Adults 18 to 79, any sex, with Dermatomyositis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Measure the Number of Patients Who Had an Increase of ≥20 Points on the Total Improvement Score (TIS)Primary· 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
Group
Value
95% CI
Placebo
21
Octagam10%
37
Proportion of TIS Responders by Improvement Category at Week 16Secondary· 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.
Primary
Group
Value
95% CI
Placebo
21
Octagam10%
37
At least moderate improvement
Group
Value
95% CI
Placebo
11
Octagam10%
32
At least major improvement
Group
Value
95% CI
Placebo
4
Octagam10%
15
Proportion of TIS Responders by Improvement Category at Week 40Secondary· 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.
At least minimal improvement
Group
Value
95% CI
Placebo
32
Octagam10%
32
At least moderate improvement
Group
Value
95% CI
Placebo
28
Octagam10%
26
At least major improvement
Group
Value
95% CI
Placebo
14
Octagam10%
17
Mean Change From Baseline (Week 0) to End of First Period (Week 16) in the Modified Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI)Secondary· 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 tota
Total Activity Score
Group
Value
95% CI
Placebo
-1.16
± 7.000
Octagam10%
-9.36
± 10.542
Total Damage Score
Group
Value
95% CI
Placebo
-0.02
± 0.771
Octagam10%
-0.67
± 1.871
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)Secondary· 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
Total Activity Score
Group
Value
95% CI
Placebo
-8.52
± 11.344
Octagam10%
-1.79
± 4.169
Total Damage Score
Group
Value
95% CI
Placebo
-0.24
± 0.969
Octagam10%
0.26
± 2.220
Mean Change From Baseline (Week 0) to End of Extension Period (Week 40) in the Modified Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI)Secondary· 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 tota
Total Activity Score
Group
Value
95% CI
Placebo
-10.44
± 10.034
Octagam10%
-10.03
± 8.995
Total Damage Score
Group
Value
95% CI
Placebo
-0.26
± 1.197
Octagam10%
-0.38
± 2.523
Mean Change From Baseline (Week 0) to End of First Period (Week 16) and Extension Period (Week 40) in: SF-36v2 Health SurveySecondary· 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.
Baseline to Week 16
Group
Value
95% CI
Placebo
2.27
± 4.598
Octagam10%
7.06
± 8.220
Baseline to Week 40
Group
Value
95% CI
Placebo
6.65
± 8.258
Octagam10%
8.77
± 10.930
Mean Change From Baseline (Week 0) to End of First Period (Week 16) and Extension Period (Week 40) in Physician's Global Disease ActivitySecondary· 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.
Baseline to Week 16
Group
Value
95% CI
Placebo
-0.60
± 1.815
Octagam10%
-2.39
± 1.987
Baseline to Week 40
Group
Value
95% CI
Placebo
-2.93
± 1.888
Octagam10%
-3.06
± 1.817
Mean Change From Baseline (Week 0) to End of First Period (Week 16) and Extension Period (Week 40) in: Patient Global Disease ActivitySecondary· 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.
Baseline to Week 16
Group
Value
95% CI
Placebo
-1.11
± 2.094
Octagam10%
-2.19
± 2.276
Baseline to Week 40
Group
Value
95% CI
Placebo
-2.77
± 2.133
Octagam10%
-2.71
± 2.651
Mean Change From Baseline (Week 0) to End of First Period (Week 16) and Extension Period (Week 40) in: MMT-8Secondary· 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.
Baseline to Week 16
Group
Value
95% CI
Placebo
3.21
± 9.390
Octagam10%
14.38
± 14.581
Baseline to Week 40
Group
Value
95% CI
Placebo
12.00
± 7.491
Octagam10%
20.09
± 14.486
Mean Change From Baseline (Week 0) to End of First Period (Week 16) and Extension Period (Week 40) in: Health Assessment QuestionnaireSecondary· From start of the trial till Week 40
Health Assessment Questionnaire (HAQ); a generic rather than a disease-specific instrument; comprised of 8 sections: dressing, arising, eating, walking, hygiene, reach, grip, and activities. There are 2 or 3 questions for each section. Scoring within each section is from 0 \[without any difficulty\] to 3 \[unable to do\]. For each section the score given to that section is the worst score within the section. The 8 scores of the 8 sections are summed and divided by 8). Assessment completed by patients. Lowest score 0 highest score 24. Higher score associated with worse outcome.
Baseline to Week 16
Group
Value
95% CI
Placebo
-0.16
± 0.366
Octagam10%
-0.56
± 0.590
Baseline to Week 40
Group
Value
95% CI
Placebo
-0.54
± 0.524
Octagam10%
-0.66
± 0.805
Mean Change From Baseline (Week 0) to End of First Period (Week 16) and Extension Period (Week 40) in Enzymes (Alanine Aminotransferase)Secondary· From start of the trial till Week 40
Baseline to Week 16
Group
Value
95% CI
Placebo
-4.47
± 29.796
Octagam10%
-8.52
± 18.474
Baseline to Week 40
Group
Value
95% CI
Placebo
-4.06
± 14.787
Octagam10%
-7.15
± 18.480
Adverse events — posted to ClinicalTrials.gov
Time frame: 40 weeks.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
First Period Placebo
Serious: 2/48 (4%)
Deaths: 0/48
Overall Period Octagam
Serious: 14/95 (15%)
Deaths: 0/95
Serious adverse events (21 terms)
Reaction
System
First Period Placebo
Overall Period Octagam
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
—
—
Sepsis
Infections and infestations
—
—
Condition aggravated
General disorders
—
—
Sinus tachycardia
Cardiac disorders
—
—
Ventricular extrasystoles
Cardiac disorders
—
—
Tropical spastic paresis
Infections and infestations
—
—
Muscle spasms
Musculoskeletal and connective tissue disorders
—
—
Dyspnoea
Respiratory, thoracic and mediastinal disorders
—
—
Hypertension
Vascular disorders
—
—
Cardiac failure congestive
Cardiac disorders
—
—
Atypical pneumonia
Infections and infestations
—
—
Escherichia bacteraemia
Infections and infestations
—
—
Pneumonia
Infections and infestations
—
—
Squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
Cerebral infarction
Nervous system disorders
—
—
Cerebrovascular accident
Nervous system disorders
—
—
Hypoaesthesia
Nervous system disorders
—
—
Loss of consciousness
Nervous system disorders
—
—
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
—
—
Deep vein thrombosis
Vascular disorders
—
—
Acute kidney injury
Renal and urinary disorders
—
—
Other adverse events (197 terms — click to expand)
Prospective, Double-blind, Randomized, Placebo-Controlled Phase III Study Evaluating Efficacy and Safety of Octagam 10% in Patients With Dermatomyositis ("ProDERM study")
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Octapharma
Last refreshed: 23 December 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02728752.