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Prospective, Double-blind, Randomized, Placebo-Controlled Phase III Study Evaluating Efficacy and Safety of Octagam 10% in Patients With Dermatomyositis ("ProDERM study")
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Subjects randomized to placebo will receive 4 infusions of placebo every 4 weeks during the blinded First Period (16 weeks). If confirmed deterioration (deterioration at 2 consecutive visits) during the First Period, subjects will be switched to Octagam 10%. After response assessment at Week 16, all subjects with no confirmed deterioration and subjects switched to Octagam 10% due to confirmed deterioration but without further confirmed deterioration during the First Period will continue to receive 2.0 g/kg of Octagam 10% every 4 weeks during the subsequent 6-months open-label Extension Period. At Week 28, subjects who are stable on 2.0 g/kg Octagam 10% can be switched to 1.0 g/kg Octagam 10%, at the discretion of the investigator. Subjects randomized to placebo and switched to Octagam 10% due to confirmed deterioration, who deteriorate also during Octagam 10% treatment at 2 consecutive visits will drop-out after response assessment at Week 16 and will not enter the Extension Period. |
|
| Octagam10% | Experimental | Subjects randomized to Octagam will receive 4 infusions of 2.0 g/kg Octagam 10% every 4 weeks during the blinded First Period (16 weeks). If confirmed deterioration (deterioration at 2 consecutive visits) during the First Period, subjects will be switched to the alternate treatment. After response assessment at Week 16, all subjects with no confirmed deterioration during the First Period will continue receiving 2.0 g/kg of Octagam 10% every 4 weeks during the subsequent 6-months open-label Extension Period. At Week 28, subjects who are stable on 2.0 g/kg Octagam 10% can be switched to 1.0 g/kg Octagam 10%, at the discretion of the investigator. Subjects randomized to Octagam and switched to the alternate treatment due to confirmed deterioration will drop-out after response assessment at Week 16 and will not enter the Extension Period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Octagam 10% | Drug | Patients to be treated with Octagam 10% |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Measure the Number of Patients Who Had an Increase of ≥20 Points on the Total Improvement Score (TIS) | 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 | At week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of TIS Responders by Improvement Category at Week 16 | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wolfgang Frenzel | International Medical Director | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Octapharma Research Site | Huntington Beach | California | 92647 | United States | ||
| Octapharma Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40616720 | Derived | Aggarwal R, Schessl J, Bata-Csorgo Z, Dimachkie MM, Griger Z, Moiseev S, Oddis CV, Schiopu E, Vencovsky J, Clodi E, Levine T, Charles-Schoeman C; ProDERM investigators. Efficacy of Intravenous Immunoglobulin for Systemic Manifestations of Dermatomyositis Beyond Muscular and Cutaneous: Sub-analysis of the ProDERM Study. Rheumatol Ther. 2025 Oct;12(5):855-871. doi: 10.1007/s40744-025-00775-5. Epub 2025 Jul 5. | |
| 39918968 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Subjects randomized to placebo will receive 4 infusions of placebo every 4 weeks during the blinded First Period (16 weeks). If confirmed deterioration (deterioration at 2 consecutive visits) during the First Period, subjects will be switched to Octagam 10%. After response assessment at Week 16, all subjects with no confirmed deterioration and subjects switched to Octagam 10% due to confirmed deterioration but without further confirmed deterioration during the First Period will continue to receive 2.0 g/kg of Octagam 10% every 4 weeks during the subsequent 6-months open-label Extension Period. At Week 28, subjects who are stable on 2.0 g/kg Octagam 10% can be switched to 1.0 g/kg Octagam 10%, at the discretion of the investigator. Subjects randomized to placebo and switched to Octagam 10% due to confirmed deterioration, who deteriorate also during Octagam 10% treatment at 2 consecutive visits will drop-out after response assessment at Week 16 and will not enter the Extension Period. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| First Period |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 18, 2019 | Oct 21, 2020 |
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| Placebo |
| Other |
Patients to be treated with a Placebo |
|
| 16 weeks |
| Proportion of TIS Responders by Improvement Category at Week 40 | 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. | 40 weeks |
| Mean Change From Baseline (Week 0) to End of First Period (Week 16) in the Modified Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) | 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. | First 16 weeks |
| 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) | 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. | From week 16 to Week 40 |
| Mean Change From Baseline (Week 0) to End of Extension Period (Week 40) in the Modified Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) | 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. | 40 weeks |
| Mean Change From Baseline (Week 0) to End of First Period (Week 16) and Extension Period (Week 40) in: SF-36v2 Health Survey | 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. | From start of the trial till Week 40 |
| Mean Change From Baseline (Week 0) to End of First Period (Week 16) and Extension Period (Week 40) in Physician's Global Disease Activity | 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. | From start of the trial till Week 40 |
