Trial · NCT03274076

Evaluation of Tofacitinib in Early Diffuse Cutaneous Systemic Sclerosis (dcSSc)

NCT03274076, Phase 1, Phase 2, Completed, University of Michigan; results first posted 2020-05-08

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Evaluation of Tofacitinib in Early Diffuse Cutaneous Systemic Sclerosis (dcSSc). Trials, record NCT03274076. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03274076

On this page

Trial

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

Title: Evaluation of Tofacitinib in Early Diffuse Cutaneous Systemic Sclerosis (dcSSc)
NCT number: NCT03274076
Status: Completed
Phases: Phase 1, Phase 2
Enrollment: 15 participants, actual
Lead sponsor: University of Michigan
Conditions: Systemic Sclerosis, Scleroderma
Interventions: Tofacitinib, Placebo Oral Tablet
First posted: 2017-09-06
Last updated: 2020-05-08
Results first posted: 2020-05-08

Source ClinicalTrials.gov

Registered outcomes6

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

List	Outcome	Time frame	Description
Primary	Number of Participants Who Experience Grade 3 or Higher Adverse Events That Occur at or Before Week 24	24 weeks	Primary outcome is met if any participants experience a grade 3 or higher event prior to Week 24. A grade 3 AE would constitute as "severe". Grading was following using CTCAE v 4.03. Note that the planned statistical analysis (Fisher's exact test) could not be performed because there were no events.
Secondary	Number of Grade 3 (Severe) or Higher Adverse Events That Occur Throughout the Study	Week 12, 24, 36, and 48	Grade 3 or higher adverse events (AEs) assessed throughout the study ( 48 weeks). A grade 3 AE would constitute as "severe". Grading was following using CTCAE v 4.03. Note that the planned statistical analysis (calculation of rate ratio and 90% CI) could not be performed at Weeks 12 and 24 due to no events, and could not be performed at Week 36 because there were no events in the placebo group (denominator).
Secondary	Number of Grade 2 (Moderate) or Higher Adverse Events That Occur Throughout the Study	Week: 12, 24, 36, and 48	Grade 2 or higher assessed 12 weeks apart. Grade 2 AEs are determined as " moderate". Grading was performed following CTCAE v 4.03 guidance.
Secondary	Number of Adverse Events of Special Interest (AESI) Throughout the Study	Weeks 12, 24, 36 and 48	AESI are pre-defined adverse events as indicated in the protocol. They include: infections, stomach perforations, malignancy, herpes zoster and lab abnormalities. Note that the planned statistical analysis (calculation of rate ratio and 90% CI) could not be performed at Weeks 12 and 24 because there were no events in placebo group (denominator).
Secondary	Change in Modified Rodnan Skin Score (mRSS)	Change from Baseline at weeks: 12, 24, 36, and 48	The Modified Rodnan Skin Score (mRSS) is a measure of skin thickness. Skin thickness in 17 anatomic areas was rated on a 0-3 scale and scores are summed to obtain the mRSS (range from 0 - 51), with higher mRSS scores indicating worse disease activity
Secondary	Provisional American College of Rheumatology Combined Response Index (CRISS) Systemic Sclerosis	Week:12, 24, and 48	CRISS components included the following domains: modified Rodnan skin score, forced vital capacity percent predicted, Physician Global Assessment, Patient Global Assessment, and Health Assessment Questionnaire Disability-Index. An algorithm determines the predicted probability of improvement from baseline by incorporating change in the mRSS, FVC percent predicted, Physician and Patient Global Assessments, and HAQ-DI. The outcome is a continuous variable between 0.0 and 1.0 (0 - 100%). A cut-off at 0.6 in the predicted probability of being improved has yielded the smallest misclassification error. Subjects are not considered improved if, between Visit 1 and 6, they develop new: 1) renal crisis; 2) decline in FVC% predicted by 15% (relative) from baseline and confirmed after 1 month; or 3) left ventricular failure (systolic ejection fraction \< 45%) or pulmonary artery hypertension. Higher CRISS scores indicates improvement.

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	Number of Participants Who Experience Grade 3 or Higher Adverse Events That Occur at or Before Week 24	24 weeks	All participants were included in this analysis although 1 placebo participant withdrew prior to week 24. They remained in the intent to treat population.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Grade 3 (Severe) or Higher Adverse Events That Occur Throughout the Study	Week 12, 24, 36, and 48	One placebo participant withdrew prior to week 24. 1 additional placebo participant and 2 tofacitinib participants withdrew prior to week 48 but after completing week 24 and entering the open label portion.	Adverse Events	NUMBER
SECONDARY	Number of Grade 2 (Moderate) or Higher Adverse Events That Occur Throughout the Study	Week: 12, 24, 36, and 48	One placebo participant withdrew prior to week 24. 1 additional placebo participant and 2 tofacitinib participants withdrew prior to week 48 but after completing week 24.	Adverse Events	NUMBER
SECONDARY	Number of Adverse Events of Special Interest (AESI) Throughout the Study	Weeks 12, 24, 36 and 48	Placebo participant withdrew prior to week 24. 1 additional placebo participant and 2 tofacitinib participants withdrew prior to week 48.	Adverse Events	NUMBER
SECONDARY	Change in Modified Rodnan Skin Score (mRSS)	Change from Baseline at weeks: 12, 24, 36, and 48	Placebo participant withdrew prior to week 24. 1 additional placebo participant and 2 tofacitinib participants withdrew prior to week 48.	score on a scale	MEDIAN
SECONDARY	Provisional American College of Rheumatology Combined Response Index (CRISS) Systemic Sclerosis	Week:12, 24, and 48	Placebo participant withdrew prior to week 24. 1 additional placebo participant and 2 tofacitinib participants withdrew prior to week 48.	score on a scale	MEDIAN

