Study Details
Testing the Drug Belimumab for People with Interstitial Lung Disease Associated with Connective Tissue Disease
(IRB#: IRB_00184246)
Interstitial Lung Disease (lung fibrosis) associated with Connective Tissue Disease is a condition when the body's immune system (the system that fights infection) attacks the bodys own cells and tissues. This study will test a study drug called belimumab to treat people with this disease. The study wants to see if it will help people with the disease and is safe. People in the study will be randomly chosen to be treated with belimumab or a placebo. A placebo looks like the study drug but does not have the medication. Being in the study requires 9 study visits at the clinic over about 1 year. Medical tests will be done to track the health of participants.
- All genders
- Over 18 years old
- Volunteers with special conditions
- In Person
- Paid
Who can participate?
Gender: All genders
Age: Over 18 years old
Volunteers: Volunteers with special conditions
Location: In Person
Inclusion Criteria
- Ages 18 years and older
- Diagnosis of Interstitial Lung Disease, AND a Connective Tissue Disorder such as Rheumatoid Arthritis, Inflammatory Myopathy, or Sjogren's Syndrome
- Currently receiving either a stable standard medication to manage Interstitial Lung Disease or Connective Tissue Disorder, or failed to tolerate the previous standard medication
- Ability to take the study drug or have a caregiver who is capable and willing to give the study drug throughout the study
- Childbearing participants must use birth control during study participation
Exclusion Criteria
- Pregnant or breastfeeding
- History of serious medical conditions such as rapidly progressing Interstitial Lung Disease, Diffuse Alveolar Haemorrhage, history of certain malignancies (cancers), organ/bone marrow transplant, recent surgeries, or disorders that alter the taking or eliminating of prescription drugs
- Active infection- like TB or Herpes Zoster- as well as a history of serious or acute chronic infection- like HIV or Hepatitis B
- Some medications such as anti-fibrotic agents, corticosteroids, cytotoxic drugs, or live vaccines that require periods of non-use for up to six months
- Any current enrollment or past participation in any other study involving a drug, vaccine, or device within 3 months before participation
Will I be paid for my time?
Yes
IRB#: IRB_00184246
PI: Mary Beth Scholand
Department: PULMONARY
Approval Date: 2025-02-19 07:00:00
Specialties: Pulmonary
I am Interested