Pigmented Villonodular Synovitis, PVNS - Pigmented Villonodular Synovitis, Tenosynovial Giant Cell Tumor, TGCT
Conditions
Keywords
Tenosynovial Giant Cell Tumor, TGCT, PVNS
Brief summary
The purpose of this Phase 2, open-label, multiple-dose, dose-escalation study is to evaluate intravenous AMB-05X in the treatment of subjects with TGCT.
Detailed description
AMB-05X drug substance is a human monoclonal antibody against the colony-stimulating factor 1 receptor (CSF1R).
Interventions
BIOLOGICALAMB-05X
AMB-05X is a fully human antibody antagonist (immunoglobulin G, type 2 \[IgG2\]) specific to the extracellular domain of human CSF1R
Sponsors
AmMax Bio, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject ≥ 18 years 2. A confirmed diagnosis of TGCT 3. Measurable disease based on RECIST v1.1 4. Symptomatic disease 5. Stable prescription of analgesic regimen 6. Agrees to follow contraception guidelines 7. Adequate hematologic, hepatic, and renal function, at Screening 8. Willing and able to complete self-assessment instruments throughout the study
Exclusion criteria
1. Prior investigational drug use within 4 weeks or 5 half-lives of Baseline 2. Current or prior radiotherapy within 3 months before Baseline 3. Current or prior active cancer within 3 years before Baseline that requires/required therapy (eg, surgery, chemotherapy, or radiation therapy) 4. Known metastatic TGCT or malignant transformation of diffuse-type TGCT 5. Hepatitis C virus (HCV) or hepatitis B virus (HBV) or known active or chronic infection with human immuno deficiency virus (HIV) 6. Known active tuberculosis (TB) 7. Significant concomitant arthropathy in the affected joint, serious illness, uncontrolled infection, or a medical or psychiatric history 8. Women who are pregnant or breastfeeding 9. Screening Fridericia-corrected QT interval(QTcF) ≥450ms (men) or ≥470ms (women) 10. MRI contraindications (eg, pacemaker, loose metallic implants) 11. History of hypersensitivity to any ingredient in the study drug 12. History of drug or alcohol abuse within 3 months before Baseline 13. Has any other severe acute or chronic medical or psychiatric condition or clinically significant laboratory abnormality that may increase the risk associated with study participation/treatment, interfere with interpretation of study results, or, in the Investigator's opinion, make the subject inappropriate for this study 14. A person who is held in detention as the result of a judicial or official decision or who is in a subordinate relationship to the Sponsor or Investigator 15. A subject who, in the opinion of the Investigator, should not participate in the study for any reason, including if there is a question about the subject's ability to comply with study requirements
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment-emergent Adverse Events (TEAEs) | 6 months | The frequency and severity of reported TEAEs in Subjects with Tenosynovial Giant Cell Tumor (TGCT) receiving Intravenous AMB 05X. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Based on Tumor Volume Score (TVS) | 24 weeks or ET visit | Tumor Volume Score (TVS) calculates tumor volume as a percentage of the estimated volume of the maximally distended synovial cavity or tendon sheath and provides a score in 10% increments. A score of 0 indicates no evidence of tumor; a score of 10 indicates a tumor that is equal in volume to that of a maximally distended synovial cavity or tendon sheath. Complete response (CR): lesion is completely gone; Partial response (PR): \>/=50% decrease in TVS relative to Baseline; Progressive disease (PD): \>/= 30% increase in TVS relative to the lowest score during the study; Stable disease (SD): does not meet any of the other classifications. |
| Mean Change From Baseline Range of Motion (ROM) (Flexion, Knee) Scores | week 12 | Mean Change from Baseline in Range of Motion (ROM) Scores - Flexion (knee only). ROM is assessed by qualified assessors and recorded in degrees. At Baseline, the plane of movement with the smallest (worst) relative ROM was identified; only this plane was used for evaluating change in ROM. Higher scores indicate greater range of motion. |
| Mean Change From Baseline in the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Score | 12 weeks | Mean change from Baseline in the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function score is used to assess physical function. PROMIS is a 10-question patient reported outcome instrument used to assess physical functioning based on use of the upper extremities (dexterity), lower extremities (walking or mobility), and central regions (neck, back) and on instrumental activities of daily living. Five questions address the degree to which the subject's health limits activities, and subjects select a response that ranges from 1-cannot do to 5-not at all. Five additional questions address the degree to which the subject is able to perform certain physical activities, and subjects select a response to each question that ranges from 1 (cannot do) to 5 (without any difficulty). Raw scores are summarized. The score range is 10 to 50, higher scores = worse physical function |
