| Primary | Reduction in Primary Joint Contracture to 5° or Less | Successfully treated or clinical success in primary joint defined as reduction in contracture to within 0-5° of normal within 30 days of injection. | Subjects who were randomized and received at least 1 injection | Posted | | Number | | Percentage of Joints | | Within 30 days after last injection | Joints | Joints | | ID | Title | Description |
|---|
| OG000 | AA4500 0.58 mg | Collagenase clostridium histolyticum 0.58 mg injected into MP and/or PIP joints | | OG001 | Placebo | Placebo (Sucrose and Tris) injection |
| | Units | Counts |
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| Participants | | | Joints | |
| | Title | Denominators | Categories |
|---|
| | |
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | Cochran-Mantel-Haenszel | | <.001 | | | | | | | | | | | | | | Superiority | | |
|
| Secondary | Clinical Improvement in Primary Joint After the Last Injection | Clinical improvement in primary joint defined as ≥50% reduction from baseline in the degree of contracture within 30 days after injection | Subjects who were randomized and received at least 1 injection | Posted | | Number | | Percentage of Joints | | Baseline, Within 30 days after last injection | Joints | Joints | | ID | Title | Description |
|---|
| OG000 | AA4500 0.58 mg | Collagenase clostridium histolyticum 0.58 mg injected into MP and/or PIP joints | | OG001 | Placebo | Placebo (Sucrose and Tris) injection |
| |
| Secondary | Percent Reduction From Baseline Contracture of Primary Joint After the Last Injection | Percent change in degree of contracture of primary joint measured as 100 * (baseline contracture - last available post-injection contracture)/baseline contracture | Subjects who were randomized and received at least 1 injection | Posted | | Mean | Standard Deviation | Percentage of change | | Baseline, Day 30 after last injection | Joints | Joints | | ID | Title | Description |
|---|
| OG000 | AA4500 0.58 mg | Collagenase clostridium histolyticum 0.58 mg injected into MP and/or PIP joints | | OG001 | Placebo | Placebo (Sucrose and Tris) injection |
| |
| Secondary | Change From Baseline Range of Motion in Primary Joint After the Last Injection | Change in degree of range of motion in primary joint measured as last available post-injection range of motion - baseline range of motion | Subjects who were randomized and received at least 1 injection | Posted | | Mean | Standard Deviation | Degrees | | Baseline, Day 30 after last injection | Joints | Joints | | ID | Title | Description |
|---|
| OG000 | AA4500 0.58 mg | Collagenase clostridium histolyticum 0.58 mg injected into MP and/or PIP joints | | OG001 | Placebo | Placebo (Sucrose and Tris) injection |
| |
| Secondary | Time to Reach Clinical Success in Primary Joint | Clinical success in primary joint defined as reduction in contracture to within 0-5° of normal within 30 days of injection, displayed in post injection time point categories | Subjects who were randomized and received at least 1 injection | Posted | | Number | | Percentage of Joints | | Within 30 days after last injection | Joints | Joints | | ID | Title | Description |
|---|
| OG000 | AA4500 0.58 mg | Collagenase clostridium histolyticum 0.58 mg injected into MP and/or PIP joints | | OG001 | Placebo | Placebo (Sucrose and Tris) injection |
| |
| Secondary | Clinical Success in Primary Joint After the First Injection | Clinical success in primary joint defined as reduction in contracture to within 0-5° of normal within 30 days of injection. | Subjects who were randomized and received at least 1 injection | Posted | | Number | | Percentage of Joints | | Within 30 days after first injection | Joints | Joints | | ID | Title | Description |
|---|
| OG000 | AA4500 0.58 mg | Collagenase clostridium histolyticum 0.58 mg injected into MP and/or PIP joints | | OG001 | Placebo | Placebo (Sucrose and Tris) injection |
| |
| Secondary | Clinical Improvement in Primary Joint After the First Injection | Clinical improvement in primary joint defined as ≥50% reduction from baseline in the degree of contracture within 30 days after injection | Subjects who were randomized and received at least 1 injection | Posted | | Number | | Percentage of Joints | | Baseline, Within 30 days after first injection | Joints | Joints | | ID | Title | Description |
