Progression of Rheumatoid Arthritis Clinical Trial
Official title:
Comparison of the Efficacy and Safety of Two Different Starting Dosages of Prednisolone in Early Active Rheumatoid Arthritis: a Randomized, Placebo Controlled Trial
Although cortisone is widely used in the treatment of patients with early rheumatoid arthritis, the best dosage is not known. Therefore we will compare two standard prednisolon starting dosages and placebo in the treatment of patients with early active rheumatoid arthritis on the background of the established therapy with methotrexate. In total 450 patients will be included into the study. Two different treatment arms starting with 10 or 60 mg of prednisolone, and one placebo arm. Duration of intervention is 12 weeks. In parallel, all patients start medication with methotrexate, usual dosage 15 mg/week. Primary efficacy endpoint is progression of radiographic damage after one year compared to baseline. Safety monitoring is performed.
BACKGROUND: Although glucocorticoids (GCs) are widely used in the treatment of patients with
early rheumatoid arthritis (RA), the best dosage for GCs, related to both, efficacy and
safety, is not known.
OBJECTIVE: To compare two standard p.o. GC starting dosages and the non-use of GCs in the
treatment of patients with early active RA on the background of the established 'anchor'
therapy with methotrexate (MTX).
METHODS: Randomised double-blind placebo-controlled trial with two treatment arms (starting
with 10 or 60 mg of p.o. prednisolone (P), tapered down to 5 mg P per day within 8 weeks) and
one placebo arm, each arm comprising 150 patients. Duration of intervention is 12 weeks. In
parallel, all patients start medication with MTX, usual dosage 15 mg/week. Primary efficacy
endpoint is progression of radiographic damage after one year compared to baseline. Secondary
endpoints are: percentage of patients in remission, changes of functional capacity etc.
Safety monitoring is performed.
The analysis is performed in three hierarchical steps. First step is an analysis of
covariance to compare the group with an initial P dosage of 60 mg (V60) and the placebo group
(Pl). In case of a statistical significant result (α = 0.05), a comparison of the group
starting with 10 mg P (V10) and Pl will be done in a second step (α = 0.05). In case of
superiority of V10 versus Pl, a third step will be a non-inferiority test for V10 versus V60
(α = 0.025).
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT02327650 -
To Examine Whether or Not the Primary Causes of OA or RA Might be Bone Alterations
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