Trial · NCT02161406

A Study of Subcutaneous Abatacept to Treat Diffuse Cutaneous Systemic Sclerosis

NCT02161406, Phase 2, Completed, Dinesh Khanna, MD, MS; results first posted 2019-06-18

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study of Subcutaneous Abatacept to Treat Diffuse Cutaneous Systemic Sclerosis. Trials, record NCT02161406. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02161406

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study of Subcutaneous Abatacept to Treat Diffuse Cutaneous Systemic Sclerosis
NCT number: NCT02161406
Status: Completed
Phases: Phase 2
Enrollment: 88 participants, actual
Lead sponsor: Dinesh Khanna, MD, MS
Conditions: Diffuse Cutaneous Systemic Sclerosis
Interventions: Abatacept, Placebo
First posted: 2014-06-11
Last updated: 2020-02-17
Results first posted: 2019-06-18

Source ClinicalTrials.gov

Registered outcomes35

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Proportion of Participants With at Least One Adverse Events (AEs) or Serious AEs (SAEs) in 1 Year	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
Primary	Change From Baseline in the Modified Rodnan Skin Score (mRSS) to Month 12	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	Change From Baseline to Month 12 in Patient Global Assessment for Overall Disease	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.
Secondary	Change From Baseline to Month 12 in Physician Global Assessment for Overall Disease	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.
Secondary	Change in % Predicted FVC	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.
Secondary	Change From Baseline to Month 12 in FVC (in ml)	Baseline and Week 52	FVC = forced vital capacity, a measure of lung function
Secondary	Change From Baseline to Month 12 in HAQ-DI - Overall	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.
Secondary	Change From Baseline to Month 12 in SHAQ-DI VAS - Overall Disease	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.
Secondary	Change From Baseline to Month 12 in SHAQ-DI VAS - Breathing	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.
Secondary	Change From Baseline to Month 12 in SHAQ-DI VAS - Raynaud's	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.

1 to 10 of 35Source ClinicalTrials.gov

See all 35 registered outcomes

Outcomes35

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Proportion of Participants With at Least One Adverse Events (AEs) or Serious AEs (SAEs) in 1 Year	52 weeks	mITT population includes all of the randomized participants who received at least one dose of study medication.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Change From Baseline in the Modified Rodnan Skin Score (mRSS) to Month 12	Baseline and 52 weeks	mITT population includes all of the randomized participants who received at least one dose of study medication.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline to Month 12 in Patient Global Assessment for Overall Disease	Baseline and Week 52	mITT population includes all of the randomized participants who received at least one dose of study medication.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline to Month 12 in Physician Global Assessment for Overall Disease	Baseline and Week 52	mITT population includes all of the randomized participants who received at least one dose of study medication.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change in % Predicted FVC	Baseline and 52 weeks	mITT population includes all of the randomized participants who received at least one dose of study medication.	percent predicted	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline to Month 12 in FVC (in ml)	Baseline and Week 52	mITT population includes all of the randomized participants who received at least one dose of study medication.	ml	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline to Month 12 in HAQ-DI - Overall	Baseline and Week 52	mITT population includes all of the randomized participants who received at least one dose of study medication.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline to Month 12 in SHAQ-DI VAS - Overall Disease	Baseline and Week 52	mITT population includes all of the randomized participants who received at least one dose of study medication.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline to Month 12 in SHAQ-DI VAS - Breathing	Baseline and Week 52	mITT population includes all of the randomized participants who received at least one dose of study medication.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline to Month 12 in SHAQ-DI VAS - Raynaud's	Baseline and Week 52	mITT population includes all of the randomized participants who received at least one dose of study medication.	score on a scale	LEAST_SQUARES_MEAN

1 to 10 of 35Source ClinicalTrials.gov

See all 35 outcomes

Results by group70

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Proportion of Participants With at Least One Adverse Events (AEs) or Serious AEs (SAEs) in 1 Year	Abatacept	35		Participants
Proportion of Participants With at Least One Adverse Events (AEs) or Serious AEs (SAEs) in 1 Year	Placebo	40		Participants
Change From Baseline in the Modified Rodnan Skin Score (mRSS) to Month 12	Abatacept	-6.24	Standard Error 1.14	units on a scale
Change From Baseline in the Modified Rodnan Skin Score (mRSS) to Month 12	Placebo	-4.49	Standard Error 1.14	units on a scale
Change From Baseline to Month 12 in Patient Global Assessment for Overall Disease	Abatacept	-0.31	Standard Error 0.423	score on a scale
Change From Baseline to Month 12 in Patient Global Assessment for Overall Disease	Placebo	-0.09	Standard Error 0.457	score on a scale
Change From Baseline to Month 12 in Physician Global Assessment for Overall Disease	Abatacept	-1.3	Standard Error 0.290	score on a scale
Change From Baseline to Month 12 in Physician Global Assessment for Overall Disease	Placebo	-0.35	Standard Error 0.318	score on a scale
Change in % Predicted FVC	Abatacept	-1.34	Standard Error 1.24	percent predicted
Change in % Predicted FVC	Placebo	-4.13	Standard Error 1.22	percent predicted

1 to 10 of 70Source ClinicalTrials.gov

See all 70 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Abatacept	44
Overall Study	STARTED	Placebo	44
Overall Study	COMPLETED	Abatacept	34
Overall Study	COMPLETED	Placebo	35
Overall Study	NOT COMPLETED	Abatacept	10
Overall Study	NOT COMPLETED	Placebo	9

Source ClinicalTrials.gov

Adverse events104

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Other Non-serious Adverse Events	General disorders	Abatacept	13	44	23
other	Other Non-serious Adverse Events	General disorders	Placebo	12	44	16
other	Other Non-serious Adverse Events	Blood and lymphatic system disorders	Abatacept	0	44	0
other	Other Non-serious Adverse Events	Blood and lymphatic system disorders	Placebo	3	44	3
other	Other Non-serious Adverse Events	Infections and infestations	Abatacept	17	44	24
other	Other Non-serious Adverse Events	Infections and infestations	Placebo	22	44	39
other	Other Non-serious Adverse Events	Musculoskeletal and connective tissue disorders	Abatacept	18	44	25
other	Other Non-serious Adverse Events	Musculoskeletal and connective tissue disorders	Placebo	17	44	23
other	Other Non-serious Adverse Events	Nervous system disorders	Abatacept	7	44	7
other	Other Non-serious Adverse Events	Nervous system disorders	Placebo	7	44	9

1 to 10 of 104Source ClinicalTrials.gov

See all 104 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Abatacept	2	44
Total, all-cause mortality	Placebo	1	44
Total, other adverse events	Abatacept	35	44
Total, other adverse events	Placebo	40	44
Total, serious adverse events	Abatacept	9	44
Total, serious adverse events	Placebo	12	44

Source ClinicalTrials.gov

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
31342624	DERIVED	PubMed
34966900	DERIVED	PubMed
36355434	DERIVED	PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
UM1AI110557	University of Michigan Autoimmunity Center of Excellence, Clinical Research Progr	FOX, DAVID ALAN	UNIVERSITY OF MICHIGAN AT ANN ARBOR	NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES	2014 to 2018

Source NIH RePORTER

Trial comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Abatacept vs Placebo: deaths from any cause	Trial comparisons
Abatacept vs Placebo: Proportion of Participants With at Least One Adverse Events (AEs) or Serious AEs (SAEs) in 1 Year	Trial comparisons
Abatacept vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02161406

GET https://conductscience.org/api/trials/v1/NCT02161406/registered?page=2

API reference For AI assistants