Condition category
Musculoskeletal Diseases
Date applied
10/07/2002
Date assigned
10/07/2002
Last edited
02/10/2007
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

Dr Ernest Choy

ORCID ID

Contact details

Academic Department of Rheumatology
GKT School of Medicines
King's College Hospital (Dulwich)
East Dulwich Grove
London
SE22 8PT
United Kingdom
+44 (0)20 7346 6446

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

C0560

Study information

Scientific title

Acronym

Study hypothesis

To evaluate the benefits of 120 mg intramuscular (IM) depomedrone versus placebo in patients with established Rheumatoid Arthritis (RA) whose disease was inadequately controlled by existing Disease Modifying Anti-Rheumatic Drugs (DMARDs).

Ethics approval

Research ethics committees at each collaborating centre approved the trial. All patients enrolled gave informed consent.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Rheumatoid arthritis

Intervention

Patients will be randomised to receive either:
1. Monthly IM injections of 120 mg depomedrone
2. Sterile normal saline as placebo

Intervention type

Drug

Phase

Not Specified

Drug names

Depomedrone

Primary outcome measures

1. Disease activity assessed every 6 months using:
1.1. Numbers of swollen and tender joints (out of 28)
1.2. Articular pain (100 mm Visual Analogue Scale [VAS])
1.3. Patient’s and physician’s global assessments (100 mm VAS)
1.4. ESR
1.5. C-Reactive Protein (CRP)
1.6. Health Assessment Questionnaire (HAQ) scores
1.7. 28 joint count Disease Activity Scores (DAS28)
2. Radiological damage in the hands and feet assessed every 12 months using a modification of Larsen’s method
3. Adverse effects assessed every 6 months, including specific information on fractures, hypertension, hyperglycaemia, weight gain, and infections. Bone density was assessed in the lumbar spine and hip by Dual energy X ray Absorptiometry (DXA) at 0 and 24 months

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/11/1997

Overall trial end date

01/04/2003

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age equal to or more than 18 years
2. Diagnosis of rheumatoid arthritis according to the 1987 American College of Rheumatology criteria
3. Disease duration equal to or more than 2 years
4. One or more erosions on plain X-rays of the hands, wrists and feet
5. Continuous treatment with a Slow-Acting Anti-Rheumatic Drug (SAARD) for at least 3 months (parenteral gold, penicillamine, sulphasalazine, methotrexate, azathioprine and cyclosporin)
6. Continuing active disease with over 6 swollen joints and an Erythrocyte Sedimentation Rate (ESR) over 30 mm/h

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

91

Participant exclusion criteria

1. End stage joint destruction (Larsen score greater than 100)
2. Previous or current oral steroid treatment
3. Contraindications to parenteral steroids (for example, recent gastric ulcer perforation or bleed)
4. Serious comorbidity (for example, end stage renal or liver disease)
5. Patients not taking DMARDs, taking experimental drugs, taking DMARDs that have no effect on x-ray progression (for example, antimalarial drugs), or taking DMARDs which may interact poorly with IM depot steroids

Recruitment start date

01/11/1997

Recruitment end date

01/04/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Academic Department of Rheumatology
London
SE22 8PT
United Kingdom

Sponsor information

Organisation

Arthritis Research Campaign (ARC) (UK)

Sponsor details

Copeman House
St Mary's Court
St Mary's Gate
Chesterfield
Derbyshire
S41 7TD
United Kingdom
-
info@arc.org.uk

Sponsor type

Charity

Website

http://www.arc.org.uk

Funders

Funder type

Charity

Funder name

Arthritis Research Campaign (UK)

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

Results in http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=retrieve&db=pubmed&list_uids=15760929

Publication citations

  1. Results

    Choy EH, Kingsley GH, Khoshaba B, Pipitone N, Scott DL, , A two year randomised controlled trial of intramuscular depot steroids in patients with established rheumatoid arthritis who have shown an incomplete response to disease modifying antirheumatic drugs., Ann. Rheum. Dis., 2005, 64, 9, 1288-1293, doi: 10.1136/ard.2004.030908.

Additional files

Editorial Notes