Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2013-001799-39 | EudraCT Number |
Not provided
Not provided
Not provided
The study was terminated prematurely after an interim analysis for futility. The study did not provide any evidence for efficacy of BAF312 in dermatomyositis.
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This study investigated the dose response relationship for the efficacy and safety of BAF312 compared to placebo in active DM patients over a treatment period of 6+6 months and to determine the minimum dose required for a maximal clinical effect. The study was composed of 2 periods: a double-blind period 1 with BAF312 administered at different daily doses (0.5, 2, 10 mg and placebo) and a fixed-dose Period 2 in which BAF312 was administered at the dose of 2 mg daily .
The study was prematurely terminated based on the results of an interim analysis where BAF312 did not demonstrate superior efficacy over placebo and a dose-response relationship was not observed. There were no safety concerns. Approximately 56 participants were planned to be randomized. A total of 17 participants were enrolled and randomized by the time the study was terminated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BAF312 0.5mg | Experimental | During period 1, participants were uptitrated daily from BAF312 0.25 mg to 0.5 mg over a 10 day period. After, participants continued on 0.5 mg daily for up to 24 weeks. During period 2, participants were uptitrated daily from BAF312 0.25 mg to 2.0 mg over a 10 day period. After, participants continued on 2.0 mg daily for up to 24 weeks. |
|
| BAF312 2mg | Experimental | During period 1, participants were uptitrated daily from BAF312 0.25 mg to 2.0 mg over a 10 day period. After, participants continued on 2.0 mg daily for up to 24 weeks. During period 2, participants were uptitrated daily from BAF312 0.25 mg to 2.0 mg over a 10 day period. After, participants continued on 2.0 mg daily for up to 24 weeks. |
|
| BAF312 10 mg | Experimental | During period 1, participants were uptitrated daily from BAF312 0.25 mg to 10.0 mg over a 10 day period. After, participants continued on 10.0 mg daily for up to 24 weeks. During period 2, participants were uptitrated daily from BAF312 0.25 mg to 2.0 mg over a 10 day period. After, participants continued on 2.0 mg daily for up to 24 weeks. |
|
| Placebo | Placebo Comparator | During period 1, participants received matching placebo daily for up to 24 weeks. During period 2, participants were uptitrated daily from BAF312 0.25 mg to 2.0 mg over a 10 day period. After, participants continued on 2.0 mg daily for up to 24 weeks. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BAF312 | Drug | BAF312 was provided as film-coated tablets in strengths of 0.25, 0,5, 1 and 2 mg for oral administration. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Manual Muscle Testing - 24 Muscles (MMT-24) Score | Each muscles tested was evaluated on a 0 - 10 scale where 0 indicated the weakest muscle score and 10 indicated the strongest muscle score. The total MMT24 score ranged from 0 - 240, where an increasing trend in the values indicates improvement. A positive change from baseline indicates improvement. | Baseline, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| BAF312 Plasma Concentration | 6 months | |
| Peripheral Blood Lymphocyte Counts | Absolute lymphocyte counts | baseline, 6 months |
Not provided
Key Inclusion Criteria:
Written informed consent must be obtained before any assessment is performed.
Key Exclusion Criteria
Not provided
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Phoenix | Arizona | 85028 | United States | ||
| Novartis Investigative Site |
Not provided
| Label | URL |
|---|---|
| A Plain Language Trial Summary is available on novartisclinicaltrials.com | View source |
Not provided
Participants were randomized to each treatment group in a1:1:1:1 ratio.
The study was composed of 2 periods: a double-blind period 1 with BAF312 administered at different daily doses (0.5, 2, 10 mg and placebo) and a fixed-dose Period 2 in which BAF312 was administered to all randomized at the dose of 2 mg daily .
