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Trial record 2 of 481 for:    april

APRIL (AbatacePt in RA-ILD) (APRIL)

This study is not yet open for participant recruitment.
Verified March 2017 by Deepak Jadon, Cambridge University Hospitals NHS Foundation Trust
Sponsor:
ClinicalTrials.gov Identifier:
NCT03084419
First Posted: March 21, 2017
Last Update Posted: March 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Deepak Jadon, Cambridge University Hospitals NHS Foundation Trust
  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).


Condition Intervention Phase
Rheumatoid Arthritis Interstitial Lung Disease Drug: Abatacept Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Safety of Abatacept in Rheumatoid Arthritis Associated Interstitial Lung Disease: A Feasibility Trial

Resource links provided by NLM:


Further study details as provided by Deepak Jadon, Cambridge University Hospitals NHS Foundation Trust:

Primary Outcome Measures:
  • Number of participants without significant decrease (≥ 10%) in Forced Vital Capacity (FVC) measurements following abatacept treatment [ Time Frame: Following 20 weeks of treatment with abatacept ]
    FVC measurements to be taken at V1, V2, V6 and V9 as part of lung function (spirometry) tests. Any changes observed over these visits will be monitored for safety reasons and assessed to give a safety profile of abatacept in participants with RA-ILD.


Secondary Outcome Measures:
  • Number of participants with improved health status following 20 weeks abatacept treatment as assessed by DLCO measurements and patient-reported questionnaires (MRC dyspnoea scale and K-BILD) [ Time Frame: within the first 20 weeks of treatment ]

    Assess changes in the following outcome measures over trial period:

    • diffusing capacity of the lung for carbon monoxide (DLCO measurements taken from gas transfer tests at V1, V6 and V9)
    • patient-reported disability associated with dyspnoea (using the MRC dyspnoea grade questionnaire) at V2, V6 and V9
    • patient-reported health status related to ILD (using the King's Brief Interstitial Lung Disease questionnaire) at V2, V6 and V9


Estimated Enrollment: 30
Anticipated Study Start Date: May 1, 2017
Estimated Study Completion Date: May 1, 2020
Estimated Primary Completion Date: May 1, 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Other Name: Orencia

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03084419


Contacts
Contact: Deepak Jadon 01223 254933 deepak.jadon@addenbrookes.nhs.uk
Contact: Katherine Stobbart 01223 596377 katherine.stobbart@addenbrookes.nhs.uk

Locations
United Kingdom
Addenbrookes Hospital Not yet recruiting
Cambridge, United Kingdom, CB2 0QQ
Contact: Deepak Jadon    01223 217457    deepak.jadon@addenbrookes.nhs.uk   
Principal Investigator: Deepak Jadon         
Papworth Hospital Not yet recruiting
Cambridge, United Kingdom, CB23 3RE
Contact: Helen Parfrey    01480 830 541    hp226@cam.ac.uk   
Sponsors and Collaborators
Cambridge University Hospitals NHS Foundation Trust
Bristol-Myers Squibb
Investigators
Principal Investigator: Deepak Jadon Addenbrookes Hospital
  More Information

Responsible Party: Deepak Jadon, Consultant Rheumatologist, Director of the Rheumatology Research Unit & Lead for Psoriatic Arthritis, Cambridge University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03084419     History of Changes
Other Study ID Numbers: A094103
First Submitted: March 7, 2017
First Posted: March 21, 2017
Last Update Posted: March 21, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Deepak Jadon, Cambridge University Hospitals NHS Foundation Trust:
Rheumatoid Arthritis
Interstitial Lung Disease
RA-ILD
Abatacept

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Lung Diseases
Lung Diseases, Interstitial
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Respiratory Tract Diseases
Abatacept
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents