Ankylosing Spondylitis
Conditions
Brief summary
This is a local, multicenter, randomized, active comparator, double-blind, parallel group study with extension will be conducted to evaluate the efficacy and safety of celecoxib versus diclofenac SR in the treatment of Chinese patients with Ankylosing Spondylitis (AS).
Interventions
DRUGCelecoxib
capsule, 200 mg QD, 6-12 weeks
DRUGDiclofenac SR
tablet, 75 mg QD,6-12 weeks
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Meet the 1984 Modified New York Criteria for Classification of Ankylosing Spondylitis * With axial involvement * Without peripheral joint involvement (synovitis) at the time of study entry, (excluding involvement of the hips, knees and shoulders) * Need for daily treatment with NSAIDs during the previous 30 days before study entry
Exclusion criteria
* Known inflammatory enteropathy (eg, ulcerative colitis, Crohn's disease, etc) * Presence of extra-articular manifestations (eg, uveitis, endocarditis, etc.) * Known vertebral compression * Need for a corset during the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Participant's Assessment of Global Pain Intensity at Week 6 | Baseline, Week 6 | 100-millimeter (mm) Visual Analog Scale (VAS) score specified participant's assessment of overall pain intensity in the previous 48 hours, in response to the following question What has been your global pain intensity in the last 48 hours? 0=no pain to 100=worst pain. Change from baseline of less than (\<) 0 indicated improvement. |
| Participant's Assessment of Global Pain Intensity at Baseline | Baseline | 100-mm VAS scores specified participant's assessment of global pain intensity in the previous 48 hours, in response to the following question What has been your global pain intensity in the last 48 hours? 0=no pain to 100=worst pain. Lower scores indicated less pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Participant's Global Assessment of Disease Activity at Weeks 2, 4, and 6 | Baseline, Weeks 2, 4, 6 | 5-point Likert scale scores specified participant's current situation in response to the following question Considering all the ways your Ankylosing Spondylitis affects you, how are you doing today? 1=very good to 5=very poor. Change from baseline \<0 indicated improvement. |
| Change From Baseline in Participant's Global Assessment of Disease Activity at Week 12 | Baseline, Week 12 | 5-point Likert scale scores specified participant's current situation in response to the following question Considering all the ways your Ankylosing Spondylitis affects you, how are you doing today? 1=very good to 5=very poor. Lower scores indicated better health. Change from baseline \<0 indicated improvement. |
| Change From Baseline in Physician's Global Assessment of Disease Activity at Weeks 2, 4, and 6 | Baseline, Weeks 2, 4, 6 | 5-point Likert scale scores specified physician's subjective assessment on how overall ankylosing spondylitis appeared at the time of participant's visit and participant's disease signs. 1=very good to 5=very poor. Change from baseline \<0 indicated improvement. |
| Change From Baseline in Physician's Global Assessment of Disease Activity at Week 12 | Baseline, Week 12 | 5-point Likert scale scores specified physician's subjective assessment on how the overall ankylosing spondylitis appeared at the time of the participant's visit and participant's disease signs. 1=very good to 5=very poor. Lower scores indicated better health. Change from baseline \<0 indicated improvement. |
| Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Weeks 2, 4, and 6 | Baseline, Weeks 2, 4, 6 | Bath Ankylosing Spondylitis Functional Index (BASFI) was comprised of 10 specific questions, each answered on a 10-mm VAS scale. 0=easy to 10=impossible. BASFI score was defined as the mean of the scaled responses to these 10 questions. Change from baseline \<0 indicated improvement. |
| Change From Baseline in BASFI at Week 12 | Baseline, Week 12 | BASFI was comprised of 10 specific questions, each answered on a 10-mm VAS scale. 0=easy to 10=impossible. BASFI score was defined as the mean of the scaled responses to these 10 questions. Lower scores indicated better functional health. Change from baseline \<0 indicated improvement. |
| Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Weeks 2, 4, and 6 | Baseline, Weeks 2, 4, 6 | Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) was comprised of 6 specific questions, each answered on a 10-mm VAS scale. Scores for the first 5 questions: 0=none to 10=severe. Score for the sixth question: 0=0 hours to 10=2 hours. BASDAI score was defined as the mean of the scaled responses to these 6 questions. Change from baseline \<0 indicated improvement. |
| Change From Baseline in BASDAI at Week 12 | Baseline, Week 12 | BASDAI is comprised of 6 specific questions, each answered on a 10-mm VAS. Scores for the first 5 questions: 0=none to 10=severe. Score for the sixth question: 0=0 hours to 10=2 hours. BASDAI score was defined as the mean of the scaled responses to these 6 questions. Lower scores indicated better health. Change from baseline \<0 indicated improvement. |
| Percentages of Participants Responding to Assessment in Ankylosing Spondylitis (ASAS)-20 | Weeks 2, 4, 6, 12 | Percentages of participants who demonstrated an improvement of greater than or equal to (≥) 20% from baseline and an absolute improvement of ≥10 mm from baseline on a 100-mm VAS in ≥3 of the 4 domains proposed by the Ankylosing Spondylitis Assessment Working Group (ASAS-20). |
| Change From Baseline in CRP at Week 12 | Baseline, Week 12 | CRP was a marker of inflammation. Lower values indicated better health. Change from baseline \<0 indicated improvement. |
| Change From Baseline in Nocturnal Pain at Weeks 2, 4, and 6 | Baseline, Weeks 2, 4, 6 | 100-mm VAS scores specified participant's nocturnal pain in response to the following question Did you have any pain in the neck, back or hips during the previous night? 0=no pain to 100=worst pain possible. Change from baseline \<0 indicated improvement. |
| Change From Baseline in Participant's Assessment of Global Pain Intensity at Weeks 2 and 4 | Baseline, Weeks 2, 4 | 100-mm VAS score specified participant's assessment of overall pain intensity in the previous 48 hours, in response to the following question What has been your global pain intensity in the last 48 hours? 0=no pain to 100=worst pain. Change from baseline of \<0 indicated improvement. |
| Change From Baseline in Fingertips to Floor Distance at Weeks 2, 4, and 6 | Baseline, Weeks 2, 4, 6 | Fingertips to floor distance measured in centimeter (cm) from the tip of the fingers to the floor with participants standing erect and feet together, knees as straight as possible, then bending forward as far as possible with fingers reaching towards the floor. The better of 2 tries was recorded. Change from baseline \<0 indicated improvement. |
| Percentage of Participants With Concomitant Use of Paracetamol | Week 6 | Percentage of participants who concomitantly took at least 1 paracetamol tablet as rescue medication at Week 6 |
| Percentage of Days With Concomitant Administration of Paracetamol | Week 6 | Calculated as days on rescue medication divided by days of exposure in the study at the end of Week 6. |
