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Immunoglobulin

Human Immunoglobulin G for Dermatomyositis (RECLAIIM Trial)

Phase 3
Waitlist Available
Research Sponsored by CSL Behring
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Disease severity defined by Physician global activity visual analog scale (VAS) with a minimum value of 2.0 cm on a 10 cm scale and MMT-8 ≤ 142 or CDASI total activity score ≥ 14.
Corticosteroid daily dose less than that or equal to 20 mg prednisolone equivalent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 8 years
Awards & highlights

RECLAIIM Trial Summary

This trial is testing if a new drug, IgPro20, is effective in treating dermatomyositis (DM) in adults. The primary objective is to compare IgPro20 to placebo in terms of Total Improvement Score (TIS) assessments.

Who is the study for?
Adults over 18 with dermatomyositis can join this trial. They should be on a low dose of steroids and have moderate disease severity, confirmed by specific scales and muscle tests. People with recent cancer, significant past damage from the disease, or improvement before starting the study cannot participate.Check my eligibility
What is being tested?
The trial is testing IgPro20, a human immunoglobulin G given under the skin against a placebo to see if it helps improve symptoms in adults with dermatomyositis. It's randomized and double-blind so neither doctors nor patients know who gets real treatment or placebo.See study design
What are the potential side effects?
Possible side effects include reactions at the injection site like redness or pain, headaches, nausea, fatigue, fever, chills and potential increased risk of infections due to immune system effects.

RECLAIIM Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My doctor rates my disease as moderately severe or worse.
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I take 20 mg or less of prednisolone or its equivalent daily.
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My doctor rates my disease as moderately severe or worse.
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I have been diagnosed with a type of muscle inflammation disease according to EULAR/ACR criteria.
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I am 18 years old or older.
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I have been diagnosed with a type of muscle inflammation disease according to EULAR/ACR criteria.
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I take 20 mg or less of corticosteroid medication daily.

RECLAIIM Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 8 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 8 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Responder Rate
Secondary outcome measures
Mean TIS
Mean Total Improvement Score (TIS)
Mean change difference (IgPro20 minus placebo) in CDASI
+35 more

RECLAIIM Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: IgPro20Experimental Treatment1 Intervention
human immunoglobulin G administered subcutaneously
Group II: PlaceboPlacebo Group1 Intervention
human albumin solution administered subcutaneously

Find a Location

Who is running the clinical trial?

CSL BehringLead Sponsor
194 Previous Clinical Trials
1,211,096 Total Patients Enrolled
Study DirectorStudy DirectorCSL Behring
1,202 Previous Clinical Trials
489,506 Total Patients Enrolled

Media Library

IgPro20 (Immunoglobulin) Clinical Trial Eligibility Overview. Trial Name: NCT04044690 — Phase 3
Dermatomyositis Research Study Groups: IgPro20, Placebo
Dermatomyositis Clinical Trial 2023: IgPro20 Highlights & Side Effects. Trial Name: NCT04044690 — Phase 3
IgPro20 (Immunoglobulin) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04044690 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

For what ailments is human immunoglobulin G often employed?

"human immunoglobulin G is a medication that can be used to treat several conditions, including bruton's agammaglobulinemia, primary immunodeficiencies (pid), and chronic inflammatory demyelinating polyradiculoneuropathy."

Answered by AI

Are there any other precedent medical studies to which this one can be compared?

"First researched in 2008 at Montefiore Medical Center, human immunoglobulin G has since been the focus of 37 active clinical trials, with 18439 completed studies. Currently, a significant number of these ongoing research projects are based in Jackson, Tennessee."

Answered by AI

Are there any current vacancies for participants in this research project?

"That is correct, the trial information available on clinicaltrials.gov indicates that this study is still looking for enrollees. The trial was first posted on October 21st, 2019 and was last updated November 1st, 2020. In total, the researchers need 126 participants across 45 different sites."

Answered by AI

How many people can join this clinical trial at its largest?

"That is correct, the clinical trial is still recruiting patients. The latest update on recruitment was on November 1st, 20202. So far, 45 sites have been utilized to look for the 126 total patients needed."

Answered by AI

Has human immunoglobulin G been cleared by the FDA?

"There is some data supporting efficacy and multiple rounds of data supporting safety, so human immunoglobulin G received a score of 3."

Answered by AI

In how many different states is this trial taking place?

"This clinical trial is currently recruiting patients out of 45 sites. The sites are located in Jackson, Dallas and Pittsburgh along with other locations across the United States. It is helpful to select the site closest you to minimize travel demands if you participate."

Answered by AI

Who else is applying?

What state do they live in?
Arizona
How old are they?
18 - 65
What site did they apply to?
Arizona Arthritis & Rheumatology Research
What portion of applicants met pre-screening criteria?
Did not meet criteria
~5 spots leftby Jun 2024