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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abatacept in patients with RA-ILD | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abatacept | Drug | The IV dose varies according to weight: <60kg=500mg ≥60 but≤100kg=750mg >100kg=1g This equates to approximately 10mg/kg. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Forced Vital Capacity (FVC) | Assessing the change of Forced Vital Capacity (FVC) across screening, baseline V2 (prior to abatacept), V6 and V9. | 28 weeks (Screening-V9) |
| Measure | Description | Time Frame |
|---|---|---|
| Transfer factor of the lung for carbon monoxide (TLCO) | Assessing the change of Transfer factor of the lung for carbon monoxide (TLCO) at screening (prior to abatacept), V6 and V9. | 28 weeks (Screening-V9) |
| MRC dyspnoea score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Frances Hall | Contact | 01223 274915 | frances.hall@addenbrookes.nhs.uk | |
| Elena Hernan-Sancho | Contact | elena.hernansancho@addenbrookes.nhs.uk |
| Name | Affiliation | Role |
|---|---|---|
| Frances Hall | Cambridge University Hospitals NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Addenbrookes Hospital | Recruiting | Cambridge | CB2 0QQ | United Kingdom |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D017563 | Lung Diseases, Interstitial |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D000069594 | Abatacept |
| ID | Term |
|---|---|
| D018796 | Immunoconjugates |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D012712 | Serum Globulins |
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The investigators will perform a small clinical trial to assess the feasibility of performing a larger randomised controlled trial.
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.
Participants will sign informed consent at visit 1 (screening visit). There is then a 28 day window before treatment starts at visit 2 (baseline). Each participants participation in the trial is estimated to last 28 weeks from visit 1.
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|
Assessing the change of MRC dyspnoea score completed at Baseline V2 (prior to abatacept), V6, V9
| 24 weeks (Baseline-V9) |
| Kings Brief Interstitial Lung Disease score (K-BILD) | Assessing the change of Kings Brief Interstitial Lung Disease score (K-BILD) questionnaire completed at Baseline V2 (prior to abatacept), V6, V9 | 24 weeks (Baseline-V9) |
| Semi-quantitative radiological scoring of the ILD | Assessing the change of HRCT chest scans performed at screening (prior to abatacept and V9 (end of trial) | 28 weeks (Screening-V9) |
| Resting oxygen saturation | Resting oxygen saturation recorded at all visits | 28 weeks |
| DAS28 | DAS28 recorded at all visits | 28 weeks |
| Leicester Cough Questionnaire score | Assessing the change of Leicester Cough Questionnaire completed at Baseline V2 (prior to abatacept), V6, V9 | 24 weeks (Baseline-V9) |
| EQ-5D | Assessing the change of EQ-5D Questionnaire completed at Baseline V2 (prior to abatacept), V6, V9 | 24 weeks (Baseline-V9) |
| Respiratory tract infection | Assessing the number of Respiratory tract infections recorded following IMP dosing between V2-V9 | 24 weeks (Baseline-V9) |
| Papworth Hospital | Recruiting | Cambridge | CB23 3RE | United Kingdom |
|
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D005916 | Globulins |