Clinical Trial Results:
Randomized placebo-controlled trial to investigate clinical efficacy, anti-inflammatory properties and
safety of prednisolone in hand osteoarthritis: a proof-of-concept study
Summary
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EudraCT number |
2015-000687-33 |
Trial protocol |
NL |
Global end of trial date |
02 Jul 2018
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Results information
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Results version number |
v1(current) |
This version publication date |
19 Mar 2022
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First version publication date |
19 Mar 2022
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
HOPE
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Other trial identifiers |
Netherlands Trial Registry: NTR5263 | ||
Sponsors
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Sponsor organisation name |
Leiden University Medical Center
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Sponsor organisation address |
Albinusdreef 2, Leiden, Netherlands,
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Public contact |
Principal investigator, Leiden University Medical Center, 0031 715263598,
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Scientific contact |
Principal investigator, Leiden University Medical Center, 0031 715263598,
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
02 Jul 2018
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
02 Jul 2018
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Global end of trial reached? |
Yes
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Global end of trial date |
02 Jul 2018
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The main objective of this study is to identify a new treatment to alleviate pain and diminish inflammation in patients with hand osteoarthritis with symptoms and signs of inflammation.
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Protection of trial subjects |
Trial subjects were monitored very well during the study.
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Background therapy |
Usual care | ||
Evidence for comparator |
Since local inflammation is recognised as contributing to osteoarthritic complaints, the Hand Osteoarthritis Prednisolone Efficacy (HOPE) study aimed to investigate the efficacy and safety of short-term prednisolone in patients with painful hand osteoarthritis and synovial inflammation | ||
Actual start date of recruitment |
03 Dec 2015
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Netherlands: 92
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Worldwide total number of subjects |
92
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EEA total number of subjects |
92
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
70
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From 65 to 84 years |
22
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85 years and over |
0
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Recruitment
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Recruitment details |
We recruited eligible adults from rheumatology outpatient clinics at two sites in the Netherlands. | ||||||||||||||||||||||||
Pre-assignment
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Screening details |
Symptomatic hand OA that fulfilled the ACR criteria and signs of inflammation in DIP/PIP joints. Required to have four or more DIP/PIP joints with OA nodes, >=1 DIP/PIP with soft swelling or erythema, >=1 DIP/PIP with positive power Doppler signal or synovial thickening >=grade 2, pain >=30/100 on VAS that flared after NSAID washout. | ||||||||||||||||||||||||
Period 1
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Period 1 title |
overall trial (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | ||||||||||||||||||||||||
Roles blinded |
Subject, Investigator, Monitor, Data analyst, Carer, Assessor | ||||||||||||||||||||||||
Blinding implementation details |
Study medication
(5 mg/mL oral prednisolone
solution or placebo solution) was provided in sequentially
numbered bottles. Prednisolone and placebo solutions
were identical in appearance, smell, and taste. Patients,
outcome assessors (not authors), and data analysts
(FPBK and SB) remained masked for treatment allocation
until the study database was locked.
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Prednisolone | ||||||||||||||||||||||||
Arm description |
- | ||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||
Investigational medicinal product name |
Prednisolone
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Suspension for oral suspension
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Routes of administration |
Oral use
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Dosage and administration details |
Patients self-administered 2 mL of 5 mg/mL
prednisolone solution (ie, a 10 mg dose)
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Arm title
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Placebo | ||||||||||||||||||||||||
Arm description |
- | ||||||||||||||||||||||||
Arm type |
Placebo | ||||||||||||||||||||||||
Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Suspension for oral suspension
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Routes of administration |
Oral use
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Dosage and administration details |
Patients self-administered 2 mL of placebo solution once
daily for 6 weeks
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Baseline characteristics reporting groups
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Reporting group title |
Prednisolone
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Prednisolone
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Reporting group description |
- | ||
Reporting group title |
Placebo
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Reporting group description |
- |
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End point title |
VAS pain fingers | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
6 weeks
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Statistical analysis title |
main analysis | ||||||||||||
Statistical analysis description |
We analysed all endpoints with generalised estimating
equations, and we used robust standard errors and the
working correlation structure specified as exchangeable.
Data from all available timepoints were used. The independent
variables included in our model were treatment
group, visit number (categorical), interaction between
treatment
group and visit number, the baseline value of
dependent variable (continuous), and study centre
(categorical).
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Comparison groups |
Prednisolone v Placebo
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Number of subjects included in analysis |
92
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
< 0.05 | ||||||||||||
Method |
Mixed models analysis | ||||||||||||
Parameter type |
Mean difference (net) | ||||||||||||
Point estimate |
-16.5
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-26.1 | ||||||||||||
upper limit |
-6.9 | ||||||||||||
Variability estimate |
Standard deviation
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Adverse events information
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Timeframe for reporting adverse events |
14 weeks
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Adverse event reporting additional description |
Safety
endpoints were the number of adverse events, serious
adverse events, withdrawals
because of adverse events,
and changes in blood glucose concentrations between baseline and week 2.
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Assessment type |
Systematic | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
none | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
0
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Reporting groups
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Reporting group title |
Prednisolone
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 0% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |