Rheumatoid Arthritis
Conditions
Keywords
Arcoxia
Brief summary
To assess the clinically active dose range of study medication in the treatment of patients with rheumatoid arthritis.
Interventions
DRUGetoricoxib
Period I: Arm 1: etoricoxib 10 mg tablet once daily. 12 weeks of treatment.
DRUGComparator: placebo
Period I: Arm 5: Pbo tablet once daily. 12 weeks of treatment.
DRUGComparator: diclofenac
Period II: Arm 2: diclofenac 75 mg tablet twice daily. 12 weeks of treatment.
Sponsors
Organon and Co
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient with diagnosed rheumatoid arthritis (RA) for at least 6 months prior who is otherwise judged to be in general good health and who is currently taking nonsteroidal anti-inflammatory drugs (NSAIDS) to treat his/her RA symptoms * Patient will need to stop taking these medications in order to participate, but can continue taking his/her other anti-rheumatic medications as long as they have been stable for certain periods of time
Exclusion criteria
* Patients with a disease or medical condition(s) that could worsen or interfere with the evaluation of the effectiveness of study medication are not allowed to participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients Who Met the ACR20 Responder Index Criteria | 12 weeks | Proportion of Patients Who Met the American College of Rheumatology Response Index (20%) Criteria (ACR20) (Based on the Time-Weighted Average Responses of the 12-Week Treatment I Period and Completed the Treatment I Period) (All Patients-Treated Population) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tender Joint Count (Out of 68 Joints) Time-Weighted Average Change From Baseline (Flare/Randomization Visit) in the 12-Week Treatment Period (All Patients-Treated Population) | Time-weighted average change from baseline across Weeks 2, 7, and 12 | — |
| Swollen Joint Count (Out of 66 Joints) Time-Weighted Average Change From Baseline (Flare/Randomization Visit) in the 12-Week Treatment Period (All Patients-Treated Population) | Time-weighted average change from baseline across Weeks 2, 7, and 12 | — |
| Patient Global Assessment of Disease Activity (0- to 100-mm Visual Analog Scale) Time Weighted Average Change From Baseline (Flare/Randomization Visit) in the 12-Week Treatment I Period (All Patients-Treated Population) | Time-weighted average change from baseline across Weeks 2, 7, and 12 | 0-mm indicates very well, 100-mm indicates very poor. |
| Investigator Global Assessment of Disease Activity (0- to 4-Likert Scale) Time Weighted Average Change From Baseline (Flare/Randomization Visit) in the 12-Week Treatment I Period (All Patients-Treated Population) | Time-weighted average change from baseline across Weeks 2, 7, and 12 | 0 indicates very well, 4 indicates very poor. |
| Patient Global Assessment of Pain (0- to 100-mm Visual Analog Scale) Time Weighted Average Change From Baseline (Flare/Randomization Visit) in the 12-Week Treatment I Period (All Patients-Treated Population) | Time-weighted average change from baseline across Weeks 2, 7, and 12 | 0-mm indicates very well, 100-mm indicates very poor. |
Participant flow
Recruitment details
90 multicenter rheumatologists: US (71), Canada (14), Colombia (3), Switzerland (2), recruited 761 study patients from their patient pool and through advertising. First Patient In 04-Jan-2006, Last Patient Last Visit 26-Mar-2008.
