum two years, as applicableFor participants who had a negative ANCA test, time to positive ANCA
Outcome measures
| Measure |
High CD5 / NO Maintenance
n=2 Participants
Participants in remission with CD19+CD5+ 43% or greater , randomized to NO maintenance immunosuppression (NO Maintenance Therapy Group)
ENUMERATION OF CD5+ B Cells: A blood test is done to assess what percentage of CD5+ is present within CD19+. The result is then used to guide choice of arm.
|
Non-Randomized
Participants who signed informed consent but could not be randomized.
|
High CD5/ on Maintenance
n=4 Participants
Participants in remission with CD19+CD5+ 43% or greater, randomized to continue on maintenance immunosuppression (Maintenance Therapy Group)
ENUMERATION OF CD5+ B Cells: A blood test is done to assess what percentage of CD5+ is present within CD19+. The result is then used to guide choice of arm.
|
Low CD5+ /on Maintenance
n=1 Participants
Participants in remission with Cluster of Differentiation (CD)19+CD5+ lower than 43% will continue on maintenance immunosuppression (Maintenance Therapy Group)- no randomization.
ENUMERATION OF CD5+ B Cells: A blood test is done to assess what percentage of CD5+ is present within CD19+. The result is then used to guide choice of arm.
|
|---|---|---|---|---|
|
Time to Positive ANCA
|
NA months
Standard Deviation NA
ANCA test did not become positive.
|
—
|
NA months
Standard Deviation NA
No data are reported because two were ANCA-positive at enrollment and two never became positive.
|
NA months
Standard Deviation NA
ANCA test did not become positive.
|
SECONDARY outcome
Timeframe: from remission to end of study, approximately 2 yearsFrequency as determined by the number of infections
Outcome measures
| Measure |
High CD5 / NO Maintenance
n=2 Participants
Participants in remission with CD19+CD5+ 43% or greater , randomized to NO maintenance immunosuppression (NO Maintenance Therapy Group)
ENUMERATION OF CD5+ B Cells: A blood test is done to assess what percentage of CD5+ is present within CD19+. The result is then used to guide choice of arm.
|
Non-Randomized
Participants who signed informed consent but could not be randomized.
|
High CD5/ on Maintenance
n=4 Participants
Participants in remission with CD19+CD5+ 43% or greater, randomized to continue on maintenance immunosuppression (Maintenance Therapy Group)
ENUMERATION OF CD5+ B Cells: A blood test is done to assess what percentage of CD5+ is present within CD19+. The result is then used to guide choice of arm.
|
Low CD5+ /on Maintenance
n=1 Participants
Participants in remission with Cluster of Differentiation (CD)19+CD5+ lower than 43% will continue on maintenance immunosuppression (Maintenance Therapy Group)- no randomization.
ENUMERATION OF CD5+ B Cells: A blood test is done to assess what percentage of CD5+ is present within CD19+. The result is then used to guide choice of arm.
|
|---|---|---|---|---|
|
Frequency of Infections
|
1 infections
|
—
|
0 infections
|
0 infections
|
SECONDARY outcome
Timeframe: from remission to end of study, approximately 2 yearsnumber of mild/moderate/severe infections
Outcome measures
| Measure |
High CD5 / NO Maintenance
n=2 Participants
Participants in remission with CD19+CD5+ 43% or greater , randomized to NO maintenance immunosuppression (NO Maintenance Therapy Group)
ENUMERATION OF CD5+ B Cells: A blood test is done to assess what percentage of CD5+ is present within CD19+. The result is then used to guide choice of arm.
|
Non-Randomized
n=2 Participants
Participants who signed informed consent but could not be randomized.
|
High CD5/ on Maintenance
n=4 Participants
Participants in remission with CD19+CD5+ 43% or greater, randomized to continue on maintenance immunosuppression (Maintenance Therapy Group)
ENUMERATION OF CD5+ B Cells: A blood test is done to assess what percentage of CD5+ is present within CD19+. The result is then used to guide choice of arm.
|
Low CD5+ /on Maintenance
n=1 Participants
Participants in remission with Cluster of Differentiation (CD)19+CD5+ lower than 43% will continue on maintenance immunosuppression (Maintenance Therapy Group)- no randomization.
