Phase 3 N=240 Randomized Double-blind Treatment

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

Ankylosing Spondylitis

Bottom Line

View on ClinicalTrials.gov: NCT00762463 ↗

Enrolled (actual)

240

Serious AEs

0.0%

Results posted

Aug 2011

Primary outcome: Primary: Change From Baseline in Participant's Assessment of Global Pain Intensity at Week 6 — -23.8; -27.1 mm — p=0.0085

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Celecoxib (Drug); Diclofenac SR (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Primary completion: Jun 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Participant's Assessment of Global Pain Intensity at Week 6	-23.8; -27.1	0.0085 sig
PRIMARY Participant's Assessment of Global Pain Intensity at Baseline	62.9; 63.6	—
SECONDARY Change From Baseline in Participant's Assessment of Global Pain Intensity at Weeks 2 and 4	-18.6; -17.9; -20.7; -23.3	0.7849
SECONDARY Change From Baseline in Participant's Assessment of Global Pain Intensity at Week 12	63.4; 61.1; 63.4; 65.6; -28.4; -30.9	—
SECONDARY Change From Baseline in Participant's Global Assessment of Disease Activity at Weeks 2, 4, and 6	-0.4; -0.4; -0.3; -0.4; -0.3; -0.4	0.8938
SECONDARY Change From Baseline in Participant's Global Assessment of Disease Activity at Week 12	3.1; 3.0; 3.2; 3.2; -0.6; -0.6	—
SECONDARY Change From Baseline in Physician's Global Assessment of Disease Activity at Weeks 2, 4, and 6	-0.4; -0.4; -0.4; -0.5; -0.5; -0.5	0.5945
SECONDARY Change From Baseline in Physician's Global Assessment of Disease Activity at Week 12	3.2; 3.0; 3.2; 3.3; -0.7; -0.5	—
SECONDARY Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Weeks 2, 4, and 6	-0.3; -0.3; -0.4; -0.6; -0.5; -0.8	0.9358
SECONDARY Change From Baseline in BASFI at Week 12	3.4; 3.5; 3.5; 3.5; -0.9; -1.0	—
SECONDARY Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Weeks 2, 4, and 6	-0.8; -0.9; -0.9; -1.1; -1.1; -1.4	0.6335
SECONDARY Change From Baseline in BASDAI at Week 12	4.71; 4.9; 4.7; 4.9; -1.7; -2.1	—
SECONDARY Percentages of Participants Responding to Assessment in Ankylosing Spondylitis (ASAS)-20	23.5; 25.4; 0; 0; 26.7; 31.6	—
SECONDARY Change From Baseline in Nocturnal Pain at Weeks 2, 4, and 6	-12.0; -16.3; -14.5; -17.1; -15.4; -19.4	0.1111
SECONDARY Change From Baseline in Nocturnal Pain at Week 12	52.2; 55.1; 54.5; 61.5; -19.4; -27.5	—
SECONDARY Change From Baseline in Fingertips to Floor Distance at Weeks 2, 4, and 6	-1.6; -1.6; -1.9; -2.2; -2.8; -3.1	0.9641
SECONDARY Change From Baseline in Fingertips to Floor Distance at Week 12	14.8; 17.6; 22.9; 14.6; -3.0; -3.7	—
SECONDARY Change From Baseline in Chest Expansion at Weeks 2, 4, and 6	0.2; 0.3; 0.6; 0.4; 0.7; 0.6	0.8780
SECONDARY Change From Baseline in Chest Expansion at Week 12	3.9; 3.8; 3.6; 3.8; 0.8; 0.8	—
SECONDARY Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 6	-2.5; -1.8	0.7003
SECONDARY Change From Baseline in ESR at Week 12	20.9; 20.8; 22.8; 23.6; -3.5; -1.3	—
SECONDARY Change From Baseline in C-Reactive Protein (CRP) at Week 6	-4.16; -2.72	0.5183
SECONDARY Change From Baseline in CRP at Week 12	18.53; 15.84; 18.80; 21.01; -4.58; -2.99	—
SECONDARY Percentage of Participants With Concomitant Use of Paracetamol	2.5; 0.0	—
SECONDARY Percentage of Days With Concomitant Administration of Paracetamol	0.1; 0.0	—
SECONDARY Paracetamol Tablets Taken Per Day by Participant	0.2; 0.0	—

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).

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00762463). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.