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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A in phase 1 | Active Comparator | Indomethacin 75 mg, extended release capsule twice daily |
|
| Group B in phase 1 | Active Comparator | Indomethacin 25 mg capsule, 2 capsule twice daily |
|
| Group A in phase 2 | Active Comparator | Etoricoxib 90 mg once daily |
|
| Group B in phase 2 | Active Comparator | Etoricoxib 60 mg once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indomethacin SR, 75 Mg Oral Capsule, Extended Release | Drug | Indomethacin SR, 75 Mg Oral Capsule, Extended Release orally twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serum creatinine change | change in serum creatinine >25% from baseline with use of indomethacin and etoricoxib in Axial Spondyloarthritis patients | 3rd week and 24th week |
| Measure | Description | Time Frame |
|---|---|---|
| Bath Ankyiosing Spodylitis Disease Activity Index (BASDAI) | <4 responded to treatment, 4 or more means not responded to treatment | 3rd week and 24th week |
| Ankylosing Spondylitis Disease Activity Score (ASDAS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Khandker Mahbub-Uz-Zaman, MD | Resident | Principal Investigator |
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| Indomethacin 25 Mg Oral Capsule | Drug | Indomethacin 25 Mg Oral Capsule, 2 capsule orally twice daily |
|
|
| Etoricoxib 90 mg | Drug | Etoricoxib 90 mg once daily orally |
|
|
| Etoricoxib 60 mg | Drug | Etoricoxib 60 mg once daily orally |
|
|
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"
| 3rd week and 24th week |
| ID | Term |
|---|---|
| D000089183 | Axial Spondyloarthritis |
| ID | Term |
|---|---|
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D000844 | Ankylosis |
| D007592 | Joint Diseases |
| D001168 | Arthritis |
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| ID | Term |
|---|---|
| D002214 | Capsules |
| D007213 | Indomethacin |
| D000077613 | Etoricoxib |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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