A Study of Subcutaneous Abatacept to Treat Diffuse Cutaneous Systemic Sclerosis (ASSET)

• ClinicalTrials.gov Identifier: NCT02161406
• Recruitment Status: Completed
• First Posted: June 11, 2014
• Results First Posted: June 18, 2019
• Last Update Posted: February 17, 2020
• Sponsor: Dinesh Khanna, MD, MS
• Collaborators: Bristol-Myers Squibb; National Institute of Allergy and Infectious Diseases (NIAID)
• Information provided by (Responsible Party): Dinesh Khanna, MD, MS, University of Michigan

Study Description

Brief Summary:

The study hypothesis is that SC abatacept is safe and shows evidence of efficacy (improvement in modified Rodnan score [mRSS]) in patients with diffuse cutaneous systemic sclerosis (dcScc) compared to matching placebo.

Condition or disease	Intervention/treatment	Phase
Diffuse Cutaneous Systemic Sclerosis	Drug: Abatacept; Drug: Placebo	Phase 2

Detailed Description:

This study is a randomized placebo-controlled double-blind phase 2 trial of patients with dcSSc. Eligible participants will be randomized in a 1:1 ratio to either 125 mg SC abatacept or matching placebo, stratified by duration of dcSSc disease duration (<18 months vs >18 to </=36 months). Study participants will be treated for 12 months on double-blind study medication, followed by an additional 24 weeks of open-label SC abatacept therapy. 86 patients will be randomized in approximately 35 centers in the US, Canada and Europe, with the goal of analyzing 74 participants. The investigators study will test whether abatacept is statistically superior to placebo in reducing the MRSS at month 12 and explore the ability of abatacept to prevent or reverse progression in patients with early disease duration and lower MRSS scores, and reverse established disease in patients with longer disease duration and higher MRSS scores.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 88 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Phase 2 Study to Evaluate Subcutaneous Abatacept vs. Placebo in Diffuse Cutaneous Systemic Sclerosis- a Double-blind, Placebo-controlled, Randomized Controlled Trial.
• Actual Study Start Date: September 2014
• Actual Primary Completion Date: September 12, 2018
• Actual Study Completion Date: October 17, 2018

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Abatacept; 125 mg SC abatacept vs SC placebo administered weekly for 12 months, with a 24-week open-label extension	Drug: Abatacept; Subjects will be treated with injections of 125 mg of abatacept or placebo weekly for 52 weeks; Other Name: Orencia
Placebo Comparator: Placebo; 125mg Placebo	Drug: Placebo; 125 mg of Placebo

Outcome Measures

Primary Outcome Measures :

1. Proportion of Participants With at Least One Adverse Events (AEs) or Serious AEs (SAEs) in 1 Year [ Time Frame: 52 weeks ]
   Safety is measured using AEs, including clinical significant changes in vital signs, laboratory test abnormalities and clinical tolerability of abatacept, and using serious AEs
2. Change From Baseline in the Modified Rodnan Skin Score (mRSS) to Month 12 [ Time Frame: Baseline and 52 weeks ]
   The efficacy of treatment on skin fibrosis will be measured by changes from baseline to month 12 in mRSS, a measure of skin thickness. mRSS scores have a range from 0 to 51, with higher score indicating greater severity of SSc (worse outcome).

Secondary Outcome Measures :

