Rituximab at Low dosE for neuromyelitiS optiCa spectrUm disordEr (RESCUE)

• Status: Completed
• Trial end date: 2020-06-01
• Target enrollment: 0
• Participant gender: All

Summary

In this research, a prospective, multicenter(Tangdu Hospital of Fourth Military Medical University, Xi'an Gaoxin Hospital of Xi'an Medical College, Xianyang Central Hospital, Baoji Central Hospital, Xi'an Central Hospital, The First Hospital of Xi'an, The Fourth Hospital of Xi'an) open-label, follow-up clinical trial will carry out to evaluate the efficacy and safety of low-dose rituximab in treating NMOSD in Northwest China.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tang-Du Hospital
• Treatments: Rituximab

Criteria

Inclusion Criteria:

Age between 16 and 75 years old;

Meet the 2007 or 2015 revised diagnostic criteria for NMOSD;

At least two relapses in recent two years and/or at least one attack or relapse in recent one years;

Expanded disability status scale (EDSS) score ≤7.0;

Willingness to sample collection, imaging study and other disease-related examinations and assessments;

Results of pregnancy tests for female patients with fertility during the screening period should be negative and effective contraception was used by the patient and her spouse during the study period;

Patients with informed consent.

Exclusion Criteria:

Other immunosuppressive agents are being used or have been discontinued for less than 3 months;

White blood cell count (WBC) <3 ×109/L, neutrophil count <1.5 ×109/L, hemoglobin (HGB) < 85 g/L, and platelet count (PLT) < 80×109/L;

Concomitant active liver disease or persistent elevation of transaminases more than three times above the normal upper limit;

Serious cardiovascular, kidney, blood and endocrine diseases, or history of malignant tumors, or severe infection;

Other chronic active immune diseases or stable conditions but requiring immunosuppressants or glucocorticoids, such as rheumatoid arthritis, scleroderma, Sjögren's syndrome, ulcerative colitis, AIDS, genetic or drug-induced immune deficiency;

Pregnant or lactating patients and those with family planning during the study period;

Allergy to rituximab and other components;

Inability to provide informed consent.