Polyradiculoneuropathy, Chronic Inflammatory DemyelinatingPhase 3CIDPRITNCT06325943

Rituximab in Chronic Inflammatory Demyelinating Polyradiculoneuropathy

A Phase 3 study testing Rituximab in people with Polyradiculoneuropathy, Chronic Inflammatory Demyelinating, run by Istituto Clinico Humanitas at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
What is being tested?: Rituximab
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 37 participants
Where: 1 siteItaly
Study dates: 1 Apr 2019to 30 Nov 2023
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subject is ≥ 18 years of age at Visit 1 (screening)
Subject has a documented diagnosis of definite or probable CIDP according to the European Federation of Neurological Societies/Peripheral Nerve Society (EFNS/PNS) criteria 2010 (Joint Task Force of the EFNS and the PNS, 2010)
Subject has an immunoglobulin-dependency confirmed by clinical examination in the 12 months before screening and documented in medical history (ie, that a decrease or withdrawal of immunoglobulin was attempted that resulted in a clinically relevant decrease in function)
If the immunoglobulin dependency has been confirmed within 12 to 6 months before screening, the subject has to be on a stable dosage (not more than ±20% deviation) for subcutaneous immunoglobulin (SCIg) or intravenous immunoglobulin (IVIg) and a fixed interval for at least 3 months of either treatment, ie, once or twice weekly ±2 days for SCIg or every 2 to 8 weeks ±5 days for intravenous immunoglobulin, respectively, for stability in functioning between dosing. If the immunoglobulin dependency has been confirmed within 6 months before Screening Visit, the stable dose and fixed interval is not required
Subject can take steroids at the maximum dosage equivalent to 12.5 mg/day of prednisone or 25 mg on alternate day or pulsed 400 mg/monthly of methylprednisolone as far as the dosage has been maintained stable (± 20%) in the previous 6 months. This treatment should be maintained unchanged during the six month treatment period and the six-month follow-up period
Subject has adequate peripheral venous access
Female subjects of childbearing potential must have a negative serum pregnancy test and agree to use a highly effective method of birth control, during the study and for a period 12 months after their last dose of study drug.
Male subject with a partner of childbearing potential must be willing to use an highly effective method of birth control when sexually active during the study and for 12 months after the final administration of rituximab/placebo.

Who cannot join

Subject has a current diagnosis or has a history of Type 1 or Type 2 diabetes mellitus
Subject with immunoglobulin M (IgM) paraproteinemia with anti-myelin associated glycoprotein antibodies (MAG)
Subject has Multifocal Motor Neuropathy with conduction block (MMN)
Patient with a CIDP relapse or significant worsening of symptoms within 6 months of randomization
Clinical or known evidence of associated medical conditions that might cause neuropathy including but not limited to connective tissue disease, Lyme disease, cancer (with the exclusion of benign skin cancer), Castleman's disease and systemic lupus erythematosus, malignant plasma cell dyscrasia, lymphoma, osteosclerotic myeloma, Polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes (POEMS), or agents that may lead to neuropathy eg, amiodarone therapy
Female who is pregnant or lactating

Show all 21Show fewer

Subjects has any medical condition (acute or chronic illness) or psychiatric condition that, in the opinion of the investigator, could harm the subject or would compromise the subject's ability to participate in the study
Subject with congestive heart failure or a moderate or higher impairment of cardiac function
Subject has renal impairment defined as: serum creatinine > 1.4 mg/dL for females and 1.5 mg/dL for males
Subject has an absolute leukocyte count <4000/mm3, lymphocyte count < 800/mm3, platelet count <100,000/mm3
Subject has liver impairment defined as total or conjugated bilirubin >1.5 × upper limit of the normal (ULN) range, unless in context of Gilbert's syndrome; aspartate aminotransferase (AST), alanine aminotransferase (ALT) >3 × ULN range; alkaline phosphatase (AP) >1.5 × ULN range; gamma glutamyl-transferase (GGT) >3 × ULN range
Subject has a history of chronic alcohol or drug abuse within the previous 12 months
Subject has a history of clinically relevant ongoing chronic infections including but not limited to human immunodeficiency virus (HIV), hepatitis B, hepatitis C, active or latent tuberculosis or is tested positive for HIV (anti-HIV1 or anti-HIV2 antibodies) hepatitis B (HBsAG positive or HBcAb positive without HBsAb) or hepatitis C (HCV antibodies) at the screening visit
Subject has a severe immunocompromising condition or a family history of primary immunodeficiency
Subject has a clinical relevant active infection (eg. sepsis, pneumonia, and abscess) or has had a serious infection (resulting in hospitalization or parenteral antibiotic treatment) within 6 weeks prior to the first dose of rituximab/placebo
Subject has an active neoplastic disease or history of neoplastic disease within 5 years of study entry (except for basal or squamous cell carcinoma of the skin or carcinoma in situ of the uterine cervix which has been definitely treated with standard of care approaches)
Subject was treated with plasma exchange or immunoabsorption within 3 months of randomization, with immunosuppressive/chemotherapeutic medications including azathioprine, cyclophosphamide, cyclosporine, mycophenolate, etanercept, methotrexate within 6 months of randomization, other immunosuppressive medications (including mitoxantrone, alemtuzumab, cladribine, pimecrolimus) at any time; total lymphoid irradiation or hematopoietic stem cell transplantation at any time; any biological therapy within 12 months of randomization
Steroids at a dose superior to the equivalent dose of 12.5mg/day or 25 mg on alternate day of oral prednisone or of pulsed 400mg/month of intravenous or intravenous methylprednisolone
Subject has received a live vaccination within 8 weeks prior to the baseline visit or intend to have live vaccination during the course of the study or within 7 weeks following the final dose of rituximab/placebo
Subject has had prior treatment with rituximab in the 12 months before inclusion
History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes.

