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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 25 November 2019
Main ID:  EUCTR2005-004385-16-GB
Date of registration: 08/12/2005
Prospective Registration: Yes
Primary sponsor: United Bristol Healthcare NHS Trust
Public title: CIRCADIAN VARIATIONS IN CYTOKINES AND THE EFFECT OF TIMED RELEASE TABLET PREDNISONE IN RHEUMATOID ARTHRITIS
Scientific title: CIRCADIAN VARIATIONS IN CYTOKINES AND THE EFFECT OF TIMED RELEASE TABLET PREDNISONE IN RHEUMATOID ARTHRITIS
Date of first enrolment: 03/01/2006
Target sample size: 12
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-004385-16
Study type:  Interventional clinical trial of medicinal product
Study design: 
Controlled: no
Randomised: no
Open: no
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: no
 
Phase:  Human pharmacology (Phase I): Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): Therapeutic use (Phase IV):
Countries of recruitment
United Kingdom
Contacts
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Affiliation: 
Name:    
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Key inclusion & exclusion criteria
Inclusion criteria:
Have rheumatoid arthritis by the criteria of the American College of Rheumatology:
Are over 50 but less than 80 years old (over 50 avoids hormonal changes due to the menopause).
Have active disease as evidenced by;
three or more swollen joints;
three or more tender joints;
morning stiffness at least 45mins;
pain at least 30mm on a 100mm VAS
ESR at least 29mm in 1st h or CRP at least 15mg/L
Stable DMARD therapy (or no therapy) for at least 28 days
Stabel NSAID/analgesic therapy for at least 7 days
(These are the same criteria as used in a large randomised controlled trial of this medication currently being conducted in Germany)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
The following criteria exclude patients who might develop adverse reactions from even small doses of glucocorticoid, or who have other conditions which might affect the things being measured in the study:
Pregnancy and lactation
Participation in a clinical trial within the past 30 days
Presence of contraindication of corticosteroids
Known hypersensitivity to prednisone/prednisolone
Parenteral treatment with corticosteroids or crystalloid injection into joints within the past 3 months
Other diseases which require corticoid treatments
Inflammatory diseases, such as IBD, Collitis, Crohn's disease, Asthma
Other auto-immune diseases
Cancer
Infections, treatment with antibiotics in the past 6 weeks
Requirement of non-permitted concomitant medication
Consumption or Benzodiazepines, Antidepressants, Antipsychotic drugs,
Antihistaminic drugs
TNF inhibitors
Working shift emplotee
Jet lag
Significant renal disease (creatinine>150 micro mol/L)
Significant hepatic impairment


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Rheumatoid arthritis
Intervention(s)

Product Name: Prednisone
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: Prednisone
CAS Number: 53-03-2
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5 -

Primary Outcome(s)
Main Objective: To find out if overnight variations in blood levels of chemicals (called cytokines) which cause or reduce inflammation in rheumatoid arthritis are changed by taking a new timed release tablet that provides a dose of the steroid prednisone in the middle of the night.
Primary end point(s): Changes in the pattern of cytokines and HPA axis constituents before and after patients have been taking nightime prednisone. The principle measures will be Interleukine-6 and cortisol. The main analytical outcome will be the relative size and timing of the rise in levels of these measures between 2am and 9am.
Secondary Objective: To find out if blood cytokine levels are related to the hormones of the hypothalamic-pituitary-adrenal axis, which is the body's natural system for making and controlling steroid production.
Secondary Outcome(s)
Secondary ID(s)
ME/2005/2073
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date:
Contact:
Results
Results available:
Date Posted:
Date Completed:
URL:
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