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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Celecoxib 200 mg QD | Experimental |
| |
| Diclofenac SR 75 mg QD | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Celecoxib | Drug | capsule, 200 mg QD, 6-12 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Week 6 |
| 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. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Weeks 2, 4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Guangzhou | Guangdong | 510630 | China | ||
| Pfizer Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25516774 | Derived | Huang F, Gu J, Liu Y, Zhu P, Zheng Y, Fu J, Pan S, Le S. Efficacy and safety of celecoxib in chinese patients with ankylosing spondylitis: a 6-week randomized, double-blinded study with 6-week open-label extension treatment. Curr Ther Res Clin Exp. 2014 Dec 5;76:126-33. doi: 10.1016/j.curtheres.2014.08.002. eCollection 2014 Dec. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Celecoxib 200 mg | Celecoxib 200 milligram (mg) capsule once daily |
| FG001 | Diclofenac SR 75 mg | Diclofenac sustained release (SR) 75 mg tablet once daily |
| FG002 | Celecoxib 200 mg, Then Celecoxib 400 mg | Celecoxib 200 mg capsule once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12 |
| FG003 | Diclofenac SR 75 mg, Then Celecoxib 400 mg | Diclofenac SR 75 mg tablet once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Double-blind Phase (Baseline to Week 6) |
|
| ||||||||||||||||||
| Enrollment in Extension Phase (Week 6) |
| |||||||||||||||||||
| Extension Phase (Week 6 to Week 12) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Celecoxib 200 mg | Celecoxib 200 mg capsule once daily |
| BG001 | Diclofenac SR 75 mg | Diclofenac SR 75 mg tablet once daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Least Squares Mean | Standard Error | mm | Baseline, Week 6 |
|
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The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Celecoxib 200 mg | Celecoxib 200 mg capsule once daily from baseline to Week 6 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 13.1 | Non-systematic Assessment |
The protocol does not specify time points for secondary endpoints; these are described in the statistical analysis plan.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D013167 | Spondylitis, Ankylosing |
| ID | Term |
|---|---|
| D000089183 | Axial Spondyloarthritis |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
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| ID | Term |
|---|---|
| D000068579 | Celecoxib |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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| Diclofenac SR |
| Drug |
tablet, 75 mg QD,6-12 weeks |
|
| 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. | Baseline, Week 12 |
| 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. | Baseline, Weeks 2, 4, 6 |
| 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. | Baseline, Week 12 |
| 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. | Baseline, Weeks 2, 4, 6 |
| 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. | Baseline, Week 12 |
| 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. | Baseline, Weeks 2, 4, 6 |
| 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. | Baseline, Week 12 |
| 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. | Baseline, Weeks 2, 4, 6 |
| 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. | Baseline, Week 12 |
| 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). | Weeks 2, 4, 6, 12 |
| 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. | Baseline, Weeks 2, 4, 6 |
| 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. | Baseline, Week 12 |
| 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. | Baseline, Weeks 2, 4, 6 |
| 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. | Baseline, Week 12 |
| 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. | Baseline, Weeks 2, 4, 6 |
| 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. | Baseline, Week 12 |
| 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. | Baseline, Week 6 |
| 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. | Baseline, Week 12 |
| 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. | Baseline, 6 Weeks |
| 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. | Baseline, Week 12 |
| 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 | Week 6 |
| 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. | Week 6 |
| Paracetamol Tablets Taken Per Day by Participant | Calculated as the total number of paracetamol tablets taken divided by days of exposure in the study. | Week 6 |
| Xi’an |
| Shanxi |
| 710032 |
| China |
| Pfizer Investigational Site | Chengdu | Sichuan | 610041 | China |
| Pfizer Investigational Site | Beijing | 100020 | China |
| Pfizer Investigational Site | Beijing | 100853 | China |
| No longer willing to participate |
|
| Adverse Event |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Diclofenac SR 75 mg |
Diclofenac SR 75 mg tablet once daily |
|
|
|
| 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. | PP | Posted | Mean | Standard Deviation | mm | Baseline |
|
|
|
| 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. | Full Analysis Set (FAS). Number of participants analyzed (N) = total evaluable participants. n = evaluable participants at that time point. | Posted | Least Squares Mean | Standard Error | mm | Baseline, Weeks 2, 4 |
|
|
|
|
| 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. | FAS. n = evaluable participants at that time point. | Posted | Mean | Standard Deviation | mm | Baseline, Week 12 |
