Axial Spondyloarthritis
Conditions
Brief summary
2 Non-steroidal anti-inflammatory drugs (NSAIDs), indomethacin and etoricoxib were prescribed sequentially in Axial Spondyloarthritis patients according to the internationally accepted guidelines to determine serum creatinine change with NSAIDs use.
Detailed description
The study had 2 phases. In phase 1, Patients of axial Spondyloarthritis were randomized into 2 groups; group A and group B. they were put on indomethacin 150 mg/day and indomethacin 100 mg/day respectively and were followed up at 3rd week. Those who had normal serum creatinine and responded with the drug were followed up to 24th week. Those who did not respond were excluded from phase 1 and were enrolled in phase 2. Non-responders of indomethacin 150mg and indomethacin 100 mg were put on etoricoxib 90 mg and etoricoxib 60 mg respectively. Again followed up to 24th week.
Interventions
DRUGIndomethacin SR, 75 Mg Oral Capsule, Extended Release
Indomethacin SR, 75 Mg Oral Capsule, Extended Release orally twice daily
DRUGIndomethacin 25 Mg Oral Capsule
Indomethacin 25 Mg Oral Capsule, 2 capsule orally twice daily
DRUGEtoricoxib 90 mg
Etoricoxib 90 mg once daily orally
DRUGEtoricoxib 60 mg
Etoricoxib 60 mg once daily orally
Sponsors
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* SpA (axial) patients according to Assessment of Spondyloarthritis International Society (ASAS) criteria with BASDAI \> 4
Exclusion criteria
* Inadequate response to therapeutic dose of indomethacin or etoricoxib, taken for at least 2 weeks continuously * Abnormal serum creatinine : serum creatinine \>1.3 mg/dl * Abnormal SGPT: SGPT \> 40 U/L * Hypertension: Systolic blood pressure \> 140 mm Hg and/ or diastolic blood pressure \>90 mm Hg or on anti-hypertensive drug * Dyspepsia or active peptic ulcer disease : upper abdominal discomfort or upper abdominal pain related with food or peptic ulcer disease diagnosed by upper gastrointestinal endoscopy * Diabetes mellitus: abnormal random plasma glucose or diagnosed case of diabetes mellitus * Ischemic heart disease: history of angina or ECG changes suggestive of ischemic heart disease * Active congestive heart failure: pedal edema with tender hepatomegaly with raised JVP or diastolic dysfunction on echocardiography * Asthma: diagnosed case of asthma or rhonchi on chest auscultation * Bleeding problems: having a history of prolonged bleeding * Pregnancy: missed period followed by positive pregnancy test * Simultaneous use with certain medications such as warfarin, phenytoin, cyclosporine, probenecid, lithium, digoxin, ACE inhibitor, thiazide
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum creatinine change | 3rd week and 24th week | change in serum creatinine \>25% from baseline with use of indomethacin and etoricoxib in Axial Spondyloarthritis patients |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bath Ankyiosing Spodylitis Disease Activity Index (BASDAI) | 3rd week and 24th week | \<4 responded to treatment, 4 or more means not responded to treatment |
| Ankylosing Spondylitis Disease Activity Score (ASDAS) | 3rd week and 24th week | ASDAS: \<1.3 between inactive disease and moderate disease activity, \<2.1 between moderate disease activity and high disease activity, and \>3.5 between high disease activity and very high disease activity |
Outcome results
None listed