Witthaut 2013 Inclusions: May receive up to 5 CCH 0.58mg Combined values for both studies Dupuytren’s disease injections (5 treatment cycles) with 18 years old maximum of 3 per cord separated by JOINT I and 63.7±9.7 ≥ Age (yrs): MP contractures between at least 30 days JOINT II Males (%): 85 20°-100° or PIP contractures White race (%): 100 between 20°-80° Only 1 cord injected within given 62.6±69.3 Duration of symptoms (months): treatment cycle Open-label Family history of Dupuytrens (%): 42 Total contracture index (degrees): Exclusions similar to CORD If needed, joints were manipulated up 135.1±106 US, Europe, trials to 3 times the day after the injection in Hand with 1 contracture (% pts.): Australian ≥ an effort to rupture cord Left hand: 29 centers Right hand: 36 Patients wore a splint to wear nightly Both hands: 35 9 months for up to 4 months Affected joints per patient (no) Total: 2.8±2.0 (range 0-13) N=587 MP joints: 1.5 ± 1.3 (range 0-8) (JOINT I PIP joints: 1.2 ± 1.3 (range 0-7) n=201; JOINT No prior tx for Dupuytren’s (%): 58 II n=386) Prior surgery for Dupuytren’s (%): 38 Physician rating of severity as mild/moderate/severe (%): 25/51/24
Witthaut 2013 JOINT I and JOINT II Open-label US, Europe, Australian centers 9 months N=587 (JOINT I n=201; JOINT II n=386) Inclusions: Dupuytren’s disease ≥ 18 years old MP contractures between 20°-100° or PIP contractures between 20°-80° Exclusions similar to CORD trials May receive up to 5 CCH 0.58mg injections (5 treatment cycles) with maximum of 3 per cord separated by at least 30 days Only 1 cord injected within given treatment cycle If needed, joints were manipulated up to 3 times the day after the injection in an effort to rupture cord Patients wore a splint to wear nightly for up to 4 months Combined values for both studies Age (yrs): 63.7±9.7 Males (%): 85 White race (%): 100 Duration of symptoms (months): 62.6±69.3 Family history of Dupuytrens (%): 42 Total contracture index (degrees): 135.1±106 Hand with ≥ 1 contracture (% pts.): Left hand: 29 Right hand: 36 Both hands: 35 Affected joints per patient (no) Total: 2.8±2.0 (range 0-13) MP joints: 1.5 ± 1.3 (range 0-8) PIP joints: 1.2 ± 1.3 (range 0-7) No prior tx for Dupuytren’s (%): 58 Prior surgery for Dupuytren’s (%): 38 Physician rating of severity as mild/moderate/severe (%): 25/51/24
Collagenase_Clostridium_Histolyticum_Monograph_update_2014.docx