| Mean Change From Baseline (Week 0) to End of First Period (Week 16) and Extension Period (Week 40) in: Patient Global Disease Activity | 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. | From start of the trial till Week 40 |
| Mean Change From Baseline (Week 0) to End of First Period (Week 16) and Extension Period (Week 40) in: MMT-8 | Manual Muscle Testing - MMT-8; a set of 8 designated muscles tested bilaterally [potential score 0 - 150]. Higher score associated with better outcome. | From start of the trial till Week 40 |
| Mean Change From Baseline (Week 0) to End of First Period (Week 16) and Extension Period (Week 40) in: Health Assessment Questionnaire | 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. | From start of the trial till Week 40 |
| Mean Change From Baseline (Week 0) to End of First Period (Week 16) and Extension Period (Week 40) in Enzymes (Alanine Aminotransferase) | From start of the trial till Week 40 |
| Mean Change From Baseline (Week 0) to End of First Period (Week 16) and Extension Period (Week 40) in Enzymes (Aspartate Aminotransferase) | From start of the trial till Week 40 |
| Mean Change From Baseline (Week 0) to End of First Period (Week 16) and Extension Period (Week 40) in Enzymes (Lactate Dehydrogenase) | From start of the trial till Week 40 |
| Mean Change From Baseline (Week 0) to End of First Period (Week 16) and Extension Period (Week 40) in Enzymes (Aldolase) | From start of the trial till Week 40 |
| Mean Change From Baseline (Week 0) to End of First Period (Week 16) and Extension Period (Week 40) in Enzymes (Creatine Kinase) | From start of the trial till Week 40 |
| Mean Change From Baseline (Week 0) to End of First Period (Week 16) and Extension Period (Week 40) in: Extra-muscular Activity | 10 cm VAS assessing extra-muscular activity from "No evidence of disease activity" to "Extremely active or severe disease activity". It encompasses an overall evaluation for the disease activity in all the extramuscular organ systems and excludes muscle disease activity. Assessment completed by physician. 0 is lowest score and 10 is highest score. Higher score associated with worse outcome. | From start of the trial until Week 40 |
| Mean TIS From Baseline (Week 0) to End of First Period (Week 16) and From Baseline (Week 0) to End of Extension Period (Week 40) | 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. | Up to 40 weeks |
| Time to Minimal, Moderate and Major Improvement in TIS | When interpreting these time to event evaluations, one has to keep in mind that eventually all patients were treated with octagam 10%, so that differences in time to response for the Overall Period reflect this delayed start of treatment rather than the true difference between treatment with octagam 10% and placebo. | Up to 40 weeks |
| Time to Confirmed Deterioration in the First Period and Overall | Confirmed deterioration is defined as disease worsening on 2 consecutive visits. Worsening criteria are defined as either Physician's Global Disease Activity worsening ≥2cm and Manual Muscle Testing worsening ≥20% or Extra-muscular Activity worsening ≥2cm or any 3 of the following scores worsening by ≥30%: Physician's Global Disease Activity, Manual Muscle Test, Extra-muscular Activity, Patient's Global Disease Activity or Health Assessment Questionnaire. | Up to 40 weeks |
| Los Angeles |
| California |
| 90095 |
| United States |
| University of California -Irvine | Orange | California | 92868 | United States |
| Octapharma Research Site | Orlando | Florida | 32819 | United States |
| NeuroMedical Research Center | Panama City | Florida | 32405 | United States |
| Octapharma Research Site | Plantation | Florida | 33324 | United States |
| University of South Florida | Tampa | Florida | 33612 | United States |
| Octapharma Research Site | Kansas City | Kansas | 66160 | United States |
| Octapharma Research Site | Ann Arbor | Michigan | 48109 | United States |
| Octapharma Research Site | Rochester | Minnesota | 55905 | United States |
| Octapharma Research Site | Great Neck | New York | 11021 | United States |
| Octapharma Research Site | Portland | Oregon | 97239 | United States |
| Octapharma Research Site | Pittsburgh | Pennsylvania | 15213 | United States |
| Stones River Dermatology | Murfreesboro | Tennessee | 37130 | United States |
| Austin Neuromuscular Center | Austin | Texas | 78756 | United States |
| Octapharma Research Site | Houston | Texas | 77034 | United States |
| Arthritis & Osteoporosis Clinic | Waco | Texas | 76710 | United States |
| Octapharma Research Site | Montreal | Quebec | H3T 1E2 | Canada |
| Revmatologický ústav | Prague | 128 50 | Czechia |
| Charité-Universitätsmedizin Berlin, Klinik für Dermatologie, Venerologie und Allergologie | Berlin | 10117 | Germany |
| Uniklinikum Münster, Klinik für Hautkrankheiten | Münster | 48149 | Germany |
| Semmelweis University Dermatology Clinic | Budapest | H-1085 | Hungary |
| University of Debrecen Dept of Internal Medicine | Debrecen | H-4032 | Hungary |
| University of Szeged Dermatology Clinic | Szeged | H-6720 | Hungary |
| Academic Medical Centre University of Amsterdam | Amsterdam | 1105AZ | Netherlands |
| Centrum Medyczne Plejady | Krakow | 30-363 | Poland |
| Narodowy Instytut Geriatrii, Reumatologii I Rehabilitacji - Warsaw | Warsaw | 02-637 | Poland |
| Octapharma Research Site | Cluj-Napoca | 400006 | Romania |
| Scientific Research Institute for Rheumatology (Moscow) | Moscow | 115522 | Russia |
| I.M. Sechenov First Moscow State Medical University | Moscow | 119435 | Russia |
| Orenburg State Medical University Based On Regional Clinical Hospital | Orenburg | 460018 | Russia |
| 3rd Rheumatology Department Of Clinical Rheumatology Hospital No. 25 | Saint Petersburg | 190068 | Russia |
