Trial Outcomes & Findings for Safety and Efficacy Study of AA4500 (XIAFLEX™, Proposed Name) in the Treatment of Advanced Dupuytren's Disease (NCT NCT00528840)

NCT ID: NCT00528840

Last Updated: 2017-12-02

Results Overview

The Primary Outcome Measure is the percentage of joints that were successfully treated where "successfully treated" was defined as reduction in contracture to within 0-5 degrees of normal within 30 days of injection

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 201 participants
• Primary outcome timeframe: Within 30 days after the last injection
• Results posted on: 2017-12-02

Participant Flow

Participant milestones

Measure	AA4500 0.58 mg collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
Overall Study STARTED	201
Overall Study COMPLETED	168
Overall Study NOT COMPLETED	33

Reasons for withdrawal

Measure	AA4500 0.58 mg collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
Overall Study Lost to Follow-up	10
Overall Study Adverse Event	1
Overall Study Withdrawal by Subject	17
Overall Study Death	2
Overall Study Administrative Reasons	1
Overall Study Other	2

Baseline Characteristics

Safety and Efficacy Study of AA4500 (XIAFLEX™, Proposed Name) in the Treatment of Advanced Dupuytren's Disease

Baseline characteristics by cohort

Measure	AA4500 0.58 mg n=201 Participants collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	95 Participants n=5 Participants
Age, Categorical >=65 years	106 Participants n=5 Participants
Age, Continuous	64.7 years STANDARD_DEVIATION 9.86 • n=5 Participants
Sex: Female, Male Female	37 Participants n=5 Participants
Sex: Female, Male Male	164 Participants n=5 Participants
Race/Ethnicity, Customized White	201 participants n=5 Participants
Region of Enrollment United States	201 participants n=5 Participants

PRIMARY outcome

Timeframe: Within 30 days after the last injection

Population: Intent to treat population (ITT) defined as all subjects who received at least one injection.

The Primary Outcome Measure is the percentage of joints that were successfully treated where "successfully treated" was defined as reduction in contracture to within 0-5 degrees of normal within 30 days of injection

Outcome measures

Measure	AA4500 0.58 mg n=292 joints collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
Reduction in Contracture to 5° or Less	52.7 percentage of joints

SECONDARY outcome

Timeframe: Baseline; within 30 days after last injection

Population: Intent to treat population (ITT) defined as all subjects who received at least one injection.

Clinical Improvement is defined as >=50% percent reduction from baseline in degree of contracture within 30 days after injection.

Outcome measures

Measure	AA4500 0.58 mg n=292 Number of joints collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
Clinical Improvement After the Last Injection	71.6 percent of joints

SECONDARY outcome

Timeframe: Baseline, within 30 days after last injection

Population: Intent to treat population (ITT) defined as all subjects who received at least one injection.

Percent change in degree of contracture measured as 100*(baseline contracture -last available post-injection contracture)/baseline contracture)

Outcome measures

Measure	AA4500 0.58 mg n=292 joints collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
Percent Reduction From Baseline Contracture After the Last Injection	66.8 percentage of joints Standard Deviation 40.91

SECONDARY outcome

Timeframe: Baseline, 30 days after last injection

Population: Intent to treat population (ITT) defined as all subjects who received at least one injection.

Change in degree of range of motion measured as last available post-injection range of motion - baseline range of motion.

Outcome measures

Measure	AA4500 0.58 mg n=292 Number of Joints collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
Change From Baseline Range of Motion After the Last Injection	28.3 degrees Standard Deviation 20.15

SECONDARY outcome

Timeframe: First evaluation visit on which clinical success is achieved through the Day 30 evaluation

Population: Intent to treat population (ITT) defined as all subjects who received at least one injection.

Clinical success is defined as reduction in contracture to within 0-5 degrees of normal within 30 days of injection, displayed in post-injection timepoint categories.

