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

Viatris

Status and phase: Completed; Phase 3

Conditions: Ankylosing Spondylitis

Treatments: Drug: Diclofenac SR; Drug: Celecoxib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00762463

A3191348

Details and patient eligibility

About

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).

Enrollment: 240 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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240 participants in 2 patient groups

Celecoxib 200 mg QD

Experimental group

Treatment:

Drug: Celecoxib

Diclofenac SR 75 mg QD

Active Comparator group

Treatment:

Drug: Diclofenac SR