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | BAF312 0.5mg | During period 1, participants were uptitrated daily from BAF312 0.25 mg to 0.5 mg over a 10 day period. After, participants continued on 0.5 mg daily for up to 24 weeks. During period 2, participants were uptitrated daily from BAF312 0.25 mg to 2.0 mg over a 10 day period. After, participants continued on 2.0 mg daily for up to 24 weeks. |
| FG001 | BAF312 2mg | During period 1, participants were uptitrated daily from BAF312 0.25 mg to 2.0 mg over a 10 day period. After, participants continued on 2.0 mg daily for up to 24 weeks. During period 2, participants were uptitrated daily from BAF312 0.25 mg to 2.0 mg over a 10 day period. After, participants continued on 2.0 mg daily for up to 24 weeks. |
| FG002 | BAF312 10 mg | During period 1, participants were uptitrated daily from BAF312 0.25 mg to 10.0 mg over a 10 day period. After, participants continued on 10.0 mg daily for up to 24 weeks. During period 2, participants were uptitrated daily from BAF312 0.25 mg to 2.0 mg over a 10 day period. After, participants continued on 2.0 mg daily for up to 24 weeks. |
| FG003 | Placebo | During period 1, participants received matching placebo daily for up to 24 weeks. During period 2, participants were uptitrated daily from BAF312 0.25 mg to 2.0 mg over a 10 day period. After, participants continued on 2.0 mg daily for up to 24 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | BAF312 0.5mg | During period 1, participants were uptitrated daily from BAF312 0.25 mg to 0.5 mg over a 10 day period. After, participants continued on 0.5 mg daily for up to 24 weeks. During period 2, participants were uptitrated daily from BAF312 0.25 mg to 2.0 mg over a 10 day period. After, participants continued on 2.0 mg daily for up to 24 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Change From Baseline in Manual Muscle Testing - 24 Muscles (MMT-24) Score | Each muscles tested was evaluated on a 0 - 10 scale where 0 indicated the weakest muscle score and 10 indicated the strongest muscle score. The total MMT24 score ranged from 0 - 240, where an increasing trend in the values indicates improvement. A positive change from baseline indicates improvement. | The pharmacodynamic (PD) analysis set, which included all randomized participants, was considered for the analysis. Participants with valid baseline MMT24 score and at least one valid post baseline MMT24 score were included in the analysis. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, 6 months |
|
Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 2.5 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Period 1 Placebo | During period 1, participants received matching placebo daily for up to 24 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA (18.1) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 |
| ID | Term |
|---|---|
| D003882 | Dermatomyositis |
| ID | Term |
|---|---|
| D017285 | Polymyositis |
| D009220 | Myositis |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C578989 | siponimod |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Placebo | Drug | Matching placebo to BAF312 as tablets for oral administration. |
|
| Change From Baseline in Manual Muscle Testing - 24 Muscles (MMT-24) Score |
Each muscles tested was evaluated on a 0-10 scale where 0 indicated the weakest muscle score and 10 indicated the strongest muscle score. the total MMT24 score ranged from 0-240, where an increasing trend in the values indicates improvement. A positive change from baseline indicates improvement. |
| baseline, 3 months |
| Change From Baseline in 6 Minutes Walking Distance (6-MWD) Test | baseline, 6 months |
| Los Angeles |
| California |
| 90095 |
| United States |
| Novartis Investigative Site | Orange | California | 92868 | United States |
| Novartis Investigative Site | Miami | Florida | 33136 | United States |
| Novartis Investigative Site | Kansas City | Kansas | 66160 | United States |
| Novartis Investigative Site | Boston | Massachusetts | 02115 | United States |
| Novartis Investigative Site | Prague | Czech Republic | 128 50 | Czechia |
| Novartis Investigative Site | Chiba | Chiba | 260-8712 | Japan |
| Novartis Investigative Site | Sendai | Miyagi | 980-8574 | Japan |
| BG001 |
| BAF312 2mg |
During period 1, participants were uptitrated daily from BAF312 0.25 mg to 2.0 mg over a 10 day period. After, participants continued on 2.0 mg daily for up to 24 weeks. During period 2, participants were uptitrated daily from BAF312 0.25 mg to 2.0 mg over a 10 day period. After, participants continued on 2.0 mg daily for up to 24 weeks. |
| BG002 | BAF312 10 mg | During period 1, participants were uptitrated daily from BAF312 0.25 mg to 10.0 mg over a 10 day period. After, participants continued on 10.0 mg daily for up to 24 weeks. During period 2, participants were uptitrated daily from BAF312 0.25 mg to 2.0 mg over a 10 day period. After, participants continued on 2.0 mg daily for up to 24 weeks. |
| BG003 | Placebo | During period 1, participants received matching placebo daily for up to 24 weeks. During period 2, participants were uptitrated daily from BAF312 0.25 mg to 2.0 mg over a 10 day period. After, participants continued on 2.0 mg daily for up to 24 weeks. |
| BG004 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | BAF312 2mg | During period 1, participants were uptitrated daily from BAF312 0.25 mg to 2.0 mg over a 10 day period. After, participants continued on 2.0 mg daily for up to 24 weeks. During period 2, participants were uptitrated daily from BAF312 0.25 mg to 2.0 mg over a 10 day period. After, participants continued on 2.0 mg daily for up to 24 weeks. |
| OG002 | BAF312 10 mg | During period 1, participants were uptitrated daily from BAF312 0.25 mg to 10.0 mg over a 10 day period. After, participants continued on 10.0 mg daily for up to 24 weeks. During period 2, participants were uptitrated daily from BAF312 0.25 mg to 2.0 mg over a 10 day period. After, participants continued on 2.0 mg daily for up to 24 weeks. |
| OG003 | Placebo | During period 1, participants received matching placebo daily for up to 24 weeks. During period 2, participants were uptitrated daily from BAF312 0.25 mg to 2.0 mg over a 10 day period. After, participants continued on 2.0 mg daily for up to 24 weeks. |