| Serum Cmax for AMB-05X at Week 10 Post Dose | 10 weeks | The maximum concentration of AMB-05X in subject serum is measured at week 10 postdose, using sensitive enzyme-linked immunosorbent assay analyses (ELISA). |
| Number of Subjects With Anti-Drug Antibodies to AMB-05X at Week 10 | 10 weeks | AMB-05X Anti-drug Antibodies (ADA) in subject serum will be measured from pre-dose samples. |
| Mean Change From Baseline in Worst Stiffness Numeric Rating Scale (NRS) Score | 12 weeks | The mean changes from Baseline in the Worst Stiffness Numeric Rating Scale (NRS) score, a Patient-Reported Outcome (PRO) Measurement. The Worst Stiffness NRS is a single-item instrument designed to assess worst stiffness at the site of the tumor in the last 24 hours. The instrument uses an 11-point numeric rating scale that ranges from 0 (no stiffness) to 10 (stiffness as bad as you can imagine). Higher scores indicate worse stiffness. |
| Overall Tumor Response (Objective Response) Per Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 | 12 weeks | Response Evaluation Criteria in Solid Tumors (RECIST) v1.1; Per RECIST v1.0 for target lesions and assessed by MRI: A Complete Response (CR) is defined as disappearance of all tumors. A Partial Response (PR) is defined as at least a 30% decrease in the sum of diameters of target tumors from the baseline sum of diameters. |
| Mean Change From Baseline in Brief Pain Inventory Severity Interference | 12 weeks | The mean changes from Baseline in Brief Pain Inventory (BPI) Severity Interference domain. The BPI Short Form is a patient-reported outcome instrument used to evaluate the severity of a subject's pain and the impact of this pain on the subject's daily functioning. For this domain, the subject is asked to rate their worst, least, average, and current pain intensity, list current treatments and their perceived effectiveness, and rate the degree that pain interferes with general activity, mood, walking ability, normal work, relations with other persons, sleep, and enjoyment of life on a scale from 0 to 10, where higher scores mean more pain interference. The reported score is the mean of the seven interference items. Higher scores indicate greater levels of pain. |
| Worst Pain Numeric Rating Scale Score | 12 weeks | Mean change from Baseline in Worst Pain Numeric Rating Scale score. The Worst Pain Numeric Rating Scale is an item in the BPI that assesses a subject's worst pain in the last 24 hours. The 11-point Numeric Rating Scale for this item ranges from 0 (no pain) to 10 (pain as bad as you can imagine). Higher scores indicate greater level of pain. |
| EuroQol 5 Dimension 5 Level Health Assessment | 12 weeks | Mean change from Baseline in the EuroQol 5 Dimension 5 Level (EQ-5D-5L) assessment Scale Score (5-25). This instrument is a self-report survey that measures quality of life across 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is scored on a 5-level severity ranking that ranges from no problems through extreme problems. Higher scores indicate a lower quality of life. |
| Colony-stimulating Factor 1 Levels | 10 weeks | Serum colony-stimulating factor-1 (CSF-1) levels are measured in patient/subject serum. Samples were collected for measurement of CSF-1 at least once at specified visits. |
| Mean Change From Baseline Rnge of Motion (Flexion, Ankle) Scores | week 12 | Mean Change from Baseline in Range of Motion (ROM) Scores - Flexion (Ankle only). ROM is assessed by qualified assessors and recorded in degrees. At Baseline, the plane of movement with the smallest (worst) relative ROM was to be identified; only this plane was used for evaluating change in ROM. Higher scores indicate greater range of motion. |
| Serum AMB-05X-Binding Anti-drug Antibody (ADA) Levels | Week 12 | Series analysis for anti-drug antibody detection and titer |
| Brief Pain Inventory Pain Severity Domain Score | 12 weeks | The mean changes from Baseline in Brief Pain Inventory (BPI) Pain Severity Domain. (Score of 0-10, where a negative score from baseline indicates a better BPI score, less severe pain) Brief Pain Inventory (BPI) is a self-administered questionnaire used to evaluate the severity of a subject's pain and the impact of this pain on the subject's daily functioning. For the Pain Severity domain the subject is asked to rate their worst, least, average, and current pain intensity, and list current treatments and their perceived effectiveness on a scale from 0 to 10, where higher scores mean more severe pain. All of the 0-10 scores are averaged to obtain the total Domain (subscale) Score. |
Countries
Hungary, Poland, Ukraine
Participant flow
Pre-assignment details
The original study design included multiple cohorts with an adaptive, dose escalation design. However, due to the early conclusion of the study, subjects were enrolled only in Cohort A, thus no additional dose cohorts were recruited.
