Trial · NCT02728752
Study Evaluating Efficacy and Safety of Octagam 10% in Patients With Dermatomyositis (Idiopathic Inflammatory Myopathy)
NCT02728752, Phase 3, Completed, Octapharma; results first posted 2021-04-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study Evaluating Efficacy and Safety of Octagam 10% in Patients With Dermatomyositis (Idiopathic Inflammatory Myopathy). Trials, record NCT02728752. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02728752
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study Evaluating Efficacy and Safety of Octagam 10% in Patients With Dermatomyositis (Idiopathic Inflammatory Myopathy)
- NCT number
- NCT02728752
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 95 participants, actual
- Lead sponsor
- Octapharma
- Conditions
- Dermatomyositis
- Interventions
- Octagam 10%, Placebo
- First posted
- 2016-04-05
- Last updated
- 2021-12-23
- Results first posted
- 2021-04-21
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Measure the Number of Patients Who Had an Increase of ≥20 Points on the Total Improvement Score (TIS) | At week 16 | Proportion of responders in the 2.0 g/kg Octagam 10% and placebo arms at Week 16 relative to baseline (Week 0). A responder being defined as a patient with an increase of ≥20 points on the Total Improvement Score (TIS, a scale from 0 to 100; 20-39 points being minimal improvement, 40-59 points being moderate improvement, and ≥60 points being major improvement |
| Secondary | Proportion of TIS Responders by Improvement Category at Week 16 | 16 weeks | The TIS (Total Improvement Score) is a scale from 0 to 100 that allows for the discrimination between minimal, moderate and major responders depending on their improvement in the combined 6 CSM: ≥20 to 39 points being minimal improvement, ≥40 to 59 points being moderate improvement, and ≥60 points being major improvement. Primary: Total number of all patients who had at least minimal, moderate, or major response. At Least Moderate: Number of patients who had moderate or major response. At Least Major: Number of patients who had a major response. |
| Secondary | Proportion of TIS Responders by Improvement Category at Week 40 | 40 weeks | The TIS (Total Improvement Score) is a scale from 0 to 100 that allows for the discrimination between minimal, moderate and major responders depending on their improvement in the combined 6 CSM: ≥20 to 39 points being minimal improvement, ≥40 to 59 points being moderate improvement, and ≥60 points being major improvement. At Least Minimal: Total number of all patients who had minimal, moderate, or major response. At Least Moderate: Number of patients who had moderate or major response. At Least Major: Number of patients who had a major response. |
| Secondary | Mean Change From Baseline (Week 0) to End of First Period (Week 16) in the Modified Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) | First 16 weeks | The modified CDASI has 3 activity measures (erythema, scale, and erosion/ulceration) and 2 damage measures (poikiloderma and calcinosis) which are assessed over 15 body areas. In addition, Gottron's papules on the hands are evaluated both for activity and damage. Lastly, the activity of periungual changes and alopecia is assessed. Absence of skin lesions as described above is scored with "0" for each of the above described areas. Skin lesion will be scored with at least "1" (present), some lesions will be graded from "1" (less severe) to "2" (severe); others with "1", "2" or "3". For the total activity score as well as for the total damage score the sub-scores will be added up. The score for total activity ranges from 0 to 100, for total damage from 0 to 32 points. Higher scores indicate greater disease activity or greater disease damage respectively. |
| Secondary | Mean Change From End of First Period (Week 16) to End of Extension Period (Week 40) in the Modified Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) | From week 16 to Week 40 | The modified CDASI has 3 activity measures (erythema, scale, and erosion/ulceration) and 2 damage measures (poikiloderma and calcinosis) which are assessed over 15 body areas. In addition, Gottron's papules on the hands are evaluated both for activity and damage. Lastly, the activity of periungual changes and alopecia is assessed Absence of skin lesions as described above is scored with "0" for each of the above described areas. Skin lesion will be scored with at least "1" (present), some lesions will be graded from "1" (less severe) to "2" (severe); others with "1", "2" or "3". For the total activity score as well as for the total damage score the sub-scores will be added up. The score for total activity ranges from 0 to 100, for total damage from 0 to 32 points. Higher scores indicate greater disease activity or greater disease damage respectively. |
