Study Of "Continuous Use" Of Celecoxib Vs. "Usual or Intermittent Use" - Study Results

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment
Conditions:	Osteoarthritis, Knee Osteoarthritis, Hip
Intervention:	Drug: Celecoxib

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
111 centers in the Americas and Europe enrolled and treated subjects (2 centers in Belgium, 4 centers in Brazil, 20 centers in Canada, 5 centers in Chile, 5 centers in Columbia, 1 center in France, 15 centers in the United Kingdom, and 59 centers in the United States).

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
17 participants completed Open-label run-in Period II and were randomized to Period III Double Blind but not treated.

	Description
Wash-Out: Discontinue Non-Steroidal Anti-Inflammatories	Period I (14+/-2 days) wash out and discontinuation of non-steroidal anti-inflammatories (NSAIDs) leading to osteoarthritis (OA) flare.
Open-Label Celecoxib Run-in Period	Period II (14+/-2 days) run-in treatment with open label celecoxib to observe successful treatment of flare. Participants successfully treated randomized to 2 treatment groups in Period III (overall study).
Celecoxib 200mg Continuous Use	Period III Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
Celecoxib 200mg Intermittent Use	Period III Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.

	Wash-Out: Discontinue Non-Steroidal Anti-Inflammatories	Open-Label Celecoxib Run-in Period	Celecoxib 200mg Continuous Use	Celecoxib 200mg Intermittent Use
STARTED	1772	0	0	0
COMPLETED	1197	0	0	0
NOT COMPLETED	575	0	0	0
Did not enter Period II	575	0	0	0

	Wash-Out: Discontinue Non-Steroidal Anti-Inflammatories	Open-Label Celecoxib Run-in Period	Celecoxib 200mg Continuous Use	Celecoxib 200mg Intermittent Use
STARTED	0	1197	0	0
COMPLETED	0	875	0	0
NOT COMPLETED	0	322	0	0
Not Randomized into Period III	0	322	0	0

	Celecoxib 200mg Continuous Use	Celecoxib 200mg Intermittent Use
STARTED	431^[1]	427^[2]
COMPLETED	355	321
NOT COMPLETED	76	106
Adverse Event	22	23
Unknown	23	34
Lack of Efficacy	10	24
Lost to Follow-up	5	4
Withdrawal by Subject	16	21

[1]	Randomized 440: 9 participants not treated
[2]	Randomized 435: 8 participants not treated

	Celecoxib 200mg Continuous Use	Celecoxib 200mg Intermittent Use	Total
Number of Participants [units: participants]	431	427	858
Age [units: years] Mean ± Standard Deviation	58.5 ± 10.00	58.7 ± 9.6	58.6 ± 9.8
Gender [units: participants]
Female	317	303	620
Male	114	124	238

Measure Type	Primary
Measure Title	Number of Flare Events Per Time of Exposure to Study Medication
Measure Description	Number of flare events per month during Period III (calculated as number of flares divided by number of months participant was enrolled during Period III). Flare was determined using pre-defined criteria, using an interactive voice response system.
Time Frame	Period III (22 weeks)
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent to treat (ITT) population included subjects who were randomized and received at least one dose of double blind study medication

Reporting Groups

	Description
Celecoxib 200mg Continuous Use	Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
Celecoxib 200mg Intermittent Use	Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.

Measured Values

	Celecoxib 200mg Continuous Use	Celecoxib 200mg Intermittent Use
Number of Participants Analyzed [units: participants]	431	427
Number of Flare Events Per Time of Exposure to Study Medication [units: flare events per month] Mean ± Standard Deviation	0.54 ± 0.74	0.93 ± 1.01

Statistical Analysis 1 for Number of Flare Events Per Time of Exposure to Study Medication

Groups ^[1]	All groups
Method ^[2]	ANOVA
P Value ^[3]	<0.0001

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Null hypothesis for primary outcome is that there is no difference in the number of flares observed between the 2 treatment arms of celecoxib 200mg continuous use and celecoxib 200mg intermittent use. Sample size calculation: Sufficient number of participants were randomized to provide at least 80% power to detect an estimated effect size of 0.2 using a 2-sided t-test at a 0.05 significant level.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Treatment as fixed effect
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Threshold for statistical significance p<0.05

Measure Type	Secondary
Measure Title	Time to Occurrence of First Osteoarthritis (OA) Flare
Measure Description	Time from first dose of double blind medication (start of Period III) to occurrence of first OA flare. Flare was determined using pre-defined criteria, using an interactive voice response system
Time Frame	Period III (22 weeks)
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent to treat (ITT) population included subjects who were randomized and received at least one dose of double blind study medication.

Reporting Groups

	Description
Celecoxib 200mg Continuous Use	Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
Celecoxib 200mg Intermittent Use	Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.

Measured Values

	Celecoxib 200mg Continuous Use	Celecoxib 200mg Intermittent Use
Number of Participants Analyzed [units: participants]	431	427
Time to Occurrence of First Osteoarthritis (OA) Flare [units: days] Median ( 95% Confidence Interval )	16.0 ( 14.0 to 22.0 )	8.0 ( 8.0 to 9.0 )

Statistical Analysis 1 for Time to Occurrence of First Osteoarthritis (OA) Flare

Groups ^[1]	All groups
Method ^[2]	Log Rank
P Value ^[3]	<0.0001

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Kaplan-Meier analysis
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Threshold for statistical significance p<0.05

Measure Type	Secondary
Measure Title	Proportion of Days Free From Osteoarthritis (OA) Flare
Measure Description	Number of days subject was free from OA flare divided by number of days on study medication in Period III. Flare was determined using pre-defined criteria, using an interactive voice response system.
Time Frame	Period III (22 weeks)
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent to treat (ITT) population included subjects who were randomized and received at least one dose of double blind study medication

Reporting Groups

	Description
Celecoxib 200mg Continuous Use	Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
Celecoxib 200mg Intermittent Use	Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.

Measured Values

	Celecoxib 200mg Continuous Use	Celecoxib 200mg Intermittent Use
Number of Participants Analyzed [units: participants]	431	427
Proportion of Days Free From Osteoarthritis (OA) Flare [units: proportion of days free from OA flare] Mean ± Standard Deviation	0.77 ± 0.28	0.67 ± 0.30

Statistical Analysis 1 for Proportion of Days Free From Osteoarthritis (OA) Flare

Groups ^[1]	All groups
Method ^[2]	ANOVA
P Value ^[3]	<0.0001

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Treatment as fixed effect
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Threshold for statistical significance p<0.05

Measure Type	Secondary
Measure Title	Proportion of Days in Osteoarthritis (OA) Flare
Measure Description	Number of days subject was in OA flare divided by number of days on study medication in Period III. Subjects may have more than one flare. Flare was determined using pre-defined criteria, using an interactive voice response system.
Time Frame	Period III (22 weeks)
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups

	Description
Celecoxib 200mg Continuous Use	Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
Celecoxib 200mg Intermittent Use	Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.

Measured Values

	Celecoxib 200mg Continuous Use	Celecoxib 200mg Intermittent Use
Number of Participants Analyzed [units: participants]	431	427
Proportion of Days in Osteoarthritis (OA) Flare [units: proportion of days in OA flare] Mean ± Standard Deviation	0.23 ± 0.28	0.33 ± 0.30

Statistical Analysis 1 for Proportion of Days in Osteoarthritis (OA) Flare

Groups ^[1]	All groups
Method ^[2]	ANOVA
P Value ^[3]	<0.0001

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Treatment as fixed effect
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Threshold for statistical significance p<0.05

Measure Type	Secondary
Measure Title	Arthritis Pain Numerical Rating Scale (NRS)
Measure Description	Participant rated intensity of osteoarthritis pain on categorical scale from 0 (no pain) to 10 (worst pain). Scores analyzed as area under the curve (AUC) of participant's scores from each assessment in Period III.
Time Frame	Period III
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent to treat (ITT) population included subjects who were randomized and received at least one dose of double blind study medication. These data are presented by the weeks from the start of Period II, 2 weeks before randomization. The weeks post-randomization, Period III, are different from the study weeks i.e. includes 2 weeks from Period II.

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

Intent to treat (ITT) population included subjects who were randomized and received at least one dose of double blind study medication.

These data are presented by the weeks from the start of Period II, 2 weeks before randomization. The weeks post-randomization, Period III, are different from the study weeks i.e. includes 2 weeks from Period II.

Reporting Groups

	Description
Celecoxib 200mg Continuous Use	Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
Celecoxib 200mg Intermittent Use	Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.