| AVA-Peter clinic (Saint-Petersburg) | Saint Petersburg | 191028 | Russia |
| Octapharma Research Site | Ivano-Frankivsk | 76018 | Ukraine |
| Octapharma Research Site | Lviv | 79000 | Ukraine |
| Octapharma Research Site | Sumy | 40022 | Ukraine |
| Octapharma Research Site | Ternopil | 46002 | Ukraine |
| Derived |
| Charles-Schoeman C, Schessl J, Bata-Csorgo Z, Dimachkie MM, Griger Z, Moiseev S, Oddis CV, Schiopu E, Vencovsky J, Clodi E, Levine T, Aggarwal R. Predictors of response to intravenous immunoglobulin in patients with dermatomyositis: the ProDERM study. Rheumatology (Oxford). 2025 Jun 1;64(6):3767-3776. doi: 10.1093/rheumatology/keaf070. |
| 38233885 | Derived | Aggarwal R, Schessl J, Charles-Schoeman C, Bata-Csorgo Z, Dimachkie MM, Griger Z, Moiseev S, Oddis CV, Schiopu E, Vencovsky J, Beckmann I, Clodi E, Levine T; ProDERM investigators. Safety and tolerability of intravenous immunoglobulin in patients with active dermatomyositis: results from the randomised, placebo-controlled ProDERM study. Arthritis Res Ther. 2024 Jan 17;26(1):27. doi: 10.1186/s13075-023-03232-2. |
| 37799613 | Derived | Werth VP, Aggarwal R, Charles-Schoeman C, Schessl J, Levine T, Kopasz N, Worm M, Bata-Csorgo Z. Efficacy of intravenous immunoglobulins (IVIg) in improving skin symptoms in patients with dermatomyositis: a post-hoc analysis of the ProDERM study. EClinicalMedicine. 2023 Oct 2;64:102234. doi: 10.1016/j.eclinm.2023.102234. eCollection 2023 Oct. |
| 36198179 | Derived | Aggarwal R, Charles-Schoeman C, Schessl J, Bata-Csorgo Z, Dimachkie MM, Griger Z, Moiseev S, Oddis C, Schiopu E, Vencovsky J, Beckmann I, Clodi E, Bugrova O, Danko K, Ernste F, Goyal NA, Heuer M, Hudson M, Hussain YM, Karam C, Magnolo N, Nelson R, Pozur N, Prystupa L, Sardy M, Valenzuela G, van der Kooi AJ, Vu T, Worm M, Levine T; ProDERM Trial Group. Trial of Intravenous Immune Globulin in Dermatomyositis. N Engl J Med. 2022 Oct 6;387(14):1264-1278. doi: 10.1056/NEJMoa2117912. |
| 33429735 | Derived | Aggarwal R, Charles-Schoeman C, Schessl J, Dimachkie MM, Beckmann I, Levine T. Prospective, double-blind, randomized, placebo-controlled phase III study evaluating efficacy and safety of octagam 10% in patients with dermatomyositis ("ProDERM Study"). Medicine (Baltimore). 2021 Jan 8;100(1):e23677. doi: 10.1097/MD.0000000000023677. |
| FG001 | Octagam10% | Subjects randomized to Octagam will receive 4 infusions of 2.0 g/kg Octagam 10% every 4 weeks during the blinded First Period (16 weeks). If confirmed deterioration (deterioration at 2 consecutive visits) during the First Period, subjects will be switched to the alternate treatment. After response assessment at Week 16, all subjects with no confirmed deterioration during the First Period will continue receiving 2.0 g/kg of Octagam 10% every 4 weeks during the subsequent 6-months open-label Extension Period. At Week 28, subjects who are stable on 2.0 g/kg Octagam 10% can be switched to 1.0 g/kg Octagam 10%, at the discretion of the investigator. Subjects randomized to Octagam and switched to the alternate treatment due to confirmed deterioration will drop-out after response assessment at Week 16 and will not enter the Extension Period. |
| COMPLETED |
|
| NOT COMPLETED |
|
| Extension Period |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Subjects randomized to placebo will receive 4 infusions of placebo every 4 weeks during the blinded First Period (16 weeks). If confirmed deterioration (deterioration at 2 consecutive visits) during the First Period, subjects will be switched to Octagam 10%. After response assessment at Week 16, all subjects with no confirmed deterioration and subjects switched to Octagam 10% due to confirmed deterioration but without further confirmed deterioration during the First Period will continue to receive 2.0 g/kg of Octagam 10% every 4 weeks during the subsequent 6-months open-label Extension Period. At Week 28, subjects who are stable on 2.0 g/kg Octagam 10% can be switched to 1.0 g/kg Octagam 10%, at the discretion of the investigator. Subjects randomized to placebo and switched to Octagam 10% due to confirmed deterioration, who deteriorate also during Octagam 10% treatment at 2 consecutive visits will drop-out after response assessment at Week 16 and will not enter the Extension Period. |
| BG001 | Octagam10% | Subjects randomized to Octagam will receive 4 infusions of 2.0 g/kg Octagam 10% every 4 weeks during the blinded First Period (16 weeks). If confirmed deterioration (deterioration at 2 consecutive visits) during the First Period, subjects will be switched to the alternate treatment. After response assessment at Week 16, all subjects with no confirmed deterioration during the First Period will continue receiving 2.0 g/kg of Octagam 10% every 4 weeks during the subsequent 6-months open-label Extension Period. At Week 28, subjects who are stable on 2.0 g/kg Octagam 10% can be switched to 1.0 g/kg Octagam 10%, at the discretion of the investigator. Subjects randomized to Octagam and switched to the alternate treatment due to confirmed deterioration will drop-out after response assessment at Week 16 and will not enter the Extension Period. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Measure the Number of Patients Who Had an Increase of ≥20 Points on the Total Improvement Score (TIS) | 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 | Posted | Count of Participants | Participants | At week 16 |
|
|
| ||||||||||||||||||||||||||||||
| Secondary | Proportion of TIS Responders by Improvement Category at Week 16 | 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. | 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. | Posted | Count of Participants | Participants | 16 weeks |
| |||||||||||||||||||||||||||||||
