The BEconneCTD-ILD Study
Thank you for your interest in this clinical research study for adults with interstitial lung disease (ILD) associated with connective tissue disease.
What is the BEconneCTD-ILD Study?
Clinical research studies help to improve the way doctors treat and prevent illnesses. The purpose of this study is to understand whether the study treatment can help improve lung function in people who have ILD (lung fibrosis) associated with connective tissue disease.
Who can participate?
To be considered for this study, you must meet these and other criteria:
Age
18 years of age or older
Medicine
Have ILD that is being treated with medicine now or has been treated with medicine in the past
Diagnosis
Have rheumatoid arthritis, systemic lupus erythematosus, idiopathic inflammatory myopathy (including polymyositis, dermatomyositis, and antisynthetase syndrome), Sjogren’s syndrome, or mixed connective tissue disease
What is the study treatment?
You will be assigned by chance to either the active study drug or a placebo. Neither you nor the study doctor and staff will know which one you are getting.
The placebo looks just like the study drug but contains no active medicine. This helps researchers understand the true effects of the study drug.
The study treatment is taken by injection once a week. You’ll be given instructions and shown how to self-inject.
What happens
during the study?
The study consists of a Screening Period, a Study Treatment Period, an optional Long-Term Extension Study, and a final Safety Follow-up Visit.
Screening Period
6 weeks
At least 1 clinic visit
The study team will collect information about your health and run tests to see if you qualify.
Study Treatment Period
52 weeks
7 scheduled clinic visits
You’ll be placed in a group by chance to receive either the active study drug or a placebo.
Long-Term Extension Study (Optional)
At least 52 weeks
(1 year)
After you complete the Study Treatment Period, you may be eligible to receive the active study drug (no placebo).
Safety Follow-up Visit
1 clinic visit
If you do not enter the Long-Term Extension Study, you will have a final Safety Follow-up Visit 8 weeks after your last dose of the study treatment.
What kind of health checks and tests can I expect?
Some of the health checks and tests you will have at study visits are listed below. You will not have every test at each visit.
Questionnaires
Vital signs
Physical exam
Questionnaires
Vital signs
Physical exam
Blood tests
Urine test
Pregnancy test
(if applicable)
Blood tests
High-resolution CT scan
(Screening and Week 52 only)
ECG heart test
Lung function tests
CT = computed tomography; ECG = electrocardiogram.