Trial Outcomes & Findings for Tenosynovial Giant Cell Tumors (TGCT) Observational Platform Project (NCT NCT02948088)
NCT ID: NCT02948088
Last Updated: 2023-10-31
Results Overview
The management plan received among the patients was collected from information routinely recorded in the patient files / medical records.
Recruitment status
COMPLETED
Target enrollment
183 participants
Primary outcome timeframe
Baseline up to end of observation period (approximately 2 years)
Results posted on
2023-10-31
Participant Flow
A total of 183 participants who met all eligibility criteria were enrolled in the study at 12 sites in Europe and the United States.
All participants with diffuse TGCT (diagnosed histologically) with a confirmed primary diagnosis or recurrent case were enrolled.
Participant milestones
| Measure |
Tenosynovial Giant Cell Tumors
All participants with diffuse tenosynovial giant cell tumors (d-TGCT) who were enrolled in the study.
|
|---|---|
|
Overall Study
STARTED
|
183
|
|
Overall Study
Full Analysis Set
|
176
|
|
Overall Study
COMPLETED
|
168
|
|
Overall Study
NOT COMPLETED
|
15
|
Reasons for withdrawal
| Measure |
Tenosynovial Giant Cell Tumors
All participants with diffuse tenosynovial giant cell tumors (d-TGCT) who were enrolled in the study.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
8
|
|
Overall Study
Death
|
1
|
|
Overall Study
Withdrawal by Subject
|
4
|
|
Overall Study
Other
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Tenosynovial Giant Cell Tumors
n=176 Participants
All participants with diffuse tenosynovial giant cell tumors (d-TGCT) who were enrolled in the study.
|
|---|---|
|
Age, Continuous
|
43.5 years
STANDARD_DEVIATION 14.3 • n=176 Participants
|
|
Age, Customized
<40 years
|
78 Participants
n=176 Participants
|
|
Age, Customized
≥40 and <60 years
|
69 Participants
n=176 Participants
|
|
Age, Customized
≥60 years
|
29 Participants
n=176 Participants
|
|
Sex: Female, Male
Female
|
108 Participants
n=176 Participants
|
|
Sex: Female, Male
Male
|
68 Participants
n=176 Participants
|
|
Region of Enrollment
Austria
|
10 participants
n=176 Participants
|
|
Region of Enrollment
Netherlands
|
61 participants
n=176 Participants
|
|
Region of Enrollment
United States
|
34 participants
n=176 Participants
|
|
Region of Enrollment
Italy
|
38 participants
n=176 Participants
|
|
Region of Enrollment
United Kingdom
|
3 participants
n=176 Participants
|
|
Region of Enrollment
France
|
4 participants
n=176 Participants
|
|
Region of Enrollment
Germany
|
12 participants
n=176 Participants
|
|
Region of Enrollment
Spain
|
14 participants
n=176 Participants
|
|
Tumor location/affected joint
Knee joint
|
120 Participants
n=176 Participants
|
|
Tumor location/affected joint
Ankle joint
|
18 Participants
n=176 Participants
|
|
Tumor location/affected joint
Hip
|
12 Participants
n=176 Participants
|
|
Tumor location/affected joint
Shoulder joint
|
8 Participants
n=176 Participants
|
|
Tumor location/affected joint
Foot
|
7 Participants
n=176 Participants
|
|
Tumor location/affected joint
Elbow joint
|
4 Participants
n=176 Participants
|
|
Tumor location/affected joint
Wrist joint
|
3 Participants
n=176 Participants
|
|
Tumor location/affected joint
Hand
|
3 Participants
n=176 Participants
|
|
Tumor location/affected joint
Temporomandibular
|
1 Participants
n=176 Participants
|
|
Current symptoms
Pain
|
138 Participants
n=176 Participants
|
|
Current symptoms
Limited range of movement
|
116 Participants
n=176 Participants
|
|
Current symptoms
Swelling
|
111 Participants
n=176 Participants
|
|
Current symptoms
Stiffness
|
99 Participants
n=176 Participants
|
|
Current symptoms
Patient unable to judge
|
0 Participants
n=176 Participants
|
|
Most disturbing symptom
Pain
|
86 Participants
n=176 Participants
|
|
Most disturbing symptom
Stiffness
|
13 Participants
n=176 Participants
|
|
Most disturbing symptom
Swelling
|
18 Participants
n=176 Participants
|
|
Most disturbing symptom
Limited range of movement
|
32 Participants
n=176 Participants
|
|
Most disturbing symptom
Patient unable to judge
|
16 Participants
n=176 Participants
|
|
Most disturbing symptom
Not applicable
|
8 Participants
n=176 Participants
|
|
Most disturbing symptom
Missing
|
3 Participants
n=176 Participants
|
|
Number of participants with current symptoms
4 current symptoms
|
60 Participants
n=176 Participants
|
|
Number of participants with current symptoms
3 current symptoms
|
36 Participants
n=176 Participants
|
|
Number of participants with current symptoms
2 current symptoms
|
47 Participants
n=176 Participants
|
|
Number of participants with current symptoms
Unknown/missing
|
33 Participants
n=176 Participants
|
PRIMARY outcome
Timeframe: Baseline up to end of observation period (approximately 2 years)Population: Management plans were assessed in participants with available data in the Full Analysis Set. Participants may have be included in more than one category.