| Secondary | Mean Change From Baseline (Week 0) to End of Extension Period (Week 40) in the Modified Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) | 40 weeks | The modified CDASI has 3 activity measures (erythema, scale, and erosion/ulceration) and 2 damage measures (poikiloderma and calcinosis) which are assessed over 15 body areas. In addition, Gottron's papules on the hands are evaluated both for activity and damage. Lastly, the activity of periungual changes and alopecia is assessed. Absence of skin lesions as described above is scored with "0" for each of the above described areas. Skin lesion will be scored with at least "1" (present), some lesions will be graded from "1" (less severe) to "2" (severe); others with "1", "2" or "3". For the total activity score as well as for the total damage score the sub-scores will be added up. The score for total activity ranges from 0 to 100, for total damage from 0 to 32 points. Higher scores indicate greater disease activity or greater disease damage respectively. |
| Secondary | Mean Change From Baseline (Week 0) to End of First Period (Week 16) and Extension Period (Week 40) in: SF-36v2 Health Survey | From start of the trial till Week 40 | The SF-36 is a multi-purpose, short-form health survey with only 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index. SF-36 scores ranging from 0 to 100. 0 represented the lowest possible score (worst health state) and 100 represented the highest possible score (best health state), with scores in between representing the percentages of the total possible score achieved by respondents on a given scale. |
| Secondary | Mean Change From Baseline (Week 0) to End of First Period (Week 16) and Extension Period (Week 40) in Physician's Global Disease Activity | From start of the trial till Week 40 | 10 cm VAS assessing global disease activity from "No evidence of disease activity" to "Extremely active or severe disease activity"; Disease Activity being defined as potentially reversible pathology or physiology resulting from the myositis). Assessment completed by physician. 0 is lowest score and 10 is highest score. Higher score associated with worse outcome. |
| Secondary | Mean Change From Baseline (Week 0) to End of First Period (Week 16) and Extension Period (Week 40) in: Patient Global Disease Activity | From start of the trial till Week 40 | Patient's Global Disease Activity (10cm VAS assessing the overall activity of the patient's disease today from "No evidence of disease activity" to "Extremely active or severe disease activity", Disease Activity being active inflammation in the patient's muscles, skin, joints, intestines, heart, lungs or other parts of the body, which can improve when treated with medicines). 0 is lowest score and 10 is highest score. Higher score associated with worse outcome. |
| Secondary | Mean Change From Baseline (Week 0) to End of First Period (Week 16) and Extension Period (Week 40) in: MMT-8 | From start of the trial till Week 40 | Manual Muscle Testing - MMT-8; a set of 8 designated muscles tested bilaterally \[potential score 0 - 150\]. Higher score associated with better outcome. |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Measure the Number of Patients Who Had an Increase of ≥20 Points on the Total Improvement Score (TIS) | At week 16 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Proportion of TIS Responders by Improvement Category at Week 16 | 16 weeks | Only responders are displayed as the intent of the outcome measure is to present the proportion of responders. And patients not accounted for were non-responders. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Proportion of TIS Responders by Improvement Category at Week 40 | 40 weeks | Only responders are displayed as the intent of the outcome measure is to present the proportion of responders. And patients not accounted for were non-responders. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Mean Change From Baseline (Week 0) to End of First Period (Week 16) in the Modified Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) | First 16 weeks | units on a scale | MEAN | |
| SECONDARY | Mean Change From End of First Period (Week 16) to End of Extension Period (Week 40) in the Modified Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) | From week 16 to Week 40 | units on a scale | MEAN | |
| SECONDARY | Mean Change From Baseline (Week 0) to End of Extension Period (Week 40) in the Modified Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) | 40 weeks | units on a scale | MEAN | |
| SECONDARY | Mean Change From Baseline (Week 0) to End of First Period (Week 16) and Extension Period (Week 40) in: SF-36v2 Health Survey | From start of the trial till Week 40 | Numbers of patients analyzed different due to patient discontinuations through study. | units on a scale | MEAN |