Measured Values

	Celecoxib 200mg Continuous Use	Celecoxib 200mg Intermittent Use
Number of Participants Analyzed [units: participants]	431	427
Arthritis Pain Numerical Rating Scale (NRS) [units: scores on a scale * weeks] Least Squares Mean ± Standard Error
Week 4 (n=415 cont; n=414 inter)	81.7 ± 1.1	90.5 ± 1.1
Week 8 (n=401 cont; n=395 inter)	148.8 ± 2.6	167.0 ± 2.6
Week 12 (n=383 cont; n=363 inter)	212.6 ± 4.1	234.3 ± 4.1
Week 16 (n=373 cont; n=339 inter)	272.7 ± 5.9	297.6 ± 5.9
Week 20 (n=362; n=323 inter)	335.9 ± 7.8	361.1 ± 7.8
Week 24 (n=350 cont; n=403 inter)	378.1 ± 9.1	403.9 ± 9.2

Statistical Analysis 1 for Arthritis Pain Numerical Rating Scale (NRS)

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	<0.001

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Week 4
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Treatment as fixed effect and baseline as covariate
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Threshold for statistical significance p<0.05

Statistical Analysis 2 for Arthritis Pain Numerical Rating Scale (NRS)

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	<0.001

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Week 8
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Treatment as fixed effect and baseline as covariate
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Threshold for statistical significance p<0.05

Statistical Analysis 3 for Arthritis Pain Numerical Rating Scale (NRS)

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	<0.001

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Week 12
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Treatment as fixed effect and baseline as covariate
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Threshold for statistical significance p<0.05

Statistical Analysis 4 for Arthritis Pain Numerical Rating Scale (NRS)

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.003

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Week 16
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Treatment as fixed effect and baseline as covariate
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Threshold for statistical significance p<0.05

Statistical Analysis 5 for Arthritis Pain Numerical Rating Scale (NRS)

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.022

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Week 20
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Treatment as fixed effect and baseline as covariate
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Threshold for statistical significance p<0.05

Statistical Analysis 6 for Arthritis Pain Numerical Rating Scale (NRS)

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.047

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Week 24
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Treatment as fixed effect and baseline as covariate
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Threshold for statistical significance p<0.05

Measure Type	Secondary
Measure Title	Patient's Global Assessment of Arthritis
Measure Description	Participant's response to question "Considering all the ways the osteoarthritis in your hip or knee affects you, how are you doing today?" on scale from 1 (very good) to 5 (very poor). Scores analyzed as area under the curve (AUC) of participant's scores from each assessment in Period III.
Time Frame	Period III
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

Intent to treat (ITT) population included subjects who were randomized and received at least one dose of double blind study medication.

These data are presented by the weeks from the start of Period II, 2 weeks before randomization. The weeks post-randomization, Period III, are different from the study weeks i.e. includes 2 weeks from Period II.

Reporting Groups

	Description
Celecoxib 200mg Continuous Use	Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
Celecoxib 200mg Intermittent Use	Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.

Measured Values

	Celecoxib 200mg Continuous Use	Celecoxib 200mg Intermittent Use
Number of Participants Analyzed [units: participants]	431	427
Patient's Global Assessment of Arthritis [units: scores on a scale * weeks] Least Squares Mean ± Standard Error
Week 4 (n=415 cont; n=414 inter)	67.9 ± 0.68	71.7 ± 0.69
Week 8 (n=401 cont; n=395 inter)	126.0 ± 1.55	133.2 ± 1.56
Week 12 (n=383 cont; n=363 inter)	182.8 ± 2.48	188.7 ± 2.48
Week 16 (n=373 cont; n=339 inter)	236.3 ± 3.59	241.2 ± 3.59
Week 20 (n=362 cont; n=323 inter)	292.4 ± 4.83	293.8 ± 4.84
Week 24 (n=350 cont; n=309 inter)	329.2 ± 5.75	328.9 ± 5.76

Statistical Analysis 1 for Patient's Global Assessment of Arthritis

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	<0.001

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Week 4
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Treatment as fixed effect and baseline as covariate
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Threshold for statistical significance p<0.05

Statistical Analysis 2 for Patient's Global Assessment of Arthritis

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.001

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Week 8
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Treatment as fixed effect and baseline as covariate
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Threshold for statistical significance p<0.05

Statistical Analysis 3 for Patient's Global Assessment of Arthritis

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.096

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Week 12
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Treatment as fixed effect and baseline as covariate
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Threshold for statistical significance p<0.05

Statistical Analysis 4 for Patient's Global Assessment of Arthritis

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.338

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Week 16
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Treatment as fixed effect and baseline as covariate
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Threshold for statistical significance p<0.05

Statistical Analysis 5 for Patient's Global Assessment of Arthritis

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.832

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Week 20
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Treatment as fixed effect and baseline as covariate
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Threshold for statistical significance p<0.05

Statistical Analysis 6 for Patient's Global Assessment of Arthritis

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.972

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Week 24
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Treatment as fixed effect and baseline as covariate
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Threshold for statistical significance p<0.05

Measure Type	Secondary
Measure Title	Physician's Global Assessment of Arthritis at Final Visit
Measure Description	Physician assessed each participant's disease symptoms on a categorical scale from 1 (very good) to 5 (very poor).
Time Frame	Period III (22 weeks)
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent to treat (ITT) population included subjects who were randomized and received at least one dose of double blind study medication

Reporting Groups

	Description
Celecoxib 200mg Continuous Use	Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
Celecoxib 200mg Intermittent Use	Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.