The management plan received among the patients was collected from information routinely recorded in the patient files / medical records.
Outcome measures
| Measure |
Baseline
n=176 Participants
All participants with diffuse tenosynovial giant cell tumors (d-TGCT) who were enrolled at baseline in the study.
|
Within 1st Year
n=173 Participants
Participants with diffuse tenosynovial giant cell tumors (d-TGCT) who were assessed within 1st year of the study.
|
Within 2nd Year
n=173 Participants
Participants with diffuse tenosynovial giant cell tumors (d-TGCT) who were assessed within 2nd year of the study.
|
18 Months
Participants with diffuse tenosynovial giant cell tumors (d-TGCT) who had BPI Pain Severity and Pain Interference assessments conducted at 18 months.
|
24 Months
Participants with diffuse tenosynovial giant cell tumors (d-TGCT) who had BPI Pain Severity and Pain Interference assessments conducted at 24 months.
|
|---|---|---|---|---|---|
|
Number of Participants According to the Management Plan in Patients With Diffuse TGCT (d-TGCT)
Any prior or concomitant therapies for managing TGCT-related symptoms
|
94 Participants
|
NA Participants
This parameter was only assessed at Baseline.
|
NA Participants
This parameter was only assessed at Baseline.
|
—
|
—
|
|
Number of Participants According to the Management Plan in Patients With Diffuse TGCT (d-TGCT)
Any changes to concomitant therapies for managing TGCT-related symptoms since the last visit
|
NA Participants
This parameter was based on changes since last visit and was only assessed within the 1st year and within the 2nd year.
|
43 Participants
|
19 Participants
|
—
|
—
|
|
Number of Participants According to the Management Plan in Patients With Diffuse TGCT (d-TGCT)
Any changes to TGCT treatment (including also planned treatments) since the last visit
|
NA Participants
This parameter was based on changes since last visit and was only assessed within the 1st year and within the 2nd year.
|
74 Participants
|
61 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline up to end of observation period (approximately 2 years)Population: The current treatment plan (currently being treated or planned) was assessed in participants with no changes at any data collection point where the data of the previous reported data collection point is being reported in the Full Analysis Set.
The current TGCT treatment plan among the patients was collected from information routinely recorded in the patient files / medical records.
Outcome measures
| Measure |
Baseline
n=176 Participants
All participants with diffuse tenosynovial giant cell tumors (d-TGCT) who were enrolled at baseline in the study.
|
Within 1st Year
n=173 Participants
Participants with diffuse tenosynovial giant cell tumors (d-TGCT) who were assessed within 1st year of the study.
|
Within 2nd Year
n=173 Participants
Participants with diffuse tenosynovial giant cell tumors (d-TGCT) who were assessed within 2nd year of the study.
|
18 Months
Participants with diffuse tenosynovial giant cell tumors (d-TGCT) who had BPI Pain Severity and Pain Interference assessments conducted at 18 months.
|
24 Months
Participants with diffuse tenosynovial giant cell tumors (d-TGCT) who had BPI Pain Severity and Pain Interference assessments conducted at 24 months.
|
|---|---|---|---|---|---|
|
Number of Participants According to the Current TGCT Treatment Plan in Patients With Diffuse TGCT (d-TGCT)
Wait and see
|
79 Participants
|
77 Participants
|
105 Participants
|
—
|
—
|
|
Number of Participants According to the Current TGCT Treatment Plan in Patients With Diffuse TGCT (d-TGCT)
Currently being treated or planned to be treated
|
97 Participants
|
85 Participants
|
65 Participants
|
—
|
—
|
|
Number of Participants According to the Current TGCT Treatment Plan in Patients With Diffuse TGCT (d-TGCT)
Unknown/Missing
|
0 Participants
|
11 Participants
|
3 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline up to end of observation period (approximately 2 years)Population: Type of treatment plans were assessed in participants with available data in the Full Analysis Set. Participants may have be included in more than one category.
Type of treatment plan received among the patients was collected from information routinely recorded in the patient files / medical records.
