[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cidp---chronic-inflammatory-demyelinating-polyneuropathy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cidp---chronic-inflammatory-demyelinating-polyneuropathy":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,43,73,96,122],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100586793","phase-3-a-study-to-assess-efficacy-and-safety-of-empasiprubart-versus-ivig-in-adults-with-cidp-100586793",false,"NCT06920004","A Study to Assess Efficacy and Safety of Empasiprubart Versus IVIg in Adults With CIDP","A Phase 3, Randomized, Double-Blinded, Double-Dummy Study Evaluating the Efficacy and Safety of Intravenous Empasiprubart Versus Intravenous Immunoglobulin in Adults With Chronic Inflammatory Demyelinating Polyneuropathy","emvigorate","Inclusion Criteria:\n\n* Meets criteria for CIDP based on EAN\u002FPNS Task Force CIDP guidelines, second revision (2021)\n* Has either typical CIDP or 1 of the following CIDP variants: motor CIDP, multifocal CIDP (also known as Lewis-Sumner syndrome), focal CIDP, or distal CIDP\n* Has responded to IVIg in the past 5 years\n* Receiving treatment with IVIg within a standard optimal maintenance dosing regimen, with a minimum weekly IVIg dose of at least 0.125 g\u002Fkg\n* Has residual disability and active disease\n\nExclusion Criteria:\n\n* Besides the indication under study, known autoimmune disease or any medical condition that would interfere with an accurate assessment of clinical symptoms of CIDP or puts the participant at undue risk, including polyneuropathy of other causes\n* Meets the criteria for possible or sensory CIDP based on EAN\u002FPNS Task Force CIDP guidelines, second revision (2021)\n* Use of other long-acting immunomodulatory treatment","ALL","18 Years",{"count":20,"type":21},218,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","The main purpose of this study is to compare empasiprubart and IVIg for treating people with CIDP. This study consists of a Part A where participants will either receive empasiprubart and a placebo resembling IVIg, or IVIg and a placebo resembling empasiprubart for 24 weeks (6 months). Following Part A, participants will enter Part B in which all participants will receive empasiprubart for 96 weeks (24 months).\n\nMore information can be found here: https:\u002F\u002Fclinicaltrials.argenx.com\u002Femvigorate",[27,28,29],"Chronic Inflammatory Demyelinating Polyneuropathy","CIDP","CIDP - Chronic Inflammatory Demyelinating Polyneuropathy","RECRUITING","2026-06-11",{"date":33,"type":34},"2026-06-12","ACTUAL",{"date":36,"type":34},"2025-08-22",{"date":38,"type":21},"2030-09",{"name":40,"class":41},"argenx","INDUSTRY",75,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":53,"conditions":54,"keywords":55,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":72},"100614000","subcutaneous-immunoglobulin-therapy-effectiveness-monitoring-in-cidp-patients-using-smart-devices-100614000","NCT07273903","Subcutaneous Immunoglobulin Therapy Effectiveness Monitoring in CIDP Patients Using Smart Devices","STEPS","Inclusion Criteria:\n\n* Diagnosed typical or possible typical CIDP according to the 2021 EAN\u002FPNS criteria\n* Age ≥18 years\n* Ability to use a smartwatch as decided by the investigator\n* switched from IVIG to fSCIG within the prior 6 months or plan to switch during study recruitment phase\n* on investigator-confirmed stable IVIG therapy pre-switch\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years\n* Inability to operate smartwatch or smartphone device\n* current pregnancy and breastfeeding status\n* CIDP variants according to the 2021 EAN\u002FPNS criteria",{"count":51,"type":21},35,"OBSERVATIONAL","Chronic inflammatory demyelinating polyneuropathy (CIDP) is a rare autoimmune disease that affects the peripheral nerves. It causes progressive weakness and sensory loss in the arms and legs, which can severely limit daily activities. Many patients need long-term treatment with immunoglobulins, either through intravenous infusions (IVIG) or subcutaneous injections (fSCIG).