Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis followed by extended treatment with BAF312

Phase 1

• Conditions: Secondary progressive multiple sclerosis; MedDRA version: 21.1Level: PTClassification code 10063400Term: Secondary progressive multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2012-003056-36-NL
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-09-21
• Last Update Posted: 18 July 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1530

Inclusion Criteria

Patients eligible for inclusion in this study have to fulfill all of the following criteria:
1.Written informed consent must be obtained before any assessment is performed.
2.Male or female patients aged 18 to 60 years (inclusive) at screening
3.Prior history of relapsing-remitting MS (RRMS) according to the 2010 Revised McDonald criteria (Polman et al. 2011)
4.Secondary progressive course of MS (SPMS), defined by a progressive increase in disability (of at least 6 months duration) in the absence of relapses or independent of, relapses (Lublin et al. 1996, 2003, Rovaris et al. 2006)
•Attestation by the investigator in a written statement that the disease has entered the progressive stage (according to the study definition) at least 6 months prior to enrollment
5.Disability status at Screening with an EDSS score of 3.0 to 6.5(inclusive)
6.Documented EDSS progression in the 2 years prior to study of =1 point for patients with EDSS <6.0 at screening, and =0.5 point for patients with EDSS =6.0 at screening. Should documented EDSS scores not be available, a written summary of the clinical evidence of disability progression in the previous 2 years, and retrospective assessment of EDSS score from data up to 2 years prior to screening must be submitted for central review.
7.No evidence of relapse or corticosteroid treatment within 3 months prior to randomization
Note 1: A central review of the available clinical evidence of disability progression will be required for patients without documented pre-trial EDSS assessments. This will be completed by submitting a disability progression form for central adjudication. The central adjudication will be led by Professor Polman and team located at the VU Medical Centre in Amsterdam. The adjudication process is outlined in a separate charter.
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 1530
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Women of child bearing potential must use reliable forms of contraception.

Diagnosis of Macular edema during screening period

Any medically unstable condition determined by investigator

Unable to undergo MRI scans

Hypersensitivity to any study drugs or drugs of similar class

Other protocol-defined inclusion criteria may apply

Study & Design

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