|---|
| OG000 | AA4500 0.58 mg | Collagenase clostridium histolyticum 0.58 mg injected into MP and/or PIP joints | | OG001 | Placebo | Placebo (Sucrose and Tris) injection |
| |
| Secondary | Percent Reduction From Baseline Contracture of Primary Joint After the First Injection | Percent change in degree of contracture of primary joint measured as 100 * (baseline contracture - last available post-injection contracture prior to next injection)/baseline contracture | Subjects who were randomized and received at least 1 injection | Posted | | Mean | Standard Deviation | Percentage of change | | Baseline, Day 30 after first injection | Joints | Joints | | ID | Title | Description |
|---|
| OG000 | AA4500 0.58 mg | Collagenase clostridium histolyticum 0.58 mg injected into MP and/or PIP joints | | OG001 | Placebo | Placebo (Sucrose and Tris) injection |
| |
| Secondary | Change From Baseline Range of Motion in Primary Joint After the First Injection | Change in degree of range of motion in primary joint measured as last available post-injection range of motion prior to the next injection - baseline range of motion | Subjects who were randomized and received at least 1 injection | Posted | | Mean | Standard Deviation | Degrees | | Baseline, Day 30 after first injection | Joints | Joints | | ID | Title | Description |
|---|
| OG000 | AA4500 0.58 mg | Collagenase clostridium histolyticum 0.58 mg injected into MP and/or PIP joints | | OG001 | Placebo | Placebo (Sucrose and Tris) injection |
| |
| Secondary | Reduction in Non-primary Joint Contracture to 5° or Less After the Last Injection | Successfully treated or clinical success in non-primary joint defined as reduction in contracture to within 0-5° of normal within 30 days of injection. | Includes evaluable non-primary joints treated with AA4500 with baseline fixed flexion contracture >5° and at least 1 post-injection contracture measurement in subjects who received at least 1 non-primary joint injection in either study period | Posted | | Number | | Percentage of Joints | | Within 30 days after last injection | Joints | Joints | | ID | Title | Description |
|---|
| OG000 | AA4500 0.58 mg | Collagenase clostridium histolyticum 0.58 mg injected into MP and/or PIP joints |
| |
| Secondary | Clinical Improvement in Non-Primary Joint After the Last Injection | Clinical improvement in non-primary joint defined as ≥50% reduction from baseline in the degree of contracture within 30 days after injection | Includes evaluable non-primary joints treated with AA4500 with baseline fixed flexion contracture >5° and at least 1 post-injection contracture measurement in subjects who received at least 1 non-primary joint injection in either study period | Posted | | Number | | Percentage of Joints | | Baseline, Within 30 days after last injection | Joints | Joints | | ID | Title | Description |
|---|
| OG000 | AA4500 0.58 mg | Collagenase clostridium histolyticum 0.58 mg injected into MP and/or PIP joints |
| |
| Secondary | Percent Reduction From Baseline Contracture of Non-Primary Joint After the Last Injection | Percent change in degree of contracture of non-primary joint measured as 100 * (baseline contracture - last available post-injection contracture)/baseline contracture | Includes evaluable non-primary joints treated with AA4500 with baseline fixed flexion contracture >5° and at least 1 post-injection contracture measurement in subjects who received at least 1 non-primary joint injection in either study period | Posted | | Mean | Standard Deviation | Percentage of change | | Baseline, Day 30 after last injection | Joints | Joints | | ID | Title | Description |
|---|
| OG000 | AA4500 0.58 mg | Collagenase clostridium histolyticum 0.58 mg injected into MP and/or PIP joints |
| |
