DRKS00028871
Recruiting
Not Applicable
Pulmonary involvement (interstitial lung disease of known etiology) in patients with Seropositive and ACPA positive Rheumatoid Arthritis (RA-ILD I and II)Early detection of lung involvement in RA - RA-ILD I and II
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- M05.9
- Sponsor
- Boehringer Ingelheim Pharma GmbH & Co. KG
- Enrollment
- 200
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •The major inclusion criteria are:
- •? diagnosis of Seropositive and ACPA positive Rheumatoid Arthritis is performed by an experienced and specialized team of rheumatologists according to the Aletaha\-EULAR/ACR\-classification criteria (2010\) 6 independent of time of diagnosis and current or past disease\-modifying anti\-rheumatic drugs (DMARDs)
- •? general anamnesis is part of the initial patient examination and will be documented including co\-relevant habits like smoking (present and past) and DMARDs usage
- •? all patients included in this project were not screened for lung function in the past, underlining the importance of lung function measurement in the context of very early lung involvement within this evaluation
- •? due to the concept of early lung involvement for ILD treatment there will be no specific ILD pre\-treatment before study inclusion. Treatment for other aspects except lung involvement might be given for individual patients (e.g. skin involvement, synovial involvement)
- •? written informed consent consistent with International Conference on Harmonisation Harmonised Tripartite Guideline for Good Clinical Practice (ICH\-GCP) and local laws signed prior to entry into the study and prior to any study procedure
- •? male or female patients aged \>\= 18 years at entry into the study
- •? two negative SARS\-CoV 2 test (PCR)
Exclusion Criteria
- •The major exclusion criteria are:
- •? diagnosis of Seronegative and / or ACPA negative Rheumatoid Arthritis, other types of arthritis ? known diagnosis of idiopathic pulmonary fibrosis (IPF)
- •? no written informed consent consistent with International Conference on Harmonisation Harmonised Tripartite Guideline for Good Clinical Practice (ICH\-GCP) and local laws signed prior to entry into the study and prior to any study procedure
- •? patients aged \< 18 years at entry into
- •Further exclusion criteria are:
- •? diagnosis of idiopathic pulmonary fibrosis (IPF)
- •? creatinine clearance \<30 ml/min calculated by Cockcroft\-Gault formula at entry into the study
- •? patients with underlying chronic liver disease (Child Pugh A, B or C hepatic impairment)
- •? previous treatment with nintedanib or pirfenidone
- •? other investigational therapy received within 1 month or 6 half\-lives (whichever was greater) prior to entry into the study
Outcomes
Primary Outcomes
Not specified
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