Neoplasms

Nervous System Diseases

Immune System Diseases

All Conditions

Musculoskeletal Diseases

Symptoms and General Pathology

Rare Diseases

Myasthenia Gravis

Muscle Weakness

Paresis

Asthenia

Muscular Diseases

Neuromuscular Manifestations

Neurologic Manifestations

Syndrome

Paraneoplastic Syndromes

Paraneoplastic Syndromes, Nervous System

Nervous System Neoplasms

Autoimmune Diseases

Autoimmune Diseases of the Nervous System

Neurodegenerative Diseases

Neuromuscular Junction Diseases

Neuromuscular Diseases

All Drugs and Chemicals

Antibodies

Immunoglobulins

Immunoglobulins, Intravenous

gamma-Globulins

Rho(D) Immune Globulin

Immunoglobulin G

Immunologic Factors

This group of MG patients will start with 2g/kg of IVIG on month 1, 1 g/kg of IVIG 4 and then 8 weeks later, and within 2 weeks switch to SCIG treatment

This group of MG patients will start with SCIG alone

subcutaneous immunoglobulin (SCIG)

10% intravenous immunoglobulin + 20% subcutaneous immunoglobulin

intravenous immunoglobulin + subcutaneous immunoglobulin (SCIG)

Eduardo Ng, MD

Hans Katzberg, MD

This is a prospective open-label, randomized, parallel arm clinical trial.

The primary objective of the study is to evaluate the safety and efficacy of Cuvitru 20% subcutaneous immunoglobulin in patients with myasthenia gravis (MG). The secondary objective is to evaluate patient preferences and effects on quality of life when treating MG patients with SCIG. Exploratory objectives are to compare de novo administration starting SCIG directly with those starting with a loading dose of IVIG followed by SCIG administration.

Patients over age 18 with moderate to severe MG with MGFA Class II-IV without contraindications to immunoglobulin will be considered for the study.

All patients will be eligible to enter either arm of the study, Arm 1: 10% Gammagard IVIG followed by 20% Cuvitry SCIG and Arm 2: Cuvitru 20% SCIG alone.

Myasthenia gravis (MG) is an autoimmune neuromuscular condition which can cause fatigable weakness of skeletal muscles including bulbar, ocular, limb, axial and respiratory muscles. Symptoms range from mild, transient double vision and ptosis to severe, life threatening diffuse weakness, and treatments which are immunosuppressive or immunomodulatory have been shown to improve outcome in MG. This includes 10% intravenous immunoglobulin (IVIG), which has previous been shown by our group to improve strength at 2 and 4 weeks in patients with MG. Due to delay in the onset of many immunosuppressives and potential side effects from steroids and other immunosuppressive medications, IVIG is also used in clinical practice as bridging of maintenance therapy until other therapies take effect or the patient stabilizes. In addition, there have been other studies suggesting that 20% subcutaneous immunoglobuin (SCIG) can be helpful to improve strength in patients with MG over a relatively short period of time (6 weeks). Some of these studies are ongoing and are further evaluating the ability of IVIG and SCIG to stabilize or improve strength IVIG in patients with MG, however, there is no current published study evaluating different administration routes of immunoglobulin (IVIG and SCIG) in patients with MG over a longer 6 month follow-up period.

The current study aims to be the first to evaluate 20% Cuvitru SCIG formulation in patients with neuromuscular conditions including MG. The study aim is to evaluate the safety and efficacy of 6 months of 20% SCIG Cuvitru treatment vs three months of 10% IVIG "pre-treatment" followed by 3 months of 20% SCIG Cuvitru treatment. The study will also be the first to use the myasthenia gravis impairment index (MGII) as primary outcome in conjunction with standard MG outcomes.