| Secondary | Proportion of TIS Responders by Improvement Category at Week 40 | 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. | 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. | Posted | Count of Participants | Participants | 40 weeks |
| |||||||||||||||||||||||||||||||
| 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) | 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. | Posted | Mean | Standard Deviation | units on a scale | First 16 weeks |
| |||||||||||||||||||||||||||||||
| 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) | 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. | Posted | Mean | Standard Deviation | units on a scale | From week 16 to Week 40 |
| |||||||||||||||||||||||||||||||
| 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) | 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. | Posted | Mean | Standard Deviation | units on a scale | 40 weeks |
| |||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline (Week 0) to End of First Period (Week 16) and Extension Period (Week 40) in: SF-36v2 Health Survey | 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. | Numbers of patients analyzed different due to patient discontinuations through study. | Posted | Mean | Standard Deviation | units on a scale | From start of the trial till Week 40 |
| ||||||||||||||||||||||||||||||
| 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 | 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. | Different numbers of patients analyzed in each group due to patient discontinuation. | Posted | Mean | Standard Deviation | score on a scale | From start of the trial till Week 40 |
| ||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline (Week 0) to End of First Period (Week 16) and Extension Period (Week 40) in: Patient Global Disease Activity | 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. | Different numbers of patients analyzed in each group due to patient discontinuation. | Posted | Mean | Standard Deviation | score on a scale | From start of the trial till Week 40 |
| ||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline (Week 0) to End of First Period (Week 16) and Extension Period (Week 40) in: MMT-8 | Manual Muscle Testing - MMT-8; a set of 8 designated muscles tested bilaterally [potential score 0 - 150]. Higher score associated with better outcome. | Different numbers of patients analyzed in each group due to patient discontinuation. | Posted | Mean | Standard Deviation | score on a scale | From start of the trial till Week 40 |
| ||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline (Week 0) to End of First Period (Week 16) and Extension Period (Week 40) in: Health Assessment Questionnaire | 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. | Different numbers of patients analyzed in each group due to patient discontinuation. | Posted | Mean | Standard Deviation | score on a scale | From start of the trial till Week 40 |
| ||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline (Week 0) to End of First Period (Week 16) and Extension Period (Week 40) in Enzymes (Alanine Aminotransferase) | Different numbers of patients analyzed in each group due to patient discontinuation. | Posted | Mean | Standard Deviation | U/L | From start of the trial till Week 40 |
| |||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline (Week 0) to End of First Period (Week 16) and Extension Period (Week 40) in Enzymes (Aspartate Aminotransferase) | Different numbers of patients analyzed in each group due to patient discontinuation. | Posted | Mean | Standard Deviation | U/L | From start of the trial till Week 40 |
| |||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline (Week 0) to End of First Period (Week 16) and Extension Period (Week 40) in Enzymes (Lactate Dehydrogenase) | Different numbers of patients analyzed in each group due to patient discontinuation. | Posted | Mean | Standard Deviation | U/L | From start of the trial till Week 40 |
| |||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline (Week 0) to End of First Period (Week 16) and Extension Period (Week 40) in Enzymes (Aldolase) | Different numbers of patients analyzed in each group due to patient discontinuation. | Posted | Mean | Standard Deviation | U/L | From start of the trial till Week 40 |
| |||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline (Week 0) to End of First Period (Week 16) and Extension Period (Week 40) in Enzymes (Creatine Kinase) | Different numbers of patients analyzed in each group due to patient discontinuation. | Posted | Mean | Standard Deviation | U/L | From start of the trial till Week 40 |
| |||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline (Week 0) to End of First Period (Week 16) and Extension Period (Week 40) in: Extra-muscular Activity | 10 cm VAS assessing extra-muscular activity from "No evidence of disease activity" to "Extremely active or severe disease activity". It encompasses an overall evaluation for the disease activity in all the extramuscular organ systems and excludes muscle disease activity. Assessment completed by physician. 0 is lowest score and 10 is highest score. Higher score associated with worse outcome. | Different numbers of patients analyzed in each group due to patient discontinuation. | Posted | Mean | Standard Deviation | units on a scale | From start of the trial until Week 40 |
| ||||||||||||||||||||||||||||||
| Secondary | Mean TIS From Baseline (Week 0) to End of First Period (Week 16) and From Baseline (Week 0) to End of Extension Period (Week 40) | 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. | Different numbers of patients analyzed in each group due to patient discontinuation. | Posted | Mean | Standard Deviation | units on a scale | Up to 40 weeks |
| ||||||||||||||||||||||||||||||