Outcome measures

Measure	AA4500 0.58 mg n=292 joints collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
Time to Reach Clinical Success Injection 3, Day 1	0.7 percentage of joints
Time to Reach Clinical Success Injection 3, Day 7	1.0 percentage of joints
Time to Reach Clinical Success Injection 3, Day 30	0.7 percentage of joints
Time to Reach Clinical Success Injection 3, Day 90	0.3 percentage of joints
Time to Reach Clinical Success Did not reach clinical success	47.3 percentage of joints
Time to Reach Clinical Success Injection 1, Day 1	9.6 percentage of joints
Time to Reach Clinical Success Injection 1, Day 7	16.4 percentage of joints
Time to Reach Clinical Success Injection 1, Day 30	16.1 percentage of joints
Time to Reach Clinical Success Injection 2, Day 0	0.0 percentage of joints
Time to Reach Clinical Success Injection 2, Day 1	2.4 percentage of joints
Time to Reach Clinical Success Injection 2, Day 7	2.4 percentage of joints
Time to Reach Clinical Success Injection 2, Day 30	3.1 percentage of joints
Time to Reach Clinical Success Injection 3, Day 0	0.0 percentage of joints

SECONDARY outcome

Timeframe: Within 30 days after first injection

Population: Intent to treat population (ITT) defined as all subjects who received at least one injection.

Clinical Success is defined as reduction in contracture to within 0-5 degrees of normal within 30 days of injection.

Outcome measures

Measure	AA4500 0.58 mg n=292 joints collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
Clinical Success After the First Injection	42.5 percentage of joints

SECONDARY outcome

Timeframe: Baseline; within 30 days after first injection

Population: Intent to treat population (ITT) defined as all subjects who received at least one injection.

Clinical Improvement is defined as >=50% reduction from baseline in the degree of contracture within 30 days after the first injection

Outcome measures

Measure	AA4500 0.58 mg n=292 joints collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
Clinical Improvement After the First Injection	64.4 percentage of joints

SECONDARY outcome

Timeframe: Baseline; within 30 days after first injection

Population: Intent to treat population (ITT) defined as all subjects who received at least one injection.

Percent change in degree of contracture is measured as 100* (baseline contracture- last available post-injection contracture)/baseline contracture.

Outcome measures

Measure	AA4500 0.58 mg n=292 joints collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
Percent Reduction From Baseline Contracture After the First Injection	60.4 percentage of change Standard Deviation 39.38

SECONDARY outcome

Timeframe: Baseline; within 30 days after first injection

Population: Intent to treat population (ITT) defined as all subjects who received at least one injection.

Change in degree of range of motion measured as last available post-injection range of motion-baseline range of motion.

Outcome measures

Measure	AA4500 0.58 mg n=292 Joints collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
Change From Baseline Range of Motion After the First Injection	25.3 degrees Standard Deviation 19.52

