NCT01785056

Brief Summary

The purpose of this research is to study the effects of Privigen (intravenous immunoglobulin) on the skin in patients with scleroderma. Approximately 24 subjects will take part in this investigator-initiated study at Georgetown University Hospital and Johns Hopkins Hospital. This study will last for one year (12 months). This research is being done because systemic sclerosis can cause severe, progressive organ involvement. The investigators hope this study treatment will improve the outcomes in this disease, including skin, muscle, joint, gastrointestinal, and lung involvement.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 6, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2013

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

July 17, 2018

Status Verified

January 1, 2018

Enrollment Period

4.8 years

First QC Date

January 28, 2013

Last Update Submit

July 13, 2018

Conditions

Systemic SclerosisDiffuse Scleroderma

Keywords

Systemic SclerosisDiffuse SclerodermaSSc

Outcome Measures

Primary Outcomes (1)

  • To study the effects of IVIG on the skin in patients with scleroderma

    The modified Rodnan Skin Score (mRSS) will be used to determine the changes in skin

    At the 4 month visit

Secondary Outcomes (3)

  • To determine any toxicity of IVIG in scleroderma

    At the 4 month visit

  • To evaluate the effects of IVIG on pulmonary function

    At the 4 month visit

  • Muscle, joint, and inflammatory parameters

    At the 4 month visit

Other Outcomes (5)

  • To study the effects of IVIG on the skin in patients with scleroderma

    At the 6 month visit

  • To determine any toxicity of IVIG in scleroderma

    At the 6 month visit

  • To evaluate the effects of IVIG on pulmonary function

    At the 6 month visit

  • +2 more other outcomes

Study Arms (2)

Privigen

EXPERIMENTAL

Privigen is a ready-to-use, sterile, 10% protein liquid preparation of polyvalent human immunoglobulin G (IgG) for intravenous administration. Subjects will be given 2 g/kg/month of IVIGfor 6 months. Each dose will be split into 2 to 4 infusions on consecutive days to achieve the total monthly dose.

Biological: Privigen

Placebo (Albuminar-5)

PLACEBO COMPARATOR

Albuminar-5 is a sterile solution of albumin obtained from large pools of adult human venous plasma and used as the placebo in this study. Albuminar-5 will be administered by the intravenous route and each dose will be split into 2 to 4 infusions on consecutive days to achieve the total monthly dose.

Biological: Privigen

Interventions

PrivigenBIOLOGICAL

Subjects will receive 2 g/kg/mo of Privigen® for 6 months if randomized to the treatment group.

Placebo (Albuminar-5)Privigen

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diffuse systemic sclerosis with active skin involvement as defined as a mRSS \>12, with no improvement or worsening in the previous 4 months in spite of treatment with methotrexate, cellcept, imuran, or anti-TNF agent;
  • years of age or older;
  • Disease duration of less than 5 years from the first non-Raynaud's symptom of scleroderma.

You may not qualify if:

  • Use of more than 10 mg of prednisone, or any dose of cytoxan, d-penicillamine, or rituximab in the last 3 months;
  • History of deep vein thrombosis (DVT), stroke, or other thromboembolic phenomenon;
  • History of anaphylaxis or other serious reaction to human blood or blood products.
  • Absolute IgA deficiency
  • A prior receipt of IVIg treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Scleroderma, SystemicScleroderma, Diffuse

Interventions

Immunoglobulins, Intravenous

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesSkin Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin GImmunoglobulin IsotypesAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Virginia D Steen, MD

    Georgetown University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2013

First Posted

February 6, 2013

Study Start

April 1, 2013

Primary Completion

January 1, 2018

Study Completion

January 1, 2019

Last Updated

July 17, 2018

Record last verified: 2018-01

Locations

US(2)