Alemtuzumab in Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIPD)

NCT01757574 | Withdrawn Phase 4 DMC

• 1 other identifier: CAMIMD01108IST
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The objectives of this study are to determine the safety, tolerability and preliminary efficacy of alemtuzumab for infusion for the treatment of CIDP. Eligible subjects will be treated with alemtuzumab at the beginning of the study and then followed for three years. During the three year period, subjects will under go monthly safety evaluations consisting of blood and urine testing, symptom surveys and examination. Detailed neurological testing including nerve conduction testing, Rasch-built Overall Disability Scale (CIDP/RODS) and Overall Neuropathy Limitations Scale (ONLS) assessments will be performed every six months for three years. The study will also investigate and compare the responsiveness of the outcome measures being used.

Conditions

Chronic Inflammatory Demyelinating Neuropathy

Keywords

CIDP- chronic inflammatory demyelinating neuropathy; demyelinating neuropathy; alemtuzumab

Outcome Measures

Primary Outcomes (1)

• Change from baseline in disability at 36 months measured by GBS/CIDP Rasch-built Overall Disability Scale (GBS/CIDP-RODS).

  The RODS CIDP scale is a validated measure of disability in CIDP/GBS.

  Every six months up to 36 months

Secondary Outcomes (1)

• Change from baseline in disability measured with Overall Neuropathy Limitations Scale (ONLS) at 36 months.

  Every six months up to 36 months

Other Outcomes (1)

• Questionnaire survey

  Monthly up to 36 months

Study Arms (1)

Alemtuzumab

EXPERIMENTAL

Open label study of alemtuzumab

Drug: Alemtuzumab infusion

Interventions

Alemtuzumab infusion DRUG

Alemtuzumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent form (ICF).
• Men or women aged ≥18 years as of the date the ICF is signed.
• Diagnosis of CIDP made by a consultant neurologist with a special interest in peripheral neuropathy. CIDP may be diagnosed in the presence of diabetes or IgG(immunoglobulin- G), IgA and IgM paraproteins without anti- MAG (myelin associated glycoprotein) antibodies. Documentation of the initial diagnosis including definite neurophysiological criteria proposed by INCAT (lnflammatory Neuropathy Cause and Treatment) or EFNS/PNS (European Federation of Neuroscience/Peripheral Nerve Society) must be available for review.
• Ongoing treatment(s) for CIDP to include IVIg (Intravenous immune globulin) or corticosteroids only. Other treatments for CIDP including plasma exchange, azathioprine, methotrexate and mycophenolate must be washed out for 3 months. Cyclophosphamide, rituximab and other monoclonal antibodies must be washed out for 12 months.
• Duration of CIDP \> 6 months prior to the date the ICF is signed.
• Treating neurologist and participant in agreement that alemtuzumab is an appropriate treatment and documents this is in clinical notes.

You may not qualify if:

• Previous treatment with alemtuzumab.
• Participation in a controlled trial of an investigational medicinal product within the past 12 weeks. The duration of required washout will be established based on the known biological and pharmacokinetic properties of the investigational drug (prior treatment with herbal medications or nutritional supplements is permitted).
• Intolerance of pulsed corticosteroids.
• Alternative cause of peripheral neuropathy such as drug or toxin, hereditary neuropathy or concomitant diseases such as HIV infection, Lyme disease, chronic active hepatitis, systemic lupus erythematosus, IgM paraprotein with anti-MAG (myelin associated glycoprotein) antibodies, vasculitis, thyroid dysfunction, hematological and non- hematological malignancies.
• Presence of neurogenic sphincter disturbance.
• Multifocal motor neuropathy (fulfilling EFNS/PNS (European Federation of Neuroscience/Peripheral Nerve Society) criteria).
• Atypical CIDP with pure sensory or persistent uni-focal impairment or significant CNS involvement.
• Active infection, e.g., deep-tissue infection that the Investigator considers sufficiently serious to preclude study participation.
• In the Investigator's opinion, is at high risk for infection (e.g., in-dwelling catheter, dysphagia, decubitus ulcer, history of prior aspiration pneumonia or recurrent urinary tract infection).
• Known infection with or seropositivity for human immunodeficiency virus (HIV).
• Previous or present infection with hepatitis C virus.
• Previous or present infection with hepatitis B (positive hepatitis B serology).
• Prior history of invasive fungal infections.
• Latent tuberculosis, unless effective anti-tuberculosis therapy has been completed, or active tuberculosis
• Cervical high risk human papillomavirus (HPV) positivity or abnormal cervical cytology other than abnormal squamous cells of undetermined significance (ASCUS). The participant may be eligible after the condition has resolved (e.g., follow-up HPV (human papilloma virus) test is negative or cervical abnormality has been effectively treated).

Sponsors & Collaborators

• Johns Hopkins University: lead
• Genzyme, a Sanofi Company: collaborator

Study Sites (1)

The Johns Hopkins Hospital

Baltimore, Maryland, 21231, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2012
• First Posted: December 31, 2012
• Study Start: November 1, 2012
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: May 18, 2017

Record last verified: 2017-05

Locations

US (1)