Rheumatoid Arthritis MedDRA version: 8.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis
Conditions
Interventions
Product Name: PG-760564
Product Code: PG-760564
Pharmaceutical Form: Capsule*
Current Sponsor code: PG-760564
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
P
Sponsors
Procter & Gamble Pharmaceuticals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who meet all of the following criteria are eligible for participation in the study: a. Men and women, 18 to 75 years of age, inclusive, at screening; b. Who meet ACR criteria for RA, with a documented diagnosis of RA for at least 6 months; c. Whose functional capacity is class I, II, or III according to the revised criteria of the ACR (Appendix 6); d. Who have active disease despite treatment with MTX before washout of any DMARDs other than MTX. Active disease for this study will be defined as follows: - At least 6 swollen joints and 6 tender joints; AND, - At least one of the following 3 criteria must be present: ESR of at least 28 mm/hour Elevated CRP Morning stiffness lasting at least 45 minutes; d. Who have been treated with MTX for at least 24 weeks. The dose of MTX must be stable for at least 8 weeks, at 15-20 mg/week, or at 10 mg/week if that is the maximal tolerated dose, before starting study medication; e. If female, must be (as documented in the patient notes): - Post menopausal (at least 1 year without spontaneous menses), or - Surgically sterile (if by tubal ligation, must have been performed at least 3 months before entry into the study), or - Using acceptable contraception (e.g., oral, intramuscular, or implanted hormonal contraception, intra-uterine device) for at least 3 months prior to randomization and for the duration of the study including the follow-up period, in conjunction with a barrier method (e.g., condom and spermicide, diaphragm and spermicide) for the duration of the study and during the follow-up period; NOTE: All contraception precautions for MTX must be followed. f. If sexually-active male, must be surgically sterile (e.g., non-reversed vasectomy with confirmed azoospermia) or use condom during the study and during the follow-up period; NOTE: All contraception precautions for MTX must be followed. g. Who are willing and able to participate in the study and provide signed informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Active or latent tuberculous infection as defined as: history of tuberculosis (TB) OR Chest X ray suggestive of former or current tuberculous infection OR Positive tuberculin skin test with purified protein derivative of tuberculin (PPD) equal to or more than 5 mm in a patient without history of vaccination with bacillus Calmette-Guérin (BCG) OR In Europe, vaccination with BCG and positive PPD equal to or more than 8 mm OR In Europe, vaccination with BCG and positive PPD equal to or more than 5 mm but =8 mm and any of the following risk factors: silicosis, residents and employees of high-risk congregate settings, weight loss more than10% of ideal body weight, gastrectomy, jejunoileal bypass - Active listeriosis - History of episode of infection requiring hospitalization within 30 days before screening or episode of infection requiring IV antibiotics within 30 days before sceening or current active infection - History of chronic or recurrent infections, or immunodeficiency - Indwelling catheters - Bronchiectasis - History of uveitis or other inflammatory eye disease - Autoimmune diseases other than RA [MCTD, seronegative spondyloarthropathy, SLE, UCTD, psoriatic arthritis, sarcoidosis, etc.], except Sjogren’s syndrome secondary to RA - Chronic liver diseases, serologic evidence for infection with hep B or hep C - History of alcohol or drug abuse - Abnormal hepatic and renal functions; patients with known elevations of transaminases greater than 1.2 times ULN on 2 or more occasions in the 6 months before screening - Platelets 28 days prior to randomisation. - Other diseases requiring immunosuppressive therapy - Treatment with leflunomide within 6 months prior to study entry - Intra-articular or intramuscular steroids within 4 weeks before screening - Change in NSAID and/or corticosteroid doses within 30 days prior to entry into the study (Day 1 of the washout period) - Treatment with any experimental/investigational therapy within the last 2 months for chemical and 6 months (from screening date) for biologic drugs - Use of the following inducers of CYP 3A4 (carbamazepine, phenobarbital, phenytoin, St John's Wort and troglitazone) or inhibitors of CYP 3A4 (diltiazem, fluvoxamine, grape
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effect of PG 760564 on the proportion of patients meeting the American College of Rheumatology 20 response criteria (ACR 20) at 12 weeks;Primary end point(s): To assess the effect of PG 760564 on the proportion of patients meeting the American College of Rheumatology 20 response criteria (ACR 20) at 12 weeks;Secondary Objective: - To assess the effect of PG 760564 on the proportion of patients meeting the ACR 50 and ACR 70 responses at 12 weeks; - To assess the effect of PG 760564 on the change from baseline in 28 joint Disease Activity Score (DAS 28) at 12 weeks; - To assess the effect of PG 760564 on the change from baseline at 12 weeks in the following parameters: Tender joint count Swollen joint count Physician’s global assessment Patient’s global assessment Patient’s assessment of pain Health Assessment Questionnaire (HAQ) score Acute phase reactants [erythrocyte sedimentation rate (ESR) and C reactive protein (CRP)] TNF-alpha, IL-1, and IL-6 Duration of morning stiffness Rheumatoid factor (RF) titer; - To assess the effect of PG-760564 on time to ACR 20. - To assess the safety and tolerability of PG 760564 in patients with RA. - To assess the pharmacokinetics of PG 760564 in patients with RA. | — |
Countries
Czech Republic, Hungary, Netherlands, United Kingdom
Outcome results
None listed