PREDICT trial
What it found
The trial ended early for another reason (see below).
What was tested
Treatment tested
- Human immunoglobulin g
Replacement therapy, immunomodulatory effects
- Octagam 5%
Compared with
- Glatiramer acetate
Unknown
- Interferon beta-1a
Interferon alpha/beta receptor agonist
- Interferon beta-1b
Interferon alpha/beta receptor agonist
What it measured
Main measures
Superiority with regard to decreased ARR of Octagam 5% treatment in patients pre-classified as predicted responders (“RO”) compared to predicted nonresponders (“NRO”) to Octagam 5% treatment
RelapsesThe primary endpoint is superiority with regard to decreased Annualised Relapse Rate (ARR) of Octagam 5% treatment in patients pre-classified as predicted responders compared to predicted non-responders. Neurological monitoring at each visit and Expanded Disability Status Scale (EDSS) and Multiple Sclerosis Functional Composite (MSFC) score at visits week 24, 52, 80, 104, 116
Disability progressionRelapses
Other measures (2)
Secondary efficacy endpoints are:
1. ARR of Octagam 5% treatment compared to active control 2. ARR of comparator treatment compared between predicted responders and non-responders to Octagam 5% treatment 3. Compare ARR of predicted responder to Octagam 5% treatment with both IMP treatment arms combined 4. Percentage of actual responders and non-responders in the 21-month period between 3 months after the first study treatment (
Relapses
Who could take part
Relapsing MS · 18 and over
Inclusion: 1) Patients aged ≥18 years Exclusion: 1) Patients who have received treatment with immunoglobulins for any reason in the last 6 months
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
To investigate the ability of the HAP score to accurately predict responders to Octagam 5%
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History
Started
May 2013
Finished
Sept 2016
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