A Phase 2 interventional study of Rituximab (genetical recombination) and Placebo in Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP), sponsored by Nagoya University. Completed at 4 sites in Japan. Open to participants aged 12 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-08-20.
Sponsored by Nagoya University · Phase 2, Interventional, and Treatment
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Among 16 studies in Polyradiculoneuropathy, Chronic Inflammatory Demyelinating with a site in Japan — 7 open to participants now, 9 under way, 8 of them phase 3. Polyradiculoneuropathy, Chronic Inflammatory Demyelinating · Japan.
Among the 16 studies in Polyradiculoneuropathy, Chronic Inflammatory Demyelinating with a site in Japan, this one is the 16th largest by enrollment, is the only one that started in 2019, is one of 3 in phase 2, and was the 5th registered.
137 studies on the registry are indexed under Polyradiculoneuropathy, Chronic Inflammatory Demyelinating; 51 are open to participants now.
Browse Polyradiculoneuropathy, Chronic Inflammatory Demyelinating studies →7 of the 16 studies in Polyradiculoneuropathy, Chronic Inflammatory Demyelinating with a site in Japan are open now. Recruiting first, the newest first:
argenx · Sites in Japan, United States, Argentina and 22 more countries
Ages 18+
argenx · Sites in Japan, United States, Argentina and 28 more countries
Ages 18+
Takeda · Sites in Japan, United States, Argentina and 8 more countries
Ages 18+
Dianthus Therapeutics · Sites in Japan, United States, Argentina and 28 more countries
Ages 18–75
Sanofi · Sites in Japan, United States, Argentina and 21 more countries
Ages 18+
A study can be open while its sites in Japan have not opened yet or have stopped. Only those recruiting at a site in Japan →
Of the 36 Polyradiculoneuropathy, Chronic Inflammatory Demyelinating studies recruiting now, 24 (67%) set no upper age limit and 9 (25%) stop at 75 or younger; 4 take children under 18; 2 take healthy volunteers.
This study: 12 Years and older · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
16 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 2 4 · Phase 3 13
First in 2012; this study’s year is marked. 1 started in 2019.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 25 is below the median of 37 across 85 interventional studies indexed under Polyradiculoneuropathy, Chronic Inflammatory Demyelinating.
Median enrollment 160 across the 16 interventional studies. Of the 7 that completed or were terminated, 5 (71%) have results posted.
This tab as a report to print or save as PDF → With an account.
15 of 16 have an industry lead sponsor. The 9 most frequent:
Nagoya University is the lead sponsor of 22 studies on the registry; 3 are open to participants now.
Nagoya University has 1 study filed under Polyradiculoneuropathy, Chronic Inflammatory Demyelinating — fewer than ten, so there is no comparison to draw.
5 of the studies in Polyradiculoneuropathy, Chronic Inflammatory Demyelinating with a site in Japan that are under way reach primary completion within a year, 4 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05327114Phase 3Janssen Research & Development, LLCEfficacy and Safety Study of Nipocalimab for Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) | 2026-12-15 |
| NCT06290141Phase 3SanofiA Study to Test the Efficacy and Safety of Riliprubart Against the Usual Treatment of Intravenous Immunoglobulin (IVIg) in People With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) | 2027-07-09 |
| NCT06920004Phase 3argenxA Study to Assess Efficacy and Safety of Empasiprubart Versus IVIg in Adults With CIDP | 2027-09 |
| NCT07091630Phase 3argenxA Study to Assess the Efficacy and Safety of Empasiprubart in Adults With CIDP | 2027-10-07 |
| NCT04280718argenxA Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP, an Autoimmune Disorder That Affects the Peripheral Nerves) | 2027-04-30 |
Add all 5 to your calendar (.ics) → With an account.
Among the 16 studies in Polyradiculoneuropathy, Chronic Inflammatory Demyelinating with a site in Japan, from their registry updates:
This tab as a report to print or save as PDF → With an account.
To evaluate the efficacy and safety of rituximab (genetical recombination) intravenously administered to CIDP patients with positive or negative IgG4 autoantibody.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients meeting one of the following conditions:
(i) Patients with positive serum IgG4 autoantibody (CNTN-1 or NF-155) confirmed by the time of enrollment in the study
(ii) Patients with negative serum IgG4 autoantibody (CNTN-1 and NF-155) confirmed by the time of enrollment in the study
Exclusion Criteria:
Patients with disease meeting one of the following exclusion criteria defined in the modified EFNS/PNS diagnostic criteria (2010).
(i) Borrelia burgdorferi infection (Lyme disease), diphtheria, drug or toxin exposure probably to have caused the neuropathy Hereditary demyelinating neuropathy
(ii) Prominent sphincter disturbance
(iii) Diagnosis of multifocal motor neuropathy
(iv) IgM monoclonal gammopathy with high titre antibodies to myelin-associated glycoprotein
(v) Other causes for a demyelinating neuropathy including POEMS syndrome, osteosclerotic myeloma, diabetic and non-diabetic lumbosacral radiculoplexus neuropathy PNS lymphoma and amyloidosis may occasionally have demyelinating features
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biological: Rituximab (genetical recombination)
Other: Placebo
Biological: Rituximab (genetical recombination)
Administer 375 mg/m2 of rituximab (genetical recombination) IV infusion once weekly for 4 doses.
