APRIL (AbatacePt in Rheumatoid Arthritis-ILD)

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03084419
• Date of registration: 07/03/2017
• Prospective Registration: Yes
• Primary sponsor: Cambridge University Hospitals NHS Foundation Trust
• Public title: APRIL (AbatacePt in Rheumatoid Arthritis-ILD) APRIL
• Scientific title: Safety of Abatacept in Rheumatoid Arthritis Associated Interstitial Lung Disease: A Feasibility Trial
• Date of first enrolment: June 26, 2018
• Target sample size: 30
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT03084419
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

United Kingdom

Contacts

• Name: Frances Hall

• Name: Frances Hall
• Affiliation: Addenbrookes Hospital

Key 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 interstitial lung disease associated with RA, with supportive findings on their
PFTs and CT Chest scans. Participants will be included if their ILD has progressed
over 14 months. Progression will be defined as EITHER:

- 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.

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 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

- Any participant who has had live vaccines within 6 weeks prior to baseline (Visit 2)

- Participant is pregnant or breastfeeding



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Interstitial Lung Disease

Intervention(s)

Drug: Abatacept

Primary Outcome(s)

Forced Vital Capacity (FVC) [Time Frame: 28 weeks (Screening-V9)]

Secondary Outcome(s)

Transfer factor of the lung for carbon monoxide (TLCO) [Time Frame: 28 weeks (Screening-V9)]

Kings Brief Interstitial Lung Disease score (K-BILD) [Time Frame: 24 weeks (Baseline-V9)]

Leicester Cough Questionnaire score [Time Frame: 24 weeks (Baseline-V9)]

EQ-5D [Time Frame: 24 weeks (Baseline-V9)]

MRC dyspnoea score [Time Frame: 24 weeks (Baseline-V9)]

DAS28 [Time Frame: 28 weeks]

Respiratory tract infection [Time Frame: 24 weeks (Baseline-V9)]

Semi-quantitative radiological scoring of the ILD [Time Frame: 28 weeks (Screening-V9)]

Resting oxygen saturation [Time Frame: 28 weeks]

Secondary ID(s)

APRIL

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Bristol-Myers Squibb