Outcome measures
| Measure |
Baseline
n=176 Participants
All participants with diffuse tenosynovial giant cell tumors (d-TGCT) who were enrolled at baseline in the study.
|
Within 1st Year
n=173 Participants
Participants with diffuse tenosynovial giant cell tumors (d-TGCT) who were assessed within 1st year of the study.
|
Within 2nd Year
n=173 Participants
Participants with diffuse tenosynovial giant cell tumors (d-TGCT) who were assessed within 2nd year of the study.
|
18 Months
Participants with diffuse tenosynovial giant cell tumors (d-TGCT) who had BPI Pain Severity and Pain Interference assessments conducted at 18 months.
|
24 Months
Participants with diffuse tenosynovial giant cell tumors (d-TGCT) who had BPI Pain Severity and Pain Interference assessments conducted at 24 months.
|
|---|---|---|---|---|---|
|
Number of Participants Based on Type of Treatment Plan in Patients With Diffuse TGCT (d-TGCT)
Radiotherapy
|
5 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants Based on Type of Treatment Plan in Patients With Diffuse TGCT (d-TGCT)
90Yttrium therapy
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants Based on Type of Treatment Plan in Patients With Diffuse TGCT (d-TGCT)
Systemic therapy
|
48 Participants
|
16 Participants
|
8 Participants
|
—
|
—
|
|
Number of Participants Based on Type of Treatment Plan in Patients With Diffuse TGCT (d-TGCT)
Surgery
|
42 Participants
|
40 Participants
|
25 Participants
|
—
|
—
|
|
Number of Participants Based on Type of Treatment Plan in Patients With Diffuse TGCT (d-TGCT)
Future surgery required
|
5 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants Based on Type of Treatment Plan in Patients With Diffuse TGCT (d-TGCT)
No current or planned treatment
|
79 Participants
|
77 Participants
|
105 Participants
|
—
|
—
|
|
Number of Participants Based on Type of Treatment Plan in Patients With Diffuse TGCT (d-TGCT)
Unchanged therapy
|
0 Participants
|
36 Participants
|
35 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline up to end of observation period (approximately 2 years)Population: Status of treatment plan was assessed in participants currently being treated or planned to be treated in the Full Analysis Set. Participants with different reported treatment plans during the period (e.g. participants who may have switched treatment plans) are counted as 'currently being treated or planned to be treated' in the corresponding period.
The status of treatment plan among the patients was collected from information routinely recorded in the patient files / medical records.
Outcome measures
| Measure |
Baseline
n=99 Participants
All participants with diffuse tenosynovial giant cell tumors (d-TGCT) who were enrolled at baseline in the study.
|
Within 1st Year
n=61 Participants
Participants with diffuse tenosynovial giant cell tumors (d-TGCT) who were assessed within 1st year of the study.
|
Within 2nd Year
n=32 Participants
Participants with diffuse tenosynovial giant cell tumors (d-TGCT) who were assessed within 2nd year of the study.
|
18 Months
Participants with diffuse tenosynovial giant cell tumors (d-TGCT) who had BPI Pain Severity and Pain Interference assessments conducted at 18 months.
|
24 Months
Participants with diffuse tenosynovial giant cell tumors (d-TGCT) who had BPI Pain Severity and Pain Interference assessments conducted at 24 months.
|
|---|---|---|---|---|---|
|
Number of Participants Based on Status of Treatment Plan in Patients With Diffuse TGCT (d-TGCT)
Planned
|
50 Participants
|
9 Participants
|
9 Participants
|
—
|
—
|
|
Number of Participants Based on Status of Treatment Plan in Patients With Diffuse TGCT (d-TGCT)
Current
|
44 Participants
|
50 Participants
|
23 Participants
|
—
|
—
|
|
Number of Participants Based on Status of Treatment Plan in Patients With Diffuse TGCT (d-TGCT)
Missing
|
5 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline up to end of observation period (approximately 2 years)Population: Status of treatment plan was assessed in participants currently being treated in the Full Analysis Set. Participants may have been included in more than one category.
Type of current TGCT treatment among the patients was collected from information routinely recorded in the patient files / medical records.
Outcome measures
| Measure |
Baseline
n=44 Participants
All participants with diffuse tenosynovial giant cell tumors (d-TGCT) who were enrolled at baseline in the study.
|
Within 1st Year
n=50 Participants
Participants with diffuse tenosynovial giant cell tumors (d-TGCT) who were assessed within 1st year of the study.
|
Within 2nd Year
n=23 Participants
Participants with diffuse tenosynovial giant cell tumors (d-TGCT) who were assessed within 2nd year of the study.
|
18 Months
Participants with diffuse tenosynovial giant cell tumors (d-TGCT) who had BPI Pain Severity and Pain Interference assessments conducted at 18 months.
|
24 Months
Participants with diffuse tenosynovial giant cell tumors (d-TGCT) who had BPI Pain Severity and Pain Interference assessments conducted at 24 months.
|
|---|---|---|---|---|---|
|
Number of Participants Based on Type of Current TGCT Treatment in Patients With Diffuse TGCT (d-TGCT)
90Yttrium therapy
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants Based on Type of Current TGCT Treatment in Patients With Diffuse TGCT (d-TGCT)
Systemic therapy
|
37 Participants
|
12 Participants
|
8 Participants
|
—
|
—
|
|
Number of Participants Based on Type of Current TGCT Treatment in Patients With Diffuse TGCT (d-TGCT)
Surgery
|
7 Participants
|
37 Participants
|
17 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: at BaselinePopulation: Tumor severity was assessed in participants in the Full Analysis Set.
