UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035753 |
|---|---|
| Receipt number | R000040728 |
| Scientific Title | 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 | 2022/05/26 20:58:42 |
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Basic information
Public title
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
Acronym
RECIPE Trial
Scientific Title
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
Scientific Title:Acronym
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.
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 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
10. Patients who have or are suspected to have active infection
11. Patients tested positive for HBs antigen, HBs antibody, HBc antibody, and/or HCV antibody(patients with positive HBs antibody or HBc antibody can be enrolled when a HBV-DNA test is negative, and hepatitis B virus-DNA and aspartate/alanine transaminase levels are monitored at fixed intervals), or patients with positive HIV antibody or HTLV-1 antibody
12. Patients with leukopenia, neutropenia, or lymphopenia
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
| 1st name | Masahiro |
| Middle name | |
| Last name | Iijima |
Organization
Nagoya University Hospital
Division name
Department of Advanced Medicine
Zip code
466-8560
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aich
TEL
052-744-2389
ijama@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Shinobu |
| Middle name | |
| Last name | Shimizu |
Organization
Nagoya University Hospital
Division name
Department of Advanced Medicine
Zip code
466-8560
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aich
TEL
052-744-2942
Homepage URL
s-shimizu@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Hospital
Institute
Department
Personal name
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.
IRB Contact (For public release)
Organization
Nagoya University Hospital Institutional review board
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aich
Tel
052-744-1958
center@med.nagoya-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
jRCT2041180037
Org. issuing International ID_1
Japan Registry of Clinical Trial
Study ID_2
NCT03864185
Org. issuing International ID_2
U.S. National Library of Medicine.
IND to MHLW
Institutions
Institutions
名古屋大学医学部附属病院（愛知県）、千葉大学医学部附属病院（千葉県）、山口大学医学部附属病院（山口県）、九州大学病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 02 | Month | 02 | Day |
Related information
URL releasing protocol
https://www.researchprotocols.org/2020/4/e17117/
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
27
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 11 | Month | 28 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 21 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 28 | Day |
Last follow-up date
| 2021 | Year | 06 | Month | 02 | Day |
Date of closure to data entry
Date trial data considered complete
| 2021 | Year | 09 | Month | 10 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 02 | Month | 02 | Day |
Last modified on
| 2022 | Year | 05 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040728