Adverse Events

AA4500 0.58 mg

Serious events: 11 serious events

Other events: 197 other events

Deaths: 0 deaths

Serious adverse events

Measure	AA4500 0.58 mg n=201 participants at risk collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
Cardiac disorders Acute myocardial infarction	0.50% 1/201 • Number of events 1 • Non-serious adverse events (non-SAEs) were collected from time of study drug administration, serious adverse events (SAEs) were collected from time subject signed ICF. Non-SAEs & SAEs were collected until 30 days after completion or discharge from study. This study was designed to be part of the larger clinical program, for adult patients with Dupuytren's contracture with a palpable cord, where the data from 2 pivotal Placebo-Controlled studies (AUX-CC-857 and AUX-CC-859) and 7 non-pivotal studies were evaluated.
Cardiac disorders Atrial fibrillation	0.50% 1/201 • Number of events 1 • Non-serious adverse events (non-SAEs) were collected from time of study drug administration, serious adverse events (SAEs) were collected from time subject signed ICF. Non-SAEs & SAEs were collected until 30 days after completion or discharge from study. This study was designed to be part of the larger clinical program, for adult patients with Dupuytren's contracture with a palpable cord, where the data from 2 pivotal Placebo-Controlled studies (AUX-CC-857 and AUX-CC-859) and 7 non-pivotal studies were evaluated.
General disorders Chest pain	0.50% 1/201 • Number of events 1 • Non-serious adverse events (non-SAEs) were collected from time of study drug administration, serious adverse events (SAEs) were collected from time subject signed ICF. Non-SAEs & SAEs were collected until 30 days after completion or discharge from study. This study was designed to be part of the larger clinical program, for adult patients with Dupuytren's contracture with a palpable cord, where the data from 2 pivotal Placebo-Controlled studies (AUX-CC-857 and AUX-CC-859) and 7 non-pivotal studies were evaluated.
Injury, poisoning and procedural complications Clavicle fracture	0.50% 1/201 • Number of events 1 • Non-serious adverse events (non-SAEs) were collected from time of study drug administration, serious adverse events (SAEs) were collected from time subject signed ICF. Non-SAEs & SAEs were collected until 30 days after completion or discharge from study. This study was designed to be part of the larger clinical program, for adult patients with Dupuytren's contracture with a palpable cord, where the data from 2 pivotal Placebo-Controlled studies (AUX-CC-857 and AUX-CC-859) and 7 non-pivotal studies were evaluated.
Injury, poisoning and procedural complications Compression fracture	0.50% 1/201 • Number of events 1 • Non-serious adverse events (non-SAEs) were collected from time of study drug administration, serious adverse events (SAEs) were collected from time subject signed ICF. Non-SAEs & SAEs were collected until 30 days after completion or discharge from study. This study was designed to be part of the larger clinical program, for adult patients with Dupuytren's contracture with a palpable cord, where the data from 2 pivotal Placebo-Controlled studies (AUX-CC-857 and AUX-CC-859) and 7 non-pivotal studies were evaluated.
Vascular disorders Deep vein thrombosis	0.50% 1/201 • Number of events 1 • Non-serious adverse events (non-SAEs) were collected from time of study drug administration, serious adverse events (SAEs) were collected from time subject signed ICF. Non-SAEs & SAEs were collected until 30 days after completion or discharge from study. This study was designed to be part of the larger clinical program, for adult patients with Dupuytren's contracture with a palpable cord, where the data from 2 pivotal Placebo-Controlled studies (AUX-CC-857 and AUX-CC-859) and 7 non-pivotal studies were evaluated.
Vascular disorders Embolism	0.50% 1/201 • Number of events 1 • Non-serious adverse events (non-SAEs) were collected from time of study drug administration, serious adverse events (SAEs) were collected from time subject signed ICF. Non-SAEs & SAEs were collected until 30 days after completion or discharge from study. This study was designed to be part of the larger clinical program, for adult patients with Dupuytren's contracture with a palpable cord, where the data from 2 pivotal Placebo-Controlled studies (AUX-CC-857 and AUX-CC-859) and 7 non-pivotal studies were evaluated.
