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Trial record 54 of 215 for:    Inflammatory Myopathies

Abatacept for the Treatment of Myositis-associated Interstitial Lung Disease (ATtackMy-ILD)

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ClinicalTrials.gov Identifier: NCT03215927
Recruitment Status : Recruiting
First Posted : July 12, 2017
Last Update Posted : February 15, 2019
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Rohit Aggarwal, MD, University of Pittsburgh

Brief Summary:
A randomized, controlled pilot trial to evaluate the efficacy and safety of subcutaneous Abatacept in treating interstitial lung disease associated with the anti-synthetase syndrome.

Condition or disease Intervention/treatment Phase
Myositis Interstitial Lung Disease Drug: Abatacept Other: Placebo Phase 2

Detailed Description:
This is a proof of concept study to evaluate the efficacy, safety and tolerability of abatacept in Syn-ILD in a multi-center randomized, placebo-controlled 6-month (24-week) pilot study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A 1:1 randomization scheme for abatacept 125 mg vs. placebo as a weekly subcutaneous (SQ) injection for 24 weeks.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Only the site pharmacist is unblinded.
Primary Purpose: Treatment
Official Title: A Randomized, Controlled Pilot Trial to Evaluate the Efficacy and Safety of Subcutaneous Abatacept in Treating Interstitial Lung Disease Associated With the Anti-synthetase Syndrome
Actual Study Start Date : June 1, 2017
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : May 1, 2021


Arm Intervention/treatment
Placebo Comparator: Placebo
Subcutaneous placebo injection weekly for 24 weeks.
Other: Placebo
Placebo

Experimental: Abatacept
Subcutaneous injection of abatacept 125 mg weekly for 24 weeks. 24 week optional follow up phase all subjects receive abatacept 125 mg weekly.
Drug: Abatacept
Abatacept 125mg subcutaneous weekly
Other Name: Orencia




Primary Outcome Measures :
  1. Forced Vital Capacity (FVC)% Change [ Time Frame: 24 Weeks ]
    The primary outcome criteria for efficacy will be the FVC% change from the baseline visit to week 24 between the 2 treatment arms (SOC/placebo vs. SOC/Abatacept).


Secondary Outcome Measures :
  1. Time to progression free survival where progression [ Time Frame: 24 weeks ]
    The first occurrence of any of the following: death or lung transplant or FVC ≥10% decline or FVC ≥5% decline with diffuse capacity of lung for carbon dioxide (DLCO) ≥15% decline.

  2. Comparison of change in patient reported dyspnea scores [ Time Frame: 24 weeks ]
    measured by University of California San Diego Shortness of Breath Questionnaire (UCSD SOBQ) (range 0-120, higher score is worsening dyspnea).

  3. Time to improvement in FVC% by ≥10 [ Time Frame: 24 weeks ]
    Comparison of FVC% results from pulmonary function tests from baseline, 3 and 6 months. Improvement is defined as an FVC% change ≥10.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥ 18 years.
  2. Anti-synthetase syndrome defined as the patient possessing 1 antisynthetase autoantibody (Jo-1, PL-12, PL-7, KS, OJ, EJ, Zo) in the presence of autoimmune ILD.
  3. ILD defined by radiographic (HRCT chest) findings of reticulation, honeycombing or ground glass opacities (GGO) without another plausible explanation. HRCT chest defining ILD for inclusion criteria, should be within last 1 year done as SOC.
  4. Active ILD (see Section 4.2).
  5. Baseline FVC % <80% as minimal threshold of ILD severity (PFT done within last 3 months is acceptable for inclusion criteria determination).
  6. SOC immunosuppressive therapy (IS) therapy:

    1. Steroids (prednisone or other forms of steroid in equivalent doses) OR one of the other immunosuppressive agent (either Mycophenolate (MMF) or Azathioprine (AZA) OR a combination of steroid and an immunosuppressive agent. MMF (maximum of 3 gm/day) or azathioprine (maximum of 200 mg/day).Goal is to start the trial drug (or placebo) soon after starting SOC (MMF/AZA/Steroids) and their doses are stable. Note that patients on steroids alone as well as not on steroids can be enrolled in the trial as well.
    2. Desired dose of the SOC therapy should be reached 4 weeks prior to first study visit (Visit 1). No dose changes are allowed 4 weeks prior to first study visit.
    3. Dose of concomitant therapy (SOC) cannot be changed during the 24 weeks of the trial unless safety/toxicity issues supervene.
    4. If on steroid, the steroid dose must be stable for 2 weeks prior to Visit 1.
  7. No other concomitant IS medications including methotrexate, cyclosporine, intravenous immunoglobulin (IVIG), tacrolimus, cyclophosphamide or tofacitinib.
  8. No concomitant biologic agents (i.e. rituximab, anti-tumor necrosis factor (TNF) agents, tocilizumab).
  9. Additional IS therapy: Patient cannot begin any new IS therapy or new steroid taper for the 24-week study period, except if severe clinical worsening (flare up) of the disease requiring rescue therapy occurs (i.e. documentation of worsening of PFT/HRCT and patient and physician determination of worsening). See section of rescue medication below for details.
  10. If the enrolling physician is planning to discontinue current IS agent or steroid before clinical trial, then following washout period is required prior to Visit 1.

    Medication Washout Period methotrexate 4 weeks Other IS agent (e.g. azathioprine, cyclosporine, tacrolimus, leflunomide, mycophenolate mofetil) 4 weeks IVIg or cyclophosphamide 3 months rituximab 6 months infliximab or adalimumab 8 weeks glucocorticoids 2 weeks etanercept 2 weeks anakinra 1 week

  11. Men and women of reproductive potential must agree to use an acceptable method of birth control during the trial period.
  12. Subject has provided written informed consent.

Exclusion Criteria:

A patient will be excluded if any of the following Exclusion Criteria are met:

  1. Severe end stage lung disease:

    1. FVC ≤30% or Forced expiratory volume (FEV1) ≤ 30% or
    2. Requirement of high O2 requirement ≥ 6 L/min at rest for >1 month before the study enrollment or
    3. Listed for lung transplantation or
    4. PI feels that ILD is severe and end stage fibrosis is such that there is low potential for improvement with any disease modifying intervention.
  2. Subjects under the age of 18.
  3. Known active current or history of recurrent bacterial, viral, fungal, mycobacterial or other infections (including but not limited to tuberculosis and atypical mycobacterial disease, hepatitis B and C, and herpes zoster, but excluding fungal infections of nail beds).
  4. Any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of screening.
  5. Active tuberculosis (TB) requiring treatment within the previous 3 years. Patients should be screened for latent TB using purified protein derivative (PPD)/or quantiferon gold within last 1 year and, if positive, treated following local practice guidelines prior to initiating abatacept (ABT). Patients treated for active tuberculosis with no recurrence in 3 years are permitted.
  6. Primary or secondary immunodeficiency (history of or currently active) unless related to primary disease under investigation.
  7. Pregnant women or nursing (breast feeding) mothers.
  8. History of alcohol, drug or chemical abuse within 1 year prior to screening or any medical condition or physical or psychological state that the PI feels would not allow the subject to safely complete the study.
  9. Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following randomization.
  10. Treatment with any other investigational agent within 4 weeks (or 5 half-lives of the investigational drug, whichever is longer) of screening.
  11. Previous treatment with the following cell-depleting therapies, including investigational agents or approved therapies: CAMPATH, anti-CD4, anti-CD5, and anti-CD3.
  12. Previous treatment with ABT.
  13. History of severe allergic or anaphylactic reactions to monoclonal antibodies.
  14. Evidence of serious uncontrolled concomitant cardiovascular, nervous system, renal, hepatic, endocrine (include uncontrolled diabetes mellitus) or gastrointestinal disease (including complicated diverticulitis, ulcerative colitis, or Crohn's disease.)
  15. Evidence of concomitant lung disease which PI feels may interfere with clinical assessment of ILD for example severe active chronic obstructive pulmonary disease (COPD), asthma, occupational lung disease, pulmonary sarcoidosis, etc.
  16. Prisoners or subjects who are compulsory detained

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): NCT03215927


Contacts
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Contact: Nicole Neiman 412-648-9989 nmn19@pitt.edu
Contact: Diane Koontz 412-383-8674 dik4@pitt.edu

Locations
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United States, California
Cedars-Sinai Medical Center Recruiting
Beverly Hills, California, United States, 90211
Contact: Laura Palmas    310-652-0010    laura.palmas@attunehealth.com   
Principal Investigator: Swamy Venuturupalli, MD         
United States, Colorado
University of Colorado Anschutz Medical Campus Recruiting
Denver, Colorado, United States, 80045
Contact: Mallary Crow Adams    303-724-8403    Mallary.CrowAdams@ucdenver.edu   
Contact: Stefanie Rowsell       stefanie.rowsell@ucdenver.edu   
Principal Investigator: Aryeh Fischer, MD         
Sub-Investigator: Joyce Lee, MD         
United States, Maryland
John Hopkins Medical Center Recruiting
Baltimore, Maryland, United States, 21205
Contact: Leena Matthews    410-550-2062    lmathew@jhmi.edu   
Sub-Investigator: Cheilonda Johnson, MD, MHS         
Principal Investigator: Sonya Danoff, MD, PhD         
United States, Massachusetts
Brigham & Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Maura Baumgartner    617-525-8686    malvarezbaumgartner@bwh.harvard.edu   
Principal Investigator: Paul F. Dellaripa, MD         
Sub-Investigator: Tracy J. Doyle, MD         
United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Nicole Neiman    412-648-9989    nmn19@pitt.edu   
Contact: Diane Koontz    412-383-8674    dik4@pitt.edu   
Principal Investigator: Rohit Aggarwal, MD         
Sponsors and Collaborators
Rohit Aggarwal, MD
Bristol-Myers Squibb
Investigators
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Principal Investigator: Rohit Aggarwal, MD University of Pittsburgh

Publications:

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Responsible Party: Rohit Aggarwal, MD, Associate Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03215927     History of Changes
Other Study ID Numbers: BMS: IM101-657
First Posted: July 12, 2017    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Rohit Aggarwal, MD, University of Pittsburgh:
ILD

Additional relevant MeSH terms:
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Myositis
Muscular Diseases
Lung Diseases
Lung Diseases, Interstitial
Respiratory Tract Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Abatacept
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents