The objective of this study is to compare the efficacy of equivalent doses of IM triamcinolone acetonide and oral prednisolone in controlling a symptomatic flare in patients with established RA. MedDRA version: 9.1 Level: LLT Classification code 10060732 Term: Rheumatoid arthritis flare up
Conditions
Interventions
Trade Name: Kenalog
Product Name: Triamcinolone acetonide
Pharmaceutical Form: Injection*
INN or Proposed INN: TRIAMCINOLONE ACETONIDE
CAS Number: 76255
Concentration unit: IU/mg international unit(s)
Sponsors
Trafford NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a. Age > 18 years b. Diagnosis of RA according to the 1987 ACR criteria c. Continuous stable DMARD treatment for > 3 months d. Active disease with > 6 swollen joints e. Active disease with > 6 tender joints f. Informed written patient consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Contraindicated for parenteral steroids (e.g. hypersensitivity to steroids, history of psychological events to steroids, systemic infection). 2. Contraindicated for oral steroids (e.g. hypersensitivity to steroids, history of psychological events to steroids, systemic infection). 3. Subjects suffering from any infection or currently taking antibiotics. 4. Subjects currently receiving steroid treatment. 5. Subjects who have received steroid treatment within the previous 3 months. 6. Subjects receiving anti-TNF therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of this study is to compare the efficacy of equivalent doses of IM triamcinolone acetonide and oral prednisolone in controlling a symptomatic flare in patients with established RA.;Secondary Objective: To identify the magnitude and duration of effect of the two treatments.;Primary end point(s): The DAS 28 score will be used to measure disease activity. This comprises the number of swollen and tender joints out of 28, the subject’s global assessment the ESR. Assessments will be made by the researcher at two-weekly intervals from week 0 (baseline) to week 8 (endpoint). The frequency of assessments is intended to establish any significant difference in duration and magnitude of effect at each assessment. Effectiveness of treatment will be assessed by measuring the change in the overall DAS28 score from baseline at weeks 2, 4, 6 and 8. The Disease Activity Score is widely used to quantify disease activity and gauge response to treatment, and the 28 joint version (DAS28) is used in the British Society for Rheumatology (BSR) guidelines. | — |
Countries
United Kingdom
Outcome results
None listed