Infections and infestations Enterococcal sepsis	0.50% 1/201 • Number of events 1 • Non-serious adverse events (non-SAEs) were collected from time of study drug administration, serious adverse events (SAEs) were collected from time subject signed ICF. Non-SAEs & SAEs were collected until 30 days after completion or discharge from study. This study was designed to be part of the larger clinical program, for adult patients with Dupuytren's contracture with a palpable cord, where the data from 2 pivotal Placebo-Controlled studies (AUX-CC-857 and AUX-CC-859) and 7 non-pivotal studies were evaluated.
Injury, poisoning and procedural complications Fall	0.50% 1/201 • Number of events 1 • Non-serious adverse events (non-SAEs) were collected from time of study drug administration, serious adverse events (SAEs) were collected from time subject signed ICF. Non-SAEs & SAEs were collected until 30 days after completion or discharge from study. This study was designed to be part of the larger clinical program, for adult patients with Dupuytren's contracture with a palpable cord, where the data from 2 pivotal Placebo-Controlled studies (AUX-CC-857 and AUX-CC-859) and 7 non-pivotal studies were evaluated.
Surgical and medical procedures Finger amputation	0.50% 1/201 • Number of events 1 • Non-serious adverse events (non-SAEs) were collected from time of study drug administration, serious adverse events (SAEs) were collected from time subject signed ICF. Non-SAEs & SAEs were collected until 30 days after completion or discharge from study. This study was designed to be part of the larger clinical program, for adult patients with Dupuytren's contracture with a palpable cord, where the data from 2 pivotal Placebo-Controlled studies (AUX-CC-857 and AUX-CC-859) and 7 non-pivotal studies were evaluated.
Musculoskeletal and connective tissue disorders Intervertebral discitis	0.50% 1/201 • Number of events 1 • Non-serious adverse events (non-SAEs) were collected from time of study drug administration, serious adverse events (SAEs) were collected from time subject signed ICF. Non-SAEs & SAEs were collected until 30 days after completion or discharge from study. This study was designed to be part of the larger clinical program, for adult patients with Dupuytren's contracture with a palpable cord, where the data from 2 pivotal Placebo-Controlled studies (AUX-CC-857 and AUX-CC-859) and 7 non-pivotal studies were evaluated.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.50% 1/201 • Number of events 1 • Non-serious adverse events (non-SAEs) were collected from time of study drug administration, serious adverse events (SAEs) were collected from time subject signed ICF. Non-SAEs & SAEs were collected until 30 days after completion or discharge from study. This study was designed to be part of the larger clinical program, for adult patients with Dupuytren's contracture with a palpable cord, where the data from 2 pivotal Placebo-Controlled studies (AUX-CC-857 and AUX-CC-859) and 7 non-pivotal studies were evaluated.
Cardiac disorders Myocardial infarction	1.00% 2/201 • Number of events 2 • Non-serious adverse events (non-SAEs) were collected from time of study drug administration, serious adverse events (SAEs) were collected from time subject signed ICF. Non-SAEs & SAEs were collected until 30 days after completion or discharge from study. This study was designed to be part of the larger clinical program, for adult patients with Dupuytren's contracture with a palpable cord, where the data from 2 pivotal Placebo-Controlled studies (AUX-CC-857 and AUX-CC-859) and 7 non-pivotal studies were evaluated.
Infections and infestations Osteomyelitis	0.50% 1/201 • Number of events 1 • Non-serious adverse events (non-SAEs) were collected from time of study drug administration, serious adverse events (SAEs) were collected from time subject signed ICF. Non-SAEs & SAEs were collected until 30 days after completion or discharge from study. This study was designed to be part of the larger clinical program, for adult patients with Dupuytren's contracture with a palpable cord, where the data from 2 pivotal Placebo-Controlled studies (AUX-CC-857 and AUX-CC-859) and 7 non-pivotal studies were evaluated.
