BridgeMD
New treatment option for Connective Tissue Diseases
Official title Early Recognition of Progressive Lung Fibrosis in Systemic Rheumatic Diseases
ClinicalTrials.gov ID: NCT07541638
What this study is testing
- What it's testing
- Connective tissue diseases (CTDs) cover a broad range of systemic rheumatic disorders characterized by abnormal immune activation, chronic inflammatory response, and fibrosis of internal organs. The most prevalent is interstitial lung disease (ILD), a severe pulmonary complication seen in 10 to 50% of CTDs and a major determinant of disability and death.
- Time commitment: about 12 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Female and male aged between 18 and 75 years.
- Signature of informed consent
- A clinical diagnosis of SSc, RA, SS, IIM, or UCTD that must adhere to internationally accepted classification criteria [Aletha 2010, Van Der Hoogen...
- A high risk of ILD based on autoantibody profile, specifically: anti-Scl70+ or anti-RNAPIII+ for SSc, anti-CCP+ and/or RF+ for RA, anti-RoSSA+ and...
- Evidence of ILD based on an HRCT documenting the presence of interstitial changes involving at least 10% of the parenchyma within the previous 6...
You likely can't join if
- Current treatment with corticosteroids \>10 mg of prednisone.
- Poor peripheral venus access that would interfere with blood sampling
See the full eligibility criteria
- Female and male aged between 18 and 75 years.
- Signature of informed consent
- A clinical diagnosis of SSc, RA, SS, IIM, or UCTD that must adhere to internationally accepted classification criteria [Aletha 2010, Van Der Hoogen 2013, Lundberg 2017, Shiboski 2016, Bottai 2017, Antunes 2019].
- A high risk of ILD based on autoantibody profile, specifically: anti-Scl70+ or anti-RNAPIII+ for SSc, anti-CCP+ and/or RF+ for RA, anti-RoSSA+ and anti-LaSSB+ for primary SS, anti-synthetase+ for IIM. For UCTD patients...
- Evidence of ILD based on an HRCT documenting the presence of interstitial changes involving at least 10% of the parenchyma within the previous 6 weeks. An HRCT scan completely negative for ILD changes performed up to 6...
- Either naive to immunosuppressants or having been on a stable immunosuppressive regimen for the three months preceding blood collection for EV characterization. Treatment with rituximab must be not administered in the...
- Current treatment with corticosteroids \>10 mg of prednisone.
- Poor peripheral venus access that would interfere with blood sampling
The study team makes the final eligibility decision.
Where it's taking place
- Roma, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Roma, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.