\n\nThe S.T.E.P.S. study aims to explore how digital health technologies-specifically smartwatches-can help monitor the disease course and treatment effects in CIDP patients who use fSCIG at home. Current clinical tests are useful but sometimes miss small changes in strength or function. Wearables may provide a more detailed and continuous picture of patients' health between clinic visits.\n\nStudy Goals:\n\nThe main goal is to find out whether smartwatch data (such as step count and physical activity) reflect disease severity and treatment response when compared to standard clinical scores like the Inflammatory Neuropathy Cause and Treatment (INCAT) scale and the Inflammatory Rasch-built Overall Disability Scale (I-RODS).\n\nSecondary goals include:\n\nAssessing how smartwatch data relate to patients' quality of life and sleep patterns.\n\nComparing smartwatch results with other clinical scores such as muscle strength (MRC sum score) and grip strength.\n\nEvaluating how well patients can use the smartwatch over the long term during home treatment.\n\nAn additional exploratory goal is to see whether smartwatch data can detect early signs of worsening disease before symptoms appear.\n\nStudy Design:\n\nThis is a 12-month observational study with five main clinic visits (at 0, 3, 6, 9, and 12 months). After enrolling, participants will begin or continue subcutaneous immunoglobulin therapy as decided by their treating physician. Each visit includes standard clinical assessments and questionnaires.\n\nParticipants will receive a smartwatch at the start of the study to continuously track their activity and sleep patterns. A follow-up phone call one week later will check that the device is working properly.\n\nDuration:\n\nRecruitment will last about 6 months, and each participant will be followed for 12 months.\n\nWhy This Matters:\n\nBy combining established clinical measures with continuous digital monitoring, the S.T.E.P.S. study may help improve understanding of disease activity and treatment response in CIDP. This could lead to more personalized therapy schedules and better long-term care for patients.",[29],[28,56,57,58,59,60,61],"IVIG","SCIG","wearable","steps","sleep","DHT","2026-06-09",{"date":64,"type":34},"2026-06-10",{"date":66,"type":34},"2026-01-15",{"date":68,"type":21},"2028-01",{"name":70,"class":71},"Heinrich-Heine University, Duesseldorf","OTHER",2,{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":80,"minAge":4,"maxAge":4,"enrollmentInfo":81,"targetDuration":83,"studyType":52,"phases":4,"briefSummary":84,"conditions":85,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},"100539123","a-worldwide-pregnancy-safety-study-to-assess-maternal-fetal-and-infant-outcomes-following-exposure-to-efgartigimod-during-pregnancy-andor-breastfeeding-100539123","NCT06299748","A Worldwide Pregnancy Safety Study to Assess Maternal, Fetal, and Infant Outcomes Following Exposure to Efgartigimod During Pregnancy and\u002For Breastfeeding.","A Worldwide Pregnancy Safety Study To Assess Maternal, Fetal, And Infant Outcomes Following Exposure To Efgartigimod During Pregnancy And\u002FOr Breastfeeding","Inclusion Criteria:\n\n* Women with exposure to efgartigimod or efgartigimod PH20 SC any time within 25 days prior to conception or any time during pregnancy, or women with exposure to efgartigimod or efgartigimod PH20 SC during breastfeeding. The timeframe of 25 days prior to conception is calculated based on five times the efgartigimod half-life, which is 3 to 5 days.\n* Written\u002Fverbal informed consent or eConsent (depending on country regulations) (for adolescents under the age of majority, written\u002Fverbal informed assent or eConsent by the pregnant minor (where applicable) and written\u002Fverbal informed consent or eConsent by the parent\u002Flegal guardian).