Participants by arm
| Arm | Count |
|---|---|
| Cohort A: Subjects With TGCT Low-Dose AMB-05X Each subject will receive a low dose of AMB-05X every 2 weeks, for a total of 6 doses over the 12-week treatment period.
AMB-05X is a fully human antibody antagonist (immunoglobulin G, type 2 \[IgG2\]) specific to the extracellular domain of human CSF1R | 4 |
| Total | 4 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
Baseline characteristics
| Characteristic | Cohort A: Subjects With TGCT |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 4 Participants |
| Region of Enrollment Hungary | 1 participants |
| Region of Enrollment Poland | 1 participants |
| Region of Enrollment Ukraine | 2 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 4 |
| other Total, other adverse events | 0 / 4 | 4 / 4 |
| serious Total, serious adverse events | 0 / 4 | 0 / 4 |
Outcome results
Primary
Treatment-emergent Adverse Events (TEAEs)
The frequency and severity of reported TEAEs in Subjects with Tenosynovial Giant Cell Tumor (TGCT) receiving Intravenous AMB 05X.
Time frame: 6 months
Population: All enrolled patients
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort A: Subjects With TGCT | Treatment-emergent Adverse Events (TEAEs) | Number of subjects without treatment-emergent adverse events | 0 Participants |
| Cohort A: Subjects With TGCT | Treatment-emergent Adverse Events (TEAEs) | Number of subjects with treatment-emergent adverse events | 4 Participants |
Secondary
Brief Pain Inventory Pain Severity Domain Score
The mean changes from Baseline in Brief Pain Inventory (BPI) Pain Severity Domain. (Score of 0-10, where a negative score from baseline indicates a better BPI score, less severe pain) Brief Pain Inventory (BPI) is a self-administered questionnaire used to evaluate the severity of a subject's pain and the impact of this pain on the subject's daily functioning. For the Pain Severity domain the subject is asked to rate their worst, least, average, and current pain intensity, and list current treatments and their perceived effectiveness on a scale from 0 to 10, where higher scores mean more severe pain. All of the 0-10 scores are averaged to obtain the total Domain (subscale) Score.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort A: Subjects With TGCT | Brief Pain Inventory Pain Severity Domain Score | -0.83 score on a scale | Standard Deviation 1.665 |
Secondary
Colony-stimulating Factor 1 Levels
Serum colony-stimulating factor-1 (CSF-1) levels are measured in patient/subject serum. Samples were collected for measurement of CSF-1 at least once at specified visits.
Time frame: 10 weeks
Population: TGCT subjects
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort A: Subjects With TGCT | Colony-stimulating Factor 1 Levels | 1216 pg/mL | Standard Deviation 372 |
Secondary
EuroQol 5 Dimension 5 Level Health Assessment
Mean change from Baseline in the EuroQol 5 Dimension 5 Level (EQ-5D-5L) assessment Scale Score (5-25). This instrument is a self-report survey that measures quality of life across 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is scored on a 5-level severity ranking that ranges from no problems through extreme problems. Higher scores indicate a lower quality of life.
Time frame: 12 weeks
Population: TGCT subjects
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort A: Subjects With TGCT | EuroQol 5 Dimension 5 Level Health Assessment | -0.3 score on a scale | Standard Deviation 0.58 |
Secondary
Mean Change From Baseline in Brief Pain Inventory Severity Interference
The mean changes from Baseline in Brief Pain Inventory (BPI) Severity Interference domain. The BPI Short Form is a patient-reported outcome instrument used to evaluate the severity of a subject's pain and the impact of this pain on the subject's daily functioning. For this domain, the subject is asked to rate their worst, least, average, and current pain intensity, list current treatments and their perceived effectiveness, and rate the degree that pain interferes with general activity, mood, walking ability, normal work, relations with other persons, sleep, and enjoyment of life on a scale from 0 to 10, where higher scores mean more pain interference. The reported score is the mean of the seven interference items. Higher scores indicate greater levels of pain.