| Paracetamol Tablets Taken Per Day by Participant | Week 6 | Calculated as the total number of paracetamol tablets taken divided by days of exposure in the study. |
| Change From Baseline in Fingertips to Floor Distance at Week 12 | Baseline, Week 12 | Fingertips to floor distance measured in cm from the tip of the fingers to the floor with participant standing erect and feet together, knees as straight as possible, then bending forward as far as possible with fingers reaching towards the floor. The better of 2 tries was recorded. Lower scores indicated better health. Change from baseline \<0 represented improvement. |
| Change From Baseline in Chest Expansion at Weeks 2, 4, and 6 | Baseline, Weeks 2, 4, 6 | Chest expansion, measured in cm, is defined as the difference in thoracic circumference during full expiration versus full inspiration, measured at the fourth intercostal space (nipple line). The better of 2 tries was recorded. Change from baseline greater than (\>) 0 represented improvement. |
| Change From Baseline in Chest Expansion at Week 12 | Baseline, Week 12 | Chest expansion, measured in cm, is defined as the difference in thoracic circumference during full expiration versus full inspiration, measured at the fourth intercostal space (nipple line). The better of 2 tries was recorded. Higher scores indicate better health. Change from baseline greater than (\>) 0 represented improvement. |
| Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 6 | Baseline, Week 6 | Erythrocyte Sedimentation Rate (ESR) was a laboratory test that providee a non-specific measure of inflammation. The test assessed the rate at which red blood cells fell in a test tube and was measured in millimeter per hour (mm/h). Change from baseline \<0 indicated improvement. |
| Change From Baseline in ESR at Week 12 | Baseline, Week 12 | ESR was a laboratory test that provided a non-specific measure of inflammation. The test assessed the rate at which red blood cells fell in a test tube. Lower values indicated better health. Change from baseline \<0 indicated improvement. |
| Change From Baseline in C-Reactive Protein (CRP) at Week 6 | Baseline, 6 Weeks | C-Reactive Protein (CRP) was a marker of inflammation, measured in milligram per liter (mg/L). Change from baseline \<0 indicated improvement. |
| Change From Baseline in Nocturnal Pain at Week 12 | Baseline, Week 12 | 100-mm VAS scores specified participant's nocturnal pain in response to the following question Did you have any pain in the neck, back or hips during the previous night? 0=no pain to 100=worst pain possible. Lower scores indicated less pain. Change from baseline \<0 indicated improvement. |
| Change From Baseline in Participant's Assessment of Global Pain Intensity at Week 12 | Baseline, Week 12 | 100-mm VAS score specified participant's assessment of overall pain intensity in the previous 48 hours, in response to the following question What has been your global pain intensity in the last 48 hours? 0=no pain to 100=worst pain. Lower scores indicated less pain. Change from baseline of \<0 indicated improvement. |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Celecoxib 200 mg Celecoxib 200 mg capsule once daily | 120 |
| Diclofenac SR 75 mg Diclofenac SR 75 mg tablet once daily | 120 |
| Total | 240 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Double-blind Phase (Baseline to Week 6) | Adverse Event | 2 | 4 | 0 | 0 |
| Double-blind Phase (Baseline to Week 6) | Insufficient clinical response | 2 | 2 | 0 | 0 |
| Double-blind Phase (Baseline to Week 6) | No longer willing to participate | 3 | 4 | 0 | 0 |
| Enrollment in Extension Phase (Week 6) | Did not sign 2nd informed consent form | 4 | 1 | 0 | 0 |
| Extension Phase (Week 6 to Week 12) | Insufficient clinical response | 1 | 1 | 0 | 1 |
| Extension Phase (Week 6 to Week 12) | Lost to Follow-up | 1 | 0 | 1 | 0 |
| Extension Phase (Week 6 to Week 12) | No longer willing to participate | 1 | 0 | 3 | 0 |
| Extension Phase (Week 6 to Week 12) | Other | 0 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Celecoxib 200 mg | Diclofenac SR 75 mg | Total |
|---|---|---|---|
| Age, Customized 18 - 44 years | 109 participants | 109 participants | 218 participants |
| Age, Customized 45 - 64 years | 11 participants | 11 participants | 22 participants |
| Sex: Female, Male Female | 15 Participants | 19 Participants | 34 Participants |
| Sex: Female, Male Male | 105 Participants | 101 Participants | 206 Participants |
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 |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 11 / 120 | 9 / 120 | 0 / 54 | 6 / 55 | 5 / 53 | 6 / 54 |
| serious Total, serious adverse events | 0 / 120 | 0 / 120 | 0 / 54 | 0 / 55 | 0 / 53 | 0 / 54 |
Outcome results
Primary
Change From Baseline in Participant's Assessment of Global Pain Intensity at Week 6
100-millimeter (mm) Visual Analog Scale (VAS) score specified participant's assessment of overall pain intensity in the previous 48 hours, in response to the following question What has been your global pain intensity in the last 48 hours? 0=no pain to 100=worst pain. Change from baseline of less than (\<) 0 indicated improvement.
Time frame: Baseline, Week 6
Population: Per-Protocol (PP): All randomized participants who received at least one dose of study medication, and had global pain intensity assessment at Week 6 and no major protocol deviations.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Celecoxib 200 mg | Change From Baseline in Participant's Assessment of Global Pain Intensity at Week 6 | -23.8 mm | Standard Error 1.98 |
| Diclofenac SR 75 mg | Change From Baseline in Participant's Assessment of Global Pain Intensity at Week 6 | -27.1 mm | Standard Error 2.02 |
Comparison: Null hypothesis: Least Squares (LS) mean difference between Celecoxib 200 mg once daily versus Diclofenac SR 75 mg once daily on change in Global Pain Intensity from baseline to Week 6 was at least 10 mm. Corresponding alternative hypothesis: This difference was \<10 mm.~For the non-inferiority test, power was 80% and significance level was 0.025 (1-sided).p-value: 0.008595% CI: [-2.2, 8.8]ANCOVA
Primary
Participant's Assessment of Global Pain Intensity at Baseline
100-mm VAS scores specified participant's assessment of global pain intensity in the previous 48 hours, in response to the following question What has been your global pain intensity in the last 48 hours? 0=no pain to 100=worst pain. Lower scores indicated less pain.
Time frame: Baseline
Population: PP
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Celecoxib 200 mg | Participant's Assessment of Global Pain Intensity at Baseline | 62.9 mm | Standard Deviation 12.68 |
| Diclofenac SR 75 mg | Participant's Assessment of Global Pain Intensity at Baseline | 63.6 mm | Standard Deviation 13.38 |
Secondary
Change From Baseline in BASDAI at Week 12
BASDAI is comprised of 6 specific questions, each answered on a 10-mm VAS. Scores for the first 5 questions: 0=none to 10=severe. Score for the sixth question: 0=0 hours to 10=2 hours. BASDAI score was defined as the mean of the scaled responses to these 6 questions. Lower scores indicated better health. Change from baseline \<0 indicated improvement.