|
|
|
| Secondary | BAF312 Plasma Concentration | Pharmacokinetics (PK) analysis set: The PK analysis set included all patients with available PK data and no protocol deviations with relevant impact on PK data. | Posted | Median | Full Range | ng/ml | 6 months |
|
|
|
| Secondary | Peripheral Blood Lymphocyte Counts | Absolute lymphocyte counts | Safety analysis set: the safety analysis set included all patients that received any study drug. | Posted | Mean | Standard Deviation | 10^9 cells/Liter | baseline, 6 months |
|
|
|
| Secondary | Change From Baseline in Manual Muscle Testing - 24 Muscles (MMT-24) Score | Each muscles tested was evaluated on a 0-10 scale where 0 indicated the weakest muscle score and 10 indicated the strongest muscle score. the total MMT24 score ranged from 0-240, where an increasing trend in the values indicates improvement. A positive change from baseline indicates improvement. | PD analysis set | Posted | Least Squares Mean | Standard Error | score on a scale | baseline, 3 months |
|
|
|
| Secondary | Change From Baseline in 6 Minutes Walking Distance (6-MWD) Test | PD analysis set | Posted | Mean | Standard Deviation | meters | baseline, 6 months |
|
|
|
| 1 |
| 5 |
| 1 |
| 5 |
| EG001 | Period 1 BAF312 0.5 mg/Day | During period 1, participants were uptitrated daily from BAF312 0.25 mg to 0.5 mg over a 10 day period. After, participants continued on 0.5 mg daily for up to 24 weeks. | 0 | 4 | 1 | 4 |
| EG002 | Period 1 BAF312 2 mg/Day | During period 1, participants were uptitrated daily from BAF312 0.25 mg to 2.0 mg over a 10 day period. After, participants continued on 2.0 mg daily for up to 24 weeks. | 0 | 4 | 4 | 4 |
| EG003 | Period 1 BAF312 10 mg/Day | During period 1, participants were uptitrated daily from BAF312 0.25 mg to 10.0 mg over a 10 day period. After, participants continued on 10.0 mg daily for up to 24 weeks. | 1 | 4 | 4 | 4 |
| EG004 | Period 2 Placebo /BAF312 2 mg/Day | During period 2, participants were uptitrated daily from BAF312 0.25 mg to 2.0 mg over a 10 day period. After, participants continued on 2.0 mg daily for up to 24 weeks. | 0 | 5 | 2 | 5 |
| EG005 | Period 2 BAF312 0.5 mg/Day/BAF312 2 mg/Day | During period 2, participants were uptitrated daily from BAF312 0.25 mg to 2.0 mg over a 10 day period. After, participants continued on 2.0 mg daily for up to 24 weeks. | 0 | 4 | 1 | 4 |
| EG006 | Period 2 BAF312 2 mg/Day/BAF312 2 mg/Day | During period 2, participants were uptitrated daily from BAF312 0.25 mg to 2.0 mg over a 10 day period. After, participants continued on 2.0 mg daily for up to 24 weeks. | 1 | 4 | 4 | 4 |
| EG007 | Period 2 BAF312 10 mg/Day/BAF312 2 mg/Day | During period 2, participants were uptitrated daily from BAF312 0.25 mg to 2.0 mg over a 10 day period. After, participants continued on 2.0 mg daily for up to 24 weeks. | 1 | 4 | 2 | 4 |
| Laceration | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
|
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Dermatomyositis | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA (18.1) | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA (18.1) | Systematic Assessment |
|
| Blepharospasm | Eye disorders | MedDRA (18.1) | Systematic Assessment |
|
| Chorioretinal atrophy | Eye disorders | MedDRA (18.1) | Systematic Assessment |
|
| Conjunctival haemorrhage | Eye disorders | MedDRA (18.1) | Systematic Assessment |
|
| Eye swelling | Eye disorders | MedDRA (18.1) | Systematic Assessment |
|
| Eyelid oedema | Eye disorders | MedDRA (18.1) | Systematic Assessment |
|
| Retinal vein occlusion | Eye disorders | MedDRA (18.1) | Systematic Assessment |
|
| Vitreous detachment | Eye disorders | MedDRA (18.1) | Systematic Assessment |
|
| Vitreous floaters | Eye disorders | MedDRA (18.1) | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Gingival recession | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA (18.1) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (18.1) | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA (18.1) | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA (18.1) | Systematic Assessment |
|
| Pain | General disorders | MedDRA (18.1) | Systematic Assessment |
|
| Peripheral swelling | General disorders | MedDRA (18.1) | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
|
| Cellulitis orbital | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
|
| Dacryocystitis | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
|
| Herpes simplex | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
|
| Skin infection | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
|
| Post procedural inflammation | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
|
| Carbon monoxide diffusing capacity decreased | Investigations | MedDRA (18.1) | Systematic Assessment |
|
| Lymphocyte count decreased | Investigations | MedDRA (18.1) | Systematic Assessment |
|
| Pulmonary function test abnormal | Investigations | MedDRA (18.1) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
|
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
|
| Fibroadenoma of breast | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | Systematic Assessment |
|
| Dizziness postural | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
|
| Exertional headache | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
|
| Transient global amnesia | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA (18.1) | Systematic Assessment |
|
| Allergic sinusitis | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Pulmonary congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
|
| Generalised erythema | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
|
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
|
| Skin fissures | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
|
| Internal limiting membrane peeling | Surgical and medical procedures | MedDRA (18.1) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (18.1) | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
| D009468 |
| Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
|
| 6 months |
|
|