REMoxTB

Partners: Medical Research Council at University College London, University College London

REMoxTB was a global Phase 3 clinical trial conducted at nearly 50 sites. The trial tested whether substituting moxifloxacin for a single drug in the standard TB therapy could reduce treatment of drug-sensitive disease from six months to four.

Background:

Overview

REMoxTB was a global Phase 3 clinical trial conducted at 50 sites across 9 countries. The trial’s aim was to determine whether a moxifloxacin-containing TB treatment regimen could reduce the time needed to treat drug-sensitive TB patients from 6 months or longer to 4 months. REMox TB was completed in 2013, after enrolling and monitoring 1931 patients across 50 trial sites around the world. 

About the New Treatments

The REMoxTB trial tested 2 new treatment regimens for drug-sensitive TB. Both of these regimens substitute moxifloxacin, an already approved antibiotic for other indications, for an individual drug in the current first-line TB treatment regimen (isoniazid + rifampin + pyrazinamide + ethambutol [HRZE]). In separate arms of the trial, REMoxTB evaluated moxifloxacin in place of isoniazid and ethambutol. 

About the REMox TB trial

REMoxTB was conducted at 50 sites around the world by TB Alliance, Bayer Healthcare AG, University College London, and the Medical Research Council. It was the first Phase 3 TB drug trial conducted and completed in accordance with the most stringent modern regulatory standards, and it helped pave the way for subsequent clinical research and influence regulatory standards in the field. The trial was also conducted with significant involvement from local communities through community advisory structures promoted by TB Alliance to give communities a voice in the research process.

Results

As reported in the New England Journal of Medicine, the REMoxTB Phase 3 trial showed that the two regimens tested in the trial were found to be safe, but did not shorten the time it takes to treat drug-sensitive TB from six to four months. The study showed that the experimental regimens, which substituted moxifloxacin for either isoniazid or ethambutol in the first-line treatment for drug-sensitive TB, were more bacteridical in the earlier stages of treatment and converted patients to negative culture sooner than the standard of care, however patients in the experimental arms were more likely to relapse in the year following therapy. Thus, there was insufficient effect to permit regimen shortening by two months.

The trial also yielded other valuable findings. Importantly, REMoxTB was the first regulatory study to confirm the safety of daily moxifloxacin over four months of therapy. Its safety, combined with its activity against TB, supports the continued clinical testing of moxifloxacin as a component of other, novel regimens, such as PaMZ.

Also of interest, it had previously been thought that there were regional differences in patients' response to treatment across the world. The trial demonstrated no evidence that populations respond differently to treatment.

Additional Resources

Phase 3

Trial Components