ong-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosis

Phase 1

• Conditions: Multiple sclerosis; MedDRA version: 20.0 Level: PT Classification code 10048393 Term: Multiple sclerosis relapse System Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2017-004703-51-ES
• Lead Sponsor: ovartis Farmacéutica, S.A

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-25
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 2233

Inclusion Criteria

Subjects eligible for inclusion in this study must fulfill all of the following criteria:
1. 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).
2. Written informed consent must be obtained before any assessment is performed
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 2233
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 accelerated elimination procedure (AEP) prior to Day 1. Only applicable to subjects completing studies COMB157G2301 and COMB157G2302
4.Subjects with a history of not being able or willing to cooperate or comply with study protocol requirements in the opinion of the Investigator
5.Subjects that have any unresolved adverse event 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)
6.Emergence of any clinically significant condition/disease during previous ofatumumab study in which study participation might result in safety risk for subjects
7. Subjects with neurological findings consistent with PML or confirmed PML
8.Subjects with active systemic bacterial, viral or fungal infections, or chronic infection (e.g. Acquired Immune Deficiency Syndrome (AIDS))
9. Subjects that have developed or have had reactivation of syphilis or tuberculosis during previous ofatumumab study
10. Subjects with severe hypoproteinemia e.g. nephrotic syndrome
11. Any of the following abnormal laboratory values prior to Day 1:
- Total or conjugated bilirubin (BIL) greater than 1.5 times the upper limit of normal (ULN) range
- Alkaline phosphatase (ALP) greater than 2 times the ULN range
- Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) greater than 3 times ULN
- Any other clinically significant laboratory assessment as determined by the Investigator (e.g. significant anemia, neutropenia, thrombocytopenia, signs of impaired bone marrow function)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified