Abatacept for the Treatment of Myositis-associated Interstitial Lung Disease (ATtackMy-ILD)
|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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03215927|
Recruitment Status : Active, not recruiting
First Posted : July 12, 2017
Last Update Posted : November 2, 2022
|Condition or disease||Intervention/treatment||Phase|
|Myositis Interstitial Lung Disease||Drug: Abatacept Other: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|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.|
|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|
|Actual Primary Completion Date :||May 30, 2022|
|Estimated Study Completion Date :||March 31, 2023|
Placebo Comparator: Placebo
Subcutaneous placebo injection weekly for 24 weeks.
Subcutaneous injection of abatacept 125 mg weekly for 24 weeks. 24 week optional follow up phase all subjects receive abatacept 125 mg weekly.
Abatacept 125mg subcutaneous weekly
Other Name: Orencia
- 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).
- 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.
- 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).
- 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.
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
|United States, California|
|Cedars-Sinai Medical Center|
|Beverly Hills, California, United States, 90211|
|United States, Colorado|
|University of Colorado Anschutz Medical Campus|
|Denver, Colorado, United States, 80045|
|United States, Maryland|
|John Hopkins Medical Center|
|Baltimore, Maryland, United States, 21205|
|United States, Massachusetts|
|Brigham & Women's Hospital|
|Boston, Massachusetts, United States, 02115|
|United States, Pennsylvania|
|University of Pittsburgh|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||Rohit Aggarwal, MD||University of Pittsburgh|