Trial Outcomes & Findings for Collagenase in the Treatment of Dupuytrens Disease (NCT NCT00260429)

Last Updated: 2010-12-09

Results Overview

The Primary Outcome Measure for patients treated with AA4500 is the percentage of 23 joints that were successfully treated where "successfully treated" was defined as reduction in contracture to 5° or less. The Primary Outcome Measure for placebo treated patients is the percentage of 12 joints that were successfully treated where "successfully treated" was defined as reduction in contracture to 5° or less.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

38 participants

Primary outcome timeframe

30 days after the last injection

Results posted on

2010-12-09

Participant Flow

Participant milestones

Participant milestones
Measure	AA4500 collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints	Placebo
Overall Study STARTED	23	12
Overall Study COMPLETED	21	12
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	AA4500 collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints	Placebo
Overall Study failure to follow appointments	1	0
Overall Study scheduled hand surgery	1	0

Baseline Characteristics

Collagenase in the Treatment of Dupuytrens Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AA4500 n=23 Participants collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints	Placebo n=12 Participants	Total n=35 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=5 Participants	5 Participants n=7 Participants	21 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Age Continuous	60.1 years STANDARD_DEVIATION 7.6 • n=5 Participants	63.8 years STANDARD_DEVIATION 10.0 • n=7 Participants	61.3 years STANDARD_DEVIATION 8.5 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	8 Participants n=7 Participants	28 Participants n=5 Participants
Region of Enrollment United States	23 participants n=5 Participants	12 participants n=7 Participants	35 participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days after the last injection

Outcome measures

Outcome measures
Measure	AA4500 n=23 Participants collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints	Placebo n=12 Participants
Primary Outcome Measure is Reduction of Flexion Contracture of the Primary Joint.	91.3 % Joints	0 % Joints

SECONDARY outcome

Timeframe: 30 days after last treatment to the primary joint

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 30 days after last treatment to the primary joint

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: First evaluation visit on which clinical success is achieved and maintained through the Day 30 evaluation of the primary joint

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 30 days after first treatment to the primary joint

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 30 days after first treatment to the primary joint

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 30 days after first treatment to the primary joint

Outcome measures

Outcome data not reported

Adverse Events

AA4500

Serious events: 2 serious events

Other events: 23 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	AA4500 n=23 participants at risk collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints	Placebo n=15 participants at risk
Nervous system disorders Cerebrovascular accident	8.7% 2/23 • Number of events 2 This study was designed to be part of the larger clinical program. For information regarding XIAFLEX-associated Serious and Non-serious Adverse events please refer to the XIAFLEX Medication Guide \& XIAFLEX Prescribing Information (see links above).	0.00% 0/12 This study was designed to be part of the larger clinical program. For information regarding XIAFLEX-associated Serious and Non-serious Adverse events please refer to the XIAFLEX Medication Guide \& XIAFLEX Prescribing Information (see links above).
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/23 This study was designed to be part of the larger clinical program. For information regarding XIAFLEX-associated Serious and Non-serious Adverse events please refer to the XIAFLEX Medication Guide \& XIAFLEX Prescribing Information (see links above).	8.3% 1/12 • Number of events 1 This study was designed to be part of the larger clinical program. For information regarding XIAFLEX-associated Serious and Non-serious Adverse events please refer to the XIAFLEX Medication Guide \& XIAFLEX Prescribing Information (see links above).

Other adverse events

Additional Information

Greg Kaufman, MD; Senior Director of Clinical Development

Auxilium Pharmaceuticals, Inc.