1. Change From Baseline to Month 12 in Patient Global Assessment for Overall Disease [ Time Frame: Baseline and Week 52 ]
   Patient global assessment for overall disease represents the patient's assessment of the patient's global scleroderma on a 0 (excellent) -10 (extremely poor) Likert scale. Higher score means worse outcome.
2. Change From Baseline to Month 12 in Physician Global Assessment for Overall Disease [ Time Frame: Baseline and Week 52 ]
   This assessment represents the physician's assessment of the patient's current disease activity on a 0 (excellent) -10 (extremely poor) Likert scale. Higher score means worse outcome.
3. Change in % Predicted FVC [ Time Frame: Baseline and 52 weeks ]
   FVC is Forced vital capacity, a measure of lung function. FVC % Predicted is calculated using equations from Hankinson [Hankinson JL, Odencrantz JR, Fedan KB. Spirometric reference values from a sample of the general U.S. population. Am J Respir Crit Care Med. 1999;159(1):179-87], incorporating age, gender, and race. It is calculated as the (FVC Observed / FVC predicted) * 100, where FVC predicted is calculated relative to a reference population.
4. Change From Baseline to Month 12 in FVC (in ml) [ Time Frame: Baseline and Week 52 ]
   FVC = forced vital capacity, a measure of lung function
5. Change From Baseline to Month 12 in HAQ-DI - Overall [ Time Frame: Baseline and Week 52 ]
   The HAQ-DI is the Health Assessment Question Disability Index that assesses the extent of a patient's functional ability. The HAQ-DI overall score ranges from 0 (no disability) to 3 (severe disability). Higher score means worse outcome.
6. Change From Baseline to Month 12 in SHAQ-DI VAS - Overall Disease [ Time Frame: Baseline and Week 52 ]
   Scleroderma-Health Assessment Question Disability Index visual analogue scales (VAS) assess the burden of digital ulcers, Raynaud's, gastrointestinal involvement, breathing, and overall disease. The VAS scale for disease severity ranges from 0 (no disease) to 150 (very severe). A higher score means a worse outcome.
7. Change From Baseline to Month 12 in SHAQ-DI VAS - Breathing [ Time Frame: Baseline and Week 52 ]
   Scleroderma-Health Assessment Question Disability Index visual analogue scales (VAS) assess the burden of digital ulcers, Raynaud's, gastrointestinal involvement, breathing, and overall disease. The VAS scale for how much breathing problems interfered with daily activities ranges from 0 (do not limit activities) to 150 (very severe limitation). A higher score means a worse outcome.
8. Change From Baseline to Month 12 in SHAQ-DI VAS - Raynaud's [ Time Frame: Baseline and Week 52 ]
   Scleroderma-Health Assessment Question Disability Index visual analogue scales (VAS) assess the burden of digital ulcers, Raynaud's, gastrointestinal involvement, breathing, and overall disease. The VAS scale for how much Raynaud's interfered with daily activities ranges from 0 (does not limit activities) to 150 (very severe limitation). A higher score means a worse outcome.
9. Change From Baseline to Month 12 in SHAQ-DI VAS - Burden of Digital Ulcers [ Time Frame: Baseline and Week 52 ]
   Scleroderma-Health Assessment Question Disability Index visual analogue scales (VAS) assess the burden of digital ulcers, Raynaud's, gastrointestinal involvement, breathing, and overall disease. The VAS scale for how much finger ulcers interfered with daily activities ranges from 0 (do not limit activities) to 150 (very severe limitation). A higher score means a worse outcome.
10. Change From Baseline to Month 12 in SHAQ-DI VAS - GI Involvement [ Time Frame: Baseline and Week 52 ]
    Scleroderma-Health Assessment Question Disability Index visual analogue scales (VAS) assess the burden of digital ulcers, Raynaud's, gastrointestinal involvement, breathing, and overall disease. The VAS scale for how much intestinal problems interfered with daily activities ranges from 0 (do not limit activities) to 150 (very severe limitation). A higher score means a worse outcome.
11. Change From Baseline to Month 12 in Swollen Joint Count [ Time Frame: Baseline and 52 weeks ]
    28 joints are assessed for swelling (positive or negative). The number of swollen joint count ranges from 0 to 28. A higher number indicates worse outcome.
12. Change From Baseline to Month 12 in Tender Joint Counts [ Time Frame: Baseline and 52 weeks ]
    28 joints are assessed for tenderness (positive or negative). The number of tender joint counts ranges from 0 to 28. A higher number indicates worse outcome.
13. Change From Baseline to Month 12 in PROMIS-29 - Physical Function [ Time Frame: Baseline and Week 52 ]
    The Patient-Reported Outcomes Measurement Information System (PROMIS) 29-item short-form health-reported quality of life measures (PROMIS-29) were administered. The transformed score (T-score) for the physical function domain was used, where 50 (10) is the mean (standard deviation) of a relevant reference population. Higher scores equals more of the concept being measured (i.e., better outcome).
14. Change From Baseline to Month 12 in PROMIS-29 - Anxiety [ Time Frame: Baseline and Week 52 ]
    The Patient-Reported Outcomes Measurement Information System (PROMIS) 29-item short-form health-reported quality of life measures (PROMIS-29) were administered. The transformed score (T-score) for the anxiety domain was used, where 50 (10) is the mean (standard deviation) of a relevant reference population. Higher scores equals more of the concept being measured (i.e., worse outcome).
15. Change From Baseline to Month 12 in PROMIS-29 - Depression [ Time Frame: Baseline and Week 52 ]
    The Patient-Reported Outcomes Measurement Information System (PROMIS) 29-item short-form health-reported quality of life measures (PROMIS-29) were administered. The transformed score (T-score) for the depression domain was used, where 50 (10) is the mean (standard deviation) of a relevant reference population. Higher scores equals more of the concept being measured (i.e., worse outcome).
16. Change From Baseline to Month 12 in PROMIS 29 - Fatigue [ Time Frame: Baseline and Week 52 ]
    The Patient-Reported Outcomes Measurement Information System (PROMIS) 29-item short-form health-reported quality of life measures (PROMIS-29) were administered. The transformed score (T-score) for the fatigue domain was used, where 50 (10) is the mean (standard deviation) of a relevant reference population. Higher scores equals more of the concept being measured (i.e., worse outcome).
17. Change From Baseline to Month 12 in PROMIS-29 - Sleep Disturbance [ Time Frame: Baseline and Week 52 ]
    The Patient-Reported Outcomes Measurement Information System (PROMIS) 29-item short-form health-reported quality of life measures (PROMIS-29) were administered. The transformed score (T-score) for the sleep disturbance domain was used, where 50 (10) is the mean (standard deviation) of a relevant reference population. Higher scores equals more of the concept being measured (i.e.,worse outcome).
