NCT03084419: APRIL

APRIL (AbatacePt in Rheumatoid Arthritis-ILD)

Status unknown Phase 2 Last updated 22 July 2019

What this trial tests

Phase 2 trial testing Abatacept in Rheumatoid Arthritis in 30 participants. Status unknown.

Timeline

26 June 2018

Primary endpoint
1 March 2020

1 March 2020

Quick facts

Lead sponsor	Cambridge University Hospitals NHS Foundation Trust
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	26 June 2018
Primary completion	1 March 2020
Estimated completion	1 March 2020
Sites	2 locations across United Kingdom

Drugs / interventions tested

• Abatacept (abatacept) — full drug profile →

Conditions studied

• Rheumatoid Arthritis — all drugs for Rheumatoid Arthritis →
• Interstitial Lung Disease — all drugs for Interstitial Lung Disease →

Sponsor

Cambridge University Hospitals NHS Foundation Trust

Who can join

18 and older, any sex, with Rheumatoid Arthritis or Interstitial Lung Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Early initiation of treatment for Rheumatoid arthritis (RA) can prevent several of the long term problems associated with the condition. However, many RA patients develop lung inflammation and scarring, called 'interstitial lung disease' (RA-ILD), contributing to early death in 1 in 5 people. There is no proven treatment for these patients and some medications for RA can in fact worsen their lung disease. There is a need therefore to find safe medications that can not only control RA joint disease, but also prevent progression of RA-ILD. Abatacept is an approved drug for treating RA and is used widely. It is a newer RA medication, with a unique mechanism of action, and it has been shown to prevent progression of joint damage and improve physical function. The investigators aim to assess the safety of this medication in patients with RA-ILD and improve our understanding of the mechanism of lung damage in rheumatoid disease.

The investigators will perform a small clinical trial to assess the feasibility of performing a larger randomized controlled trial. A total of 30 patients with RA-ILD will be treated with abatacept infusions fortnightly for the first month, then every 4 weeks for a total of 20 weeks. In order to be eligible for the study, a patient must be able to provide written informed consent, be aged ≥18 years, and have interstitial lung disease that has not responded to or progressed over 6 months despite conventional immunosuppression. Change in lung function (forced vital capacity) at 24 weeks will be evaluated. To assess the mechanisms that may be involved with the development of ILD, the investigators will assess the effects of abatacept on biomarkers obtained from the blood and the lung (bronchoalveolar lavage), including markers of infection (the lung microbiome).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Rheumatoid arthritis-interstitial lung disease: manifestations and current concepts in pathogenesis and management.
   Kadura S, Raghu G. · · 2021 · cited 182× · PMID 34168062 · DOI 10.1183/16000617.0011-2021
2. Treatment of Rheumatoid Arthritis-Associated Interstitial Lung Disease: Lights and Shadows.
   Cassone G, Manfredi A, Vacchi C, Luppi F, et al · · 2020 · cited 75× · PMID 32290218 · DOI 10.3390/jcm9041082
3. Management issues in rheumatoid arthritis-associated interstitial lung disease.
   England BR, Hershberger D. · · 2020 · cited 56× · PMID 32141954 · DOI 10.1097/bor.0000000000000703
4. Rheumatoid arthritis-associated interstitial lung disease: Current update on prevalence, risk factors, and pharmacologic treatment.
   Huang S, Kronzer VL, Dellaripa PF, Deane KD, et al · · 2020 · cited 52× · PMID 33282632 · DOI 10.1007/s40674-020-00160-z
5. Safety of Abatacept in Italian Patients with Rheumatoid Arthritis and Interstitial Lung Disease: A Multicenter Retrospective Study.
   Cassone G, Manfredi A, Atzeni F, Venerito V, et al · · 2020 · cited 46× · PMID 31963908 · DOI 10.3390/jcm9010277
6. Interstitial Lung Disease in Rheumatoid Arthritis: A Practical Review.
   Laria A, Lurati AM, Zizzo G, Zaccara E, et al · · 2022 · cited 37× · PMID 35646974 · DOI 10.3389/fmed.2022.837133
7. Management of Connective Tissue Disease-related Interstitial Lung Disease.
   Ahmed S, Handa R. · · 2022 · cited 24× · PMID 35530438 · DOI 10.1007/s13665-022-00290-w
8. Unmet needs and perspectives in rheumatoid arthritis-associated interstitial lung disease: A critical review.
   Stainer A, Tonutti A, De Santis M, Amati F, et al · · 2023 · cited 22× · PMID 37007765 · DOI 10.3389/fmed.2023.1129939