ong-term Safety, Tolerability and Effectiveness Study of Ofatumumab in Patients With Relapsing MS

Phase 3

• Conditions: Health Condition 1: - Health Condition 2: F82- Specific developmental disorder ofmotor function

• Registration Number: CTRI/2019/07/020149
• Lead Sponsor: ovartis Healthcare Private Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Must have participated in a Novartis MS study

a.which dosed ofatumumab 20 mg sc q4 weeks,

b.was an adult (= 18 years of age) study in RMS,

c.must have completed the study on study treatment

2. Written informed consent

Exclusion Criteria

1.Premature discontinuation from previous ofatumumab study or from study treatment in previous ofatumumab study

2.Subjects that have had their previous ofatumumab study end of study(EOS) > 6 months prior to screening and/or been given another MS

disease-modifying treatment (DMT) between EOS of previous study and screening of this study

3 Less than 3.5-month washout of teriflunomide for subjects that will not complete the accelerated elimination procedure (AEP) prior to Day 1.

4 Only applicable to subjects completing studies COMB157G2301 and COMB157G2302

5 Subjects with a history of not being able or willing to cooperate or comply with study protocol requirements in the opinion of the

Investigator

6 Subjects that have any unresolved adverse event (AE) or condition from the previous study that necessitates temporary interruption of the study treatment, until such time as the event or condition has resolved (the subject will be monitored within the safety follow-up of the previous study during this time)

7 Emergence of any clinically significant condition/disease during previous ofatumumab study in which study participation might result in

safety risk for subjects

8 Subjects with neurological findings consistent with Progressive Multifocal Leukoencephalopathy (PML) or confirmed PML

9 Subjects with active systemic bacterial, viral or fungal infections, or chronic infection (e.g. Acquired Immune Deficiency Syndrome (AIDS))

10 Subjects that have developed or have had reactivation of syphilis or tuberculosis during previous ofatumumab study

Study & Design

• Study Type: Interventional
• Study Design: Not specified