Measured Values

	Celecoxib 200mg Continuous Use	Celecoxib 200mg Intermittent Use
Number of Participants Analyzed [units: participants]	431	427
Physician's Global Assessment of Arthritis at Final Visit [units: participants]
Grade 1 (very good)	68	39
Grade 2 (good)	242	244
Grade 3 (fair)	91	113
Grade 4 (poor)	23	27
Grade 5 (very poor)	2	2

Statistical Analysis 1 for Physician's Global Assessment of Arthritis at Final Visit

Groups ^[1]	All groups
Method ^[2]	Cochran-Mantel-Haenszel
P Value ^[3]	0.0046

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Test of row mean score differences based on modified ridits (standardizing the mid-rank)
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Overall p-value Threshold for statistical significance p<0.05

Measure Type	Secondary
Measure Title	Total Rescue Medication Taken (Mean)
Measure Description	Total amount of rescue medication (acetaminophen in milligrams [mg]) taken per month per participant
Time Frame	Period III (22 weeks)
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

Intent to treat (ITT) population included subjects who were randomized and received at least one dose of double blind study medication.

Subjects who did not take rescue medication were assumed to have taken 0mg and were included in the analysis.

Number of subjects taking rescue medication: continuous use n=220; intermittent use n=239.

Reporting Groups

	Description
Celecoxib 200mg Continuous Use	Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
Celecoxib 200mg Intermittent Use	Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.

Measured Values

	Celecoxib 200mg Continuous Use	Celecoxib 200mg Intermittent Use
Number of Participants Analyzed [units: participants]	431	427
Total Rescue Medication Taken (Mean) [units: mg taken per month per participant] Mean ± Standard Deviation	1566 ± 4840	2428 ± 4974

Statistical Analysis 1 for Total Rescue Medication Taken (Mean)

Groups ^[1]	All groups
Method ^[2]	ANOVA
P Value ^[3]	0.0102

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Treatment as fixed effect
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Threshold for statistical significance p<0.05

Measure Type	Secondary
Measure Title	Proportion of Days on Rescue Medication
Measure Description	Days on rescue medication divided by number of days on study medication in Period III
Time Frame	Period III (22 weeks)
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

Intent to treat (ITT) population included subjects who were randomized and received at least one dose of double blind study medication. Number of subjects taking rescue medication: continuous use n=220; intermittent use n=239.

Subjects who did not take rescue medication were calculated as 0 and included in the analysis.

Reporting Groups

	Description
Celecoxib 200mg Continuous Use	Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
Celecoxib 200mg Intermittent Use	Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.

Measured Values

	Celecoxib 200mg Continuous Use	Celecoxib 200mg Intermittent Use
Number of Participants Analyzed [units: participants]	431	427
Proportion of Days on Rescue Medication [units: proportion of days] Mean ± Standard Deviation	0.044 ± 0.102	0.069 ± 0.121

Statistical Analysis 1 for Proportion of Days on Rescue Medication

Groups ^[1]	All groups
Method ^[2]	ANOVA
P Value ^[3]	0.0012

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Treatment as fixed effect
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Threshold for statistical significance p<0.05

Measure Type	Secondary
Measure Title	Days on Flare Medication
Measure Description	Number of days on flare medication per month per subject calculated as number of days on flare medication divided by the number of days on study medication in Period III
Time Frame	Period III (22 weeks)
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

Intent to treat (ITT) population included subjects who were randomized and received at least one dose of double blind study medication.

Subjects who did not take flare medication were calculated as 0 and included in the analysis.

Number of subjects taking flare medication: continuous use n=282; intermittent use n=339.

Reporting Groups

	Description
Celecoxib 200mg Continuous Use	Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
Celecoxib 200mg Intermittent Use	Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.

Measured Values

	Celecoxib 200mg Continuous Use	Celecoxib 200mg Intermittent Use
Number of Participants Analyzed [units: participants]	431	427
Days on Flare Medication [units: days on medication per month per subject] Mean ± Standard Deviation	6.589 ± 8.589	9.793 ± 9.253

Statistical Analysis 1 for Days on Flare Medication

Groups ^[1]	All groups
Method ^[2]	ANOVA
P Value ^[3]	<0.0001

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Treatment as fixed effect
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Threshold for statistical significance p<0.05

Measure Type	Secondary
Measure Title	Change in Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Scores
Measure Description	Score at end of Period III minus score at start of Period III. WOMAC assesses subject responses to 24 components regarding subscales of pain, stiffness and physical function (score range: 0=none to 4= extreme). Total score is sum of the 3 subscale scores. Negative change indicates improvement.
Time Frame	Period III (22 weeks)
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent to treat (ITT) population included subjects who were randomized and received at least one dose of double blind study medication. Number of subjects evaluable: continuous use Period III start n=428, end n=427; intermittent use Period III start n=424, end n=424

Reporting Groups

	Description
Celecoxib 200mg Continuous Use	Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
Celecoxib 200mg Intermittent Use	Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.