Tumor severity classification was collected from information routinely recorded in the patient files / medical records. ). Tumor severity classification was based on MRI. In this classification scheme, moderate diffuse TGCT is characterized by intra- and/or extra-articular disease, without or with involvement of muscle/tendinous tissue/ligaments. Severe diffuse TGCT is characterized by intra- and extra-articular involvement and involvement of at least one of the 3 structures (muscle/tendinous tissue/ligaments).
Outcome measures
| Measure |
Baseline
n=176 Participants
All participants with diffuse tenosynovial giant cell tumors (d-TGCT) who were enrolled at baseline in the study.
|
Within 1st Year
Participants with diffuse tenosynovial giant cell tumors (d-TGCT) who were assessed within 1st year of the study.
|
Within 2nd Year
Participants with diffuse tenosynovial giant cell tumors (d-TGCT) who were assessed within 2nd year of the study.
|
18 Months
Participants with diffuse tenosynovial giant cell tumors (d-TGCT) who had BPI Pain Severity and Pain Interference assessments conducted at 18 months.
|
24 Months
Participants with diffuse tenosynovial giant cell tumors (d-TGCT) who had BPI Pain Severity and Pain Interference assessments conducted at 24 months.
|
|---|---|---|---|---|---|
|
Number of Participants Based on Tumor Severity Classification at Baseline Based on MRI in Patients With Diffuse TGCT (d-TGCT)
Moderate diffuse
|
66 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Based on Tumor Severity Classification at Baseline Based on MRI in Patients With Diffuse TGCT (d-TGCT)
Severe diffuse
|
90 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Based on Tumor Severity Classification at Baseline Based on MRI in Patients With Diffuse TGCT (d-TGCT)
Not assessable
|
20 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: at Baseline (prior to any d-TGCT therapy)Population: Complications were assessed among participants with documented surgeries.
Complications due to surgery were collected from information routinely recorded in the patient files / medical records.
Outcome measures
| Measure |
Baseline
n=210 Surgeries
All participants with diffuse tenosynovial giant cell tumors (d-TGCT) who were enrolled at baseline in the study.
|
Within 1st Year
Participants with diffuse tenosynovial giant cell tumors (d-TGCT) who were assessed within 1st year of the study.
|
Within 2nd Year
Participants with diffuse tenosynovial giant cell tumors (d-TGCT) who were assessed within 2nd year of the study.
|
18 Months
Participants with diffuse tenosynovial giant cell tumors (d-TGCT) who had BPI Pain Severity and Pain Interference assessments conducted at 18 months.
|
24 Months
Participants with diffuse tenosynovial giant cell tumors (d-TGCT) who had BPI Pain Severity and Pain Interference assessments conducted at 24 months.
|
|---|---|---|---|---|---|
|
Number of Cases With Complications Due to Surgery in Patients With Diffuse TGCT (d-TGCT)
|
9 surgical cases
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: at BaselinePopulation: Tumor recurrence was assessed in participants with available baseline data in the Full Analysis Set.
Tumor recurrence was collected from information routinely recorded in the patient files / medical records.
Outcome measures
| Measure |
Baseline
n=78 Participants
All participants with diffuse tenosynovial giant cell tumors (d-TGCT) who were enrolled at baseline in the study.
|
Within 1st Year
Participants with diffuse tenosynovial giant cell tumors (d-TGCT) who were assessed within 1st year of the study.
|
Within 2nd Year
Participants with diffuse tenosynovial giant cell tumors (d-TGCT) who were assessed within 2nd year of the study.
|
18 Months
Participants with diffuse tenosynovial giant cell tumors (d-TGCT) who had BPI Pain Severity and Pain Interference assessments conducted at 18 months.
|
24 Months
Participants with diffuse tenosynovial giant cell tumors (d-TGCT) who had BPI Pain Severity and Pain Interference assessments conducted at 24 months.
|
|---|---|---|---|---|---|
|
Number of Participants With Tumor Recurrence at Baseline in Patients With Diffuse TGCT (d-TGCT)
1 recurrence
|
40 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Tumor Recurrence at Baseline in Patients With Diffuse TGCT (d-TGCT)
2 recurrences
|
18 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Tumor Recurrence at Baseline in Patients With Diffuse TGCT (d-TGCT)
3 recurrences and more
|
19 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Tumor Recurrence at Baseline in Patients With Diffuse TGCT (d-TGCT)
Missing
|
1 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: at BaselinePopulation: Time since last recent tumor recurrence until baseline was assessed in participants with available baseline data in the Full Analysis Set.
Time since most recent tumor recurrence was collected from information routinely recorded in the patient files / medical records.
