Long-term Safety, Tolerability and Effectiveness Study of Ofatumumab in Patients With Relapsing MS
Status: | Recruiting |
---|---|
Conditions: | Neurology, Neurology |
Therapuetic Areas: | Neurology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/4/2019 |
Start Date: | December 28, 2018 |
End Date: | June 4, 2025 |
Contact: | Novartis Pharmaceuticals |
Email: | Novartis.email@novartis.com |
Phone: | 1-888-669-6682 |
An Open-label, Single Arm, Multi-center Extension Study Evaluating Long-term Safety, Tolerability and Effectiveness of Ofatumumab in Subjects With Relapsing Multiple Sclerosis
The purpose of this study is to collect long-term safety, tolerability, effectiveness and
health outcomes data in eligible subjects who have participated in a Novartis ofatumumab
clinical MS study.
health outcomes data in eligible subjects who have participated in a Novartis ofatumumab
clinical MS study.
Inclusion Criteria:
1. Must have completed a selected Novartis MS study which dosed ofatumumab 20 mg sc every
4 weeks
2. Written informed consent
Exclusion Criteria:
- Emergence of any clinically significant condition/disease during the previous
ofatumumab study in which study participation might result in safety risk for the
subject
- Subjects with active systemic bacterial, viral or fingal infections, or chronic
infection (e.g. AIDS)
- Subjects taking medications prohibited by the protocol
- Pregnant or nursing (lactating) women Other protocol-defined inclusion/exclusion
criteria may apply
We found this trial at
30
sites
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Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
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