Trial · NCT00955279

A Study to Evaluate the Safety and Effectiveness of Ustekinumab or Golimumab Administered Subcutaneously (SC) in Patients With Sarcoidosis

NCT00955279, Phase 2, Completed, Centocor, Inc.; results first posted 2014-07-17

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study to Evaluate the Safety and Effectiveness of Ustekinumab or Golimumab Administered Subcutaneously (SC) in Patients With Sarcoidosis. Trials, record NCT00955279. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00955279

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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 Effectiveness of Ustekinumab or Golimumab Administered Subcutaneously (SC) in Patients With Sarcoidosis
NCT number: NCT00955279
Status: Completed
Phases: Phase 2
Enrollment: 173 participants, actual
Lead sponsor: Centocor, Inc.
Conditions: Sarcoidosis
Interventions: Placebo, Golimumab, Ustekinumab
First posted: 2009-08-10
Last updated: 2014-07-17
Other registries' IDs: eudract:2009-010714-30
Results first posted: 2014-07-17

Source ClinicalTrials.gov

Registered outcomes5

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

List	Outcome	Time frame	Description
Primary	Change From Baseline in Percent-predicted Forced Vital Capacity (FVC) at Week 16	Baseline (Day 1) and Week 16	Forced vital capacity (FVC) is a standard pulmonary function test used to quantify respiratory muscle weakness . FVC was the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in liters. Predicted forced vital capacity is based on a formula using sex, age and height of a person, and is an estimate of healthy lung capacity. Percent of predicted FVC = (observed value)/(predicted value) \* 100%. Change was calculated as the value at Week 16 minus the baseline value.
Secondary	Change From Baseline in 6-minute Walk Distance at Week 28	Baseline (Day 1) and Week 28	Change from Baseline in 6-minute walk distance at Week 28 was calculated as 6-minute walk distance at Week 28 minus 6-minute walk distance at Baseline. The 6-minute walk distance was the total distance walked during the 6-minute walk test.
Secondary	Change From Baseline in the St. George's Respiratory Questionnaire (SGRQ) Total Score at Week 28	Baseline (Day 1) and Week 28	St. George's Respiratory Questionnaire (SGRQ) is a health related quality of life questionnaire consisting of 51 items in three components: symptoms, activity, and impacts. The lowest possible value is zero and the highest 100. Higher values correspond to greater impairment in quality of life. Change from Baseline was calculated as the value at Week 28 minus value at Baseline.
Secondary	Percentage of Responders With a Score of Less Than or Equal to 1 on Skin Physician's Global Assessment (SPGA) Scale	Week 28	The SPGA is 7-point scale used to assess the condition of skin in participants. The physician checks the state of the skin and gives them score from 0 (clear) to 5 (severe). Higher scores indicate worsening of skin condition.
Secondary	Change From Baseline in Percent-predicted Forced Vital Capacity (FVC) at Week 28	Baseline (Day 1) and Week 28	Forced vital capacity (FVC) is a standard pulmonary function test used to quantify respiratory muscle weakness. FVC is the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in liters. Predicted forced vital capacity is based on a formula using sex, age and height of a person, and is an estimate of healthy lung capacity. Percent of predicted FVC = (observed value)/(predicted value) \* 100%. Change is calculated as the value at week 28 minus the baseline value.

Source ClinicalTrials.gov

Outcomes5

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in Percent-predicted Forced Vital Capacity (FVC) at Week 16	Baseline (Day 1) and Week 16	Modified intent-to-treat (mITT) population included all the participants who were randomized and who received at least 1 dose of study medication.	percent of predicted FVC	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in 6-minute Walk Distance at Week 28	Baseline (Day 1) and Week 28	mITT population included all the participants who were randomized and who received at least 1 dose of study medication.	meters	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in the St. George's Respiratory Questionnaire (SGRQ) Total Score at Week 28	Baseline (Day 1) and Week 28	mITT population included all the participants who were randomized and who received at least 1 dose of study medication.	Units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Percentage of Responders With a Score of Less Than or Equal to 1 on Skin Physician's Global Assessment (SPGA) Scale	Week 28	Secondary population included all the participants with chronic sarcoidosis with skin involvement who have received at least 1 dose of study medication.	Percentage of Participants	NUMBER
SECONDARY	Change From Baseline in Percent-predicted Forced Vital Capacity (FVC) at Week 28	Baseline (Day 1) and Week 28	mITT population included all the participants who were randomized and who received at least 1 dose of study medication.	percent of predicted FVC	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group15

