Clinical Trials – STELARA™ (Ustekinumab)

Posted on June 30, 2011 by

A Study to Evaluate the Safety and Effectiveness of Ustekinumab or Golimumab Administered Subcutaneously (SC) in Patients With Sarcoidosis
This study is currently recruiting participants.
Verified on June 2011 by Centocor, Inc.
First Received on August 6, 2009.
Last Updated on June 23, 2011
Sponsor: Centocor, Inc.
Information provided by: Centocor, Inc.
ClinicalTrials.gov Identifier: NCT00955279
Purpose

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 sarcoidosis. The study will be conducted at approximately 40 sites globally. Patients can remain on usual, accepted treatment for sarcoid while enrolled in the study. Patients receiving corticosteroids at the beginning of the study will be required to begin tapering at Week 16 of the study. Participating in other experimental studies or taking other experimental medications while participating in this study will not be allowed.

Condition Intervention Phase
Sarcoidosis Drug: golimumab
Drug: Placebo
Drug: ustekinumab
Phase II
Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Multicenter, Randomized, Double-Blind, Parallel-group, Placebo-controlled Study Evaluating the Safety and Efficacy of Treatment With Ustekinumab or Golimumab in Subjects With Chronic Sarcoidosis
Resource links provided by NLM:
Further study details as provided by Centocor, Inc.:
Primary Outcome Measures: 

  • The primary endpoint is the change from baseline in percent-predicted Forced Vital Capacity (measure of lung volume at maximum rate of exhalation) at Week 16 in the primary population. [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
Secondary Outcome Measures: 

  • Change from baseline in 6 minute walk distance at Week 28 in the primary population [ Time Frame: Week 28 ] [ Designated as safety issue: No ]
  • Change from baseline in St. George’s Respiratory Questionnaire total score at Week 28 in the primary population [ Time Frame: Week 28 ] [ Designated as safety issue: No ]
  • Proportion of Skin Physician Global Assessment responders at Week 28 in the secondary population [ Time Frame: Week 28 ] [ Designated as safety issue: No ]
  • Change from baseline in percent-predicted Forced Vital Capacity at Week 28 in the primary population. [ Time Frame: Week 28. ] [ Designated as safety issue: No ]
Estimated Enrollment: 180
Study Start Date: November 2009
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
001: Placebo Comparator 

Placebo Placebo (subcutaneous injection) at Weeks 0 4 8 12 16 20 and 24
Intervention: Drug: Placebo
Drug: Placebo 

Placebo (subcutaneous injection) at Weeks 0, 4, 8, 12, 16, 20, and 24
002: Experimental 

ustekinumab 180 mg (subcutaneous injection) at Wk 0 90 mg at Wks 8 16 and 24
Intervention: Drug: ustekinumab
Drug: ustekinumab 

180 mg (subcutaneous injection) at Wk 0, 90 mg at Wks 8, 16, and 24
003: Experimental 

golimumab 200 mg (subcutaneous injection) at Wk 0 100 mg at Wks 4 8 12 16 20 and 24
Intervention: Drug: golimumab
Drug: golimumab 

200 mg (subcutaneous injection) at Wk 0, 100 mg at Wks 4, 8, 12, 16, 20, and 24

Detailed Description:

Ustekinumab is approved for dosing in patients with psoriasis and golimumab is approved for dosing in patients with rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. This study will use either drug in patients with chronic sarcoidosis. Ustekinumab and golimumab are being tested to see if they may be useful in treating chronic sarcoidosis. This study will compare the effects (both good and bad) of ustekinumab and golimumab to those of placebo. The purpose of this study is to evaluate the safety and effectiveness of ustekinumab and golimumab (administered as individual treatments) in patients with chronic sarcoidosis with lung and/or skin involvement who still have symptoms even though receiving current therapy. About 180 patients will take part in the study. While in this study, patients may not take part in any other medical research studies. Ustekinumab and golimumab are not approved by the national health authorities for treatment of chronic sarcoidosis; therefore, they can only be used in a research setting to treat this condition. The screening phase of the study, where the doctor will determine if a patient is eligible for the study, will last 1 to 4 weeks. Patients are put into 1 of 3 groups and each group will get a different treatment. The results of the golimumab group and the ustekinumab group are compared to placebo. Patients will either receive ustekinumab, golimumab or placebo. Placebo looks like ustekinumab and golimumab and is given in the same way, by injection, but contains no active drug. Patients will receive study agent until Week 24 and will continue to be followed through Week 44 for assessment of safety and any other effects after discontinuation of therapy. The patient will continue to take all sarcoidosis medication(s) at current, stable dose for the first part of the study. If the patient remained on a stable steroid dose from Week 0 through Week 16 of the study, the study doctor will begin to taper (lower) the steroid dose. The steroid taper will continue through to the end of the Week 28 visit. The patient will continue to take their other sarcoidosis medication(s) at the same dose for the rest of the study. An independent Data Monitoring Committee will be responsible for reviewing the safety data for the study. Patients will be in the study for about 48 weeks. The end of the study is defined as the last visit of the last patient. A site-specific substudy is being implemented to collect serum and lung samples from patients who are currently enrolled in this study. A separate protocol is being implemented to collect lung fluid and serum samples from normal, healthy subjects to be used as comparators for similar samples obtained in the 1275148SCD2001 substudy. Patients will be randomly assigned to 1 of 3 treatment groups: ustekinumab (180 mg at Week 0, followed by 90 mg at Weeks 8, 16, and 24 with placebo at Weeks 4, 12, and 20), golimumab (200 mg at Week 0, followed by 100 mg at Weeks 4, 8, 12, 16, 20, and 24) or placebo (at Weeks 0, 4, 8, 12, 16, 20, and 24) administered by SC injection.

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