German RA-ILD Study Group

German RA-ILD Study Group - GRAIL

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00039837

Enrollment

500

Registered

2026-04-07

Start date

2026-06-03

Completion date

Unknown

Last updated

2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

M05.1

Interventions

Group 1: Patients with Rheumatoid Arthritis and interstitial lung disease (RA-ILD) - Patients are monitored at enrollment and once a year for the next six years regarding disease progression, medicati

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 2. patients who meet the ACR classification criteria for rheumatoid arthritis 2010 3. written informed consent 3. ILD confirmed by CT Thorax 4. ILD diagnosis must be within 3 years prior to inclusion All inclusion criteria must be fulfilled.

Exclusion criteria

Exclusion criteria: 1. Decline/ withdrawal of consent 2. Preexisting RA-ILD longer than 3 years 3. Participants in ongoing clinical drug trials 4. Pregnancy or lactation

Design outcomes

Primary

Measure	Time frame
1a. To show an association of dominant or recessive genetic variations linked to inborn errors of immunity (IEI) or with the JAK/STAT pathway with RA-ILD, compared to age- and disease-duration-matched RA patients without ILD 1b. To show an association of dominant or recessive genetic variations linked to inborn errors of immunity or with the JAK/STAT pathway with a progressive fibrosis course of the ILD defined by pulmonary function test, 6-minute walk, O2-saturation and CT-scans.	—

Measure

Time frame

1a. To show an association of dominant or recessive genetic variations linked to inborn errors of immunity (IEI) or with the JAK/STAT pathway with RA-ILD, compared to age- and disease-duration-matched RA patients without ILD 1b. To show an association of dominant or recessive genetic variations linked to inborn errors of immunity or with the JAK/STAT pathway with a progressive fibrosis course of the ILD defined by pulmonary function test, 6-minute walk, O2-saturation and CT-scans.

—

Secondary

Measure	Time frame
1. To identify risk factors for a severe course of ILD according to ATS guidelines, e.g. RF/ ACPA positivity, smoking status including pack years, male gender, occupational history (construction work/dust exposure), UIP versus NSIP pattern 2a. To identify an association of novel and classic autoantibody markers of secondary Sjögren`s syndrome (SS) with RA-ILD 2b. To identify an association of novel and classic autoantibody markers of SS with a progressive fibrosis course of RA-ILD 3. To identify transcriptomic signatures predicting the progression of RA-ILD	—

Measure

Time frame

1. To identify risk factors for a severe course of ILD according to ATS guidelines, e.g. RF/ ACPA positivity, smoking status including pack years, male gender, occupational history (construction work/dust exposure), UIP versus NSIP pattern 2a. To identify an association of novel and classic autoantibody markers of secondary Sjögren`s syndrome (SS) with RA-ILD 2b. To identify an association of novel and classic autoantibody markers of SS with a progressive fibrosis course of RA-ILD 3. To identify transcriptomic signatures predicting the progression of RA-ILD

—

Countries

Germany

Contacts

Public ContactTorsten Witte

Medizinische Hochschule Hannover

rheumatologie@mh-hannover.de0511 532 6656

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 29, 2026