Multiple Sclerosis, Relapsing-RemittingPhase 2PRIVIGNCT00220779
Immune Globulin Intravenous (IGIV) To Treat Relapsing, Remitting Multiple Sclerosis
A Phase 2 study testing Immune Globulin IV [Human], 10% Caprylate/Chromatography Purified and Albumin (Human) 25%, United States Pharmacopeia (USP) in people with Multiple Sclerosis, Relapsing-Remitting, run by Grifols Therapeutics LLC at 37 sites in 12 countries.
Trial summary
The trial will study 2 doses of Immune Globulin Intravenous (Human), 10% Caprylate/Chromatography Purified (IGIV-C) for the number of relapses that occur in a 1 year treatment period. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Multiple Sclerosis, Relapsing-Remitting
- What is being tested?
- Immune Globulin IV [Human], 10% Caprylate/Chromatography Purified and Albumin (Human) 25%, United States Pharmacopeia (USP)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 37 sitesin 12 countries
- Study dates
- Dec 2002to Feb 2005
- Phase
- Phase 2
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Symptoms consistent with Multiple Sclerosis up to 5 years
- Diagnosis of multiple sclerosis according to McDonald criteria.
- Diagnosis of relapsing-remitting (RR) multiple sclerosis (MS) (Defined as periods of worsening of neurological function with full recovery or with sequelae and residual deficit upon recovery; periods between disease relapses characterized by lack of disease progression
- Kurtzke Extended Disability Status Scale (EDSS) < 5.0
- At least 1 defined and documented relapse during the last year. Prior relapses where symptoms were due solely to a change in Bowel/Bladder Function or Cognitive Function will not be considered relapses as defined by this protocol and therefore not counted for inclusion into the study.
- Females or males; females of childbearing potential must use adequate contraception
Show all 10Show fewer
- Clinically stable for at least 30 days prior to entry
- At least 9 hyperintense T2 lesions on MRI or 1 Gd-enhancing lesion according to McDonald/Barkhof dissemination-in-space criteria at entry
- Patients who have been informed about available treatments and decided, not to go on these treatments
- Written informed consent obtained prior to the initiation of any study related procedures
Who cannot join
- Females who are pregnant, breast feeding, or if, of childbearing potential, unwilling to practice adequate contraception throughout the study
- Prior therapy with azathioprine or any immunosuppressant agents within 6 months prior to study entry
- Prior steroid, methylprednisolone or adrenocorticotropic hormone (ACTH) therapy within 30 days prior to study entry
- Therapy with interferons (Betaseron®, Avonex®, Rebif®), glatiramer acetate (Copaxone®) or IGIV within 3 months prior to study entry or during the study
- Use of an investigational compound within 6 months prior to study entry
- Previous lymphoid irradiation or prior to treatment with cyclophosphamide, methotrexate or mitoxantrone
Show all 12Show fewer
- Cardiac insufficiency (NYHA III/IV), cardiomyopathy, significant cardiac dysrhythmia requiring treatment, unstable or advanced ischemic heart disease (CCS III or IV), or malignant hypertension
- History of renal insufficiency or serum creatinine levels greater than 2.5 mg/dL (221 µmol/L)
- Known selective immunoglobulin A (IgA) deficiency or known antibodies to IgA
- Conditions whose symptoms and effects could alter protein catabolism and/or immunoglobulin G (IgG) utilization (e.g., protein-losing enteropathies, nephrotic syndrome)
- Any medical, psychiatric or other circumstances which impede or restrict the patient's participation in the study or any contraindication to contrast enhanced MRI (e.g.,pacemaker, aortic clip or any metal implant)
- Patients with clinically significant medical conditions including, but not limited to cardiac, pulmonary, hepatic, hematological (e.g. known coagulation disorder, history of deep venous thrombosis and/or pulmonary embolism), endocrine,or renal dysfunction, autoimmune disorders, severe environmental allergies or chronic infections
Trial locations and contacts
37 sites in 12 countries.