Outcome measures
| Measure |
Baseline
n=77 Participants
All participants with diffuse tenosynovial giant cell tumors (d-TGCT) who were enrolled at baseline in the study.
|
Within 1st Year
Participants with diffuse tenosynovial giant cell tumors (d-TGCT) who were assessed within 1st year of the study.
|
Within 2nd Year
Participants with diffuse tenosynovial giant cell tumors (d-TGCT) who were assessed within 2nd year of the study.
|
18 Months
Participants with diffuse tenosynovial giant cell tumors (d-TGCT) who had BPI Pain Severity and Pain Interference assessments conducted at 18 months.
|
24 Months
Participants with diffuse tenosynovial giant cell tumors (d-TGCT) who had BPI Pain Severity and Pain Interference assessments conducted at 24 months.
|
|---|---|---|---|---|---|
|
Time Since Most Recent Tumor Recurrence Until Baseline in Patients With Diffuse TGCT (d-TGCT)
|
12.55 months
Interval 0.03 to 137.49
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline up to end of observation period (approximately 2 years)Population: Time from baseline to first tumor recurrence was assessed in participants with available data in the Full Analysis Set.
Time from baseline to first tumor recurrence was collected from information routinely recorded in the patient files / medical records.
Outcome measures
| Measure |
Baseline
n=6 Participants
All participants with diffuse tenosynovial giant cell tumors (d-TGCT) who were enrolled at baseline in the study.
|
Within 1st Year
n=9 Participants
Participants with diffuse tenosynovial giant cell tumors (d-TGCT) who were assessed within 1st year of the study.
|
Within 2nd Year
n=15 Participants
Participants with diffuse tenosynovial giant cell tumors (d-TGCT) who were assessed within 2nd year of the study.
|
18 Months
Participants with diffuse tenosynovial giant cell tumors (d-TGCT) who had BPI Pain Severity and Pain Interference assessments conducted at 18 months.
|
24 Months
Participants with diffuse tenosynovial giant cell tumors (d-TGCT) who had BPI Pain Severity and Pain Interference assessments conducted at 24 months.
|
|---|---|---|---|---|---|
|
Time From Baseline to First Tumor Recurrence in Patients With Diffuse TGCT (d-TGCT)
|
8.4 months
Interval 2.0 to 15.0
|
19.0 months
Interval 12.0 to 24.0
|
14.8 months
Interval 2.0 to 24.0
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline up to end of observation period (approximately 2 years)Population: Brief Pain Inventory Pain Severity and Pain Interference were assessed in participants with available data in the Full Analysis Set.
The BPI short form is a self administered questionnaire that assesses severity of pain, impact of pain on daily function, location of pain, pain medications and amount of pain relief in the past 24 hours or the past week. The BPI pain severity and interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes), where lower scores indicate better clinical outcome.
Outcome measures
| Measure |
Baseline
n=166 Participants
All participants with diffuse tenosynovial giant cell tumors (d-TGCT) who were enrolled at baseline in the study.
|
Within 1st Year
n=130 Participants
Participants with diffuse tenosynovial giant cell tumors (d-TGCT) who were assessed within 1st year of the study.
|
Within 2nd Year
n=125 Participants
Participants with diffuse tenosynovial giant cell tumors (d-TGCT) who were assessed within 2nd year of the study.
|
18 Months
n=125 Participants
Participants with diffuse tenosynovial giant cell tumors (d-TGCT) who had BPI Pain Severity and Pain Interference assessments conducted at 18 months.
|
24 Months
n=132 Participants
Participants with diffuse tenosynovial giant cell tumors (d-TGCT) who had BPI Pain Severity and Pain Interference assessments conducted at 24 months.
|
|---|---|---|---|---|---|
|
Mean Brief Pain Inventory (BPI) Pain Severity and Interference Score From Baseline Through 24 Months
Brief Pain Inventory Pain Severity
|
3.35 score on a scale
Standard Deviation 2.36
|
3.12 score on a scale
Standard Deviation 2.26
|
3.15 score on a scale
Standard Deviation 2.22
|
3.05 score on a scale
Standard Deviation 2.30
|
2.60 score on a scale
Standard Deviation 2.19
|
|
Mean Brief Pain Inventory (BPI) Pain Severity and Interference Score From Baseline Through 24 Months
Brief Pain Inventory Pain Interference
|
2.97 score on a scale
Standard Deviation 2.65
|
2.94 score on a scale
Standard Deviation 2.56
|
2.80 score on a scale
Standard Deviation 2.44
|
2.80 score on a scale
Standard Deviation 2.47
|
2.53 score on a scale
Standard Deviation 2.57
|
PRIMARY outcome
Timeframe: Baseline up to end of observation period (approximately 2 years)Population: Worst stiffness was assessed in participants with available data in the Full Analysis Set.
The Worst Stiffness numerical rating scale (NRS) is a one-item self-administered, patient-reported outcome questionnaire assessing the "worst" stiffness in the last 24 hours. The NRS for this item ranges from 0 ("no stiffness") to 10 ("stiffness as bad as you can imagine"), where lower scores indicate better clinical outcome.