Time frame: Baseline, Week 12
Population: FAS. n = evaluable participants at that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Celecoxib 200 mg | Change From Baseline in BASDAI at Week 12 | Baseline (n=55, 55, 54, 54) | 4.71 mm | Standard Deviation 1.79 |
| Celecoxib 200 mg | Change From Baseline in BASDAI at Week 12 | Change from Baseline at Week 12 (n=52, 54, 46, 51) | -1.7 mm | Standard Deviation 1.86 |
| Diclofenac SR 75 mg | Change From Baseline in BASDAI at Week 12 | Change from Baseline at Week 12 (n=52, 54, 46, 51) | -2.1 mm | Standard Deviation 1.94 |
| Diclofenac SR 75 mg | Change From Baseline in BASDAI at Week 12 | Baseline (n=55, 55, 54, 54) | 4.9 mm | Standard Deviation 1.8 |
| Celecoxib 200 mg, Then Celecoxib 400 mg | Change From Baseline in BASDAI at Week 12 | Baseline (n=55, 55, 54, 54) | 4.7 mm | Standard Deviation 1.48 |
| Celecoxib 200 mg, Then Celecoxib 400 mg | Change From Baseline in BASDAI at Week 12 | Change from Baseline at Week 12 (n=52, 54, 46, 51) | -0.6 mm | Standard Deviation 1.87 |
| Diclofenac SR 75 mg, Then Celecoxib 400 mg | Change From Baseline in BASDAI at Week 12 | Baseline (n=55, 55, 54, 54) | 4.9 mm | Standard Deviation 1.88 |
| Diclofenac SR 75 mg, Then Celecoxib 400 mg | Change From Baseline in BASDAI at Week 12 | Change from Baseline at Week 12 (n=52, 54, 46, 51) | -1.4 mm | Standard Deviation 2.14 |
Secondary
Change From Baseline in BASFI at Week 12
BASFI was comprised of 10 specific questions, each answered on a 10-mm VAS scale. 0=easy to 10=impossible. BASFI score was defined as the mean of the scaled responses to these 10 questions. Lower scores indicated better functional health. Change from baseline \<0 indicated improvement.
Time frame: Baseline, Week 12
Population: FAS. n = evaluable participants at that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Celecoxib 200 mg | Change From Baseline in BASFI at Week 12 | Change from Baseline at Week 12 (n=52, 54, 46, 51) | -0.9 mm | Standard Deviation 1.78 |
| Celecoxib 200 mg | Change From Baseline in BASFI at Week 12 | Baseline (n=55, 55, 54, 54) | 3.4 mm | Standard Deviation 1.98 |
| Diclofenac SR 75 mg | Change From Baseline in BASFI at Week 12 | Baseline (n=55, 55, 54, 54) | 3.5 mm | Standard Deviation 2.13 |
| Diclofenac SR 75 mg | Change From Baseline in BASFI at Week 12 | Change from Baseline at Week 12 (n=52, 54, 46, 51) | -1.0 mm | Standard Deviation 1.64 |
| Celecoxib 200 mg, Then Celecoxib 400 mg | Change From Baseline in BASFI at Week 12 | Change from Baseline at Week 12 (n=52, 54, 46, 51) | -0.6 mm | Standard Deviation 1.97 |
| Celecoxib 200 mg, Then Celecoxib 400 mg | Change From Baseline in BASFI at Week 12 | Baseline (n=55, 55, 54, 54) | 3.5 mm | Standard Deviation 1.83 |
| Diclofenac SR 75 mg, Then Celecoxib 400 mg | Change From Baseline in BASFI at Week 12 | Change from Baseline at Week 12 (n=52, 54, 46, 51) | -1.0 mm | Standard Deviation 2.3 |
| Diclofenac SR 75 mg, Then Celecoxib 400 mg | Change From Baseline in BASFI at Week 12 | Baseline (n=55, 55, 54, 54) | 3.5 mm | Standard Deviation 2.25 |
Secondary
Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Weeks 2, 4, and 6
Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) was comprised of 6 specific questions, each answered on a 10-mm VAS scale. Scores for the first 5 questions: 0=none to 10=severe. Score for the sixth question: 0=0 hours to 10=2 hours. BASDAI score was defined as the mean of the scaled responses to these 6 questions. Change from baseline \<0 indicated improvement.
Time frame: Baseline, Weeks 2, 4, 6
Population: FAS. N = total evaluable participants. n = evaluable participants at that time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Celecoxib 200 mg | Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Weeks 2, 4, and 6 | Week 2 (n=116, 115) | -0.8 mm | Standard Error 0.14 |
| Celecoxib 200 mg | Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Weeks 2, 4, and 6 | Week 4 (n=117, 115) | -0.9 mm | Standard Error 0.15 |
| Celecoxib 200 mg | Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Weeks 2, 4, and 6 | Week 6 (n=117, 115) | -1.1 mm | Standard Error 0.16 |
| Diclofenac SR 75 mg | Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Weeks 2, 4, and 6 | Week 2 (n=116, 115) | -0.9 mm | Standard Error 0.14 |
| Diclofenac SR 75 mg | Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Weeks 2, 4, and 6 | Week 4 (n=117, 115) | -1.1 mm | Standard Error 0.15 |
| Diclofenac SR 75 mg | Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Weeks 2, 4, and 6 | Week 6 (n=117, 115) | -1.4 mm | Standard Error 0.16 |
Comparison: Change from baseline to Week 2. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.p-value: 0.633595% CI: [-0.3, 0.5]ANCOVA
Comparison: Change from baseline to Week 4. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.p-value: 0.272995% CI: [-0.2, 0.6]ANCOVA
Comparison: Change from baseline to Week 6. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.p-value: 0.155995% CI: [-0.1, 0.8]ANCOVA
Secondary
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Weeks 2, 4, and 6
Bath Ankylosing Spondylitis Functional Index (BASFI) was comprised of 10 specific questions, each answered on a 10-mm VAS scale. 0=easy to 10=impossible. BASFI score was defined as the mean of the scaled responses to these 10 questions. Change from baseline \<0 indicated improvement.
Time frame: Baseline, Weeks 2, 4, 6
Population: FAS. N = total evaluable participants. n = evaluable participants at that time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Celecoxib 200 mg | Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Weeks 2, 4, and 6 | Week 2 (n=116, 115) | -0.3 mm | Standard Error 0.13 |
| Celecoxib 200 mg | Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Weeks 2, 4, and 6 | Week 4 (n=117, 115) | -0.4 mm | Standard Error 0.14 |
| Celecoxib 200 mg | Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Weeks 2, 4, and 6 | Week 6 (n=117, 115) | -0.5 mm | Standard Error 0.15 |
| Diclofenac SR 75 mg | Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Weeks 2, 4, and 6 | Week 2 (n=116, 115) | -0.3 mm | Standard Error 0.13 |
| Diclofenac SR 75 mg | Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Weeks 2, 4, and 6 | Week 4 (n=117, 115) | -0.6 mm | Standard Error 0.14 |
| Diclofenac SR 75 mg | Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Weeks 2, 4, and 6 | Week 6 (n=117, 115) | -0.8 mm | Standard Error 0.15 |
Comparison: Change from baseline to Week 2. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.p-value: 0.935895% CI: [-0.3, 0.4]ANCOVA
Comparison: Change from baseline to Week 4. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.p-value: 0.591695% CI: [-0.3, 0.5]ANCOVA
Comparison: Change from baseline to Week 6. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.p-value: 0.17995% CI: [-0.1, 0.7]ANCOVA
Secondary
Change From Baseline in Chest Expansion at Week 12
Chest expansion, measured in cm, is defined as the difference in thoracic circumference during full expiration versus full inspiration, measured at the fourth intercostal space (nipple line). The better of 2 tries was recorded. Higher scores indicate better health. Change from baseline greater than (\>) 0 represented improvement.