\n\nExclusion Criteria:\n\n* None","FEMALE",{"count":82,"type":21},279,"1 Year","This is a multi-country, prospective safety study of pregnant women exposed to efgartigimod or efgartigimod PH20 SC any time within 25 days prior to conception or any time during pregnancy. Women exposed to efgartigimod or efgartigimod PH20 SC only during breastfeeding will also be eligible to enroll. Background rates of major congenital malformations (MCMs) will be obtained from populations within the same countries\u002Fregions as the countries\u002Fregions in which the efgartigimod or efgartigimod PH20 SC exposed pregnancies were reported.",[86,29],"Myasthenia Gravis","2026-02-13",{"date":89,"type":34},"2026-02-17",{"date":91,"type":34},"2023-11-30",{"date":93,"type":21},"2033-12",{"name":40,"class":41},4,{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":100,"acronym":101,"eligibilityCriteria":102,"healthyVolunteers":103,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":104,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":106,"conditions":107,"keywords":109,"overallStatus":113,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":118,"leadSponsor":120,"locationsCount":4},"100602321","multispectral-optoacoustic-imaging-for-the-detection-of-inflammation-and-damage-of-peripheral-nerves-in-guillain-barr-syndrome-and-chronic-inflammatory-demyelinating-polyneuropathy-100602321","NCT07121985","Multispectral Optoacoustic Imaging for the Detection of Inflammation and Damage of Peripheral Nerves in Guillain-Barré Syndrome and Chronic Inflammatory Demyelinating Polyneuropathy","MIND","Inclusion Criteria Patient Cohort(s):\n\n* Established diagnosis or suspected CIDP or GBS\n* Age: 18 years or older\n* Written informed consent provided by participant\n\nInclusion Criteria Control Cohort:\n\n* Written informed consent provided by participant\n* Age: 18 years or older\n* No pre-existing conditions that may affect peripheral nerves (e.g., diabetes, traumatic nerve injuries, etc.)\n\nExclusion Criteria:\n\n* Pregnancy\n* Breastfeeding mothers\n* Cardiopulmonary instability\n* Tattoo in the examination area\n* Subcutaneous fat tissue \\> 3 cm",true,{"count":105,"type":21},30,"The aim of this study is to assess disease activity in patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) and Guillain-Barré Syndrome (GBS) using multispectral optoacoustic tomography (MSOT).\n\nThe currently available diagnostic procedures for CIDP and GBS do not allow for a clear distinction between remission and active disease and show limitations in sensitivity and specificity during acute diagnostics. This can lead to delayed diagnosis, which is crucial for timely initiation of therapy and, consequently, for a better prognosis. Long-term therapy management is also challenging, as objective parameters for assessing therapeutic success are largely lacking.\n\nMSOT can detect inflammation through the measurement of hemoglobin, a method that our research group has already successfully demonstrated in patients with chronic inflammatory bowel diseases (Knieling, NEJM 2017). The use of MSOT could therefore also be applied to nerve inflammation, allowing for earlier detection of inflammation and nerve damage and contributing to timely treatment of patients.\n\nFor nerve imaging, a CE-certified MSOT device from iThera Medical is available at the Pediatric Clinic in Erlangen. In addition, a non-CE-certified device with lower laser power is available, which can be used for bedside examinations.\n\nThe arm nerves will be examined in three cohorts, which will be compared with each other and with standard diagnostics (blood tests, electrophysiology, conventional ultrasound).