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NCT00955279 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study, sponsored by Centocor.

Completed
Registry status
Phase 2
Development phase
173
Enrollment target

NCT00955279: Completed Phase 2 study, sponsored by Centocor.

NCT00955279 is a Phase 2 study that has completed, run by Centocor. The registered enrollment target is 173 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (30% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00955279, a Phase 2 study, has completed, sponsored by Centocor.

COMPLETED
Registry status
Phase 2
Development phase
173 participants
Enrollment target

Study Summary

This study tests the safety and effectiveness of ustekinumab or golimumab compared to placebo (placebo looks like the drugs being studied, but has no active ingredients). The purpose of this research study is to determine if ustekinumab or golimumab is safe and to determine its effects (good and bad) on patients with chronic sarcoidosis with pulmonary and/or skin involvement. Patients with pulmonary involvement constitute the primary population for analysis, and patients with skin involvement constitute the secondary population; a patient may be in both populations. The study will be conducted at approximately 40 sites globally.

Primary Outcome

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 t

Interventions

  • DRUG Placebo
  • DRUG Ustekinumab
  • DRUG Golimumab

Trial Details

FieldValue
Enrollment Target 173 participants
Start Date 2009-11
Est. Completion 2012-08
Phase Phase 2
Centocor

33 total trials

What the finished NCT00955279 record still lists

NCT00955279 is an interventional study that assigns participants to a tested intervention. The registered 173 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (30% higher).

The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.

NCT00955279 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00955279 about?

NCT00955279 is a clinical study titled "A Study to Evaluate the Safety and Effectiveness of Ustekinumab or Golimumab Administered Subcutaneously (SC) in Patients With Sarcoidosis". This study tests the safety and effectiveness of ustekinumab or golimumab compared to placebo (placebo looks like the drugs being studied, but has no active ingredients). The purpose of this research study is to determine if ustekinumab or golimumab is safe and to determine its effects (good and bad...

What is the current status of trial NCT00955279?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 173 participants. The study started on 2009-11. Estimated completion is 2012-08.

What interventions are being tested in trial NCT00955279?

The interventions under investigation include: Placebo (DRUG), Ustekinumab (DRUG), Golimumab (DRUG).

Who is sponsoring clinical trial NCT00955279?

This trial is sponsored by Centocor, which has 33 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00955279's enrollment target sits among peer trials

173 397th of 2000 higher than 1,604 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00955279, the US trial registry maintained by the National Library of Medicine. NCT00955279 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.