M.A.I.N. trial
What it found
The trial was designed to show the treatment was not worse than another, and it did.
“Non-inferiority analysis showed that azathioprine was at least as effective as β interferons (relapse RRAZA/IFN 0.67, one-sided 95% CI 0.96; p<0.01).”Read by software from the paper's abstract
annualized relapse rate ratio (RR) over 2 years · 2 years
| Group | n | Value |
|---|---|---|
| azathioprine | 77 | Annualized relapse rate 0.26 (95% CI 0.19-0.37) |
| β interferons | 73 | Annualized relapse rate 0.39 (95% CI 0.30-0.51) |
relapse rate ratio (AZA/IFN) 0.67
p = <0.01
Total participants: 150
Read by software from the paper's abstract
What was tested
Treatment tested
- Azathioprine
Amidophosphoribosyltransferase inhibitor|DNA inhibitor
Compared with
- Interferon beta-1a
Interferon alpha/beta receptor agonist
- Interferon beta-1b
Interferon alpha/beta receptor agonist
What it measured
Main measures
cumulative relapse count per patient over 2 years.
Relapses
Who could take part
Relapsing MS
Inclusion: age 18-55 years; diagnosis of multiple sclerosis McDonald criteria 2001 with relapsin remitting course; at least 2 exacerbation in the preceding 2 years;Baseline EDSS score of 1 to 5,5; no clinical relapses within 30 days of study entry;effective method of contraception if women with childbearing potential; signed informed patient consent. Exclusion: immunomodulatory or immunosoppressive tratments in the preceding 6 mounths; steroid therapy in the last 30 days before study entry; concomitant diseases precluding interferon beta or azathioprine treatment; pregnancy or breastfeeding; inability to give the informed consent; pathological conditions interfering with multiple sclerosis evolution; allergy to paracetamol or known intolerance to azathioprine or interferon beta.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
to directly compare in patients with relapsing remitting multiple sclerosis azathioprine to Interferon beta efficacy in modifying disease activity.
Papers
Results
Azathioprine versus beta interferons for relapsing-remitting multiple sclerosis: a multicentre randomized non-inferiority trial.PLoS One · 2014
Non-inferiority analysis showed that azathioprine was at least as effective as β interferons (relapse RRAZA/IFN 0.67, one-sided 95% CI 0.96; p<0.01).
Read by software from the paper's abstract
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Related trials
History
Started
Jul 2007
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