ENUMERATION OF CD5+ B Cells: A blood test is done to assess what percentage of CD5+ is present within CD19+. The result is then used to guide choice of arm.
|
|---|---|---|---|---|
|
Number of Infections, Categorized by Severity
Moderate
|
1 infection
|
0 infection
|
0 infection
|
0 infection
|
|
Number of Infections, Categorized by Severity
Severe
|
0 infection
|
0 infection
|
0 infection
|
0 infection
|
|
Number of Infections, Categorized by Severity
Mild
|
0 infection
|
0 infection
|
0 infection
|
0 infection
|
SECONDARY outcome
Timeframe: from enrollment to end of study, approximately 2.5 to 3 yearsTime to IL-10 secreting B regulatory cells \> 45% or CD5+ B cells \> 43% of total B cells
Outcome measures
| Measure |
High CD5 / NO Maintenance
n=2 Participants
Participants in remission with CD19+CD5+ 43% or greater , randomized to NO maintenance immunosuppression (NO Maintenance Therapy Group)
ENUMERATION OF CD5+ B Cells: A blood test is done to assess what percentage of CD5+ is present within CD19+. The result is then used to guide choice of arm.
|
Non-Randomized
Participants who signed informed consent but could not be randomized.
|
High CD5/ on Maintenance
n=4 Participants
Participants in remission with CD19+CD5+ 43% or greater, randomized to continue on maintenance immunosuppression (Maintenance Therapy Group)
ENUMERATION OF CD5+ B Cells: A blood test is done to assess what percentage of CD5+ is present within CD19+. The result is then used to guide choice of arm.
|
Low CD5+ /on Maintenance
n=1 Participants
Participants in remission with Cluster of Differentiation (CD)19+CD5+ lower than 43% will continue on maintenance immunosuppression (Maintenance Therapy Group)- no randomization.
ENUMERATION OF CD5+ B Cells: A blood test is done to assess what percentage of CD5+ is present within CD19+. The result is then used to guide choice of arm.
|
|---|---|---|---|---|
|
Time to Interleukin (IL)-10 Secreting B Regulatory Cells > 45% or CD5+ B Cells > 43% of Total B Cells
|
NA months
Standard Deviation NA
No participants experienced relapse.
|
—
|
NA months
Standard Deviation NA
No participants experienced relapse.
|
NA months
Standard Deviation NA
The participant who experienced relapse did not have IL-10 secreting B regulatory cells \> 45% or CD5+ B cells \> 43% of total B cells.
|
Adverse Events
Low CD5+ /on Maintenance
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
High CD5/ on Maintenance
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
High CD5 / NO Maintenance
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Non-Randomized
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Low CD5+ /on Maintenance
n=1 participants at risk
Participants in remission with Cluster of Differentiation (CD)19+CD5+ lower than 43% will continue on maintenance immunosuppression (Maintenance Therapy Group)- no randomization.
ENUMERATION OF CD5+ B Cells: A blood test is done to assess what percentage of CD5+ is present within CD19+. The result is then used to guide choice of arm.
|
High CD5/ on Maintenance
n=4 participants at risk
Participants in remission with CD19+CD5+ 43% or greater, randomized to continue on maintenance immunosuppression (Maintenance Therapy Group)
ENUMERATION OF CD5+ B Cells: A blood test is done to assess what percentage of CD5+ is present within CD19+. The result is then used to guide choice of arm.
|
High CD5 / NO Maintenance
n=2 participants at risk
Participants in remission with CD19+CD5+ 43% or greater , randomized to NO maintenance immunosuppression (NO Maintenance Therapy Group)
ENUMERATION OF CD5+ B Cells: A blood test is done to assess what percentage of CD5+ is present within CD19+. The result is then used to guide choice of arm.
