An open-label extension study following the RIN-1 study to investigate the efficacy of rituximab against a relapse of neuromyelitis optica

• Register: JPRN
• Last refreshed on: 17 October 2023
• Main ID: JPRN-UMIN000017217
• Date of registration: 21/04/2015
• Prospective Registration: Yes
• Primary sponsor: Clinical Research Center, Utano National Hospital, National Hospital Organization
• Public title: An open-label extension study following the RIN-1 study to investigate the efficacy of rituximab against a relapse of neuromyelitis optica
• Scientific title: An open-label extension study following the RIN-1 study to investigate the efficacy of rituximab against a relapse of neuromyelitis optica - RIN-2
• Date of first enrolment: 2015/04/21
• 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=R000019971
• Study type: Interventional
• Study design: Single arm Non-randomized
• Phase: Phase II,III

Countries of recruitment

Japan

Contacts

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

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

Key inclusion & exclusion criteria

Inclusion criteria:
Exclusion criteria: 1) Patients who have completed RIN-1 study 6 months ago or earlier. 2) Patients who required to continue acute-phase treatments such as methylprednisolone pulse therapy or plasma exchange. 3) Patients treated with oral corticosteroid more than 30 mg per day (in prednisolone conversion). 4) Patients with hypersensitivity to mouse protein derivatives or those with a history of anaphylactic reaction to components of rituximab. 5) Patients infected with HBV, HCV, or HIV, those with an active infectious diseases, or those with a history of severe chronic or recurrent infections. 6) Patients who received a monoclonal antibody (e.g., natalizumab or rituximab, except for rituximab use according to the protocol in the RIN-1 study), cladribine, radiation treatment (whole-body irradiation or lymphoid irradiation), stem-cell transplant, mitoxantrone, cyclophosphamide infusion, immunoglobulin therapy, immunomodulatory drugs (interferon beta, glatiramer acetate), oral immunosuppressive agents other than steroids (e.g., azathioprine, tacrolimus, cyclosporine, cyclophosphamide, methotrexate, or fingolimod), or live vaccines within 6 months before Visit 1. 7) Patients with autoimmune diseases, such as Sjogren's syndrome or systemic lupus erythematosus, requiring treatment with immunosuppressants. 8) Patients who are pregnant or feeding a baby. 9) Patients who are participating in other clinical trials for NMO. 10) Patients diagnosed as having a cancer. 11) 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

Primary Outcome(s)

Safety

Secondary Outcome(s)

Changes of Expanded Disability Status Scale (EDSS) and Quantification of Optic nerve and Spinal cord Impairment (QOSI) from the baseline score, and the proportion of steroid-free patients

Source(s) of Monetary Support

Japan Agency for Medical Research and Development, AMED

Zenyaku Kogyo Co., Ltd. (2018.4.1-)

Secondary Sponsor(s)

Zenyaku Kogyo Co., Ltd.

Ethics review

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

[e-mail]

NHO Utano National Hospital

075-461-5121

[e-mail]

Results

• Results available: Yes
• Date Completed: 29/03/2019