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Chronic Inflammatory Demyelinating Poly(Radiculo)NeuropathyPhase 3CIDPNCT02638207

Study to Evaluate Safety and Efficacy of Three Different Dosages of NewGam in Patients With Chronic Inflammatory Demyelinating Poly (Radiculo) Neuropathy

A Phase 3 study testing NewGam in people with Chronic Inflammatory Demyelinating Poly(Radiculo)Neuropathy, run by Octapharma at 26 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Study to evaluate the Efficacy and Safety of Three Different Dosages of NewGam in Patients With Chronic Inflammatory Demyelinating Poly(radiculo)neuropathy Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
NewGam
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
142 participants
Where
26 sitesin 9 countries
Study dates
27 Sep 2017to 5 Sep 2019
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 <80 years of age
  • Adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) disability score between 2 and 9 (with a score of 2 coming exclusively from leg disability)
  • Voluntarily given, fully informed written consent obtained from patient before any study-related procedures are conducted

Who cannot join

  • Unifocal forms of Chronic inflammatory demyelinating polyneuropathy (CIDP)
  • Pure sensory Chronic inflammatory demyelinating polyneuropathy (CIDP)
  • Multifocal motor neuropathy (MMN) with conduction block [van den Bergh et al., 2010]
  • Patients who previously failed immunoglobulin treatment
  • Treatment with immunomodulatory/suppressive agents (cyclosporin, methotrexate, mitoxantrone, mycophenolate mofetil or azathioprine) during the six months prior to baseline visit
  • Patients on or treated with rituximab, alemtuzumab, cyclophosphamide, or other intensive chemotherapeutic regimens, previous lymphoid irradiation or stem cell transplantation during the 12 months prior to baseline visit
Show all 30Show fewer
  • Respiratory impairment requiring mechanical ventilation
  • Myelopathy or evidence of central nervous system demyelination or significant persisting neurological deficits from stroke, or central nervous system (CNS) trauma
  • Clinical evidence of peripheral neuropathy from another cause such as
  • connective tissue disease or systemic lupus erythematosus (SLE)
  • HIV infection, hepatitis, Lyme disease
  • cancer (with the exception of basal cell skin cancer)
  • IgM paraproteinemia with anti-myelin associated glycoprotein antibodies
  • Diabetic neuropathy
  • Cardiac insufficiency (New York Heart Association [NYHA] III/IV), cardiomyopathy, significant cardiac dysrhythmia requiring treatment, unstable or advanced ischemic heart disease
  • Severe liver disease (ALAT 3x > 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

Trial locations and contacts

26 sites in 9 countries.

26 sites in 9 countries

Russia5 sites

  • Republican Clinical Neurological Centre

    Kazan', 420021

  • Neurology Research Centre

    Moscow, 125367

  • Nizhny Novgorod Regional Clinical Hospital N.A. N.A.Semashko

    Nizhny Novgorod, 603126

  • National Medical Research Centre of Psychiatry and Neurology n.a. V.M.Bekhterev

    Saint Petersburg, 192019

  • City Multifield Hospital #2

    Saint Petersburg, 194354

Other trials in Russia

Ukraine5 sites

  • Ivano Frankivsk National Medical University

    Ivano-Frankivsk, 76008

  • National Medical Academy Of Postgraduate Education Named After P.L. Shupyk

    Kyiv, 4112

  • Volyn Regional Clinical Hospital

    Lutsk, 4300

  • Vinnytsia National Medical University

    Vinnytsia, 21005

  • Municipal Institution Zaporizhzhya Regional Clinical Hospital

    Zaporizhzhya, 69600

Other trials in Ukraine

Czechia3 sites

  • Outpatient Clinic of Neurology

    Hradec Králové, 500 03

  • Regional Hospital Pardubice

    Pardubice, 532 03

  • Thomayer Faculty Hospital

    Prague, 140 00

Other trials in Czechia

Poland3 sites

  • Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie Klinika Neurologii

    Lublin, 20-954

  • Wojewodzki Szpital Specjalistyczny W Olsztynie

    Olsztyn, 10-561

  • Uniwersytecki Szpital Kliniczny

    Wroclaw, 50-556

Other trials in Poland

Romania3 sites

  • Theo Health S.R.L.