Measured Values

	Celecoxib 200mg Continuous Use	Celecoxib 200mg Intermittent Use
Number of Participants Analyzed [units: participants]	431	427
Change in Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Scores [units: scores on a scale] Least Squares Mean ± Standard Error
Total WOMAC score	1.60 ± 0.71	4.99 ± 0.71
WOMAC pain subscale	0.37 ± 0.15	1.18 ± 0.15
WOMAC stiffness subscale	0.12 ± 0.07	0.40 ± 0.07
WOMAC physical function subscale	1.13 ± 0.51	3.43 ± 0.51

Statistical Analysis 1 for Change in Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Scores

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	<0.001

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Total WOMAC score
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Treatment as fixed effect and baseline as covariate
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Threshold for statistical significance p<0.05

Statistical Analysis 2 for Change in Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Scores

Groups ^[1]	Celecoxib 200mg Continuous Use
Mean Difference (Final Values) ^[2]	1.60
Standard Error of the mean	± 0.71
95% Confidence Interval	( 0.21 to 2.99 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Total WOMAC score - Continuous use
[2]	Other relevant estimation information:
	Change in LSmean (score at end of Period III minus score at start of Period III)

Statistical Analysis 3 for Change in Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Scores

Groups ^[1]	Celecoxib 200mg Intermittent Use
Mean Difference (Final Values) ^[2]	4.99
Standard Error of the mean	± 0.71
95% Confidence Interval	( 3.60 to 6.38 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Total WOMAC score - Intermittent use
[2]	Other relevant estimation information:
	Change in LSmean (score at end of Period III minus score at start of Period III)

Statistical Analysis 4 for Change in Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Scores

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	<0.001

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	WOMAC pain subscale
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Treatment as fixed effect and baseline as covariate
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Threshold for statistical significance p<0.05

Statistical Analysis 5 for Change in Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Scores

Groups ^[1]	Celecoxib 200mg Continuous Use
Mean Difference (Final Values) ^[2]	0.37
Standard Error of the mean	± 0.15
95% Confidence Interval	( 0.06 to 0.67 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	WOMAC pain subscale - Continuous use
[2]	Other relevant estimation information:
	Change in LSmean (score at end of Period III minus score at start of Period III)

Statistical Analysis 6 for Change in Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Scores

Groups ^[1]	Celecoxib 200mg Intermittent Use
Mean Difference (Final Values) ^[2]	1.18
Standard Error of the mean	± 0.15
95% Confidence Interval	( 0.88 to 1.49 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	WOMAC pain subscale - Intermittent use
[2]	Other relevant estimation information:
	Change in LSmean (score at end of Period III minus score at start of Period III)

Statistical Analysis 7 for Change in Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Scores

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.004

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	WOMAC stiffness subscale
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Treatment as fixed effect and baseline as covariate
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Threshold for statistical significance p<0.05

Statistical Analysis 8 for Change in Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Scores

Groups ^[1]	Celecoxib 200mg Continuous Use
Mean Difference (Final Values) ^[2]	0.12
Standard Error of the mean	± 0.07
95% Confidence Interval	( -0.02 to 0.25 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	WOMAC stiffness subscale - Continuous use
[2]	Other relevant estimation information:
	Change in LSmean (score at end of Period III minus score at start of Period III)

Statistical Analysis 9 for Change in Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Scores

Groups ^[1]	Celecoxib 200mg Intermittent Use
Mean Difference (Final Values) ^[2]	0.40
Standard Error of the mean	± 0.07
95% Confidence Interval	( 0.26 to 0.53 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	WOMAC stiffness subscale - Intermittent use
[2]	Other relevant estimation information:
	Change in LSmean (score at end of Period III minus score at start of Period III)

Statistical Analysis 10 for Change in Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Scores

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.002

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	WOMAC physical function subscale
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Treatment as fixed effect and baseline as covariate
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Threshold for statistical significance p<0.05

Statistical Analysis 11 for Change in Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Scores

Groups ^[1]	Celecoxib 200mg Continuous Use
Mean Difference (Final Values) ^[2]	1.13
Standard Error of the mean	± 0.51
95% Confidence Interval	( 0.13 to 2.14 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	WOMAC physical function subscale - Continuous use
[2]	Other relevant estimation information:
	Change in LSmean (score at end of Period III minus score at start of Period III)