Gastrointestinal disorders Peritonitis	0.50% 1/201 • Number of events 1 • Non-serious adverse events (non-SAEs) were collected from time of study drug administration, serious adverse events (SAEs) were collected from time subject signed ICF. Non-SAEs & SAEs were collected until 30 days after completion or discharge from study. This study was designed to be part of the larger clinical program, for adult patients with Dupuytren's contracture with a palpable cord, where the data from 2 pivotal Placebo-Controlled studies (AUX-CC-857 and AUX-CC-859) and 7 non-pivotal studies were evaluated.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cell carcinoma stage unspecified	0.50% 1/201 • Number of events 1 • Non-serious adverse events (non-SAEs) were collected from time of study drug administration, serious adverse events (SAEs) were collected from time subject signed ICF. Non-SAEs & SAEs were collected until 30 days after completion or discharge from study. This study was designed to be part of the larger clinical program, for adult patients with Dupuytren's contracture with a palpable cord, where the data from 2 pivotal Placebo-Controlled studies (AUX-CC-857 and AUX-CC-859) and 7 non-pivotal studies were evaluated.
Renal and urinary disorders Renal failure	0.50% 1/201 • Number of events 1 • Non-serious adverse events (non-SAEs) were collected from time of study drug administration, serious adverse events (SAEs) were collected from time subject signed ICF. Non-SAEs & SAEs were collected until 30 days after completion or discharge from study. This study was designed to be part of the larger clinical program, for adult patients with Dupuytren's contracture with a palpable cord, where the data from 2 pivotal Placebo-Controlled studies (AUX-CC-857 and AUX-CC-859) and 7 non-pivotal studies were evaluated.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.50% 1/201 • Number of events 1 • Non-serious adverse events (non-SAEs) were collected from time of study drug administration, serious adverse events (SAEs) were collected from time subject signed ICF. Non-SAEs & SAEs were collected until 30 days after completion or discharge from study. This study was designed to be part of the larger clinical program, for adult patients with Dupuytren's contracture with a palpable cord, where the data from 2 pivotal Placebo-Controlled studies (AUX-CC-857 and AUX-CC-859) and 7 non-pivotal studies were evaluated.
Infections and infestations Rocky mountain spotted fever	0.50% 1/201 • Number of events 1 • Non-serious adverse events (non-SAEs) were collected from time of study drug administration, serious adverse events (SAEs) were collected from time subject signed ICF. Non-SAEs & SAEs were collected until 30 days after completion or discharge from study. This study was designed to be part of the larger clinical program, for adult patients with Dupuytren's contracture with a palpable cord, where the data from 2 pivotal Placebo-Controlled studies (AUX-CC-857 and AUX-CC-859) and 7 non-pivotal studies were evaluated.
Gastrointestinal disorders Small intestinal obstruction	0.50% 1/201 • Number of events 1 • Non-serious adverse events (non-SAEs) were collected from time of study drug administration, serious adverse events (SAEs) were collected from time subject signed ICF. Non-SAEs & SAEs were collected until 30 days after completion or discharge from study. This study was designed to be part of the larger clinical program, for adult patients with Dupuytren's contracture with a palpable cord, where the data from 2 pivotal Placebo-Controlled studies (AUX-CC-857 and AUX-CC-859) and 7 non-pivotal studies were evaluated.
Gastrointestinal disorders Small intestinal perforation	0.50% 1/201 • Number of events 1 • Non-serious adverse events (non-SAEs) were collected from time of study drug administration, serious adverse events (SAEs) were collected from time subject signed ICF. Non-SAEs & SAEs were collected until 30 days after completion or discharge from study. This study was designed to be part of the larger clinical program, for adult patients with Dupuytren's contracture with a palpable cord, where the data from 2 pivotal Placebo-Controlled studies (AUX-CC-857 and AUX-CC-859) and 7 non-pivotal studies were evaluated.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid gland cancer	0.50% 1/201 • Number of events 1 • Non-serious adverse events (non-SAEs) were collected from time of study drug administration, serious adverse events (SAEs) were collected from time subject signed ICF. Non-SAEs & SAEs were collected until 30 days after completion or discharge from study. This study was designed to be part of the larger clinical program, for adult patients with Dupuytren's contracture with a palpable cord, where the data from 2 pivotal Placebo-Controlled studies (AUX-CC-857 and AUX-CC-859) and 7 non-pivotal studies were evaluated.