18. Change From Baseline to Month 12 in PROMIS-29 - Pain Interference [ Time Frame: Baseline and Week 52 ]
    The Patient-Reported Outcomes Measurement Information System (PROMIS) 29-item short-form health-reported quality of life measures (PROMIS-29) were administered. The transformed score (T-score) for the pain interference domain was used, where 50 (10) is the mean (standard deviation) of a relevant reference population. Higher scores equals more of the concept being measured (i.e., worse outcome).
19. Change From Baseline to Month 12 in PROMIS-29 - Ability to Participate in Social Roles & Activities [ Time Frame: Baseline and Week 52 ]
    The Patient-Reported Outcomes Measurement Information System (PROMIS) 29-item short-form health-reported quality of life measures (PROMIS-29) were administered. The transformed score (T-score) for the ability to participate in social roles and activities domain was used, where 50 (10) is the mean (standard deviation) of a relevant reference population. Higher scores equals more of the concept being measured (i.e., better outcome).
20. Change From Baseline to Month 12 in PROMIS-29 - Pain Intensity [ Time Frame: Baseline and Week 52 ]
    The Patient-Reported Outcomes Measurement Information System (PROMIS) 29-item short-form health-reported quality of life measures (PROMIS-29) were administered. The transformed score (T-score) for the pain intensity domain was used, where 50 (10) is the mean (standard deviation) of a relevant reference population. Higher scores equals more of the concept being measured (i.e., worse outcome).
21. Change From Baseline to Month 12 in SCTC GIT - Composite Score [ Time Frame: Baseline and Week 52 ]
    The SCTC GIT is the UCLA Scleroderma Clinical Trial Consortium Gastrointestinal Instrument. It assesses scleroderma-related gastrointestinal symptoms. The composite score ranges from 0 to 2.83; 0 indicates better health and higher score indicates worse health.
22. ACR CRISS at 12 Months [ Time Frame: Week 52 ]
    The American College of Rheumatology Combined Response Index in Systemic Sclerosis is a composite endpoint. It is determined in a 2-step process. The first step assesses whether the patient has had a significant decline in renal or cardiopulmonary involvement. If none of these apply, the second step assesses the probability of improvement by measuring changes in five outcomes and integrating them into a single number using an equation described in Khanna D, Berrocal VJ, et al. [The American College of Rheumatology Provisional Composite Response Index for Clinical Trials in Early Diffuse Cutaneous Systemic Sclerosis. Arthritis and Rheumatology. 2016; 68(2):299-311.]. It incorporates changes in the modified Rodnan skin score, percent predicted forced vital capacity (FVC), patient and physician global assessments, and SHAQ-DI over 1 year. The score ranges from 0 to 1; a higher score indicates better outcome.
23. Change From Baseline to Month 12 in PROMIS - Fatigue [ Time Frame: Baseline and Week 52 ]
    The Patient-Reported Outcomes Measurement Information System (PROMIS) 8-question short-form health-reported quality of life measure fatigue domain was administered. The transformed score (T-score) was used, where 50 (10) is the mean (standard deviation) of a relevant reference population. Higher scores equals more of the concept being measured (i.e., worse outcome).
24. Change From Baseline to Month 12 in PROMIS - Sleep Disturbance [ Time Frame: Baseline and Week 52 ]
    The Patient-Reported Outcomes Measurement Information System (PROMIS) 4-question short-form health-reported quality of life measure sleep disturbance domain was administered. The transformed score (T-score) was used, where 50 (10) is the mean (standard deviation) of a relevant reference population. Higher scores equals more of the concept being measured (i.e., better outcome).
25. Change From Baseline to Month 12 in PROMIS - Sleep Impairment [ Time Frame: Baseline and Week 52 ]
    The Patient-Reported Outcomes Measurement Information System (PROMIS) 8-question short-form health-reported quality of life measure sleep impairment domain was administered. The transformed score (T-score) was used, where 50 (10) is the mean (standard deviation) of a relevant reference population. Higher scores equals more of the concept being measured (i.e., worse outcome).
26. Change From Baseline to Month 12 in HAQ-DI - Dressing and Grooming [ Time Frame: Baseline and Week 52 ]
    The HAQ-DI is the Health Assessment Question Disability Index that assesses the extent of a patient's functional ability. The HAQ-DI subscore ranges from 0 (no disability) to 3 (severe disability). A higher score means worse outcome.
27. Change From Baseline to Month 12 in HAQ-DI - Hygiene [ Time Frame: Baseline and Week 52 ]
    The HAQ-DI is the Health Assessment Question Disability Index that assesses the extent of a patient's functional ability. The HAQ-DI subscore ranges from 0 (no disability) to 3 (severe disability). A higher score means worse outcome.
28. Change From Baseline to Month 12 in HAQ-DI - Arising [ Time Frame: Baseline and Week 52 ]
    The HAQ-DI is the Health Assessment Question Disability Index that assesses the extent of a patient's functional ability. The HAQ-DI subscore ranges from 0 (no disability) to 3 (severe disability). A higher score means worse outcome.
29. Change From Baseline to Month 12 in HAQ-DI - Reach [ Time Frame: Baseline and Week 52 ]
    The HAQ-DI is the Health Assessment Question Disability Index that assesses the extent of a patient's functional ability. The HAQ-DI subscore ranges from 0 (no disability) to 3 (severe disability). A higher score means worse outcome.
30. Change From Baseline to Month 12 in HAQ-DI - Eating [ Time Frame: Baseline and Week 52 ]
    The HAQ-DI is the Health Assessment Question Disability Index that assesses the extent of a patient's functional ability. The HAQ-DI subscore ranges from 0 (no disability) to 3 (severe disability). A higher score means worse outcome.
31. Change From Baseline to Month 12 in HAQ-DI - Grip [ Time Frame: Baseline and Week 52 ]
    The HAQ-DI is the Health Assessment Question Disability Index that assesses the extent of a patient's functional ability. The HAQ-DI subscore ranges from 0 (no disability) to 3 (severe disability). A higher score means worse outcome.
32. Change From Baseline to Month 12 in HAQ-DI - Walking [ Time Frame: Baseline and Week 52 ]
    The HAQ-DI is the Health Assessment Question Disability Index that assesses the extent of a patient's functional ability. The HAQ-DI subscore ranges from 0 (no disability) to 3 (severe disability). A higher score means worse outcome.
33. Change From Baseline to Month 12 in HAQ-DI - Common Daily Activities [ Time Frame: Baseline and Week 52 ]
    The HAQ-DI is the Health Assessment Question Disability Index that assesses the extent of a patient's functional ability. The HAQ-DI subscore ranges from 0 (no disability) to 3 (severe disability). A higher score means worse outcome.

