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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01067521 | A Study in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS) to Assess the Efficacy, Safety and Tolerability of Glatiramer Acetate (GA) Injection 40 mg Administered Three Times a Week Compared to Placebo | PHASE3 | COMPLETED | 1,404 | — | — | Jun 22, 2010 | May 12, 2017 | Dec 9, 2021 | 176 | United States, Bulgaria +15 |
| NCT00947752 | Safety of New Formulation of Glatiramer Acetate | PHASE3 | COMPLETED | 147 | — | — | Jul 1, 2009 | Nov 1, 2009 | Mar 14, 2017 | - | — |
| NCT00337779 | Clinical Trial Comparing Treatment of Relapsing-Remitting Multiple Sclerosis (RR-MS) With Two Doses of Glatiramer Acetate (GA). | PHASE3 | COMPLETED | 1,155 | — | — | Aug 1, 2006 | Oct 1, 2008 | Oct 10, 2011 | - | — |
| NCT00203073 | A Study to Evaluate the Safety and Effectiveness of Novantrone Therapy Followed by Copaxone for Multiple Sclerosis. | PHASE2 | COMPLETED | 40 | — | — | Jun 1, 2003 | Apr 1, 2005 | Apr 14, 2011 | - | — |
Relapses were monitored throughout the study. During the PC Period, two neurologists/physicians assessed subjects' general medical and neurological evaluations separately. A relapse was defined as the appearance of 1+ new neurological abnormalities or the reappearance of 1+ previously observed neurological abnormalities lasting \>= 48 hours and immediately preceded by an improving neurological state of at \>=30 days from onset of previous relapse. An event was counted as a relapse only when the subject's symptoms were accompanied by observed objective neurological changes, consistent with \>= one of the following: - An increase of \>= 0.5 in the Expanded Disability Status Scale (EDSS) score as compared to previous evaluation. - An increase of one grade in the actual score of \>=2 of the 7 functional systems (FS), as compared to previous evaluation. - An increase of 2 grades in the actual score of one FS as compared to the previous evaluation. Adjusted mean values are displayed.
The annualized relapse rate (ARR) was calculated for the study by dividing the cumulative number of confirmed relapses by the number of person-years of exposure to treatment. The analysis of the annualized relapse rate is based on estimating a contrast (early start vs delayed start) derived from a baseline-adjusted, Negative Binomial Regression model to the number of confirmed relapses observed during study (post randomization) with an "offset" based on the log of exposure to treatment.
A visual analog scale (VAS) was used for subjective characteristics that cannot be directly measured. Respondents specified their level of agreement to a statement by indicating a position along a continuous line between two end-points. The VAS scale used 0 mm to represent "no pain" and up to 100 mm to represent "worst possible pain;" subjects drew a continuous line to represent their level of pain.
A confirmed relapse is defined as the appearance of one or more new neurological abnormalities or the reappearance of one or more previously observed neurological abnormalities. This change in clinical state must last at least 48 hours and be immediately preceded by an improving neurological state of at least thirty (30) days from onset of previous relapse.
| Arm | Type | Description |
|---|---|---|
| GA 40 mg / GA 40 mg | EXPERIMENTAL | Also referred to as the 'Early Start' treatment arm, participants were administered glatiramer acetate (GA) 40 mg/mL by subcutaneous injection three times a week for 12 months during the Double-Blind Period, and then continued that treatment as open-label therapy until the drug was commercially available or development stopped. |
| Placebo / GA 40 mg | PLACEBO_COMPARATOR | Also referred to as the 'Delayed Start' treatment arm, participants were administered placebo subcutaneous injections three times a week for 12 months during the Double-Blind Period, and then switched to GA 40 mg/mL subcutaneous injections three times a week as open-label therapy until the drug was commercially available or development stopped. |
| F1 Glatiramer acetate 20mg/1.0ml | ACTIVE_COMPARATOR | - |
| F2 Glatiramer acetate 20mg/0.5ml | EXPERIMENTAL | - |
| glatiramer acetate 40 mg | ACTIVE_COMPARATOR | - |
| glatiramer acetate 20 mg | ACTIVE_COMPARATOR | - |
| Copaxone 20 mg | ACTIVE_COMPARATOR | Copaxone 20 mg |
| Copaxone 20mg with Novantrone induction | ACTIVE_COMPARATOR | Copaxone 20mg with Novantrone induction |
| Name | Type | Description |
|---|---|---|
| Glatiramer acetate (GA) | DRUG | GA 40 mg/mL administered 3 times a week by subcutaneous injection for a period of 12 months for participants assigned to GA treatment in the Double-Blind Period, and GA 40 mg/mL administered 3 times a week by subcutaneous injection for all participants in the Open-Label Extension Period. |
| Placebo | DRUG | Placebo comparator administered by subcutaneous injection three times each week for 12 months during the Double-Blind Period. |
| Glatiramer Acetate | DRUG | Subjects received both doses once daily in a crossover fashion, for a total treatment duration of five weeks, including a one-week run-in period. Subject-reported injection pain was recorded in a daily diary. |
| Experimental Glatiramer Acetate | DRUG | GA 20 mg/0.5 mL |
| Glatiramer Acetate (GA) 40 mg | DRUG | Glatiramer Acetate Injection 40 mg/ml Daily subcutaneous injection for 12 months |
| glatiramer acetate 20 mg | DRUG | Glatiramer Acetate Injection 20 mg/ml Daily subcutaneous injection for 12 months |
| glatiramer acetate 20 mg, with mitoxantrone | DRUG | glatiramer acetate 20 mg, with mitoxantrone |
Inclusion Criteria: 1. Subjects must have a confirmed and documented MS diagnosis as defined by the Revised McDonald criteria with a relapsing-remitting disease course. 2. Subjects must be ambulatory with an EDSS score of 0-5.5 in both screening and baseline visits. 3. Subjects must be in a relapse...