TANGO
What it found
The main measure showed a statistically significant benefit.
“Eight (14%) of 59 patients in the tocilizumab group and 28 (47%) of 59 patients in the azathioprine group had a relapse at the end of the study (hazard ratio [HR] 0·236 [95% CI 0·107-0·518]; p<0·0001).”Read by software from the paper's abstract
| Group | n | Value |
|---|---|---|
| Tocilizumab | 59 | median time to first relapse 78.9 weeks [IQR 58.3-90.6]; 8 (14%) relapsed |
| Azathioprine | 59 | median time to first relapse 56.7 [32.9-81.7] weeks; 28 (47%) relapsed |
hazard ratio 0.236
p = <0.0001
Total participants: 118
Read by software from the paper's abstract
What was tested
Treatment tested
- Tocilizumab
Interleukin-6 receptor alpha subunit inhibitor
Compared with
- Azathioprine
Amidophosphoribosyltransferase inhibitor|DNA inhibitor
What it measured
Main measures
Time to first relapse
From baseline to one year after
Relapses
Other measures (17)
Proportion of patients who experience relapse-free
From baseline to 60 weeks
RelapsesWorsening in EDSS
Worsening from baseline in EDSS to 60 weeks
Disability progressionTime to Onset of Confirmed Disability Progression (CDP) for at Least 12 Weeks
From baseline to 60 weeks
Disability progressionPercentage of Participants With Confirmed Disability Improvement (CDI) for at Least 12 Weeks
From baseline to 60 weeks
Disability progressionTime to Onset of Confirmed Disability Progression (CDP) for at Least 24 Weeks
From baseline to 60 weeks
Disability progressionPercentage of Participants With Confirmed Disability Improvement (CDI) for at Least 24 Weeks
From baseline to 60 weeks
Disability progressionPercentage Change in Spectral-domain Optical Coherence Tomography (SD-OCT) Average Retinal Nerve Fiber Layer (RNFL) Thickness at Week 60
From baseline to 60 weeks
Retina scans (OCT)Percentage change in SD-OCT Average Retinal Ganglion Cell Layer/Inner Plexiform Retinal Layer (RGCL/IPL) at Week 60
From baseline to 60 weeks
Retina scans (OCT)Change in Low-contrast Letter Acuity (LCLA) at Week 60
From baseline to 60 weeks
VisionChange in High-contrast Letter Acuity (HCLA) at Week 60
From baseline to 60 weeks
Who could take part
NMOSD · 18 and over
Inclusion Criteria: 1. Male or female patients ≥ 18 years old 2. Diagnosis of NMO or NMO spectrum disorder 3. Clinical evidence of at least 2 relapses in last 12 months or 3 relapses in the last 24 months 4. Able and willing to give written informed consent and comply with the requirements of the study protocol. 5. EDSS \<= 7.5 (8 in special circumstances) 6. Men and women of reproductive potential must agree to use a highly effective method of birth control from screening to 6 months after final dose of the investigational product. Exclusion Criteria: 1. Current evidence or known history of clinically significant infection (Herpes simplex virus, varicella-zoster virus, cytomegalovirus, Epstein-Barr virus,human immunodeficiency virus, Hepatitis viruses, Syphilis, etc) 2. Pregnant, breastfeeding, or child-bearing potential during the course of the study 3. Patients will not participate in any other clinical therapeutic study or will not have participated in any other experimental treatment study within 30 days of screening 4. Participation in another interventional trial within the last 3 months 5. Heart or kidney insufficiency 6. Tumor disease currently or within last 5 years 7. Clinically relevant liver, kidney or bone marrow function disorder 8. Intolerance of azathioprine or previous relapses on azathioprine treatment 9. Receipt of rituximab or any experimental B-cell depleting agent within 6 months prior screening and B-cells below the lower limit of normal.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
In neuromyelitis optica spectrum disorder (NMOSD),interleukin-6 (IL-6) may play an important role in facilitating plasma cells to produce pathological aquaporin 4 (AQP4) autoantibody. Inhibition of IL-6 signaling pathway by Tocilizumab (ACTEMRA®), a humanized monoclonal antibody may have shown beneficial clinical effects in a few patients with NMOSD. Larger scale clincial trials may be needed to observe its efficacy and safety. Here, by choosing azathioprine, one of the most frequently used medication in case of relapses, the investigators compare the safety and efficacy of tocilizumab in preventing NMOSD attacks.
Papers
Results
Safety and efficacy of tocilizumab versus azathioprine in highly relapsing neuromyelitis optica spectrum disorder (TANGO): an open-label, multicentre, randomised, phase 2 trial.Lancet Neurol · 2020
Eight (14%) of 59 patients in the tocilizumab group and 28 (47%) of 59 patients in the azathioprine group had a relapse at the end of the study (hazard ratio [HR] 0·236 [95% CI 0·107-0·518]; p<0·0001).
Read by software from the paper's abstract
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History
Started
Nov 2017
Main results due
Sept 2019
Finished
Sept 2019
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