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
- Conditions
- M05.9M05.1Seropositive rheumatoid arthritis, unspecifiedJ99.0Rheumatoid lung disease
- Registration Number
- DRKS00028871
- Lead Sponsor
- Boehringer Ingelheim Pharma GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 200
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)
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
? significant pulmonary arterial hypertension defined by any of the following:
o previous clinical or echocardiographic evidence of significant right heart failure
o history of right heart catheterization showing a cardiac index <= 2 l/min/m²
o pulmonary arterial hypertension requiring parenteral therapy with epoprostenol / treprostinil
o primary obstructive airway physiology (pre-bronchodilator FEV1/FVC < 0.7 at entry into the study; Tiffeneau Index)
o in the opinion of the Investigator, other clinically significant pulmonary abnormalities
? major extrapulmonary physiological restriction (e.g. chest wall abnormality, large pleural effusion)
? significant cardiovascular diseases, any of the following:
o severe hypertension, uncontrolled under treatment (=160/100 mmHg), within 6 month of entry into the study
o myocardial infarction within 6 months of entry into the study
o unstable cardiac angina within 6 months of entry into the study
? other disease that may interfere with testing procedures or in the judgment of the investigator may interfere with trial participation or may put the patient at risk when participating in this trial
? life expectancy for disease other than ILD < 2.5 years (investigator assessment)
? planned major surgical procedures
? women who are pregnant
? patients not able to understand or follow trial procedures including completion of self-administered questionnaires without help
? in the opinion of the investigator, active alcohol or drug abuse
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of patients with reduction of forced vital capacity (FVC predicted = 80 % versus FVC predicted > 80 %) for Seropositive and ACPA positive RA patients (as an indicator for an early and significant pulmonary manifestations of rheumatoid arthritis = RA-ILD)
- Secondary Outcome Measures
Name Time Method Reduction of CO-diffusion capacity (DLCOc-SB predicted = 80 % versus DLCOc-SB predicted < 80 %) for Seropositive and ACPA positive RA patients (as an indicator for an early and significant pulmonary manifestations of rheumatoid arthritis = RA-ILD)<br><br>Further Rheumatoid Arthritis-associated secondary endpoints: age, sex, BMI, smoking, time since diagnosis Seropositive and ACPA positive Rheumatoid Arthritis, patients´ condition (FFbH, RAID, PHQ-2), disease activity (scores, i. e. VAS physician, VAS patient, TJC, SJC, CDAI, SDAI, DAS28), inflammatory activity (inflammatory markers, i. e. CRP, ESR), erosive joint disease,<br>medication (i. e. Disease Modifying Anti-Rheumatic Drugs = DMARDs), comorbidities, impact on follow-up- and therapy-strategies