Learn about Research & Clinical Trials
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
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.
|Eligible Ages||18 Years and Over|
- - 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 interstitial lung disease associated with RA, with supportive findings on their PFTs and CT Chest scans.
- - A decrease in FVC by at least 5% when comparing two sets of PFTs done in the last 24 months, but with an interval of up to 14 months between the PFTs OR.
- - Progression of lung fibrosis on a high-resolution CT chest, as reported by a chest radiologist.
- - 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.
- - 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 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 < 60%.
- - 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 or 5 half-lives of IMP, whichever is longer, prior to baseline (visit 2) (participation in 'observational' studies is allowed) - Hypersensitivity to any excipients of abatacept.
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.
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.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Cambridge University Hospitals NHS Foundation Trust|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||Addenbrookes Hospital|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Rheumatoid Arthritis, Interstitial Lung Disease|
Experimental: Abatacept in patients with RA-ILD
Thirty participants with RA-ILD will be treated with abatacept infusions, which will be given fortnightly for the first 4 weeks, then every 4 weeks for a total of 20 weeks.
Drug: - Abatacept
The IV dose varies according to weight: <60kg=500mg ≥60 but≤100kg=750mg >100kg=1g This equates to approximately 10mg/kg.
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.