IVIG vs SCIG in CIDP
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorRutgers, The State University of New Jersey
About this trial
Current dosing practices for immunoglobulin G (IgG) may be inadequate in extreme body weight. The current study will evaluate the influence of body composition on intravenous and subcutaneous administration of immunoglobulin G in patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged >18 years with a current diagnosis of CIDP (based on European Federation of Neurological sciences / Peripheral Nerve Society CIDP diagnostic criteria).
1:1 conversion of IVIG to SCIG (weekly dose conversion) must fall within 0.2-to-0.4 mg/kg dose for SCIG.
Disqualifiers
Patients receiving IVIG for indications other than CIDP will be excluded.
Patients with liver impairment (elevations in liver enzymes of greater than 3 times the upper limit of normal) or reduced renal function (CrCl < 50 mL/min) will be excluded
Active malignancies
Diabetes
Trial design
Design model
Crossover
Treatments tested in this trial
Intravenous immune globulin G
DrugIntravenous immune globulin G dosed based on the subjects's current dose received for the treatment of CIDP.
Subcutaneous immune globulin G
DrugSubcutaneous immune globulin G converted from the subject's current IVIG dose 1:1.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Intravenous immune globulin GExperimental treatment 1 intervention
Group B: Subcutaneous immune globulin GExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Assessment of drug half-life
Calculation of drug half-life based on data obtained from serum samples
Time frame
Through study completion, an average of 4 weeks2
Assessment of immune globulin G serum concentration after intravenous immune globulin G administration
Serum IgG concentration (including subtype) will be measured using a human IgG ELISA kit
Time frame
Just before drug administration, immediately after drug administration, approximately days 7 and 14 post drug administration3
Assessment of immune globulin G serum concentration after subcutaneous immune globulin G administration
Serum IgG concentration (including subtype) will be measured using a human IgG ELISA kit
Time frame
Just before drug administration, immediately after drug administration, approximately days 2, 4 and 7 post drug administrationSecondary outcomes
1
Assessment of grip strength
Grip strength will be measured using the handheld Martin Vigorimeter just before each dose of IgG is administered during the study period. Subjects will be asked to squeeze the dynamometer as hard as possible with each of his or her hands in a standing position.
Time frame
Baseline and just before administration of next immune globulin dose.2
Assessment of muscle function
The Medical Research Council (MRC) system for testing and grading of muscle function aims to provide a standardized and objective way to assess muscle function. It was originally introduced in 1943 and has a long history of use in neurology, rehabilitation and general medicine examinations. Assessments of muscles are done bilaterally, meaning that for each muscle tested, the same muscle on the opposite side of the body is also tested. The MRC sum score is finally calculated by adding the score of each individually assessed muscle. The MRC score ranges from 0 - 30 with 0 as the worst outcome.
Time frame
Baseline and just before administration of next immune globulin dose.3
Assessment of patient disability
The Rasch Overall Disability scale (I-RODS) and the Inflammatory Neuropathy Cause and Treatment Sensory (INCAT) sum score disability scale will be completed before the infusion of IgG. The I-RODS score can range from 0 to 48 with 0 representing the greatest disability. The INCAT score ranges from 0 - 10 with 10 representing worse outcome.
Time frame
Baseline and just before administration of next immune globulin dose.4
Assessment of fatigue
Fatigue is a common patient concern in CIDP and the Rasch-built fatigue severity scale (R-FSS) will be completed before the infusion of IgG. The R-FSS ranges from 9 to 63 with 63 being the worst score
Time frame
Baseline and just before administration of next immune globulin dose.Sponsors and contacts
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Source ClinicalTrials.gov