Time frame: Baseline, Week 12
Population: FAS. n = evaluable participants at that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Celecoxib 200 mg | Change From Baseline in Chest Expansion at Week 12 | Baseline (n=55, 55, 54, 54) | 3.9 cm | Standard Deviation 1.93 |
| Celecoxib 200 mg | Change From Baseline in Chest Expansion at Week 12 | Change from Baseline at Week 12 (n=52, 54, 46, 51) | 0.8 cm | Standard Deviation 1.26 |
| Diclofenac SR 75 mg | Change From Baseline in Chest Expansion at Week 12 | Change from Baseline at Week 12 (n=52, 54, 46, 51) | 0.8 cm | Standard Deviation 1.39 |
| Diclofenac SR 75 mg | Change From Baseline in Chest Expansion at Week 12 | Baseline (n=55, 55, 54, 54) | 3.8 cm | Standard Deviation 1.63 |
| Celecoxib 200 mg, Then Celecoxib 400 mg | Change From Baseline in Chest Expansion at Week 12 | Change from Baseline at Week 12 (n=52, 54, 46, 51) | 0.8 cm | Standard Deviation 1.29 |
| Celecoxib 200 mg, Then Celecoxib 400 mg | Change From Baseline in Chest Expansion at Week 12 | Baseline (n=55, 55, 54, 54) | 3.6 cm | Standard Deviation 1.82 |
| Diclofenac SR 75 mg, Then Celecoxib 400 mg | Change From Baseline in Chest Expansion at Week 12 | Baseline (n=55, 55, 54, 54) | 3.8 cm | Standard Deviation 1.62 |
| Diclofenac SR 75 mg, Then Celecoxib 400 mg | Change From Baseline in Chest Expansion at Week 12 | Change from Baseline at Week 12 (n=52, 54, 46, 51) | 0.8 cm | Standard Deviation 1.02 |
Secondary
Change From Baseline in Chest Expansion at Weeks 2, 4, and 6
Chest expansion, measured in cm, is defined as the difference in thoracic circumference during full expiration versus full inspiration, measured at the fourth intercostal space (nipple line). The better of 2 tries was recorded. Change from baseline greater than (\>) 0 represented improvement.
Time frame: Baseline, Weeks 2, 4, 6
Population: FAS. N = total evaluable participants. n = evaluable participants at that time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Celecoxib 200 mg | Change From Baseline in Chest Expansion at Weeks 2, 4, and 6 | Week 2 (n=117, 115) | 0.2 cm | Standard Error 0.08 |
| Celecoxib 200 mg | Change From Baseline in Chest Expansion at Weeks 2, 4, and 6 | Week 4 (n=118, 115) | 0.6 cm | Standard Error 0.09 |
| Celecoxib 200 mg | Change From Baseline in Chest Expansion at Weeks 2, 4, and 6 | Week 6 (n=118, 115) | 0.7 cm | Standard Error 0.1 |
| Diclofenac SR 75 mg | Change From Baseline in Chest Expansion at Weeks 2, 4, and 6 | Week 2 (n=117, 115) | 0.3 cm | Standard Error 0.08 |
| Diclofenac SR 75 mg | Change From Baseline in Chest Expansion at Weeks 2, 4, and 6 | Week 4 (n=118, 115) | 0.4 cm | Standard Error 0.09 |
| Diclofenac SR 75 mg | Change From Baseline in Chest Expansion at Weeks 2, 4, and 6 | Week 6 (n=118, 115) | 0.6 cm | Standard Error 0.1 |
Comparison: Change from baseline to Week 2. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.p-value: 0.87895% CI: [-0.2, 0.2]ANCOVA
Comparison: Change from baseline to Week 4. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.p-value: 0.220295% CI: [-0.1, 0.4]ANCOVA
Comparison: Change from baseline to Week 6. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.p-value: 0.53495% CI: [-0.2, 0.4]ANCOVA
Secondary
Change From Baseline in C-Reactive Protein (CRP) at Week 6
C-Reactive Protein (CRP) was a marker of inflammation, measured in milligram per liter (mg/L). Change from baseline \<0 indicated improvement.
Time frame: Baseline, 6 Weeks
Population: FAS
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Celecoxib 200 mg | Change From Baseline in C-Reactive Protein (CRP) at Week 6 | -4.16 mg/L | Standard Error 1.587 |
| Diclofenac SR 75 mg | Change From Baseline in C-Reactive Protein (CRP) at Week 6 | -2.72 mg/L | Standard Error 1.6 |
Comparison: The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.p-value: 0.518395% CI: [-5.82, 2.94]ANCOVA
Secondary
Change From Baseline in CRP at Week 12
CRP was a marker of inflammation. Lower values indicated better health. Change from baseline \<0 indicated improvement.
Time frame: Baseline, Week 12
Population: FAS. n = evaluable participants at that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Celecoxib 200 mg | Change From Baseline in CRP at Week 12 | Baseline (n=53, 55, 53, 54) | 18.53 mg/L | Standard Deviation 28.749 |
| Celecoxib 200 mg | Change From Baseline in CRP at Week 12 | Change from Baseline at Week 12 (n=47, 49, 42, 47) | -4.58 mg/L | Standard Deviation 9.682 |
| Diclofenac SR 75 mg | Change From Baseline in CRP at Week 12 | Change from Baseline at Week 12 (n=47, 49, 42, 47) | -2.99 mg/L | Standard Deviation 13.242 |
| Diclofenac SR 75 mg | Change From Baseline in CRP at Week 12 | Baseline (n=53, 55, 53, 54) | 15.84 mg/L | Standard Deviation 20.464 |
| Celecoxib 200 mg, Then Celecoxib 400 mg | Change From Baseline in CRP at Week 12 | Baseline (n=53, 55, 53, 54) | 18.80 mg/L | Standard Deviation 25.774 |
| Celecoxib 200 mg, Then Celecoxib 400 mg | Change From Baseline in CRP at Week 12 | Change from Baseline at Week 12 (n=47, 49, 42, 47) | -4.77 mg/L | Standard Deviation 24.656 |
| Diclofenac SR 75 mg, Then Celecoxib 400 mg | Change From Baseline in CRP at Week 12 | Baseline (n=53, 55, 53, 54) | 21.01 mg/L | Standard Deviation 21.36 |
| Diclofenac SR 75 mg, Then Celecoxib 400 mg | Change From Baseline in CRP at Week 12 | Change from Baseline at Week 12 (n=47, 49, 42, 47) | -2.13 mg/L | Standard Deviation 20.879 |
Secondary
Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 6
Erythrocyte Sedimentation Rate (ESR) was a laboratory test that providee a non-specific measure of inflammation. The test assessed the rate at which red blood cells fell in a test tube and was measured in millimeter per hour (mm/h). Change from baseline \<0 indicated improvement.
Time frame: Baseline, Week 6
Population: FAS
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Celecoxib 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 6 | -2.5 mm/h | Standard Error 1.3 |
| Diclofenac SR 75 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 6 | -1.8 mm/h | Standard Error 1.3 |
Comparison: The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.p-value: 0.700395% CI: [-4.3, 2.9]ANCOVA
Secondary
Change From Baseline in ESR at Week 12
ESR was a laboratory test that provided a non-specific measure of inflammation. The test assessed the rate at which red blood cells fell in a test tube. Lower values indicated better health. Change from baseline \<0 indicated improvement.
