Trial Outcomes & Findings for Repurposing Anti-TNF for Treating Dupuytren's Disease (NCT NCT03180957)
NCT ID: NCT03180957
Last Updated: 2024-06-28
Results Overview
Tonometry - A hardness score in arbitrary units with 0 being the lowest hardness and 100 being the greatest hardness units on a scale.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
140 participants
Primary outcome timeframe
12 months
Results posted on
2024-06-28
Participant Flow
Participant milestones
| Measure |
Anti-TNF
Adalimumab
Adalimumab
|
Placebo
Saline
Saline
|
|---|---|---|
|
Overall Study
STARTED
|
70
|
70
|
|
Overall Study
COMPLETED
|
59
|
54
|
|
Overall Study
NOT COMPLETED
|
11
|
16
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Anti-TNF
n=70 Participants
Adalimumab
Adalimumab
|
Placebo
n=70 Participants
Saline
Saline
|
Total
n=140 Participants
Total of all reporting groups
|
|---|---|---|---|
|
alcohol consumption (Units/week)
Non Drinker
|
9 Participants
n=70 Participants
|
7 Participants
n=70 Participants
|
16 Participants
n=140 Participants
|
|
alcohol consumption (Units/week)
up to 13
|
36 Participants
n=70 Participants
|
41 Participants
n=70 Participants
|
77 Participants
n=140 Participants
|
|
alcohol consumption (Units/week)
14-35
|
23 Participants
n=70 Participants
|
20 Participants
n=70 Participants
|
43 Participants
n=140 Participants
|
|
alcohol consumption (Units/week)
over 35
|
2 Participants
n=70 Participants
|
2 Participants
n=70 Participants
|
4 Participants
n=140 Participants
|
|
Current smoker
Yes
|
4 Participants
n=70 Participants
|
3 Participants
n=70 Participants
|
7 Participants
n=140 Participants
|
|
Current smoker
no
|
66 Participants
n=70 Participants
|
67 Participants
n=70 Participants
|
133 Participants
n=140 Participants
|
|
Hand Dominance
right
|
65 Participants
n=70 Participants
|
59 Participants
n=70 Participants
|
124 Participants
n=140 Participants
|
|
Hand Dominance
left
|
5 Participants
n=70 Participants
|
10 Participants
n=70 Participants
|
15 Participants
n=140 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=70 Participants
|
0 Participants
n=70 Participants
|
0 Participants
n=140 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
47 Participants
n=70 Participants
|
47 Participants
n=70 Participants
|
94 Participants
n=140 Participants
|
|
Age, Categorical
>=65 years
|
23 Participants
n=70 Participants
|
23 Participants
n=70 Participants
|
46 Participants
n=140 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=70 Participants
|
20 Participants
n=70 Participants
|
47 Participants
n=140 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=70 Participants
|
50 Participants
n=70 Participants
|
93 Participants
n=140 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United Kingdom
|
70 participants
n=70 Participants
|
70 participants
n=70 Participants
|
140 participants
n=140 Participants
|
|
Hand Dominance
missing
|
0 Participants
n=70 Participants
|
1 Participants
n=70 Participants
|
1 Participants
n=140 Participants
|
|
Epilepsy
no
|
69 Participants
n=70 Participants
|
68 Participants
n=70 Participants
|
137 Participants
n=140 Participants
|
|
Epilepsy
yes
|
1 Participants
n=70 Participants
|
2 Participants
n=70 Participants
|
3 Participants
n=140 Participants
|
|
Liver disease
no
|
70 Participants
n=70 Participants
|
70 Participants
n=70 Participants
|
140 Participants
n=140 Participants
|
|
Liver disease
yes
|
0 Participants
n=70 Participants
|
0 Participants
n=70 Participants
|
0 Participants
n=140 Participants
|
|
Significant exposure to occupational vibration
no
|
66 Participants
n=70 Participants
|
64 Participants
n=70 Participants
|
130 Participants
n=140 Participants
|
|
Significant exposure to occupational vibration
yes
|
4 Participants
n=70 Participants
|
6 Participants
n=70 Participants
|
10 Participants
n=140 Participants
|
|
Previous significant trauma to affected hand
no
|
57 Participants
n=70 Participants
|
56 Participants
n=70 Participants
|
113 Participants
n=140 Participants
|
|
Previous significant trauma to affected hand
yes
|
13 Participants
n=70 Participants
|
14 Participants
n=70 Participants
|
27 Participants
n=140 Participants
|
|
Diabetes
no
|
67 Participants
n=70 Participants
|
64 Participants
