Overview

This trial is active, not recruiting.

Condition relapsing-remitting multiple sclerosis
Treatment natalizumab
Sponsor Biogen
Start date November 2011
End date December 2017
Trial size 191 participants
Trial identifier NCT01943526, TYS-IRL-11-4

Summary

The objectives of this study are to assess the long-term safety and impact on disease activity and progression of natalizumab (Tysabri) in participants with relapsing remitting multiple sclerosis (RRMS) in a clinical practice setting.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only

Primary Outcomes

Measure
Number of participants experiencing Serious Adverse Events (SAEs)
time frame: up to 3 years

Secondary Outcomes

Measure
Disability progression as determined by Expanded Disability Status Scale (EDSS)
time frame: Up to 3 years
MS disease activity as determined by annualized relapse rate (ARR)
time frame: Up to 3 years
MS disease activity as determined by distribution of the total number of relapses during the study
time frame: Up to 3 years
MS disease activity as determined by time to first relapse
time frame: Up to 3 years
MS disease activity as determined by number of participants with relapse
time frame: Up to 3 years
MS disability progression and MS disease activity summarized for subpopulations according to baseline characteristics
time frame: Up to 3 years
MS disease activity as determined by MRI parameters
time frame: Up to 3 years
Evaluation of short-term disease outcomes as assessed by EDSS progression
time frame: Up to 1 year
Evaluation of short-term disease outcomes as assessed by occurrence of relapses
time frame: Up to 1 year

Eligibility Criteria

Male or female participants of any age.

Key Inclusion Criteria: - Must give written informed consent and assent, as applicable. - Decision to treat with natalizumab must precede enrollment. - Patient characteristics and contraindications to treatment with natalizumab in accordance with prescribing information. - Must be receiving natalizumab (Tysabri) for the treatment of RRMS in accordance with the natalizumab indication statement. - Must have a documented diagnosis of Relapsing Remitting Multiple Sclerosis (RRMS). NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Additional Information

Official title Ireland Natalizumab (TYSABRI®) Observational Program (iTOP)
Description iTOP is a retrospective and prospective Irish observational study of participants receiving natalizumab, with each participant to be followed for 3 years. This study is designed to address the long-term safety profile and the long-term impact on disease activity and progression of natalizumab with marketed use. Collection of efficacy and safety data at 6- monthly intervals to coincide with regular clinic visits and routine clinical practice will therefore be undertaken during the iTOP observational period.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Biogen.