Time frame: Baseline, Week 12
Population: FAS. n = evaluable participants at that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Celecoxib 200 mg | Change From Baseline in ESR at Week 12 | Baseline (n=54, 54, 52, 54) | 20.9 mm/h | Standard Deviation 14.6 |
| Celecoxib 200 mg | Change From Baseline in ESR at Week 12 | Change from Baseline at Week 12 (n=45, 44, 41, 43) | -3.5 mm/h | Standard Deviation 13.96 |
| Diclofenac SR 75 mg | Change From Baseline in ESR at Week 12 | Change from Baseline at Week 12 (n=45, 44, 41, 43) | -1.3 mm/h | Standard Deviation 11.14 |
| Diclofenac SR 75 mg | Change From Baseline in ESR at Week 12 | Baseline (n=54, 54, 52, 54) | 20.8 mm/h | Standard Deviation 18.98 |
| Celecoxib 200 mg, Then Celecoxib 400 mg | Change From Baseline in ESR at Week 12 | Baseline (n=54, 54, 52, 54) | 22.8 mm/h | Standard Deviation 21.99 |
| Celecoxib 200 mg, Then Celecoxib 400 mg | Change From Baseline in ESR at Week 12 | Change from Baseline at Week 12 (n=45, 44, 41, 43) | -6.3 mm/h | Standard Deviation 13.46 |
| Diclofenac SR 75 mg, Then Celecoxib 400 mg | Change From Baseline in ESR at Week 12 | Baseline (n=54, 54, 52, 54) | 23.6 mm/h | Standard Deviation 19.64 |
| Diclofenac SR 75 mg, Then Celecoxib 400 mg | Change From Baseline in ESR at Week 12 | Change from Baseline at Week 12 (n=45, 44, 41, 43) | -0.7 mm/h | Standard Deviation 19.47 |
Secondary
Change From Baseline in Fingertips to Floor Distance at Week 12
Fingertips to floor distance measured in cm from the tip of the fingers to the floor with participant standing erect and feet together, knees as straight as possible, then bending forward as far as possible with fingers reaching towards the floor. The better of 2 tries was recorded. Lower scores indicated better health. Change from baseline \<0 represented improvement.
Time frame: Baseline, Week 12
Population: FAS. n = evaluable participants at that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Celecoxib 200 mg | Change From Baseline in Fingertips to Floor Distance at Week 12 | Baseline (n=55, 55, 54, 54) | 14.8 cm | Standard Deviation 12.89 |
| Celecoxib 200 mg | Change From Baseline in Fingertips to Floor Distance at Week 12 | Change from Baseline at Week 12 (n=52, 54, 46, 51) | -3.0 cm | Standard Deviation 9.38 |
| Diclofenac SR 75 mg | Change From Baseline in Fingertips to Floor Distance at Week 12 | Change from Baseline at Week 12 (n=52, 54, 46, 51) | -3.7 cm | Standard Deviation 6.82 |
| Diclofenac SR 75 mg | Change From Baseline in Fingertips to Floor Distance at Week 12 | Baseline (n=55, 55, 54, 54) | 17.6 cm | Standard Deviation 15.23 |
| Celecoxib 200 mg, Then Celecoxib 400 mg | Change From Baseline in Fingertips to Floor Distance at Week 12 | Baseline (n=55, 55, 54, 54) | 22.9 cm | Standard Deviation 19.49 |
| Celecoxib 200 mg, Then Celecoxib 400 mg | Change From Baseline in Fingertips to Floor Distance at Week 12 | Change from Baseline at Week 12 (n=52, 54, 46, 51) | -3.1 cm | Standard Deviation 8.18 |
| Diclofenac SR 75 mg, Then Celecoxib 400 mg | Change From Baseline in Fingertips to Floor Distance at Week 12 | Baseline (n=55, 55, 54, 54) | 14.6 cm | Standard Deviation 14.48 |
| Diclofenac SR 75 mg, Then Celecoxib 400 mg | Change From Baseline in Fingertips to Floor Distance at Week 12 | Change from Baseline at Week 12 (n=52, 54, 46, 51) | -1.3 cm | Standard Deviation 7.75 |
Secondary
Change From Baseline in Fingertips to Floor Distance at Weeks 2, 4, and 6
Fingertips to floor distance measured in centimeter (cm) from the tip of the fingers to the floor with participants standing erect and feet together, knees as straight as possible, then bending forward as far as possible with fingers reaching towards the floor. The better of 2 tries was recorded. Change from baseline \<0 indicated improvement.
Time frame: Baseline, Weeks 2, 4, 6
Population: FAS. N = total evaluable participants. n = evaluable participants at that time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Celecoxib 200 mg | Change From Baseline in Fingertips to Floor Distance at Weeks 2, 4, and 6 | Week 2 (n=117, 115) | -1.6 cm | Standard Error 0.62 |
| Celecoxib 200 mg | Change From Baseline in Fingertips to Floor Distance at Weeks 2, 4, and 6 | Week 4 (n=118, 115) | -1.9 cm | Standard Error 0.69 |
| Celecoxib 200 mg | Change From Baseline in Fingertips to Floor Distance at Weeks 2, 4, and 6 | Week 6 (n=118, 115) | -2.8 cm | Standard Error 0.67 |
| Diclofenac SR 75 mg | Change From Baseline in Fingertips to Floor Distance at Weeks 2, 4, and 6 | Week 2 (n=117, 115) | -1.6 cm | Standard Error 0.62 |
| Diclofenac SR 75 mg | Change From Baseline in Fingertips to Floor Distance at Weeks 2, 4, and 6 | Week 4 (n=118, 115) | -2.2 cm | Standard Error 0.71 |
| Diclofenac SR 75 mg | Change From Baseline in Fingertips to Floor Distance at Weeks 2, 4, and 6 | Week 6 (n=118, 115) | -3.1 cm | Standard Error 0.69 |
Comparison: Change from baseline to Week 2. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.p-value: 0.964195% CI: [-1.7, 1.8]ANCOVA
Comparison: Change from baseline to Week 4. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.p-value: 0.774995% CI: [-1.6, 2.2]ANCOVA
Comparison: Change from baseline to Week 6. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.p-value: 0.752995% CI: [-1.6, 2.2]ANCOVA
Secondary
Change From Baseline in Nocturnal Pain at Week 12
100-mm VAS scores specified participant's nocturnal pain in response to the following question Did you have any pain in the neck, back or hips during the previous night? 0=no pain to 100=worst pain possible. Lower scores indicated less pain. Change from baseline \<0 indicated improvement.
