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Trial record 2 of 81 for:    Polymyositis AND Myopathy

Rituximab for the Treatment of Refractory Adult and Juvenile Dermatomyositis (DM) and Adult Polymyositis (PM)

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ClinicalTrials.gov Identifier: NCT00106184
Recruitment Status : Completed
First Posted : March 22, 2005
Results First Posted : March 4, 2015
Last Update Posted : March 4, 2015
Sponsor:
Collaborators:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Genentech, Inc.
Biogen
Information provided by (Responsible Party):
Chester Oddis, University of Pittsburgh

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions: Myositis
Dermatomyositis
Polymyositis
Juvenile Dermatomyositis
Interventions: Drug: Rituximab
Drug: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subject were screened and enrolled at 26 US and 4 international sites.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
In an effort to exclude IBM (Inclusion Body Myositis) and other myositis mimics, the medical records and muscle biopsy results (if available) of adults with PM were reviewed by a 3-member Adjudication Committee before enrollment.

Reporting Groups
  Description
Treatment Group A (Rituximab Wks 0 and 1)

Subjects received rituximab at Weeks 0 and 1 followed by placebo at Weeks 8 and 9 (Treatment Group A)

Rituximab : Treatment Group A - intravenous rituximab 750mg/m2 BSA (Body Surface Area) up to a maximum dose of 1 gram at Weeks 0 and 1 Placebo : Treatment Group A: placebo infusion at Weeks 8 and 9

Treatment Group B (Rituximab Wks 8 and 9)

Subjects received placebo at Weeks 0 and 1 followed by rituximab at Weeks 8 and 9 (Treatment Group B)

Group B - intravenous rituximab 750mg/m2 BSA up to a maximum does of 1 gram at Weeks 8 and 9

Treatment Group B: placebo infusion at Weeks 0 and 1


Participant Flow:   Overall Study
    Treatment Group A (Rituximab Wks 0 and 1)   Treatment Group B (Rituximab Wks 8 and 9)
STARTED   96   104 
Treated   93 [1]   102 [2] 
COMPLETED   93   102 
NOT COMPLETED   3   2 
Withdrawal by Subject                3                2 
[1] 96 subjects were randomized.
[2] 104 subjects were randomized.



  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.
3 subjects in Group A and 2 subjects in Group B were excluded from analysis due to withdrawing from the study. These subjects either did not receive a full dose of study drug at week 0 or no study drug at all.

Reporting Groups
  Description
Group A

Subjects received rituximab at Weeks 0 and 1 followed by placebo at Weeks 8 and 9 (Treatment Group A)

Rituximab : Treatment Group A - intravenous rituximab 750mg/m2 BSA up to a maximum dose of 1 gram at Weeks 0 and 1

Placebo : Treatment Group A: placebo infusion at Weeks 8 and 9

Group B

Subjects received placebo at Weeks 0 and 1 followed by rituximab at Weeks 8 and 9 (Treatment Group B)

Group B - intravenous rituximab 750mg/m2 BSA up to a maximum does of 1 gram at Weeks 8 and 9

Treatment Group B: placebo infusion at Weeks 0 and 1

Total Total of all reporting groups

Baseline Measures
   Group A   Group B   Total 
Overall Participants Analyzed 
[Units: Participants]
 96   104   200 
Age 
[Units: Participants]
     
<=18 years   17   19   36 
Between 18 and 65 years   70   80   150 
>=65 years   9   5   14 
Age 
[Units: Years]
Mean (Standard Deviation)
 43.1  (18.23)   40.7  (18.4)   41.8  (18.3) 
Gender 
[Units: Participants]
     
Female   68   78   146 
Male   28   26   54 
Region of Enrollment 
[Units: Participants]
     
United States   87   98   185 
Czech Republic   4   3   7 
Canada   2   3   5 
Sweden   3   0   3 


  Outcome Measures

1.  Primary:   Comparison Between the Time to Improvement Between the Two Groups of IIM (Idiopathic Inflammatory Myopathy) Patients   [ Time Frame: Week 44 of treatment phase ]

2.  Secondary:   Response Rates (Proportion of Improved Patients) Between Groups A (Rituximab Wks 0 and 1) and B (Rituximab Wks 8 and 9) at Week 8   [ Time Frame: Week 8 of the treatment phase ]

3.  Secondary:   20% Improvement in Manual Muscle Testing (MMT) Over Baseline on Two Consecutive Time Points (Muscle is the Primary Organ of Involvement, and MMT is the One Objective Measurement of the Definition of Improvement [DOI])   [ Time Frame: Week 44 of treatment phase ]


  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
There was an overestimate of the rapidity of the rituximab response and an underestimate of DOI in those receiving placebo.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Chester V. Oddis, MD
Organization: University of Pittsburgh
phone: 412-383-8861
e-mail: cvo5@pitt.edu


Publications of Results:
Other Publications:

Responsible Party: Chester Oddis, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00106184     History of Changes
Obsolete Identifiers: NCT00393237
Other Study ID Numbers: N01 AR042273
5R01AR061298-02 ( U.S. NIH Grant/Contract )
HHSN26420042273C
First Submitted: March 21, 2005
First Posted: March 22, 2005
Results First Submitted: October 10, 2013
Results First Posted: March 4, 2015
Last Update Posted: March 4, 2015