n=70 Participants
|
131 Participants
n=140 Participants
|
|
Diabetes
Type 1
|
0 Participants
n=70 Participants
|
1 Participants
n=70 Participants
|
1 Participants
n=140 Participants
|
|
Diabetes
Type 2
|
3 Participants
n=70 Participants
|
5 Participants
n=70 Participants
|
8 Participants
n=140 Participants
|
|
Frozen Shoulder
None
|
51 Participants
n=70 Participants
|
52 Participants
n=70 Participants
|
103 Participants
n=140 Participants
|
|
Frozen Shoulder
Right
|
6 Participants
n=70 Participants
|
6 Participants
n=70 Participants
|
12 Participants
n=140 Participants
|
|
Frozen Shoulder
Left
|
10 Participants
n=70 Participants
|
5 Participants
n=70 Participants
|
15 Participants
n=140 Participants
|
|
Frozen Shoulder
Both Sides
|
3 Participants
n=70 Participants
|
7 Participants
n=70 Participants
|
10 Participants
n=140 Participants
|
|
Ray affected by study nodule
Index
|
0 Participants
n=70 Participants
|
2 Participants
n=70 Participants
|
2 Participants
n=140 Participants
|
|
Ray affected by study nodule
Middle
|
15 Participants
n=70 Participants
|
6 Participants
n=70 Participants
|
21 Participants
n=140 Participants
|
|
Ray affected by study nodule
Ring
|
39 Participants
n=70 Participants
|
39 Participants
n=70 Participants
|
78 Participants
n=140 Participants
|
|
Ray affected by study nodule
Little
|
16 Participants
n=70 Participants
|
23 Participants
n=70 Participants
|
39 Participants
n=140 Participants
|
|
Affected joint
metacarpophalangeal
|
54 Participants
n=70 Participants
|
60 Participants
n=70 Participants
|
114 Participants
n=140 Participants
|
|
Affected joint
proximal interphalangeal
|
16 Participants
n=70 Participants
|
10 Participants
n=70 Participants
|
26 Participants
n=140 Participants
|
|
Bilateral Dupytrens's disease
no
|
31 Participants
n=70 Participants
|
34 Participants
n=70 Participants
|
65 Participants
n=140 Participants
|
|
Bilateral Dupytrens's disease
yes
|
39 Participants
n=70 Participants
|
36 Participants
n=70 Participants
|
75 Participants
n=140 Participants
|
|
Treatment for Dupytren's disease in other hand
No
|
53 Participants
n=70 Participants
|
56 Participants
n=70 Participants
|
109 Participants
n=140 Participants
|
|
Treatment for Dupytren's disease in other hand
Yes
|
17 Participants
n=70 Participants
|
14 Participants
n=70 Participants
|
31 Participants
n=140 Participants
|
|
Associated medical conditions
No
|
39 Participants
n=70 Participants
|
33 Participants
n=70 Participants
|
72 Participants
n=140 Participants
|
|
Associated medical conditions
Yes
|
31 Participants
n=70 Participants
|
36 Participants
n=70 Participants
|
67 Participants
n=140 Participants
|
|
Associated medical conditions
Missing
|
0 Participants
n=70 Participants
|
1 Participants
n=70 Participants
|
1 Participants
n=140 Participants
|
|
Plantar Disease
No
|
58 Participants
n=70 Participants
|
59 Participants
n=70 Participants
|
117 Participants
n=140 Participants
|
|
Plantar Disease
Yes
|
12 Participants
n=70 Participants
|
10 Participants
n=70 Participants
|
22 Participants
n=140 Participants
|
|
Plantar Disease
Missing
|
0 Participants
n=70 Participants
|
1 Participants
n=70 Participants
|
1 Participants
n=140 Participants
|
|
Peyronie's disease
No
|
67 Participants
n=70 Participants
|
67 Participants
n=70 Participants
|
134 Participants
n=140 Participants
|
|
Peyronie's disease
Yes
|
3 Participants
n=70 Participants
|
3 Participants
n=70 Participants
|
6 Participants
n=140 Participants
|
|
Garrod's Knuckle pads
No
|
58 Participants
n=70 Participants
|
51 Participants
n=70 Participants
|
109 Participants
n=140 Participants
|
|
Garrod's Knuckle pads
Yes
|
12 Participants
n=70 Participants
|
19 Participants
n=70 Participants
|
31 Participants
n=140 Participants
|
|
Family History (1st Degree Relatives)
No
|
45 Participants
n=70 Participants
|
40 Participants
n=70 Participants
|
85 Participants
n=140 Participants
|
|
Family History (1st Degree Relatives)
Yes
|
25 Participants
n=70 Participants
|
30 Participants
n=70 Participants
|
55 Participants
n=140 Participants
|
PRIMARY outcome
Timeframe: 12 monthsTonometry - A hardness score in arbitrary units with 0 being the lowest hardness and 100 being the greatest hardness units on a scale.
