Abatacept for the Treatment of Myositis-associated Interstitial Lung Disease
NCT ID: NCT03215927
Last Updated: 2025-01-07
Study Results
Results available
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View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE2
Total Enrollment
20 participants
Study Classification
INTERVENTIONAL
Study Start Date
2018-01-01
Study Completion Date
2023-07-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Myositis
Interstitial Lung Disease
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
A 1:1 randomization scheme for abatacept 125 mg vs. placebo as a weekly subcutaneous (SQ) injection for 24 weeks.
Primary Study Purpose
TREATMENT
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Only the site pharmacist is unblinded.
Study Groups
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Placebo
Subcutaneous placebo injection weekly for 24 weeks.
Group Type
PLACEBO_COMPARATOR
Placebo
Intervention Type
OTHER
Placebo
Abatacept
Subcutaneous injection of abatacept 125 mg weekly for 24 weeks. 24 week optional follow up phase all subjects receive abatacept 125 mg weekly.
Group Type
EXPERIMENTAL
Abatacept
Intervention Type
DRUG
Abatacept 125mg subcutaneous weekly
Interventions
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Abatacept
Abatacept 125mg subcutaneous weekly
Intervention Type
DRUG
Placebo
Placebo
Intervention Type
OTHER
Other Intervention Names
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Orencia
Eligibility Criteria
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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.
4. Active ILD (see Section 4.2).
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 pirfenidone 4 weeks
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.
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.
4. Active ILD (see Section 4.2).
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 pirfenidone 4 weeks
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
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
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
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Sponsor Role
collaborator
Rohit Aggarwal, MD
OTHER
Sponsor Role
lead
Responsible Party
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Rohit Aggarwal, MD
Associate Professor
Responsibility Role
SPONSOR_INVESTIGATOR
Principal Investigators
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Rohit Aggarwal, MD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Locations
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Cedars-Sinai Medical Center
Beverly Hills, California, United States
Site Status
University of Colorado Anschutz Medical Campus
Denver, Colorado, United States
Site Status
John Hopkins Medical Center
Baltimore, Maryland, United States
Site Status
Brigham & Women's Hospital
Boston, Massachusetts, United States
Site Status
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Site Status
Countries
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United States
References
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Kurasawa K, Nawata Y, Takabayashi K, Kumano K, Kita Y, Takiguchi Y, Kuriyama T, Sueishi M, Saito Y, Iwamoto I. Activation of pulmonary T cells in corticosteroid-resistant and -sensitive interstitial pneumonitis in dermatomyositis/polymyositis. Clin Exp Immunol. 2002 Sep;129(3):541-8. doi: 10.1046/j.1365-2249.2002.01933.x.
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Nagaraju K, Raben N, Villalba ML, Danning C, Loeffler LA, Lee E, Tresser N, Abati A, Fetsch P, Plotz PH. Costimulatory markers in muscle of patients with idiopathic inflammatory myopathies and in cultured muscle cells. Clin Immunol. 1999 Aug;92(2):161-9. doi: 10.1006/clim.1999.4743.
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Buch MH, Boyle DL, Rosengren S, Saleem B, Reece RJ, Rhodes LA, Radjenovic A, English A, Tang H, Vratsanos G, O'Connor P, Firestein GS, Emery P. Mode of action of abatacept in rheumatoid arthritis patients having failed tumour necrosis factor blockade: a histological, gene expression and dynamic magnetic resonance imaging pilot study. Ann Rheum Dis. 2009 Jul;68(7):1220-7. doi: 10.1136/ard.2008.091876. Epub 2008 Sep 4.
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Lumsden JM, Roberts JM, Harris NL, Peach RJ, Ronchese F. Differential requirement for CD80 and CD80/CD86-dependent costimulation in the lung immune response to an influenza virus infection. J Immunol. 2000 Jan 1;164(1):79-85. doi: 10.4049/jimmunol.164.1.79.
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Platt AM, Gibson VB, Patakas A, Benson RA, Nadler SG, Brewer JM, McInnes IB, Garside P. Abatacept limits breach of self-tolerance in a murine model of arthritis via effects on the generation of T follicular helper cells. J Immunol. 2010 Aug 1;185(3):1558-67. doi: 10.4049/jimmunol.1001311. Epub 2010 Jul 2.
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Mitsui T, Kuroda Y, Ueno S, Kaji R. The effects of FK506 on refractory inflammatory myopathies. Acta Neurol Belg. 2011 Sep;111(3):188-94.
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Ochi S, Nanki T, Takada K, Suzuki F, Komano Y, Kubota T, Miyasaka N. Favorable outcomes with tacrolimus in two patients with refractory interstitial lung disease associated with polymyositis/dermatomyositis. Clin Exp Rheumatol. 2005 Sep-Oct;23(5):707-10.
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Ando M, Miyazaki E, Yamasue M, Sadamura Y, Ishii T, Takenaka R, Ito T, Nureki S, Kumamoto T. Successful treatment with tacrolimus of progressive interstitial pneumonia associated with amyopathic dermatomyositis refractory to cyclosporine. Clin Rheumatol. 2010 Apr;29(4):443-5. doi: 10.1007/s10067-009-1358-x. Epub 2010 Feb 4.
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Takada K, Nagasaka K, Miyasaka N. Polymyositis/dermatomyositis and interstitial lung disease: a new therapeutic approach with T-cell-specific immunosuppressants. Autoimmunity. 2005 Aug;38(5):383-92. doi: 10.1080/08916930500124023.
