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Your search keyword '"Zecevic, Dusanka"' showing total 12 results
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12 results on '"Zecevic, Dusanka"'

1. OCARINA I, Phase Ib Study: Dose Selection of Subcutaneous Ocrelizumab in Patients with Multiple Sclerosis (P10-6.003)

Author

Newsome, Scott, primary, Goldstick, Lawrence, additional, Townsend, Ben, additional, Zecevic, Dusanka, additional, Augustin, Aisha, additional, Figueiredo, Catarina, additional, Clinch, Susanne, additional, Giacobino, Caroline, additional, Bortolami, Oscar, additional, Shen, Yun-An, additional, Kletzl, Heidemarie, additional, and Bermel, Robert, additional

Published
2024
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2. OCARINA II, Phase III Study: Results of Subcutaneous Ocrelizumab Administration in Patients with Multiple Sclerosis (S31.006)

Author

Newsome, Scott, primary, Krzystanek, Ewa, additional, Selmaj, Krzysztof, additional, Goldstick, Lawrence, additional, Figueiredo, Catarina, additional, Townsend, Ben, additional, Wolf, Christian, additional, Zecevic, Dusanka, additional, Giacobino, Caroline, additional, Bortolami, Oscar, additional, Shen, Yun-An, additional, Kletzl, Heidemarie, additional, Clinch, Susanne, additional, and Centonze, Diego, additional

Published
2024
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3. Pregnancy and Infant Outcomes in Females Receiving Ocrelizumab for the Treatment of Multiple Sclerosis: Analysis of over 3,000 Pregnancies to Date (S7.004)

Author

Bove, Riley, primary, Pietrasanta, Carlo, additional, Oreja-Guevara, Celia, additional, Hellwig, Kerstin, additional, Dobson, Ruth, additional, Vukusic, Sandra, additional, Lin, Chien-Ju, additional, Alvarez, Daniela Goncalves Pereira, additional, Zecevic, Dusanka, additional, Ferreira, Germano, additional, Craveiro, Licinio, additional, Pasquarelli, Noemi, additional, and McElrath, Thomas, additional

Published
2024
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5. Ocrelizumab during pregnancy and lactation: Rationale and design of the MINORE and SOPRANINO studies in women with MS and their infants

Author

Bove, Riley, primary, Hellwig, Kerstin, additional, Pasquarelli, Noemi, additional, Borriello, Francesco, additional, Dobson, Ruth, additional, Oreja-Guevara, Celia, additional, Lin, Chien-Ju, additional, Zecevic, Dusanka, additional, Craveiro, Licinio, additional, McElrath, Thomas, additional, and Vukusic, Sandra, additional

Published
2022
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12. Subcutaneous ocrelizumab in multiple sclerosis: Results of the Phase 1b OCARINA I study.

Author

Newsome, Scott D., Goldstick, Lawrence, Robertson, Derrick S., Bowen, James D., Naismith, Robert T., Townsend, Ben, Figueiredo, Catarina, Kletzl, Heidemarie, Giraudon, Mylene, Bortolami, Oscar, Zecevic, Dusanka, Giacobino, Caroline, Clinch, Susanne, Shen, Yun‐An, Deol-Bhullar, Gurpreet, and Bermel, Robert A.

Subjects
*MULTIPLE sclerosis, *IMMUNE response, *WOMEN patients, *PHARMACOKINETICS, *DISABILITIES
Abstract

Objective Methods Results Interpretation Subcutaneous ocrelizumab is being developed to provide treatment flexibility and additional choice to patients with multiple sclerosis. OCARINA I (NCT03972306) is an open‐label, multicenter, Phase 1b, dose‐finding study to investigate the pharmacokinetics, safety, tolerability, and immunogenicity of subcutaneous ocrelizumab and to select a dose for the Phase 3 OCARINA II study (NCT05232825).Patients with relapsing or primary progressive multiple sclerosis (aged 18–65 years; Expanded Disability Status Scale score 0.0–6.5) were enrolled into two groups: previously treated with intravenous ocrelizumab (Group A) or naïve to ocrelizumab (Group B). Patients received single ascending doses of subcutaneous ocrelizumab up to 1200 mg. Following dose escalation, new patients in Group A were randomized (1:1) to receive a single 600 mg intravenous ocrelizumab dose or the candidate subcutaneous dose, which was predicted to result in similar exposure as the 600 mg intravenous dose while being safe and well tolerated. The area under the concentration–time curve for both formulations was used to select the subcutaneous ocrelizumab dose. Patients in all cohorts could enter a dose‐continuation phase.Eighty‐eight and 47 patients were enrolled into Group A and B, respectively; most patients were female (72.7%/63.0%), and mean age at baseline was 45.7 and 39.7 years, respectively. Subcutaneous ocrelizumab was well tolerated across all doses tested. The 920 mg subcutaneous ocrelizumab dose was selected for the OCARINA II study based on pharmacokinetic and safety data.Subcutaneous ocrelizumab may provide patients with multiple sclerosis with an additional treatment option. [ABSTRACT FROM AUTHOR]

Published
2024
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