Outcome measures
| Measure |
Baseline
n=164 Participants
All participants with diffuse tenosynovial giant cell tumors (d-TGCT) who were enrolled at baseline in the study.
|
Within 1st Year
n=132 Participants
Participants with diffuse tenosynovial giant cell tumors (d-TGCT) who were assessed within 1st year of the study.
|
Within 2nd Year
n=129 Participants
Participants with diffuse tenosynovial giant cell tumors (d-TGCT) who were assessed within 2nd year of the study.
|
18 Months
n=125 Participants
Participants with diffuse tenosynovial giant cell tumors (d-TGCT) who had BPI Pain Severity and Pain Interference assessments conducted at 18 months.
|
24 Months
n=133 Participants
Participants with diffuse tenosynovial giant cell tumors (d-TGCT) who had BPI Pain Severity and Pain Interference assessments conducted at 24 months.
|
|---|---|---|---|---|---|
|
Mean Worst Stiffness Score From Baseline Through 24 Months
|
4.4 score on a scale
Standard Deviation 2.8
|
4.2 score on a scale
Standard Deviation 2.6
|
4.2 score on a scale
Standard Deviation 2.8
|
4.2 score on a scale
Standard Deviation 2.7
|
3.9 score on a scale
Standard Deviation 2.7
|
PRIMARY outcome
Timeframe: Baseline up to end of observation period (approximately 2 years)Population: PROMIS physical function was assessed in participants with available data in the Full Analysis Set.
PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of person-centered measures that evaluates and monitors physical, mental, and social health. Physical function scores range from 0 (worst physical function) to 100 (best physical function, where higher scores indicate better clinical outcome.
Outcome measures
| Measure |
Baseline
n=168 Participants
All participants with diffuse tenosynovial giant cell tumors (d-TGCT) who were enrolled at baseline in the study.
|
Within 1st Year
n=132 Participants
Participants with diffuse tenosynovial giant cell tumors (d-TGCT) who were assessed within 1st year of the study.
|
Within 2nd Year
n=130 Participants
Participants with diffuse tenosynovial giant cell tumors (d-TGCT) who were assessed within 2nd year of the study.
|
18 Months
n=126 Participants
Participants with diffuse tenosynovial giant cell tumors (d-TGCT) who had BPI Pain Severity and Pain Interference assessments conducted at 18 months.
|
24 Months
n=136 Participants
Participants with diffuse tenosynovial giant cell tumors (d-TGCT) who had BPI Pain Severity and Pain Interference assessments conducted at 24 months.
|
|---|---|---|---|---|---|
|
Mean PROMIS Physical Function Score From Baseline Through 24 Months
|
41.9 score on a scale
Standard Deviation 8.2
|
41.6 score on a scale
Standard Deviation 9.2
|
43.2 score on a scale
Standard Deviation 9.3
|
42.2 score on a scale
Standard Deviation 8.8
|
43.0 score on a scale
Standard Deviation 9.0
|
SECONDARY outcome
Timeframe: Baseline up to end of observation period (approximately 2 years)Population: Quality of life assessed by EQ-5D index score was assessed in participants with available data in the Full Analysis Set.
The EQ-5D-5L questionnaire measures the patient's quality of life (QoL) based on the 5 dimensions mobility, self care, usual activities, pain/discomfort, and anxiety/depression. The EQ-5D index score ranges from 0 (worst QoL) to 1 (best QoL), where lower scores indicate worse clinical outcome. The EQ-5D VAS reports patient's self rated health ranging from 0 (worst health) to 100 (best health you can imagine), where lower scores indicate worse clinical outcome.
Outcome measures
| Measure |
Baseline
n=168 Participants
All participants with diffuse tenosynovial giant cell tumors (d-TGCT) who were enrolled at baseline in the study.
|
Within 1st Year
n=133 Participants
Participants with diffuse tenosynovial giant cell tumors (d-TGCT) who were assessed within 1st year of the study.
|
Within 2nd Year
n=130 Participants
Participants with diffuse tenosynovial giant cell tumors (d-TGCT) who were assessed within 2nd year of the study.
|
18 Months
n=126 Participants
Participants with diffuse tenosynovial giant cell tumors (d-TGCT) who had BPI Pain Severity and Pain Interference assessments conducted at 18 months.
|
24 Months
n=135 Participants
Participants with diffuse tenosynovial giant cell tumors (d-TGCT) who had BPI Pain Severity and Pain Interference assessments conducted at 24 months.
|
|---|---|---|---|---|---|
|
Mean EuroQol Questionnaire (EQ) of 5 Dimensions (5D) Index Score and EQ Visual Analog Scale Score From Baseline Through 24 Months
EQ-5D Index Score
|
0.714 score on a scale
Standard Deviation 0.20
|
0.742 score on a scale
Standard Deviation 0.18
|
0.740 score on a scale
Standard Deviation 0.20
|
0.741 score on a scale
Standard Deviation 0.20
|
0.746 score on a scale
Standard Deviation 0.21
|
|
Mean EuroQol Questionnaire (EQ) of 5 Dimensions (5D) Index Score and EQ Visual Analog Scale Score From Baseline Through 24 Months
EQ-5D VAS
|
69.3 score on a scale
Standard Deviation 20.95
|
69.0 score on a scale
Standard Deviation 19.84
|
73.0 score on a scale
Standard Deviation 18.23
|
69.8 score on a scale
Standard Deviation 20.53
|
71.7 score on a scale
Standard Deviation 20.74
|
SECONDARY outcome
Timeframe: 13-24 months before baseline up to end of observation period (approximately 2 years)Population: Health resource utilization was assessed in participants with available data in the Full Analysis Set.
