A multi-center, randomized, double-blind, placebo-controlled trial to determine the efficacy of rituximab against a relapse of neuromyelitis optica spectrum disorders with anti-aquaporin 4 antibody

• Register: JPRN
• Last refreshed on: 17 October 2023
• Main ID: JPRN-UMIN000013453
• Date of registration: 18/03/2014
• Prospective Registration: Yes
• Primary sponsor: Clinical Research Center, NHO Utano National Hospital
• Public title: A multi-center, randomized, double-blind, placebo-controlled trial to determine the efficacy of rituximab against a relapse of neuromyelitis optica spectrum disorders with anti-aquaporin 4 antibody
• Scientific title: A multi-center, randomized, double-blind, placebo-controlled trial to determine the efficacy of rituximab against a relapse of neuromyelitis optica spectrum disorders with anti-aquaporin 4 antibody - RIN-1
• Date of first enrolment: 2014/05/10
• Target sample size: 40
• Recruitment status: Complete: follow-up complete
• URL: https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015709
• Study type: Interventional
• Study design: Parallel Randomized
• Phase: Phase II,III

Countries of recruitment

Japan

Contacts

• Name: Masayuki Tahara
• Affiliation: NHO Utano National Hospital Clinical Research Center

• Name: Masayuki Tahara
• Affiliation: NHO Utano National Hospital Clinical Research Center

Key inclusion & exclusion criteria

Inclusion criteria:
Exclusion criteria: 1) Patients with hypersensitivity to mouse protein derivatives or those with a history of anaphylactic reaction to components of rituximab. 2) Patients infected with HBV, HCV, or HIV, and those having active infectious diseases. 3) Patients with severe chronic infection or a history of recurrent infections. 4) Patients who have used a live vaccine within 6 months. 5) Patients under treatment with oral corticosteroid drugs of dosage of higher than 30 mg per day in prednisolone conversion. 6) Patients with previous use of cladribine or a monoclonal antibody, such as natalizumab or rituximab. 7) Patients with a history of radiation treatment (whole body irradiation or lymphoid irradiation) or a stem cell transplant. 8) Patients under treatment with mitoxantrone or cyclophosphamide within 12 months. 9) Patients under treatment with immunomodulatory drugs (interferon beta, glatiramer acetate) or immunoglobulin therapy within 6 months. 10) Patients under treatment with oral immunosuppressive agents other than steroids (e.g., azathioprine, tacrolimus, cyclosporine, cyclophosphamide, methotrexate, or fingolimod) within 3 months. 11) Patients who have received plasma exchange or intravenous steroid pulse therapy within 3 months. 12) Patients with autoimmune diseases, such as Sjogren's syndrome or systemic lupus erythematosus, requiring treatment with immunosuppressants. 13) Patients who are pregnant or feeding a baby. 14) Patients who are participating in other clinical trials for NMO. 15) Patients diagnosed as having a cancer. 16) Patients who are considered unfit for the enrollment in the trial after an investigation.

Age minimum: 16years-old
Age maximum: 80years-old
Gender: Male and Female

Health Condition(s) or Problem(s) studied

Neuromyelitis optica

Intervention(s)

Rituximab intravenous infusion
Placebo

Primary Outcome(s)

Time to the first relapse from the allocation

Secondary Outcome(s)

Changes in Expanded Disability Status Scale (EDSS) and Quantification of Optic nerve and Spinal cord Impairment (QOSI) from the baseline condition, and reduction rate of steroid

Source(s) of Monetary Support

Zenyaku Kogyo Co., Ltd.

Japan Agency for Medical Research and Development, AMED

Secondary Sponsor(s)

Zenyaku Kogyo Co., Ltd.

Ethics review

Status: YES
Approval date: 18/04/2014
Contact:

[e-mail]

Institutional Review Board, National Hospital Organization Utano National Hospital

[phone]

[e-mail]

Results

• Results available: Yes
• Date Posted: 20/08/2020
• Date Completed: 17/01/2019
• URL: https://www.thelancet.com/journals/laneur/issue/vol19no4/PIIS1474-4422(20)X0004-4