Outcome measures
| Measure |
Anti-TNF
n=59 Participants
Adalimumab
Adalimumab
|
Placebo
n=54 Participants
Saline
Saline
|
|---|---|---|
|
Early Disease: Nodule Hardness at 12 Months
|
58.1 Durometer Arbitrary Units (AU)
Standard Deviation 11.8
|
61.2 Durometer Arbitrary Units (AU)
Standard Deviation 9.8
|
SECONDARY outcome
Timeframe: 12 monthsMeasured in mm\^2 where 0 is the smallest and 50 is the largest unit on a scale
Outcome measures
| Measure |
Anti-TNF
n=61 Participants
Adalimumab
Adalimumab
|
Placebo
n=63 Participants
Saline
Saline
|
|---|---|---|
|
Early Disease: Nodule Size
|
21.8 mm^2
Standard Deviation 18.7
|
35.9 mm^2
Standard Deviation 28.9
|
SECONDARY outcome
Timeframe: 12 monthsJamar meter
Outcome measures
| Measure |
Anti-TNF
n=63 Participants
Adalimumab
Adalimumab
|
Placebo
n=64 Participants
Saline
Saline
|
|---|---|---|
|
Early Disease: Grip Strength
|
34.5 kg
Standard Deviation 10.7
|
38.3 kg
Standard Deviation 11.9
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: baseline were mean imputed. 12 Months: Adalimumab n=63, Saline n=65
Overall passive extension deficit of joint affected by treated nodule (degrees)
Outcome measures
| Measure |
Anti-TNF
n=63 Participants
Adalimumab
Adalimumab
|
Placebo
n=65 Participants
Saline
Saline
|
|---|---|---|
|
Early Disease: Extension Deficit of Affected Joint
Overall passive extension deficit of joint affected by treatment nodule
|
3.3 degrees
Standard Deviation 10.2
|
5.0 degrees
Standard Deviation 12.8
|
|
Early Disease: Extension Deficit of Affected Joint
MCP:passive extension deficit of joint affected by treated nodule
|
0.0 degrees
Standard Deviation 0.0
|
1.4 degrees
Standard Deviation 5.7
|
|
Early Disease: Extension Deficit of Affected Joint
PIP: passive extension deficit of joint affected by treated nodule
|
14.7 degrees
Standard Deviation 17.7
|
30.0 degrees
Standard Deviation 20.4
|
SECONDARY outcome
Timeframe: 12 monthsMichigan Hand Questionnaire - overall hand function with 0 as the lowest ability and 100 best possible ability units on a scale.
Outcome measures
| Measure |
Anti-TNF
n=64 Participants
Adalimumab
Adalimumab
|
Placebo
n=66 Participants
Saline
Saline
|
|---|---|---|
|
Early Disease: Patient Reported Outcomes
|
83.5 score on a scale
Standard Deviation 16.1
|
78.8 score on a scale
Standard Deviation 16.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 18 monthsPatient completed questionnaire about health \& social care and financial costs of Dupuytren's disease
Outcome measures
Outcome data not reported
Adverse Events
Anti-TNF
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Anti-TNF
n=70 participants at risk
Adalimumab
Adalimumab
|
Placebo
n=70 participants at risk
Saline
Saline
|
|---|---|---|
|
Cardiac disorders
Pericarditis
|
0.00%
0/70 • Adverse events were collected from consent until 28 days after the last injection of trial, which was administered about 9 months from baseline. Therefore, adverse events were collected over approximately 10 months from baseline
No related grade 3+ AEs were reported during the follow-up for this trial
|
1.4%
1/70 • Number of events 1 • Adverse events were collected from consent until 28 days after the last injection of trial, which was administered about 9 months from baseline. Therefore, adverse events were collected over approximately 10 months from baseline
No related grade 3+ AEs were reported during the follow-up for this trial
|
Other adverse events
| Measure |
Anti-TNF
n=70 participants at risk
Adalimumab
Adalimumab
|
Placebo
n=70 participants at risk
Saline
Saline
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Adverse Events
|
8.6%
6/70 • Number of events 6 • Adverse events were collected from consent until 28 days after the last injection of trial, which was administered about 9 months from baseline. Therefore, adverse events were collected over approximately 10 months from baseline
No related grade 3+ AEs were reported during the follow-up for this trial
|
5.7%
4/70 • Number of events 4 • Adverse events were collected from consent until 28 days after the last injection of trial, which was administered about 9 months from baseline. Therefore, adverse events were collected over approximately 10 months from baseline
No related grade 3+ AEs were reported during the follow-up for this trial
|
|
Skin and subcutaneous tissue disorders
Adverse event
|
4.3%
3/70 • Number of events 3 • Adverse events were collected from consent until 28 days after the last injection of trial, which was administered about 9 months from baseline. Therefore, adverse events were collected over approximately 10 months from baseline
No related grade 3+ AEs were reported during the follow-up for this trial
|
7.1%
5/70 • Number of events 5 • Adverse events were collected from consent until 28 days after the last injection of trial, which was administered about 9 months from baseline. Therefore, adverse events were collected over approximately 10 months from baseline
No related grade 3+ AEs were reported during the follow-up for this trial
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place