|
|
|
| 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. | FAS. N = total evaluable participants. n = evaluable participants at that time point. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Weeks 2, 4, 6 |
|
|
|
|
| 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. | FAS. n = evaluable participants at that time point. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 12 |
|
|
|
| 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. | FAS. N = total evaluable participants. n = evaluable participants at that time point. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Weeks 2, 4, 6 |
|
|
|
|
| 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. | FAS. n = evaluable participants at that time point. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 12 |
|
|
|
| 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. | FAS. N = total evaluable participants. n = evaluable participants at that time point. | Posted | Least Squares Mean | Standard Error | mm | Baseline, Weeks 2, 4, 6 |
|
|
|
|
| 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. | FAS. n = evaluable participants at that time point. | Posted | Mean | Standard Deviation | mm | Baseline, Week 12 |
|
|
|
| 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. | FAS. N = total evaluable participants. n = evaluable participants at that time point. | Posted | Least Squares Mean | Standard Error | mm | Baseline, Weeks 2, 4, 6 |
|
|
|
|
| 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. | FAS. n = evaluable participants at that time point. | Posted | Mean | Standard Deviation | mm | Baseline, Week 12 |
|
|
|
| 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). | FAS. N = total evaluable participants. n = evaluable participants at that time point. | Posted | Number | percentage of participants | Weeks 2, 4, 6, 12 |
|
|
|
| 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. | FAS. N = total evaluable participants. n = evaluable participants at that time point. | Posted | Least Squares Mean | Standard Error | mm | Baseline, Weeks 2, 4, 6 |
|
|
|
|
| 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. | FAS. n = evaluable participants at that time point. | Posted | Mean | Standard Deviation | mm | Baseline, Week 12 |
|
|
|
| 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. | FAS. N = total evaluable participants. n = evaluable participants at that time point. | Posted | Least Squares Mean | Standard Error | cm | Baseline, Weeks 2, 4, 6 |
|
|
|
|
| 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. | FAS. n = evaluable participants at that time point. | Posted | Mean | Standard Deviation | cm | Baseline, Week 12 |
|
|
|
| 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. | FAS. N = total evaluable participants. n = evaluable participants at that time point. | Posted | Least Squares Mean | Standard Error | cm | Baseline, Weeks 2, 4, 6 |
|
|
|
|
| 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. | FAS. n = evaluable participants at that time point. | Posted | Mean | Standard Deviation | cm | Baseline, Week 12 |
|
|
|
| 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. | FAS | Posted | Least Squares Mean | Standard Error | mm/h | Baseline, Week 6 |
|
|
|
|
| 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. | FAS. n = evaluable participants at that time point. | Posted | Mean | Standard Deviation | mm/h | Baseline, Week 12 |
|
|
|
| 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. | FAS | Posted | Least Squares Mean | Standard Error | mg/L | Baseline, 6 Weeks |
|
|
|
|
| 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. | FAS. n = evaluable participants at that time point. | Posted | Mean | Standard Deviation | mg/L | Baseline, Week 12 |
|
|
|
| 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 | FAS | Posted | Number | percentage of participants | Week 6 |
|
|
|
| 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. | FAS | Posted | Mean | Standard Deviation | percentage of days | Week 6 |
|
|
|
| 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. | FAS | Posted | Mean | Standard Deviation | tablets per day | Week 6 |
|
|
|
| 0 |
| 120 |
| 11 |
| 120 |
| EG001 | Diclofenac SR 75 mg | Diclofenac SR 75 mg tablet once daily from baseline to Week 6 | 0 | 120 | 9 | 120 |
| EG002 | Celecoxib 200 mg, Then Celecoxib 200 mg | Celecoxib 200 mg capsule once daily from baseline to Week 6, followed by Celecoxib 200 mg capsule once daily from Week 6 to Week 12 | 0 | 54 | 0 | 54 |
| EG003 | Diclofenac SR 75 mg, Then Diclofenac SR 75 mg | Diclofenac SR 75 mg tablet once daily from baseline to Week 6 followed by Diclofenac SR 75 mg tablet once daily from Week 6 to Week 12 | 0 | 55 | 6 | 55 |
| EG004 | Celecoxib 200 mg, Then Celecoxib 400 mg | Celecoxib 200 mg capsule once daily from baseline to Week 6, followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12 | 0 | 53 | 5 | 53 |
| EG005 | Diclofenac SR 75 mg, Then Celecoxib 400 mg | Diclofenac SR 75 mg tablet once daily from baseline to Week 6, followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12 | 0 | 54 | 6 | 54 |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Wolff-Parkinson-White Syndrome | Cardiac disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Uveitis | Eye disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Epigastric discomfort | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Mouth ulceration | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 13.1 | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 13.1 | Non-systematic Assessment |