Time frame: Baseline, Week 12
Population: FAS. n = evaluable participants at that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Celecoxib 200 mg | Change From Baseline in Nocturnal Pain at Week 12 | Baseline (n=55, 55, 54, 54) | 52.2 mm | Standard Deviation 20.45 |
| Celecoxib 200 mg | Change From Baseline in Nocturnal Pain at Week 12 | Change from Baseline at Week 12 (n=52, 54, 46, 51) | -19.4 mm | Standard Deviation 22.54 |
| Diclofenac SR 75 mg | Change From Baseline in Nocturnal Pain at Week 12 | Change from Baseline at Week 12 (n=52, 54, 46, 51) | -27.5 mm | Standard Deviation 25.62 |
| Diclofenac SR 75 mg | Change From Baseline in Nocturnal Pain at Week 12 | Baseline (n=55, 55, 54, 54) | 55.1 mm | Standard Deviation 19.24 |
| Celecoxib 200 mg, Then Celecoxib 400 mg | Change From Baseline in Nocturnal Pain at Week 12 | Baseline (n=55, 55, 54, 54) | 54.5 mm | Standard Deviation 20.14 |
| Celecoxib 200 mg, Then Celecoxib 400 mg | Change From Baseline in Nocturnal Pain at Week 12 | Change from Baseline at Week 12 (n=52, 54, 46, 51) | -12.5 mm | Standard Deviation 20.31 |
| Diclofenac SR 75 mg, Then Celecoxib 400 mg | Change From Baseline in Nocturnal Pain at Week 12 | Baseline (n=55, 55, 54, 54) | 61.5 mm | Standard Deviation 19.17 |
| Diclofenac SR 75 mg, Then Celecoxib 400 mg | Change From Baseline in Nocturnal Pain at Week 12 | Change from Baseline at Week 12 (n=52, 54, 46, 51) | -22.6 mm | Standard Deviation 30.36 |
Secondary
Change From Baseline in Nocturnal Pain at Weeks 2, 4, and 6
100-mm VAS scores specified participant's nocturnal pain in response to the following question Did you have any pain in the neck, back or hips during the previous night? 0=no pain to 100=worst pain possible. Change from baseline \<0 indicated improvement.
Time frame: Baseline, Weeks 2, 4, 6
Population: FAS. N = total evaluable participants. n = evaluable participants at that time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Celecoxib 200 mg | Change From Baseline in Nocturnal Pain at Weeks 2, 4, and 6 | Week 2 (n=116, 115) | -12.0 mm | Standard Error 1.9 |
| Celecoxib 200 mg | Change From Baseline in Nocturnal Pain at Weeks 2, 4, and 6 | Week 4 (n=117, 115) | -14.5 mm | Standard Error 1.94 |
| Celecoxib 200 mg | Change From Baseline in Nocturnal Pain at Weeks 2, 4, and 6 | Week 6 (n=117, 115) | -15.4 mm | Standard Error 1.95 |
| Diclofenac SR 75 mg | Change From Baseline in Nocturnal Pain at Weeks 2, 4, and 6 | Week 2 (n=116, 115) | -16.3 mm | Standard Error 1.91 |
| Diclofenac SR 75 mg | Change From Baseline in Nocturnal Pain at Weeks 2, 4, and 6 | Week 4 (n=117, 115) | -17.1 mm | Standard Error 1.96 |
| Diclofenac SR 75 mg | Change From Baseline in Nocturnal Pain at Weeks 2, 4, and 6 | Week 6 (n=117, 115) | -19.4 mm | Standard Error 1.98 |
Comparison: Change from baseline to Week 2. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.p-value: 0.111195% CI: [-1, 9.5]ANCOVA
Comparison: Change from baseline to Week 4. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.p-value: 0.357495% CI: [-2.9, 7.9]ANCOVA
Comparison: Change from baseline to Week 6. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.p-value: 0.146495% CI: [-1.4, 9.5]ANCOVA
Secondary
Change From Baseline in Participant's Assessment of Global Pain Intensity at Week 12
100-mm VAS score specified participant's assessment of overall pain intensity in the previous 48 hours, in response to the following question What has been your global pain intensity in the last 48 hours? 0=no pain to 100=worst pain. Lower scores indicated less pain. Change from baseline of \<0 indicated improvement.
Time frame: Baseline, Week 12
Population: FAS. n = evaluable participants at that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Celecoxib 200 mg | Change From Baseline in Participant's Assessment of Global Pain Intensity at Week 12 | Baseline (n=55, 55, 54, 54) | 63.4 mm | Standard Deviation 13.58 |
| Celecoxib 200 mg | Change From Baseline in Participant's Assessment of Global Pain Intensity at Week 12 | Change from Baseline at Week 12 (n=52, 54, 46, 51) | -28.4 mm | Standard Deviation 21.39 |
| Diclofenac SR 75 mg | Change From Baseline in Participant's Assessment of Global Pain Intensity at Week 12 | Change from Baseline at Week 12 (n=52, 54, 46, 51) | -30.9 mm | Standard Deviation 24.24 |
| Diclofenac SR 75 mg | Change From Baseline in Participant's Assessment of Global Pain Intensity at Week 12 | Baseline (n=55, 55, 54, 54) | 61.1 mm | Standard Deviation 13.08 |
| Celecoxib 200 mg, Then Celecoxib 400 mg | Change From Baseline in Participant's Assessment of Global Pain Intensity at Week 12 | Baseline (n=55, 55, 54, 54) | 63.4 mm | Standard Deviation 12.05 |
| Celecoxib 200 mg, Then Celecoxib 400 mg | Change From Baseline in Participant's Assessment of Global Pain Intensity at Week 12 | Change from Baseline at Week 12 (n=52, 54, 46, 51) | -20.8 mm | Standard Deviation 21.86 |
| Diclofenac SR 75 mg, Then Celecoxib 400 mg | Change From Baseline in Participant's Assessment of Global Pain Intensity at Week 12 | Baseline (n=55, 55, 54, 54) | 65.6 mm | Standard Deviation 13.26 |
| Diclofenac SR 75 mg, Then Celecoxib 400 mg | Change From Baseline in Participant's Assessment of Global Pain Intensity at Week 12 | Change from Baseline at Week 12 (n=52, 54, 46, 51) | -28.1 mm | Standard Deviation 25.96 |
Secondary
Change From Baseline in Participant's Assessment of Global Pain Intensity at Weeks 2 and 4
100-mm VAS score specified participant's assessment of overall pain intensity in the previous 48 hours, in response to the following question What has been your global pain intensity in the last 48 hours? 0=no pain to 100=worst pain. Change from baseline of \<0 indicated improvement.
Time frame: Baseline, Weeks 2, 4
Population: Full Analysis Set (FAS). Number of participants analyzed (N) = total evaluable participants. n = evaluable participants at that time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Celecoxib 200 mg | Change From Baseline in Participant's Assessment of Global Pain Intensity at Weeks 2 and 4 | Week 2 (n=116, 115) | -18.6 mm | Standard Error 1.78 |
| Celecoxib 200 mg | Change From Baseline in Participant's Assessment of Global Pain Intensity at Weeks 2 and 4 | Week 4 (n=117, 115) | -20.7 mm | Standard Error 1.86 |
| Diclofenac SR 75 mg | Change From Baseline in Participant's Assessment of Global Pain Intensity at Weeks 2 and 4 | Week 2 (n=116, 115) | -17.9 mm | Standard Error 1.79 |
| Diclofenac SR 75 mg | Change From Baseline in Participant's Assessment of Global Pain Intensity at Weeks 2 and 4 | Week 4 (n=117, 115) | -23.3 mm | Standard Error 1.89 |
Comparison: Change from baseline to Week 2. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.p-value: 0.784995% CI: [-5.6, 4.2]ANCOVA
Comparison: Change from baseline to Week 4. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.p-value: 0.322395% CI: [-2.6, 7.8]ANCOVA
Secondary
Change From Baseline in Participant's Global Assessment of Disease Activity at Week 12
5-point Likert scale scores specified participant's current situation in response to the following question Considering all the ways your Ankylosing Spondylitis affects you, how are you doing today? 1=very good to 5=very poor. Lower scores indicated better health. Change from baseline \<0 indicated improvement.