Administer placebo IV infusion once weekly for 4 doses.
Rate of patients with improvement in adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) disability scale
Primary analysis will compare scores of adjusted INCAT Disability Scale evaluated prior to treatment (at the time of enrollment) and scores at each timepoint after week 26 to calculate the proportion of patients who achieve an improvement of one and more from the baseline. The INCAT Disability Scale is an index to evaluate disorders in lower (gait) and upper (elevation of the upper arms and fine movement of the fingertips) extremities. The INCAT score is a 10-point scale and ranges from 0 (normal) to 10 (worst). For the "adjusted" INCAT score, a change in upper extremity score from 0 to 1 or 1 to 0 will not be considered meaningful in this evaluation.
Time frame: Up to 52 weeks
Change in grip strength (kPa)
The differences of Grip strength (kPa) between prior to treatment and at each timepoint are summarized.
Time frame: Up to 52 weeks
Change in Rasch-built Overall Disability Scale (R-ODS) score
The differences of R-ODS score between prior to treatment and at each timepoint are summarized. R-ODS is consist of a 24-item questionnaire about daily living task with 3 response options: (0) "impossible to perform," (1) "performed with difficulty," and (2) "easily performed. The R-ODS score is a 48-point scale (range: 0-48), and is converted into a centile metric score with values ranging from 0 (most severe activity and social participation limitations) to 100 (no activity and social participation limitations).
Time frame: Up to 52 weeks
Change in Medical Research Council (MRC) Sum Score
The differences of MRC Sum Score between prior to treatment and at each timepoint are summarized. The MRC Sum Score is a scale to assess for 8 muscle groups (right and left side) as follow: Shoulder abduction, Elbow flexion, Wrist extension, Index finger abduction, Hip flexion, Knee extension, Foot dorsiflexion, Great toe dorsiflexion.The MRC Sum Score is a 80-point scale and ranges from 0 (paralysis) to 80 (normal strength).
Time frame: Up to 52 weeks
Change in motor nerve distal latency
The differences of distal latency between prior to treatment and at each timepoint are summarized.
Time frame: Up to 52 weeks
Change in motor nerve proximal latency
The differences of proximal latency between prior to treatment and at each timepoint are summarized.
Time frame: Up to 52 weeks
Change in motor nerve compound muscle action potential (CMAP)
The differences of CMAP between prior to treatment and at each timepoint are summarized.
Time frame: Up to 52 weeks
Change in motor nerve conduction velocity
The differences of motor nerve conduction velocity between prior to treatment and at each timepoint are summarized.
Time frame: Up to 52 weeks
Cerebrospinal fluid protein level
Cerebrospinal fluid protein level at each timepoint are summarized.
Time frame: Up to 52 weeks
B cell counts (CD19 positive and CD20 positive cell counts) and T cell counts (CD3 positive, CD4 positive, and CD8 positive cell counts)
B cell counts (CD19 positive and CD20 positive cell counts) and T cell counts (CD3 positive, CD4 positive, and CD8 positive cell counts) at each timepoint are summarized.
Time frame: Up to 52 weeks
Expression of HACA
The number of patients expressing HACA, and the proportion and its 95% confidence interval of these patients at each timepoint are summarized.
Time frame: Up to 52 weeks
Serum rituximab (genetical recombination) level
Serum rituximab (genetical recombination) level at each timepoint are summarized.
Time frame: Up to 52 weeks
Maximum serum concentration (Cmax) of rituximab (genetical recombination)
Cmax of rituximab (genetical recombination) is summarized.
Time frame: Up to 52 weeks
Area under the curve (AUC) of blood concentration of rituximab (genetical recombination)
AUC of blood concentration of rituximab (genetical recombination) is summarized.
Time frame: Up to 52 weeks
Half-life (t1/2) of rituximab (genetical recombination)
t1/2 of rituximab (genetical recombination) is summarized.
Time frame: Up to 52 weeks
Clearance (CL) of rituximab (genetical recombination)
CL of rituximab (genetical recombination) is summarized.
Time frame: Up to 52 weeks
Mean residence time (MRT) of rituximab (genetical recombination)
MRT of rituximab (genetical recombination) is summarized.
Time frame: Up to 52 weeks
Volume of distribution (Vds) of rituximab (genetical recombination) level
Vds of rituximab (genetical recombination) is summarized.
Time frame: Up to 52 weeks
Serum antibody titers of IgG4 (CNTN-1 and NF-155) and these IgG subclass
Serum titers (CNTN-1 and NF-155, and these IgG subclasses 1 to 4) at each timepoint are summarized.
Time frame: Up to 52 weeks
Serum neurofilament
Serum neurofilament level at each timepoint is summarized.
Time frame: Up to 52 weeks
Plan to share: No
Ran from Mar 2019 to primary completion in May 2021, 25 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Rituximab
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating →
Nagoya University