37 sites in 12 countries
Germany7 sites
Medizinische Einrichtungen der Heinrich Heine Universitat, Neurologische Klinik
Düsseldorf, 40225
HELIOS Klinikum Erfurt GmbH, Klinik und Poliklinik fur Neurologie
Erfurt, 99089
Klinikum der Justus-Liebig-Universitat, Zentrum fur Neurologie und Neurochirurgie
Giessen
Universitatsklinikum Munster, Klinik und Poliklinik fur Neurologie
Münster, 48149
Klinikum Osnabrück GmbH
Osnabrück, 49076
Universitatsklinikum Ulm, Poliklinik fur Neurologie
Ulm, 89075
Klinijum der Universitat Wurzburg, Neurologische Klinik und Poliklinik
Würzburg
United States6 sites
Neurology Health Care Service, Fletcher Allen Health Care
Burlington, Vermont, 05401
The Mt. Sinai Medical Center, Department of Neurology
New York, New York, 10029
Barrow Neurological Institute at St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013
SUNY Health Science Center at Stony Brook, Department of Neurology
Stony Brook, New York, 11794-8121
Northwest NeuroSpecialists, PLLC
Tucson, Arizona, 85741-3537
Wake Forest University - School of Medicine
Winston-Salem, North Carolina, 27157
Canada4 sites
Foothills Hospital
Calgary, Alberta, T2N 2T9
London Health Sciences Centre
London, Ontario, N6A 5A5
CHUM Hospital Notre Dame
Montreal, Quebec, H2L4M1
The Ottawa Hospital, General Campus - Neurology Division
Ottawa, Ontario, K1H 8L6
Czechia4 sites
Fakultni nemocnice Brno-Bohunice
Brno, 63900
St. Anna's Teaching Hospital
Brno, 65691
Všeobecná fakultní nemocnice
Prague, 12808
Department of Neurology, Motol Teaching Hospital
Prague, 15600
Hungary4 sites
Szent Imre Korhaz Neurologia
Budapest, 115
Uzsoki Street Hospital
Budapest, H-1145
Jahn Ferenc Delpesti Teaching Hospital
Budapest, H-1204
Szeged University of Science
Szeged, H-5720
Poland4 sites
Katedra I Klinika Neurologii; Slaskiej Akademii Medycznej, Samodzielny Publiczny Centralny Szpital Kliniczny
Katowice-Ligota, 40-752
Katedra I Klinika Neurologii, Univerytetu Medycznego w Lodzi
Lodz, 90-153
Katedra I Klinika Neurologii
Lublin, 20-954
Klinika Neurologiczna, Wojskowy Instut Medyczny
Warsaw, 00-909
Slovakia2 sites
Fakultna menocnica Bratislava
Bratislava, 83-305
Dererova nemocnica s Poliklinikou Nerologicka Klinika
Bratislava, 833 05
United Kingdom1 site
University Hospital, Queens Medical Centre
Nottingham, NG7 2UH
About this study
Official title: Randomized, Double-Blind, Placebo-Controlled Study to Compare the Effects of Different Dose Regimens of IGIV Chromatography (IGIV-C), 10% Treatment on Relapses in Patients With Relapsing Remitting Multiple Sclerosis
The trial will study 2 doses of Immune Globulin Intravenous (Human), 10% Caprylate/Chromatography Purified (IGIV-C) for the number of relapses that occur in a 1 year treatment period.
Read the detailed description
This trial is designed as a multi-national, randomized, double-blind, placebo-controlled prospective trial with three parallel groups.
One hundred twenty (120) patients, 40 per treatment arm, with relapsing-remitting (RR) multiple sclerosis will be enrolled in this trial. Eligible patients must have a diagnosis of MS as per the McDonald Criteria. In addition, patients must have a diagnosis of relapsing-remitting course of MS defined as periods of worsening of neurological function with full recovery or with sequelae and residual deficit upon recovery; periods between disease relapses characterized by lack of disease progression. Patients must also have active disease with at least 1 defined documented relapse in the last year.
During a 2 month run-in period, 2 MRIs will be performed 6 weeks apart and patients will be stratified based on the presence or absence of 1 or more Gadolinium enhancing lesions on the first MRI (Gd-enhancing lesion yes-no) and will be randomized to one of two dose regimens of IGIV-C or matching placebo. Patients will receive study drug infusions every 4 weeks for 48 weeks for a total of 12 infusions. Patients will be evaluated by MRI every 6 weeks and by clinical assessments every 3 months. A follow-up visit will occur 4 weeks after the last infusion.
The treatment groups are as follows:
- IGIV-C - 0.2 g/kg body weight (bw)/infusion (2 ml/kg bw)
- IGIV-C - 0.4 g/kg bw/infusion (4 ml/kg bw)
- placebo (0.1% albumin) - 4 ml/kg bw/infusion
For blinding purposes, at each infusion, all patients will receive a total volume of 4 ml/kg bw. For patients receiving 0.2 g/kg bw of IGIV-C, the final volume of 4 ml/kg bw will be adjusted by the addition of dextrose 5%. Placebo will be supplied as Albumin 5% or Albumin 25% and diluted with either dextrose 5% or saline to a final concentration of 0.1% albumin.
Dose adaptation will be performed for subsequent infusions in case the patient's body weight has changed > 10%. The maximum amount available per infusion will be 400 ml (8 vials) calculated for a patient with a body weight of 100 kg. The suggested initial infusion rate will be 0.02 ml/kg/min for the first 15 minutes. If there is no evidence of a hypersensitivity reaction, the infusion may be given at a slowly increasing rate over the next 30 minutes up to a maximum allowable rate of 0.08 ml/kg/min. As such, the infusion for a 70 kg patient will take approximately 1hour 15 min. The overall infusion time may have a range from 1 to 2 hours.