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

Outcome	Group	Value	Spread	Units
Change From Baseline in Percent-predicted Forced Vital Capacity (FVC) at Week 16	Placebo	2.02	Standard Error 1.350	percent of predicted FVC
Change From Baseline in Percent-predicted Forced Vital Capacity (FVC) at Week 16	Golimumab	1.15	Standard Error 1.413	percent of predicted FVC
Change From Baseline in Percent-predicted Forced Vital Capacity (FVC) at Week 16	Ustekinumab	-0.15	Standard Error 1.279	percent of predicted FVC
Change From Baseline in 6-minute Walk Distance at Week 28	Placebo	14.52	Standard Error 14.223	meters
Change From Baseline in 6-minute Walk Distance at Week 28	Golimumab	12.53	Standard Error 14.919	meters
Change From Baseline in 6-minute Walk Distance at Week 28	Ustekinumab	-13.22	Standard Error 13.584	meters
Change From Baseline in the St. George's Respiratory Questionnaire (SGRQ) Total Score at Week 28	Placebo	-9.50	Standard Error 2.790	Units on a scale
Change From Baseline in the St. George's Respiratory Questionnaire (SGRQ) Total Score at Week 28	Golimumab	-6.86	Standard Error 2.921	Units on a scale
Change From Baseline in the St. George's Respiratory Questionnaire (SGRQ) Total Score at Week 28	Ustekinumab	-4.25	Standard Error 2.662	Units on a scale
Percentage of Responders With a Score of Less Than or Equal to 1 on Skin Physician's Global Assessment (SPGA) Scale	Placebo	30.0	2.790	Percentage of Participants

1 to 10 of 15Source ClinicalTrials.gov

See all 15 results by group

Participant flow9

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	58
Overall Study	STARTED	Golimumab	55
Overall Study	STARTED	Ustekinumab	60
Overall Study	COMPLETED	Placebo	55
Overall Study	COMPLETED	Golimumab	51
Overall Study	COMPLETED	Ustekinumab	52
Overall Study	NOT COMPLETED	Placebo	3
Overall Study	NOT COMPLETED	Golimumab	4
Overall Study	NOT COMPLETED	Ustekinumab	8

Source ClinicalTrials.gov

Adverse events306

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
other	Abdominal Pain	Gastrointestinal disorders	Placebo	3	58
other	Abdominal Pain	Gastrointestinal disorders	Golimumab	0	55
other	Abdominal Pain	Gastrointestinal disorders	Ustekinumab	2	60
other	Abdominal Pain Upper	Gastrointestinal disorders	Placebo	3	58
other	Abdominal Pain Upper	Gastrointestinal disorders	Golimumab	1	55
other	Abdominal Pain Upper	Gastrointestinal disorders	Ustekinumab	2	60
other	Constipation	Gastrointestinal disorders	Placebo	2	58
other	Constipation	Gastrointestinal disorders	Golimumab	3	55
other	Constipation	Gastrointestinal disorders	Ustekinumab	3	60
other	Diarrhoea	Gastrointestinal disorders	Placebo	11	58

1 to 10 of 306Source ClinicalTrials.gov

See all 306 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo
Total, all-cause mortality	Golimumab
Total, all-cause mortality	Ustekinumab
Total, other adverse events	Placebo	52	58
Total, other adverse events	Golimumab	49	55
Total, other adverse events	Ustekinumab	52	60
Total, serious adverse events	Placebo	9	58
Total, serious adverse events	Golimumab	7	55
Total, serious adverse events	Ustekinumab	10	60

Source ClinicalTrials.gov

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
25034562	DERIVED	PubMed
25428650	DERIVED	PubMed
25594886	DERIVED	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 comparisons0

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

None in this release.

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/NCT00955279

GET https://conductscience.org/api/trials/v1/NCT00955279/events?page=2

API reference For AI assistants