|
Non-Randomized
n=2 participants at risk
Participants who signed informed consent but could not be randomized.
|
|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intracranial mass
|
0.00%
0/1 • From the time of signing informed consent through study completion, up to 2 years
|
0.00%
0/4 • From the time of signing informed consent through study completion, up to 2 years
|
0.00%
0/2 • From the time of signing informed consent through study completion, up to 2 years
|
50.0%
1/2 • Number of events 1 • From the time of signing informed consent through study completion, up to 2 years
|
Other adverse events
| Measure |
Low CD5+ /on Maintenance
n=1 participants at risk
Participants in remission with Cluster of Differentiation (CD)19+CD5+ lower than 43% will continue on maintenance immunosuppression (Maintenance Therapy Group)- no randomization.
ENUMERATION OF CD5+ B Cells: A blood test is done to assess what percentage of CD5+ is present within CD19+. The result is then used to guide choice of arm.
|
High CD5/ on Maintenance
n=4 participants at risk
Participants in remission with CD19+CD5+ 43% or greater, randomized to continue on maintenance immunosuppression (Maintenance Therapy Group)
ENUMERATION OF CD5+ B Cells: A blood test is done to assess what percentage of CD5+ is present within CD19+. The result is then used to guide choice of arm.
|
High CD5 / NO Maintenance
n=2 participants at risk
Participants in remission with CD19+CD5+ 43% or greater , randomized to NO maintenance immunosuppression (NO Maintenance Therapy Group)
ENUMERATION OF CD5+ B Cells: A blood test is done to assess what percentage of CD5+ is present within CD19+. The result is then used to guide choice of arm.
|
Non-Randomized
n=2 participants at risk
Participants who signed informed consent but could not be randomized.
|
|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Tendon nodules
|
0.00%
0/1 • From the time of signing informed consent through study completion, up to 2 years
|
25.0%
1/4 • Number of events 1 • From the time of signing informed consent through study completion, up to 2 years
|
0.00%
0/2 • From the time of signing informed consent through study completion, up to 2 years
|
0.00%
0/2 • From the time of signing informed consent through study completion, up to 2 years
|
|
Musculoskeletal and connective tissue disorders
"Trigger finger"
|
0.00%
0/1 • From the time of signing informed consent through study completion, up to 2 years
|
25.0%
1/4 • Number of events 1 • From the time of signing informed consent through study completion, up to 2 years
|
0.00%
0/2 • From the time of signing informed consent through study completion, up to 2 years
|
0.00%
0/2 • From the time of signing informed consent through study completion, up to 2 years
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/1 • From the time of signing informed consent through study completion, up to 2 years
|
25.0%
1/4 • Number of events 1 • From the time of signing informed consent through study completion, up to 2 years
|
0.00%
0/2 • From the time of signing informed consent through study completion, up to 2 years
|
0.00%
0/2 • From the time of signing informed consent through study completion, up to 2 years
|
|
General disorders
Pain at vaccination site
|
0.00%
0/1 • From the time of signing informed consent through study completion, up to 2 years
|
25.0%
1/4 • Number of events 1 • From the time of signing informed consent through study completion, up to 2 years
|
0.00%
0/2 • From the time of signing informed consent through study completion, up to 2 years
|
0.00%
0/2 • From the time of signing informed consent through study completion, up to 2 years
|
|
Eye disorders
Small left eye hemorrhage at inner area
|
0.00%
0/1 • From the time of signing informed consent through study completion, up to 2 years
|
25.0%
1/4 • Number of events 1 • From the time of signing informed consent through study completion, up to 2 years
|
0.00%
0/2 • From the time of signing informed consent through study completion, up to 2 years
|
0.00%
0/2 • From the time of signing informed consent through study completion, up to 2 years
|
|
Gastrointestinal disorders
Heart burn when lying down
|
0.00%
0/1 • From the time of signing informed consent through study completion, up to 2 years
|
0.00%
0/4 • From the time of signing informed consent through study completion, up to 2 years
|
50.0%
1/2 • Number of events 1 • From the time of signing informed consent through study completion, up to 2 years
|
0.00%