Statistical Analysis 12 for Change in Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Scores

Groups ^[1]	Celecoxib 200mg Intermittent Use
Mean Difference (Final Values) ^[2]	3.43
Standard Error of the mean	± 0.51
95% Confidence Interval	( 2.42 to 4.43 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	WOMAC physical function subscale - Intermittent use
[2]	Other relevant estimation information:
	Change in LSmean (score at end of Period III minus score at start of Period III)

Measure Type	Secondary
Measure Title	Area Under the Curve (AUCs) of Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Scores
Measure Description	WOMAC assesses subject responses to 24 components regarding subscales of pain, stiffness and physical function (score range: 0=none to 4= extreme). Total score is sum of the 3 subscale scores. Scores analyzed as area under the curve (AUC) of participant's WOMAC scores from each assessment in Period III.
Time Frame	Period III (22 weeks)
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

Intent to treat (ITT) population included subjects who were randomized and received at least one dose of double blind study medication.

Number of subjects evaluable: continuous use Period III start n=428, end n=427; intermittent use Period III start n=424, end n=424

Reporting Groups

	Description
Celecoxib 200mg Continuous Use	Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
Celecoxib 200mg Intermittent Use	Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.

Measured Values

	Celecoxib 200mg Continuous Use	Celecoxib 200mg Intermittent Use
Number of Participants Analyzed [units: participants]	431	427
Area Under the Curve (AUCs) of Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Scores [units: scores on a scale * weeks] Mean ± Standard Deviation
Total WOMAC score	604.9 ± 313.10	693.6 ± 317.30
WOMAC pain subscale	119.2 ± 63.36	138.4 ± 65.95
WOMAC stiffness subscale	54.5 ± 27.57	62.1 ± 27.7
WOMAC physical function subscale	431.4 ± 229.38	493.6 ± 230.74

Statistical Analysis 1 for Area Under the Curve (AUCs) of Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Scores

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	<0.001

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	WOMAC total score
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Treatment as fixed effect and baseline as covariate
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Threshold for statistical significance p<0.05

Statistical Analysis 2 for Area Under the Curve (AUCs) of Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Scores

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	<0.001

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	WOMAC pain subscale
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Treatment as fixed effect and baseline as covariate
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Threshold for statistical significance p<0.05

Statistical Analysis 3 for Area Under the Curve (AUCs) of Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Scores

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	<0.001

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	WOMAC stiffness subscale
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Treatment as fixed effect and baseline as covariate
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Threshold for statistical significance p<0.05

Statistical Analysis 4 for Area Under the Curve (AUCs) of Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Scores

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	<0.001

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	WOMAC physical function subscale
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Treatment as fixed effect and baseline as covariate
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Threshold for statistical significance p<0.05

Measure Type	Other Pre-specified
Measure Title	Change in Medical Outcomes Study Sleep Scale - All Assessments
Measure Description	Subject assessment on 7 sleep associated categories. Raw scores are transformed to a 0-100 scale. Higher score indicates more of the outcome (e.g. more snoring, more adequate sleep). Score at end of Period III minus score at start of Period III.
Time Frame	Period III
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent to treat (ITT) population included subjects who were randomized and received at least one dose of double blind study medication. Subjects assessed per scale n=continuous use (cont); n=intermittent use (inter)

Reporting Groups

	Description
Celecoxib 200mg Continuous Use	Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
Celecoxib 200mg Intermittent Use	Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.

Measured Values

	Celecoxib 200mg Continuous Use	Celecoxib 200mg Intermittent Use
Number of Participants Analyzed [units: participants]	431	427
Change in Medical Outcomes Study Sleep Scale - All Assessments [units: scores on a scale] Mean ± Standard Deviation
Sleep disturbance (n=415 cont; n=410 inter)	0.5 ± 15.95	-1.4 ± 15.55
Snoring (n=415 cont; n=412 inter)	0.9 ± 22.36	0.7 ± 21.73
Awaken short of breath (n=417 cont; n=411 inter)	1.9 ± 16.14	1.1 ± 20.00
Quantity of sleep (n=417 cont; n=413 inter)	-0.1 ± 0.91	-0.1 ± 0.89
Sleep adequacy (n=416 cont; n=413 inter)	0.1 ± 24.47	-1.3 ± 22.26
Somnolence (n=416 cont; n=413 inter)	1.4 ± 14.55	0.6 ± 13.70
Sleep problems index I (n=416 cont; n=410 inter)	0.9 ± 13.20	0.5 ± 13.18
Sleep problems index II (n=413 cont; n=408 inter)	0.7 ± 12.29	-0.1 ± 12.14