Phone: 484 321 5900

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	AA4500 n=23 participants at risk collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints	Placebo n=15 participants at risk
General disorders Edema peripheral	100.0% 23/23 This study was designed to be part of the larger clinical program. For information regarding XIAFLEX-associated Serious and Non-serious Adverse events please refer to the XIAFLEX Medication Guide \& XIAFLEX Prescribing Information (see links above).	6.7% 1/15 This study was designed to be part of the larger clinical program. For information regarding XIAFLEX-associated Serious and Non-serious Adverse events please refer to the XIAFLEX Medication Guide \& XIAFLEX Prescribing Information (see links above).
General disorders Injection site pain	100.0% 23/23 This study was designed to be part of the larger clinical program. For information regarding XIAFLEX-associated Serious and Non-serious Adverse events please refer to the XIAFLEX Medication Guide \& XIAFLEX Prescribing Information (see links above).	46.7% 7/15 This study was designed to be part of the larger clinical program. For information regarding XIAFLEX-associated Serious and Non-serious Adverse events please refer to the XIAFLEX Medication Guide \& XIAFLEX Prescribing Information (see links above).
Skin and subcutaneous tissue disorders Ecchymosis	52.2% 12/23 This study was designed to be part of the larger clinical program. For information regarding XIAFLEX-associated Serious and Non-serious Adverse events please refer to the XIAFLEX Medication Guide \& XIAFLEX Prescribing Information (see links above).	0.00% 0/15 This study was designed to be part of the larger clinical program. For information regarding XIAFLEX-associated Serious and Non-serious Adverse events please refer to the XIAFLEX Medication Guide \& XIAFLEX Prescribing Information (see links above).
Skin and subcutaneous tissue disorders Blood blister	43.5% 10/23 This study was designed to be part of the larger clinical program. For information regarding XIAFLEX-associated Serious and Non-serious Adverse events please refer to the XIAFLEX Medication Guide \& XIAFLEX Prescribing Information (see links above).	0.00% 0/15 This study was designed to be part of the larger clinical program. For information regarding XIAFLEX-associated Serious and Non-serious Adverse events please refer to the XIAFLEX Medication Guide \& XIAFLEX Prescribing Information (see links above).
Blood and lymphatic system disorders Lymphadenopathy	43.5% 10/23 This study was designed to be part of the larger clinical program. For information regarding XIAFLEX-associated Serious and Non-serious Adverse events please refer to the XIAFLEX Medication Guide \& XIAFLEX Prescribing Information (see links above).	0.00% 0/15 This study was designed to be part of the larger clinical program. For information regarding XIAFLEX-associated Serious and Non-serious Adverse events please refer to the XIAFLEX Medication Guide \& XIAFLEX Prescribing Information (see links above).
Skin and subcutaneous tissue disorders Pruritus	30.4% 7/23 This study was designed to be part of the larger clinical program. For information regarding XIAFLEX-associated Serious and Non-serious Adverse events please refer to the XIAFLEX Medication Guide \& XIAFLEX Prescribing Information (see links above).	0.00% 0/15 This study was designed to be part of the larger clinical program. For information regarding XIAFLEX-associated Serious and Non-serious Adverse events please refer to the XIAFLEX Medication Guide \& XIAFLEX Prescribing Information (see links above).
Musculoskeletal and connective tissue disorders Pain in extremity	13.0% 3/23 This study was designed to be part of the larger clinical program. For information regarding XIAFLEX-associated Serious and Non-serious Adverse events please refer to the XIAFLEX Medication Guide \& XIAFLEX Prescribing Information (see links above).	0.00% 0/15 This study was designed to be part of the larger clinical program. For information regarding XIAFLEX-associated Serious and Non-serious Adverse events please refer to the XIAFLEX Medication Guide \& XIAFLEX Prescribing Information (see links above).
Injury, poisoning and procedural complications Skin laceration	13.0% 3/23 This study was designed to be part of the larger clinical program. For information regarding XIAFLEX-associated Serious and Non-serious Adverse events please refer to the XIAFLEX Medication Guide \& XIAFLEX Prescribing Information (see links above).	0.00% 0/15 This study was designed to be part of the larger clinical program. For information regarding XIAFLEX-associated Serious and Non-serious Adverse events please refer to the XIAFLEX Medication Guide \& XIAFLEX Prescribing Information (see links above).
General disorders Tenderness	13.0% 3/23 This study was designed to be part of the larger clinical program. For information regarding XIAFLEX-associated Serious and Non-serious Adverse events please refer to the XIAFLEX Medication Guide \& XIAFLEX Prescribing Information (see links above).	0.00% 0/15 This study was designed to be part of the larger clinical program. For information regarding XIAFLEX-associated Serious and Non-serious Adverse events please refer to the XIAFLEX Medication Guide \& XIAFLEX Prescribing Information (see links above).
Investigations Body temperature increased	8.7% 2/23 This study was designed to be part of the larger clinical program. For information regarding XIAFLEX-associated Serious and Non-serious Adverse events please refer to the XIAFLEX Medication Guide \& XIAFLEX Prescribing Information (see links above).	0.00% 0/15 This study was designed to be part of the larger clinical program. For information regarding XIAFLEX-associated Serious and Non-serious Adverse events please refer to the XIAFLEX Medication Guide \& XIAFLEX Prescribing Information (see links above).
Nervous system disorders Headache	8.7% 2/23 This study was designed to be part of the larger clinical program. For information regarding XIAFLEX-associated Serious and Non-serious Adverse events please refer to the XIAFLEX Medication Guide \& XIAFLEX Prescribing Information (see links above).	0.00% 0/15 This study was designed to be part of the larger clinical program. For information regarding XIAFLEX-associated Serious and Non-serious Adverse events please refer to the XIAFLEX Medication Guide \& XIAFLEX Prescribing Information (see links above).
Musculoskeletal and connective tissue disorders Trigger finger	8.7% 2/23 This study was designed to be part of the larger clinical program. For information regarding XIAFLEX-associated Serious and Non-serious Adverse events please refer to the XIAFLEX Medication Guide \& XIAFLEX Prescribing Information (see links above).	0.00% 0/15 This study was designed to be part of the larger clinical program. For information regarding XIAFLEX-associated Serious and Non-serious Adverse events please refer to the XIAFLEX Medication Guide \& XIAFLEX Prescribing Information (see links above).
Infections and infestations Upper respiratory tract infection	8.7% 2/23 This study was designed to be part of the larger clinical program. For information regarding XIAFLEX-associated Serious and Non-serious Adverse events please refer to the XIAFLEX Medication Guide \& XIAFLEX Prescribing Information (see links above).	20.0% 3/15 This study was designed to be part of the larger clinical program. For information regarding XIAFLEX-associated Serious and Non-serious Adverse events please refer to the XIAFLEX Medication Guide \& XIAFLEX Prescribing Information (see links above).
Vascular disorders Hypertension	4.3% 1/23 This study was designed to be part of the larger clinical program. For information regarding XIAFLEX-associated Serious and Non-serious Adverse events please refer to the XIAFLEX Medication Guide \& XIAFLEX Prescribing Information (see links above).	13.3% 2/15 This study was designed to be part of the larger clinical program. For information regarding XIAFLEX-associated Serious and Non-serious Adverse events please refer to the XIAFLEX Medication Guide \& XIAFLEX Prescribing Information (see links above).
Infections and infestations nasopharyngitis	4.3% 1/23 This study was designed to be part of the larger clinical program. For information regarding XIAFLEX-associated Serious and Non-serious Adverse events please refer to the XIAFLEX Medication Guide \& XIAFLEX Prescribing Information (see links above).	13.3% 2/15 This study was designed to be part of the larger clinical program. For information regarding XIAFLEX-associated Serious and Non-serious Adverse events please refer to the XIAFLEX Medication Guide \& XIAFLEX Prescribing Information (see links above).