| Secondary | Time to Minimal, Moderate and Major Improvement in TIS | When interpreting these time to event evaluations, one has to keep in mind that eventually all patients were treated with octagam 10%, so that differences in time to response for the Overall Period reflect this delayed start of treatment rather than the true difference between treatment with octagam 10% and placebo. | Number of participants based on number of responders. 95% confidence interval not available for all measurements. | Posted | Median | 95% Confidence Interval | days | Up to 40 weeks |
| ||||||||||||||||||||||||||||||
| Secondary | Time to Confirmed Deterioration in the First Period and Overall | Confirmed deterioration is defined as disease worsening on 2 consecutive visits. Worsening criteria are defined as either Physician's Global Disease Activity worsening ≥2cm and Manual Muscle Testing worsening ≥20% or Extra-muscular Activity worsening ≥2cm or any 3 of the following scores worsening by ≥30%: Physician's Global Disease Activity, Manual Muscle Test, Extra-muscular Activity, Patient's Global Disease Activity or Health Assessment Questionnaire. | All patients analyzed and only those that had confirmed deterioration are presented. | Posted | Median | Full Range | days | Up to 40 weeks |
|
40 weeks
Note that the AE tables summarize data by the actual treatment at the time of the AE. An AE was considered to be associated with the most recent treatment administered, octagam 10% or placebo. Patients who were switched to the alternate treatment during the First Period were therefore considered to be 'at risk' for AEs in both treatment groups.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | First Period Placebo | Subjects randomized to placebo will receive 4 infusions of placebo every 4 weeks during the blinded First Period (16 weeks). If confirmed deterioration (deterioration at 2 consecutive visits) during the First Period, subjects will be switched to Octagam 10%. After response assessment at Week 16, all subjects with no confirmed deterioration and subjects switched to Octagam 10% due to confirmed deterioration but with not further confirmed deterioration during the First Period will continue to receive 2.0 g/kg of Octagam 10% every 4 weeks during the subsequent 6-months open-label Extension Period. At Week 28, subjects who are stable on 2.0 g/kg Octagam 10% can be switched to 1.0 g/kg Octagam 10%, at the discretion of the investigator. Subjects randomized to placebo and switched to Octagam 10% due to confirmed deterioration, who deteriorate also during Octagam 10% treatment at 2 consecutive visits will drop-out after response assessment at Week 16 and will not enter the Extension Period. | 0 | 48 | 2 | 48 | 28 | 48 |
| EG001 | Overall Period Octagam | Subjects randomized to Octagam will receive 4 infusions of 2.0 g/kg Octagam 10% every 4 weeks during the blinded First Period (16 weeks). If confirmed deterioration (deterioration at 2 consecutive visits) during the First Period, subjects will be switched to the alternate treatment. After response assessment at Week 16, all subjects with no confirmed deterioration during the First Period will continue receiving 2.0 g/kg of Octagam 10% every 4 weeks during the subsequent 6-months open-label Extension Period. At Week 28, subjects who are stable on 2.0 g/kg Octagam 10% can be switched to 1.0 g/kg Octagam 10%, at the discretion of the investigator. Subjects randomized to Octagam and switched to the alternate treatment due to confirmed deterioration will drop-out after response assessment at Week 16 and will not enter the Extension Period. | 0 | 95 | 14 | 95 | 84 | 95 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sinus tachycardia | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Ventricular extrasystoles | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Tropical spastic paresis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Condition aggravated | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Atypical pneumonia | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Escherichia bacteraemia | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Atrioventricular block first degree | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Mitral valve calcification | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Ventricular extrasystoles | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pulmonary valve incompetence | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Deafness | Ear and labyrinth disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Conjunctival haemorrhage | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Eye pruritus | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Ocular hyperaemia | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Faecal incontinence | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hypoaesthesia oral | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Catheter site erythema | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Chills | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Condition aggravated | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Extravastation | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Feeling cold | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Infusion site bruising | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hepatic steatosis | Hepatobiliary disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Asymptomatic bacteriuria | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Rash pustular | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Tendon injury | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Blood potassium increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Blood pressure decreased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Blood pressure diastolic increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Blood pressure systolic increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Blood urea increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Body temperature increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Coombs test positive | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Lactic acidosis | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Muscle tightness | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Myopathy | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Thyroid neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Systematic Assessment |