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Being tested
- Immune Globulin IV [Human], 10% Caprylate/Chromatography Purified, Albumin (Human) 25%, United States Pharmacopeia (USP)
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immune Globulin IV [Human], 10% Caprylate/Chromatography PurifiedDrug
Also called Gamunex®, IGIVnex®, Gaminex, IGIV-C
Albumin (Human) 25%, United States Pharmacopeia (USP)Drug
Also called Plasbumin®-5, Plasbumin®-25, Plasbumin®-5 (Low Aluminum), Plasbumin®-25 (Low Aluminum)
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | IGIV-C 0.2 g/kg bw/infusion (2 ml/kg bw) Receives: Drug: Immune Globulin IV [Human], 10% Caprylate/Chromatography Purified |
| Group 2 | Experimental | IGIV-C 0.4 g/kg bw/infusion (4 ml/kg bw) Receives: Drug: Immune Globulin IV [Human], 10% Caprylate/Chromatography Purified |
| Group 3 | Placebo comparator | placebo (0.1% albumin) 4 ml/kg bw/infusion Receives: Drug: Albumin (Human) 25%, United States Pharmacopeia (USP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Relapse Free Subjects (no Relapse)
A relapse was defined for the purposes of this study as the appearance or reappearance of one or more neurological symptoms or worsening of an old symptom attributed to multiple sclerosis (MS) persisting for at least 48 hours and immediately preceded by a relatively stable or improving neurological state of at least 30 days.
Measured: 12 months
Secondary outcomes (1)
Effect on the Combined Unique Lesion Activity on Magnetic Resonance Imaging (MRI)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startDec 2002
- Primary completionFeb 2005
- Study completionFeb 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple Sclerosis, Relapsing-RemittingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grifols Therapeutics LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fred D Lublin, MD, Principal investigator, Mt Sinai Medical Center, New York, NY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00220779
- Sponsor's protocol ID
- 100434
- Acronym
- PRIVIG
- Status last verified
- Mar 2016
- First submitted
- 13 Sep 2005
- Last updated
- 27 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Fazekas F, Lublin FD, Li D, Freedman MS, Hartung HP, Rieckmann P, Sorensen PS, Maas-Enriquez M, Sommerauer B, Hanna K; PRIVIG Study Group; UBC MS/MRI Research Group. Intravenous immunoglobulin in relapsing-remitting multiple sclerosis: a dose-finding trial. Neurology. 2008 Jul 22;71(4):265-71. doi: 10.1212/01.wnl.0000318281.98220.6f.
PubMed 18645164
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Placebo-Controlled Study to Compare the Effects of Different Dose Regimens of IGIV Chromatography (IGIV-C), 10% Treatment on Relapses in Patients With Relapsing Remitting Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT00220779
- Acronym / sponsor ID
- PRIVIG / 100434
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Grifols Therapeutics LLCIndustry (pharma, biotech, devices)
- Study start
- Dec 2002
- Primary completion
- Feb 2005 (actual)
- Study completion
- Feb 2005 (actual)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Posted 11 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The trial will study 2 doses of Immune Globulin Intravenous (Human), 10% Caprylate/Chromatography Purified (IGIV-C) for the number of relapses that occur in a 1 year treatment period.
Detailed description
This trial is designed as a multi-national, randomized, double-blind, placebo-controlled prospective trial with three parallel groups.
One hundred twenty (120) patients, 40 per treatment arm, with relapsing-remitting (RR) multiple sclerosis will be enrolled in this trial. Eligible patients must have a diagnosis of MS as per the McDonald Criteria. In addition, patients must have a diagnosis of relapsing-remitting course of MS defined as periods of worsening of neurological function with full recovery or with sequelae and residual deficit upon recovery; periods between disease relapses characterized by lack of disease progression. Patients must also have active disease with at least 1 defined documented relapse in the last year.
During a 2 month run-in period, 2 MRIs will be performed 6 weeks apart and patients will be stratified based on the presence or absence of 1 or more Gadolinium enhancing lesions on the first MRI (Gd-enhancing lesion yes-no) and will be randomized to one of two dose regimens of IGIV-C or matching placebo. Patients will receive study drug infusions every 4 weeks for 48 weeks for a total of 12 infusions. Patients will be evaluated by MRI every 6 weeks and by clinical assessments every 3 months. A follow-up visit will occur 4 weeks after the last infusion.
The treatment groups are as follows:
- IGIV-C - 0.2 g/kg body weight (bw)/infusion (2 ml/kg bw)
- IGIV-C - 0.4 g/kg bw/infusion (4 ml/kg bw)
- placebo (0.1% albumin) - 4 ml/kg bw/infusion
For blinding purposes, at each infusion, all patients will receive a total volume of 4 ml/kg bw. For patients receiving 0.2 g/kg bw of IGIV-C, the final volume of 4 ml/kg bw will be adjusted by the addition of dextrose 5%. Placebo will be supplied as Albumin 5% or Albumin 25% and diluted with either dextrose 5% or saline to a final concentration of 0.1% albumin.