Statistical Analysis 1 for Change in Medical Outcomes Study Sleep Scale - All Assessments

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.2712

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Sleep disturbance
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Treatment as fixed effect and baseline as covariate
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Threshold for statistical significance p<0.05

Statistical Analysis 2 for Change in Medical Outcomes Study Sleep Scale - All Assessments

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.8737

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Snoring
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Treatment as fixed effect and baseline as covariate
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Threshold for statistical significance p<0.05

Statistical Analysis 3 for Change in Medical Outcomes Study Sleep Scale - All Assessments

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.7703

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Awaken short of breath
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Treatment as fixed effect and baseline as covariate
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Threshold for statistical significance p<0.05

Statistical Analysis 4 for Change in Medical Outcomes Study Sleep Scale - All Assessments

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.3769

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Quantity of sleep
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Treatment as fixed effect and baseline as covariate
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Threshold for statistical significance p<0.05

Statistical Analysis 5 for Change in Medical Outcomes Study Sleep Scale - All Assessments

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.4075

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Sleep adequacy
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Treatment as fixed effect and baseline as covariate
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Threshold for statistical significance p<0.05

Statistical Analysis 6 for Change in Medical Outcomes Study Sleep Scale - All Assessments

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.5854

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Somnolence
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Treatment as fixed effect and baseline as covariate
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Threshold for statistical significance p<0.05

Statistical Analysis 7 for Change in Medical Outcomes Study Sleep Scale - All Assessments

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.8358

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Sleep problems index I
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Treatment as fixed effect and baseline as covariate
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Threshold for statistical significance p<0.05

Statistical Analysis 8 for Change in Medical Outcomes Study Sleep Scale - All Assessments

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.5878

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Sleep problems index II
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Treatment as fixed effect and baseline as covariate
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Threshold for statistical significance p<0.05

Measure Type	Other Pre-specified
Measure Title	Medical Outcomes Study Sleep Scale - Number of Participants With Optimal, Mixed and Not Optimal Sleep
Measure Description	Transformed score scale: 1=optimal; 0=not optimal; mixed = both optimal and non-optimal sleep during Period III
Time Frame	Period III
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent to treat (ITT) population included subjects who were randomized and received at least one dose of double blind study medication

Reporting Groups

	Description
Celecoxib 200mg Continuous Use	Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
Celecoxib 200mg Intermittent Use	Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.

Measured Values

	Celecoxib 200mg Continuous Use	Celecoxib 200mg Intermittent Use
Number of Participants Analyzed [units: participants]	431	427
Medical Outcomes Study Sleep Scale - Number of Participants With Optimal, Mixed and Not Optimal Sleep [units: participants]
Optimal (all scores are 1)	139	123
Mixed (scores are both 1 and 0)	166	165
Not optimal (all scores are 0)	115	132

Statistical Analysis 1 for Medical Outcomes Study Sleep Scale - Number of Participants With Optimal, Mixed and Not Optimal Sleep

Groups ^[1]	All groups
Method ^[2]	Cochran-Mantel-Haenszel
P Value ^[3]	0.1437

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Analysis across all 3 sleep scores for Period III
[2]	Other relevant information, such as adjustments or degrees of freedom:
	by general association
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Threshold for statistical significance p<0.05

Measure Type	Other Pre-specified
Measure Title	Change in the Quality of Life Short Form-12v2 (SF-12v2) Scale Scores - All Assessments
Measure Description	SF-12v2 is a 12 item health survey covering 7 topics. Raw scores are transformed to a 0 to 100 scale. Higher scores indicate better state of health. Score at end of Period III minus score at start of Period III.
Time Frame	Period III
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

Intent to treat (ITT) population included subjects who were randomized and received at least one dose of double blind study medication.

Subjects assessed per scale n=continuous use (cont); n=intermittent use (inter)

Reporting Groups

	Description
Celecoxib 200mg Continuous Use	Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
Celecoxib 200mg Intermittent Use	Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.