    Brasov, 500091

  • Institutul Clinic Fundeni

    Bucharest, 022328

  • Spitalul Clinic Judetean de Urgenta "Sf.Apostol Andrei" Constanta

    Constanța, 900591

Other trials in Romania

Bulgaria2 sites

  • MHAT Puls EOOD

    Blagoevgrad, 2700

  • St. Naum Hospital

    Sofia, 1797

Other trials in Bulgaria

Canada2 sites

  • Octapharma Research Site

    Montreal, H3A2B4

  • Toronto General Hospital

    Toronto, Ontario, M5G 2C4

Other trials in Canada

Hungary2 sites

  • Jahn Ferenc Del Pesti Korhaz

    Budapest, 1204

  • Szegedi Tudományegyetem ÁOK Neurológiai Klinika

    Szeged, 6725

Other trials in Hungary

Germany1 site

  • University Medical Center Goettigen

    Goettigen, 37075

Other trials in Germany

About this study

Official title: Prospective, Double-blind, Randomized, Multicenter Phase III Study Evaluating Efficacy and Safety of Three Different Dosages of NewGam in Patients With Chronic Inflammatory Demyelinating Poly(Radiculo)Neuropathy

Study to evaluate the Efficacy and Safety of Three Different Dosages of NewGam in Patients With Chronic Inflammatory Demyelinating Poly(radiculo)neuropathy

Read the detailed description

Prospective, Double-blind, Randomized, Multicenter Phase III Study Evaluating Efficacy and Safety of Three Different Dosages of NewGam in Patients With Chronic Inflammatory Demyelinating Poly(radiculo)neuropathy ("ProCID trial")

Being tested
NewGam
Keywords
Chronic Inflammatory Demyelinating Poly Neuropathy (CIDP)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NewGamDrug

    Also called Panzyga

    In the Dose-evaluation Phase, all patients will receive a loading dose of 2.0 g/kg Newgam (administered over two consecutive days), followed by seven infusions of the maintenance dose the patient has been randomized to (0.5, 1.0 or 2.0 g/kg NewGam), also administered over two consecutive days every 3 weeks (±4 days). If a patient is randomized to receive the low or medium NewGam dose, the same volume with the same infusion rate as would have been applied in case the patient would have been randomized to 2.0 g/kg NewGam will be used, thus supplemented with an authorized 0.9% w/v isotonic sodium chloride solution as appropriate and detailed in the following infusion bag split to maintain the blinding

Study groups in NCT02638207
Study groupRoleWhat they receive
0.5 g/kg NewGamExperimentalAll patients will receive a loading dose of 2.0 g/kg Newgam (administered over two consecutive days), followed by seven infusions of the maintenance dose the patient has been randomized to (0.5g/kg NewGam), also administered over two consecutive days every 3 weeks (±4 days).
Receives: Drug: NewGam
1.0 g/kg NewGamExperimentalAll patients will receive a loading dose of 2.0 g/kg Newgam (administered over two consecutive days), followed by seven infusions of the maintenance dose the patient has been randomized to (1.0g/kg NewGam), also administered over two consecutive days every 3 weeks (±4 days).
Receives: Drug: NewGam
2.0 g/kg NewGamExperimentalAll patients will receive a loading dose of 2.0 g/kg Newgam (administered over two consecutive days), followed by seven infusions of the maintenance dose the patient has been randomized to (2.0g/kg NewGam), also administered over two consecutive days every 3 weeks (±4 days).
Receives: Drug: NewGam

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Decrease in the Inflammatory Neuropathy Cause and Treatment (INCAT) Disability Score

    Efficacy - Proportion of responders in the 1.0 g/kg NewGam arm at Week 24 (Termination Visit) relative to baseline (Week 0). A responder being defined as a patient with a decrease of at least 1 point on the adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) disability score (a scale from 0 to 10, from healthy to unable to make any purposeful movements with arms and/or legs)

    Measured: at Week 24

Secondary outcomes (11)

  1. Decrease in the Inflammatory Neuropathy Cause and Treatment (INCAT) Disability Score

    Proportion of responders in the 0.5 g/kg and 2.0 g/kg NewGam arms at Week 24 relative to baseline compared to the 1.0 g/kg arm, based on the adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) disability score

    Measured: at Week 24

  2. Grip Strength Score

    Proportion of responders in the 0.5 g/kg and 2.0 g/kg NewGam arms at Week 24 relative to baseline at Week 0 compared to the 1.0 g/kg arm, based on the grip strength (Martin Vigorimeter) using the previously published minimum clinically important difference (MCID) cut-off of 8 kilopascal (kPa)

    Measured: at Week 24

  3. Inflammatory Rasch-built Overall Disability Scale (I-RODS Score)

    Proportion of responders in the 0.5 g/kg and 2.0 g/kg NewGam arms at Week 24 relative to baseline at Week 0 compared to the 1.0 g/kg arm, based on the Inflammatory Rasch-built overall disability scale (I-RODS Score) using the MCID concept related to the varying standard errors (MCID-SE) as recently demonstrated

    Measured: at Week 24

  4. Worsening in the Inflammatory Neuropathy Cause and Treatment (INCAT) Disability Score

    Time to first confirmed worsening on the adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) disability scale by at least 1 point from the value at baseline (Week 0)

    Measured: Week 24

  5. Mean Change in Grip Strength

    Mean change from baseline (Week 0) to Termination Visit in grip strength of both hands (assessed by Martin vigorimeter). The reported change was calculated from two time points as the value at the later time point minus the value at the earlier time point.