Pre-assignment details
Patients must have taken Non Steroidal Anti-inflammatory Drugs (NSAIDs) at a therapeutic labeled dose on a regular basis and demonstrated a clinical response in the past and at screening. Following a protocol-specified washout, patients must have demonstrated disease activity and worsening in symptoms of Rheumatoid Arthritis from the screening.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Treatment I: Placebo orally once daily | 161 |
| Etoricoxib 10 mg Treatment I: Etoricoxib 10 mg orally once daily | 154 |
| Etoricoxib 30 mg Treatment I: Etoricoxib 30 mg orally once daily | 151 |
| Etoricoxib 60 mg Treatment I: Etoricoxib 60 mg orally once daily | 140 |
| Etoricoxib 90 mg Treatment I: Etoricoxib 90 mg orally once daily | 155 |
| Total | 761 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Treatment II Period | Adverse Event | 0 | 0 | 0 | 0 | 9 | 9 |
| Treatment II Period | Laboratory Adverse Event | 0 | 0 | 0 | 0 | 0 | 1 |
| Treatment II Period | Lack of Efficacy | 0 | 0 | 0 | 0 | 20 | 19 |
| Treatment II Period | Lost to Follow-up | 0 | 0 | 0 | 0 | 1 | 1 |
| Treatment II Period | Pre-scheduled total hip replacement | 0 | 0 | 0 | 0 | 0 | 1 |
| Treatment II Period | Withdrawal by Subject | 0 | 0 | 0 | 0 | 3 | 2 |
| Treatment I Period | Adverse Event | 3 | 6 | 3 | 5 | 7 | 0 |
| Treatment I Period | Laboratory Adverse Event | 0 | 0 | 0 | 1 | 0 | 0 |
| Treatment I Period | Lack of Efficacy | 6 | 2 | 8 | 0 | 1 | 0 |
| Treatment I Period | Lost to Follow-up | 1 | 0 | 0 | 1 | 1 | 0 |
| Treatment I Period | Patient out of town for an extended time | 0 | 1 | 0 | 0 | 0 | 0 |
| Treatment I Period | Protocol Violation | 2 | 2 | 0 | 0 | 0 | 0 |
| Treatment I Period | Reassigned to Treatment II Period | 84 | 72 | 65 | 63 | 45 | 0 |
| Treatment I Period | Unblinded due to Serious Adverse Event | 0 | 0 | 1 | 0 | 0 | 0 |
| Treatment I Period | Withdrawal by Subject | 2 | 0 | 0 | 2 | 2 | 0 |
Baseline characteristics
| Characteristic | Placebo | Total | Etoricoxib 90 mg | Etoricoxib 60 mg | Etoricoxib 30 mg | Etoricoxib 10 mg |
|---|---|---|---|---|---|---|
| Age, Continuous | 57.4 years STANDARD_DEVIATION 11.8 | 57.0 years STANDARD_DEVIATION 11.75 | 54.9 years STANDARD_DEVIATION 12.54 | 57.7 years STANDARD_DEVIATION 10.96 | 56.2 years STANDARD_DEVIATION 11.17 | 58.7 years STANDARD_DEVIATION 11.92 |
| American Rheumatism Association Functional Class Class I | 44 Participants | 221 Participants | 38 Participants | 41 Participants | 49 Participants | 49 Participants |
| American Rheumatism Association Functional Class Class II | 102 Participants | 439 Participants | 98 Participants | 73 Participants | 83 Participants | 83 Participants |
| American Rheumatism Association Functional Class Class III | 15 Participants | 101 Participants | 19 Participants | 26 Participants | 19 Participants | 22 Participants |
| Body Weight | 76.42 Kilograms STANDARD_DEVIATION 16.54 | 76.73 Kilograms STANDARD_DEVIATION 18.58 | 77.97 Kilograms STANDARD_DEVIATION 18.61 | 75.72 Kilograms STANDARD_DEVIATION 19.54 | 77.36 Kilograms STANDARD_DEVIATION 20 | 76.12 Kilograms STANDARD_DEVIATION 18.48 |
| Corticosteroid User No | 111 Participants | 529 Participants | 106 Participants | 99 Participants | 109 Participants | 104 Participants |
| Corticosteroid User Yes | 50 Participants | 232 Participants | 49 Participants | 41 Participants | 42 Participants | 50 Participants |
| Disease Modifying Antirheumatic Drug or Corticosteroid User No | 22 Participants | 107 Participants | 19 Participants | 21 Participants | 25 Participants | 20 Participants |
| Disease Modifying Antirheumatic Drug or Corticosteroid User Yes | 139 Participants | 654 Participants | 136 Participants | 119 Participants | 126 Participants | 134 Participants |
| Disease Modifying Antirheumatic Drug User No | 28 Participants | 132 Participants | 24 Participants | 26 Participants | 29 Participants | 25 Participants |
| Disease Modifying Antirheumatic Drug User Yes | 133 Participants | 629 Participants | 131 Participants | 114 Participants | 122 Participants | 129 Participants |
