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Trial Outcomes & Findings for Timed Release Tablet Prednisone in Polymyalgia Rheumatica (NCT NCT00836810)

NCT ID: NCT00836810

Last Updated: 2022-09-13

Results Overview

Pre-treatment (Night A) peak minus post-treatment (Night B) peak. Peaks defined as the highest value for each patient from measures at 0, 1.5, 3, 4.5, 5.5, 6.5, 7.5, 8.5, 9.5, 10.5, 11.5, 12.5, 13.5, 14.5, 15.5, 17, 19, 20.5, 22, and 24 hours after 16.30 on day before treatment (Night A) and last day of treatment (Night B) and the peak identified for each one.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

12 participants

Primary outcome timeframe

24 hours

Results posted on

2022-09-13

Participant Flow

Of 35 sequential eligible patients invited to participate 12 agreed to do so.

One patient was a technical failure (unable to take 24 hour blood samples) before the treatment randomisation step, leaving 11 patients included.

Participant milestones

Participant milestones
Measure
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.
Overall Study
STARTED
5
6
Overall Study
COMPLETED
4
6
Overall Study
NOT COMPLETED
1
0

Reasons for withdrawal

Reasons for withdrawal
Measure
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.
Overall Study
New diagnosis
1
0

Baseline Characteristics

Timed Release Tablet Prednisone in Polymyalgia Rheumatica

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Timed Release Tablet Prednisone
n=4 Participants
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
n=6 Participants
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
n=10 Participants
Total of all reporting groups
Age, Continuous
77.5 years
n=5 Participants
72.5 years
n=7 Participants
76 years
n=5 Participants
Sex: Female, Male
Female
3 Participants
n=5 Participants
4 Participants
n=7 Participants
7 Participants
n=5 Participants
Sex: Female, Male
Male
1 Participants
n=5 Participants
2 Participants
n=7 Participants
3 Participants
n=5 Participants
Region of Enrollment
United Kingdom
4 participants
n=5 Participants
6 participants
n=7 Participants
10 participants
n=5 Participants
plasma IL-6 peak values (pg/ml)
53.5 pg/ml
STANDARD_DEVIATION 46.7 • n=5 Participants
40.1 pg/ml
STANDARD_DEVIATION 22.3 • n=7 Participants
45.5 pg/ml
STANDARD_DEVIATION 32.4 • n=5 Participants
plasma IL-6 AUC
191 pg*hr/ml
STANDARD_DEVIATION 232 • n=5 Participants
236 pg*hr/ml
STANDARD_DEVIATION 246 • n=7 Participants
218 pg*hr/ml
STANDARD_DEVIATION 228 • n=5 Participants
plasma viscosity (mPa.s)
1.77 mPa.s
n=5 Participants
1.875 mPa.s
n=7 Participants
1.8 mPa.s
n=5 Participants
Morning stiffness
75 minutes
STANDARD_DEVIATION 38.7 • n=5 Participants
115 minutes
STANDARD_DEVIATION 55 • n=7 Participants
96.7 minutes
STANDARD_DEVIATION 48.3 • n=5 Participants
Pain
54.8 mm
STANDARD_DEVIATION 23.6 • n=5 Participants
62.2 mm
STANDARD_DEVIATION 15.0 • n=7 Participants
59.2 mm
STANDARD_DEVIATION 25.1 • n=5 Participants
Patient's opinion of condition
54.8 VAS 0mm (better) - 100mm (worse)
STANDARD_DEVIATION 29.3 • n=5 Participants
64.2 VAS 0mm (better) - 100mm (worse)
STANDARD_DEVIATION 16.3 • n=7 Participants
60.4 VAS 0mm (better) - 100mm (worse)
STANDARD_DEVIATION 21.4 • n=5 Participants
Clinician's opinion of disease activity
54.8 VAS 0mm (better) - 100mm (worse)
STANDARD_DEVIATION 23.6 • n=5 Participants
62.0 VAS 0mm (better) - 100mm (worse)
STANDARD_DEVIATION 15.0 • n=7 Participants
59.1 VAS 0mm (better) - 100mm (worse)
STANDARD_DEVIATION 18.0 • n=5 Participants
Polymyalgia Rheumatica Disease Activity Score
29.1 units on a scale
STANDARD_DEVIATION 8.7 • n=5 Participants
47.1 units on a scale
STANDARD_DEVIATION 22.2 • n=7 Participants
39.9 units on a scale
STANDARD_DEVIATION 19.6 • n=5 Participants

