Condition category
Musculoskeletal Diseases
Date applied
16/08/2007
Date assigned
04/10/2007
Last edited
18/01/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof John Kirwan

ORCID ID

Contact details

Academic Rheumatology Unit
Bristol Royal Infirmary
Bristol
BS2 8HW
United Kingdom
+44 (0)117 928 2904
John.Kirwan@Bristol.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ME/2005/2073

Study information

Scientific title

Acronym

Study hypothesis

Rheumatoid Arthritis (RA) is a systemic, inflammatory condition causing joint pain and swelling, disability, and psychological distress.

To document overnight variations of serum pro-inflammatory and anti-inflammatory cytokines in 12 volunteers with rheumatoid arthritis on one night before and one night during treatment with a Timed Release Tablet (TRT) containing 5 mg prednisone, and to relate blood cytokine levels to biogenic amines and the hormones of the hypothalamic-pituitary-adrenal axis.

Ethics approval

Approval received from the North Somerset and South Bristol Research Ethics Committee (REC) on the 28th November 2005 (ref: 054/Q2006/185).

Study design

Non-randomised, non-controlled interventional single centre study of patients before and after two weeks treatment with night time prednisone

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Rheumatoid Arthritis (RA)

Intervention

The study uses a delayed (timed) release formulation of prednisone which will release the full dose of the active drug during sleep after a lag time of 4 hours, allowing the patient to take the medication at a convenient point in time, namely at 22:00 hours +/- 30 minutes.

Intervention: Timed-Release Tablet (TRT) prednisone 5 mg, one tablet taken at 22.00 each evening for 12 - 16 nights (depending on the convenience of the final study night for the patient). There is no study follow-up after the end of medication.

Intervention type

Drug

Phase

Not Specified

Drug names

Prednisone

Primary outcome measures

Changes in overnight pattern of plasma cortisol and interleukin-6 concentrations, determined at baseline and two weeks.

Secondary outcome measures

Standard assessment tools will be used to assess the state of the patient's arthritis. These assessments will be:
1. Swollen and tender joint counts
2. Pain (visual analogue scale)
3. Morning stiffness (minutes)
4. Patient's opinion of condition
5. Clinician's opinion of condition
6. Health Assessment Questionnaire
7. The Multidimensional Assessment of Fatigue scale
8. Hospital Anxiety and Depression Scale

The secondary outcome measures are determined at baseline and two weeks.

Overall trial start date

15/06/2006

Overall trial end date

14/06/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Have rheumatoid arthritis by the criteria of the American College of Rheumatology
2. Are over 50 but less than 80 years old
3. Have active disease as evidenced by:
3.1. Three or more swollen joints
3.2. Three or more tender joints
3.3. Morning stiffness at least 45 minutes
3.4. Pain at least 30 mm on a 100 mm Visual Analogue Scale (VAS)
3.5. Erythrocyte Sedimentation Rate (ESR) at least 29 mm in first hour or C-Reactive Protein (CRP) at least 15 mg/L
4. Stable Disease-Modifying Anti-Rheumatic Drug (DMARD) therapy (or no therapy) for at least 28 days
5. Stable Non-Steroidal Anti-Inflammatory Drug (NSAID)/analgesic therapy for at least seven days

It is anticipated that the ratio of female to male patients will be approximately 2:1, in accordance with the pattern of disease occurrence. To be safe, we will invite women of childbearing potential to take part in the study only if they are using contraception.

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

12

Participant exclusion criteria

1. Pregnancy and lactation
2. Participation in a clinical trial within the past 30 days
3. Presence of contraindication of corticosteroids
4. Known hypersensitivity to prednisone/prednisolone
5. Parenteral treatment with corticosteroids or crystalloid injection into joints within the past three months
6. Other diseases which require corticoid treatments
7. Inflammatory diseases, such as Irritable Bowel Disease (IBD), Colitis, Crohn's Disease, Asthma
8. Other auto-immune diseases
9. Cancer
10. Infections, treatment with antibiotics within the past six weeks
11. Requirement of non-permitted concomitant medication
12. Consumption of benzodiazepines, antidepressants, antipsychotic drugs, antihistaminic drugs
13. Tumour Necrotising Factor - alpha (TNFα) inhibitors
14. Working shift employee
15. Jet lag
16. Significant renal disease (creatinine greater than 150 µmol/L)
17. Significant hepatic impairment

Recruitment start date

15/06/2006

Recruitment end date

14/06/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Academic Rheumatology Unit
Bristol
BS2 8HW
United Kingdom

Sponsor information

Organisation

United Bristol Healthcare NHS Trust (UK)

Sponsor details

Marlborough Street
Bristol
BS2 8HW
United Kingdom
+44 (0)117 928 3473
Maria.Palmer@ubht.swest.nhs.uk

Sponsor type

Government

Website

http://www.ubht.nhs.uk/R&D/

Funders

Funder type

Industry

Funder name

Nitec Pharma AG (Switzerland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20398018

Publication citations

  1. Results

    Kirwan JR, Clarke L, Hunt LP, Perry MG, Straub RH, Jessop DS, Effect of novel therapeutic glucocorticoids on circadian rhythms of hormones and cytokines in rheumatoid arthritis., Ann. N. Y. Acad. Sci., 2010, 1193, 127-133, doi: 10.1111/j.1749-6632.2009.05289.x.

Additional files

Editorial Notes