Eligibility Criteria

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

Criteria

Inclusion Criteria:

1. Diagnosis of Systematic Sclerosis (SSc), as defined using the 2013 American College of Rheumatology/ European Union League Against Rheumatism classification of SSc
2. Diffuse Systemic Sclerosis (dcSSc) as defined by LeRoy and Medsger
3. Disease duration of ≤ 36 months (defined as time from the first non-Raynaud phenomenon manifestation)
4. For disease duration of ≤ 18 months: ≥ 10 and ≤ 35 mRSS units at the screening visit

5. For disease duration of >18-36 months: ≥ 15 and ≤ 45 mRSS units at the screening visit and one of the following:

   • Increase ≥ 3 in mRSS units compared with the last visit within previous 1-6 months
   • Involvement of one new body area with ≥ 2 mRSS units compared with the last visit within the previous 1-6 months
   • Involvement of two new body areas with ≥ 1 mRSS units compared with the last visit within the previous 1-6 months
   • Presence of 1 or more Tendon Friction Rub
6. Age ≥ 18 years at the screening visit
7. If female of childbearing potential, the patient must have a negative pregnancy test at screening and baseline visits

8. Oral corticosteroids (≤ 10 mg/day of prednisone or equivalent) and NSAIDs are permitted if the patient is on a stable dose regimen for

   • 2 weeks prior to and including the baseline visit.
9. ACE inhibitors, calcium-channel blockers, proton-pump inhibitors, and/or oral vasodilators are permitted if the patient is on a stable dose for ≥ 2 weeks prior to and including the baseline visit.

