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Timed Release Tablet Prednisone in Polymyalgia Rheumatica

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ClinicalTrials.gov Identifier: NCT00836810
Recruitment Status : Completed
First Posted : February 4, 2009
Results First Posted : February 2, 2018
Last Update Posted : February 2, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospitals Bristol NHS Foundation Trust

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Polymyalgia Rheumatica
Interventions: Drug: Timed Release Tablet Prednisone
Drug: Prednisolone

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Of 35 sequential eligible patients invited to participate 12 agreed to do so.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
One patient was a technical failure (unable to take 24 hour blood samples) before the treatment randomisation step, leaving 11 patients included.

Reporting Groups
  Description
Timed Release Tablet Prednisone

11 patients will be taking the intervention night time timed release tablet (TRT) prednisone at a dose of 7mg a day over 2 weeks.

Timed Release Tablet Prednisone: Dose: 7mg, taken at 10pm every night for 2 weeks in the form of oral tablets.
Standard Prednisolone

11 patients will be taking morning Prednisolone at a dose of 7mg over 2 weeks.

Prednisolone: Dose: 7mg, taken in the morning for 2 weeks in the form of oral tablets.

Participant Flow:   Overall Study
    Timed Release Tablet Prednisone   Standard Prednisolone
STARTED   5   6 
COMPLETED   4 [1]   6 
NOT COMPLETED   1   0 
New diagnosis                1                0 
[1] 1 patient was subsequently diagnosed with SLE and, per protocol, was not included.



  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.
Fewer participants were recruited than anticipateed within the time frame of the trial.

Reporting Groups
  Description
Timed Release Tablet Prednisone

Patients will be taking the intervention night time timed release tablet (TRT) prednisone at a dose of 7mg a day over 2 weeks.

Timed Release Tablet Prednisone: Dose: 7mg, taken at 10pm every night for 2 weeks in the form of oral tablets.
Standard Prednisolone

Patients will be taking morning Prednisolone at a dose of 7mg over 2 weeks.

Prednisolone: Dose: 7mg, taken in the morning for 2 weeks in the form of oral tablets.
Total Total of all reporting groups

Baseline Measures
   Timed Release Tablet Prednisone   Standard Prednisolone   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 4   6   10 
Age 
[Units: Years]
Median (Full Range) 		 77.5 
 (67 to 79)  		 72.5 
 (67 to 79)  		 76 
 (67 to 79) 
Sex: Female, Male 
[Units: Participants]
Count of Participants 		     
Female      3  75.0%      4  66.7%      7  70.0% 
Male      1  25.0%      2  33.3%      3  30.0% 
Region of Enrollment 
[Units: Participants]
 		     
United Kingdom   4   6   10 
plasma IL-6 peak values (pg/ml) 
[Units: Pg/ml]
Mean (Standard Deviation) 		 53.5  (46.7)   40.1  (22.3)   45.5  (32.4) 
plasma IL-6 AUC 
[Units: Pg*hr/ml]
Mean (Standard Deviation) 		 191  (232)   236  (246)   218  (228) 
plasma viscosity (mPa.s) 
[Units: mPa.s]
Median (Full Range) 		 1.77 
 (1.73 to 1.9)  		 1.875 
 (1.75 to 2.13)  		 1.8 
 (1.73 to 2.13) 
Morning stiffness 
[Units: Minutes]
Mean (Standard Deviation) 		 75  (38.7)   115  (55)   96.7  (48.3) 
Pain [1] 
[Units: Mm]
Mean (Standard Deviation) 		 54.8  (23.6)   62.2  (15.0)   59.2  (25.1) 
[1] VAS 0mm (better) -100mm (worse)
Patient's opinion of condition 
[Units: VAS 0mm (better) - 100mm (worse)]
Mean (Standard Deviation) 		 54.8  (29.3)   64.2  (16.3)   60.4  (21.4) 
Clinician's opinion of disease activity 
[Units: VAS 0mm (better) - 100mm (worse)]
Mean (Standard Deviation) 		 54.8  (23.6)   62.0  (15.0)   59.1  (18.0) 
Polymyalgia Rheumatica Disease Activity Score [1] 
[Units: Units on a scale]
Mean (Standard Deviation) 		 29.1  (8.7)   47.1  (22.2)   39.9  (19.6) 
[1]

PMR Disease Activity Score (PMR-AS). Formula:

PMR-AS = C-reactive protein (mg/L) + visual analogue scale, patient (0[better]-10[worse] cm) + visual analogue scale, physician (0[better]-10[worse] cm) + morning stiffness (min) x 0.1 + elevation of the upper limbs (3 = none; 2 = below shoulder girdle; 1 = up to shoulder girdle; 0 = above shoulder girdle)

A score below 7 implies low disease activity, a score range of 7 – 17 reflects medium activity and a score of more than 17 indicates an active disease.


  Outcome Measures

1.  Primary:   Change in Peak Serum IL-6 Concentration   [ Time Frame: 24 hours ]
  Show Outcome Measure 1

2.  Primary:   Change in Area Under the Curve (AUC) of Plasma IL-6   [ Time Frame: 24 hour measurements 2 weeks apart ]
  Show Outcome Measure 2

3.  Secondary:   Percentage Change in Morning Stiffness   [ Time Frame: 2 weeks ]
  Show Outcome Measure 3

4.  Secondary:   Pain (Severity)   [ Time Frame: 24 hour period after 2 weeks of treatment ]
  Show Outcome Measure 4

5.  Secondary:   Patient's Opinion of Condition   [ Time Frame: Current value at baseline and after 2 weeks treatment ]
  Show Outcome Measure 5

6.  Secondary:   Clinician's Opinion of Disease Activity.   [ Time Frame: Current at baseline and after 2 weeks treatment ]
  Show Outcome Measure 6


  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
Small number of patients not blind to study treatment which may have influenced reports of morning stiffness.


  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: Professor John Kirwan
Organization: University of Bristol
phone: +44 117 342 2904
e-mail: John.Kirwan@Bristol.ac.uk



Responsible Party: University Hospitals Bristol NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT00836810     History of Changes
Other Study ID Numbers: ME/2008/3031
First Submitted: February 2, 2009
First Posted: February 4, 2009
Results First Submitted: February 1, 2017
Results First Posted: February 2, 2018
Last Update Posted: February 2, 2018