| |
| Basilar artery stenosis | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Urine abnormality | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Diffuse alopecia | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Telangiectasia | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Essential hypertension | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Haemolysis | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Peripheral coldness | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Thrombocytosis | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Eye disorder | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Frequent bowel movements | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Infusion site extravasation | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Infusion site pain | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Infusion site reaction | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Infusion site swelling | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Injection site induration | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Local swelling | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Nodule | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Lyme disease | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Tracheitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Joint injury | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cardiac murmur | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Free haemoglobin present | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Heart rate increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Muscle enzyme increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Muscle fatigue | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Tenosynovitis | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pulmonary congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Tachypnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Poikiloderma | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Rash generalised | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Skin burning sensation | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Urticaria contact | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Menopause | Social circumstances | MedDRA (Unspecified) | Systematic Assessment |
| |
| Postmenopause | Social circumstances | MedDRA (Unspecified) | Systematic Assessment |
| |
| Brachiocephalic arteriosclerosis | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Infusion site erythema | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mikaela Raymond | CRMG | 866-337-1868 | ctgov@clinicalresearchmgt.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 18, 2019 | Oct 21, 2020 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D003882 | Dermatomyositis |
| ID | Term |
|---|---|
| D017285 | Polymyositis |
| D009220 | Myositis |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG001 | Octagam10% | Subjects randomized to Octagam will receive 4 infusions of 2.0 g/kg Octagam 10% every 4 weeks during the blinded First Period (16 weeks). If confirmed deterioration (deterioration at 2 consecutive visits) during the First Period, subjects will be switched to the alternate treatment. After response assessment at Week 16, all subjects with no confirmed deterioration during the First Period will continue receiving 2.0 g/kg of Octagam 10% every 4 weeks during the subsequent 6-months open-label Extension Period. At Week 28, subjects who are stable on 2.0 g/kg Octagam 10% can be switched to 1.0 g/kg Octagam 10%, at the discretion of the investigator. Subjects randomized to Octagam and switched to the alternate treatment due to confirmed deterioration will drop-out after response assessment at Week 16 and will not enter the Extension Period. Octagam 10%: Patients to be treated with Octagam 10% |
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| OG001 | Octagam10% | Subjects randomized to Octagam will receive 4 infusions of 2.0 g/kg Octagam 10% every 4 weeks during the blinded First Period (16 weeks). If confirmed deterioration (deterioration at 2 consecutive visits) during the First Period, subjects will be switched to the alternate treatment. After response assessment at Week 16, all subjects with no confirmed deterioration during the First Period will continue receiving 2.0 g/kg of Octagam 10% every 4 weeks during the subsequent 6-months open-label Extension Period. At Week 28, subjects who are stable on 2.0 g/kg Octagam 10% can be switched to 1.0 g/kg Octagam 10%, at the discretion of the investigator. Subjects randomized to Octagam and switched to the alternate treatment due to confirmed deterioration will drop-out after response assessment at Week 16 and will not enter the Extension Period. |
|
|