\n\nEach cohort will include ten healthy control subjects, ten patients with CIDP, and ten patients with GBS.",[29,108],"Guillain-Barré Syndrome (GBS)",[110,111,112],"MSOT","PAI","Nerve Ultrasound","NOT_YET_RECRUITING","2025-08-06",{"date":116,"type":34},"2025-08-14",{"date":114,"type":21},{"date":119,"type":21},"2027-08-06",{"name":121,"class":71},"University of Erlangen-Nürnberg Medical School",{"id":123,"slug":124,"hasResults":11,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":128,"eligibilityCriteria":129,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":130,"targetDuration":4,"studyType":22,"phases":132,"briefSummary":134,"conditions":135,"keywords":136,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":95},"100407736","phase-4-subcutaneous-immunoglobulin-in-de-novo-cidp-sidec-100407736","NCT04589299","Subcutaneous Immunoglobulin in De-novo CIDP (SIDEC)","Randomized, Parallel Study of Subcutaneous Versus Intravenous Immunoglobulin in Treatment-naïve Patients With Chronic Inflammatory Demyelinating Polyneuropathy","SIDEC","Inclusion Criteria:\n\n* Fulfilling EFNS\u002FPNS criteria for definite, probable or pure motor CIDP.\n* No previous treatment with IVIG or SCIG.\n* Age ≥ 18.\n* ODSS ≥ 2 - either (arm\u002Fleg): 1\u002F1, 2\u002F0 or 0\u002F2 at the time of inclusion.\n\nClinical criteria for typical CIDP\n\n* Chronically progressive, stepwise, or recurrent symmetric proximal and distal weakness and sensory dysfunction of all extremities, developing over at least 2 months; cranial nerves may be affected.\n* Absent or reduced tendon reflexes in all extremities.\n\nCriteria for pure motor CIDP • Pure motor affection; otherwise as for typical CIDP.\n\nElectrophysiological criteria for CIDP\n\n1. Motor distal latency prolongation ≥50% above ULN in two nerves (excluding median neuropathy at the wrist from carpal tunnel syndrome), or\n2. Reduction of motor conduction velocity ≥30% below LLN in two nerves, or\n3. Prolongation of F-wave latency ≥30% above ULN in two nerves (≥50% if amplitude of distal negative peak CMAP ≤80% of LLN values), or\n4. Absence of F-waves in two nerves of these nerves have distal negative peak CMAP amplitudes ≥20% of LLN + ≥1 other demyelinating parameter in ≥1 other nerve, or\n5. Partial motor conduction block: ≥50% amplitude reduction of the proximal negative peak CMAP relative to distal, if distal negative peak CMAP \\>20% of LLN, in two nerves, or in one nerve + ≥1 other demyelinating parameter in ≥1 other nerve, or\n6. Abnormal dispersion (≥30% duration increase between the proximal and distal negative peak CMAP) in ≥2 nerves, or\n7. Distal CMAP duration (interval between onset of the first negative peak an return to baseline of the last negative peak) increase in ≥1 nerve (median ≥6.6 ms, ulnar ≥6.7 ms, peroneal ≥7.6 ms, tibial ≥8.8 ms) + ≥1 other demyelinating parameter in ≥1 other nerve\n\nElectrophysiological criteria for probable CIDP\n\n(a) ≥30% amplitude reduction of the proximal negative peak CMAP relative to distal, excluding the posterior tibial nerve, if distal negative peak CMAP ≥20% of LLN, in two nerves, or in one nerve + ≥1 other demyelinating parameter in ≥1 other nerve\n\nExclusion Criteria:\n\n* Other causes of neuropathy\n* Increased risk of thromboembolism\n* Pregnancy (Plasma HCG is tested at inclusion in all fertile women)\n* Breast feeding\n* Malignancy\n* Severe medical disease\n* Other immune modulating treatment than low dose steroid (prednisolon \\\u003C 25 mg daily) within the last 6 months prior to inclusion\n* Hepatitis B or C or HIV infection (screening at inclusion)\n* Known IgA deficiency\n* Known allergy to consents in PRIVIGEN or HIZENTRA\n* Body weight \\> 120 kg\n\nAfter treatment initiation:\n\n* Pregnancy\n* Serious medical disease that affects treatment or examinations\n* Non-compliance to treatment\n* Initiation of other immune modulating therapy\n* Unacceptable side effects\n* Withdrawal of consent to participate (drop-out)",{"count":131,"type":21},60,[133],"PHASE4","SIDEC - (Subcutaneous Immunoglobulin in De-novo CIDP) ia a study designed as a randomized, parallel study with an open-label extension phase. The aims are to compare the effect of SCIG and IVIG in 60 treatment-naïve CIDP patients, and to detect the lowest effective dosage for maintenance treatment.",[29],[137,138],"Immunoglobulins, Intravenous","Injections, Subcutaneous","2024-05-15",{"date":141,"type":34},"2024-05-17",{"date":143,"type":34},"2020-06-04",{"date":145,"type":21},"2030-12-31",{"name":147,"class":71},"University of Aarhus"]