|
| Red blood cell urine positive | Investigations | MedDRA 13.1 | Non-systematic Assessment |
|
| Transaminases increased | Investigations | MedDRA 13.1 | Non-systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 13.1 | Non-systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 13.1 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| VIIth nerve paralysis | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Rash generalised | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D013122 |
| Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D000844 | Ankylosis |
| D007592 | Joint Diseases |
| D001168 | Arthritis |
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
|
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. |
| ANCOVA |
Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate. |
| 0.3223 |
| LS Mean Difference |
| 2.6 |
| Standard Error of the Mean |
| 2.62 |
| 2-Sided |
| 95 |
| -2.6 |
| 7.8 |
| Superiority or Other (legacy) |
| Change from Baseline at Week 12 (n=52, 54, 46, 51) |
|
| Week 6 (n=117, 115) |
|
|
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. |
| ANCOVA |
Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate. |
| 0.0426 |
| LS Mean Difference |
| 0.2 |
| Standard Error of the Mean |
| 0.08 |
| 2-Sided |
| 95 |
| 0.01 |
| 0.31 |
| Superiority or Other (legacy) |
| 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. | ANCOVA | Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate. | 0.1502 | LS Mean Difference | 0.1 | Standard Error of the Mean | 0.09 | 2-Sided | 95 | -0.05 | 0.29 | Superiority or Other (legacy) |
| Change from Baseline at Week 12 (n=52, 54, 46, 51) |
|
| Week 6 (n=117, 115) |
|
|
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. |
| ANCOVA |
Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate. |
| 0.3427 |
| LS Mean Difference |
| 0.1 |
| Standard Error of the Mean |
| 0.07 |
| 2-Sided |
| 95 |
| -0.1 |
| 0.2 |
| Superiority or Other (legacy) |
| 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. | ANCOVA | Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate. | 0.6522 | LS Mean Difference | 0.0 | Standard Error of the Mean | 0.08 | 2-Sided | 95 | -0.1 | 0.2 | Superiority or Other (legacy) |
| Change from Baseline at Week 12 (n=52, 54, 46, 51) |
|
| Week 6 (n=117, 115) |
|
|
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. |
| ANCOVA |
Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate. |
| 0.5916 |
| LS Mean Difference |
| 0.1 |
| Standard Error of the Mean |
| 0.20 |
| 2-Sided |
| 95 |
| -0.3 |
| 0.5 |
| Superiority or Other (legacy) |
| 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. | ANCOVA | Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate. | 0.1790 | LS Mean Difference | 0.3 | Standard Error of the Mean | 0.20 | 2-Sided | 95 | -0.1 | 0.7 | Superiority or Other (legacy) |
| Change from Baseline at Week 12 (n=52, 54, 46, 51) |
|
| Week 6 (n=117, 115) |
|
|
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. |
| ANCOVA |
Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate. |
| 0.2729 |
| LS Mean Difference |
| 0.2 |
| Standard Error of the Mean |
| 0.21 |
| 2-Sided |
| 95 |
| -0.2 |
| 0.6 |
| Superiority or Other (legacy) |
| 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. | ANCOVA | Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate. | 0.1559 | LS Mean Difference | 0.3 | Standard Error of the Mean | 0.22 | 2-Sided | 95 | -0.1 | 0.8 | Superiority or Other (legacy) |
| Change from Baseline at Week 12 (n=52, 54, 46, 51) |
|
| Week 4 (n=116, 114) |
|
| Week 6 (n=54, 54, 54, 54) |
|
| Week 12 (n=51, 53, 46, 51) |
|
| Week 6 (n=117, 115) |
|
|
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. |
| ANCOVA |
Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate. |
| 0.3574 |
| LS Mean Difference |
| 2.5 |
| Standard Error of the Mean |
| 2.74 |
| 2-Sided |
| 95 |
| -2.9 |
| 7.9 |
| Superiority or Other (legacy) |
| 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. | ANCOVA | Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate. | 0.1464 | LS Mean Difference | 4.0 | Standard Error of the Mean | 2.76 | 2-Sided | 95 | -1.4 | 9.5 | Superiority or Other (legacy) |
| Change from Baseline at Week 12 (n=52, 54, 46, 51) |
|
| Week 6 (n=118, 115) |
|
|
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. |
| ANCOVA |
Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate. |
| 0.7749 |
| LS Mean Difference |
| 0.3 |
| Standard Error of the Mean |
| 0.98 |
| 2-Sided |
| 95 |
| -1.6 |
| 2.2 |
| Superiority or Other (legacy) |
| 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. | ANCOVA | Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate. | 0.7529 | LS Mean Difference | 0.3 | Standard Error of the Mean | 0.95 | 2-Sided | 95 | -1.6 | 2.2 | Superiority or Other (legacy) |
| Change from Baseline at Week 12 (n=52, 54, 46, 51) |
|
| Week 6 (n=118, 115) |
|
|
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. |
| ANCOVA |
Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate. |
| 0.2202 |
| LS Mean Difference |
| 0.2 |
| Standard Error of the Mean |
| 0.13 |
| 2-Sided |
| 95 |
| -0.1 |
| 0.4 |
| Superiority or Other (legacy) |
| 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. | ANCOVA | Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate. | 0.5340 | LS Mean Difference | 0.1 | Standard Error of the Mean | 0.14 | 2-Sided | 95 | -0.2 | 0.4 | Superiority or Other (legacy) |
| Change from Baseline at Week 12 (n=52, 54, 46, 51) |
|
| Change from Baseline at Week 12 (n=45, 44, 41, 43) |
|
| Change from Baseline at Week 12 (n=47, 49, 42, 47) |
|