Health resource utilization was assessed by mean number of general practitioner visits, specialist visits, and physical therapy sessions. In addition, the mean number of days in rehabilitation and the number of work days missed were also reported.
Outcome measures
| Measure |
Baseline
n=176 Participants
All participants with diffuse tenosynovial giant cell tumors (d-TGCT) who were enrolled at baseline in the study.
|
Within 1st Year
n=176 Participants
Participants with diffuse tenosynovial giant cell tumors (d-TGCT) who were assessed within 1st year of the study.
|
Within 2nd Year
n=176 Participants
Participants with diffuse tenosynovial giant cell tumors (d-TGCT) who were assessed within 2nd year of the study.
|
18 Months
n=173 Participants
Participants with diffuse tenosynovial giant cell tumors (d-TGCT) who had BPI Pain Severity and Pain Interference assessments conducted at 18 months.
|
24 Months
n=176 Participants
Participants with diffuse tenosynovial giant cell tumors (d-TGCT) who had BPI Pain Severity and Pain Interference assessments conducted at 24 months.
|
|---|---|---|---|---|---|
|
Mean Number of General Practitioner, Specialist, or Physical Therapy Visits to Assess the Health Resource Utilization in Patients With Diffuse TGCT Through 24 Months
General practitioner visits
|
3.9 visits
Standard Deviation 4.80
|
3.0 visits
Standard Deviation 4.60
|
3.8 visits
Standard Deviation 4.03
|
3.3 visits
Standard Deviation 4.83
|
4.7 visits
Standard Deviation 5.71
|
|
Mean Number of General Practitioner, Specialist, or Physical Therapy Visits to Assess the Health Resource Utilization in Patients With Diffuse TGCT Through 24 Months
Specialists visits
|
7.0 visits
Standard Deviation 8.55
|
5.2 visits
Standard Deviation 5.89
|
4.1 visits
Standard Deviation 3.76
|
2.6 visits
Standard Deviation 2.80
|
5.1 visits
Standard Deviation 4.82
|
|
Mean Number of General Practitioner, Specialist, or Physical Therapy Visits to Assess the Health Resource Utilization in Patients With Diffuse TGCT Through 24 Months
Physical therapy sessions
|
20.3 visits
Standard Deviation 22.93
|
25.4 visits
Standard Deviation 27.96
|
17.7 visits
Standard Deviation 14.34
|
33.1 visits
Standard Deviation 31.12
|
31.3 visits
Standard Deviation 32.44
|
SECONDARY outcome
Timeframe: 13-24 months before baseline up to end of observation period (approximately 2 years)Population: Number of days in rehabilitation was assessed in the Full Analysis Set. A participant could have documented days in rehabilitation for the 1st year visit as well as for the 2nd year visit which resulted in a sum greater than the single results per visit/year.
The median number of days in rehabilitation and the number of work days missed were also reported.
Outcome measures
| Measure |
Baseline
n=176 Participants
All participants with diffuse tenosynovial giant cell tumors (d-TGCT) who were enrolled at baseline in the study.
|
Within 1st Year
n=176 Participants
Participants with diffuse tenosynovial giant cell tumors (d-TGCT) who were assessed within 1st year of the study.
|
Within 2nd Year
n=176 Participants
Participants with diffuse tenosynovial giant cell tumors (d-TGCT) who were assessed within 2nd year of the study.
|
18 Months
n=173 Participants
Participants with diffuse tenosynovial giant cell tumors (d-TGCT) who had BPI Pain Severity and Pain Interference assessments conducted at 18 months.
|
24 Months
n=176 Participants
Participants with diffuse tenosynovial giant cell tumors (d-TGCT) who had BPI Pain Severity and Pain Interference assessments conducted at 24 months.
|
|---|---|---|---|---|---|
|
Median Number of Days in Rehabilitation and Work Days Missed in Patients With Diffuse TGCT Through 24 Months
Work days missed
|
25.50 days
Interval 0.5 to 180.0
|
16 days
Interval 1.0 to 180.0
|
6 days
Interval 1.0 to 180.0
|
8 days
Interval 1.0 to 73.0
|
10 days
Interval 1.0 to 180.0
|
|
Median Number of Days in Rehabilitation and Work Days Missed in Patients With Diffuse TGCT Through 24 Months
Days in rehabilitation
|
15 days
Interval 3.0 to 60.0
|
15 days
Interval 1.0 to 60.0
|
12 days
Interval 1.0 to 45.0
|
20 days
Interval 4.0 to 150.0
|
16 days
Interval 1.0 to 151.0
|
SECONDARY outcome
Timeframe: At end of observation period (approximately 2 years post-baseline)Population: TGCT outcome status was assessed in participants with available data in the Full Analysis Set.