Exclusion Criteria:

1. Rheumatic disease other than dcSSc; it is acceptable to include patients with fibromyalgia and scleroderma-associated myopathy
2. Limited cutaneous systemic sclerosis or sine scleroderma at the screening visit
3. Major surgery (including joint surgery) within 8 weeks prior to screening visit
4. Infected ulcer prior to randomization
5. Treatment with any investigational agent within ≤ 4 weeks (or 5 half-lives of the investigational drug, whichever is longer) of the baseline visit
6. Previous treatment with cell-depleting therapies, including investigational agents, including but not limited to, CAMPATH, anti-CD4, anti-CD5, anti-CD3, anti-CD19, and ABA
7. Anti-CD20, and cyclophosphamide within 12 months prior to baseline visit.
8. Use of Intravenous Immunoglobulin (IVIG) within 12 weeks prior to baseline visit
9. Previous treatment with chlorambucil, bone marrow transplantation, or total lymphoid irradiation
10. Immunization with a live/attenuated vaccine within ≤ 4 weeks prior to the baseline visit
11. Treatment with methotrexate, hydroxychloroquine, cyclosporine A, azathioprine, mycophenolate mofetil rapamycin, colchicine, or D-penicillamine, within≤ 4 weeks prior to the baseline visit
12. Treatment with etanercept within ≤ 2 weeks, infliximab, certolizumab, golimumab, ABA or adalimumab within ≤ 8 weeks, anakinra within ≤ 1 week prior to the baseline visit
13. Pulmonary disease with FVC ≤ 50% of predicted, or DLCO (uncorrected for hemoglobin ) ≤ 40% of predicted at the screening visit
14. Pulmonary arterial hypertension (PAH) as determined by right heart catheterization or on PAH approved medications for PAH. It is acceptable to use PDFE-5 inhibitors for Raynaud's and digital ulcers.
15. Subjects at risk for tuberculosis (TB). Specifically excluded from this study will be participants with a history of active TB within the last 3 years, even if it was treated; a history of active TB greater than 3 years ago, unless there is documentation that the prior anti-TB treatment was appropriate in duration and type; current clinical, radiographic, or laboratory evidence of active TB; and latent TB that was not successfully treated (≥ 4 weeks).
16. Positive for hepatitis B surface antigen prior to the baseline visit
17. Positive for hepatitis C antigen, if the presence of hepatitis C virus was also shown with polymerase chain reaction or recombinant immunoblot assay prior to baseline visit
18. Subjects at risk for tuberculosis (TB). Specifically excluded from this study will be participants with a history of active TB within the last 3 years, even if it was treated; a history of active TB greater than 3 years ago, unless there is documentation that the prior anti-TB treatment was appropriate in duration and type; current clinical, radiographic, or laboratory evidence of active TB; and latent TB that was not successfully treated (≥ 4 weeks).
19. Any of the following at the screening visit: Hemoglobin <8.5 g/dL; WBC < 3,000/mm3 (<3 x 109/L); platelets < 100,000/mm3 (<3 x 109/L); serum creatinine > 2 x ULN; serum ALT or AST > 2 x ULN
20. Severe skin thickening (mRSS 3) on the inner aspects of thighs, upper arms, or abdomen
21. Patients with a history of anaphylaxis to abatacept

