Tocilizumab vs Azathioprine in Neuromyelitis Optica Spectrum Disorders

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03350633
• Date of registration: 10/11/2017
• Prospective Registration: No
• Primary sponsor: Tianjin Medical University General Hospital
• Public title: Tocilizumab vs Azathioprine in Neuromyelitis Optica Spectrum Disorders TANGO
• Scientific title: Safety and Efficacy of Tocilizumab Versus Azathioprine in Neuromyelitis Optica Spectrum Disorders: a Randomized, Controlled, Open-label, Phase 2 Trial
• Date of first enrolment: November 1, 2017
• Target sample size: 118
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03350633
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2/Phase 3

Countries of recruitment

China

Contacts

• Name: Fu-Dong Shi, MD,PhD
• Affiliation: Tianjin Medical University General Hospital

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Neuromyelitis Optica Spectrum Disorders

Neuromyelitis Optica

Intervention(s)

Drug: Azathioprine

Drug: Tocilizumab Injection

Primary Outcome(s)

Time to first relapse [Time Frame: From baseline to one year after]

Secondary Outcome(s)

Proportion of patients who experience relapse-free [Time Frame: From baseline to 60 weeks]

Change in Low-contrast Letter Acuity (LCLA) at Week 60 [Time Frame: From baseline to 60 weeks]

Determination of serum immunoglobulins [Time Frame: From baseline to 60 weeks]

Number of Participants with Adverse Events as a Measure of Safety and Tolerability [Time Frame: From baseline to 60 weeks]

Time to Onset of Confirmed Disability Progression (CDP) for at Least 12 Weeks [Time Frame: From baseline to 60 weeks]

Determination of serum AQP4 antibodies [Time Frame: From baseline to 60 weeks]

Overall safety and tolerability of tocilizumab or azathioprine [Time Frame: From baseline to 60 weeks]

Counts of peripheral blood B cell subsets [Time Frame: From baseline to 60 weeks]

Percentage Change in Spectral-domain Optical Coherence Tomography (SD-OCT) Average Retinal Nerve Fiber Layer (RNFL) Thickness at Week 60 [Time Frame: From baseline to 60 weeks]

Percentage of Participants With Confirmed Disability Improvement (CDI) for at Least 12 Weeks [Time Frame: From baseline to 60 weeks]

Percentage of Participants With Confirmed Disability Improvement (CDI) for at Least 24 Weeks [Time Frame: From baseline to 60 weeks]

Time to Onset of Confirmed Disability Progression (CDP) for at Least 24 Weeks [Time Frame: From baseline to 60 weeks]

Worsening in EDSS [Time Frame: Worsening from baseline in EDSS to 60 weeks]

Change in High-contrast Letter Acuity (HCLA) at Week 60 [Time Frame: From baseline to 60 weeks]

Determination of serum cytokines [Time Frame: From baseline to 60 weeks]

Percentage change in SD-OCT Average Retinal Ganglion Cell Layer/Inner Plexiform Retinal Layer (RGCL/IPL) at Week 60 [Time Frame: From baseline to 60 weeks]

Number of New, and/or Enlarging T2 Hyperintense Lesions as Detected by Brain Magnetic Resonance Imaging (MRI) [Time Frame: From baseline to 60 weeks]

Secondary ID(s)

IRB2017-YX-009

Source(s) of Monetary Support

Please refer to primary and secondary sponsors