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 |
| Secondary identifying numbers | C0560 |
- 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
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
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Depomedrone |
| Primary outcome measure | 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 |
| Secondary outcome measures | No secondary outcome measures |
| Overall study start date | 01/11/1997 |
| Completion date | 01/04/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
- England
- United Kingdom
Study participating centre
Academic Department of Rheumatology
London
SE22 8PT
United Kingdom
SE22 8PT
United Kingdom
Sponsor information
Arthritis Research Campaign (ARC) (UK)
Charity
Charity
Copeman House
St Mary's Court
St Mary's Gate
Chesterfield
Derbyshire
S41 7TD
United Kingdom
| info@arc.org.uk | |
| Website | http://www.arc.org.uk |
"ROR" |
https://ror.org/02jkpm469 |
Funders
Funder type
Charity
Arthritis Research Campaign (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