Time frame: 12 weeks
Population: TGCT subjects
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort A: Subjects With TGCT | Mean Change From Baseline in Brief Pain Inventory Severity Interference | 0.81 score on a scale | Standard Deviation 1.528 |
Secondary
Mean Change From Baseline in the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Score
Mean change from Baseline in the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function score is used to assess physical function. PROMIS is a 10-question patient reported outcome instrument used to assess physical functioning based on use of the upper extremities (dexterity), lower extremities (walking or mobility), and central regions (neck, back) and on instrumental activities of daily living. Five questions address the degree to which the subject's health limits activities, and subjects select a response that ranges from 1-cannot do to 5-not at all. Five additional questions address the degree to which the subject is able to perform certain physical activities, and subjects select a response to each question that ranges from 1 (cannot do) to 5 (without any difficulty). Raw scores are summarized. The score range is 10 to 50, higher scores = worse physical function
Time frame: 12 weeks
Population: Subjects with TGCT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort A: Subjects With TGCT | Mean Change From Baseline in the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Score | 0 score on a scale | Standard Deviation 2.65 |
Secondary
Mean Change From Baseline in Worst Stiffness Numeric Rating Scale (NRS) Score
The mean changes from Baseline in the Worst Stiffness Numeric Rating Scale (NRS) score, a Patient-Reported Outcome (PRO) Measurement. The Worst Stiffness NRS is a single-item instrument designed to assess worst stiffness at the site of the tumor in the last 24 hours. The instrument uses an 11-point numeric rating scale that ranges from 0 (no stiffness) to 10 (stiffness as bad as you can imagine). Higher scores indicate worse stiffness.
Time frame: 12 weeks
Population: TGCT subjects
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort A: Subjects With TGCT | Mean Change From Baseline in Worst Stiffness Numeric Rating Scale (NRS) Score | -2.7 score on a scale | Standard Deviation 2.52 |
Secondary
Mean Change From Baseline Range of Motion (ROM) (Flexion, Knee) Scores
Mean Change from Baseline in Range of Motion (ROM) Scores - Flexion (knee only). ROM is assessed by qualified assessors and recorded in degrees. At Baseline, the plane of movement with the smallest (worst) relative ROM was identified; only this plane was used for evaluating change in ROM. Higher scores indicate greater range of motion.
Time frame: week 12
Population: Modified intent-to-treat, 3 subjects with ROM data in right and left knee were analyzed
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort A: Subjects With TGCT | Mean Change From Baseline Range of Motion (ROM) (Flexion, Knee) Scores | Subjects with no change in ROM from baseline | 1 Participants |
| Cohort A: Subjects With TGCT | Mean Change From Baseline Range of Motion (ROM) (Flexion, Knee) Scores | Subjects with change in ROM Left Knee | 1 Participants |
| Cohort A: Subjects With TGCT | Mean Change From Baseline Range of Motion (ROM) (Flexion, Knee) Scores | Subjects with change in ROM Right Knee | 1 Participants |
Secondary
Mean Change From Baseline Rnge of Motion (Flexion, Ankle) Scores
Mean Change from Baseline in Range of Motion (ROM) Scores - Flexion (Ankle only). ROM is assessed by qualified assessors and recorded in degrees. At Baseline, the plane of movement with the smallest (worst) relative ROM was to be identified; only this plane was used for evaluating change in ROM. Higher scores indicate greater range of motion.
Time frame: week 12
Population: Although the protocol allowed patients with TGCT of the ankle, no subjects with TGCT of the ankle were enrolled.
Secondary
Number of Subjects With Anti-Drug Antibodies to AMB-05X at Week 10
AMB-05X Anti-drug Antibodies (ADA) in subject serum will be measured from pre-dose samples.
Time frame: 10 weeks
Population: All enrolled subjects
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort A: Subjects With TGCT | Number of Subjects With Anti-Drug Antibodies to AMB-05X at Week 10 | Subjects ADA positive at any visit analyzed | 1 Participants |
| Cohort A: Subjects With TGCT | Number of Subjects With Anti-Drug Antibodies to AMB-05X at Week 10 | Subjects ADA negative at every visit analyzed | 3 Participants |
Secondary
Overall Response Based on Tumor Volume Score (TVS)
Tumor Volume Score (TVS) calculates tumor volume as a percentage of the estimated volume of the maximally distended synovial cavity or tendon sheath and provides a score in 10% increments. A score of 0 indicates no evidence of tumor; a score of 10 indicates a tumor that is equal in volume to that of a maximally distended synovial cavity or tendon sheath. Complete response (CR): lesion is completely gone; Partial response (PR): \>/=50% decrease in TVS relative to Baseline; Progressive disease (PD): \>/= 30% increase in TVS relative to the lowest score during the study; Stable disease (SD): does not meet any of the other classifications.
