Multinational randomised controlled clinical trial of etoricoxib in the treatment of rheumatoid arthritis

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Mr Sean Curtis
Scientific

Merck & Co Inc
126 E Lincoln Avenue
Rahway
NJ 07065
United States of America

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Not provided at time of registration
Ethics approval(s)	Each site received the approval of its Ethics Review Committee or Institutional Review Board to perform the study.
Health condition(s) or problem(s) studied	Rheumatoid arthritis
Intervention	1. Etoricoxib 90 mg once daily, naproxen 500 mg twice daily 2. Placebo for 12 weeks
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Etoricoxib, naproxen
Primary outcome measure(s)	Not provided at time of registration
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/06/2000

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	891
Key inclusion criteria	1. Patients with rheumatoid arthritis 2. Aged greater than or equal to 18 years
Key exclusion criteria	Does not match inclusion criteria
Date of first enrolment	01/11/1999
Date of final enrolment	01/06/2000

Merck & Co Inc

Rahway
NJ 07065
United States of America

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	22/05/2002		Yes	No