A Phase 3 interventional study of Rituximab and Placebo in Polyradiculoneuropathy, Chronic Inflammatory Demyelinating, sponsored by Istituto Clinico Humanitas. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-26.
Sponsored by Istituto Clinico Humanitas · Phase 3, Interventional, and Treatment
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Among 28 studies in Polyradiculoneuropathy, Chronic Inflammatory Demyelinating with a site in Italy — 11 open to participants now, 15 under way, 8 of them phase 3. Polyradiculoneuropathy, Chronic Inflammatory Demyelinating · Italy.
Among the 28 studies in Polyradiculoneuropathy, Chronic Inflammatory Demyelinating with a site in Italy, this one is the 23rd largest by enrollment of the 26 interventional ones that give a count, is one of 2 that started in 2019, is one of 16 in phase 3, and was the 14th 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 →11 of the 28 studies in Polyradiculoneuropathy, Chronic Inflammatory Demyelinating with a site in Italy are open now. Recruiting first, the newest first:
argenx · Sites in Italy, United States, Argentina and 22 more countries
Ages 18+
argenx · Sites in Italy, United States, Argentina and 28 more countries
Ages 18+
Takeda · Sites in Italy, United States, Argentina and 8 more countries
Ages 18+
Immunovant Sciences GmbH · Sites in Italy, United States, Argentina and 27 more countries
Ages 18+
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta · Sites in Italy
Ages 18+
A study can be open while its sites in Italy have not opened yet or have stopped. Only those recruiting at a site in Italy →
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: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
28 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 8 · Phase 3 17 · Phase 4 1
First in 2004; this study’s year is marked. 2 started in 2019.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 37 is close to the median of 37 across 85 interventional studies indexed under Polyradiculoneuropathy, Chronic Inflammatory Demyelinating.
Median enrollment 113 across the 26 interventional studies, 159 across the 2 observational. Of the 13 that completed or were terminated, 9 (69%) have results posted.
This tab as a report to print or save as PDF → With an account.
23 of 28 have an industry lead sponsor. The 10 most frequent:
Istituto Clinico Humanitas is the lead sponsor of 279 studies on the registry; 70 are open to participants now.
Istituto Clinico Humanitas has 3 studies filed under Polyradiculoneuropathy, Chronic Inflammatory Demyelinating — fewer than ten, so there is no comparison to draw.
6 of the studies in Polyradiculoneuropathy, Chronic Inflammatory Demyelinating with a site in Italy 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 6 to your calendar (.ics) → With an account.
Among the 28 studies in Polyradiculoneuropathy, Chronic Inflammatory Demyelinating with a site in Italy, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Randomized double-blind controlled study of rituximab versus placebo in patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) on chronic treatment with immunoglobulins. The primary objective of the study is to determine whether rituximab treatment is effective in preventing the disease from getting worse after stopping immunoglobulin treatment for six months in patients with CIDP. The secondary objective is to evaluate whether treatment with rituximab can improve the response to therapy compared to placebo in patients treated with immunoglobulins and whether it can allow to delay the mean time of worsening after discontinuation of immunoglobulin therapy.
Exploratory objectives are the correlation between response to rituximab therapy and the clinical form of CIDP and the presence of antibody reactivity against node of Ranvier antigens. Intervention will be Rituximab or placebo, 1 g by intravenous infusion on day 1 and 15 after randomization and concomitant treatment for 6 months with intravenous or subcutaneous immunoglobulin at the same dosage as before randomization.
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.
Exclusion Criteria:
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.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
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.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
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.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
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.
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.
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.
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.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
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.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
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.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
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.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
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.
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.
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.
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.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
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.
Rituximab Patients will receive two doses of rituximab 1 g at two-week interval and one dose of rituximab 1 g at month 6
Drug: Rituximab
Placebo Patients will receive two doses of placebo at two-week interval and one dose of placebo at month 6
Other: Placebo
Patients will receive two doses of rituximab 1 g at two-week interval and one dose of rituximab 1 g at month 6
Patients will receive two doses of placebo at two-week interval and one dose of placebo at month 6
Inflammatory Neuropathy Cause and Treatment (INCAT) scale, range 0-10 points with higher values meaning more severe disability
proportion of patients with CIDP who worsen by at least one point in the INCAT score within six months after suspension of six-month treatment with intravenous or subcutaneous immunoglobulin
Time frame: 6 months
Medical Research Council (MRC), range 0-60 with lower values meaning more severe disability
proportion of patients with CIDP who worsen by at least two points in the MRC sum score within six months after suspension of six-month treatment with intravenous or subcutaneous immunoglobulin
Time frame: 6 months
Inflammatory Rasch-built Overall Disability Scale (I-RODS), range 0-48 with lower values meaning more severe disability
proportion of patients with CIDP who worsen by at least four points in the I-RODS scale within six months after suspension of six-month treatment with intravenous or subcutaneous immunoglobulin
Time frame: 6 months
Inflammatory Neuropathy Cause and Treatment (INCAT) scale, , range 0-10 points with higher values meaning more severe disability
improvement of disability (INCAT score) compared to placebo after 6, 12 and 18 months from the start of treatment
Time frame: 6,12,18 months
Inflammatory Neuropathy Cause and Treatment (INCAT) scale, range 0-10 points with higher values meaning more severe disability
efficacy of rituximab compared to placebo in reducing the number of patients with CIDP who worsen by at least one point in the INCAT score within 12 months after suspension of six-month treatment with intravenous or subcutaneous immunoglobulin
Time frame: 12 months
treatment suspension
proportion of patients who suspend the treatment with rituximab or placebo for adverse events or for voluntary reasons or who develop adverse events in the 12 months following the start of treatment.
Time frame: 12 months
time to worsening
to compare the mean time for patients with CIDP treated with rituximab or placebo to worsen by at least one point in the INCAT score after suspension of six-month treatment with intravenous or subcutaneous immunoglobulin
Time frame: 6 months
Short Form Health Survey 36 (SF-36), range from 0 to 100, with a higher score defining a more favorable health state
to determine whether the association of rituximab to intravenous immunoglobulin (IVIg) or subcutaneous immunoglobulin (SCIg) in patients with CIDP may improve compared to placebo the quality of life of the patients determined by SF-36 after 6, 12 and 18 months from the start of treatment.
Time frame: 6,12,18 months
motor conduction block in the two most relevant nerves, range 0-100% with lower score defining lesser degree of impairment
To determine the difference between patients treated with rituximab or placebo in the mean variation of motor conduction block in the two most relevant nerves between at the baseline and months 6 and 12 from the start of treatment
Time frame: 6 and 12 months
clinical form
to correlate the response to therapy with rituximab with the clinical form of typical or atypical CIDP
Time frame: 6,12, and 18 months
response to rituximab in patients with antinerve antibodies
to correlate the response to therapy with rituximab in patients with CIDP with the presence of antibody reactivities against proteins at the node of Ranvier (contactin 1 and neurofascin 155).
Time frame: 6, 12 and 18 months
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Apr 2019 to primary completion in May 2023, 49 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2024. 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 →