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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035753
Receipt No. R000040728
Official scientific title of the study The Evaluation of Efficacy and Safety of Rituximab (Genetical Recombination) in Refractory Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Patients with Immunoglobulin G4 (IgG4) Autoantibodies in the Exploratory Clinical Trial
Date of disclosure of the study information 2019/02/02
Last modified on 2019/02/02

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Basic information
Official scientific title of the study The Evaluation of Efficacy and Safety of Rituximab (Genetical Recombination) in Refractory Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Patients with Immunoglobulin G4 (IgG4) Autoantibodies in the Exploratory Clinical Trial
Title of the study (Brief title) RECIPE Trial
Region
Japan

Condition
Condition Chronic Inflammatory Demyelinating Polyneuropathy
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of rituximab (genetical recombination) intravenously administered to CIDP patients with positive or negative IgG4 autoantibody.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Adjusted INCAT Disability Scale
Key secondary outcomes 1) Grip strength (left/right)
2) Rasch-built Overall Disability Scale (R-ODS)
3) Medical Research Council (MRC) Sum Score
4) Nerve conduction study (motor nerves: median, ulnar, tibial, and peroneal nerves)
5) Cerebrospinal fluid protein level
6) B cell counts (CD19 positive and CD20 positive cell counts) and T cell counts (CD3 positive, CD4 positive, and CD8 positive cell counts)
7) Expression of human anti-chimeric antibodies (HACA)
8) Serum rituximab (genetical recombination) level
9) Serum antibody titers of IgG4 (CNTN-1 and NF-155) and these IgG subclasses
10) Serum neurofilament
11) Adverse events
12) Vital signs, laboratory values

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 CIDP patients with positive IgG4 autoantibody (CNTN-1 or NF-155):
Administer 375 mg/m2 of rituximab (genetical recombination) IV infusion once weekly for 4 doses.
Interventions/Control_2 CIDP patients with positive IgG4 autoantibody (CNTN-1 or NF-155):
Administer placebo IV infusion once weekly for 4 doses.
Interventions/Control_3 CIDP patients with negative IgG4 autoantibody (CNTN-1 and NF-155):
Administer 375 mg/m2 of rituximab (genetical recombination) IV infusion once weekly for 4 doses.
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
12 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Patients with definite CIDP diagnosed according to the modified diagnostic criteria of the European Federation of Neurological Societies/Peripheral Nerve Society (EFNS/PNS) (2010) by the time of enrollment in the study
2. Patients meeting one of the following conditions:
1) Patients with positive serum IgG4 autoantibody (CNTN-1 or NF-155) confirmed by the time of enrollment in the study
2) Patients with negative serum IgG4 autoantibody (CNTN-1 and NF-155) confirmed by the time of enrollment in the study
3. Patients with refractory CIDP not responding adequately to treatment with corticosteroids for 12 weeks, and intravenous immunoglobulin therapy (IVIg) for 8 weeks by the time of enrollment in the study, or those who are unable to administer or continue corticosteroids and IVIg
4. Patients with total adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) Disability Scale scores of 2 to 8 at both preliminary enrollment and enrollment, and with the total score at enrollment equal to or worse than that at preliminary enrollment
5. Patients aged 12 years or older at informed consent
6. Patients who give their voluntary written consent after having received adequate information on this study
Key exclusion criteria 1. Patients with disease meeting one of the following exclusion criteria defined in the modified EFNS/PNS diagnostic criteria (2010).
2. Patients who have started or have increased the dose of corticosteroids for CIDP within 12 weeks prior to the enrollment
3. Patients who have started or have increased the dose of IVIg within 8 weeks prior to the enrollment
4. Patients who have undergone plasmapheresis within 8 weeks prior to the enrollment or patients with refractory disease not responding adequately to 8 weeks of plasmapheresis (plasma exchange or double-filtration plasmapheresis)
5. Patients who have started or have increased the dose of an immunosuppressant within 12 weeks prior to the enrollment
6. Patients who have undergone hematopoietic stem cell transplant prior to the enrollment
7. Patients who have used rituximab (genetical recombination) prior to the enrollment
8. Patients who have participated in another clinical study within 3 months prior to the enrollment or patients who are participating in another study
9. Patients with poorly controlled diabetes (HbA1c of 7 % or higher)
10. Patients who have or are suspected to have active infection at the time of the enrollment
11. Patients tested positive for HBs antigen, HBs antibody, HBc antibody, and/or HCV antibody, or patients with positive HIV antibody or HTLV-1 antibody at the time of the enrollment
12. Patients with leukopenia (less than 2,000 /mm3), neutropenia (less than 1,000 /mm3), or lymphopenia (less than 500 /mm3) at the time of the enrollment
13. Patients with history of serious hypersensitivity or anaphylactic reaction to one of the ingredients in the investigational drug or murine protein-containing products
14. Patients with serious comorbidity
15. Female patients who are pregnant, lactating, or potentially pregnant, or patients who are not willing to use contraceptive measures during the study period
16. Patients who are judged to be unsuitable by the investigator or a sub-investigator
Target sample size 25

Research contact person
Name of lead principal investigator Masahiro Iijima
Organization Nagoya University Hospital
Division name Department of Advanced Medicine
Address 65 Tsurumai-cho, Showa-ku, Nagoya, Aich
TEL 052-744-2389
Email ijama@med.nagoya-u.ac.jp

Public contact
Name of contact person Shinobu Shimizu
Organization Nagoya University Hospital
Division name Department of Advanced Medicine
Address 65 Tsurumai-cho, Showa-ku, Nagoya, Aich
TEL 052-744-2942
Homepage URL
Email s-shimizu@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Hospital
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor Zenyaku Kogyo Co., Ltd.
Name of secondary funder(s) Zenyaku Kogyo Co., Ltd.

Secondary IDs
Secondary IDs YES
Study ID_1 jRCT2041180037
Org. issuing International ID_1 Japan Registry of Clinical Trial
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2019 Year 02 Month 02 Day

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 11 Month 28 Day
Anticipated trial start date
2019 Year 03 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2019 Year 02 Month 02 Day
Last modified on
2019 Year 02 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040728

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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