COX-2 Inhibitor Study In Patients With Rheumatoid Arthritis

Not Applicable

• Conditions: -M06; M06

• Registration Number: PER-022-05
• Lead Sponsor: GLAXOSMITHKLINE PERU S.A.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-06-08
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. The person is an outpatient male or female, not under 18 years of age.
2. The person is trained and willing to give written informed consent.
3. The person can read, understand and memorize information required in the protocol.
4. AR onset in> 16 years of age and duration of symptoms> 12 months.
5. Diagnosis of RA according to the American Rheumatism Association, 1987 criteria.
6. Class I, II or II Functional of AAR.
7. An NSAID or COX-2 inhibitor was needed to treat their RA for at least 5 of the 7 days of each week for the 4 weeks prior to selection.
8. It satisfies all definitions of active disease and criteria of
initial evaluation.

Exclusion Criteria

1. Known history of hypersensitivity or intolerance to NSAIDs, aspirin, COX-2 inhibitors.
2. Any biological or clinical abnormality discovered at the screening visit.
3. History of perforations and / or gastroduodenal obstructions.
4. History of some gastric or duodenal operation.
5. Active gastrointestinal ulceration of the upper gastrointestinal tract within the previous 6 months, bleeding from the upper gastrointestinal tract within the previous year.
6. History of bleeding of the lower gastrointestinal tract within
of the previous year.
7. History of inflammatory digestive diseases.
8. Use of proton pump inhibitors.
9. History of congestive heart failure, coronary instability, stenosis of the renal artery or any of the following: myocardial infarction, angina, stoppage, or transient ischemic attack.
10. Uncontrolled hypertension.
11. Use of a diuretic combination with angiotensin-converting enzyme (AGE) inhibitor or an angiotensin receptor blocker (ARB).
12. Use of anticoagulants (warfarin, heparin) or antiplatelet aggregation agents.
13. Identification of creatinine, bilirubin, alanine aminotransferase (ALAT) or aspartate aminotransferase (ASAT)> 1.5 times the upper limit of normal (LNS).
14. History of clinically significant drug or alcohol abuse.
15. Proven allergic-type reactions to sulfonamides.
16. Participation in another model or drug research study during the previous 3 months.
17. Previous participation in a research study of GW406381.
18. Initiation or change in the dose of a standard disease-modifying antirheumatic drug (DMARD) within 12 months before the initial evaluation.
19. Use of methotrexate at doses of> 20 mg / week or initiation or change of methotrexate dose within 8 weeks before the initial evaluation.
20. Use of targeted anti-cytokine biological therapeutics.
21. Use of therapies for B cells if it is not stable for 6 months
before the selection visit.
22. Use of oral corticosteroids at a dose greater than the equivalent of 10 mg / day prednisolone / prednisone or initiation of corticosteroid therapy within 4 weeks prior to commencement
of the consumption of the study drug.
23. Intra-articular injections within 4 weeks before starting to take the study drug.
24. Start or change to a physiotherapeutic program established within 2 weeks before or during the study period.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:1) Count of Weak / Sore Joints. 2) Swollen Joint Count. 3) EAV pain scale. 3) Global Evaluation of the Condition of Arthritis in the Patient. 4) Global Appraisal of the Investigator on the Condition of Arthritis 5) Index of Functional Disability 6) Abbreviated Form of the McGill Pain Questionnaire 7) C Reactive Protein (CRP) 8) Amount of Supplemental Analgesic Therapy 9) Health Related Results<br>Measure:Efficacy of GW40638<br>Timepoints:Items 1 to 9 (with the exception of 8), will be evaluated on day 1 (initial visit), weeks 2, 4, 8 and 12<br>

Secondary Outcome Measures

Name	Time	Method
<br>Outcome name:1) Questionnaire SF-36v2 2) Questionnaire EQ-5D 3) Impact on the Mood, Questionnaire POMS-B<br>Measure:Quality of life of the patient<br>Timepoints:Day 1 and week 12<br>;<br>Outcome name:Determination of plasma concentrations of GW406381 in a sample of 3 ml<br>Measure:Farmacokinetics of GW40638<br>Timepoints:Weeks 2, 4, 8 y 12<br>