Study to asses if the immunoglobulin product for subcutaneous use in combination with Hyaluronidase has a positive effect on your disease, and if it safe to use. The study will also assess if the intravenous immunoglobulin product has a positive effect and is safe to use.
- Conditions
- Therapeutic area: Diseases [C] - Nervous System Diseases [C10]MedDRA version: 20.0Level: PTClassification code 10057645Term: Chronic inflammatory demyelinating polyradiculoneuropathySystem Organ Class: 10029205 - Nervous system disordersChronic inflammatory demyelinating polyradiculoneuropathy
- Registration Number
- EUCTR2014-005496-87-AT
- Lead Sponsor
- Baxalta Innovations GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 232
1. Males or females of age =18 years old at the time of screening.
2. Subject has a documented diagnosis of definite or probable CIDP (focal atypical CIDP and pure sensory atypical CIDP will be excluded).
3. Subject has responded to IgG treatment in the past, (partial or complete resolution of neurological symptoms and deficits), and must currently be on stable doses of IGIV treatment within the dose range equivalent to a cumulative monthly dose of 0.4 to 2.4 g/kg BW (inclusive) administered intravenously for at least 12 weeks prior to screening. The dosing interval of IGIV treatment must be between 2 to 6 weeks (inclusive). Variations in the dosing interval of up to ±7 days or monthly dose amount of up to ±20% between subject's pre study IgG infusions are within acceptable limits.
4. INCAT disability score between 0 to 7 (inclusive). Subjects with INCAT scores of 0, 1 (whether from upper or lower extremities), or 2 (if at least 1 point is from an upper extremity) at screening and/or baseline will be required to have a history of significant disability as defined by an INCAT disability score of 2 (must be exclusively from the lower extremities) or greater documented in the medical record. Subjects will be eligible if one of the below eligibility criteria are met:
a. Screening and Baseline INCAT disability score of between 3 and 7 inclusive.
b. Screening and/or Baseline INCAT disability score of 2 (both points are from lower extremities)
c. Screening and/or Baseline INCAT disability score of 2 (both points are from lower extremities) AND has at least a score of 2 or greater documented in the clinical record prior to screening. If a score was greater than 2 documented in the medical record prior to screening at least 2 points must be from lower extremities.
d. Screening and/or Baseline INCAT disability score of 0 and 1 AND has at least a score of 2 or greater (both from lower extremities) documented in the medical record prior to screening, at least 2 points must be from lower extremities.
5. If female of childbearing potential, the subject must have a negative pregnancy test at screening and agree to employ a highly effective contraceptive measure throughout the course of the study and for at least 30 days after the last administration of investigational product.
6. Subject is willing and able to sign an Informed Consent Form (ICF).
7. Subject is willing and able to comply with the requirements of the protocol.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 197
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 35
1.Subjects with focal atypical CIDP or pure sensory atypical CIDP.
2. Any neuropathy of other causes, including:
a. Hereditary demyelinating neuropathies, such as hereditary sensory and motor neuropathy (Charcot-Marie-Tooth [CMT] disease), multifocal acquired demyelinating sensory and motor neuropathy (MADSAM), and hereditary sensory and autonomic neuropathies.
b. Neuropathies secondary to infections, disorders, or systemic diseases such as Borrelia burgdorferi infection (Lyme disease), diphtheria, systemic lupus erythematosus, POEMS (polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes) syndrome, osteosclerotic myeloma, diabetic and non-diabetic lumbosacral radiculoplexus neuropathy, lymphoma, and amyloidosis
c. Multifocal motor neuropathy
d. Drug-, biologic-, chemotherapy-, or toxin-induced peripheral neuropathy
3. Immunoglobulin M (IgM) paraproteinemia, including IgM monoclonal gammopathy with high titre antibodies to myelin-associated glycoprotein.
4. Presence of prominent sphincter disturbance.
5. Any central demyelinating disorders such as multiple sclerosis.
6. Any chronic or debilitating disease, or central nervous disorder that causes neurological symptoms or may interfere with assessment of CIDP or outcome measures, including (but not limited to) arthritis, stroke, and Parkinson’s disease and diabetic peripheral neuropathy.
7. The subject has received or is currently receiving treatment with immunomodulatory/immunosuppressive agents within 6 months prior to screening.
8. The subject has received or is currently receiving treatment with corticosteroids within 3 months prior to screening. The following exceptions for prednisolone or its equivalent are allowed: stable dosages of low-dose systemic corticosteroids (=10 mg prednisolone/day or its equivalent) and non-systemic corticosteroids (topical, ophthalmic, or inhaled glucocorticoids). In addition and for the purpose of treating AE or non-CIDP intercurrent disease, a single corticosteroid dose >10 mg prednisolone or a single short-term course of = to 7 days (such as Methylprednisolone Dose Pack) within 3 months prior to screening is allowed.
9. The subject has undergone plasma exchange within 3 months prior to screening.
10. The subject has any disorder or condition that in the investigator’s judgment may impede the subject’s participation in the study, pose increased risk to the subject, or confound the results of the study.
11. The subject is nursing or intends to begin nursing during the course of the study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method