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| [ Print-friendly version ] |
| Can monthly low dose intramuscular (IM) steroids prevent erosive damage in established rheumatoid arthritis? A randomised placebo controlled trial |
| ISRCTN | ISRCTN79105828 |
| ClinicalTrials.gov identifier | |
| Public title | Can monthly low dose intramuscular (IM) steroids prevent erosive damage in established rheumatoid arthritis? A randomised placebo controlled trial |
| Scientific title | |
| Acronym | N/A |
| Serial number at source | C0560 |
| 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 |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Rheumatoid arthritis |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 01/11/1997 |
| Anticipated end date | 01/04/2003 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 91 |
| Interventions |
Patients will be randomised to receive either:
1. Monthly IM injections of 120 mg depomedrone 2. Sterile normal saline as placebo |
| 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. 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 measure(s) | No secondary outcome measures |
| Sources of funding | Arthritis Research Campaign (UK) |
| Trial website | |
| Publications | Results in http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=retrieve&db=pubmed&list_uids=15760929 |
| Contact name | Dr Ernest Choy |
| Address |
Academic Department of Rheumatology
GKT School of Medicines King's College Hospital (Dulwich) East Dulwich Grove |
| City/town | London |
| Zip/Postcode | SE22 8PT |
| Country | United Kingdom |
| Tel | +44 (0)20 7346 6446 |
| Fax | +44 (0)20 7346 6475 |
| ernest.choy@kcl.ac.uk | |
| Sponsor | Arthritis Research Campaign (ARC) (UK) |
| Address |
Copeman House
St Mary's Court St Mary's Gate Chesterfield |
| City/town | Derbyshire |
| Zip/Postcode | S41 7TD |
| Country | United Kingdom |
| info@arc.org.uk | |
| Sponsor website: | http://www.arc.org.uk |
| Date applied | 10/07/2002 |
| Last edited | 02/10/2007 |
| Date ISRCTN assigned | 10/07/2002 |
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