Rheumatoid Arthritis (RA) MedDRA version: 20.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Trade Name: ARCOXIA
Product Name: Etoricoxib
Product Code: MK-0663
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: ETORICOX
Sponsors
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co.,
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient is a male or female = 18 years of age on the day of signing informed consent. 2. Patient understands the study procedures, the alternative treatments available, the risks involved with the study, and voluntarily agrees to participate by giving written informed consent. 3. Patient is able to read, understand and complete study questionnaires, including questions requiring a visual analog scale (VAS) response. 4. Female patients of reproductive potential must demonstrate a serum ß-hCG level consistent with a nongravid state at the prestudy visit and agree to remain abstinent, use oral, barrier, intramuscular, or implanted contraceptives from the prestudy Visit 1 until 28 days after the last dose of study medication. Women who are postmenopausal or have had a hysterectomy or bilateral tubal ligation or bilateral oophorectomy are exempt from this requirement. (Postmenopausal is defined as no menses for the previous 1 year). Note: Serum FSH sample will be obtained only from women with cessation of menses within 1 year prior to Visit 1. If a patient’s Visit 1 FSH result is not within the postmenopausal range (as defined by the central laboratory), serum ß-hCG must be tested. The patient must demonstrate a serum ß-hCG level consistent with a nongravid state at the screening to continue in the study. 5. Patient is willing to limit alcohol intake to 2 drinks or equivalent per day for the duration of the study and follow-up period (one drink is defined as 2 oz. of hard alcohol, 5 oz. of wine, or 12 oz. of beer) and avoid unaccustomed physical activity (e.g., weight lifting) for the duration of the study. 6. Excepting RA, patient is judged to be in otherwise general good health based on medical history, physical examination, and routine laboratory tests. 7. Patient has satisfied (for RA diagnosis) at least 4 of 7 ARA 1987 revised criteria for the diagnosis of RA. 8. Patient is ACR Functional Class I, II, or III. 9. Patient has had a diagnosis of RA made at least 6 months prior to study start and was = 16 years of age when diagnosed. 10. Patient global assessment of disease activity (VAS of 100 mm) at Visit 1 is less than 80 mm. 11. Patient has a history of positive therapeutic benefit with NSAIDs and has taken an NSAID on a regular basis and at a therapeutic dose level (see Appendix 6.1) prior to study enrollment ( basis is defined as greater than 20 of the previous 30 days, including 7 of the last 10 days). 12. Patient’s approved nonstudy antirheumatic therapy has been at stable dosing for the required time periods listed below AND is not anticipated to undergo a change during the study. Similarly, patients must not have discontinued such therapy within the timeframe given below. Abatacept: 6 months; Adalimumab: 6 months; Anakinra: 2 months; Antimalarials: 6 weeks; Azathioprine: 3 months; Certolizumab pegol: 6 months; Cyclosporin A: 3 months; d-Penicillamine: 3 months; Etanercept: 6 months; Gold salts (oral or injectable): 3 months; Golimumab: 6 months; Infliximab: 6 months; Leflunomide: 3 months; Methotrexate: 2 months; Sulfasalazine: 6 weeks; Tocilizumab: 6 months; Note: Treatment with rituximab or epratuzumab is not a
Exclusion criteria
Exclusion criteria: Patients meeting any of the following criteria cannot participate in the study. Previous or Concurrent Diseases 1. Patient is legally incompetent (e.g., a minor or mentally incapacitated), or has active psychosis, or significant emotional problems at the time of the study which in the view of the investigator are sufficient to interfere with the conduct of the study. 2. Patient has a concurrent medical/arthritic disease that could confound or interfere with evaluation of efficacy including, but not limited to: inflammatory arthritis (e.g., systemic lupus erythematosus, spondyloarthropathy, polymyalgia rheumatica), recent acute attacks of gout or pseudogout, Paget’s disease affecting the study joint, a history of septic arthritis or intra-articular fracture of the study joint, osteochondritis desiccans or osteonecrosis of the study joint, Wilson’s disease, hemachromomatosis, ochronosis, or primary osteochondromatosis and inflammatory muscle diseases (e.g. polymyositis, dermatomyositis). 3. Patient has a history of gastric or biliary surgery (including gastric bypass surgery) or small intestine surgery that causes clinical malabsorption. Note: Patients who have had gastric banding are allowed to participate. 4. Patient has an active gastric ulcer or history of inflammatory bowel disease. 5. Patient has established ischemic heart disease, cerebrovascular disease, or peripheral vascular disease. In countries in which the use of selective COX-2 inhibitors has not been contraindicated in patients with these conditions, patients can otherwise participate (with the exception of those patients who have undergone coronary artery bypass graft surgery, angioplasty, or had a cerebrovascular accident or transient ischemic attack within the past 6 months). 6. Patient has class II-IV congestive heart failure (See Appendix 6.5). 7. Patient has uncontrolled hypertension (systolic >160 mm Hg or diastolic > 90 mm Hg) at Visit 1 and/or Visit 2. Investigators are encouraged to maximize blood pressure control according to local guidelines. Note: Local product labeling should be followed. In countries where the use of etoricoxib is contraindicated in patients with blood pressure values that are persistently elevated above 140/90 mm Hg, this definition of uncontrolled hypertension should be used. Note: Patients may be rescreened one time if blood pressure at Visit 1 is outside of the ranges listed above; patients must be excluded if blood pressure at Visit 2 is outside of the ranges listed above. 8. Patient has a history of neoplastic disease; Exceptions: (1) patients with adequately treated basal cell carcinoma or carcinoma in situ of the cervix may participate; (2) patients with other malignancies which have been successfully treated = 5 years prior to screening, where in the judgment of both the investigator and treating physician, appropriate follow-up has revealed no evidence of recurrence from the time of treatment through the time of screening. However, patients with a history of leukemia, lymphoma, malignant melanoma, and myeloproliferative disease are ineligible for the study regardless of the time since treatment, and in
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Objective 1: To compare the effects of etoricoxib 90 mg vs. placebo after 6 weeks of treatment Objective 2: To compare the effects of etoricoxib 60 mg vs. placebo after 6 weeks of treatment in Part I Obejctive 3: To assess the safety and tolerability profile of etoricoxib 60 mg and 90 mg in the treatment of RA ; Secondary Objective: Objective 1: To compare the effects between etoricoxib 90 mg and etoricoxib 60 mg daily after 6 weeks of treatment in Part I Objective 2: To evaluate the incremental benefit in those who are considered nonresponders to etoricoxib 60 mg in Part I, and who subsequently increase their dose to etoricoxib 90 mg in Part II, to those non-responders on etoricoxib 60 mg in Part I who subsequently remain on etoricoxib 60 mg in Part II ; Primary end point(s): The Primary Hypotheses 1 and 2 will be evaluated by comparing etoricoxib (90 mg, 60 mg) to placebo on the proportion of patients achieving the ACR20 Responder Index Criteria and completing Part I, and the time-weighted average change from baseline over the 6 weeks in Part I in Patient Global Assessment of Pain (VAS). An etoricoxib dose (90 mg, 60 mg) will be declared superior to placebo if it demonstrates significantly greater efficacy than placebo in both of these endpoints (alpha= 0.05, 2-sided). | — |
Countries
Austria, Belgium, Czech Republic, Finland, Germany, Lithuania, Slovakia, United Kingdom
Outcome results
None listed