Other adverse events

Measure	AA4500 0.58 mg n=201 participants at risk collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
Musculoskeletal and connective tissue disorders Arthralgia	5.0% 10/201 • Number of events 10 • Non-serious adverse events (non-SAEs) were collected from time of study drug administration, serious adverse events (SAEs) were collected from time subject signed ICF. Non-SAEs & SAEs were collected until 30 days after completion or discharge from study. This study was designed to be part of the larger clinical program, for adult patients with Dupuytren's contracture with a palpable cord, where the data from 2 pivotal Placebo-Controlled studies (AUX-CC-857 and AUX-CC-859) and 7 non-pivotal studies were evaluated.
Skin and subcutaneous tissue disorders Blood blister	5.0% 10/201 • Number of events 11 • Non-serious adverse events (non-SAEs) were collected from time of study drug administration, serious adverse events (SAEs) were collected from time subject signed ICF. Non-SAEs & SAEs were collected until 30 days after completion or discharge from study. This study was designed to be part of the larger clinical program, for adult patients with Dupuytren's contracture with a palpable cord, where the data from 2 pivotal Placebo-Controlled studies (AUX-CC-857 and AUX-CC-859) and 7 non-pivotal studies were evaluated.
Injury, poisoning and procedural complications Contusion	49.8% 100/201 • Number of events 174 • Non-serious adverse events (non-SAEs) were collected from time of study drug administration, serious adverse events (SAEs) were collected from time subject signed ICF. Non-SAEs & SAEs were collected until 30 days after completion or discharge from study. This study was designed to be part of the larger clinical program, for adult patients with Dupuytren's contracture with a palpable cord, where the data from 2 pivotal Placebo-Controlled studies (AUX-CC-857 and AUX-CC-859) and 7 non-pivotal studies were evaluated.
Skin and subcutaneous tissue disorders Ecchymosis	21.4% 43/201 • Number of events 98 • Non-serious adverse events (non-SAEs) were collected from time of study drug administration, serious adverse events (SAEs) were collected from time subject signed ICF. Non-SAEs & SAEs were collected until 30 days after completion or discharge from study. This study was designed to be part of the larger clinical program, for adult patients with Dupuytren's contracture with a palpable cord, where the data from 2 pivotal Placebo-Controlled studies (AUX-CC-857 and AUX-CC-859) and 7 non-pivotal studies were evaluated.
Skin and subcutaneous tissue disorders Erythema	6.0% 12/201 • Number of events 15 • Non-serious adverse events (non-SAEs) were collected from time of study drug administration, serious adverse events (SAEs) were collected from time subject signed ICF. Non-SAEs & SAEs were collected until 30 days after completion or discharge from study. This study was designed to be part of the larger clinical program, for adult patients with Dupuytren's contracture with a palpable cord, where the data from 2 pivotal Placebo-Controlled studies (AUX-CC-857 and AUX-CC-859) and 7 non-pivotal studies were evaluated.
Vascular disorders Haematoma	6.0% 12/201 • Number of events 13 • Non-serious adverse events (non-SAEs) were collected from time of study drug administration, serious adverse events (SAEs) were collected from time subject signed ICF. Non-SAEs & SAEs were collected until 30 days after completion or discharge from study. This study was designed to be part of the larger clinical program, for adult patients with Dupuytren's contracture with a palpable cord, where the data from 2 pivotal Placebo-Controlled studies (AUX-CC-857 and AUX-CC-859) and 7 non-pivotal studies were evaluated.
General disorders Injection site haemorrhage	54.2% 109/201 • Number of events 168 • Non-serious adverse events (non-SAEs) were collected from time of study drug administration, serious adverse events (SAEs) were collected from time subject signed ICF. Non-SAEs & SAEs were collected until 30 days after completion or discharge from study. This study was designed to be part of the larger clinical program, for adult patients with Dupuytren's contracture with a palpable cord, where the data from 2 pivotal Placebo-Controlled studies (AUX-CC-857 and AUX-CC-859) and 7 non-pivotal studies were evaluated.
General disorders Injection site pain	57.7% 116/201 • Number of events 182 • Non-serious adverse events (non-SAEs) were collected from time of study drug administration, serious adverse events (SAEs) were collected from time subject signed ICF. Non-SAEs & SAEs were collected until 30 days after completion or discharge from study. This study was designed to be part of the larger clinical program, for adult patients with Dupuytren's contracture with a palpable cord, where the data from 2 pivotal Placebo-Controlled studies (AUX-CC-857 and AUX-CC-859) and 7 non-pivotal studies were evaluated.