Measured Values

	Celecoxib 200mg Continuous Use	Celecoxib 200mg Intermittent Use
Number of Participants Analyzed [units: participants]	431	427
Change in the Quality of Life Short Form-12v2 (SF-12v2) Scale Scores - All Assessments [units: scores on a scale] Mean ± Standard Deviation
Physical function (n=417 cont; n=413 inter)	1.8 ± 23.03	-3.2 ± 22.77
Role physical (n=416 cont; n=412 inter)	3.5 ± 19.93	-1.1 ± 20.07
Bodily pain (n=417 cont; n=414 inter)	3.8 ± 20.11	-0.3 ± 21.56
General health (n=417 cont; n=414 inter)	-0.3 ± 17.60	-0.8 ± 17.27
Vitality (n=416 cont; n=414 inter)	0.3 ± 20.43	-3.5 ± 18.34
Social functioning (n=416 cont; n=414 inter)	-1.9 ± 20.16	-3.5 ± 22.37
Role emotional (n=417 cont; n=413 inter)	-0.7 ± 18.62	-2.1 ± 19.80
Mental health (n=416 cont; n=413 inter)	-0.9 ± 15.57	-1.3 ± 16.05
Physical component summary(n=416 cont;n=411 inter)	9.0 ± 55.55	-5.2 ± 57.48
Mental component summary (n=416 cont;n=411 inter)	-3.1 ± 51.59	-10.5 ± 55.66

Statistical Analysis 1 for Change in the Quality of Life Short Form-12v2 (SF-12v2) Scale Scores - All Assessments

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	<0.0001

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Physical function
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Treatment as fixed effect and baseline as covariate
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Threshold for statistical significance p<0.05

Statistical Analysis 2 for Change in the Quality of Life Short Form-12v2 (SF-12v2) Scale Scores - All Assessments

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	<0.0001

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Role physical
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Treatment as fixed effect and baseline as covariate
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Threshold for statistical significance p<0.05

Statistical Analysis 3 for Change in the Quality of Life Short Form-12v2 (SF-12v2) Scale Scores - All Assessments

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	<0.0001

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Bodily pain
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Treatment as fixed effect and baseline as covariate
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Threshold for statistical significance p<0.05

Statistical Analysis 4 for Change in the Quality of Life Short Form-12v2 (SF-12v2) Scale Scores - All Assessments

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.3097

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	General health
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Treatment as fixed effect and baseline as covariate
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Threshold for statistical significance p<0.05

Statistical Analysis 5 for Change in the Quality of Life Short Form-12v2 (SF-12v2) Scale Scores - All Assessments

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.0139

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Vitality
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Treatment as fixed effect and baseline as covariate
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Threshold for statistical significance p<0.05

Statistical Analysis 6 for Change in the Quality of Life Short Form-12v2 (SF-12v2) Scale Scores - All Assessments

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.1303

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Social functioning
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Treatment as fixed effect and baseline as covariate
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Threshold for statistical significance p<0.05

Statistical Analysis 7 for Change in the Quality of Life Short Form-12v2 (SF-12v2) Scale Scores - All Assessments

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.1404

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Role emotional
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Treatment as fixed effect and baseline as covariate
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Threshold for statistical significance p<0.05

Statistical Analysis 8 for Change in the Quality of Life Short Form-12v2 (SF-12v2) Scale Scores - All Assessments

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.4015

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Mental health
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Treatment as fixed effect and baseline as covariate
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Threshold for statistical significance p<0.05

Statistical Analysis 9 for Change in the Quality of Life Short Form-12v2 (SF-12v2) Scale Scores - All Assessments

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	<0.0001

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Physical component summary
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Treatment as fixed effect and baseline as covariate
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Threshold for statistical significance p<0.05

Statistical Analysis 10 for Change in the Quality of Life Short Form-12v2 (SF-12v2) Scale Scores - All Assessments

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.0301

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Mental component summary
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Treatment as fixed effect and baseline as covariate
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Threshold for statistical significance p<0.05

Measure Type	Other Pre-specified
Measure Title	Serious Adverse Events in Open Label run-in Period
Measure Description	Serious adverse events occuring during the 2 week run-in period (Period II) when all participants were dosed with celecoxib 200 mg daily
Time Frame	2 weeks prior to double blind dosing
Safety Issue	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
1197 participants entered the open-label run-in (period II) to allow observation of successful treatment of an osteoarthritis flare. 875 participants were randomized to double blind treatment (period III). 322 participants were not randomized.

Reporting Groups

	Description
Celecoxib 200mg Open Label	Period II run-in (2 weeks). Celecoxib 200 mg daily until resolution of screening osteoarthritis flare as defined by IVRS

Measured Values

	Celecoxib 200mg Open Label
Number of Participants Analyzed [units: participants]	1197
Serious Adverse Events in Open Label run-in Period [units: participants]
Anaemia	1
Vitreous haemorrhage	1

No statistical analysis provided for Serious Adverse Events in Open Label run-in Period

Responsible Party:	Pfizer ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A3191173
Study First Received:	August 29, 2005
Results First Received:	February 20, 2009
Last Updated:	June 24, 2009
ClinicalTrials.gov Identifier:	NCT00139776 History of Changes
Health Authority:	United States: Food and Drug Administration