Trial · NCT00442611

A Study to Evaluate the Safety and Efficacy of Abatacept in Patients With Diffuse Systemic Sclerosis (Scleroderma)

NCT00442611, Phase 1, Phase 2, Completed, Stanford University; results first posted 2015-04-24

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study to Evaluate the Safety and Efficacy of Abatacept in Patients With Diffuse Systemic Sclerosis (Scleroderma). Trials, record NCT00442611. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00442611

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Trial

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

Title: A Study to Evaluate the Safety and Efficacy of Abatacept in Patients With Diffuse Systemic Sclerosis (Scleroderma)
NCT number: NCT00442611
Status: Completed
Phases: Phase 1, Phase 2
Enrollment: 10 participants, actual
Lead sponsor: Stanford University
Conditions: Scleroderma, Diffuse, Scleroderma, Systemic
Interventions: Abatacept, Placebo
First posted: 2007-03-02
Last updated: 2017-10-31
Results first posted: 2015-04-24

Source ClinicalTrials.gov

Registered outcomes6

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

List	Outcome	Time frame	Description
Primary	Change in Modified Rodnan Skin Score	6 months	Modified Rodnan Skin Score measures skin thickness and is the sum of scores from 17 surface anatomic areas rated on a 0-3 scale (0=normal skin; 1=mild thickness; 2=moderate thickness; 3=severe thickness with inability to pinch the skin into a fold). Total modified Rodnan Skin Score ranges from 0 (best possible outcome) to 51 (worst possible outcome).
Secondary	Oral Aperture at Baseline and Month 6	Baseline; Month 6
Secondary	Hand Extension at Baseline and Month 6	Baseline; Month 6
Secondary	Digital Ulcerations at Baseline and Month 6	Baseline; Month 6
Secondary	Change in Pulmonary Function Tests	6 months	FVC (Forced Vital Capacity) is the amount of air that can be forcibly exhaled from the lungs after taking the deepest possible breath. DLCO (Diffusing capacity of the lung for carbon monoxide) is the extent to which oxygen passes from the lungs to the blood.
Secondary	Change in Scleroderma Health Assessment Questionnaire	6 months	The HAQ Disability Index (HAQ-DI) includes 20 items in 8 functional domains (dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities) assessing the patient's usual abilities in the past seven days. Each item is scored on a 0-3 scale (0=without any difficulty; 1=with some difficulty; 2=with much difficulty; 3=unable to do). The use of assistive devices for any domain increases the domain score by 1 point to a maximum of 3. The overall score is calculated by summing the highest item score in each of the domains and dividing the sum by 8, with an overall score of 0 indicating no disability, and a score of 3 indicating severe disability. The time points compared were 6 months to baseline (6 months minus baseline).

Source ClinicalTrials.gov

Outcomes6

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in Modified Rodnan Skin Score	6 months		MRSS score	MEAN
SECONDARY	Oral Aperture at Baseline and Month 6	Baseline; Month 6		mm	MEAN
SECONDARY	Hand Extension at Baseline and Month 6	Baseline; Month 6		mm	MEAN
SECONDARY	Digital Ulcerations at Baseline and Month 6	Baseline; Month 6		ulcers	MEAN
SECONDARY	Change in Pulmonary Function Tests	6 months	Participants with available data were analyzed.	% Predicted	MEAN
SECONDARY	Change in Scleroderma Health Assessment Questionnaire	6 months	Participants with available data were analyzed.	HAQ-DI score	MEAN

Source ClinicalTrials.gov

Results by group32

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

Outcome	Group	Category	Value	Spread	Units
Change in Modified Rodnan Skin Score	Abatacept		-8.6	Standard Deviation 7.5	MRSS score
Change in Modified Rodnan Skin Score	IV Fluid		-2.3	Standard Deviation 15	MRSS score
Oral Aperture at Baseline and Month 6	Abatacept	Right side baseline	31.1	Standard Deviation 6.51	mm
Oral Aperture at Baseline and Month 6	IV Fluid	Right side baseline	21.0	Standard Deviation 4.32	mm
Oral Aperture at Baseline and Month 6	Abatacept	Right side month 6	29.4	Standard Deviation 4.98	mm
Oral Aperture at Baseline and Month 6	IV Fluid	Right side month 6	21.0	Standard Deviation 1.41	mm
Oral Aperture at Baseline and Month 6	Abatacept	Left side baseline	30.9	Standard Deviation 7.18	mm
Oral Aperture at Baseline and Month 6	IV Fluid	Left side baseline	20.0	Standard Deviation 2.45	mm
Oral Aperture at Baseline and Month 6	Abatacept	Left side month 6	29.3	Standard Deviation 4.65	mm
Oral Aperture at Baseline and Month 6	IV Fluid	Left side month 6	20.0	Standard Deviation 4.08	mm

1 to 10 of 32Source ClinicalTrials.gov

See all 32 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Abatacept	7
Overall Study	STARTED	IV Fluid	3
Overall Study	COMPLETED	Abatacept	6
Overall Study	COMPLETED	IV Fluid	3
Overall Study	NOT COMPLETED	Abatacept	1
Overall Study	NOT COMPLETED	IV Fluid	0

Source ClinicalTrials.gov

Adverse events16

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	infection	Respiratory, thoracic and mediastinal disorders	Abatacept	2	7	2
other	infection	Respiratory, thoracic and mediastinal disorders	IV Fluid	1	3	1
other	pruritus	Skin and subcutaneous tissue disorders	Abatacept	2	7	2
other	pruritus	Skin and subcutaneous tissue disorders	IV Fluid	0	3	0
other	lower extremity edema	Vascular disorders	Abatacept	0	7	0
other	lower extremity edema	Vascular disorders	IV Fluid	1	3	1
other	headache	General disorders	Abatacept	1	7	1
other	headache	General disorders	IV Fluid	0	3	0
other	dry mouth	General disorders	Abatacept	0	7	0
other	dry mouth	General disorders	IV Fluid	1	3	1

1 to 10 of 16Source ClinicalTrials.gov

See all 16 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Abatacept
Total, all-cause mortality	IV Fluid
Total, other adverse events	Abatacept	6	7
Total, other adverse events	IV Fluid	3	3
Total, serious adverse events	Abatacept	1	7
Total, serious adverse events	IV Fluid	0	3

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
26071192	DERIVED

Source PubMed

Grants0

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.

None in this release.

Trial comparisons1

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

Comparison
Abatacept vs IV Fluid: serious adverse events

Source 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/NCT00442611

GET https://conductscience.org/api/trials/v1/NCT00442611/results?page=2

API reference For AI assistants