Time frame: Baseline, Week 12
Population: FAS. n = evaluable participants at that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Celecoxib 200 mg | Change From Baseline in Participant's Global Assessment of Disease Activity at Week 12 | Baseline (n=55, 55, 54, 54) | 3.1 units on a scale | Standard Deviation 0.83 |
| Celecoxib 200 mg | Change From Baseline in Participant's Global Assessment of Disease Activity at Week 12 | Change from Baseline at Week 12 (n=52, 54, 46, 51) | -0.6 units on a scale | Standard Deviation 0.99 |
| Diclofenac SR 75 mg | Change From Baseline in Participant's Global Assessment of Disease Activity at Week 12 | Change from Baseline at Week 12 (n=52, 54, 46, 51) | -0.6 units on a scale | Standard Deviation 0.78 |
| Diclofenac SR 75 mg | Change From Baseline in Participant's Global Assessment of Disease Activity at Week 12 | Baseline (n=55, 55, 54, 54) | 3.0 units on a scale | Standard Deviation 0.64 |
| Celecoxib 200 mg, Then Celecoxib 400 mg | Change From Baseline in Participant's Global Assessment of Disease Activity at Week 12 | Baseline (n=55, 55, 54, 54) | 3.2 units on a scale | Standard Deviation 0.66 |
| Celecoxib 200 mg, Then Celecoxib 400 mg | Change From Baseline in Participant's Global Assessment of Disease Activity at Week 12 | Change from Baseline at Week 12 (n=52, 54, 46, 51) | -0.4 units on a scale | Standard Deviation 0.71 |
| Diclofenac SR 75 mg, Then Celecoxib 400 mg | Change From Baseline in Participant's Global Assessment of Disease Activity at Week 12 | Baseline (n=55, 55, 54, 54) | 3.2 units on a scale | Standard Deviation 0.7 |
| Diclofenac SR 75 mg, Then Celecoxib 400 mg | Change From Baseline in Participant's Global Assessment of Disease Activity at Week 12 | Change from Baseline at Week 12 (n=52, 54, 46, 51) | -0.6 units on a scale | Standard Deviation 0.96 |
Secondary
Change From Baseline in Participant's Global Assessment of Disease Activity at Weeks 2, 4, and 6
5-point Likert scale scores specified participant's current situation in response to the following question Considering all the ways your Ankylosing Spondylitis affects you, how are you doing today? 1=very good to 5=very poor. Change from baseline \<0 indicated improvement.
Time frame: Baseline, Weeks 2, 4, 6
Population: FAS. N = total evaluable participants. n = evaluable participants at that time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Celecoxib 200 mg | Change From Baseline in Participant's Global Assessment of Disease Activity at Weeks 2, 4, and 6 | Week 2 (n=116, 115) | -0.4 units on a scale | Standard Error 0.06 |
| Celecoxib 200 mg | Change From Baseline in Participant's Global Assessment of Disease Activity at Weeks 2, 4, and 6 | Week 4 (n=117, 115) | -0.3 units on a scale | Standard Error 0.06 |
| Celecoxib 200 mg | Change From Baseline in Participant's Global Assessment of Disease Activity at Weeks 2, 4, and 6 | Week 6 (n=117, 115) | -0.3 units on a scale | Standard Error 0.06 |
| Diclofenac SR 75 mg | Change From Baseline in Participant's Global Assessment of Disease Activity at Weeks 2, 4, and 6 | Week 2 (n=116, 115) | -0.4 units on a scale | Standard Error 0.06 |
| Diclofenac SR 75 mg | Change From Baseline in Participant's Global Assessment of Disease Activity at Weeks 2, 4, and 6 | Week 4 (n=117, 115) | -0.4 units on a scale | Standard Error 0.06 |
| Diclofenac SR 75 mg | Change From Baseline in Participant's Global Assessment of Disease Activity at Weeks 2, 4, and 6 | Week 6 (n=117, 115) | -0.4 units on a scale | Standard Error 0.06 |
Comparison: Change from baseline to Week 2. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.p-value: 0.893895% CI: [-0.15, 0.17]ANCOVA
Comparison: Change from baseline to Week 4. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.p-value: 0.042695% CI: [0.01, 0.31]ANCOVA
Comparison: Change from baseline to Week 6. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.p-value: 0.150295% CI: [-0.05, 0.29]ANCOVA
Secondary
Change From Baseline in Physician's Global Assessment of Disease Activity at Week 12
5-point Likert scale scores specified physician's subjective assessment on how the overall ankylosing spondylitis appeared at the time of the participant's visit and participant's disease signs. 1=very good to 5=very poor. Lower scores indicated better health. Change from baseline \<0 indicated improvement.
Time frame: Baseline, Week 12
Population: FAS. n = evaluable participants at that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Celecoxib 200 mg | Change From Baseline in Physician's Global Assessment of Disease Activity at Week 12 | Baseline (n=55, 55, 54, 54) | 3.2 units on a scale | Standard Deviation 0.57 |
| Celecoxib 200 mg | Change From Baseline in Physician's Global Assessment of Disease Activity at Week 12 | Change from Baseline at Week 12 (n=52, 54, 46, 51) | -0.7 units on a scale | Standard Deviation 0.6 |
| Diclofenac SR 75 mg | Change From Baseline in Physician's Global Assessment of Disease Activity at Week 12 | Change from Baseline at Week 12 (n=52, 54, 46, 51) | -0.5 units on a scale | Standard Deviation 0.64 |
| Diclofenac SR 75 mg | Change From Baseline in Physician's Global Assessment of Disease Activity at Week 12 | Baseline (n=55, 55, 54, 54) | 3.0 units on a scale | Standard Deviation 0.45 |
| Celecoxib 200 mg, Then Celecoxib 400 mg | Change From Baseline in Physician's Global Assessment of Disease Activity at Week 12 | Baseline (n=55, 55, 54, 54) | 3.2 units on a scale | Standard Deviation 0.43 |
| Celecoxib 200 mg, Then Celecoxib 400 mg | Change From Baseline in Physician's Global Assessment of Disease Activity at Week 12 | Change from Baseline at Week 12 (n=52, 54, 46, 51) | -0.5 units on a scale | Standard Deviation 0.51 |
| Diclofenac SR 75 mg, Then Celecoxib 400 mg | Change From Baseline in Physician's Global Assessment of Disease Activity at Week 12 | Baseline (n=55, 55, 54, 54) | 3.3 units on a scale | Standard Deviation 0.5 |
| Diclofenac SR 75 mg, Then Celecoxib 400 mg | Change From Baseline in Physician's Global Assessment of Disease Activity at Week 12 | Change from Baseline at Week 12 (n=52, 54, 46, 51) | -0.7 units on a scale | Standard Deviation 0.75 |
Secondary
Change From Baseline in Physician's Global Assessment of Disease Activity at Weeks 2, 4, and 6
5-point Likert scale scores specified physician's subjective assessment on how overall ankylosing spondylitis appeared at the time of participant's visit and participant's disease signs. 1=very good to 5=very poor. Change from baseline \<0 indicated improvement.