| Duration of Rheumatoid Arthritis (Years) | 10.0 Years STANDARD_DEVIATION 9.78 | 10.3 Years STANDARD_DEVIATION 9.62 | 9.9 Years STANDARD_DEVIATION 9.98 | 10.3 Years STANDARD_DEVIATION 10.18 | 11.2 Years STANDARD_DEVIATION 8.4 | 10.1 Years STANDARD_DEVIATION 9.76 |
| Height | 161.93 Centimeters STANDARD_DEVIATION 9.71 | 163.30 Centimeters STANDARD_DEVIATION 9.37 | 163.49 Centimeters STANDARD_DEVIATION 10.04 | 162.96 Centimeters STANDARD_DEVIATION 9.22 | 164.57 Centimeters STANDARD_DEVIATION 9.13 | 163.63 Centimeters STANDARD_DEVIATION 8.55 |
| Investigator Global Assessment of Disease Activity (0 to 4 - Likert Scale) | 2.71 units on a scale STANDARD_DEVIATION 0.61 | 2.72 units on a scale STANDARD_DEVIATION 0.64 | 2.73 units on a scale STANDARD_DEVIATION 0.65 | 2.69 units on a scale STANDARD_DEVIATION 0.63 | 2.75 units on a scale STANDARD_DEVIATION 0.66 | 2.71 units on a scale STANDARD_DEVIATION 0.67 |
| Methotrexate User No | 62 Participants | 289 Participants | 62 Participants | 47 Participants | 55 Participants | 63 Participants |
| Methotrexate User Yes | 99 Participants | 472 Participants | 93 Participants | 93 Participants | 96 Participants | 91 Participants |
| Patient Global Assessment of Disease Activity (0-To- 100 Millimeter Visual Analog Scale) | 66.08 units on a scale STANDARD_DEVIATION 18.67 | 66.79 units on a scale STANDARD_DEVIATION 19.3 | 65.42 units on a scale STANDARD_DEVIATION 18.45 | 66.60 units on a scale STANDARD_DEVIATION 19.58 | 66.56 units on a scale STANDARD_DEVIATION 20.47 | 69.28 units on a scale STANDARD_DEVIATION 19.37 |
| Patient Global Assessment of Pain (0- To- 100-mm Visual Analog Scale) | 72.66 units on a scale STANDARD_DEVIATION 16.03 | 71.38 units on a scale STANDARD_DEVIATION 17.14 | 71.08 units on a scale STANDARD_DEVIATION 17.55 | 69.54 units on a scale STANDARD_DEVIATION 18.24 | 70.95 units on a scale STANDARD_DEVIATION 16.67 | 72.42 units on a scale STANDARD_DEVIATION 17.32 |
| Race/Ethnicity Asian | 1 participants | 4 participants | 1 participants | 1 participants | 1 participants | 0 participants |
| Race/Ethnicity Black | 5 participants | 29 participants | 6 participants | 7 participants | 3 participants | 8 participants |
| Race/Ethnicity Hispanic | 41 participants | 175 participants | 36 participants | 34 participants | 25 participants | 39 participants |
| Race/Ethnicity Indian | 0 participants | 1 participants | 0 participants | 0 participants | 0 participants | 1 participants |
| Race/Ethnicity Native American | 0 participants | 3 participants | 0 participants | 2 participants | 1 participants | 0 participants |
| Race/Ethnicity White | 114 participants | 549 participants | 112 participants | 96 participants | 121 participants | 106 participants |
| Rheumatoid Factor Negative | 40 Participants | 161 Participants | 34 Participants | 20 Participants | 30 Participants | 37 Participants |
| Rheumatoid Factor Not Reported | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Rheumatoid Factor Positive | 120 Participants | 599 Participants | 121 Participants | 120 Participants | 121 Participants | 117 Participants |
| Sex: Female, Male Female | 136 Participants | 613 Participants | 122 Participants | 112 Participants | 126 Participants | 117 Participants |
| Sex: Female, Male Male | 25 Participants | 148 Participants | 33 Participants | 28 Participants | 25 Participants | 37 Participants |
| Smoking Status Current | 27 Participants | 129 Participants | 22 Participants | 23 Participants | 29 Participants | 28 Participants |
| Smoking Status Ex-User | 53 Participants | 220 Participants | 40 Participants | 39 Participants | 42 Participants | 46 Participants |
| Smoking Status Non-User | 81 Participants | 412 Participants | 93 Participants | 78 Participants | 80 Participants | 80 Participants |
| Swollen Joint Count (Out of 66 Joints) | 16.05 Number of Swollen Joints STANDARD_DEVIATION 9.79 | 16.53 Number of Swollen Joints STANDARD_DEVIATION 10.06 | 16.30 Number of Swollen Joints STANDARD_DEVIATION 10.05 | 15.79 Number of Swollen Joints STANDARD_DEVIATION 9.4 | 16.74 Number of Swollen Joints STANDARD_DEVIATION 10.11 | 17.75 Number of Swollen Joints STANDARD_DEVIATION 10.86 |
