Trial Outcomes & Findings for Retreatment of Recurrent Dupuytren's Contractures (NCT NCT01498640)
NCT ID: NCT01498640
Last Updated: 2017-10-05
Results Overview
Clinical success defined as reduction in fixed-flexion contracture to less than or equal to 5 degrees 30 days after the last injection of AA4500
COMPLETED
PHASE4
52 participants
30 days after last injection
2017-10-05
Participant Flow
Participant milestones
| Measure |
XIAFLEX/XIAPEX
XIAFLEX/XIAPEX: up to three 0.58 mg injections
|
|---|---|
|
Overall Study
STARTED
|
52
|
|
Overall Study
COMPLETED
|
47
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
XIAFLEX/XIAPEX
XIAFLEX/XIAPEX: up to three 0.58 mg injections
|
|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Death
|
1
|
|
Overall Study
Other
|
3
|
Baseline Characteristics
Retreatment of Recurrent Dupuytren's Contractures
Baseline characteristics by cohort
| Measure |
XIAFLEX/XIAPEX
n=52 Participants
XIAFLEX/XIAPEX: up to three 0.58 mg injections
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
32 Participants
n=5 Participants
|
|
Age, Continuous
|
66.5 Years
STANDARD_DEVIATION 9.53 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
52 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
52 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
21 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
4 participants
n=5 Participants
|
|
Region of Enrollment
Sweden
|
6 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 days after last injectionPopulation: Efficacy assessment based on modified intent-to-treat (mITT) population which includes all enrolled subjects who received at least 1 AA4500 injection to the treated joint and had at least 1 post-injection efficacy measure
Clinical success defined as reduction in fixed-flexion contracture to less than or equal to 5 degrees 30 days after the last injection of AA4500
Outcome measures
| Measure |
XIAFLEX/XIAPEX MP Joint
n=31 Participants
Up to 3 injections of collagenase clostridium histolyticum 0.58 mg in the metacarpophalangeal (MP) joint cord
|
XIAFLEX/XIAPEX PIP Joint
n=20 Participants
Up to 3 injections of collagenase clostridium histolyticum 0.58 mg in the proximal interphalangeal (PIP) joint cord
|
|---|---|---|
|
Clinical Success
|
64.5 percentage of particpants
Interval 45.37 to 80.77
|
45.0 percentage of particpants
Interval 23.06 to 68.47
|
PRIMARY outcome
Timeframe: Baseline and 30 days after last injectionPopulation: Efficacy assessment based on mITT population which includes all enrolled subjects who received at least 1 AA4500 injection to the treated joint and had at least 1 post-injection efficacy measure
Change in fixed-flection contracture measured in degrees where a decrease of 100% would correspond to a reduction in contracture to 0 degrees
Outcome measures
| Measure |
XIAFLEX/XIAPEX MP Joint
n=31 Participants
Up to 3 injections of collagenase clostridium histolyticum 0.58 mg in the metacarpophalangeal (MP) joint cord
|
XIAFLEX/XIAPEX PIP Joint
n=20 Participants
Up to 3 injections of collagenase clostridium histolyticum 0.58 mg in the proximal interphalangeal (PIP) joint cord
|
|---|---|---|
|
Percent Change From Baseline in Degree of Contracture
|
83.24 percentage of contracture change
Standard Deviation 24.275
|
69.10 percentage of contracture change
Standard Deviation 26.776
|
PRIMARY outcome
Timeframe: Baseline and 30 days after last injectionPopulation: Efficacy assessment based on mITT population which includes all enrolled subjects who received at least 1 AA4500 injection to the treated joint and had at least 1 post-injection efficacy measure
Range of motion defined as difference between full flexion angle and full extension angle expressed in degrees
Outcome measures
| Measure |
XIAFLEX/XIAPEX MP Joint
n=31 Participants
Up to 3 injections of collagenase clostridium histolyticum 0.58 mg in the metacarpophalangeal (MP) joint cord
|
XIAFLEX/XIAPEX PIP Joint
n=20 Participants
Up to 3 injections of collagenase clostridium histolyticum 0.58 mg in the proximal interphalangeal (PIP) joint cord
|
|---|---|---|
|
Change in Range of Motion
|
31.4 degrees
Standard Deviation 17.52
|
26.8 degrees
Standard Deviation 17.39
|
SECONDARY outcome
Timeframe: 30 days after last injectionPopulation: Efficacy assessment based on mITT population which includes all enrolled subjects who received at least 1 AA4500 injection to the treated joint and had at least 1 post-injection efficacy measure
Physician global assessment of change (improvement) in subject's Dupuytren's contracture
Outcome measures
| Measure |
XIAFLEX/XIAPEX MP Joint
n=31 Participants
Up to 3 injections of collagenase clostridium histolyticum 0.58 mg in the metacarpophalangeal (MP) joint cord
|
XIAFLEX/XIAPEX PIP Joint
n=20 Participants
Up to 3 injections of collagenase clostridium histolyticum 0.58 mg in the proximal interphalangeal (PIP) joint cord
|
|---|---|---|
|
Physician Global Assessment of Improvement