General disorders Injection site pruritus	9.5% 19/201 • Number of events 23 • Non-serious adverse events (non-SAEs) were collected from time of study drug administration, serious adverse events (SAEs) were collected from time subject signed ICF. Non-SAEs & SAEs were collected until 30 days after completion or discharge from study. This study was designed to be part of the larger clinical program, for adult patients with Dupuytren's contracture with a palpable cord, where the data from 2 pivotal Placebo-Controlled studies (AUX-CC-857 and AUX-CC-859) and 7 non-pivotal studies were evaluated.
General disorders Injection site swelling	28.4% 57/201 • Number of events 98 • Non-serious adverse events (non-SAEs) were collected from time of study drug administration, serious adverse events (SAEs) were collected from time subject signed ICF. Non-SAEs & SAEs were collected until 30 days after completion or discharge from study. This study was designed to be part of the larger clinical program, for adult patients with Dupuytren's contracture with a palpable cord, where the data from 2 pivotal Placebo-Controlled studies (AUX-CC-857 and AUX-CC-859) and 7 non-pivotal studies were evaluated.
General disorders Oedema peripheral	75.1% 151/201 • Number of events 431 • Non-serious adverse events (non-SAEs) were collected from time of study drug administration, serious adverse events (SAEs) were collected from time subject signed ICF. Non-SAEs & SAEs were collected until 30 days after completion or discharge from study. This study was designed to be part of the larger clinical program, for adult patients with Dupuytren's contracture with a palpable cord, where the data from 2 pivotal Placebo-Controlled studies (AUX-CC-857 and AUX-CC-859) and 7 non-pivotal studies were evaluated.
Musculoskeletal and connective tissue disorders Pain in extremity	23.9% 48/201 • Number of events 61 • Non-serious adverse events (non-SAEs) were collected from time of study drug administration, serious adverse events (SAEs) were collected from time subject signed ICF. Non-SAEs & SAEs were collected until 30 days after completion or discharge from study. This study was designed to be part of the larger clinical program, for adult patients with Dupuytren's contracture with a palpable cord, where the data from 2 pivotal Placebo-Controlled studies (AUX-CC-857 and AUX-CC-859) and 7 non-pivotal studies were evaluated.
Skin and subcutaneous tissue disorders Pruritus	11.9% 24/201 • Number of events 35 • Non-serious adverse events (non-SAEs) were collected from time of study drug administration, serious adverse events (SAEs) were collected from time subject signed ICF. Non-SAEs & SAEs were collected until 30 days after completion or discharge from study. This study was designed to be part of the larger clinical program, for adult patients with Dupuytren's contracture with a palpable cord, where the data from 2 pivotal Placebo-Controlled studies (AUX-CC-857 and AUX-CC-859) and 7 non-pivotal studies were evaluated.
Injury, poisoning and procedural complications Skin laceration	15.9% 32/201 • Number of events 36 • Non-serious adverse events (non-SAEs) were collected from time of study drug administration, serious adverse events (SAEs) were collected from time subject signed ICF. Non-SAEs & SAEs were collected until 30 days after completion or discharge from study. This study was designed to be part of the larger clinical program, for adult patients with Dupuytren's contracture with a palpable cord, where the data from 2 pivotal Placebo-Controlled studies (AUX-CC-857 and AUX-CC-859) and 7 non-pivotal studies were evaluated.
General disorders Swelling	5.0% 10/201 • Number of events 13 • Non-serious adverse events (non-SAEs) were collected from time of study drug administration, serious adverse events (SAEs) were collected from time subject signed ICF. Non-SAEs & SAEs were collected until 30 days after completion or discharge from study. This study was designed to be part of the larger clinical program, for adult patients with Dupuytren's contracture with a palpable cord, where the data from 2 pivotal Placebo-Controlled studies (AUX-CC-857 and AUX-CC-859) and 7 non-pivotal studies were evaluated.
General disorders Tenderness	23.9% 48/201 • Number of events 68 • Non-serious adverse events (non-SAEs) were collected from time of study drug administration, serious adverse events (SAEs) were collected from time subject signed ICF. Non-SAEs & SAEs were collected until 30 days after completion or discharge from study. This study was designed to be part of the larger clinical program, for adult patients with Dupuytren's contracture with a palpable cord, where the data from 2 pivotal Placebo-Controlled studies (AUX-CC-857 and AUX-CC-859) and 7 non-pivotal studies were evaluated.

Additional Information

Clinical Trial Coordinator

Endo Pharmaceuticals, Inc.

Email: clinicalsite.inquiries@endo.com

Results disclosure agreements

• Principal investigator is a sponsor employee Auxilium Pharmaceuticals, Inc. agreements may vary with individual investigators but will not prohibit any investigator from publishing. Auxilium supports the publication of results from all centers of a multicenter trial but requests that reports based on single site data not preceed the primary publication of the entire clinical trial.
• Publication restrictions are in place

Restriction type: OTHER