0/2 • From the time of signing informed consent through study completion, up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain from frozen shoulder
|
100.0%
1/1 • Number of events 1 • From the time of signing informed consent through study completion, up to 2 years
|
0.00%
0/4 • From the time of signing informed consent through study completion, up to 2 years
|
0.00%
0/2 • From the time of signing informed consent through study completion, up to 2 years
|
0.00%
0/2 • From the time of signing informed consent through study completion, up to 2 years
|
|
General disorders
Pain
|
100.0%
1/1 • Number of events 1 • From the time of signing informed consent through study completion, up to 2 years
|
0.00%
0/4 • From the time of signing informed consent through study completion, up to 2 years
|
0.00%
0/2 • From the time of signing informed consent through study completion, up to 2 years
|
0.00%
0/2 • From the time of signing informed consent through study completion, up to 2 years
|
|
Metabolism and nutrition disorders
Low vitamin B
|
100.0%
1/1 • Number of events 1 • From the time of signing informed consent through study completion, up to 2 years
|
0.00%
0/4 • From the time of signing informed consent through study completion, up to 2 years
|
0.00%
0/2 • From the time of signing informed consent through study completion, up to 2 years
|
0.00%
0/2 • From the time of signing informed consent through study completion, up to 2 years
|
|
Immune system disorders
rituximab infusion reaction
|
100.0%
1/1 • Number of events 1 • From the time of signing informed consent through study completion, up to 2 years
|
0.00%
0/4 • From the time of signing informed consent through study completion, up to 2 years
|
0.00%
0/2 • From the time of signing informed consent through study completion, up to 2 years
|
0.00%
0/2 • From the time of signing informed consent through study completion, up to 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma skin lesion on right arm above elbow-removed
|
0.00%
0/1 • From the time of signing informed consent through study completion, up to 2 years
|
0.00%
0/4 • From the time of signing informed consent through study completion, up to 2 years
|
50.0%
1/2 • Number of events 1 • From the time of signing informed consent through study completion, up to 2 years
|
0.00%
0/2 • From the time of signing informed consent through study completion, up to 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Further removal of squamous cell carcinoma on right arm
|
0.00%
0/1 • From the time of signing informed consent through study completion, up to 2 years
|
0.00%
0/4 • From the time of signing informed consent through study completion, up to 2 years
|
50.0%
1/2 • Number of events 1 • From the time of signing informed consent through study completion, up to 2 years
|
0.00%
0/2 • From the time of signing informed consent through study completion, up to 2 years
|
|
Skin and subcutaneous tissue disorders
Right foot Planter's wart removal
|
0.00%
0/1 • From the time of signing informed consent through study completion, up to 2 years
|
0.00%
0/4 • From the time of signing informed consent through study completion, up to 2 years
|
50.0%
1/2 • Number of events 1 • From the time of signing informed consent through study completion, up to 2 years
|
0.00%
0/2 • From the time of signing informed consent through study completion, up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff tear left shoulder
|
0.00%
0/1 • From the time of signing informed consent through study completion, up to 2 years
|
0.00%
0/4 • From the time of signing informed consent through study completion, up to 2 years
|
50.0%
1/2 • Number of events 1 • From the time of signing informed consent through study completion, up to 2 years
|
0.00%
0/2 • From the time of signing informed consent through study completion, up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Increased arthralgia
|
100.0%
1/1 • Number of events 1 • From the time of signing informed consent through study completion, up to 2 years
|
0.00%
0/4 • From the time of signing informed consent through study completion, up to 2 years
|
0.00%
0/2 • From the time of signing informed consent through study completion, up to 2 years
|
0.00%
0/2 • From the time of signing informed consent through study completion, up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Lower back pain
|
100.0%
1/1 • Number of events 1 • From the time of signing informed consent through study completion, up to 2 years
|
0.00%
0/4 • From the time of signing informed consent through study completion, up to 2 years
