A Study Of PF-04171327 In The Treatment Of The Signs And Symptoms Of Rheumatoid Arthritis
- Conditions
- -M053M053
- Registration Number
- PER-126-09
- Lead Sponsor
- PFIZER S.A.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
• Evidence of an informed consent signed and dated personally indicating that the participant (or his legally accepted representative) has been informed of all relevant aspects of the study.
• Participants who wish or are able to meet scheduled visits, treatment plan, laboratory tests and other study procedures.
• Men and women> 18 years old.
• The participant must have RA (ACR criteria, 1987 revised criteria) with a minimum duration of 3 months and have met 4/7 criteria for the diagnosis of RA.
• The participant must have a minimum disease activity level
• Have observed the following periods of drug rest
• Meet the Revised Criteria of ACR 1991 for the Global Punctual State in RA. Class I, II or III.
• Participants must have been receiving MTX or permitted combination of MTX-DMARD (for example, MTX + hydroxychloroquine or MTX-t-chloroquine) for at least 3 months and must be at a stable dose of MTX for at least 6 weeks (8 weeks for antimalarials) before selection. In addition, the dose of MTX or the permitted combination of DMARD as well as any other concomitant medication will remain unchanged during the treatment period.
• The participant must be receiving MTX at a dose> 7.5 mg weekly (po / sc / im) and ^ 5 mg weekly unless a documented intolerance requires a lower dose. MTX should be administered as a single dose for a minimum of 28 days before randomization. If the proportion of enrolled participants receiving the parenteral formulation (sc or im) exceeds 10% of the total, the sponsor may, at its discretion, limit subsequent enrollment in participants receiving oral MTX.
• For participants with inhaled or chronic topical glucocorticoids, treatment should be stable for> 4 weeks before admission and remain unchanged throughout the 2-week treatment period.
• If you are potentially fertile, you accept that if you have sexual activity, you must use 2 effective contraceptive methods and obey the time frames indicated in the Contraception section of the Lifestyle Guidelines.
• Potentially fertile women should have a negative pregnancy test before enrollment in this study.
• Absence of evidence or history of infection treated improperly or actively or latently with Mycobacterium tuberculosis (TB)
• Diagnosis of other arthritides (inflammatory or non-inflammatory) or chronic pain condition (fibromyalgia, neuropathy) that, in the opinion of the researcher, would interfere with evaluations of disease activity.
• Nephropathy, liver disease, hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiac, severe neurological, progressive or uncontrolled disease; or any other condition that would make the participant unsuitable for the study.
• Any lymphoproliferative disorder, such as Epstein-Barr Virus (EBV), history of lymphoma, leukemia, myeloproliferative disorders, multiple myeloma or signs and symptoms that suggest current lymphatic disease.
• Active TB or treatment currently in progress for active or latent TB.
• Any solid malignant tumor that has been in remission for less than 10 years, excluding participants with basal cell carcinoma! Non-metastatic or squamous cell skin or cervical carcinoma in situ, which are eligible immediately after proper treatment.
• Blood dyscrasias
• Liver transaminase elevations (AST or ALT)> 1.5 ULN, confirmed at the selection visit.
• Participant diagnosed with insulin-dependent diabetes mellitus or poorly controlled non-insulin dependent diabetes mellitus (HgbA1c value> 7.0% [ADA recommendation poorly controlled]).
• Drug addiction or alcoholism with less than 6 months of continuous abstinence before the selection visit.
• Clinically significant infections (those that require hospitalization or require parenteral antimicrobial therapy) within 6 months of the selection visit.
• A body temperature of 38 ^ C or higher at the baseline visit or fever within 14 days before the first dose.
• An infection with the human immunodeficiency virus (HIV) or Hepatitis B or C.
• Any condition that possibly affects the oral absorption of the drug (for example, clinically significant gastrectomy or diabetic gastroenteropathy).
• Significant trauma, blood loss or major surgery (including anesthesia or respiratory assistance within 4 weeks of the selection visit).
• Fracture and / or lack of movement / bone immobilization within 3 months of the selection visit.
• An ECG of 12 standard electrodes demonstrating a QTc> 460 ms for males and QTc> 480 ms for females or another clinically significant abnormality in the selection visit. If the QTc is greater than 460 ms (for men) or 480 ms (for women) the ECG must be repeated two more times and the average of the three QTc values must be used to determine the participant´s eligibility.
• Treatment with an investigational drug within 30 days (or as determined by the local requirement, the longest term) or 5 half-lives before the first dose of the study medication.
• Blood donation of approximately 1 pint (500 mL) within 60 days of the selection visit.
• Participants with a previous or current history of glaucoma or herpetic eye infections.
• Participants known to not respond to glucocorticoids or with a previous history of intolerance or significant adverse effects with glucocorticoid therapy.
• Documented history of peptic ulcer disease within 5 years.
• Participants requiring prohibited concomitant medications listed in Appendix 1. This list includes CYP3A4 inhibitors, CYP3A4 inducers, selected CYP3A4 substrates and / or other medications.
• Participants who are pregnant or breastfeeding.
• Current contact at home with children who have received the va
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:The exploratory analyzes, the differential effects of gender, age, disease duration, severity of the disease and their interaction with the treatment for the primary efficacy variable in the Week 2 analyzes will be examined. Differences between the centers will be examined. of the researcher (or country / region).<br>Measure:DAS28-4 (CRP)<br>Timepoints:14 days<br>
- Secondary Outcome Measures
Name Time Method