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Human Immunoglobulin G for Dermatomyositis (RECLAIIM Trial)
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.
RECLAIIM Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowRECLAIIM Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.RECLAIIM Trial Design
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Who is running the clinical trial?
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- I am 18 years old or older.My doctor rates my disease as moderately severe or worse.I take 20 mg or less of prednisolone or its equivalent daily.I have been diagnosed with cancer or had active cancer in the last 5 years.My doctor rates my disease as moderately severe or worse.I have been diagnosed with a type of muscle inflammation disease according to EULAR/ACR criteria.I have muscle inflammation related to my cancer.My doctor rates my condition as significantly damaged or improved recently.I am 18 years old or older.I have been diagnosed with a type of muscle inflammation disease according to EULAR/ACR criteria.I take 20 mg or less of corticosteroid medication daily.
- Group 1: IgPro20
- Group 2: Placebo
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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."
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."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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