Time frame: 24 weeks or ET visit
Population: TGCT - Modified Intent-to-treat (ITT) - All TGCT subjects who received at least 1 dose of study drug and had both baseline and post-baseline data for at least 1 efficacy endpoint.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort A: Subjects With TGCT | Overall Response Based on Tumor Volume Score (TVS) | Subjects with CR | 0 Participants |
| Cohort A: Subjects With TGCT | Overall Response Based on Tumor Volume Score (TVS) | Subjects with PR | 0 Participants |
| Cohort A: Subjects With TGCT | Overall Response Based on Tumor Volume Score (TVS) | Subjects with SD | 3 Participants |
Secondary
Overall Tumor Response (Objective Response) Per Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1
Response Evaluation Criteria in Solid Tumors (RECIST) v1.1; Per RECIST v1.0 for target lesions and assessed by MRI: A Complete Response (CR) is defined as disappearance of all tumors. A Partial Response (PR) is defined as at least a 30% decrease in the sum of diameters of target tumors from the baseline sum of diameters.
Time frame: 12 weeks
Population: TGCT - Modified Intent-to-treat (ITT)- All TGCT subjects who received at least 1 dose of study drug and had both baseline and post-baseline data for at least 1 efficacy endpoint.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort A: Subjects With TGCT | Overall Tumor Response (Objective Response) Per Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 | Subjects with CR | 0 Participants |
| Cohort A: Subjects With TGCT | Overall Tumor Response (Objective Response) Per Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 | Subjects with PR | 1 Participants |
| Cohort A: Subjects With TGCT | Overall Tumor Response (Objective Response) Per Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 | Subjects with stable disease | 2 Participants |
Secondary
Serum AMB-05X-Binding Anti-drug Antibody (ADA) Levels
Series analysis for anti-drug antibody detection and titer
Time frame: Week 12
Population: Measurement of serum AMB-05X-Binding anti-drug antibody (ADA) levels was a prespecified secondary outcome measure. ADA data for 4 subjects enrolled prior to study termination are provided. One of 4 subjects provided only a baseline sample. Three of 4 subjects provided both baseline (Visit 2) and Week 10 (Visit 7) samples. No conclusions were made based on the limited information collected at study termination (Sponsor stopped developing intravenous AMB-05X for patients with TGCT).
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Cohort A: Subjects With TGCT | Serum AMB-05X-Binding Anti-drug Antibody (ADA) Levels | Baseline visit | Subjects ADA negative | 3 Participants |
| Cohort A: Subjects With TGCT | Serum AMB-05X-Binding Anti-drug Antibody (ADA) Levels | Baseline visit | Subjects ADA positive | 1 Participants |
| Cohort A: Subjects With TGCT | Serum AMB-05X-Binding Anti-drug Antibody (ADA) Levels | Visit 7 | Subjects ADA negative | 2 Participants |
| Cohort A: Subjects With TGCT | Serum AMB-05X-Binding Anti-drug Antibody (ADA) Levels | Visit 7 | Subjects ADA positive | 1 Participants |
Secondary
Serum Cmax for AMB-05X at Week 10 Post Dose
The maximum concentration of AMB-05X in subject serum is measured at week 10 postdose, using sensitive enzyme-linked immunosorbent assay analyses (ELISA).
Time frame: 10 weeks
Population: All enrolled subjects
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Cohort A: Subjects With TGCT | Serum Cmax for AMB-05X at Week 10 Post Dose | 54,457 ng/mL |
Secondary
Worst Pain Numeric Rating Scale Score
Mean change from Baseline in Worst Pain Numeric Rating Scale score. The Worst Pain Numeric Rating Scale is an item in the BPI that assesses a subject's worst pain in the last 24 hours. The 11-point Numeric Rating Scale for this item ranges from 0 (no pain) to 10 (pain as bad as you can imagine). Higher scores indicate greater level of pain.
Time frame: 12 weeks
Population: TGCT subjects
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort A: Subjects With TGCT | Worst Pain Numeric Rating Scale Score | -0.3 score on a scale | Standard Deviation 1.53 |