| OG001 | Octagam10% | Subjects randomized to Octagam will receive 4 infusions of 2.0 g/kg Octagam 10% every 4 weeks during the blinded First Period (16 weeks). If confirmed deterioration (deterioration at 2 consecutive visits) during the First Period, subjects will be switched to the alternate treatment. After response assessment at Week 16, all subjects with no confirmed deterioration during the First Period will continue receiving 2.0 g/kg of Octagam 10% every 4 weeks during the subsequent 6-months open-label Extension Period. At Week 28, subjects who are stable on 2.0 g/kg Octagam 10% can be switched to 1.0 g/kg Octagam 10%, at the discretion of the investigator. Subjects randomized to Octagam and switched to the alternate treatment due to confirmed deterioration will drop-out after response assessment at Week 16 and will not enter the Extension Period. |
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| OG001 | Octagam10% | Subjects randomized to Octagam will receive 4 infusions of 2.0 g/kg Octagam 10% every 4 weeks during the blinded First Period (16 weeks). If confirmed deterioration (deterioration at 2 consecutive visits) during the First Period, subjects will be switched to the alternate treatment. After response assessment at Week 16, all subjects with no confirmed deterioration during the First Period will continue receiving 2.0 g/kg of Octagam 10% every 4 weeks during the subsequent 6-months open-label Extension Period. At Week 28, subjects who are stable on 2.0 g/kg Octagam 10% can be switched to 1.0 g/kg Octagam 10%, at the discretion of the investigator. Subjects randomized to Octagam and switched to the alternate treatment due to confirmed deterioration will drop-out after response assessment at Week 16 and will not enter the Extension Period. |
|
|
| OG001 | Octagam10% | Subjects randomized to Octagam will receive 4 infusions of 2.0 g/kg Octagam 10% every 4 weeks during the blinded First Period (16 weeks). If confirmed deterioration (deterioration at 2 consecutive visits) during the First Period, subjects will be switched to the alternate treatment. After response assessment at Week 16, all subjects with no confirmed deterioration during the First Period will continue receiving 2.0 g/kg of Octagam 10% every 4 weeks during the subsequent 6-months open-label Extension Period. At Week 28, subjects who are stable on 2.0 g/kg Octagam 10% can be switched to 1.0 g/kg Octagam 10%, at the discretion of the investigator. Subjects randomized to Octagam and switched to the alternate treatment due to confirmed deterioration will drop-out after response assessment at Week 16 and will not enter the Extension Period. |
|
|
| OG001 | Octagam10% | Subjects randomized to Octagam will receive 4 infusions of 2.0 g/kg Octagam 10% every 4 weeks during the blinded First Period (16 weeks). If confirmed deterioration (deterioration at 2 consecutive visits) during the First Period, subjects will be switched to the alternate treatment. After response assessment at Week 16, all subjects with no confirmed deterioration during the First Period will continue receiving 2.0 g/kg of Octagam 10% every 4 weeks during the subsequent 6-months open-label Extension Period. At Week 28, subjects who are stable on 2.0 g/kg Octagam 10% can be switched to 1.0 g/kg Octagam 10%, at the discretion of the investigator. Subjects randomized to Octagam and switched to the alternate treatment due to confirmed deterioration will drop-out after response assessment at Week 16 and will not enter the Extension Period. |
|
|
| OG001 | Octagam10% | Subjects randomized to Octagam will receive 4 infusions of 2.0 g/kg Octagam 10% every 4 weeks during the blinded First Period (16 weeks). If confirmed deterioration (deterioration at 2 consecutive visits) during the First Period, subjects will be switched to the alternate treatment. After response assessment at Week 16, all subjects with no confirmed deterioration during the First Period will continue receiving 2.0 g/kg of Octagam 10% every 4 weeks during the subsequent 6-months open-label Extension Period. At Week 28, subjects who are stable on 2.0 g/kg Octagam 10% can be switched to 1.0 g/kg Octagam 10%, at the discretion of the investigator. Subjects randomized to Octagam and switched to the alternate treatment due to confirmed deterioration will drop-out after response assessment at Week 16 and will not enter the Extension Period. |
|
|
| OG001 | Octagam10% | Subjects randomized to Octagam will receive 4 infusions of 2.0 g/kg Octagam 10% every 4 weeks during the blinded First Period (16 weeks). If confirmed deterioration (deterioration at 2 consecutive visits) during the First Period, subjects will be switched to the alternate treatment. After response assessment at Week 16, all subjects with no confirmed deterioration during the First Period will continue receiving 2.0 g/kg of Octagam 10% every 4 weeks during the subsequent 6-months open-label Extension Period. At Week 28, subjects who are stable on 2.0 g/kg Octagam 10% can be switched to 1.0 g/kg Octagam 10%, at the discretion of the investigator. Subjects randomized to Octagam and switched to the alternate treatment due to confirmed deterioration will drop-out after response assessment at Week 16 and will not enter the Extension Period. |
|
|
Subjects randomized to Octagam will receive 4 infusions of 2.0 g/kg Octagam 10% every 4 weeks during the blinded First Period (16 weeks). If confirmed deterioration (deterioration at 2 consecutive visits) during the First Period, subjects will be switched to the alternate treatment. After response assessment at Week 16, all subjects with no confirmed deterioration during the First Period will continue receiving 2.0 g/kg of Octagam 10% every 4 weeks during the subsequent 6-months open-label Extension Period. At Week 28, subjects who are stable on 2.0 g/kg Octagam 10% can be switched to 1.0 g/kg Octagam 10%, at the discretion of the investigator. Subjects randomized to Octagam and switched to the alternate treatment due to confirmed deterioration will drop-out after response assessment at Week 16 and will not enter the Extension Period.
