A Phase 2/3 interventional study of Tocilizumab Injection and Azathioprine in Neuromyelitis Optica Spectrum Disorders and Neuromyelitis Optica, sponsored by Tianjin Medical University General Hospital. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-10-24.
Sponsored by Tianjin Medical University General Hospital · Phase 2/3, Interventional, and Treatment
Among 15 studies in Neuromyelitis Optica by Tianjin Medical University General Hospital — 5 open to participants now, 8 under way, 3 of them phase 3. Neuromyelitis Optica · Tianjin Medical University General Hospital.
Among the 15 studies in Neuromyelitis Optica by Tianjin Medical University General Hospital, this one is the 4th largest by enrollment of the 14 interventional ones that give a count, is the only one that started in 2017, is one of 2 in phase 2/3, and was the 3rd registered.
178 studies on the registry are indexed under Neuromyelitis Optica; 78 are open to participants now.
Browse Neuromyelitis Optica studies →5 of the 15 studies in Neuromyelitis Optica by Tianjin Medical University General Hospital are open now, in 1 country. Recruiting first, the newest first:
Tianjin Medical University General Hospital · Sites in China
Ages 18–80
Tianjin Medical University General Hospital · Sites in China
Ages 18–60
Tianjin Medical University General Hospital
Ages 18–60
Tianjin Medical University General Hospital
Ages 18+
Tianjin Medical University General Hospital
Ages 18–75
By country, each count listing its studies:
Of the 50 Neuromyelitis Optica studies recruiting now, 29 (58%) set no upper age limit and 16 (32%) stop at 75 or younger; 11 take children under 18; 9 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
15 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 5 · Phase 2 11 · Phase 3 4
First in 2013; this study’s year is marked. 1 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 118 is above the median of 29 across 108 interventional studies indexed under Neuromyelitis Optica.
Median enrollment 24 across the 14 interventional studies, 34 across the 1 observational. Of the 4 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
Tianjin Medical University General Hospital is the lead sponsor of 75 studies on the registry; 31 are open to participants now.
4 of the studies in Neuromyelitis Optica by Tianjin Medical University General Hospital that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07420296Phase 3Tianjin Medical University General HospitalModified Zipper Therapy for AQP4-IgG Positive Neuromyelitis Optica Spectrum Disorder | 2026-12-31 |
| NCT07132398Phase 3Tianjin Medical University General HospitalSlow vs. Rapid Glucocorticoids Tapering With Inebilizumab in NMOSD | 2027-08-31 |
| NCT05792462Tianjin Medical University General HospitalEfficacy and Safety of Baricitinib in Neuromyelitis Optica Spectrum Disorders | 2027-03-01 |
| NCT06561009Tianjin Medical University General HospitalSafety and Efficacy of BAFFR CART for Relapsed/ Refractory Neuromyelitis Optica Spectrum Disorder | 2027-10-01 |
Add all 4 to your calendar (.ics) → With an account.
Among the 15 studies in Neuromyelitis Optica by Tianjin Medical University General Hospital, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
The investigators primarily aim to observe the time to first relapse from initiation of tocilizumab or azathioprine treatment. The proportion of participants who experience relapse-free in one year follow-up will be compared.
The secondary outcomes are to determine: The safety profile of tocilizumab and azathioprine in participants with NMO and whether tocilizumab improves visual function, Expanded Disability Status Scale (EDSS), et al.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Tocilizumab Injection (ACTEMRA®) , a IL-6 receptor blockade
Drug: Tocilizumab Injection
Imuran
Drug: Azathioprine
Tocilizumab Injection will be intravenously administered with a dose of 8 mg/kg every 4 weeks.
Also known as: ACTEMRA®
Azathioprine will be orally given at a dose of 2-3 mg/kg/d
Also known as: Imuran
Time to first relapse
An acute attack was defined as a new neurological worsening lasting for at least 24 hours and occurring more than 30 days after the previous attack.
Time frame: From baseline to one year after
Proportion of patients who experience relapse-free
To record whether the patients had no relapses in the follow-ups
Time frame: From baseline to 60 weeks
Worsening in EDSS
The Expanded Disability Status Scale (EDSS) is a rating system that is frequently used for classifying and standardizing the severity and progression. EDSS ranges from 0 to 10.