Source ClinicalTrials.gov

Results by group40

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

Outcome	Group	Category	Value	Units
Number of Participants Who Experience Grade 3 or Higher Adverse Events That Occur at or Before Week 24	Tofacitinib Double Blind 0-24 Weeks		0	Participants
Number of Participants Who Experience Grade 3 or Higher Adverse Events That Occur at or Before Week 24	Placebo Double Blind 0-24 Weeks		0	Participants
Number of Grade 3 (Severe) or Higher Adverse Events That Occur Throughout the Study	Tofacitinib Double Blind 0-24 Weeks	Week 12	0	Adverse Events
Number of Grade 3 (Severe) or Higher Adverse Events That Occur Throughout the Study	Placebo Double Blind 0-24 Weeks	Week 12	0	Adverse Events
Number of Grade 3 (Severe) or Higher Adverse Events That Occur Throughout the Study	Tofacitinib Double Blind 0-24 Weeks	Week 24	0	Adverse Events
Number of Grade 3 (Severe) or Higher Adverse Events That Occur Throughout the Study	Placebo Double Blind 0-24 Weeks	Week 24	0	Adverse Events
Number of Grade 3 (Severe) or Higher Adverse Events That Occur Throughout the Study	Tofacitinib to Tofacitinib Open Label 24-48 Weeks	Week 36	2	Adverse Events
Number of Grade 3 (Severe) or Higher Adverse Events That Occur Throughout the Study	Placebo to Tofacitinib Open Label 24-48 Weeks	Week 36	0	Adverse Events
Number of Grade 3 (Severe) or Higher Adverse Events That Occur Throughout the Study	Tofacitinib to Tofacitinib Open Label 24-48 Weeks	Week 48	1	Adverse Events
Number of Grade 3 (Severe) or Higher Adverse Events That Occur Throughout the Study	Placebo to Tofacitinib Open Label 24-48 Weeks	Week 48	1	Adverse Events

1 to 10 of 40Source ClinicalTrials.gov

See all 40 results by group

Participant flow24

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

Period	Milestone	Group	Participants
24 Weeks Double Blind	STARTED	Tofacitinib Double Blind 0-24 Weeks	10
24 Weeks Double Blind	STARTED	Placebo Double Blind 0-24 Weeks	5
24 Weeks Double Blind	STARTED	Tofacitinib to Tofacitinib Open Label 24-48 Weeks	0
24 Weeks Double Blind	STARTED	Placebo to Tofacitinib Open Label 24-48 Weeks	0
24 Weeks Double Blind	COMPLETED	Tofacitinib Double Blind 0-24 Weeks	10
24 Weeks Double Blind	COMPLETED	Placebo Double Blind 0-24 Weeks	4
24 Weeks Double Blind	COMPLETED	Tofacitinib to Tofacitinib Open Label 24-48 Weeks	0
24 Weeks Double Blind	COMPLETED	Placebo to Tofacitinib Open Label 24-48 Weeks	0
24 Weeks Double Blind	NOT COMPLETED	Tofacitinib Double Blind 0-24 Weeks	0
24 Weeks Double Blind	NOT COMPLETED	Placebo Double Blind 0-24 Weeks	1

1 to 10 of 24Source ClinicalTrials.gov

See all 24 participant flow

Adverse events204

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	Hypercholesterolemia	Investigations	Tofacitinib Double Blind 0-24 Weeks	0	10	0
other	Hypercholesterolemia	Investigations	Placebo Double Blind 0-24 Weeks	0	5	0
other	Hypercholesterolemia	Investigations	Tofacitinib to Tofacitinib Open Label 24-48 Weeks	1	10	1
other	Hypercholesterolemia	Investigations	Placebo to Tofacitinib Open Label 24-48 Weeks	0	4	0
other	Hyperkalemia	Investigations	Tofacitinib Double Blind 0-24 Weeks	0	10	0
other	Hyperkalemia	Investigations	Placebo Double Blind 0-24 Weeks	0	5	0
other	Hyperkalemia	Investigations	Tofacitinib to Tofacitinib Open Label 24-48 Weeks	0	10	0
other	Hyperkalemia	Investigations	Placebo to Tofacitinib Open Label 24-48 Weeks	1	4	1
other	Urinary Tract Infection	Renal and urinary disorders	Tofacitinib Double Blind 0-24 Weeks	2	10	2
other	Urinary Tract Infection	Renal and urinary disorders	Placebo Double Blind 0-24 Weeks	0	5	0

1 to 10 of 204Source ClinicalTrials.gov

See all 204 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Tofacitinib Double Blind 0-24 Weeks	0	10
Total, all-cause mortality	Placebo Double Blind 0-24 Weeks	0	5
Total, all-cause mortality	Tofacitinib to Tofacitinib Open Label 24-48 Weeks	0	10
Total, all-cause mortality	Placebo to Tofacitinib Open Label 24-48 Weeks	0	4
Total, other adverse events	Tofacitinib Double Blind 0-24 Weeks	9	10
Total, other adverse events	Placebo Double Blind 0-24 Weeks	5	5
Total, other adverse events	Tofacitinib to Tofacitinib Open Label 24-48 Weeks	9	10
Total, other adverse events	Placebo to Tofacitinib Open Label 24-48 Weeks	3	4
Total, serious adverse events	Tofacitinib Double Blind 0-24 Weeks	0	10
Total, serious adverse events	Placebo Double Blind 0-24 Weeks	0	5

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
35943798	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
Tofacitinib Double Blind 0-24 Weeks vs Placebo Double Blind 0-24 Weeks: Number of Participants Who Experience Grade 3 or Higher Adverse Events That Occur at or Before Week 24

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.

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