AN OPEN-LABEL EXTENSION STUDY EVALUATING LONG-TERM SAFETY, TOLERABILITY AND EFFECTIVENESS OF OFATUMUMAB IN SUBJECTS WITH RMS

Not Applicable

• Conditions: -G35 Multiple sclerosis; Multiple sclerosis; G35

• Registration Number: PER-003-19
• Lead Sponsor: OVARTIS BIOSCIENSES PERU S.A.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-28
• Last Update Posted: 20 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Must have participated in a Novartis MS study:
•which dosed ofatumumab 20 mg sc every 4 weeks,
•was an adult (≥ 18 years of age) study in RMS,
•must have completed the study on study treatment (subjects that are on temporary drug interruption at the time of End of Study are considered completers).

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 EOS > 6 months prior to screening and/or been given another MS 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 AEP prior to Day 1 (refer to Section 6.6.1.1). Only applicable to subjects completing studies COMB157G2301 and COMB157G2302

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:Poisson model<br>Measure:Assess the long-term safety and tolerability of ofatumumab 20 mg sc<br>Timepoints:once q4 weeks<br>

Secondary Outcome Measures

Name	Time	Method
<br>Outcome name:Negative Binomial Model<br>Measure:number of T1 gadolinium (Gd)-enhancing lesions, number of new or enlarging T2 lesions<br>Timepoints:Anually<br>;<br>Outcome name:Cox proportional hazards models<br>Measure:Disability endpoints<br>Timepoints:3 months and 6 months.<br>