Time frame: Baseline, Weeks 2, 4, 6
Population: FAS. N = total evaluable participants. n = evaluable participants at that time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Celecoxib 200 mg | Change From Baseline in Physician's Global Assessment of Disease Activity at Weeks 2, 4, and 6 | Week 2 (n=116, 115) | -0.4 units on a scale | Standard Error 0.05 |
| Celecoxib 200 mg | Change From Baseline in Physician's Global Assessment of Disease Activity at Weeks 2, 4, and 6 | Week 4 (n=117, 115) | -0.4 units on a scale | Standard Error 0.05 |
| Celecoxib 200 mg | Change From Baseline in Physician's Global Assessment of Disease Activity at Weeks 2, 4, and 6 | Week 6 (n=117, 115) | -0.5 units on a scale | Standard Error 0.06 |
| Diclofenac SR 75 mg | Change From Baseline in Physician's Global Assessment of Disease Activity at Weeks 2, 4, and 6 | Week 2 (n=116, 115) | -0.4 units on a scale | Standard Error 0.05 |
| Diclofenac SR 75 mg | Change From Baseline in Physician's Global Assessment of Disease Activity at Weeks 2, 4, and 6 | Week 4 (n=117, 115) | -0.5 units on a scale | Standard Error 0.05 |
| Diclofenac SR 75 mg | Change From Baseline in Physician's Global Assessment of Disease Activity at Weeks 2, 4, and 6 | Week 6 (n=117, 115) | -0.5 units on a scale | Standard Error 0.06 |
Comparison: Change from baseline to Week 2. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.p-value: 0.594595% CI: [-0.2, 0.1]ANCOVA
Comparison: Change from baseline to Week 4. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.p-value: 0.342795% CI: [-0.1, 0.2]ANCOVA
Comparison: Change from baseline to Week 6. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.p-value: 0.652295% CI: [-0.1, 0.2]ANCOVA
Secondary
Paracetamol Tablets Taken Per Day by Participant
Calculated as the total number of paracetamol tablets taken divided by days of exposure in the study.
Time frame: Week 6
Population: FAS
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Celecoxib 200 mg | Paracetamol Tablets Taken Per Day by Participant | 0.2 tablets per day | Standard Deviation 0.16 |
| Diclofenac SR 75 mg | Paracetamol Tablets Taken Per Day by Participant | 0.0 tablets per day | Standard Deviation 0 |
Secondary
Percentage of Days With Concomitant Administration of Paracetamol
Calculated as days on rescue medication divided by days of exposure in the study at the end of Week 6.
Time frame: Week 6
Population: FAS
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Celecoxib 200 mg | Percentage of Days With Concomitant Administration of Paracetamol | 0.1 percentage of days | Standard Deviation 0.08 |
| Diclofenac SR 75 mg | Percentage of Days With Concomitant Administration of Paracetamol | 0.0 percentage of days | Standard Deviation 0 |
Secondary
Percentage of Participants With Concomitant Use of Paracetamol
Percentage of participants who concomitantly took at least 1 paracetamol tablet as rescue medication at Week 6
Time frame: Week 6
Population: FAS
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Celecoxib 200 mg | Percentage of Participants With Concomitant Use of Paracetamol | 2.5 percentage of participants |
| Diclofenac SR 75 mg | Percentage of Participants With Concomitant Use of Paracetamol | 0.0 percentage of participants |
Secondary
Percentages of Participants Responding to Assessment in Ankylosing Spondylitis (ASAS)-20
Percentages of participants who demonstrated an improvement of greater than or equal to (≥) 20% from baseline and an absolute improvement of ≥10 mm from baseline on a 100-mm VAS in ≥3 of the 4 domains proposed by the Ankylosing Spondylitis Assessment Working Group (ASAS-20).
Time frame: Weeks 2, 4, 6, 12
Population: FAS. N = total evaluable participants. n = evaluable participants at that time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Celecoxib 200 mg | Percentages of Participants Responding to Assessment in Ankylosing Spondylitis (ASAS)-20 | Week 2 (n=115, 114) | 23.5 percentage of participants |
| Celecoxib 200 mg | Percentages of Participants Responding to Assessment in Ankylosing Spondylitis (ASAS)-20 | Week 4 (n=116, 114) | 26.7 percentage of participants |
| Celecoxib 200 mg | Percentages of Participants Responding to Assessment in Ankylosing Spondylitis (ASAS)-20 | Week 6 (n=54, 54, 54, 54) | 40.7 percentage of participants |
| Celecoxib 200 mg | Percentages of Participants Responding to Assessment in Ankylosing Spondylitis (ASAS)-20 | Week 12 (n=51, 53, 46, 51) | 49.0 percentage of participants |
| Diclofenac SR 75 mg | Percentages of Participants Responding to Assessment in Ankylosing Spondylitis (ASAS)-20 | Week 4 (n=116, 114) | 31.6 percentage of participants |
| Diclofenac SR 75 mg | Percentages of Participants Responding to Assessment in Ankylosing Spondylitis (ASAS)-20 | Week 6 (n=54, 54, 54, 54) | 42.6 percentage of participants |
| Diclofenac SR 75 mg | Percentages of Participants Responding to Assessment in Ankylosing Spondylitis (ASAS)-20 | Week 12 (n=51, 53, 46, 51) | 47.2 percentage of participants |
| Diclofenac SR 75 mg | Percentages of Participants Responding to Assessment in Ankylosing Spondylitis (ASAS)-20 | Week 2 (n=115, 114) | 25.4 percentage of participants |
| Celecoxib 200 mg, Then Celecoxib 400 mg | Percentages of Participants Responding to Assessment in Ankylosing Spondylitis (ASAS)-20 | Week 6 (n=54, 54, 54, 54) | 22.2 percentage of participants |
| Celecoxib 200 mg, Then Celecoxib 400 mg | Percentages of Participants Responding to Assessment in Ankylosing Spondylitis (ASAS)-20 | Week 4 (n=116, 114) | 0 percentage of participants |
| Celecoxib 200 mg, Then Celecoxib 400 mg | Percentages of Participants Responding to Assessment in Ankylosing Spondylitis (ASAS)-20 | Week 12 (n=51, 53, 46, 51) | 32.6 percentage of participants |
| Celecoxib 200 mg, Then Celecoxib 400 mg | Percentages of Participants Responding to Assessment in Ankylosing Spondylitis (ASAS)-20 | Week 2 (n=115, 114) | 0 percentage of participants |
| Diclofenac SR 75 mg, Then Celecoxib 400 mg | Percentages of Participants Responding to Assessment in Ankylosing Spondylitis (ASAS)-20 | Week 12 (n=51, 53, 46, 51) | 37.3 percentage of participants |
| Diclofenac SR 75 mg, Then Celecoxib 400 mg | Percentages of Participants Responding to Assessment in Ankylosing Spondylitis (ASAS)-20 | Week 4 (n=116, 114) | 0 percentage of participants |
| Diclofenac SR 75 mg, Then Celecoxib 400 mg | Percentages of Participants Responding to Assessment in Ankylosing Spondylitis (ASAS)-20 | Week 2 (n=115, 114) | 0 percentage of participants |
| Diclofenac SR 75 mg, Then Celecoxib 400 mg | Percentages of Participants Responding to Assessment in Ankylosing Spondylitis (ASAS)-20 | Week 6 (n=54, 54, 54, 54) | 29.6 percentage of participants |