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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN79105828

Enrollment

Registered

2002-07-10

Start date

1997-11-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid arthritis Musculoskeletal Diseases Rheumatoid arthritis

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
No secondary outcome measures	—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026