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Study of Tocilizumab to Treat Polymyalgia Rheumatica

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: NCT01396317
Recruitment Status : Completed
First Posted : July 18, 2011
Results First Posted : January 17, 2018
Last Update Posted : January 17, 2018
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Polymyalgia Rheumatica (PMR)
Intervention: Drug: Tocilizumab

  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
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Reporting Groups
  Description
Tocilizumab + Corticosteroid Taper In a single-center open-label study, subjects with newly diagnosed PMR (Healey criteria) and prior treatment with <1 month of corticosteroids (CS) were treated with TCZ 8mg/kg IV monthly for 12 months plus a rapid CS taper. Subjects were followed for 15 months. Those with concurrent GCA or those treated with >30mg prednisone were excluded.
Control (Corticosteroid Taper Alone) A cohort of consecutively evaluated patients with newly diagnosed PMR who declined participation in the trial or failed to meet inclusion criteria served as a control group. These patients were treated contemporaneously by a single rheumatologist with expertise in PMR and received CS alone, tapered at the treating physician’s discretion.

Participant Flow:   Overall Study
    Tocilizumab + Corticosteroid Taper   Control (Corticosteroid Taper Alone)
STARTED   10   10 
COMPLETED   9   10 
NOT COMPLETED   1   0 
Adverse Event                1                0 



  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.
No text entered.

Reporting Groups
  Description
Tocilizumab + Corticosteroid Taper

All subjects will receive the open-label active study treatment for 12 months, and will then be evaluated for 3 months of long-term follow-up.

Tocilizumab: Tocilizumab is a humanized anti-interleukin-6 receptor antibody that has been FDA approved for the treatment of rheumatoid arthritis (RA). This molecule binds to the IL-6 binding site of human IL-6 receptor, and competitively inhibits IL-6 signaling.

Control (Corticosteroid Taper Alone) A cohort of consecutively evaluated patients with newly diagnosed PMR who declined participation in the trial, or failed to meet inclusion criteria, served as a comparator group.These patients were treated contemporaneously with the comparator group by a single rheumatologist with expertise in PMR and received glucocorticoids alone, tapered at the treating physician’s discretion, as is the standard of care in PMR.
Total Total of all reporting groups

Baseline Measures
   Tocilizumab + Corticosteroid Taper   Control (Corticosteroid Taper Alone)   Total 
Overall Participants Analyzed 
[Units: Participants]
 10   10   20 
Age 
[Units: Years]
Mean (Standard Deviation)
 68  (8.5)   72  (10.7)   70  (9.6) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      5  50.0%      5  50.0%      10  50.0% 
Male      5  50.0%      5  50.0%      10  50.0% 
Region of Enrollment 
[Units: Participants]
     
United States   10   10   20 


  Outcome Measures

1.  Primary:   Proportion of Patients in Disease Remission at Six Months From Trial Entry   [ Time Frame: Six months ]

2.  Primary:   Number of Participants With Adverse Events as a Measure of Safety and Tolerability   [ Time Frame: 15 months ]

3.  Secondary:   Proportion of Patients Able to Achieve Disease Remission (DR) Off Corticosteroids, Without Disease Relapse or Recurrence   [ Time Frame: 12 and 15 months from trial entry ]

4.  Secondary:   Proportion of Patients Who Develop Disease Relapses   [ Time Frame: 6, 12 and 15 months from trial entry ]

5.  Secondary:   The Cumulative Dose of Prednisone   [ Time Frame: 6, 12 and 15 months from trial entry ]

6.  Secondary:   Total Number of Relapses/Recurrences   [ Time Frame: 12 months ]


  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
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  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Robert Spiera
Organization: Hospital for Special Surgery
phone: 212-774-2048
e-mail: spierar@hss.edu



Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT01396317     History of Changes
Other Study ID Numbers: 11081
First Submitted: July 11, 2011
First Posted: July 18, 2011
Results First Submitted: April 21, 2017
Results First Posted: January 17, 2018
Last Update Posted: January 17, 2018