Trial locations and contacts

1 site in 1 country.

Italy1 site

IRCCS Istituto Clinico Humanitas
Rozzano

Other trials in Italy

About this study

Official title: An Italian Database-based Randomized Controlled Trial With Rituximab in Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

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.

Conditions: Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Being tested: Rituximab, Placebo
Medical subject headings: Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RituximabDrug
Patients will receive two doses of rituximab 1 g at two-week interval and one dose of rituximab 1 g at month 6
PlaceboOther
Patients will receive two doses of placebo at two-week interval and one dose of placebo at month 6

Study groups in NCT06325943
Study group	Role	What they receive
Treatment arm	Active comparator	Rituximab Patients will receive two doses of rituximab 1 g at two-week interval and one dose of rituximab 1 g at month 6 Receives: Drug: Rituximab
Placebo arm	Placebo comparator	Placebo Patients will receive two doses of placebo at two-week interval and one dose of placebo at month 6 Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: 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
Measured: 6 months

Secondary outcomes (5)

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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 6,12,18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Apr 201930 Nov 2023

First posted22 Mar 2024
Study start1 Apr 2019
Primary completion30 May 2023
Study completion30 Nov 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Polyradiculoneuropathy, Chronic Inflammatory DemyelinatingStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: This study is a phase 3, multicenter, randomized, placebo-controlled, parallel-group, double-blind study
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 37 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06325943
Sponsor's protocol ID: CIDPRIT
Acronym: CIDPRIT
Status last verified: Mar 2024
First submitted: 17 May 2023
Last updated: 26 Mar 2024
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Nobile-Orazio E, Cocito D, Manganelli F, Fazio R, Lauria Pinter G, Benedetti L, Mazzeo A, Peci E, Spina E, Falzone Y, Dalla Bella E, Germano F, Gentile L, Liberatore G, Gallia F, Collet-Vidiella R, Bianchi E, Doneddu PE. Rituximab versus placebo for chronic inflammatory demyelinating polyradiculoneuropathy: a randomized trial. Brain. 2025 Apr 3;148(4):1112-1121. doi: 10.1093/brain/awae400.
PubMed 39658326

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
A Study to Assess Efficacy and Safety of Empasiprubart Versus IVIg in Adults With CIDP
Chronic Inflammatory Demyelinating Polyneuropathy, CIDP
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
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RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of DNTH103 in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CAPTIVATE)
Chronic Inflammatory Demyelinating Polyneuropathy
RecruitingObservational study
Multimodal Characterization of Movement Trajectories in Chronic Inflammatory Demyelinating Polyneuropathy
CIDP - Chronic Inflammatory Demyelinating Polyneuropathy
RecruitingPhase 3
A Study to Assess the Efficacy and Safety of Empasiprubart in Adults With CIDP
Chronic Inflammatory Demyelinating Polyneuropathy, CIDP

All Polyradiculoneuropathy, Chronic Inflammatory Demyelinating trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Italian Database-based Randomized Controlled Trial With Rituximab in Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
ClinicalTrials.gov ID: NCT06325943
Acronym / sponsor ID: CIDPRIT / CIDPRIT
Conditions: Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 37 participants (actual)
Lead sponsor: Istituto Clinico HumanitasUniversity, hospital or other
Collaborators: Ospedale Mondino di Pavia, University of Turin, Italy, Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta, San Raffaele University Hospital, Italy, Università di Messina, Universita degli Studi di Genova, Istituto Di Ricerche Farmacologiche Mario Negri, Federico II University
Study start: 1 Apr 2019 (actual)
Primary completion: 30 May 2023 (actual)
Study completion: 30 Nov 2023 (actual)
First posted: 22 Mar 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: This study is a phase 3, multicenter, randomized, placebo-controlled, parallel-group, double-blind study