|
0.00%
0/2 • From the time of signing informed consent through study completion, up to 2 years
|
0.00%
0/2 • From the time of signing informed consent through study completion, up to 2 years
|
|
General disorders
Fever
|
100.0%
1/1 • Number of events 1 • From the time of signing informed consent through study completion, up to 2 years
|
0.00%
0/4 • From the time of signing informed consent through study completion, up to 2 years
|
0.00%
0/2 • From the time of signing informed consent through study completion, up to 2 years
|
0.00%
0/2 • From the time of signing informed consent through study completion, up to 2 years
|
|
Nervous system disorders
Dizziness
|
100.0%
1/1 • Number of events 1 • From the time of signing informed consent through study completion, up to 2 years
|
0.00%
0/4 • From the time of signing informed consent through study completion, up to 2 years
|
0.00%
0/2 • From the time of signing informed consent through study completion, up to 2 years
|
0.00%
0/2 • From the time of signing informed consent through study completion, up to 2 years
|
|
Infections and infestations
Periorbital cellulitis
|
0.00%
0/1 • From the time of signing informed consent through study completion, up to 2 years
|
0.00%
0/4 • From the time of signing informed consent through study completion, up to 2 years
|
50.0%
1/2 • Number of events 1 • From the time of signing informed consent through study completion, up to 2 years
|
0.00%
0/2 • From the time of signing informed consent through study completion, up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Right knee swollen and hot to touch
|
0.00%
0/1 • From the time of signing informed consent through study completion, up to 2 years
|
0.00%
0/4 • From the time of signing informed consent through study completion, up to 2 years
|
50.0%
1/2 • Number of events 1 • From the time of signing informed consent through study completion, up to 2 years
|
0.00%
0/2 • From the time of signing informed consent through study completion, up to 2 years
|
|
Reproductive system and breast disorders
Increase in right hydrocele
|
0.00%
0/1 • From the time of signing informed consent through study completion, up to 2 years
|
0.00%
0/4 • From the time of signing informed consent through study completion, up to 2 years
|
50.0%
1/2 • Number of events 1 • From the time of signing informed consent through study completion, up to 2 years
|
0.00%
0/2 • From the time of signing informed consent through study completion, up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Bilateral leg weakness
|
0.00%
0/1 • From the time of signing informed consent through study completion, up to 2 years
|
0.00%
0/4 • From the time of signing informed consent through study completion, up to 2 years
|
50.0%
1/2 • Number of events 1 • From the time of signing informed consent through study completion, up to 2 years
|
0.00%
0/2 • From the time of signing informed consent through study completion, up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Right knee pain
|
0.00%
0/1 • From the time of signing informed consent through study completion, up to 2 years
|
0.00%
0/4 • From the time of signing informed consent through study completion, up to 2 years
|
50.0%
1/2 • Number of events 1 • From the time of signing informed consent through study completion, up to 2 years
|
0.00%
0/2 • From the time of signing informed consent through study completion, up to 2 years
|
|
Gastrointestinal disorders
Belching
|
0.00%
0/1 • From the time of signing informed consent through study completion, up to 2 years
|
25.0%
1/4 • Number of events 1 • From the time of signing informed consent through study completion, up to 2 years
|
0.00%
0/2 • From the time of signing informed consent through study completion, up to 2 years
|
0.00%
0/2 • From the time of signing informed consent through study completion, up to 2 years
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/1 • From the time of signing informed consent through study completion, up to 2 years
|
25.0%
1/4 • Number of events 1 • From the time of signing informed consent through study completion, up to 2 years
|
0.00%
0/2 • From the time of signing informed consent through study completion, up to 2 years
|
0.00%
0/2 • From the time of signing informed consent through study completion, up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Fracture of left radius
|
0.00%
0/1 • From the time of signing informed consent through study completion, up to 2 years
|
25.0%