Dose adaptation will be performed for subsequent infusions in case the patient's body weight has changed > 10%. The maximum amount available per infusion will be 400 ml (8 vials) calculated for a patient with a body weight of 100 kg. The suggested initial infusion rate will be 0.02 ml/kg/min for the first 15 minutes. If there is no evidence of a hypersensitivity reaction, the infusion may be given at a slowly increasing rate over the next 30 minutes up to a maximum allowable rate of 0.08 ml/kg/min. As such, the infusion for a 70 kg patient will take approximately 1hour 15 min. The overall infusion time may have a range from 1 to 2 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: Immune Globulin IV [Human], 10% Caprylate/Chromatography PurifiedIGIV-C 0.2 g/kg bw/infusion (2 ml/kg bw) |
| Group 2 | Experimental | Drug: Immune Globulin IV [Human], 10% Caprylate/Chromatography PurifiedIGIV-C 0.4 g/kg bw/infusion (4 ml/kg bw) |
| Group 3 | Placebo comparator | Drug: Albumin (Human) 25%, United States Pharmacopeia (USP)placebo (0.1% albumin) 4 ml/kg bw/infusion |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Symptoms consistent with Multiple Sclerosis up to 5 years
- Diagnosis of multiple sclerosis according to McDonald criteria.
- Diagnosis of relapsing-remitting (RR) multiple sclerosis (MS) (Defined as periods of worsening of neurological function with full recovery or with sequelae and residual deficit upon recovery; periods between disease relapses characterized by lack of disease progression
- Kurtzke Extended Disability Status Scale (EDSS) < 5.0
- At least 1 defined and documented relapse during the last year. Prior relapses where symptoms were due solely to a change in Bowel/Bladder Function or Cognitive Function will not be considered relapses as defined by this protocol and therefore not counted for inclusion into the study.
Key exclusion criteria (12 listed)
- Females who are pregnant, breast feeding, or if, of childbearing potential, unwilling to practice adequate contraception throughout the study
- Prior therapy with azathioprine or any immunosuppressant agents within 6 months prior to study entry
- Prior steroid, methylprednisolone or adrenocorticotropic hormone (ACTH) therapy within 30 days prior to study entry
- Therapy with interferons (Betaseron®, Avonex®, Rebif®), glatiramer acetate (Copaxone®) or IGIV within 3 months prior to study entry or during the study
- Use of an investigational compound within 6 months prior to study entry
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immune Globulin IV [Human], 10% Caprylate/Chromatography PurifiedAlso: Gamunex®, IGIVnex®, Gaminex, IGIV-C | Drug | Group 1, Group 2 |
| Albumin (Human) 25%, United States Pharmacopeia (USP)Also: Plasbumin®-5, Plasbumin®-25, Plasbumin®-5 (Low Aluminum), Plasbumin®-25 (Low Aluminum) | Drug | Group 3 |
Primary outcome
Percentage of Relapse Free Subjects (no Relapse)
Time frame: 12 months
A relapse was defined for the purposes of this study as the appearance or reappearance of one or more neurological symptoms or worsening of an old symptom attributed to multiple sclerosis (MS) persisting for at least 48 hours and immediately preceded by a relatively stable or improving neurological state of at least 30 days.
1 secondary outcome
Effect on the Combined Unique Lesion Activity on Magnetic Resonance Imaging (MRI)
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 18645164Fazekas F, Lublin FD, Li D, Freedman MS, Hartung HP, Rieckmann P, Sorensen PS, Maas-Enriquez M, Sommerauer B, Hanna K; PRIVIG Study Group; UBC MS/MRI Research Group. Intravenous immunoglobulin in relapsing-remitting multiple sclerosis: a dose-finding trial. Neurology. 2008 Jul 22;71(4):265-71. doi: 10.1212/01.wnl.0000318281.98220.6f.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fred D Lublin, MD principal investigator
Mt Sinai Medical Center, New York, NY
37 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Immune Globulin IV [Human], 10% Caprylate/Chromatography Purified and Albumin (Human) 25%, United States Pharmacopeia (USP) in people with Multiple Sclerosis, Relapsing-Remitting, run by Grifols Therapeutics LLC at 37 sites in 12 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 10 inclusion and 12 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 27 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in Germany, United States, Canada, Czechia, Hungary and 7 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 11 Apr 2014). 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?
Percentage of Relapse Free Subjects (no Relapse) (time frame: 12 months). 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 NCT00220779, which also lists 1 linked publication.
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 27 Apr 2016.