    Measured: Up to 24 weeks

  6. Inflammatory Rasch-built Overall Disability Scale (I-RODS)

    Mean change from baseline (Week 0) to Termination Visit in Inflammatory Rasch-built overall disability sum score (I-RODS using the concept of MCID-SE as recently reported) and number of improvers. The reported change was calculated from two time points as the value at the later time point minus the value at the earlier time point.

    A scale from 0 to 48, from "Not possible to perform" to "Possible without any difficulty". Higher values represent a better outcome.

    Measured: Up to 24 weeks

  7. Motor Nerves

    Mean change from baseline (Week 0) to Termination Visit in sum of the distal evoked amplitude of 4 right sided and 4 left sided motor nerves (peroneal, tibial, ulnar and median). The reported change was calculated from two time points as the value at the later time point minus the value at the earlier time point.

    Measured: Up to 24 weeks

  8. Mean Change in Pain Intensity Numerical Rating Scale (PI-NRS Scale)

    Mean change from baseline (Week 0) to Termination Visit in Pain Intensity Numeric Rating Scale (PI-NRS). The reported change was calculated from two time points as the value at the later time point minus the value at the earlier time point.

    The Pain Intensity Numeric Rating Scale (PI-NRS, a numeric scale where 0 = no pain and 10 = worst possible pain) is an 11-point scale for patient self-reporting of pain. A higher value represents a worse outcome.

    Measured: Up to 24 weeks

  9. Worsening on the Inflammatory Rasch-built Overall Disability Scale (I-RODS Scale)

    Time to first confirmed worsening on the I-RODS scale. The reported change was calculated from two time points as the value at the later time point minus the value at the earlier time point. A scale from 0 to 48, from "Not possible to perform" to "Possible without any difficulty". Higher values represent a better outcome.

    Worsening is determined using the concept of MCID (minimum clinically important difference) using the individually obtained standard errors (MCID-SE).

    Measured: 24 weeks

  10. 1 Point Decrease in the INCAT Disability Score

    Time to 1 point decrease (improvement of disability) in adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) disability score

    Measured: 24 weeks

  11. Decrease in Inflammatory Rasch-built Overall Disability Scale (I-RODS Scale)

    Time to decrease in Inflammatory Rasch-built overall disability scale (I-RODS) scores

    Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Dec 2015 (estimated)
  2. Study start27 Sep 2017
  3. Primary completion5 Sep 2019
  4. Study completion5 Sep 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
142 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02638207
Sponsor's protocol ID
NGAM-08
Acronym
CIDP
Status last verified
Jan 2021
First submitted
16 Dec 2015
Last updated
16 Feb 2021
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bus SR, de Haan RJ, Vermeulen M, van Schaik IN, Eftimov F. Intravenous immunoglobulin for chronic inflammatory demyelinating polyradiculoneuropathy. Cochrane Database Syst Rev. 2024 Feb 14;2(2):CD001797. doi: 10.1002/14651858.CD001797.pub4.

    PubMed 38353301

  • Cornblath DR, van Doorn PA, Hartung HP, Merkies ISJ, Katzberg HD, Hinterberger D, Clodi E; ProCID Investigators. Safety and Tolerability of Intravenous Immunoglobulin in Chronic Inflammatory Demyelinating Polyneuropathy: Results of the ProCID Study. Drug Saf. 2023 Sep;46(9):835-845. doi: 10.1007/s40264-023-01326-z. Epub 2023 Jun 28.

    PubMed 37378806

  • Cornblath DR, van Doorn PA, Hartung HP, Merkies ISJ, Katzberg HD, Hinterberger D, Clodi E; ProCID Investigators. Randomized trial of three IVIg doses for treating chronic inflammatory demyelinating polyneuropathy. Brain. 2022 Apr 29;145(3):887-896. doi: 10.1093/brain/awab422.

    PubMed 35038723

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing NewGam in people with Chronic Inflammatory Demyelinating Poly(Radiculo)Neuropathy, run by Octapharma at 26 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in Russia, Ukraine, Czechia, Poland, Romania and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Decrease in the Inflammatory Neuropathy Cause and Treatment (INCAT) Disability Score (time frame: at Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02638207, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2021.

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