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Wilkes MR, Sereika SM, Fertig N, Lucas MR, Oddis CV. Treatment of antisynthetase-associated interstitial lung disease with tacrolimus. Arthritis Rheum. 2005 Aug;52(8):2439-46. doi: 10.1002/art.21240.
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Guglielmo S, Bertinaria M, Rolando B, Crosetti M, Fruttero R, Yardley V, Croft SL, Gasco A. A new series of amodiaquine analogues modified in the basic side chain with in vitro antileishmanial and antiplasmodial activity. Eur J Med Chem. 2009 Dec;44(12):5071-9. doi: 10.1016/j.ejmech.2009.09.012. Epub 2009 Sep 15.
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Kerola AM, Nieminen TV, Kauppi MJ, Kautiainen H, Puolakka K, Virta LJ, Kerola T. Increased risk of levothyroxine-treated hypothyroidism preceding the diagnosis of rheumatoid arthritis: a nationwide registry study. Clin Exp Rheumatol. 2014 Jul-Aug;32(4):455-9. Epub 2014 Jun 6.
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Arabshahi B, Silverman RA, Jones OY, Rider LG. Abatacept and sodium thiosulfate for treatment of recalcitrant juvenile dermatomyositis complicated by ulceration and calcinosis. J Pediatr. 2012 Mar;160(3):520-2. doi: 10.1016/j.jpeds.2011.11.057. Epub 2012 Jan 13.
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Maeshima K, Kiyonaga Y, Imada C, Iwakura M, Hamasaki H, Haranaka M, Ishii K. Successful treatment of refractory anti-signal recognition particle myopathy using abatacept. Rheumatology (Oxford). 2014 Feb;53(2):379-80. doi: 10.1093/rheumatology/ket251. Epub 2013 Aug 6. No abstract available.
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Elhai M, Meunier M, Matucci-Cerinic M, Maurer B, Riemekasten G, Leturcq T, Pellerito R, Von Muhlen CA, Vacca A, Airo P, Bartoli F, Fiori G, Bokarewa M, Riccieri V, Becker M, Avouac J, Muller-Ladner U, Distler O, Allanore Y; EUSTAR (EULAR Scleroderma Trials and Research group). Outcomes of patients with systemic sclerosis-associated polyarthritis and myopathy treated with tocilizumab or abatacept: a EUSTAR observational study. Ann Rheum Dis. 2013 Jul;72(7):1217-20. doi: 10.1136/annrheumdis-2012-202657. Epub 2012 Dec 19.
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Mera-Varela A, Perez-Pampin E. Abatacept therapy in rheumatoid arthritis with interstitial lung disease. J Clin Rheumatol. 2014 Dec;20(8):445-6. doi: 10.1097/RHU.0000000000000084. No abstract available.
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Khanna D, Mittoo S, Aggarwal R, Proudman SM, Dalbeth N, Matteson EL, Brown K, Flaherty K, Wells AU, Seibold JR, Strand V. Connective Tissue Disease-associated Interstitial Lung Diseases (CTD-ILD) - Report from OMERACT CTD-ILD Working Group. J Rheumatol. 2015 Nov;42(11):2168-71. doi: 10.3899/jrheum.141182. Epub 2015 Mar 1.
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BACKGROUND
Aggarwal R, Pongtarakulpanit N, Sullivan DI, Moghadam-Kia S, Bae SS, Wilkerson J, Saygin D, Marder G, Venuturupalli S, Dellaripa PF, Danoff SK, Doyle T, Hunninghake GM, Lee JS, Fischer A, Falk J, Johnson C, Koontz D, Ascherman DP, Oddis CV. Abatacept for the treatment of myositis-associated interstitial lung disease (ATtackMy-ILD). Rheumatology (Oxford). 2025 Apr 24:keaf218. doi: 10.1093/rheumatology/keaf218. Online ahead of print.
Reference Type
DERIVED
Bae SS, Abtin F, Kim G, Markovic D, Chan C, Moghadam-Kia S, Oddis CV, Sullivan D, Marder G, Venuturupalli S, Dellaripa PF, Doyle TJ, Hunninghake GM, Falk J, Charles-Schoeman C, Tashkin DP, Goldin J, Aggarwal R. Relationship between high-resolution computed tomography quantitative imaging analysis and physiological and clinical features in antisynthetase syndrome-related interstitial lung disease. RMD Open. 2024 Nov 27;10(4):e004592. doi: 10.1136/rmdopen-2024-004592.
Reference Type
DERIVED
Bae SS, Markovic D, Saygin D, Sullivan D, Yamaguchi K, Moghadam-Kia S, Oddis CV, Abtin F, Kim GHJ, Marder G, Venuturupalli S, Dellaripa PF, Danoff S, Doyle T, Hunninghake G, Lee JS, Falk J, Johnson C, Goldin J, Tashkin D, Charles-Schoeman C, Aggarwal R. Associations between 6-minute walk distance and physiologic measures and clinical outcomes in myositis-associated interstitial lung disease. Rheumatology (Oxford). 2024 Sep 2:keae477. doi: 10.1093/rheumatology/keae477. Online ahead of print.
Reference Type
DERIVED
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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BMS: IM101-657
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
STUDY19030443
Identifier Type: -
Identifier Source: org_study_id
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