Safety and Efficacy of Celecoxib Versus Diclofenac in the Treatment of Ankylosing Spondylitis

Study Overview
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Brief Summary
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To compare the safety and efficacy of once-daily and twice-daily celecoxib versus diclofenac for the treatment of ankylosing spondylitis

Official Title
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A 12-Week Symptomatic Effect Evaluation to Compare Celecoxib 200 mg QD, Celecoxib 200 mg BID and Diclofenac 75 mg SR BID in Patients With Ankylosing Spondylitis

Conditions
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Spondylitis, Ankylosing

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of ankylosing spondylitis defined according to modified New York criteria, and with axial involvement Requiring daily treatment with nonsteroidal anti-inflammatory drugs during the previous 30 days Exclusion Criteria: Patients with inflammatory enterophathy, and with extra-articular manifestations Patients with known vertebral compression Received corticosteroids 6 weeks prior to the baseline visit; patients on stable dose of prednisolone equivalents ≤ 10 mg/ day for at least 14 days before randomization were permitted

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: A<br> | Drug: Celecoxib<br>* 200 mg oral capsule once daily for 12 weeks<br>|
| Experimental: B<br> | Drug: Celecoxib<br>* 200 mg oral capsule twice daily for 12 weeks<br>|
| Active Comparator: C<br> | Drug: Diclofenac<br>* 75 mg oral capsule twice daily for 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 global pain intensity as assessed by visual analog scale (VAS) |  | Week 12 | 
| Responder rates, defined as 50% improvement in VAS from baseline |  | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient's and physician's global assessment of disease activity |  | Weeks 1, 2, 6, and 12 | 
| Spinal pain |  | Weeks 1, 2, 6, and 12 | 
| Short Form-12 |  | Weeks 1, 2, 6, and 12 | 
| Adverse events |  | Week 12 | 
| Physical evaluation |  | Week 12 | 
| Laboratory tests |  | Week 12 | 
| Nocturnal pain |  | Weeks 1, 2, 6, and 12 | 
| Composite Bath Ankylosing Spondylitis Disease Activity Index |  | Weeks 1, 2, 6, and 12 | 
| Bath Ankylosing Spondylitis Metrology Index |  | Weeks 1, 2, 6, and 12 | 
| Change from baseline in C-reactive protein measurement |  | Week 12 | 
| Responder rates, defined as 50% improvement in VAS from baseline |  | Weeks 1, 2, and 6 | 
| Mobility parameters |  | Weeks 1, 2, 6, and 12 | 
| Change from baseline in Assessments in Ankylosing Spondylitis 20 score |  | Weeks 1, 2, 6, and 12 | 
| Change from baseline in global pain intensity |  | Weeks 1, 2, and 6 | 
| Bath Ankylosing Spondylitis Functional Index |  | Weeks 1, 2, 6, and 12 |