Phase II Randomized Study of Collagenase in Patients With Residual Type Dupuytren's Disease

PROTOCOL OUTLINE: This is a randomized, investigator-blinded, placebo-controlled study.

Patients receive a single dose of either collagenase or placebo into the target finger on
day 0. Patients who do not respond at the 1 month follow up visit may receive an injection
of open label collagenase, if IgE antibody levels are no greater than 15 ng/mL.

Following treatment, patients use a nighttime extension splint for 4 months and perform
finger flexion/extension exercises. Patients are followed at 1, 7, and 14 days, and at 1,
2, 3, 6, 9, and 12 months, for each joint treated.

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Diagnosis of residual Dupuytren's disease with fixed flexion
deformity of the fingers of at least 20-30 degrees caused by a palpable cord Positive
table top test (inability to simultaneously place affected finger and palm flat against a
table top) --Prior/Concurrent Therapy-- Surgery: At least 30 days since surgery for
Dupuytren's disease Other: At least 30 days since prior investigational drug --Patient
Characteristics-- Hematopoietic: No history of hematologic disease Hepatic: No history of
hepatic disease Renal: No history of renal disease Cardiovascular: No congestive heart
failure within 6 months No angina within 6 months No myocardial infarction within 6 months
Pulmonary: No history of respiratory disease Other: HIV negative Not immunocompromised No
history of significant illness, e.g., endocrine or neurologic disease No history of
illicit drug abuse or alcoholism within 1 year No psychosis At least 2 weeks since
infectious illness No chronic or debilitating disease No IgE antibodies to collagenase
greater than 15 ng/mL No known allergy to collagenase or any of the inactive ingredients
in the injection Not pregnant or nursing Fertile patients must use effective contraception