CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 128 enrolled
Drug / intervention
Immune Globulin IV [Human], 10% Caprylate/Chromatography Purified +1 moredrug
Likely dose
IGIV-C (Immune Globulin IV [Human], 10% Caprylate/Chromatography Purified) - specific dose regimen not specified in arms or interventionsAI-extracted
Key inclusion· 6
  • ✓Confirmed relapsing-remitting MS diagnosis per McDonald criteria
  • ✓EDSS score <5.0
  • ✓At least 1 documented relapse in the past year (excluding bowel/bladder or cognitive changes alone)
  • ✓MRI evidence: ≥9 hyperintense T2 lesions OR ≥1 Gd-enhancing lesion per McDonald/Barkhof criteria
Key exclusion· 9
  • ✕Azathioprine or any immunosuppressant within 6 months
  • ✕Steroids, methylprednisolone, or ACTH within 30 days
  • ✕Interferons (Betaseron, Avonex, Rebif), glatiramer acetate (Copaxone), or IGIV within 3 months
  • ✕Prior lymphoid irradiation or cyclophosphamide, methotrexate, mitoxantrone

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00220779
NCT00220779Phase 2Completed
CompareCT.gov

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

Grifols Therapeutics LLC·interventional·Posted Sep 22, 2005·Updated Apr 27, 2016

In Brief

A Phase 2 clinical trial evaluating Immune Globulin IV [Human], 10% Caprylate/Chromatography Purified and Albumin (Human) 25%, United States Pharmacopeia (USP) for Multiple Sclerosis, Relapsing-Remitting. Completed, enrolled 128 participants across 37 sites in 12 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMultiple Sclerosis, Relapsing-Remitting
CountriesAustria, Canada, Czechia, Germany, Greece, Hungary, Israel, Poland, Slovakia, Sweden, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 22, 2005
Enrollment StartDec 1, 2002
Primary CompletionFeb 1, 2005
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 20.8 years ago

Interventions

Immune Globulin IV [Human], 10% Caprylate/Chromatography Purifieddrug

Albumin (Human) 25%, United States Pharmacopeia (USP)drug