Very much improved
|
18 participants
|
12 participants
|
|
Physician Global Assessment of Improvement
Much improved
|
11 participants
|
5 participants
|
|
Physician Global Assessment of Improvement
Minimally improved
|
0 participants
|
2 participants
|
|
Physician Global Assessment of Improvement
No change
|
1 participants
|
1 participants
|
|
Physician Global Assessment of Improvement
Minimally worse
|
0 participants
|
0 participants
|
|
Physician Global Assessment of Improvement
Much worse
|
0 participants
|
0 participants
|
|
Physician Global Assessment of Improvement
Very much worse
|
0 participants
|
0 participants
|
|
Physician Global Assessment of Improvement
Not done
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 30 days after last injectionPopulation: Efficacy assessment based on mITT population which includes all enrolled subjects who received at least 1 AA4500 injection to the treated joint and had at least 1 post-injection efficacy measure
Subject global assessment of overall treatment satisfaction
Outcome measures
| Measure |
XIAFLEX/XIAPEX MP Joint
n=31 Participants
Up to 3 injections of collagenase clostridium histolyticum 0.58 mg in the metacarpophalangeal (MP) joint cord
|
XIAFLEX/XIAPEX PIP Joint
n=20 Participants
Up to 3 injections of collagenase clostridium histolyticum 0.58 mg in the proximal interphalangeal (PIP) joint cord
|
|---|---|---|
|
Subject Global Assessment of Satisfaction
Very satisfied
|
20 participants
|
10 participants
|
|
Subject Global Assessment of Satisfaction
Quite satisfied
|
9 participants
|
5 participants
|
|
Subject Global Assessment of Satisfaction
Neither satisfied nor dissatisfied
|
1 participants
|
2 participants
|
|
Subject Global Assessment of Satisfaction
Quite dissatisfied
|
0 participants
|
1 participants
|
|
Subject Global Assessment of Satisfaction
Very dissatisfied
|
0 participants
|
0 participants
|
|
Subject Global Assessment of Satisfaction
Not done
|
1 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Day 365Population: Efficacy assessment based on mITT population which includes all enrolled subjects who received at least 1 AA4500 injection to the treated joint and had at least 1 post-injection efficacy measure; only joints that were successfully treated (reduction in contracture to 5 degrees or less) 30 days after last injection were assessed
Recurrence of contracture in the joint at day 365 that was successfully treated 30 days after last injection assessed. Recurrence was defined as 20 degree or greater increase of contracture of the treated joint at day 365 or medication intervention of the treated joint between the 2 time points.
Outcome measures
| Measure |
XIAFLEX/XIAPEX MP Joint
n=29 Joints
Up to 3 injections of collagenase clostridium histolyticum 0.58 mg in the metacarpophalangeal (MP) joint cord
|
XIAFLEX/XIAPEX PIP Joint
Up to 3 injections of collagenase clostridium histolyticum 0.58 mg in the proximal interphalangeal (PIP) joint cord
|
|---|---|---|
|
Recurrence of Contracture
|
6 joints
|
—
|
Adverse Events
XIAFLEX/XIAPEX
Serious adverse events
| Measure |
XIAFLEX/XIAPEX
n=52 participants at risk
XIAFLEX/XIAPEX: up to three 0.58 mg injections
|
|---|---|
|
Nervous system disorders
Cerebellar infarction
|
1.9%
1/52 • Number of events 1 • 1 year
|
|
Cardiac disorders
Acute coronary syndrome
|
1.9%
1/52 • Number of events 1 • 1 year
|
|
Cardiac disorders
Acute myocardial infarction
|
1.9%
1/52 • Number of events 1 • 1 year
|
|
General disorders
Chest pain
|
1.9%
1/52 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Dupuytren's contracture
|
1.9%
1/52 • Number of events 1 • 1 year
|
|
Infections and infestations
Urosepsis
|
1.9%
1/52 • Number of events 1 • 1 year
|
Other adverse events
| Measure |
XIAFLEX/XIAPEX
n=52 participants at risk
XIAFLEX/XIAPEX: up to three 0.58 mg injections
|
|---|---|
|
General disorders
Oedema peripheral
|
61.5%
32/52 • Number of events 41 • 1 year
|
|
Injury, poisoning and procedural complications
Contusion
|
44.2%
23/52 • Number of events 28 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
30.8%
16/52 • Number of events 22 • 1 year
|
|
General disorders
Injection site pain
|
19.2%
10/52 • Number of events 14 • 1 year
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
19.2%
10/52 • Number of events 13 • 1 year
|
|
General disorders
Injection site haematoma
|
15.4%
8/52 • Number of events 12 • 1 year
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
15.4%
8/52 • Number of events 8 • 1 year
|
|
Injury, poisoning and procedural complications
Skin laceration
|
13.5%
7/52 • Number of events 7 • 1 year
|
|
General disorders
Injection site pruritus
|
9.6%
5/52 • Number of events 5 • 1 year
|
|
General disorders
Injection site swelling
|
9.6%
5/52 • Number of events 9 • 1 year
|
|
Vascular disorders
Hypertension
|
5.8%
3/52 • Number of events 3 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER