Comparison of the Effect of Etoricoxib and Diclofenac on Early Morning Activity in Rheumatoid Arthritis (RA)

Launched by NORTHUMBRIA HEALTHCARE NHS FOUNDATION TRUST · Feb 10, 2010

Keywords

ClinConnect Summary

Rheumatoid Arhthitis (RA) is a chronic inflammatory condition characterised by prolonged morning stiffness. Anti-inflammatory medication is effective in relieving the pain and stiffness associated with this inflammation. By having a long half-life, Etoricoxib has a simple once daily dosing regime and the long action overnight should mean that patients experience more effective relief of symptoms first thing in the morning compared to shorter half life medication such as Diclofenac. The activity of people can be measured using the NuMact monitor which has been validated against observation a...

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Eligibility criteria

• Inclusion Criteria:
• • Male and female subjects aged 18 years and over.
• • Subjects who are NSAID tolerant.
• • Subjects with a clinical diagnosis of rheumatoid arthritis.
• • Subjects who are willing to complete QOL questionnaires.
• • Written informed consent
• Exclusion Criteria:
• • Co-occurrence of other disabling conditions in addition to rheumatoid arthritis likely to warrant the persistent use of escape analgesia.
• • Subjects who have received an intra-articular or muscular steroid injection within 3 months of study entry or in whom such treatment is planned within the study period.
• • Subjects scheduled for elective surgery of the disease site or any other elective major surgery which would fall within the study period.
• • Severe respiratory impairment.
• • Clinically significant hepatic or renal dysfunction, subjects whose LFTs and serum creatinine is outside normal recognized limits.
• • Subjects with convulsive disorders, head injury, shock, reduced level of consciousness of uncertain origin, intracranial lesions or increased intracranial pressure.
• • Subjects with a known allergy or hypersensitivity to NSAIDs.
• • Subjects with unstable gastro-intestinal complications or disease.
• • Subjects who currently abuse alcohol or drugs, or have a recent history of alcohol or drug abuse, or who in the Investigator's opinion, have previously demonstrated drug-seeking behaviour.
• • Subjects who are currently participating in another clinical research study involving a new chemical entity or who have participated in a clinical study within the previous 30 days.