Contacts and Locations

Locations

United States, California

Arthritis Associates of Southern California

Los Angeles, California, United States, 90045

University of California- Los Angeles

Los Angeles, California, United States, 90095

Stanford University

Redwood City, California, United States, 94063

United States, District of Columbia

Georgetown University

Washington, District of Columbia, United States, 20009

United States, Illinois

Northwestern University

Chicago, Illinois, United States, 60611

United States, Massachusetts

Harvard Mass General

Boston, Massachusetts, United States, 02116

Boston University

Boston, Massachusetts, United States, 02118

United States, Michigan

University of Michigan

Ann Arbor, Michigan, United States, 48109

United States, Minnesota

University of Minnesota

Minneapolis, Minnesota, United States, 55455

Mayo Clinic

Rochester, Minnesota, United States, 55905

United States, New Jersey

Rutgers University Clinical Research Center

New Brunswick, New Jersey, United States, 08831

United States, New York

Steffens Scleroderma Center

Albany, New York, United States, 12203

NorthWell Health

Great Neck, New York, United States, 11021

Hospital for Special Surgery

New York, New York, United States, 10021

Columbia University

New York, New York, United States, 10032

United States, Ohio

Cleveland Clinic

Cleveland, Ohio, United States, 44195

Ohio State University Medical Center

Columbus, Ohio, United States, 43221

United States, Pennsylvania

University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

University of Pittsburgh

Pittsburgh, Pennsylvania, United States, 15261

United States, South Carolina

Medical University of South Carolina

Charleston, South Carolina, United States, 29425

United States, Texas

University of Texas Health Center at Houston

Houston, Texas, United States, 77030

United States, Utah

University of Utah

Salt Lake City, Utah, United States, 84132

United States, Washington

Swedish Health Services

Seattle, Washington, United States, 98122

Canada, Ontario

St. Joseph Health Care London

London, Ontario, Canada, N6A4V2

Mount Sinai Hospital

Toronto, Ontario, Canada, M5T 3L9

Canada, Quebec

Jewish General Hospital

Montreal, Quebec, Canada, H3T 1E2

United Kingdom

Royal Free Hospital

London, United Kingdom, NW3 2QG

Sponsors and Collaborators

Dinesh Khanna, MD, MS

Bristol-Myers Squibb

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

• Principal Investigator: Dinesh Khanna, MD, MS; University of Michigan

  Study Documents (Full-Text)

Documents provided by Dinesh Khanna, MD, MS, University of Michigan:

Study Protocol  [PDF] December 8, 2015

Statistical Analysis Plan  [PDF] April 6, 2018

More Information

Additional Information:

To learn more about the Scleroderma program at the University of Michigan 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Chung L, Spino C, McLain R, Johnson SR, Denton CP, Molitor JA, Steen VD, Lafyatis R, Simms RW, Kafaja S, Frech TM, Hsu V, Domsic RT, Pope JE, Gordon JK, Mayes MD, Sandorfi N, Hant FN, Bernstein EJ, Chatterjee S, Castelino FV, Ajam A, Allanore Y, Matucci-Cerinic M, Whitfield ML, Distler O, Singer O, Young A, Nagaraja V, Fox DA, Furst DE, Khanna D. Safety and efficacy of abatacept in early diffuse cutaneous systemic sclerosis (ASSET): open-label extension of a phase 2, double-blind randomised trial. Lancet Rheumatol. 2020 Dec;2(12):e743-e753. doi: 10.1016/s2665-9913(20)30237-x. Epub 2020 Oct 19.

Khanna D, Spino C, Johnson S, Chung L, Whitfield ML, Denton CP, Berrocal V, Franks J, Mehta B, Molitor J, Steen VD, Lafyatis R, Simms RW, Gill A, Kafaja S, Frech TM, Hsu V, Domsic RT, Pope JE, Gordon JK, Mayes MD, Schiopu E, Young A, Sandorfi N, Park J, Hant FN, Bernstein EJ, Chatterjee S, Castelino FV, Ajam A, Wang Y, Wood T, Allanore Y, Matucci-Cerinic M, Distler O, Singer O, Bush E, Fox DA, Furst DE. Abatacept in Early Diffuse Cutaneous Systemic Sclerosis: Results of a Phase II Investigator-Initiated, Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial. Arthritis Rheumatol. 2020 Jan;72(1):125-136. doi: 10.1002/art.41055. Epub 2019 Dec 10.

• Responsible Party: Dinesh Khanna, MD, MS, Associate Professor of Rheumatology/ Internal Medicine, University of Michigan
• ClinicalTrials.gov Identifier: NCT02161406
• Other Study ID Numbers: IM101-344; 1UM1AI110557 ( U.S. NIH Grant/Contract )
• First Posted: June 11, 2014
• Results First Posted: June 18, 2019
• Last Update Posted: February 17, 2020
• Last Verified: February 2020

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dinesh Khanna, MD, MS, University of Michigan:

Scleroderma

Additional relevant MeSH terms:

Scleroderma, Systemic; Scleroderma, Diffuse; Sclerosis; Pathologic Processes; Connective Tissue Diseases; Skin Diseases; Abatacept; Immune Checkpoint Inhibitors; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents, Immunological; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Antirheumatic Agents