None listed
Conditions
Interventions
GROUP 1 Type of group
Placebo, in capsules, PO, QD for 12 weeks. They will continue with their usual medication against rheumatoid arthritis.
Group name:GROUP 5 Type of group
This group will be treated with PH-797804, in capsules, at a dose of 10 mg, PO, QD for 12 weeks. They will continue with their usual medication against rheumatoid arthritis.
Sponsors
PFIZER S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: 1. Have provided written informed consent and be willing to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. 2. Have an age> 18 years. 3. Having presented a failure to at least 1 DMARD regimen. 4. During the last 6 months prior to the Screening visit, have received a diagnosis of RA based on the Revised Criteria of the American Society of Rheumatology. 5. Under the current treatment regimen, currently maintain a minimum disease activity level characterized by: a) ≥ 6 tender or painful joints to movement. b) ≥ 6 joints inflamed. c) C-reactive protein (CRP) (1 mg / dL (10 mg / L). 6. Complies with the Revised Criteria ACR 1991 for Global Functional Status in AR, Class I, II, or III. 7. The patient has complied with the washing periods if he has been treated with any of the treatments that require one. 8. If the patient is female, she must have met either: a) If she is not potentially fertile, the patient is amenorrheic for at least 2 years, or has had a hysterectomy and / or bilateral oophorectomy at least 8 weeks before screening. OR b) If the potentially fertile patient, must agree to use acceptable contraceptive methods. 9. If the patient is male, he or she must agree to use acceptable contraceptive methods.
Exclusion criteria
Exclusion criteria: 1. A diagnosis of any other inflammatory arthritis or fibromyalgia. 2. A history of: a) Hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological disease severe, progressive, and uncontrolled within 6 months before the first dose. b) Associated significant cardiac disease. c) Chronic or serious or life-threatening infection within 6 months of the first dose. d) Untreated tuberculosis and / or positive tuberculin reaction to PPD without known vaccination with the Bacillus Calmette-Guerin (BCG) vaccine. e) Positive result to T-SPOT ™ .TB. f) Significant trauma or major surgery within 8 weeks of the first dose of study medication. f) Alcohol abuse with less than 6 months of sobriety; drug abuse within 3 years of the start of the study. g) Cancer, which has been in remission for 38 ° C (98.6 ° F). d) Infection with human immunodeficiency virus (HIV) or Hepatitis B or C. e) Any clinically significant active infection. f) Congestive heart failure Class III-IV. g) A confirmed average of the QTc interval in triplicate to the Selection> 450 ms. h) A clinically significant abnormal finding on the ECG. 4. Evidence of organic dysfunction or hematopoietic disorder. 5. Patients who require prohibited concomitant medications. 6. Pregnant or breast-feeding patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Criterion 1: Clinical evaluation of all adverse medical events that arise after starting the study medication. Criterion 2: A standard physical examination will be performed, evaluating all organs and systems. Criterion 3: Hematology and serum chemistry panels, urinalysis, liver function tests. Criteria 4 and 5: For PA, the same PA cuff size should be used, which should be appropriately sized and calibrated correctly. The pulse rate will be measured in the brachial / radial artery for at least 30 seconds. Criterion 6 and 7: 12-lead ECG for 10 minutes. ECGs in triplicate spaced at intervals of 2 to 4 minutes will be performed. Especially evaluating the QTc interval. Measure:Safety: 1) Incidence and severity of adverse events. 2) Incidence and severity of the clinical findings upon physical examination. 3) Incidence and severity of laboratory clinical abnormalities. 4) Average change from baseline in vital signs measurements. 5) Categorical summary of absolute vital signs and changes in vital signs compared to baseline per patient. 6) Change of the average from Basal in the ECG parameters of 12 electrodes. 7) Categorical summary of absolute parameters of the ECG and changes of the ECG compared to baseline per patient. Timepoints:Days 1, 7, 14, 21, 28, 42, 56, 84 and 112. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Plasma concentrations of PH-797804. Measure:Pharmacokinetics. Timepoints:Days 1, 7, 14, 21, 28, 42, 56, 84 and 112. ; Outcome name:Criteria 1, 2, 3, 4 and 5: Clinical evaluation of the affected joints according to the criteria of the American Society of Rheumatology at 20%, 50% and 70% (ACR20 / 50/70). Criterion 6: Visual analog scale of 100 mm (VAS). Criteria 7 and 8: Visual analog scale of 100 mm (VAS), by the patient and the doctor. Criterion 9: The HAQ-DI evaluates the degree of difficulty experienced in 8 categories of daily activities. Criterion 10: CRP levels in peripheral blood. Criterion 11: DAS28-4 (CRP), is calculated using a formula based on: TJC28 (Count of Sensitive Joints - 28), SJC28 (Count of Inflated Joints - 28), In (natural algorithm), CRP and PGA (Global Assessment) of the Arthritis of the Patient) Criterion 12: Evaluation of the time of discontinuation of the disease due to lack of efficacy. Criterion 13: mBPI-SF is a tool for pain assessment used to measure pain intensity and pain interference using a 11-point graduation scale. Criterion 14: The SF-36 health survey is a generic measurement of the health status of 36 items. Measures 8 general concepts of health: physical functioning, physical role, body pain, general health, vitality, social functioning, emotional role, and mental health. Measure:Efficacy: 1) Response rate of the American Society of Rheumatology 20 (ACR20) to Week 12. 2) Response rate ACR20 to Weeks 1,2, 4, 8, and 16. 3) Response rate ACR50 / 70 . 4) Counting of sensitive / painful joints (28). 5) Counting of inflamed joints (28). 6) Evaluation of the Arthritis Pain Patient. 7) Global Evaluation of the Arthritis Patient (VAS). 8) Global Evaluation of the Arthritis Doctor (VAS). 9) Health Assessment Questionnaire - Disability Index (HAQ-DI). 10) C-reactive protein (CRP). 11) Disease Activity Score. 12) Incidence and time to discontinuation due to lack of effectivene | — |
Countries
Australia, Brazil, Chile, Czech Republic, Estonia, India, Korea South, Poland, Russian Federation, South Africa, Spain
Outcome results
None listed