| Tender Joint Count (Out of 68 Joints) | 26.91 Number of Tender Joints STANDARD_DEVIATION 14.17 | 27.30 Number of Tender Joints STANDARD_DEVIATION 15 | 27.25 Number of Tender Joints STANDARD_DEVIATION 16.11 | 26.76 Number of Tender Joints STANDARD_DEVIATION 14.37 | 27.19 Number of Tender Joints STANDARD_DEVIATION 14.97 | 28.33 Number of Tender Joints STANDARD_DEVIATION 15.42 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 28 / — | 19 / — | 29 / — | 37 / — | 39 / — | 25 / — | 30 / — |
| serious Total, serious adverse events | 0 / — | 1 / — | 4 / — | 1 / — | 5 / — | 3 / — | 3 / — |
Outcome results
Primary
Proportion of Patients Who Met the ACR20 Responder Index Criteria
Proportion of Patients Who Met the American College of Rheumatology Response Index (20%) Criteria (ACR20) (Based on the Time-Weighted Average Responses of the 12-Week Treatment I Period and Completed the Treatment I Period) (All Patients-Treated Population)
Time frame: 12 weeks
Population: All-Patients-Treated Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Proportion of Patients Who Met the ACR20 Responder Index Criteria | 28.57 Proportion of Patients |
| Etoricoxib 10 mg | Proportion of Patients Who Met the ACR20 Responder Index Criteria | 35.06 Proportion of Patients |
| Etoricoxib 30 mg | Proportion of Patients Who Met the ACR20 Responder Index Criteria | 37.75 Proportion of Patients |
| Etoricoxib 60 mg | Proportion of Patients Who Met the ACR20 Responder Index Criteria | 38.57 Proportion of Patients |
| Etoricoxib 90 mg | Proportion of Patients Who Met the ACR20 Responder Index Criteria | 47.10 Proportion of Patients |
p-value: <0.001Cochran-Armitage trend test
p-value: 0.057Cochran-Armitage trend test
95% CI: [7.84, 28.65]
95% CI: [-0.66, 20.46]
95% CI: [-1.25, 19.39]
95% CI: [-3.76, 16.61]
Secondary
Investigator Global Assessment of Disease Activity (0- to 4-Likert Scale) Time Weighted Average Change From Baseline (Flare/Randomization Visit) in the 12-Week Treatment I Period (All Patients-Treated Population)
0 indicates very well, 4 indicates very poor.
Time frame: Time-weighted average change from baseline across Weeks 2, 7, and 12
Population: All-Patients-Treatment Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Investigator Global Assessment of Disease Activity (0- to 4-Likert Scale) Time Weighted Average Change From Baseline (Flare/Randomization Visit) in the 12-Week Treatment I Period (All Patients-Treated Population) | -0.68 Units on a Scale | Standard Deviation 1.06 |
| Etoricoxib 10 mg | Investigator Global Assessment of Disease Activity (0- to 4-Likert Scale) Time Weighted Average Change From Baseline (Flare/Randomization Visit) in the 12-Week Treatment I Period (All Patients-Treated Population) | -0.93 Units on a Scale | Standard Deviation 0.94 |
| Etoricoxib 30 mg | Investigator Global Assessment of Disease Activity (0- to 4-Likert Scale) Time Weighted Average Change From Baseline (Flare/Randomization Visit) in the 12-Week Treatment I Period (All Patients-Treated Population) | -1.09 Units on a Scale | Standard Deviation 1.01 |
| Etoricoxib 60 mg | Investigator Global Assessment of Disease Activity (0- to 4-Likert Scale) Time Weighted Average Change From Baseline (Flare/Randomization Visit) in the 12-Week Treatment I Period (All Patients-Treated Population) | -1.01 Units on a Scale | Standard Deviation 0.94 |
| Etoricoxib 90 mg | Investigator Global Assessment of Disease Activity (0- to 4-Likert Scale) Time Weighted Average Change From Baseline (Flare/Randomization Visit) in the 12-Week Treatment I Period (All Patients-Treated Population) | -1.24 Units on a Scale | Standard Deviation 0.94 |
p-value: <0.001ANCOVA
p-value: <0.001ANCOVA
p-value: <0.001ANCOVA
p-value: 0.018ANCOVA
95% CI: [-0.77, -0.35]
95% CI: [-0.55, -0.13]
95% CI: [-0.61, -0.19]
95% CI: [-0.46, -0.04]
Secondary
Patient Global Assessment of Disease Activity (0- to 100-mm Visual Analog Scale) Time Weighted Average Change From Baseline (Flare/Randomization Visit) in the 12-Week Treatment I Period (All Patients-Treated Population)
0-mm indicates very well, 100-mm indicates very poor.
