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Immunomodulator

CTLA4-Ig (Abatacept) for Type 1 Diabetes

Q: At how many hospitals is this research project being conducted?

The trial is being conducted at 17 sites, including the Benaroya Research Institute at <a href="https://www.withpower.com/clinical-trials/virginia">Virginia</a> Mason in Seattle, University of Pittsburgh in Miami, and University of Miami School of Medicine in Gainesville.

Q: Are there any current openings for participants in this research study?

According to the information available on clinicaltrials.gov, this particular trial is not looking for new participants at this time. The study was initially posted on March 1st, 2013 and received its latest update on April 13th, 2022. That being said, there are 1444 other trials that are currently enrolling patients.

Q: Does the FDA currently sanction the use of CTLA4-Ig (Abatacept)?

Abatacept (CTLA4-Ig) has received a safety score of 2. While there is some clinical data to support its safety, none of the available studies have looked at whether or not it is effective.

Q: Does this experiment only require participants who are 55 and older?

According to the inclusion criteria for this trial, patients must be aged 6-45. Out of 1,309 similar clinical trials, 241 allow for participants that are under 18 and 1068 have an age limit of 65 or above.

Q: What are some preceding examples of CTLA4-Ig (Abatacept) research?

Currently, there are 36 ongoing studies investigating CTLA4-Ig (Abatacept). Of these, 8 are in Phase 3. Many of the clinical trials for CTLA4-Ig (Abatacept) are located in Toronto, Ontario; however, there are 773 locations operating clinical trials for CTLA4-Ig (Abatacept) globally.

Q: How many participants can sign up for this research project?

As of right now, this clinical trial is not recruiting any new patients. The study was first posted on March 1st, 2013 and was last updated on April 13th, 2022. For those interested in other trials, there are 1408 active studies for glucose intolerance and 36 for CTLA4-Ig (Abatacept).

Phase 2

Waitlist Available

Research Sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up every six months for 5-6 years

Awards & highlights

Study Summary

This trial is a 2-arm, multicenter, 1:1 randomized, placebo controlled clinical trial that will test the safety, efficacy, and mode of action of Abatacept to prevent AGT and T1DM. The primary objective is to determine whether intervention with Abatacept will prevent or delay the development of AGT in at-risk autoantibody positive non-diabetic relatives of patients with T1DM.

Eligible Conditions

Type 1 Diabetes
Diabetes

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ every six months for 5-6 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~every six months for 5-6 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and every six months for 5-6 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

Change from Normal Glucose Tolerance to Abnormal Glucose Tolerance

Secondary outcome measures

Change in C-peptide response to Oral Glucose Tolerance Test (OGTT)

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: abatacept IV infusionExperimental Treatment1 Intervention

CTLA4-Ig (Abatacept) will be administered as 14 (30 minute) infusions over one year (3 infusions every other week the first month; monthly for the following 11 months)

Group II: PlaceboPlacebo Group1 Intervention

The placebo arm will receive 14 (30 minute) IV infusions (containing saline) given 3 times (every other week) the first month and monthly for the following 11 months.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

CTLA4-Ig (Abatacept)

2013

Completed Phase 2

~220

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Lead Sponsor

2,359 Previous Clinical Trials

4,315,283 Total Patients Enrolled

Juvenile Diabetes Research FoundationOTHER

232 Previous Clinical Trials

141,572 Total Patients Enrolled

Carla J Greenbaum, MDStudy ChairType 1 Diabetes TrialNet

1 Previous Clinical Trials

76 Total Patients Enrolled

Frequently Asked Questions

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

What patients does CTLA4-Ig (Abatacept) usually help?

"CTLA4-Ig (Abatacept) is not only an effective medication for treating rheumatoid arthritis, but also psoriatic arthritis, polyarticular juvenile idiopathic arthritis, and severe juvenile idiopathic arthritis."

Answered by AI

If I wanted to, could I join this clinical trial as a test subject?

"This trial is looking for 212 participants who fit the following criteria: glucose intolerance, between the ages of 6 and 45, must have participated in the TrialNet Natural History/Pathway to Prevention Study, willing to provide Informed Consent or have a parent or legal guardian provide informed consent if the subject is <18 years of age, normal glucose tolerance by OGTT confirmed within 7 weeks (no more than 52 days) of baseline (visit 0), fasting plasma glucose < 110 mg/dL (6.1 mmol/L), 2 hour plasma glucose <140 mg/dL (7.8 mmol/L), 30, 60"

Answered by AI

At how many hospitals is this research project being conducted?

"The trial is being conducted at 17 sites, including the Benaroya Research Institute at Virginia Mason in Seattle, University of Pittsburgh in Miami, and University of Miami School of Medicine in Gainesville."

Answered by AI

Are there any current openings for participants in this research study?

"According to the information available on clinicaltrials.gov, this particular trial is not looking for new participants at this time. The study was initially posted on March 1st, 2013 and received its latest update on April 13th, 2022. That being said, there are 1444 other trials that are currently enrolling patients."

Answered by AI

Does the FDA currently sanction the use of CTLA4-Ig (Abatacept)?

"Abatacept (CTLA4-Ig) has received a safety score of 2. While there is some clinical data to support its safety, none of the available studies have looked at whether or not it is effective."

Answered by AI

Does this experiment only require participants who are 55 and older?

"According to the inclusion criteria for this trial, patients must be aged 6-45. Out of 1,309 similar clinical trials, 241 allow for participants that are under 18 and 1068 have an age limit of 65 or above."

Answered by AI

What are some preceding examples of CTLA4-Ig (Abatacept) research?

"Currently, there are 36 ongoing studies investigating CTLA4-Ig (Abatacept). Of these, 8 are in Phase 3. Many of the clinical trials for CTLA4-Ig (Abatacept) are located in Toronto, Ontario; however, there are 773 locations operating clinical trials for CTLA4-Ig (Abatacept) globally."

Answered by AI

How many participants can sign up for this research project?

"As of right now, this clinical trial is not recruiting any new patients. The study was first posted on March 1st, 2013 and was last updated on April 13th, 2022. For those interested in other trials, there are 1408 active studies for glucose intolerance and 36 for CTLA4-Ig (Abatacept)."

Answered by AI

Recent research and studies

The LancetJournal

Co-stimulation Modulation with Abatacept in Patients with Recent-onset Type 1 Diabetes: A Randomised, Double-blind, Placebo-controlled Trial

Orban, Tihamer, Brian Bundy, Dorothy J Becker, Linda A DiMeglio, Stephen E Gitelman, Robin Goland, Peter A Gottlieb, et al.. 2011. “Co-stimulation Modulation with Abatacept in Patients with Recent-onset Type 1 Diabetes: A Randomised, Double-blind, Placebo-controlled Trial”. The Lancet. Elsevier BV. doi:10.1016/s0140-6736(11)60886-6.

clinicaltrials.govStudy

CTLA4-Ig (Abatacept)for Prevention of Abnormal Glucose Tolerance and Diabetes in Relatives At -Risk for Type 1

2013. "CTLA4-Ig (Abatacept)for Prevention of Abnormal Glucose Tolerance and Diabetes in Relatives At -Risk for Type 1". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01773707.