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Autoantibody Reduction for Idiopathic Pulmonary Fibrosis (STRIVE-IPF Trial)

Phase 2

Recruiting

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

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

Must have

Age between 40-85 years old

Ground-glass abnormality and/or consolidation superimposed on a reticular or honeycomb usual interstitial pneumonitis (UIP) pattern on locally read chest CT scan

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year

Awards & highlights

STRIVE-IPF Trial Summary

This trial is testing a new therapy for idiopathic pulmonary fibrosis that improves respiratory function in people with the disease.

Who is the study for?

This trial is for adults aged 40-85 with worsening symptoms of idiopathic pulmonary fibrosis (IPF) within the last month. Participants must meet specific criteria for IPF diagnosis and be able to consent and follow study procedures. Exclusions include hemodynamic instability, current infections, other causes of respiratory dysfunction, certain blood conditions, hepatitis B or C infection, positive autoimmune tests, recent use of high-dose steroids or immunosuppressants, history of certain cancers, unwillingness to accept blood transfusions or use contraception if applicable.Check my eligibility

What is being tested?

The trial investigates a combination therapy aimed at reducing autoantibodies that may worsen IPF. This includes therapeutic plasma exchange plus rituximab and intravenous immunoglobulin compared to standard treatment. The goal is to see if this approach can improve outcomes in acute exacerbations of IPF where traditional treatments have failed.See study design

What are the potential side effects?

Potential side effects could involve reactions related to plasma exchange such as dizziness or fainting; allergic responses from rituximab including rash or difficulty breathing; and side effects from intravenous immunoglobulin like muscle pain or headache. Each patient's experience may vary.

STRIVE-IPF Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 40 and 85 years old.

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My chest CT shows a specific type of lung scarring and abnormality.

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I have been diagnosed with idiopathic pulmonary fibrosis.

STRIVE-IPF Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Survival

Secondary outcome measures

Adverse Events

Oxygen requirements

Walk distance

STRIVE-IPF Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Autoantibody Reductive TherapyExperimental Treatment1 Intervention

Therapeutic Plasma Exchange (TPE) consisting of 1x estimated plasma volume exchanges for 3 successive days (1-3) and then, after a one day interval to enable equilibration of autoantibodies between intra- and extra-vascular spaces, again on days 5, 6, 9, 11, 13, and 15. Rituximab: One gm i.v. will be administered on day 6 and day 15 after completion of the TPE on those days. Intravenous immunoglobulin (IVIG): 0.5 gm/kg/day i.v. on days 16-19 All subjects in this trial, including patients in this arm, will receive identical empiric antibiotics and steroids. The steroid dose is: Prednisone 60 mg (p.o.) on day 1, followed by 20 mg/day on days 2-5, 7-14, and 16-19 (or the i.v. methylprednisolone equivalent). Methylprednisolone 100 mg i.v. will be administered on days 6 and 15, as a premedication prior to the rituximab.

Group II: Treatment as Usual (TAU)Active Control1 Intervention

The same steroid regimen as described for the experimental arm, i.e., prednisone 60 mg (p.o.) on day 1, followed by 20 mg/day on days 2-5, 7-14, and 16-19 (or the i.v. methylprednisolone equivalent), and methylprednisolone 100 mg i.v. administered on days 6 and 15, as well as empiric antibiotics.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of PittsburghOTHER

1,722 Previous Clinical Trials

16,342,885 Total Patients Enrolled

9 Trials studying Idiopathic Pulmonary Fibrosis

7,233 Patients Enrolled for Idiopathic Pulmonary Fibrosis

Brigham and Women's HospitalOTHER

1,615 Previous Clinical Trials

11,470,779 Total Patients Enrolled

1 Trials studying Idiopathic Pulmonary Fibrosis

58 Patients Enrolled for Idiopathic Pulmonary Fibrosis

Temple UniversityOTHER

297 Previous Clinical Trials

82,922 Total Patients Enrolled

6 Trials studying Idiopathic Pulmonary Fibrosis

3,561 Patients Enrolled for Idiopathic Pulmonary Fibrosis

Media Library

Autoantibody Reductive Therapy (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03286556 — Phase 2

Idiopathic Pulmonary Fibrosis Research Study Groups: Autoantibody Reductive Therapy, Treatment as Usual (TAU)

Idiopathic Pulmonary Fibrosis Clinical Trial 2023: Autoantibody Reductive Therapy Highlights & Side Effects. Trial Name: NCT03286556 — Phase 2

Autoantibody Reductive Therapy (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03286556 — Phase 2

Idiopathic Pulmonary Fibrosis Patient Testimony for trial: Trial Name: NCT03286556 — Phase 2

Frequently Asked Questions

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

What types of individuals are qualified to enroll in this experimental program?

"Patients with usual interstitial pneumonia aged between 40 and 85 are eligible for this medical trial, which is currently seeking to recruit a total of 51 individuals."

Answered by AI

How many healthcare centers are actively participating in this experiment?

"Currently, 7 clinical sites are running this trial. Birmingham, Pittsburgh and Houston are some of the locations hosting these studies with additional centres in other locales. Choosing a clinic near you can reduce your travel burden if you decide to partake in this medical research."

Answered by AI

Is the enrollment period for this clinical trial still open?

"Affirmative, the information accessible on clinicaltrials.gov confirms that this medical investigation is presently enlisting patients. The study was initially published on September 4th 2018 and has been amended most recently on September 5th 2022. Approximately 51 participants need to be recruited from 7 different research centres."

Answered by AI

Are participants under 85 years old allowed to take part in this trial?

"This trial has an age limit of 40 to 85, with all participants in the specified range qualified for enrollment."

Answered by AI

What potential perils may be associated with Autoantibody Reductive Therapy?

"The safety of Autoantibody Reductive Therapy has been estimated at 2 based on the fact that this is a phase two trial, thus there is some evidence to suggest its safety but no data proving efficacy."

Answered by AI

What is the greatest number of individuals taking part in this clinical trial?

"This clinical trial requires 51 eligible participants from various locations, including the University of Alabama at Birmingham in Birmingham and the University of Pittsburgh Medical Center. Those who satisfy all inclusion criteria can take part."

Answered by AI