ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 27 of 703 for:    lupus AND Lupus Erythematosus, Systemic

A Study to Evaluate the Safety of Rituximab Retreatment in Subjects With Systemic Lupus Erythematosus (EXPLORER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00137969
Recruitment Status : Completed
First Posted : August 30, 2005
Results First Posted : December 10, 2010
Last Update Posted : May 19, 2015
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Lupus Erythematosus, Systemic
Interventions: Drug: Rituximab
Drug: Placebo
Drug: Prednisone
Drug: Acetaminophen
Drug: Diphenhydramine

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Rituximab 1000 mg + Prednisone Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
Placebo + Prednisone Participants received placebo intravenously on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.

Participant Flow:   Overall Study
    Rituximab 1000 mg + Prednisone   Placebo + Prednisone
STARTED   174   88 
Received Study Drug   169   88 
COMPLETED   107   67 
NOT COMPLETED   67   21 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent-to-treat population: All randomized participants who received any amount of study drug.

Reporting Groups
  Description
Rituximab 1000 mg + Prednisone Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
Placebo + Prednisone Participants received placebo intravenously on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
Total Total of all reporting groups

Baseline Measures
   Rituximab 1000 mg + Prednisone   Placebo + Prednisone   Total 
Overall Participants Analyzed 
[Units: Participants]
 169   88   257 
Age 
[Units: Years]
Mean (Standard Deviation)
 40.2  (11.4)   40.5  (12.8)   40.3  (11.9) 
Age, Customized 
[Units: Participants]
     
< 20 years   2   2   4 
20 to 64 years   166   83   249 
> 64 years   1   3   4 
Gender 
[Units: Participants]
     
Female   152   82   234 
Male   17   6   23 


  Outcome Measures

1.  Primary:   Number of Participants Who Achieved a Major Clinical Response (MCR), Partial Clinical Response (PCR), or Nonclinical Response (NCR) Defined by British Isles Lupus Assessment Group (BILAG) Scores Over The 52-week Treatment Period   [ Time Frame: From baseline to 52 weeks ]

2.  Secondary:   Time-adjusted Area Under The Curve Minus Baseline (AUCMB) of BILAG Score Over The 52-week Treatment Period   [ Time Frame: From baseline to 52 weeks ]

3.  Secondary:   Number of Participants Who Achieved an MCR (Excluding PCR)   [ Time Frame: From baseline to 52 weeks ]

4.  Secondary:   Number of Participants Who Achieved a PCR (Including MCR)   [ Time Frame: From baseline to 52 Weeks ]

5.  Secondary:   Number of Participants Who Achieved a BILAG C or Better in All Domains   [ Time Frame: 24 weeks ]

6.  Secondary:   Time to First Moderate or Severe Flare   [ Time Frame: 52 weeks ]

7.  Secondary:   Change in SLE Expanded Health Survey Physical Function Score From Baseline   [ Time Frame: From baseline to 52 weeks ]

8.  Secondary:   Number of Participants Who Achieved an MCR in The ITT Population   [ Time Frame: From Weeks 24 to 52 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Medical Communications
Organization: Hoffman-LaRoche
phone: 800-821-8590
e-mail: genentech@druginfo.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00137969     History of Changes
Other Study ID Numbers: U2971g
First Submitted: August 26, 2005
First Posted: August 30, 2005
Results First Submitted: June 5, 2009
Results First Posted: December 10, 2010
Last Update Posted: May 19, 2015