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Rheumatoid ArthritisPhase 2APRILNCT03084419

APRIL (AbatacePt in Rheumatoid Arthritis-ILD)

A Phase 2 study testing Abatacept in people with Rheumatoid Arthritis and Interstitial Lung Disease, run by Cambridge University Hospitals NHS Foundation Trust at 2 sites in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Abatacept
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
2 sitesUnited Kingdom
Study dates
26 Jun 2018to 1 Mar 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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%.
Show all 12Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country.

Frances Hall contact

01223 274915

frances.hall@addenbrookes.nhs.uk

Elena Hernan-Sancho contact

elena.hernansancho@addenbrookes.nhs.uk

United Kingdom2 sites, 2 recruiting

  • Addenbrookes Hospital

    Cambridge, CB2 0QQ

    Frances Hall, 01223 216182, ffrances.hall@addenbrookes.nhs.uk

    Elena Hernan-Sancho, elena.hernansancho@addenbrookes.nhs.uk

    Recruiting

  • Papworth Hospital

    Cambridge, CB23 3RE

    Helen Parfrey, 01480 830 541, hp226@cam.ac.uk

    Recruiting

Other trials in United Kingdom

About this study

Official title: Safety of Abatacept in Rheumatoid Arthritis Associated Interstitial Lung Disease: A Feasibility Trial

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).

Being tested
Abatacept
Keywords
Rheumatoid Arthritis, Interstitial Lung Disease, RA-ILD, Abatacept
Medical subject headings
Arthritis, Rheumatoid, Lung Diseases, Interstitial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AbataceptDrug

    Also called Orencia

    The IV dose varies according to weight:

    <60kg=500mg

    ≥60 but≤100kg=750mg >100kg=1g

    This equates to approximately 10mg/kg.

Study groups in NCT03084419
Study groupRoleWhat they receive
Abatacept in patients with RA-ILDExperimentalThirty 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.
Receives: Drug: Abatacept

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Forced Vital Capacity (FVC)

    Assessing the change of Forced Vital Capacity (FVC) across screening, baseline V2 (prior to abatacept), V6 and V9.

    Measured: 28 weeks (Screening-V9)

Secondary outcomes (9)

  1. 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.

    Measured: 28 weeks (Screening-V9)

  2. MRC dyspnoea score

    Assessing the change of MRC dyspnoea score completed at Baseline V2 (prior to abatacept), V6, V9

    Measured: 24 weeks (Baseline-V9)

  3. 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

    Measured: 24 weeks (Baseline-V9)

  4. 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)

    Measured: 28 weeks (Screening-V9)

  5. Resting oxygen saturation

    Resting oxygen saturation recorded at all visits

    Measured: 28 weeks

  6. DAS28

    DAS28 recorded at all visits

    Measured: 28 weeks

  7. Leicester Cough Questionnaire score

    Assessing the change of Leicester Cough Questionnaire completed at Baseline V2 (prior to abatacept), V6, V9

    Measured: 24 weeks (Baseline-V9)

  8. EQ-5D

    Assessing the change of EQ-5D Questionnaire completed at Baseline V2 (prior to abatacept), V6, V9

    Measured: 24 weeks (Baseline-V9)

  9. Respiratory tract infection

    Assessing the number of Respiratory tract infections recorded following IMP dosing between V2-V9

    Measured: 24 weeks (Baseline-V9)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Mar 2017
  2. Study start26 Jun 2018
  3. Primary completion1 Mar 2020 (estimated)
  4. Study completion1 Mar 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
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.
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03084419
Sponsor's protocol ID
APRIL
Acronym
APRIL
Status last verified
Jul 2019
First submitted
7 Mar 2017
Last updated
22 Jul 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Abatacept in people with Rheumatoid Arthritis and Interstitial Lung Disease, run by Cambridge University Hospitals NHS Foundation Trust at 2 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Frances Hall (01223 274915, frances.hall@addenbrookes.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Forced Vital Capacity (FVC) (time frame: 28 weeks (Screening-V9)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03084419.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2019.

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