Phase 3
Completed N=142
Study to Evaluate Safety and Efficacy of Three Different Dosages of NewGam in Patients With Chronic Inflammatory Demyelinating Poly (Radiculo) Neuropathy
Source: ClinicalTrials.gov NCT02638207 ↗Enrolled (actual)
142
Serious AEs
4.2%
Results posted
Feb 2021
Primary outcomePrimary: Decrease in the Inflammatory Neuropathy Cause and Treatment (INCAT) Disability Score — .7971 proportion of subjects
◆ Published Evidence
Established
42citations · ~11 / year
Randomized trial of three IVIg doses for treating chronic inflammatory demyelinating polyneuropathy.
Summary
Study to evaluate the Efficacy and Safety of Three Different Dosages of NewGam in Patients With Chronic Inflammatory Demyelinating Poly(radiculo)neuropathy
Linked Publications (3)
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Randomized trial of three IVIg doses for treating chronic inflammatory demyelinating polyneuropathy.
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Intravenous immunoglobulin for chronic inflammatory demyelinating polyradiculoneuropathy.
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Safety and Tolerability of Intravenous Immunoglobulin in Chronic Inflammatory Demyelinating Polyneuropathy: Results of the ProCID Study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Decrease in the Inflammatory Neuropathy Cause and Treatment (INCAT) Disability Score |
.6471; .7971; .9167 | — |
| SECONDARY Decrease in the Inflammatory Neuropathy Cause and Treatment (INCAT) Disability Score |
.6471; .7971; .9167 | — |
| SECONDARY Grip Strength Score |
.5588; .6522; .8333 | — |
| SECONDARY Inflammatory Rasch-built Overall Disability Scale (I-RODS Score) |
.3824; .5507; .7222 | — |
| SECONDARY Worsening in the Inflammatory Neuropathy Cause and Treatment (INCAT) Disability Score |
NA; NA; NA | — |
| SECONDARY Mean Change in Grip Strength |
23.91; 19.38; 26.06; 23.94; 17.43; 24.53 | — |
| SECONDARY Inflammatory Rasch-built Overall Disability Scale (I-RODS) |
11.38; 10.32; 13.86 | — |
| SECONDARY Motor Nerves |
2.16; 2.69; 3.93 | — |
| SECONDARY Mean Change in Pain Intensity Numerical Rating Scale (PI-NRS Scale) |
-2.29; -2.19; -2.17 | — |
| SECONDARY Worsening on the Inflammatory Rasch-built Overall Disability Scale (I-RODS Scale) |
NA; NA; NA | — |
| SECONDARY 1 Point Decrease in the INCAT Disability Score |
22.0; 26.0; 23.0 | — |
| SECONDARY Decrease in Inflammatory Rasch-built Overall Disability Scale (I-RODS Scale) |
NA; NA; NA | — |
Eligibility Criteria
Inclusion Criteria
- Patients with diagnosis of definite or probable Chronic inflammatory demyelinating polyneuropathy (CIDP) according to the European Federation of Neurological Societies/Peripheral Nerve Society (EFNS/PNS) Guideline 2010 [van den Bergh et al., 2010]; including patients with Multifocal Acquired Demyelinating Sensory And Motor Neuropathy (MADSAM) or pure motor Chronic inflammatory demyelinating polyneuropathy (CIDP )
- Patients currently depending on treatment with immunoglobulins or corticosteroids
- Patients with active disease, i.e. not being in remission, who are progressive or relapsing prior to trial start or during the Wash-out Phase
- Weakness of at least 2 limbs
- >18 to normal value)
- Severe kidney disease (creatinine 1.5x > normal value)
- Hepatitis B, hepatitis C or HIV infection
- Thromboembolic events: patients with a history of deep vein thrombosis (DVT) within the last year prior to baseline visit or pulmonary embolism ever; patients with susceptibility to embolism or deep vein thrombosis (DVT)
- Body mass index (BMI) ≥40 kg/m2
- Patients with uncompensated hypothyroidism (abnormally high Thyroid-Stimulating Hormone [TSH] and abnormally low Thyroxine [T4]) or known vitamin B12 deficiency if patients don't receive adequate substitution therapy
- Medical conditions whose symptoms and effects could alter protein catabolism and/or Immunoglobulin G (IgG) utilization (e.g. protein-losing enteropathies, nephrotic syndrome)
- Known Immunoglobulin A (IgA) deficiency with antibodies to Immunoglobulin A (IgA)
- History of severe hypersensitivity, e.g. anaphylaxis or severe systemic response to immuno-globulin, blood or plasma derived products, or any component of NewGam
- Known blood hyperviscosity, or other hypercoagulable states
- Use of other blood or plasma-derived products within three months prior to Visit 2
- Patients with a past or present history of drug abuse or alcohol abuse within the preceding five years prior to baseline visit
- Patients unable or unwilling to understand or comply with the study protocol
- Participation in another interventional clinical study with investigational medicinal product (IMP) treatment currently or during the three months prior to Visit 2
- Women who are breast feeding, pregnant, or planning to become pregnant, or are unwilling to use an effective birth control method (such as implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), sexual abstinence or vasectomized partner) while on study
Data sourced from ClinicalTrials.gov (NCT02638207) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.