Time frame: Time-weighted average change from baseline across Weeks 2, 7, and 12
Population: All Patients-Treated Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Patient Global Assessment of Disease Activity (0- to 100-mm Visual Analog Scale) Time Weighted Average Change From Baseline (Flare/Randomization Visit) in the 12-Week Treatment I Period (All Patients-Treated Population) | -12.32 Units on a Scale | Standard Deviation 25.66 |
| Etoricoxib 10 mg | Patient Global Assessment of Disease Activity (0- to 100-mm Visual Analog Scale) Time Weighted Average Change From Baseline (Flare/Randomization Visit) in the 12-Week Treatment I Period (All Patients-Treated Population) | -19.90 Units on a Scale | Standard Deviation 23.61 |
| Etoricoxib 30 mg | Patient Global Assessment of Disease Activity (0- to 100-mm Visual Analog Scale) Time Weighted Average Change From Baseline (Flare/Randomization Visit) in the 12-Week Treatment I Period (All Patients-Treated Population) | -21.12 Units on a Scale | Standard Deviation 24.47 |
| Etoricoxib 60 mg | Patient Global Assessment of Disease Activity (0- to 100-mm Visual Analog Scale) Time Weighted Average Change From Baseline (Flare/Randomization Visit) in the 12-Week Treatment I Period (All Patients-Treated Population) | -21.49 Units on a Scale | Standard Deviation 26.71 |
| Etoricoxib 90 mg | Patient Global Assessment of Disease Activity (0- to 100-mm Visual Analog Scale) Time Weighted Average Change From Baseline (Flare/Randomization Visit) in the 12-Week Treatment I Period (All Patients-Treated Population) | -25.75 Units on a Scale | Standard Deviation 25.71 |
p-value: <0.001ANCOVA
p-value: <0.001ANCOVA
p-value: <0.001ANCOVA
p-value: 0.023ANCOVA
95% CI: [-19.38, -8.95]
95% CI: [-14.52, -3.9]
95% CI: [-14.11, -3.63]
95% CI: [-11.27, -0.83]
Secondary
Patient Global Assessment of Pain (0- to 100-mm Visual Analog Scale) Time Weighted Average Change From Baseline (Flare/Randomization Visit) in the 12-Week Treatment I Period (All Patients-Treated Population)
0-mm indicates very well, 100-mm indicates very poor.
Time frame: Time-weighted average change from baseline across Weeks 2, 7, and 12
Population: All-Patients-Treated Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Patient Global Assessment of Pain (0- to 100-mm Visual Analog Scale) Time Weighted Average Change From Baseline (Flare/Randomization Visit) in the 12-Week Treatment I Period (All Patients-Treated Population) | -17.44 Units on a Scale | Standard Deviation 23.42 |
| Etoricoxib 10 mg | Patient Global Assessment of Pain (0- to 100-mm Visual Analog Scale) Time Weighted Average Change From Baseline (Flare/Randomization Visit) in the 12-Week Treatment I Period (All Patients-Treated Population) | -21.95 Units on a Scale | Standard Deviation 22.87 |
| Etoricoxib 30 mg | Patient Global Assessment of Pain (0- to 100-mm Visual Analog Scale) Time Weighted Average Change From Baseline (Flare/Randomization Visit) in the 12-Week Treatment I Period (All Patients-Treated Population) | -22.75 Units on a Scale | Standard Deviation 23.86 |
| Etoricoxib 60 mg | Patient Global Assessment of Pain (0- to 100-mm Visual Analog Scale) Time Weighted Average Change From Baseline (Flare/Randomization Visit) in the 12-Week Treatment I Period (All Patients-Treated Population) | -22.25 Units on a Scale | Standard Deviation 26.58 |
| Etoricoxib 90 mg | Patient Global Assessment of Pain (0- to 100-mm Visual Analog Scale) Time Weighted Average Change From Baseline (Flare/Randomization Visit) in the 12-Week Treatment I Period (All Patients-Treated Population) | -31.07 Units on a Scale | Standard Deviation 24.18 |