PRIMARY outcome

Timeframe: 24 hours

Pre-treatment (Night A) peak minus post-treatment (Night B) peak. Peaks defined as the highest value for each patient from measures at 0, 1.5, 3, 4.5, 5.5, 6.5, 7.5, 8.5, 9.5, 10.5, 11.5, 12.5, 13.5, 14.5, 15.5, 17, 19, 20.5, 22, and 24 hours after 16.30 on day before treatment (Night A) and last day of treatment (Night B) and the peak identified for each one.

Outcome measures

Outcome measures
Measure
Timed Release Tablet Prednisone
n=4 Participants
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
n=6 Participants
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.
Change in Peak Serum IL-6 Concentration
11.5 pg/ml
Standard Deviation 8.3
29.3 pg/ml
Standard Deviation 15.1

PRIMARY outcome

Timeframe: 24 hour measurements 2 weeks apart

Pre-treatment (Night A) AUC minus post-treatment (Night B) AUC. AUC calculated from measures at 0, 1.5, 3, 4.5, 5.5, 6.5, 7.5, 8.5, 9.5, 10.5, 11.5, 12.5, 13.5, 14.5, 15.5, 17, 19, 20.5, 22, and 24 hours after 16.30 on day before treatment (Night A) and last day of treatment (Night B).

Outcome measures

Outcome measures
Measure
Timed Release Tablet Prednisone
n=4 Participants
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
n=6 Participants
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.
Change in Area Under the Curve (AUC) of Plasma IL-6
113.5 pg*hr/ml
Standard Deviation 77.7
97.9 pg*hr/ml
Standard Deviation 84.3

SECONDARY outcome

Timeframe: 2 weeks

How long was your morning stiffness today? Pre-treatment (Night A) value minus post-treatment (Night B) value divided by pre-treatment value.

Outcome measures

Outcome measures
Measure
Timed Release Tablet Prednisone
n=4 Participants
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
n=6 Participants
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.
Percentage Change in Morning Stiffness
75.0 percentage of baseline morning stiffness
Standard Deviation 38.7
115.0 percentage of baseline morning stiffness
Standard Deviation 55.0

SECONDARY outcome

Timeframe: 24 hour period after 2 weeks of treatment

100mm visual analogue scale. Question: How much pain have you had in the last 24 hours? Anchors: No pain; Severe pain. Min score 0, Max score 100. Higher value is worse outcome.

Outcome measures

Outcome measures
Measure
Timed Release Tablet Prednisone
n=4 Participants
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
n=6 Participants
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.
Pain (Severity)
26.5 mm
Standard Deviation 25.3
19.5 mm
Standard Deviation 13.1

SECONDARY outcome

Timeframe: Current value at baseline and after 2 weeks treatment

100mm visual analogue scale. Question: Considering all the ways your pain and/or stiffness affect(s) you, please mark on the line how well you are doing. Anchors: Very well; Very badly. Min 0 Max 100 (poor outcome).

Outcome measures

Outcome measures
Measure
Timed Release Tablet Prednisone
n=4 Participants
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
n=6 Participants
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.
Patient's Opinion of Condition
17.8 mm
Standard Deviation 20.6
26.0 mm
Standard Deviation 17.6

SECONDARY outcome

Timeframe: Current at baseline and after 2 weeks treatment

100mm visual analogue scale. Question: Clinician's opinion of disease activity. Anchors: None; Severe Min 0 Max 100 (worse)

Outcome measures

Outcome measures
Measure
Timed Release Tablet Prednisone
n=4 Participants
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
n=6 Participants
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.
Clinician's Opinion of Disease Activity.
19.0 mm
Standard Deviation 18.1
20.3 mm
Standard Deviation 9.3

Adverse Events

Timed Release Tablet Prednisone

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Standard Prednisolone

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Professor John Kirwan

University of Bristol

Phone: +44 117 342 2904

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place