PFF Clinical Trial Finder

APRIL (AbatacePt in RA-ILD)

Study Purpose

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 an urgent 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 randomised 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, have moderate to severe RA joint disease activity (DAS28 ≥3.2) 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).

Recruitment Criteria

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
No

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Study Type
Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Aged 18 years or over - Agree to use 2 acceptable forms of effective contraception for the duration of the study trial and a further 14 weeks after completion - Meet a diagnosis of RA by 2010 EULAR/ACR criteria - Have moderate/severe RA joint disease activity, as demonstrated by a DAS28 score ≥ 3.2 - Have interstitial lung disease associated with RA, with supportive findings on their PFTs and CT Chest scans.
Participants will be included if their ILD has not responded to conventional immunosuppressive therapy, or has progressed over 24 weeks, regardless of the severity of the ILD at the time of inclusion to the trial.

Exclusion Criteria:

  • - Unable to provide informed written consent - Participants who are taking other immunosuppressants, e.g. mycophenolate mofetil (MMF), unless this has been discontinued with an adequate washout period.
The exceptions to this exclusion criterion are methotrexate (MTX) and hydroxychloroquine, which are allowed provided the dose has been stable for 6 weeks prior to baseline (visit 2).
  • - Participants who have been taking ≥ 10mg Prednisolone daily within the last 6 weeks prior to baseline (visit 2) - Participants who have had rituximab, within the 24 weeks prior to baseline (Visit 2) - Any participant with active signs or symptoms of infection at the time of recruitment baseline (visit 2) or requiring antibiotic treatment within the preceding 4 weeks - Any participant with significant co-existing lung disease, such as asthma, bronchiectasis, emphysema, Chronic Obstructive Pulmonary Disease (COPD) or if their pre-bronchodilator FEV1/FVC ratio is < 70%.
- Significant other co-morbidity (e.g. active malignancy/liver disease/renal disease) within the last 5 years - Prior use of abatacept at any time - Participation in any other clinical trial within 8 weeks prior to baseline visit (Visit 2) (Participation on 'observational' studies is allowed) - Hypersensitivity to any excipients of abatacept - Any participant who has had live vaccines within 6 weeks prior to baseline (Visit 2) - Participant is pregnant or breastfeeding

Trial Details

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

Trial ID:
NCT03084419

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase
Phase 2

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
Cambridge University Hospitals NHS Foundation Trust

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator
Deepak Jadon
Principal Investigator Affiliation Addenbrookes Hospital

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
OtherIndustry
Overall Status Not yet recruiting
Countries United Kingdom

The disease, disorder, syndrome, illness, or injury that is being studied.

Conditions
Rheumatoid Arthritis, Interstitial Lung Disease

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Addenbrookes Hospital, Cambridge, United Kingdom

Status

Not yet recruiting

Address

Addenbrookes Hospital

Cambridge, , CB2 0QQ

Papworth Hospital, Cambridge, United Kingdom

Status

Not yet recruiting

Address

Papworth Hospital

Cambridge, , CB23 3RE

Site Contact

Helen Parfrey

hp226@cam.ac.uk

01480 830 541

Terms of Service

The PFF does not promote or represent that any investigational new drugs mentioned are safe or effective. The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. For a full description of terms please refer to our Terms, Conditions & Privacy.

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