Safety & Reduction in Disease Activity with Rituximab and Tocilizumab
Research type
Research Study
Full title
A randomised, placebo controlled, double-blind, parallel group study to compare the safety and reduction in disease activity with the combination of rituximab (MabThera®) and tocilizumab (RoActemra®) versus tocilizumab therapy in patients with active rheumatoid arthritis with an incomplete response to methotrexate.
IRAS ID
10912
Contact name
C J Edwards
Contact email
Sponsor organisation
F Hoffmann-La Roche Ltd AG
Eudract number
2008-005525-11
ISRCTN Number
n/a
Clinicaltrials.gov Identifier
n/a
Research summary
This is a study of medications to treat people with rheumatoid arthritis (RA). Two drugs - rituximab and tocilizumab have individually been shown to be effective in treating the symptoms of RA. This is the first study to compare giving the two drugs in combination against treatment with tocilizumab alone.
Participants on the study will have RA. They must also have previously been given a common treatment for RA called methotrexate and this will not have worked sufficiently to relieve their symptoms.
The study has two parts - the first phase will determine which dose of tocilizumab is the best to use in combination with a standard dose of rituximab. The best dose will be that which is the most effective yet safe. When the best dose has been decided upon, in the second phase of the study, a larger number of participants will be given the chosen dose of tocilizumab in combination with rituximab and further information will be gathered on the effectiveness and safety of giving this combination of drugs. Participants in the study will be treated on an outpatient basis with the study drugs being given on several occasions over a 12 week period.
For both of these phases of the study, there will be a comparator group of participants who will receive only tocilizumab. This way the combination of rituximab plus tocilizumab can be compared to treatment with just tocilizumab.
All participants who complete part 1 or part 2 of the trial will enter an extension phase of the study where they will be given tocilizumab every four weeks for eight months. After completion of this treatment, participants will be followed up for a further amount of time (typically 12 weeks) in order to further monitor them for the effectiveness and safety of the study drugs.
REC name
South Central - Hampshire A Research Ethics Committee
REC reference
08/H0502/163
Date of REC Opinion
19 Dec 2008
REC opinion
Favourable Opinion