Arm	Type	Receives
Treatment arm	Active comparator	Drug: RituximabRituximab Patients will receive two doses of rituximab 1 g at two-week interval and one dose of rituximab 1 g at month 6
Placebo arm	Placebo comparator	Other: PlaceboPlacebo Patients will receive two doses of placebo at two-week interval and one dose of placebo at month 6

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Subject is ≥ 18 years of age at Visit 1 (screening)
Subject has a documented diagnosis of definite or probable CIDP according to the European Federation of Neurological Societies/Peripheral Nerve Society (EFNS/PNS) criteria 2010 (Joint Task Force of the EFNS and the PNS, 2010)
Subject has an immunoglobulin-dependency confirmed by clinical examination in the 12 months before screening and documented in medical history (ie, that a decrease or withdrawal of immunoglobulin was attempted that resulted in a clinically relevant decrease in function)
If the immunoglobulin dependency has been confirmed within 12 to 6 months before screening, the subject has to be on a stable dosage (not more than ±20% deviation) for subcutaneous immunoglobulin (SCIg) or intravenous immunoglobulin (IVIg) and a fixed interval for at least 3 months of either treatment, ie, once or twice weekly ±2 days for SCIg or every 2 to 8 weeks ±5 days for intravenous immunoglobulin, respectively, for stability in functioning between dosing. If the immunoglobulin dependency has been confirmed within 6 months before Screening Visit, the stable dose and fixed interval is not required
Subject can take steroids at the maximum dosage equivalent to 12.5 mg/day of prednisone or 25 mg on alternate day or pulsed 400 mg/monthly of methylprednisolone as far as the dosage has been maintained stable (± 20%) in the previous 6 months. This treatment should be maintained unchanged during the six month treatment period and the six-month follow-up period

Key exclusion criteria (21 listed)

Subject has a current diagnosis or has a history of Type 1 or Type 2 diabetes mellitus
Subject with immunoglobulin M (IgM) paraproteinemia with anti-myelin associated glycoprotein antibodies (MAG)
Subject has Multifocal Motor Neuropathy with conduction block (MMN)
Patient with a CIDP relapse or significant worsening of symptoms within 6 months of randomization
Clinical or known evidence of associated medical conditions that might cause neuropathy including but not limited to connective tissue disease, Lyme disease, cancer (with the exclusion of benign skin cancer), Castleman's disease and systemic lupus erythematosus, malignant plasma cell dyscrasia, lymphoma, osteosclerotic myeloma, Polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes (POEMS), or agents that may lead to neuropathy eg, amiodarone therapy

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
RituximabPatients will receive two doses of rituximab 1 g at two-week interval and one dose of rituximab 1 g at month 6	Drug	Treatment arm
PlaceboPatients will receive two doses of placebo at two-week interval and one dose of placebo at month 6	Other	Placebo arm

Primary outcome

Inflammatory Neuropathy Cause and Treatment (INCAT) scale, range 0-10 points with higher values meaning more severe disability
Time frame: 6 months
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
Medical Research Council (MRC), range 0-60 with lower values meaning more severe disability
Time frame: 6 months
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
Inflammatory Rasch-built Overall Disability Scale (I-RODS), range 0-48 with lower values meaning more severe disability
Time frame: 6 months
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

5 secondary outcomes

Inflammatory Neuropathy Cause and Treatment (INCAT) scale, , range 0-10 points with higher values meaning more severe disability
Time frame: 6,12,18 months
Inflammatory Neuropathy Cause and Treatment (INCAT) scale, range 0-10 points with higher values meaning more severe disability
Time frame: 12 months
treatment suspension
Time frame: 12 months
time to worsening
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
Time frame: 6,12,18 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
Derived from this study: PubMed 39658326Nobile-Orazio E, Cocito D, Manganelli F, Fazio R, Lauria Pinter G, Benedetti L, Mazzeo A, Peci E, Spina E, Falzone Y, Dalla Bella E, Germano F, Gentile L, Liberatore G, Gallia F, Collet-Vidiella R, Bianchi E, Doneddu PE. Rituximab versus placebo for chronic inflammatory demyelinating polyradiculoneuropathy: a randomized trial. Brain. 2025 Apr 3;148(4):1112-1121. doi: 10.1093/brain/awae400.
Individual participant dataSharing planned: Undecided

Related trials for Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

RecruitingPhase 3
A Study to Assess Efficacy and Safety of Empasiprubart Versus IVIg in Adults With CIDP
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rituximab in people with Polyradiculoneuropathy, Chronic Inflammatory Demyelinating, run by Istituto Clinico Humanitas at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Inflammatory Neuropathy Cause and Treatment (INCAT) scale, range 0-10 points with higher values meaning more severe disability (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06325943, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2024.