Subcutaneous Immunoglobulin for Myasthenia Gravis

Efficacy and Safety of Subcutaneous Immunoglobulin in Patients With Myasthenia Gravis

Change in the Myasthenia Gravis Impairment Index (score 0-84, with 84 being the maximal score indicating the most severe MG status) at baseline compared to end of study

Change in the Quantitative Myasthenia Gravis Score (score 0-39, with 39 indicating the most severe clinical findings related to MG) at baseline compared to end of study

Change in the MG Activities of Daily Living (score 0-24, with 24 indicating the most severe clinical findings related to MG) at baseline compared to end of study

Change in the Myasthenia Gravis Composite Score (score 0-50, with 50 indicating the most severe clinical findings related to MG) at baseline compared to end of study) at baseline compared to end of study

Change in the 15-Item Myasthenia Gravis Quality of Life Score (score 0-45, with 45 indicating the most severe clinical findings related to MG) at baseline compared to end of study) at baseline compared to end of study

All the above outcomes including the myasthenia gravis impairment index, quantitative myasthenia gravis score, myasthenia gravis activities of daily living, myasthenia gravis composite score, myasthenia gravis quality of life 15 score in patients receiving de novo administration starting SCIG directly with those starting with a loading dose of IVIG followed by SCIG administration will be compared.

o evaluate the adverse event profile of high dose (20% Cuvitru) SCIG in MG and compare this with existing published adverse events of 20% high-dose SCIG in neuromuscular diseases. Specifically the total number of adverse events as defined in Part C, Division 5 of the Health Canada Food and Drug Regulations will be compared to existing published adverse events of 20% SCIG and the total number of adverse events occuring in the IVIG vs SCIG arms will also be compared.

University Health Network, Toronto

Neurologist, Principle Investigator

Infections

Epilepsy

Drug Resistant Epilepsy

Encephalitis

Seizures

Epilepsies, Partial

Limbic Encephalitis

Brain Diseases

Central Nervous System Diseases

Neuroinflammatory Diseases

Virus Diseases

Central Nervous System Viral Diseases

Communicable Diseases

Central Nervous System Infections

Autoantibodies

IVIG 2 mg/kg in two divided doses with placebo crossover

IVIG

Charles M. Epstein, M.D.

The purpose of the initial screening study is to find out if immune problems are an unrecognized cause of epilepsy in some patients. This study consists of a single blood sample, which will be tested for possible immune abnormalities. If enough patients are found who show immune abnormalities, those patients who are still having uncontrolled seizures will be invited to participate in a study of immune treatment with a compound called intravenous immunoglobulin (IVIG).

The study hypothesis is that a significant proportion of the young-onset, refractory, image-negative, partial-onset epilepsy population have an underlying autoimmune disorder, and many of these patients will respond to immune therapies, including IVIG.

At present, the importance of immune abnormalities in causing epilepsy, and the proper treatment when they are found, are both poorly understood. The investigators hope that this study will help us understand the cause of some cases that are difficult to treat.

The study is divided into two phases:

Phase I: The investigators will screen for evidence of neuronal nuclear, cytoplasmic, and cell surface autoantibodies in our population of new onset refractory, imaging-negative young adult epilepsy patients. This part of the study involves obtaining a single blood sample, equal to about 2 teaspoons.

Phase 2: If a sufficient number of cases are identified, a double-blind crossover study of IVIG treatment will be performed in these patients.

IVIG Treatment for Refractory Immune-Related Adult Epilepsy

neuronal nuclear, cytoplasmic, and cell surface autoantibodies

Baxter Healthcare Corporation

Emory University

Professsor of Neurology - Divsion of Epilepsy

IVIG

IVIG: IVIG 2 mg/kg in two divided doses with placebo crossover

No AE's.

All Subjects

IVIG

IVIG: IVIG 2 mg/kg in two divided doses with placebo crossover

Age, Categorical

Sex: Female, Male

United States

Region of Enrollment

Study was terminated early. Subject eligibility for phase 2 not available.

Dr. Charles M. Epstein

No analysis occurred and study was terminated early due to subject numbers not eligible for the 2nd phase of the study.