|
|
|
| OG001 | Octagam10% | Subjects randomized to Octagam will receive 4 infusions of 2.0 g/kg Octagam 10% every 4 weeks during the blinded First Period (16 weeks). If confirmed deterioration (deterioration at 2 consecutive visits) during the First Period, subjects will be switched to the alternate treatment. After response assessment at Week 16, all subjects with no confirmed deterioration during the First Period will continue receiving 2.0 g/kg of Octagam 10% every 4 weeks during the subsequent 6-months open-label Extension Period. At Week 28, subjects who are stable on 2.0 g/kg Octagam 10% can be switched to 1.0 g/kg Octagam 10%, at the discretion of the investigator. Subjects randomized to Octagam and switched to the alternate treatment due to confirmed deterioration will drop-out after response assessment at Week 16 and will not enter the Extension Period. |
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| OG001 | Octagam10% | Subjects randomized to Octagam will receive 4 infusions of 2.0 g/kg Octagam 10% every 4 weeks during the blinded First Period (16 weeks). If confirmed deterioration (deterioration at 2 consecutive visits) during the First Period, subjects will be switched to the alternate treatment. After response assessment at Week 16, all subjects with no confirmed deterioration during the First Period will continue receiving 2.0 g/kg of Octagam 10% every 4 weeks during the subsequent 6-months open-label Extension Period. At Week 28, subjects who are stable on 2.0 g/kg Octagam 10% can be switched to 1.0 g/kg Octagam 10%, at the discretion of the investigator. Subjects randomized to Octagam and switched to the alternate treatment due to confirmed deterioration will drop-out after response assessment at Week 16 and will not enter the Extension Period. |
|
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|
| OG001 |
| Octagam10% |
Subjects randomized to Octagam will receive 4 infusions of 2.0 g/kg Octagam 10% every 4 weeks during the blinded First Period (16 weeks). If confirmed deterioration (deterioration at 2 consecutive visits) during the First Period, subjects will be switched to the alternate treatment. After response assessment at Week 16, all subjects with no confirmed deterioration during the First Period will continue receiving 2.0 g/kg of Octagam 10% every 4 weeks during the subsequent 6-months open-label Extension Period. At Week 28, subjects who are stable on 2.0 g/kg Octagam 10% can be switched to 1.0 g/kg Octagam 10%, at the discretion of the investigator. Subjects randomized to Octagam and switched to the alternate treatment due to confirmed deterioration will drop-out after response assessment at Week 16 and will not enter the Extension Period. |
|
|
| Octagam10% |
Subjects randomized to Octagam will receive 4 infusions of 2.0 g/kg Octagam 10% every 4 weeks during the blinded First Period (16 weeks). If confirmed deterioration (deterioration at 2 consecutive visits) during the First Period, subjects will be switched to the alternate treatment. After response assessment at Week 16, all subjects with no confirmed deterioration during the First Period will continue receiving 2.0 g/kg of Octagam 10% every 4 weeks during the subsequent 6-months open-label Extension Period. At Week 28, subjects who are stable on 2.0 g/kg Octagam 10% can be switched to 1.0 g/kg Octagam 10%, at the discretion of the investigator. Subjects randomized to Octagam and switched to the alternate treatment due to confirmed deterioration will drop-out after response assessment at Week 16 and will not enter the Extension Period. |
|
|
| OG001 | Octagam10% | Subjects randomized to Octagam will receive 4 infusions of 2.0 g/kg Octagam 10% every 4 weeks during the blinded First Period (16 weeks). If confirmed deterioration (deterioration at 2 consecutive visits) during the First Period, subjects will be switched to the alternate treatment. After response assessment at Week 16, all subjects with no confirmed deterioration during the First Period will continue receiving 2.0 g/kg of Octagam 10% every 4 weeks during the subsequent 6-months open-label Extension Period. At Week 28, subjects who are stable on 2.0 g/kg Octagam 10% can be switched to 1.0 g/kg Octagam 10%, at the discretion of the investigator. Subjects randomized to Octagam and switched to the alternate treatment due to confirmed deterioration will drop-out after response assessment at Week 16 and will not enter the Extension Period. |
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