Study Of Celecoxib Or Diclofenac For Efficacy and Safety In Chinese Patients With Ankylosing Spondylitis

Study Overview
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Brief Summary
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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).

Official Title
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A 6-Week, Randomized, Double-Blind, Parallel-Group Study To Evaluate The Symptomatic Effects And Safety Of Celecoxib 200mg QD Compared To Diclofenac 75mg SR QD In Chinese Patients With Ankylosing Spondylitis, With 6-Week Extension Phase Treatment On Celecoxib 400 Mg QD Or Maintaining Double-Blind Phase Therapy

Conditions
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Ankylosing Spondylitis

Intervention / Treatment
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* Drug: Celecoxib
* Drug: Diclofenac SR


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Celecoxib 200 mg QD<br> | Drug: Celecoxib<br>* capsule, 200 mg QD, 6-12 weeks<br>|
| Active Comparator: Diclofenac SR 75 mg QD<br> | Drug: Diclofenac SR<br>* tablet, 75 mg QD,6-12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |