Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01874145 | Safety and Tolerability of Glatiramer Acetate | PHASE3 | COMPLETED | 209 | — | — | Jun 1, 2013 | May 1, 2014 | Jan 14, 2016 | 35 | United States |
Injection-related (IR) adverse events refers to all local injection site reactions and/or symptoms or events related to immediate post injection reaction (flushing, chest pain, palpitations, anxiety, dyspnea, throat constriction, and/or urticaria). Rate was calculated as # IR events/the total exposure to study drug in years. For cases in which more than 1 IR adverse event started on the same date for the same patient, these were counted as 1 IR adverse event for that patient. Parameter statistics were generated from a Poisson regression model with natural log of treatment duration (years) as an offset variable, and adjusted for baseline EDSS score, treatment group, age, sex, number of relapses in the 2 years prior to screening, in which a contrast comparing treatment groups were constructed. Adjusted mean estimates were adjusted estimates of event rates within treatment group.
Injection-related (IR) adverse events refers to all local injection site reactions and/or symptoms or events related to immediate post injection reaction (flushing, chest pain, palpitations, anxiety, dyspnea, throat constriction, and/or urticaria). Rate was calculated as # IR events/the total exposure to study drug in years. For cases in which more than 1 IR adverse event started on the same date for the same patient, these were counted as 1 IR adverse event for that patient.
Injection-related (IR) adverse events refers to all local injection site reactions and/or symptoms or events related to immediate post injection reaction (flushing, chest pain, palpitations, anxiety, dyspnea, throat constriction, and/or urticaria).
| Arm | Type | Description |
|---|---|---|
| GA 20 mg/mL every day | ACTIVE_COMPARATOR | Glatiramer acetate (GA) 20 mg in 1 mL SC injection administered every day (QD) for the 4 months of the core study. |
| GA 40 mg/mL 3 times a week | EXPERIMENTAL | Glatiramer acetate (GA) 40 mg in 1 mL SC injection administered three times a week (TIW) for the 4 months of the core study. During the Extension period, all participants to continue treatment with GA 40 mg/mL TIW until this dose regimen is commercially available for the treatment of RRMS patients. |
| Name | Type | Description |
|---|---|---|
| GA 20 mg/mL | DRUG | Glatiramer acetate (GA) 20 mg/mL subcutaneous (SC) injection, the commercial product, is a single-use pre-filled syringe (PFS) containing 1.0 ml of a clear, colorless to slightly yellow, sterile, non-pyrogenic solution. |
| GA 40 mg/mL | DRUG | Glatiramer acetate (GA) 40 mg/mL subcutaneous (SC) injection, is a single-use pre-filled syringe (PFS) containing 1.0 ml of a clear, colorless to slightly yellow, sterile, non-pyrogenic solution. |
Inclusion Criteria: 1. Men or women at least 18 years of age or older 2. Subjects must have a confirmed and documented RRMS diagnosis as defined by the Revised McDonald criteria, with relapse onset disease or a relapsing-remitting disease course 3. Subjects must be ambulatory with a Kurtzke Expande...