Immune Abnormalities

Overall Study

Intravenous Immunoglobulin, 2G/Kg, infused over 2 days in the Medical Day Unit of the University Health Network

Patients received one plasma volume plasma exchanges with 5% albumin replacement fluid. Five plasma exchange procedures occurred every second day with breaks over the weekend allowed. Patients treated in the apheresis units at the University Health Network.

Plasma exchange: removal of pathogenic antibodies and constituents and replacement with albumin.

PLEX

Vera Bril, BSc, MD, FRCPC

David Barth, MD

Immunomodulation is effective in treating patients with myasthenia gravis (MG), but prior studies have not adequately defined if plasma exchange (PLEX) in superior to intravenous immunoglobulin (IVIG) in the treatment of myasthenia gravis. This study aimed to determine if PLEX was superior to IVIG in the treatment of patients with myasthenia gravis.

Patients with MG requiring immunomodulation are randomized to IVIG or PLEX and treated with a full course of immunomodulation. The quantitative myasthenia gravis score (QMGS) will be evaluated as the primary efficacy parameter at day 14 to determine if PLEX is superior to IVIG.

Intravenous Immunoglobulin and Plasma Exchange in Myasthenia Gravis

A Randomized Trial of Plasma Exchange vs. IVIG in the Treatment of Myasthenia Gravis

QMGS is a validated clinical measure of myasthenia gravis ranging from 0 points (no myasthenic weakness) to a maximum of 39 points, with a defined change of 3.4 units required for clinical significance.

Change in QMGS with time to see if effect ad day 14 is sustained.

Categorical scale of improvement, worsening, or no change for myasthenia gravis.

Electrophysiological assessment of neuromuscular transmission.

Laboratory measure of pathogenic antibody

Grifols Therapeutics LLC

Vera Bril

Diseases and Abnormalities at or Before Birth

Neoplasm Metastasis

Immunologic Deficiency Syndromes

Primary Immunodeficiency Diseases

Neoplastic Processes

Genetic Diseases, Inborn

Adults with primary or secondary immunodeficiency for whom human immunoglobulin-assisted recombinant human hyaluronidase treatment is initiated

Data record and questionnaires passation (SF36)

Data record and questionnaires passation

Amélie SERVETTAZ

Gauthier LEJEUNE

Primary immunodeficiencies (PID) represent more than 150 diseases affecting the immune system. More than 50% of PIDs are due to a lack or an insufficiency in antibody production. Some of these immunodeficiencies as well as some secondary immune deficiency with deficient antibody production (especially in hematology and oncology) are responsible for repeated and/or severe infections, requiring long-term replacement therapy with intravenous polyclonal immunoglobulin. Intravenous replacement therapy is administered every 21 or 28 days in hospital. Subcutaneous administration (weekly or bi-weekly) can be initiated for patients who cannot tolerate intravenous infusions or who have difficult venous access. However, some patients experience a decrease in quality of life with these more frequent administration at home. A new treatment is available in France since 2017, which is a subcutaneous infusion of human immunoglobulin facilitated by recombinant human hyaluronidase (IGHy), administered every 3 to 4 weeks in a single abdominal site, at home. No direct data are available in adults to evaluate tolerance and satisfaction with this treatment, but we know it is a preferred option in children and adolescents.

The objective of the study is to describe the continuation of the human immunoglobulin-assisted recombinant human hyaluronidase (IGHy) therapy at 6 months from the start of treatment.

The secondary objectives are to evaluate the quality of life of patients treated with human immunoglobulin-assisted recombinant human hyaluronidase (IGHy) therapy.