Time frame: Worsening from baseline in EDSS to 60 weeks
Time to Onset of Confirmed Disability Progression (CDP) for at Least 12 Weeks
Disability progression was defined as an increase in the Expanded Disability Status Scale (EDSS) score of: A) \>=1.0 point from the baseline EDSS score when the baseline score was less than or equal to (\<=) 5.5 B) \>=0.5 point from the baseline EDSS score when the baseline score was \>5.5 The EDSS scale ranges from 0 (normal neurological exam) to 10 (death due to multiple sclerosis). Disability progression was considered confirmed when the increase in the EDSS was confirmed at a regularly scheduled visit at least 12 weeks after the initial documentation of neurological worsening. Participants who had initial disability progression with no confirmatory EDSS assessment and who were on treatment at time of clinical cut-off date were censored at the date of their last EDSS assessment.
Time frame: From baseline to 60 weeks
Percentage of Participants With Confirmed Disability Improvement (CDI) for at Least 12 Weeks
Disability improvement was assessed only for the subgroup of participants with a baseline EDSS score of \>= 2.0. It was defined as a reduction in EDSS score of: A) \>=1.0 from the baseline EDSS score when the baseline score was \>=2 and \<=5.5 B) \>= 0.5 when the baseline EDSS score \> 5.5. The EDSS scale ranges from 0 (normal neurological exam) to 10 (death).
Time frame: From baseline to 60 weeks
Time to Onset of Confirmed Disability Progression (CDP) for at Least 24 Weeks
Disability progression was defined as an increase in the Expanded Disability Status Scale (EDSS) score of: A) \>=1.0 point from the baseline EDSS score when the baseline score was less than or equal to (\<=) 5.5 B) \>=0.5 point from the baseline EDSS score when the baseline score was \>5.5 The EDSS scale ranges from 0 (normal neurological exam) to 10 (death). Disability progression was considered confirmed when the increase in the EDSS was confirmed at a regularly scheduled visit at least 24 weeks after the initial documentation of neurological worsening. Participants who had initial disability progression with no confirmatory EDSS assessment and who were on treatment at time of clinical cut-off date were censored at the date of their last EDSS assessment.
Time frame: From baseline to 60 weeks
Percentage of Participants With Confirmed Disability Improvement (CDI) for at Least 24 Weeks
Disability improvement was assessed only for the subgroup of participants with a baseline EDSS score of \>= 2.0. It was defined as a reduction in EDSS score of: A) \>=1.0 from the baseline EDSS score when the baseline score was \>=2 and \<=5.5 B) \>= 0.5 when the baseline EDSS score \> 5.5. The EDSS scale ranges from 0 (normal neurological exam) to 10 (death).
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
Adjusted mean percentage change in thickness of the RNFL at Week 60 for the affected eye from the baseline as determined by SD-OCT.
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
Adjusted mean change in thicknesses of the RGCL/IPL at Week 60 for the affected eye from the baseline as determined by segmentation of SD-OCT.
Time frame: From baseline to 60 weeks
Change in Low-contrast Letter Acuity (LCLA) at Week 60
Adjusted mean change in LCLA at Week 60 from baseline as determined by 2.5% low contrast Sloan letter charts, adjusted for the baseline LCLA value.
Time frame: From baseline to 60 weeks
Change in High-contrast Letter Acuity (HCLA) at Week 60
Adjusted mean change in HCLA at Week 60 from baseline as determined by 100% high contrast Sloan letter charts, adjusted for the baseline HCLA value.
Time frame: From baseline to 60 weeks
Number of New, and/or Enlarging T2 Hyperintense Lesions as Detected by Brain Magnetic Resonance Imaging (MRI)
The total number of new and/or enlarging T2 lesions for all participants in the treatment group was calculated as the sum of the individual number of lesions at Weeks 12, 36, and 60
Time frame: From baseline to 60 weeks
Overall safety and tolerability of tocilizumab or azathioprine
Adverse events related to tocilizumab or azathioprine are recorded.
Time frame: From baseline to 60 weeks
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Treatment-emergent adverse events, treatment-emergent serious adverse events (TESAEs), including laboratory measurements as well as their changes or shift from baseline over time
Time frame: From baseline to 60 weeks
Counts of peripheral blood B cell subsets
Compare peripheral blood plasma cells before and one year after initial intervention
Time frame: From baseline to 60 weeks
Determination of serum immunoglobulins
Compare immunoglobulins before and one year after initial intervention
Time frame: From baseline to 60 weeks
Determination of serum AQP4 antibodies
Compare serum AQP4-ab titers before and one year after initial intervention
Time frame: From baseline to 60 weeks
Determination of serum cytokines
Compare serum cytokines before and one year after initial intervention
Time frame: From baseline to 60 weeks
Plan to share: No
Ran from Nov 2017 to primary completion in Sep 2019, 22 months.
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This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tocilizumab
Tianjin Medical University General Hospital