Can monthly low dose intramuscular (IM) steroids prevent erosive damage in established rheumatoid arthritis? A randomised placebo controlled trial

ISRCTN	ISRCTN79105828
DOI	https://doi.org/10.1186/ISRCTN79105828
Protocol serial number	C0560
Sponsor	Arthritis Research Campaign (ARC) (UK)
Funder	Arthritis Research Campaign (UK)

Submission date: 10/07/2002
Registration date: 10/07/2002
Last edited: 02/10/2007

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Ernest Choy
Scientific

Academic Department of Rheumatology
GKT School of Medicines
King's College Hospital (Dulwich)
East Dulwich Grove
London
SE22 8PT
United Kingdom

Phone	+44 (0)20 7346 6446

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Research ethics committees at each collaborating centre approved the trial. All patients enrolled gave informed consent.
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Depomedrone
Primary outcome measure(s)	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. Patients and physicians 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 Larsens 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
Key secondary outcome measure(s)	No secondary outcome measures
Completion date	01/04/2003

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	91
Key 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
Key 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
Date of first enrolment	01/11/1997
Date of final enrolment	01/04/2003

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Academic Department of Rheumatology

London
SE22 8PT
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	01/09/2005		Yes	No