1/4 • Number of events 1 • From the time of signing informed consent through study completion, up to 2 years
|
0.00%
0/2 • From the time of signing informed consent through study completion, up to 2 years
|
0.00%
0/2 • From the time of signing informed consent through study completion, up to 2 years
|
|
Renal and urinary disorders
Abnormal urinalysis
|
0.00%
0/1 • From the time of signing informed consent through study completion, up to 2 years
|
25.0%
1/4 • Number of events 1 • From the time of signing informed consent through study completion, up to 2 years
|
0.00%
0/2 • From the time of signing informed consent through study completion, up to 2 years
|
0.00%
0/2 • From the time of signing informed consent through study completion, up to 2 years
|
|
Blood and lymphatic system disorders
Iron deficiency
|
0.00%
0/1 • From the time of signing informed consent through study completion, up to 2 years
|
25.0%
1/4 • Number of events 1 • From the time of signing informed consent through study completion, up to 2 years
|
0.00%
0/2 • From the time of signing informed consent through study completion, up to 2 years
|
0.00%
0/2 • From the time of signing informed consent through study completion, up to 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/1 • From the time of signing informed consent through study completion, up to 2 years
|
25.0%
1/4 • Number of events 1 • From the time of signing informed consent through study completion, up to 2 years
|
0.00%
0/2 • From the time of signing informed consent through study completion, up to 2 years
|
0.00%
0/2 • From the time of signing informed consent through study completion, up to 2 years
|
|
General disorders
Prolonged fatigue
|
0.00%
0/1 • From the time of signing informed consent through study completion, up to 2 years
|
0.00%
0/4 • From the time of signing informed consent through study completion, up to 2 years
|
50.0%
1/2 • Number of events 1 • From the time of signing informed consent through study completion, up to 2 years
|
0.00%
0/2 • From the time of signing informed consent through study completion, up to 2 years
|
|
Skin and subcutaneous tissue disorders
Pruritic rash
|
0.00%
0/1 • From the time of signing informed consent through study completion, up to 2 years
|
0.00%
0/4 • From the time of signing informed consent through study completion, up to 2 years
|
50.0%
1/2 • Number of events 1 • From the time of signing informed consent through study completion, up to 2 years
|
0.00%
0/2 • From the time of signing informed consent through study completion, up to 2 years
|
|
Immune system disorders
Reaction to Shingrix vaccination
|
0.00%
0/1 • From the time of signing informed consent through study completion, up to 2 years
|
0.00%
0/4 • From the time of signing informed consent through study completion, up to 2 years
|
50.0%
1/2 • Number of events 1 • From the time of signing informed consent through study completion, up to 2 years
|
0.00%
0/2 • From the time of signing informed consent through study completion, up to 2 years
|
|
Cardiac disorders
Syncopal episode resulting in fall with head trauma
|
0.00%
0/1 • From the time of signing informed consent through study completion, up to 2 years
|
0.00%
0/4 • From the time of signing informed consent through study completion, up to 2 years
|
50.0%
1/2 • Number of events 1 • From the time of signing informed consent through study completion, up to 2 years
|
0.00%
0/2 • From the time of signing informed consent through study completion, up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
0.00%
0/1 • From the time of signing informed consent through study completion, up to 2 years
|
0.00%
0/4 • From the time of signing informed consent through study completion, up to 2 years
|
50.0%
1/2 • Number of events 1 • From the time of signing informed consent through study completion, up to 2 years
|
0.00%
0/2 • From the time of signing informed consent through study completion, up to 2 years
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/1 • From the time of signing informed consent through study completion, up to 2 years
|
0.00%
0/4 • From the time of signing informed consent through study completion, up to 2 years
|
50.0%
1/2 • Number of events 1 • From the time of signing informed consent through study completion, up to 2 years
|
0.00%
0/2 • From the time of signing informed consent through study completion, up to 2 years
|
Additional Information
Anne Froment
University of North Carolina at Chapel Hill
Phone: 919-445-2622
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place