| Secondary | Change From Baseline Range of Motion in Non-Primary Joint After the Last Injection | Change in degree of range of motion in non-primary joint measured as last available post-injection range of motion - baseline range of motion | Includes evaluable non-primary joints treated with AA4500 with baseline fixed flexion contracture >5° and at least 1 post-injection contracture measurement in subjects who received at least 1 non-primary joint injection in either study period | Posted | | Mean | Standard Deviation | Degrees | | Baseline, Day 30 after last injection | Joints | Joints | | ID | Title | Description |
|---|
| OG000 | AA4500 0.58 mg | Collagenase clostridium histolyticum 0.58 mg injected into MP and/or PIP joints |
| |
| Secondary | Time to Reach Clinical Success in Non-Primary Joint | Clinical success in non-primary joint defined as reduction in contracture to within 0-5° of normal within 30 days of injection, displayed in post injection time point categories | Includes evaluable non-primary joints treated with AA4500 with baseline fixed flexion contracture >5° and at least 1 post-injection contracture measurement in subjects who received at least 1 non-primary joint injection in either study period | Posted | | Number | | Percentage of Joints | | Within 30 days after last injection | Joints | Joints | | ID | Title | Description |
|---|
| OG000 | AA4500 0.58 mg | Collagenase clostridium histolyticum 0.58 mg injected into MP and/or PIP joints |
| |
| Secondary | Clinical Success in Non-Primary Joint After the First Injection | Clinical success in non-primary joint defined as reduction in contracture to within 0-5° of normal within 30 days of injection. | Includes evaluable non-primary joints treated with AA4500 with baseline fixed flexion contracture >5° and at least 1 post-injection contracture measurement in subjects who received at least 1 non-primary joint injection in either study period | Posted | | Number | | Percentage of Joints | | Within 30 days after first injection | Joints | Joints | | ID | Title | Description |
|---|
| OG000 | AA4500 0.58 mg | Collagenase clostridium histolyticum 0.58 mg injected into MP and/or PIP joints |
| |
| Secondary | Clinical Improvement in Non-Primary Joint After the First Injection | Clinical improvement in non-primary joint defined as ≥50% reduction from baseline in the degree of contracture within 30 days after injection | Includes evaluable non-primary joints treated with AA4500 with baseline fixed flexion contracture >5° and at least 1 post-injection contracture measurement in subjects who received at least 1 non-primary joint injection in either study period | Posted | | Number | | Percentage of Joints | | Baseline, Within 30 days after first injection | Joints | Joints | | ID | Title | Description |
|---|
| OG000 | AA4500 0.58 mg | Collagenase clostridium histolyticum 0.58 mg injected into MP and/or PIP joints |
| |
| Secondary | Percent Reduction From Baseline Contracture of Non-Primary Joint After the First Injection | Percent change in degree of contracture of non-primary joint measured as 100 * (baseline contracture - last available post-injection contracture prior to next injection)/baseline contracture | Includes evaluable non-primary joints treated with AA4500 with baseline fixed flexion contracture >5° and at least 1 post-injection contracture measurement in subjects who received at least 1 non-primary joint injection in either study period | Posted | | Mean | Standard Deviation | Percentage of change | | Baseline, Day 30 after first injection | Joints | Joints | | ID | Title | Description |
|---|
| OG000 | AA4500 0.58 mg | Collagenase clostridium histolyticum 0.58 mg injected into MP and/or PIP joints |
| |
| Secondary | Change From Baseline Range of Motion in Non-Primary Joint After the First Injection | Change in degree of range of motion in non-primary joint measured as last available post-injection range of motion prior to the next injection - baseline range of motion | Includes evaluable non-primary joints treated with AA4500 with baseline fixed flexion contracture >5° and at least 1 post-injection contracture measurement in subjects who received at least 1 non-primary joint injection in either study period | Posted | | Mean | Standard Deviation | Degrees | | Baseline, Day 30 after first injection | Joints | Joints | | ID | Title | Description |
|---|
| OG000 | AA4500 0.58 mg | Collagenase clostridium histolyticum 0.58 mg injected into MP and/or PIP joints |
| |