p-value: <0.001ANCOVA
p-value: 0.018ANCOVA
p-value: 0.017ANCOVA
p-value: 0.08ANCOVA
95% CI: [-19.62, -9.26]
95% CI: [-11.52, -0.92]
95% CI: [-11.53, -1.12]
95% CI: [-9.81, 0.55]
Secondary
Swollen Joint Count (Out of 66 Joints) Time-Weighted Average Change From Baseline (Flare/Randomization Visit) in the 12-Week Treatment Period (All Patients-Treated Population)
Time frame: Time-weighted average change from baseline across Weeks 2, 7, and 12
Population: All-Patients-Treatment Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Swollen Joint Count (Out of 66 Joints) Time-Weighted Average Change From Baseline (Flare/Randomization Visit) in the 12-Week Treatment Period (All Patients-Treated Population) | -5.39 Swollen Joint Count | Standard Deviation 7.34 |
| Etoricoxib 10 mg | Swollen Joint Count (Out of 66 Joints) Time-Weighted Average Change From Baseline (Flare/Randomization Visit) in the 12-Week Treatment Period (All Patients-Treated Population) | -6.58 Swollen Joint Count | Standard Deviation 8.11 |
| Etoricoxib 30 mg | Swollen Joint Count (Out of 66 Joints) Time-Weighted Average Change From Baseline (Flare/Randomization Visit) in the 12-Week Treatment Period (All Patients-Treated Population) | -6.91 Swollen Joint Count | Standard Deviation 7.27 |
| Etoricoxib 60 mg | Swollen Joint Count (Out of 66 Joints) Time-Weighted Average Change From Baseline (Flare/Randomization Visit) in the 12-Week Treatment Period (All Patients-Treated Population) | -6.25 Swollen Joint Count | Standard Deviation 7.48 |
| Etoricoxib 90 mg | Swollen Joint Count (Out of 66 Joints) Time-Weighted Average Change From Baseline (Flare/Randomization Visit) in the 12-Week Treatment Period (All Patients-Treated Population) | -7.77 Swollen Joint Count | Standard Deviation 7.17 |
p-value: 0.001ANCOVA
p-value: 0.125ANCOVA
95% CI: [-3.64, -0.84]
95% CI: [-2.44, 0.41]
95% CI: [-2.63, 0.18]
95% CI: [-1.89, 0.91]
Secondary
Tender Joint Count (Out of 68 Joints) Time-Weighted Average Change From Baseline (Flare/Randomization Visit) in the 12-Week Treatment Period (All Patients-Treated Population)
Time frame: Time-weighted average change from baseline across Weeks 2, 7, and 12
Population: All-Patients-Treatment Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Tender Joint Count (Out of 68 Joints) Time-Weighted Average Change From Baseline (Flare/Randomization Visit) in the 12-Week Treatment Period (All Patients-Treated Population) | -8.13 Tender Joint Count | Standard Deviation 9.55 |
| Etoricoxib 10 mg | Tender Joint Count (Out of 68 Joints) Time-Weighted Average Change From Baseline (Flare/Randomization Visit) in the 12-Week Treatment Period (All Patients-Treated Population) | -11.01 Tender Joint Count | Standard Deviation 13.07 |
| Etoricoxib 30 mg | Tender Joint Count (Out of 68 Joints) Time-Weighted Average Change From Baseline (Flare/Randomization Visit) in the 12-Week Treatment Period (All Patients-Treated Population) | -10.96 Tender Joint Count | Standard Deviation 11 |
| Etoricoxib 60 mg | Tender Joint Count (Out of 68 Joints) Time-Weighted Average Change From Baseline (Flare/Randomization Visit) in the 12-Week Treatment Period (All Patients-Treated Population) | -9.56 Tender Joint Count | Standard Deviation 11.85 |
| Etoricoxib 90 mg | Tender Joint Count (Out of 68 Joints) Time-Weighted Average Change From Baseline (Flare/Randomization Visit) in the 12-Week Treatment Period (All Patients-Treated Population) | -12.06 Tender Joint Count | Standard Deviation 11.22 |
p-value: 0.002ANCOVA
p-value: 0.221ANCOVA
95% CI: [-6.44, -1.68]
95% CI: [-3.91, 0.93]
95% CI: [-5.13, -0.35]
95% CI: [-4.88, -0.12]