Tolerance and Patients' Satisfaction With IGHy

Tolerance and Patients' Satisfaction of Subcutaneous Infusion of Human Immunoglobulin Facilitated by Recombinant Human Hyaluronidase for Primary or Secondary Immunodeficiency

Percentage of patients continuing IGHy treatment at 6 months

quality of life assessed by the SF-36. The Medical Outcomes Short-Form 36-Item Health Survey (SF-36v2) is a self-administered questionnaire comprising 36-items measuring eight dimensions of general HRQOL: physical functioning (10 items), role limitation due to physical health problems (4 items), bodily pain (2 items), general health perceptions (5 items), vitality (4 items), social functioning (2 items), role limitations due to emotional problems (3 items), and general mental health (5 items). In addition to scores for individual dimensions, two summary scores assessing physical and mental dimensions of health and well-being can also be calculated: Physical Component Summary (PCS) score and the Mental Component Summary (MCS) score, respectively

CHU de Reims

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Skin and Connective Tissue Diseases

Digestive System Diseases

Prostatic Neoplasms

Melanoma

Urologic Neoplasms

Colonic Neoplasms

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Urologic Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Neuroendocrine Tumor

Neuroepithelioma

Herbal and Botanical

Cola

Biological Therapy

Jacob Schachter, M.D

Dov Barak, R.N.

Jacob Schachter, M.D.

Dan Aderka

Dan Aderka, M.D

Alberto Gabison, M.D.

Rama Sapir, M.Sc.

Dan Aderka, M.D.

The purpose of this study is to evaluate the safety and efficacy of IVIG in the treatment of metastatic cancer of the prostate, colon and melanoma.

This study is a one arm, open label, multi-center, phase II study. Its aim is to evaluate the safety and efficacy of IVIG administered as treatment for metastasis solid tumors. IVIG was proven as affecting the growth of tumor metastasis in animals' models.

Study population is including male or female, 18 and older, diagnosed as having a primary tumor (colon, melanoma or prostate) with measurable metastasis (according to the RECIST criteria) in soft tissues and/ or tumor markers in prostate cancer, for which there is no better alternate treatment.

The patients receive the IVIG calculated as 1g/kg/bodyweight per cycle (defined as every 21 days) until progression disease is noted. All patients are being followed for a period of 6 months after patient's withdrawal.

IVIG in the Treatment of Metastatic Cancers of the Prostate, Colon and Melanoma

A One Arm, Open Label,Multi - Center Phase II Study to Evaluate the Safety and Efficacy of IVIG in the Treatment of Various Metastatic Solid Tumors for Which There is no Better Alternate Treatment

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Subcutaneous Immunoglobulin for Myasthenia Gravis	NCT04728425	Myasthenia Grav...	subcutaneous im... intravenous imm...	18 Years - 100 Years	University Health Network, Toronto
IVIG Treatment for Refractory Immune-Related Adult Epilepsy	NCT01545518	Epilepsy, Crypt... Epilepsy, Parti... Seizure Disorde... Autoimmune Dise... Limbic Encephal...	IVIG	18 Years - 50 Years	Emory University
Subcutaneous Immunoglobulin for Myasthenia Gravis	NCT04728425	Myasthenia Grav...	subcutaneous im... intravenous imm...	18 Years - 100 Years	University Health Network, Toronto
Intravenous Immunoglobulin and Plasma Exchange in Myasthenia Gravis	NCT01179893	Myasthenia Grav...	IVIG PLEX	18 Years -	University Health Network, Toronto
Tolerance and Patients' Satisfaction With IGHy	NCT03668288	Secondary or Pr...	Data record and...	18 Years -	CHU de Reims
IVIG in the Treatment of Metastatic Cancers of the Prostate, Colon and Melanoma	NCT00294476	Cancer of Colon Malignant Melan... Urologic Cancer	IVIG Biological Ther...	18 Years -	GammaCan
Intravenous Immunoglobulin and Plasma Exchange in Myasthenia Gravis	NCT01179893	Myasthenia Grav...	IVIG PLEX	18 Years -	University Health Network, Toronto

Spots Global Cancer Trial Database for ivig

Every month we try and update this database with for ivig cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for ivig

Every month we try and update this database with for ivig cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for ivig cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.