A 12-week trial consisting of 5 visits (6 if follow up is needed) to find out how effective and safe three different doses of meloxicam are compared with placebo in Rheumatoid Arthritis. Patient will take one dose of study medication daily.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
DOUBLE
Enrollment
1,000
Response according to American College of Rheumatology 20% (ACR20) classification
Time frame: at 12 weeks
Number of painful or tender joints
Time frame: up to 12 weeks
Number of swollen joints
Time frame: up to 12 weeks
Patient's global (overall) assessment of disease activity
Time frame: up to 12 weeks
Investigator's global (overall) assessment of disease activity
Time frame: up to 12 weeks
Patient's assessment of pain
Time frame: up to 12 weeks
Patient's assessment of physical function (mHAQ)
Time frame: up to 12 weeks
C-Reactive Protein (CRP)
Time frame: up to 12 weeks
Withdrawal due to lack of efficacy
Time frame: up to 12 weeks
Duration of morning stiffness
Time frame: up to of 12 weeks
Patient's final global (overall) assessment of efficacy
Time frame: at end of 12 weeks
Investigator's final global (overall) assessment of efficacy
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Suites 570 (research) & 600 (PI)
Huntsville, Alabama, United States
Suite 200
Montgomery, Alabama, United States
Suite 140
Anchorage, Alaska, United States
#106
Glendale, Arizona, United States
Suite 601
Phoenix, Arizona, United States
Suite 201
Phoenix, Arizona, United States
Boehringer Ingelheim Investigational Site
Los Angeles, California, United States
Boehringer Ingelheim Investigational Site
Pasadena, California, United States
Suite 100
Rancho Cucamonga, California, United States
Boehringer Ingelheim Investigational Site
Rancho Mirage, California, United States
...and 143 more locations
Time frame: at end of 12 weeks
Patient status with regard to change in arthritic condition
Time frame: at end of 12 weeks
Use of rescue medication
Time frame: up to 12 weeks
Incidence and intensity of adverse events
Time frame: until 4 weeks post treatment
Patient's final global assessment of tolerability
Time frame: at end of 12 weeks
Investigator's final global assessment of tolerability
Time frame: at end of 12 weeks
Withdrawals due to adverse events
Time frame: at end of 12 weeks