| SECONDARY | Mean Change From Baseline (Week 0) to End of First Period (Week 16) and Extension Period (Week 40) in Physician's Global Disease Activity | From start of the trial till Week 40 | Different numbers of patients analyzed in each group due to patient discontinuation. | score on a scale | MEAN |
| SECONDARY | Mean Change From Baseline (Week 0) to End of First Period (Week 16) and Extension Period (Week 40) in: Patient Global Disease Activity | From start of the trial till Week 40 | Different numbers of patients analyzed in each group due to patient discontinuation. | score on a scale | MEAN |
| SECONDARY | Mean Change From Baseline (Week 0) to End of First Period (Week 16) and Extension Period (Week 40) in: MMT-8 | From start of the trial till Week 40 | Different numbers of patients analyzed in each group due to patient discontinuation. | score on a scale | MEAN |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 outcomesResults by group89
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Measure the Number of Patients Who Had an Increase of ≥20 Points on the Total Improvement Score (TIS) | Placebo | 21 | Participants | ||
| Measure the Number of Patients Who Had an Increase of ≥20 Points on the Total Improvement Score (TIS) | Octagam10% | 37 | Participants | ||
| Proportion of TIS Responders by Improvement Category at Week 16 | Placebo | Primary | 21 | Participants | |
| Proportion of TIS Responders by Improvement Category at Week 16 | Octagam10% | Primary | 37 | Participants | |
| Proportion of TIS Responders by Improvement Category at Week 16 | Placebo | At least moderate improvement | 11 | Participants | |
| Proportion of TIS Responders by Improvement Category at Week 16 | Octagam10% | At least moderate improvement | 32 | Participants | |
| Proportion of TIS Responders by Improvement Category at Week 16 | Placebo | At least major improvement | 4 | Participants | |
| Proportion of TIS Responders by Improvement Category at Week 16 | Octagam10% | At least major improvement | 15 | Participants | |
| Proportion of TIS Responders by Improvement Category at Week 40 | Placebo | At least minimal improvement | 32 | Participants | |
| Proportion of TIS Responders by Improvement Category at Week 40 | Octagam10% | At least minimal improvement | 32 | Participants |
1 to 10 of 89Source ClinicalTrials.gov
See all 89 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| First Period | STARTED | Placebo | 48 | |
| First Period | STARTED | Octagam10% | 47 | |
| First Period | COMPLETED | Placebo | 46 | |
| First Period | COMPLETED | Octagam10% | 45 | |
| First Period | NOT COMPLETED | Placebo | 2 | |
| First Period | NOT COMPLETED | Octagam10% | 2 | |
| Extension Period | STARTED | Placebo | 46 | |
| Extension Period | STARTED | Octagam10% | 45 | |
| Extension Period | COMPLETED | Placebo | 35 | |
| Extension Period | COMPLETED | Octagam10% | 34 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events436
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Lymphopenia | Blood and lymphatic system disorders | First Period Placebo | 1 | 48 | 1 |
| other | Lymphopenia | Blood and lymphatic system disorders | Overall Period Octagam | 2 | 95 | 2 |
| other | Atrioventricular block first degree | Cardiac disorders | First Period Placebo | 1 | 48 | 1 |
| other | Atrioventricular block first degree | Cardiac disorders | Overall Period Octagam | 0 | 95 | 0 |
| other | Bradycardia | Cardiac disorders | First Period Placebo | 2 | 48 | 2 |
| other | Bradycardia | Cardiac disorders | Overall Period Octagam | 1 | 95 | 2 |
| other | Mitral valve calcification | Cardiac disorders | First Period Placebo | 1 | 48 | 1 |
| other | Mitral valve calcification | Cardiac disorders | Overall Period Octagam | 0 | 95 | 0 |
| other | Palpitations | Cardiac disorders | First Period Placebo | 2 | 48 | 2 |
| other | Palpitations | Cardiac disorders | Overall Period Octagam | 1 | 95 | 1 |
1 to 10 of 436Source ClinicalTrials.gov
See all 436 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | First Period Placebo | 0 | 48 |
| Total, all-cause mortality | Overall Period Octagam | 0 | 95 |
| Total, other adverse events | First Period Placebo | 28 | 48 |
| Total, other adverse events | Overall Period Octagam | 84 | 95 |
| Total, serious adverse events | First Period Placebo | 2 | 48 |
| Total, serious adverse events | Overall Period Octagam | 14 | 95 |
Source ClinicalTrials.gov
Papers6
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Octagam10% vs Placebo: Measure the Number of Patients Who Had an Increase of ≥20 Points on the Total Improvement Score (TIS) | Trial comparisons |
| Overall Period Octagam vs First Period Placebo: deaths from any cause | Trial comparisons |
| Overall Period Octagam vs First Period Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02728752
GET https://conductscience.org/api/trials/v1/NCT02728752/results?page=2