TGCT outcome status was collected from information routinely recorded in the patient files / medical records.
Outcome measures
| Measure |
Baseline
n=166 Participants
All participants with diffuse tenosynovial giant cell tumors (d-TGCT) who were enrolled at baseline in the study.
|
Within 1st Year
Participants with diffuse tenosynovial giant cell tumors (d-TGCT) who were assessed within 1st year of the study.
|
Within 2nd Year
Participants with diffuse tenosynovial giant cell tumors (d-TGCT) who were assessed within 2nd year of the study.
|
18 Months
Participants with diffuse tenosynovial giant cell tumors (d-TGCT) who had BPI Pain Severity and Pain Interference assessments conducted at 18 months.
|
24 Months
Participants with diffuse tenosynovial giant cell tumors (d-TGCT) who had BPI Pain Severity and Pain Interference assessments conducted at 24 months.
|
|---|---|---|---|---|---|
|
Overall TGCT Outcome Status in Patients With Diffuse TGCT (d-TGCT)
Radiological residual disease (only pts with radiological residual disease): Awaiting surgery
|
4 Participants
|
—
|
—
|
—
|
—
|
|
Overall TGCT Outcome Status in Patients With Diffuse TGCT (d-TGCT)
Radiological residual disease (only pts with radiological residual disease): Awaiting medication
|
16 Participants
|
—
|
—
|
—
|
—
|
|
Overall TGCT Outcome Status in Patients With Diffuse TGCT (d-TGCT)
TCGT status at end of observational period: No evidence of disease (NED)
|
39 Participants
|
—
|
—
|
—
|
—
|
|
Overall TGCT Outcome Status in Patients With Diffuse TGCT (d-TGCT)
TCGT status at end of observational period: Radiological residual disease
|
107 Participants
|
—
|
—
|
—
|
—
|
|
Overall TGCT Outcome Status in Patients With Diffuse TGCT (d-TGCT)
TCGT status at end of observational period: Radiological recurrent disease
|
20 Participants
|
—
|
—
|
—
|
—
|
|
Overall TGCT Outcome Status in Patients With Diffuse TGCT (d-TGCT)
TCGT status at end of observational period: Missing
|
10 Participants
|
—
|
—
|
—
|
—
|
|
Overall TGCT Outcome Status in Patients With Diffuse TGCT (d-TGCT)
NED (only pts with NED): With complaints
|
21 Participants
|
—
|
—
|
—
|
—
|
|
Overall TGCT Outcome Status in Patients With Diffuse TGCT (d-TGCT)
NED (only pts with NED): Without complaints
|
18 Participants
|
—
|
—
|
—
|
—
|
|
Overall TGCT Outcome Status in Patients With Diffuse TGCT (d-TGCT)
NED (only pts with NED): Missing
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Overall TGCT Outcome Status in Patients With Diffuse TGCT (d-TGCT)
Radiological residual disease (only pts with radiological residual disease): Watchful waiting
|
84 Participants
|
—
|
—
|
—
|
—
|
|
Overall TGCT Outcome Status in Patients With Diffuse TGCT (d-TGCT)
Radiological residual disease (only pts with radiological residual disease):Awaiting other treatment
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Overall TGCT Outcome Status in Patients With Diffuse TGCT (d-TGCT)
Radiological residual disease (only pts with radiological residual disease): Missing
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Overall TGCT Outcome Status in Patients With Diffuse TGCT (d-TGCT)
Radiological recurrent disease (only pts with radiological recurrent disease): Watchful waiting
|
12 Participants
|
—
|
—
|
—
|
—
|
|
Overall TGCT Outcome Status in Patients With Diffuse TGCT (d-TGCT)
Radiological recurrent disease (only pts with radiological recurrent disease): Awaiting surgery
|
6 Participants
|
—
|
—
|
—
|
—
|
|
Overall TGCT Outcome Status in Patients With Diffuse TGCT (d-TGCT)
Radiological recurrent disease (only pts with radiological recurrent disease): Awaiting medication
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Overall TGCT Outcome Status in Patients With Diffuse TGCT (d-TGCT)
Radiological recurrent disease (only pts with radiological recurrent): Awaiting other treatment
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Overall TGCT Outcome Status in Patients With Diffuse TGCT (d-TGCT)
Radiological recurrent disease (only pts with radiological recurrent disease): Missing
|
0 Participants
|
—
|
—
|
—
|
—
|
Adverse Events
Overall
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place